AMERICAN FRAUD and The Tylenol Murders

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DRUG DIVERSION
 
 
 

 
 

Counterfeit Pills Buy Prison Time

Magazine article by Dixie Farley; FDA Consumer, Vol. 24, December 1990

* A pharmacist in Racine, Wis., noticed that the brand name on some Ovulen-21 tablets was spelled wrong.
 
* A pharmaceutical purchasing agent in Clearwater, Fla., received complaints that Ovulen-21 birth control pills had caused breakthrough bleeding in some users.
 
* A Chicago pharmacist wondered why the price of his latest order of Ovulen-21 was so much cheaper than previous batches.
 

These were the first clues in a two-year FDA investigation that led to exposure of an international drug counterfeiting ring, seizure of some 1.5 million bogus Ovulen-21 tablets, and the longest prison terms ever imposed for violation of the federal Food, Drug, and Cosmetic Act. The case culminated in convictions of seven individuals, including an 11-year prison term for a defendant who went to trial last March, after five postponements and a mistrial, and 24-year prison terms for two others.
 

After receiving reports of the initial problems, G.D. Searle and Company of Skokie, III., the registered manufacturer of Ovulen-21 oral contraceptives, notified FDA's Chicago district office on Oct. 16, 1984, that counterfeit Ovulen-21 tablets were on the market. Analyses of the two drug lots in question showed that the pills were not only counterfeit, but also subpotent, thus providing unreliable contraception.
 

On Oct. 17, the Tennessee and Kentucky State Boards of Pharmacy informed FDA's Nashville office that some complaints had been received from pharmacies in Kentucky and Tennessee. FDA traced sales of the tablets to Interstate Drug Exchange, Inc. (IDE), in Plainview, N.Y. Inspection of IDE by FDA's New York office revealed that the firm had bought the phony Ovulen-21 from Lantor Corp., Miami. IDE recalled the pills from its consignees on Oct. 25, and investigators from FDA's Orlando office inspected Lantor. They learned from Fermin Alfonso, the firm's president, that Lantor also had sold the counterfeit drugs to other New York distributors: Interstate Cigar Company in Westbury and Quality King Distributors, Inc., in Deer Park.
 

Alfonso, however, denied knowing anything about the origin of the pills, claiming a wholesaler in Panama had obtained them for him. He denied knowing about some shipments FDA already had documented.
 

On Nov. 1, Searle initiated a recall of the two suspect drug lots, including authentic tablets. The decision cost the company more than a million dollars but provided immediate notification of the problem to the public and removed the lots from the market.
 

In an interview on Nov. 12, Alfonso mentioned that he had borrowed money for his business from a friend, Beatriz Villalon.

FDA suspected Alfonso and Villalon were involved in counterfeiting the Ovulen-21 because, among other things, Alfonso persisted in trying -- unsuccessfully -- to sell the tablets, even after Searle's announced recall and after FDA had talked with him.
 

Visits to various drug distributors in November by investigators from FDA offices resulted in 13 seizures of the counterfeit drugs at locations in Alabama, California, Florida, Illinois, Kentucky, Mississippi, New York, Rhode Island, Tennessee, Texas, and Washington.

Investigation of some of the seized product led to Gulfcoast Drug Supply, Inc., Miami. From Gulfcoast's president, Robert Pollock, FDA learned about another suspect, Sheldon Harwin.
 

But here the trail cooled. As a result of previous, unrelated charges, Harwin was in prison and refused to talk to FDA.

To try to document the origin of the counterfeit Ovulen-21 and find out other facts, FDA in 1985 and 1986 extended its investigation to foreign countries, enlisted Interpol and the U.S. Customs Service, and visited additional drug distributors and other businesses, including airlines, telephone companies, banks, and printing and packaging firms. Agency investigators interviewed individuals repeatedly and pored over hundreds of documents.
 

Gradually, two conspiracies emerged: The first one began in 1981 and involved imported drugs from Spain; the second began in 1984 with drugs smuggled from Guatemala.
 

One of the leads in FDA's investigation pointed to involvement by Gilbert Yurubi, Alfonso's cousin. FDA questioned Yurubi during 1985 and early in 1986. He agreed to cooperate and provided information that confirmed the first conspiracy. Following other leads, agency investigators in June 1986 visited the manufacturer involved in the second conspiracy.
 

On July 7, 1986, after release from jail, Harwin provided some information, including the name of the Barcelona, Spain, manufacturer, whom FDA interviewed in August.
 

The First Conspiracy
 

In December 1981 at a bank office building in Coral Gables, Fla., Sheldon Harwin and Edward Peterson met with the owner of a Barcelona pharmaceutical company to arrange purchase of oral contraceptives. Within a few weeks, 10,000 cycles of the pills were shipped through Texas to Monterrey, Mexico, from where they could later be smuggled.

 

For help with the smuggling, Peterson contacted a person known as "J.J.," who Peterson believed was a smuggler but actually was an undercover agent for the U.S. Drug Enforcement Administration (DEA). Thinking Peterson was smuggling controlled drugs, the agent agreed to help Peterson, and the pills were smuggled back into Texas in January 1982. (The DEA tape recordings of the conversations between J.J. and Peterson provided early records for FDA's investigation.)

 

with a Hollywood, Fla., firm to print the Ovulen-21 trademark and logo in brown ink on 10,000 blue envelopes. These were outer envelopes; the pills were sealed in one-month cycle blister packs.

Harwin sold the drugs to Gulfcoast Drug Supply for $39,720, splitting the profits with Peterson. This was Peterson's last known participation in the conspiracy.

 

In September 1982, Harwin again met the Barcelona manufacturer in Coral Gables to discuss another shipment. A month later, Harwin asked Fermin Alfonso to help bring the pills into the United States. Alfonso agreed and introduced Harwin to a contact at a commercial airline who could smuggle pills into the United States when they came through the Miami airport en route to Haiti. The plan worked. Harwin received 50,000 cycles in December.

 

Harwin had more "Ovulen" packaging printed and in January 1983 made a deal to sell the entire shipment to Gulfcoast. The pills were delivered to Gulfcoast on Feb. 2. But Gulfcoast's Pollock noticed the pills weren't exactly like Searle's Ovulen-21 and decided they weren't authentic. He telephoned Harwin to cancel the deal and returned the shipment to Harwin at a warehouse in Hollywood, Fla. Pollock retained more than 3,000 cycles, however, which he later sold to a drug distributor--knowing they were counterfeit.

 

Meanwhile, a Florida judge revoked Harwin's previous probation and on March 30 sentenced him to five years in prison for an unrelated offense.

 

Shortly after Harwin was jailed, Alfonso and Beatriz Villalon delivered part of the stored pills to another buyer, a Florida agent for H.L. Moore Drug Exchange of Mellville, N.Y. But Searle was now using white envelopes instead of blue, and the agent noticed the envelopes were the wrong color and decided the pills were counterfeit. Like Pollock, the agent refused delivery but, also like Pollock, didn't notify FDA.

 

During the summer, Villalon and Alfonso approached Gilbert Yurubi and Jacques Behar, a business partner of Yurubi, and persuaded them to invest $40,000 to buy the Barcelona pills from Harwin for a share of the profits. Yurubi paid the $40,000 to Harwin's son, and the Barcelona pills were turned over to Alfonso, Villalon, Behar, and Yurubi.

 

About this same time, Alfonso made arrangements with a Miami printer to have envelopes printed in blue ink on white paper to resemble Searle's new packaging.

 

In October 1983, Alfonso and Villalon delivered 20,250 blister packs to Interstate Drug Exchange for $115,425. Payment was made by wire to bank accounts in Panama City, and on Nov. 28, they delivered another 25,350 packs for $107,000, also wired to a Panama account.

 

The Second Conspiracy

 

In March 1984, Alfonso and Villalon traveled to Guatemala City and met with the owner of a small pharmaceutical laboratory there. The owner refused to make tablets with the name "SEARLE" but did agree to make products imprinted "SEABLE."

 

The conspirators obtained the active ingredients and packaging materials and shipped them to the Guatemalan laboratory, usually using the name Vibe Export Corporation (Villalon's company). They ordered 50,000 cycles in unlabeled packets from the owner, reformulated to reduce by half the tablets' estrogen component and to substitute progesterone hormone for the tablets' other active ingredient, ethynodiol diacetate. In turn, the laboratory supplied 43,267 cycles to a Guatemala City exporter, who sent them to a Panama firm for labeling and subsequent shipment to the United States.

 

In August 1984, Alfonso and Villalon sold 12,000 cycles of the pills to Interstate Cigar Company. In September and early October, under the name Fenix World Trade Corporation, they sold some 22,000 cycles to Quality King Distributors, with delivery through a shipping company in Panama.

 

Over the summer and fall of 1984, Alfonso and Villalon had ordered approximately 319,000 more Ovulen envelopes, visited packaging-machine manufacturers in Florida and New Jersey to look into buying automated equipment (even after they knew FDA was aware of the counterfeiting), and ordered 250,000 envelopes for Demulen, another Searle contraceptive. The two were gearing up for large-scale counterfeiting of additional prescription drugs for U.S. distribution. This never happened.

Justice

 

On Feb. 11, 1987, six defendants were charged in a 29-count indictment in the U.S. District Court for the Southern District of Florida. Due to Harwin's complaints of poor health, his trial was delayed several times until March 1990.

 

A seventh defendant, Pollock, pleaded guilty to one count of distributing a counterfeit drug and cooperated with the government. He received six months' probation and a $7,500 fine.

 

Behar and Yurubi pleaded guilty to one count each of conspiracy and cooperated with the government. Peterson pleaded guilty to one count of conspiracy and a second count of distributing a counterfeit drug. Behar and Yurubi were each given jail terms of 10 months and Peterson, five years. All three have since been released on probation.

 

Alfonso and Villalon pleaded not guilty and waived a jury trial. On July 13, 1987, the judge found them guilty on all 21 counts charged, and they were sentenced the following September to 24 years in prison, which they are currently serving in the Federal Bureau of Prisons.

 

Harwin initially signed a plea bargain and cooperated but withdrew the plea on the eve of the Alfonso-Villalon trial. He was ultimately found guilty on the five counts charged and was sentenced on May 1, 1990, to 11 years in jail. He reported June 1 to prison and must serve at least 48 months before becoming eligible for parole.

 

The press has reported lawsuits over pregnancies allegedly resulting from use of the bogus drugs, but FDA is unaware of any final judgments.

 

As a result of these and other prescription drug smuggling schemes, FDA has stepped up efforts to prevent unauthorized reimportation of prescription drugs. In September 1985, the agency issued an import alert by which prescription drugs returned to the United States are automatically detained at the border until documents are produced to show they originated here. In addition, the U.S. Congress enacted the Prescription Drug Marketing Act of 1987, which bans the reimportation of drugs produced in the United States unless the drug is imported by the person who manufactured it.

 

 

 

 

Shulton reaches $4M settlement in diversion case against 4 firms

 

July 24, 1989

 

WAYNE, N.J. --American Cyanamid Co.'s Shulton Group has reached a $4 million settlement with four supplier companies it charged with illegally obtaining and diverting Shulton products intended for export.

 

The voluntary payments by the four companies--Moore Medical Corp., Interstate Cigar Co., Quality King Distributors and Tereza Merchandising Corp.--close the books on a court battle that began in 1985.

 

In its original lawsuit, Shulton charged the four firms under the Racketeer Influenced and Corrupt Organizations Act (RICO) with a range of deceptive practices allegedly used to obtain and deal in gray-market merchandise in 1981 and 1982. Those practices cost Shulton $5 million in lost revenues, according to the charges.

 

In a statement, Shulton alleged that the firms "used `front' companies, fake shipping documents, deceptive letters of credit and other unlawful acts to obtain and divert Shulton merchandise sold for export."

Prohibitions instituted

 

In addition to the $4 million in total payments, the four defendants are also prohibited from dealing in American Cyanamid products obtained through fraud or other illegal means. A court order by Judge Nicholas Politan of the U.S. District Court in Newark also prohibits Moore Medical and Tereza from dealing in any of the Cyanamid's products without its written consent.

 

As part of the negotiated settlement, Interstate Cigar and Quality King are also restricted from dealing in any Cyanamid merchandise intended for export or made overseas and not intended for U.S. distribution.

 

 

 

 

 

 

Illegal Prescription Drug Diversion

 

Previously, in 1995, the FDA’s OCI’s Los Angeles Field Office (LAFO), initiated numerous investigations of persons and businesses involved in illegal prescription (Rx) drug diversion schemes. As a result of these investigations, the scope and volume of prescription drug diversion activities was identified. The LAFO subsequently established an undercover wholesale company to facilitate the investigation and identification of buyers, sellers and/or brokers involved in the fraudulent diversion of prescription drug products.

 

In April 1995, the LAFO initiated an undercover operation to corroborate intelligence relative to prescription drug diversion activities by the Las Vegas Pharmaceutical Distributors, Inc., (LVPD). LVPD was a secondary pharmaceutical wholesaler, located in Las Vegas, Nevada. Incident to the investigation of LVPD, a second diversion network operated by Health Express, Inc., Las Vegas, Nevada, was also identified as supplying large quantities of diverted prescription drug products to LVPD.

 

This investigation and undercover operation revealed that LVPD utilized commissioned brokers to canvass and recruit closed-door/institutional pharmacies nationwide to purchase millions of dollars worth of prescription drug products at or below wholesale cost. The prescription drugs were purportedly destined for use by nursing homes or other institutionalized patients.

 

The closed door/institutional pharmacy then illegally diverted the products to LVPD for subsequent re-sale to other secondary wholesalers at substantial profits. LVPD was operated by Benjamin Ross, a son-in-law of the Chief Executive Officer of LVPD. An associated wholesale business of LVPD, C.D. Smith, was operated by another son-in-law of the CEO and was utilized by LVPD to “wash” the pedigree (paper trail) of the diverted prescription drug products so as not to reveal the closed-door/institutional pharmacies as the original sources of the drugs.

 

C.D. Smith was purportedly able to legitimately purchase prescription drug products directly from approximately 300 pharmaceutical manufacturers. The direct purchase authority of C.D. Smith enabled LVPD to covertly transfer their illegally purchased products to C.D. Smith and then buy them back. The pedigree only reflected the “legitimate sale” from C.D. Smith to LVPD.

 

Additionally, investigation and undercover contacts disclosed that LVPD had a business relationship with the Bindley Western Drug Company (B/W), San Dimas, California Division, whereby LVPD returned diverted prescription drug products for credit. The Bindley Western Drug Company, home offices in Indianapolis, Indiana, was one of the top ten drug wholesalers in the United States. The undercover operation revealed aggressive “kickback” and diversion schemes with closed-door/institutional pharmacies. These schemes were perpetrated by the San Dimas California Division management team headed by David Brinkley and Steven Wathen.

 

OCI’s undercover operation also corroborated information provided by various confidential sources that the corporate offices of Bindley Western Drug Company had tacit knowledge of and involvement in the illicit prescription drug diversion activities.

 

On April 9, 1997, OCI and the Federal Bureau of Investigation (FBI) served federal search warrants at LVPD and Health Express, Inc. The search warrants resulted in the seizure of thousands of documents and records which led to the identification of additional entities engaged in the illegal diversion activities. Concurrent with the search warrants, numerous federal grand jury subpoenas were served on known closed door/institutional pharmacy sources located throughout the United States who engaged in prescription drug diversion activities with LVPD.

 

Another tangent of the investigation was the identification of a second fraudulent scheme between Lawrence Ray, formerly employed as a District Sales Manager for Fisons Pharmaceutical Corporation, Salt Lake City, Utah, and LVPD. Ray illegally sold to LVPD more than $500,000 worth of prescription drug samples which were intended solely for promotional purposes to physicians.

LVPD falsely categorized the monies paid for the drug samples as “consulting fees” and coached Ray in the proper responses should he be questioned by law enforcement.


On February 4, 2000, Ross was convicted of 18 U.S.C. § 371- Conspiracy to Commit Mail Fraud. LVPD ceased all operations and is now defunct. Ross was sentenced to 6 months home confinement and 3 years formal probation.

 

On February 18 1998, Ray was convicted of 18 U.S.C. § 371- Conspiracy to Transport Stolen Goods in Interstate Commerce; and 21 U.S.C. § 331(t) - Illegal Diversion of Drug Samples. Ray was sentenced to 15 months in federal prison and ordered to pay a criminal fine in the amount of $5,000.

 

On August 28, 2000, Bindley Western Drug Company, Indianapolis, Indiana, was convicted of 18 U.S.C. § 371- Conspiracy to Transport Goods and/or Property Obtained by Fraud. Bindley Western Drug Company was ordered to pay a criminal fine in the amount of $20 million dollars.

On October 5, 1999, Brinkley was convicted of 18 U.S.C. § 371- Conspiracy to Commit Mail Fraud. Brinkley was sentenced to 2 years formal probation.

 

On February 26, 2001, Wathen, was convicted of 18 U.S.C. § 371- Conspiracy to Transport Stolen Goods. Wathen was sentenced to 1 year formal probation and ordered to pay a criminal fine in the amount of $1,000.

Diversion of Pharmaceutical Drugs

OCI’s New York Field Office initiated this investigation in October 1998. Over the course of several years, James Duncan, a Proctor and Gamble representative, diverted and sold pharmaceutical drugs.

 

On January 9, 2002, Duncan was arrested at his residence by the OCI and the Federal Bureau of Investigation. Duncan had previously rejected a plea agreement offered to him by the United States Attorney’s Office, Eastern District of New York.

 

At the time of his arrest, Duncan was found to be in possession of 11 registered handguns that were subsequently seized by the Suffolk County Licensing Bureau. As a condition of his release, Duncan surrendered several rifles, approximately 250,000 rounds of ammunition, and a flak jacket to the Suffolk County Police Department. In addition to small quantities of several types of prescription drugs seized at Duncan’s residence, pursuant to a search warrant, 134 boxes of Prilosec physician samples were seized.

 

On July 23, 2002, Duncan was convicted of 18 U.S.C. § 371- Conspiracy; 21 U.S.C. § 331(t) and § 353(c) (1) - Knowingly and Intentionally Conspiring to Sell and Trade Drug Samples; and 26 U.S.C. § 7206 (1) - Filing a False Tax Return.

 

On February 21, 2003, Duncan was sentenced to 21 months incarceration.

 

 

 

Diversion of Pharmaceuticals 

 

OCI initiated this case based on information from the Wyoming State Board of Pharmacy. The case involves the diversion of pharmaceuticals through Central Pharmacy, Inc., Omaha, Nebraska, Capitol Pharmacies, Inc., Cheyenne, Wyoming, and Casper Care Pharmacy, Inc., Casper, Wyoming. Jonathan M. Rosen owned and operated these closed-door pharmacies with related wholesale companies.

 

On June 3, 1998, the Wyoming State Board of Pharmacy reported possible diversion activities occurring at Casper Care Pharmacy, Inc., and Capitol Pharmacies, Inc. OCI’s investigation revealed that Rosen fraudulently purchased and diverted more than three million dollars worth of pharmaceuticals utilizing these closed-door pharmacies and defrauded drug manufacturers of more than $ 2.1 million dollars.

 

On April 28, 2003, Rosen was convicted of violating Title 18 U.S.C. §§ 1341 and 2 - Mail Fraud and Aiding and Abetting.

On October 24, 2003, Rosen was sentenced to one year and a day federal incarceration, and ordered to pay restitution in the amount of $2,188,536.50.

 
 
 
 
 
 

Alliance Wholesale Distributors/Local Repack Inc./Phil & Kathy’s

Counterfeit Contraceptive Patches

 

On February 4, 2004, the FDA issued a press release warning the public about an Internet site selling contraceptive patches that contained no active ingredient, thereby providing no protection against pregnancy. The website's domain name,  www.rxpharmacy.ws, is registered to American Style Products of New Delhi, India. That firm was also listed in the return address of mail parcels containing the bogus contraceptive patches. The website also sold other products that purported to be versions of FDA-approved drugs. FDA is currently analyzing these other products as well, and has urged consumers to treat any drugs purchased from this firm as being suspect. FDA also sought and obtained the cooperation of the U.S. based Internet service provider (ISP) in discontinuing service to this website.

 

The bogus contraceptive patches were promoted on the website as Ortho Evra transdermal patches, which are FDA approved, and made by Johnson & Johnson’s Ortho-McNeil Pharmaceutical, Inc. subsidiary. Instead of receiving the advertised Ortho Evra patches, customers received patches without the active ingredient necessary to make the patches effective. Moreover, the patches were sent in simple plastic zip-lock bags without identifying materials, lot numbers, expiration dating or any other labeling information needed to safely and effectively use this prescription product.

 

On February 12, 2004, FDA also obtained the cooperation of a U.S. based Internet Service Provider in discontinuing service for three additional foreign Internet sites associated with www.rxpharmacy.ws. The three newly discovered Internet sites involved were  www.usarxstore.com,  www.europeanrxpharmacy.com, and  www.generic.com. These sites also sold other drugs that purported to be the same as FDA-approved drugs, but were in fact from unknown sources and of unknown safety and efficacy.

 

FDA believes these four websites are indicative of the dangers consumers face when they purchase pharmaceuticals off the Internet. The content of each of these websites was written in perfect English, and to the average U.S. consumer, these websites might appear to be of domestic origin. On closer inspection, none of the websites listed a physical address, telephone number or other identifiers. In fact, all four websites appear to be controlled by largely unknown business entities in various parts of the world, which sell questionable and dangerous products to unsuspecting consumers for pure profit motives.

 

FDA’s Office of Criminal Investigation is working with Johnson & Johnson and the Department of Homeland Security's Bureau of Immigration and Customs Enforcement (ICE) to combat illegal/counterfeit drug imports, to include those facilitated by the Internet. These criminal investigations are ongoing.

 

Alliance Wholesale Distributors/Local Repack Inc./Phil & Kathy’s

 

On September 15, 2003, FDA announced the seizure of all drug products labeled in a foreign language and/or labeled as repacked by Phil and Kathy’s, Inc., d.b.a. Alliance Wholesale Distributor and/or Local Repack, Inc. of Richton Park, Ill.

 

FDA acted to prevent these drug products from entering the U.S. drug distribution system because there was no assurance that they were safe or effective. Many of the products received and repackaged at Local Repack were of unknown origin and their storage and handling was unverifiable. Local Repack repeatedly failed to comply with cGMP requirements.

 

FDA inspections conducted after an August 1999 Warning Letter to Local Repack revealed significant and continuing violations. A series of inspections and other recent evidence revealed numerous deficiencies including the failure to properly handle customer complaints, discrepancies surrounding the signatures of quality control employees, records indicating the review and approval of repackaging operations before the operations were completed, incomplete or missing repackaging records, duplicate and inconsistent repackaging records for the same batch, and unreliable receiving and distribution records for drugs.

 

The September seizure followed the July 9, 2003, seizure of more than 4,500 bottles of prescription drugs that were being repackaged by Local Repack stemming from an investigation of counterfeit Lipitor. Many of the products seized in July were marked with expiration dates to permit them to be sold after similar U.S.-approved drugs would have expired. For example, Portuguese-labeled product that Local Repack labeled as Lipitor had expiration dates well beyond the two-year limit that is based on stability studies performed under the new drug application (NDA) approved in the U.S. for Lipitor.

On April 8, 2004, Phil and Kathy’s signed a consent decree agreeing to operate in full compliance with FDA’s regulations. Under the consent decree, Phil and Kathy’s is prohibited from manufacturing, labeling and distributing any article of drug until it meets certain conditions, the most important of which is the FDA’s determination that the firm’s repackaging operations comply with cGMPs. In addition, Phil and Kathy’s agreed not to repackage any foreign-labeled drugs or drugs that are in any manner inconsistent with FDA’s standards for approval.

 

 
 
 
 
 
 
 
 
 

A CASE OF PHARMACEUTICAL DIVERSION

United States of America, Plaintiff-appellee, v. Philip Weinstein "dr. Philip Adamelli", Wilhelmina Harichweinstein, Solomon Richman, A/k/a "sol" A/k/a"silver Fox", Robert "bobby" Falvo,defendants-appellants.united States of America, Plaintiff-appellant, v. Stanley Kowitt, Defendant-appellant

United States Court of Appeals, Eleventh Circuit. - 762 F.2d 1522

June 12, 1985

Philip Weinstein and Wilhelmina Harich Weinstein, pro se.

David R. Mackenzie P.A., Lauderhill, Fla., Harvey M. Stone, New York City, for Falvo.

Drew Neville, B.J. Rothbaum, Jr., Oklahoma City, Okl., Richard H. Dolan, New York City, for Richman.

Fine, Jacobson, Block, Klein, Colan & Simon, P.A., Irwin J. Block, Theodore Klein, Miami, Fla., for Kowitt.

Gloria C. Phares, Washington, D.C., for U.S.

Appeals from the United States District Court for the Southern District of Florida.

Before HILL, FAY and SMITH*, Circuit Judges.

JAMES C. HILL, Circuit Judge:

 

 

 1

This appeal addresses two separate criminal actions joined at trial and consolidated for purposes of oral argument on appeal. For clarity and efficiency we address both actions in one opinion, setting out a separate disposition as to each appellant.

I. INTRODUCTION

2

Appellants herein, Philip Weinstein, Wilhelmina Harich Weinstein,1 Solomon Richman, Robert Falvo, and Stanley Kowitt (hereinafter and collectively, "appellants"), were convicted by jury trial in the United States District Court for the Southern District of Florida of conspiracy in violation of the Racketeer Influenced and Corrupt Organizations Act, 18 U.S.C. Secs. 1961-68 (1982) ("RICO"), and of one or more counts of mail or wire fraud in violation of 18 U.S.C. Secs. 1341-1343 (1982). Each appellant appeals his or her conviction, alleging insufficient evidence to support prosecution under RICO. A number of evidentiary, constitutional, and procedural grounds of error are also raised.

3

The crime which the government sought to prove was a simple one, a conspiracy to defraud pharmaceutical manufacturers by misrepresentations made through use of interstate mail and wire transmissions. The case is complicated, however, by the context in which this crime took place, the so-called diversion market of the American pharmaceutical industry. An understanding of the case therefore requires an understanding of diversion and its role in the marketing of pharmaceuticals in this country.

II. FACTUAL BACKGROUND

4

A. Diversion In the American Pharmaceutical Industry

5

The Robinson Patman Act, 15 U.S.C. Sec. 13 et seq. (1982), prohibits anticompetitive discrimination in the pricing of goods sold for use, consumption or resale within the United States. An exception to the Act allows discriminatory prices for sales to nonprofit organizations. By its terms, the Act does not cover sales of goods for export.

6

In response to the Act, pharmaceutical manufacturers maintain a bifurcated pricing structure. One price is quoted for drugs sold to domestic wholesalers for resale in the United States. A much lower price is quoted for sales to exporters and nonprofit organizations. Pharmaceutical manufacturers thus discount products sold to exporters and nonprofit organizations. In most cases, the pharmaceutical products so sold are exported for resale in foreign countries or are used by nonprofit organizations for charitable purposes. Occasionally, however, exporters or nonprofit organizations may purchase a surplus of pharmaceutical products and later seek to resell that surplus in the domestic market. Because Robinson Patman only prohibits discriminatory pricing with anticompetitive effect, it is contended that it does not apply to such resales; no issue is raised as to that position. Notably, resale under these circumstances is also at a significant advantage. Nonprofit and export organizations can, because of the low price at which they were able to obtain the products, undercut the domestic prices pharmaceutical manufacturers offer on their own goods. This is the diversion market. It is a significant source of supply for many discount pharmacies and hospitals throughout the nation.

7

Understandably, diversion is unpopular with pharmaceutical manufacturers. While there was testimony in this case that in many instances pharmaceutical manufacturers used nonprofit and export organizations as a "dumping-ground" for pharmaceutical products nearing expiration, it was clear that many pharmaceutical houses actively seek to prevent diversion of products sold to export and nonprofit organizations. Some companies, in fact, go so far as to maintain investigators whose sole function is to trace sources of diversion supply.

8

These facts inform our disposition of the case. They are not, however, ultimately material to our decision. The financial motives a pharmaceutical manufacturer may have to favor or disfavor diversion are a matter of company policy. Diversion, whether boon or bane to the pharmaceutical industry, is not contended to be illegal as a matter of federal law.

B. The Conspiracy Scenario

9

While it represents no illegality in itself, the diversion industry clearly presents unique opportunities for the development of fraudulent practices. The appellants, most of whom were established diverters, were convicted of using the interstate mail and wires to misrepresent themselves to pharmaceutical manufacturers as nonprofit or export organizations in order to obtain pharmaceuticals. That mail and wire fraud is the crime with which this appeal is concerned. We turn to the proof put on by the government at trial.

10

In May, 1975, John Berkey, a commodities broker, was authorized to establish an American branch of Opus Christi, a legitimate, nondenominational, charitable organization headquartered in Rome, Italy and dedicated to the distribution of medicines and foodstuffs to developing countries. Berkey registered Opus Christi as a nonprofit corporation in the District of Columbia and opened offices in the Watergate complex. Uneducated in the pharmaceutical business, Berkey contacted David Pollard, another commodities broker, and indicated to Pollard that, through Opus Christi's status as a charitable organization, Berkey would be able to acquire pharmaceutical products at preferential prices. Berkey merely required expertise as to which pharmaceutical products to purchase and at what prices. Pollard, responding to Berkey's request, contacted Philip Weinstein, Peter Fixler, and Lionel Harris, parties whom Pollard felt would be interested in Berkey's proposition because of their acquaintance with the diversion industry. Weinstein, Fixler and Harris, in response to Pollard's information, formed American Medicinal International, Ltd. ("AMI") as an outlet for the sale in the diversion market of pharmaceutical products obtained by Berkey through Opus Christi. Berkey, Pollard, Weinstein, Fixler, and Harris agreed to share the profits of the pharmaceutical diversion among themselves. These events occurred between May and November, 1975.

11

In November, 1975, (then) Wilhelmina Harich joined AMI as a secretary. Over the course of time her involvement with the company apparently increased until she became Weinstein's de facto partner.

12

At trial, the government sought to prove that, beginning in July, 1975, Berkey, at the behest of AMI, began soliciting pharmaceutical products from manufacturers, purportedly on behalf of Opus Christi. He sent a form letter through the mail to approximately twenty companies and represented that Opus Christi, a charitable organization, would export all merchandise obtained from manufacturers and that this merchandise was to be used in the charitable undertakings of the organization. Upon certain of the manufacturers' further inquiries about the nature of the charity, Berkey provided, via the U.S. mail, misrepresentative documentation about Opus Christi America.

13

At approximately the same point in time, Lionel Harris, one of the principals of AMI, introduced Peter Fixler and Philip Weinstein to Stanley Kowitt, an established diverter of pharmaceutical products in southern Florida. At that time Mr. Kowitt owned and operated American Drug Brokers, later renamed Majestic Sales, Inc. Mr. Kowitt would soon come to purchase the substantial majority of all pharmaceuticals diverted through Opus Christi to AMI.

14

The government sought to prove at trial that, once these entities and characters were in place, Kowitt would place an order with AMI directing delivery of pharmaceutical products be made to Majestic Sales. David Pollard would then telex or mail this information to John Berkey. Additionally, the order information would be typed onto an AMI purchase order and sent to Berkey. Berkey would then prepare an Opus Christi purchase order for the benefit of the manufacturer and direct that the manufacturer deliver the merchandise to a specified warehouse. The merchandise would then be shipped by truck or air to Florida, either to Weinstein at AMI or directly to Kowitt at Majestic Sales. Payment for these transactions was demanded upon delivery by the manufacturers. Initially, the principals of AMI advanced money to Berkey who, prior to delivery, paid the manufacturer. Upon delivery of the merchandise to Majestic Sales, Kowitt would issue a check to AMI which would be deposited immediately. Weinstein would withdraw cash sufficient to pay Berkey and Pollard their respective shares and Pollard or Weinstein would then fly to Washington to deliver Berkey's share. Later cash flow contributions were obtained from another appellant, Robert Falvo, in return for 25% of Berkey's share in Opus Christi. Falvo also subsequently obtained 50% of Pollard's income from Berkey as remuneration for similar financing.

15

By the end of 1975, Pollard and Fixler had dropped out of the diversion scheme. As a consequence, the operation was simplified. Kowitt would transmit Majestic Sales purchase orders directly to AMI. AMI and the Weinsteins dealt with Berkey at Opus Christi, who in turn dealt with the manufacturers.

16

In early 1976, certain manufacturers became aware that merchandise supplied to Opus Christi was appearing in the domestic market. In response to a perceived reluctance on the part of these manufacturers to deal with Opus Christi, John Berkey arranged to do business with a second charitable organization, Inter-Church Medical Assistance ("IMA"). Like Opus Christi, IMA was a well-known and well-regarded umbrella organization acting on behalf of protestant churches in the solicitation of pharmaceutical supplies and the distribution of those supplies to sponsored medical missions in developing nations. Berkey began to use IMA as a purchasing agent on behalf of Opus Christi. With this advent, the purchases were made through purchase orders by Majestic Sales and AMI to Opus Christi. Opus Christi then sent its purchase orders to IMA. IMA in turn prepared purchase orders for the manufacturers. This procedure continued until pharmaceutical companies began to make inquiries at IMA about pharmaceutical products purchased by IMA for Opus Christi which were later returned for refund to the manufacturers from merchants in the United States.

17

In June, 1976, a new charitable organization, the Church of God World Missions, Inc. ("Church of God"), was established with offices and a warehouse in Alexandria, Virginia. The government sought to prove that Church of God was a continuation of Opus Christi under a new name. The Church of God warehouse was rented by Opus Christi; the solicitation letters bearing the Church of God logo were Opus Christi letters that Berkey and assistants altered by changing names and enclosing different brochures; furthermore, the day-to-day business of the Church of God was handled by the Weinsteins at AMI. The organization set up a Church of God checking account, drawn on a Virginia bank, which was maintained by AMI. Evidence establishes that Philip Weinstein conducted the Church of God activities, and in doing so adopted the name "Dr. Philip Adamelli."

18

Contemporaneously with these activities, David Pollard became acquainted with Solomon Richman, a business associate of Robert Falvo. It was Falvo's opinion that Richman, who was the director of a Brussels company, S.P.R.L. GABAR ("GABAR"), would be well suited to handle distribution of pharmaceuticals acquired through Opus Christi. Subsequently, GABAR was used as an export front in continuation of the diversion scheme. Weinstein, on behalf of GABAR, would solicit merchandise from pharmaceutical companies at export prices for sale overseas. Weinstein referred to GABAR as an "associate firm" of AMI. In February, 1977, one of the manufacturers with whom Opus Christi and the other charitable organizations had dealt, Wyeth Company, notified Richman and GABAR that it would not complete GABAR's order because products shipped to GABAR for sale in Zaire had been found in the United States. Richman assured Wyeth that sales made to GABAR were legitimately for resale in Zaire. In March, 1977, Richman visited AMI in Miami and inspected Philip Weinstein's operation. In June, 1977, Richman authored a letter to Weinstein complaining of Weinstein's indiscretion in conducting the diversion enterprise.

19

This synopsis of evidence at trial establishes the nature of the conspiracy sought to be proved by the government. John Berkey, purportedly acting under the auspices of legitimate charitable organizations, would obtain pharmaceutical products at preferential prices. Through the medium of AMI and Philip Weinstein, Wilhelmina Weinstein (nee Wilhelmina Harich), Peter Fixler and Lionel Harris, these pharmaceutical products would be diverted for resale in the United States. Financing for this arrangement came initially from the principals of AMI and, at a later time, from Robert Falvo. The ultimate domestic resale was accomplished through Majestic Sales and Stanley Kowitt, or through GABAR and Solomon Richman. Interstate mails and wires were used to commit fraud upon manufacturers in furtherance of this conspiracy.

C. Procedural Background

20

A superseding seven-count indictment was filed in the Southern District of Florida charging all appellants with conspiracy to violate RICO, and one or more overt acts of wire fraud or mail fraud supporting the conspiracy charge. Trial by jury was held in the Southern District of Florida before Judge Norman Roettger, Jr. The trial lasted approximately one month and generated a transcript over 4,000 pages in length. Appellants Philip Weinstein, Solomon Richman and Robert Falvo were each sentenced to imprisonment for six years and a $25,000 fine. Appellant Stanley Kowitt was sentenced to imprisonment for five years and a $25,000 fine. Appellant Wilhelmina Harich Weinstein was sentenced to imprisonment for three years. All appellants appeal their convictions alleging a total of 32 grounds of error.3 For ease of reference we have grouped these claims thematically. Part III of this opinion examines the validity of the evidence at trial. Part IV addresses the sufficiency of the evidence as to each appellant. Part V examines claimed errors in the indictment. Part VI considers issues of misjoinder and severance. Part VII examines claimed prosecutorial misconduct. Part VIII summarizes our holding in this case.

III. THE VALIDITY OF THE EVIDENCE

A. Fourth Amendment Challenges

21

Appellants Philip Weinstein and Stanley Kowitt challenge the validity of the evidence offered against them on the basis of claimed fourth amendment violations in FBI searches of their respective places of business. We examine these claims as to each appellant.

22

1. Philip Weinstein.

23

On July 13, 1977, FBI agents executed a search warrant at the premises of American Medicinal Corporation ("AMC") in Ft. Lauderdale, Florida. Pursuant to this search warrant numerous corporate documents were seized. Moreover, information obtained during the July 13 search led to a subsequent search warrant executed at AMC offices on July 18, 1977. Documents seized from both searches were introduced at trial. The appellant Philip Weinstein filed pretrial motions to suppress evidence obtained through both searches. During evidentiary hearings on these motions the district court ruled, and the government conceded, that the defendant had legal standing to raise the issue of fourth amendment violations. We assume that this is so.

24

After evidentiary hearings, the district court denied the motions to suppress in all respects. The district court later denied a renewed motion to suppress and a consequent motion for judgment of acquittal or a new trial on this ground.

25

Appellant Philip Weinstein's attack on the validity of this evidence is two-fold. He argues, first, that the warrant executed on July 13, 1977 was impermissibly overbroad in light of the probable cause shown in support of that warrant. Alternatively, he argues the July 13, 1977 warrant was insufficiently particular. We will address both claims.

26

a. Overbreadth

27

Attached to the July 13, 1977 warrant and incorporated therein by reference was an Exhibit A listing 28 individuals, companies, and organizations thought by the FBI to be involved in the pharmaceutical fraud scheme. Included in this list of individuals and organizations were Philip Weinstein and his companies, AMI and AMC, Robert Falvo, Wilhelmina Harich Weinstein, Stanley Kowitt, Solomon Richman and his company, GABAR, and the purportedly charitable organizations of Opus Christi America, IMA and Church of God World Missions, Inc. Exhibit A also noted the types of documents which were thought to be material to the investigation: correspondence, invoices, cancelled checks, check stubs, address books, diaries, and other documents typically used in a business organization. Also attached to the warrant was an affidavit by FBI agent Claude Roberts reciting the operative facts upon which a conclusion of probable cause was sought. The affidavit set forth in detail the scope and operation of the pharmaceutical fraud scheme. The affidavit did not, however, make mention of the role of GABAR or Solomon Richman in that scheme.

28

On the basis of these facts the appellant Philip Weinstein argues that, because the affidavit did not mention GABAR or Solomon Richman, the magistrate could not conclude probable cause existed as to these entities. Because Exhibit A to the warrant did authorize the seizure of documents pertaining to Richman and GABAR, however, the warrant is alleged to be overbroad.

29

As noted previously, the FBI entered the AMC premises to peruse documents authorized by the magistrate's warrant. The warrant and Exhibit A appended thereto gave clear indication that correspondence addressed to Solomon Richman or GABAR was within the scope of probable cause shown. We believe seizure of a document so apparently within the scope of the warrant would be made in good faith, hence valid. United States v. Leon, --- U.S. ----, 104 S.Ct. 3405, 3421-23, 82 L.Ed.2d 677 (1984).

30

In the instant case, however, we are presented with an officer exercising the utmost of good faith. Entering the AMC premises on July 13, warrant and affidavit in hand, the agent viewed the GABAR file and concluded that, because the affidavit did not recite facts about Solomon Richman or GABAR (even though the exhibit to the warrant did), the content of the file might be beyond probable cause shown. Appellant Philip Weinstein urges that the good faith exception is inapplicable here because, by refusing to seize the GABAR file during the first search, the agent, an experienced member of the FBI, manifested his awareness that he did not have probable cause as to Richman or GABAR. We reject this argument. By declining to seize the GABAR file during the initial search, the agent showed careful respect for the judicial limitations upon his authority to search. We approve such caution, and refuse to allow what is clearly a good faith attempt to abide the fourth amendment's mandate to become, through judicial interpretation, the indicium of bad faith. Assuming arguendo that the warrant authorizing the initial search of AMC premises was overbroad, we nevertheless hold that documents viewed during the course of that search and seized during the course of a second, need not be excluded. They were obtained in good faith reliance upon the warrant. United States v. Leon, --- U.S. at ----, 104 S.Ct. at 3423 (1984).

 

31

b. Particularity

32

Appellant Philip Weinstein also argues that the initial search warrant was insufficiently particular and invalid. Consequently the second search warrant obtained as a fruit of the first was also invalid. The warrant in question authorized the FBI to search the premises of American Medicinal Corporation for property identified in Exhibit A, attached to the warrant and expressly incorporated within it. The warrant stated that the property sought was

33

relevant and material to alleged violations of the mail fraud statute (Title 18 U.S.C. Sec. 1341), the wire fraud statute (Title 18 U.S.C. Sec. 1343) and Racketeer Influenced Corrupt [sic] Organizations statute (Title 18, U.S.C. Sections 1961 to 1968 inclusive) committed in the Southern District of Florida and elsewhere....

34

Exhibit A identified the property sought as:

35

[c]orrespondence, invoices, cancelled checks, check stubs, telegrams, bills of lading, warehouse receipts, bank statements, ledgers, work papers, purchase orders, telephone toll records, address books, daily diaries, calendars, customer lists, autodexes, intracorporate and intercorporate memoranda, and credit card statements pertaining to the following individuals, business firms, and/or purported charities: ...

36

Exhibit A then set out twenty-eight individuals, business firms, and purported charities which were suspected of involvement in the pharmaceutical fraud scheme.

37

Clearly, an affidavit incorporated into a warrant by express reference and attached to and accompanying the warrant can cure ambiguity in the warrant itself. United States v. Wuagneux, 683 F.2d 1343, 1351 n. 6 (11th Cir.1982), cert. denied, --- U.S. ----, 104 S.Ct. 69, 78 L.Ed.2d 83 (1983); United States v. Haydel, 649 F.2d 1152, 1154-58 (5th Cir.), corrected, 664 F.2d 84 (5th Cir.1981), cert. denied, 455 U.S. 1022, 102 S.Ct. 1721, 72 L.Ed.2d 140 (1982). The affidavit of FBI agent Roberts, attached to the warrant, set out the scope and operation of the pharmaceutical fraud scheme thought to be operated by, inter alia, AMC, AMI and Philip Weinstein. Included within that affidavit were the dates during which the scheme was believed to have operated. Moreover, the agents conducting the challenged searches were briefed about the investigation; the agent who investigated the case was available to answer questions. On the basis of this showing we believe that the warrant, both as issued and as executed, was sufficiently particular in scope to pass muster under the fourth amendment.4 As the initial warrant was valid, so the second warrant, issued on the basis of probable cause ascertained during the initial search, was likewise valid.

38

2. Stanley Kowitt.

39

As with Philip Weinstein and AMC, the FBI twice searched the offices of Majestic Sales, the business of the appellant Stanley Kowitt. Appellant Kowitt disputes the admission of evidence seized in these searches because the description of the premises contained in the warrants was, he asserts, legally insufficient. Majestic Sales was in the southwest, not the northwest corner of the building as indicated in the warrant. This discrepancy, appellant Kowitt claims, left to the searching officers a degree of discretion not countenanced by the Constitution. We disagree.

40

As we stated in Haydel, "[a] warrant's description of the place to be searched need not meet technical requirements nor have the specificity sought by conveyancers. It need only describe the place to be searched with sufficient particularity to direct the searcher, to confine his examination to the place described, and to advise those being searched of his authority." 649 F.2d at 1157. See also Steele v. United States No. 1, 267 U.S. 498, 503, 45 S.Ct. 414, 416, 69 L.Ed. 757 (1925); United States v. Prout, 526 F.2d 380, 386-88 (5th Cir.), cert. denied, 429 U.S. 840, 97 S.Ct. 114, 50 L.Ed.2d 109 (1976); United States v. Gitcho, 601 F.2d 369, 371-72 (8th Cir.), cert. denied, 444 U.S. 871, 100 S.Ct. 148, 62 L.Ed.2d 96 (1979); United States v. Campanile, 516 F.2d 288, 291 (2d Cir.1975). An erroneous description of premises to be searched is not necessarily fatal to the validity of a warrant. United States v. Melancon, 462 F.2d 82, 94 (5th Cir.), cert. denied, 409 U.S. 1038, 93 S.Ct. 516, 34 L.Ed.2d 487 (1972). The fourth amendment requires merely that the search warrant describe the premises in such a way that the searching officer may "with reasonable effort ascertain and identify the place intended." Steele, 267 U.S. at 503, 45 S.Ct. at 416 (1925).

41

The evidence demonstrated that there were two unconnected offices on the west side of the building housing Majestic Sales. One of those offices was occupied by Majestic Sales, the other by an automobile supply firm. Each office had a separate door on the west side of the building. The agent conducting the searches testified that he had been to the premises before and that he had had no doubt which door gave access to Majestic Sales. Furthermore, when the agents arrived at the Majestic Sales office, their knock was unanswered. They inquired to no avail in the automobile supply firm for information about disconnecting the burglar alarm at Majestic Sales. They then called the burglar alarm company to disconnect the alarm and a locksmith to open the door.

42

We hold that under the circumstances presented here the warrants' erroneous designation of the wrong corner of the building did not invalidate the warrants or the searches conducted pursuant to them. Steele, 267 U.S. at 503, 45 S.Ct. at 416; Prout, 526 F.2d at 386-88; United States v. Darensbourg, 520 F.2d 985, 986-88 (5th Cir.1975); Melancon, 462 F.2d at 94.

43

As a preface to their arguments against sufficiency of the evidence, all appellants raise a number of issues concerning the district court's rulings on the admissibility of evidence. We address these contentions here.

44

1. Erroneous exclusion of defense evidence.

45

A recurring theme in the briefs and arguments of all appellants is that the district court incorrectly excluded evidence concerning the nature of the appellant's activities in the context of the pharmaceutical market. Through one fashion or another, this evidence was calculated to show that the antitrust laws of the United States relieved the appellants of criminal responsibility and that evidence of the operation of these laws was material to the defense. Two arguments are made.

46

Appellants first argue that the pricing scheme avoided by their misrepresentations was itself illegal under antitrust law. Avoidance of an illegal scheme is not a crime, they urge, and thus, because they did not believe their misrepresentations to have been criminal, scienter was absent and a finding of fraud precluded. We find this argument untenable. The merits of manufacturers' claims of right to sell drugs domestically at uniform prices is immaterial to the issue of fraud. If defendants doubted the legality of that practice their recourse would have been through antitrust action, not through a scheme of misrepresentations communicated through U.S. mails and wires.

47

Secondly, appellants argue that their misrepresentations were not material because the manufacturers were aware appellants did not really represent charitable or export interests. Without materiality, they point out, there could be no fraud. This argument, too, cannot stand. The district court, while he excluded evidence on the antitrust laws, allowed considerable evidence on the operation and the legitimacy of the American diversion industry, including defendants' allegation that some manufacturers "wink" at representations of nonprofit or export status in order to use the diversion market as a "dumping-ground" for drugs nearing expiration. Thus the issue of materiality was framed for the jury, and in finding fraud they determined that issue.

48

a. Telexes in support of wire fraud counts.

49

Philip Weinstein and Wilhelmina Harich Weinstein argue that a purported telex in support of Count V (wire fraud) was improperly admitted because there was no evidence that the telex was actually transmitted.

50

Identification and admissibility of evidence is within the discretion of the trial court. Bury v. Marietta Dodge, 692 F.2d 1335, 1338 (11th Cir.1982); Meadows and Walker Drilling Co. v. Phillips Petroleum Co., 417 F.2d 378, 382 (5th Cir.1969). Moreover, letters and presumably telegrams are prima facie authentic if their content is responsive to prior properly admitted communications. 3 Wharton's Criminal Evidence Sec. 525 (1973); 5 J. Weinstein and Burger, Weinstein's Evidence paragraphs 901(b)(4) and (1983).

51

The telexes in question were responsive to a June 9, 1977 letter from Solomon Richman to Philip Weinstein. The admission of the June 9 letter is not disputed. The evidence is therefore sufficient to support a finding that the telex in question is what the government claims it to be. Fed.R.Evid. 901(a). Additionally, we hold that the content of the telexes evidence use of interstate communications facilities. See United States v. Goss, 650 F.2d 1336, 1343 (5th Cir. Unit A 1981).

52

b. The GABAR envelope.

53

More problematical is the appellant Wilhelmina Weinstein's argument that the government failed to authenticate an envelope attached to the government's Exhibit 230. Government's Exhibit 230 is a copy of a letter dated June 9, 1977 from Richman and GABAR in Belgium addressed to the AMC offices of Philip Weinstein in Ft. Lauderdale, Florida. The June 9th letter summarized the sales and purchases between GABAR and AMC from November, 1976, to February, 1977. The letter also voiced concern about the appearance of pharmaceutical products diverted through AMC on the pharmaceutical diversion market and the pharmaceutical manufacturers' awareness of these appearances. The letter also set out proposed conditions for continued business between GABAR and AMC. The June 9 letter was seized by the FBI at the AMC offices pursuant to the second warrant executed on July 18, 1977. The letter was identified at trial by the FBI officer in charge of the investigation. Counsel for Wilhelmina Weinstein objected to the connection of the letter and envelope at the close of the government's case. The court reserved ruling on the envelope's admissibility until further evidence was received.

54

The June 9th letter was addressed to Philip Weinstein. Attached to the letter at trial was an envelope, postmarked June 21, 1977, Brussels, addressed to Wilhelmina Weinstein at her residence. The envelope was evidently seized at the same time and place as the letter. Wilhelmina Weinstein does not contest the content of the letter, but argues that the envelope which connects her to that content was not part of the original exhibit, and was improperly admitted because it was not independently authenticated. At the close of all evidence in the case she moved for judgment of acquittal or new trial on this ground, pointing out that there was no testimony whatsoever as to the envelope. The government responded that the envelope was at all times attached to the letter and that, as early as the grand jury investigation, the document was described as "a letter addressed to Ms. Wilma Harich postmarked June 21, 1977, at Brussels, Belgium." Moreover, the government now argues that certain remarks of appellants' counsel at a pretrial hearing indicate their awareness that an envelope was attached to the letter. The district court permitted the envelope to remain stapled to the government's exhibit and denied without opinion the defendant's motion for judgment of acquittal or new trial on this issue.6

55

In our careful review of this record we have been unable to find (and counsel for the government has been unable to point out) any evidence linking the envelope addressed to Wilhelmina Harich Weinstein to the letter addressed to Philip Weinstein. Indeed the only connection between these two documents which the evidence in this case supports is the fact that the letter and the envelope were stapled together at the time of their production before the grand jury. If this letter were sent in the envelope at issue, the defense of the appellant Wilhelmina Harich Weinstein would have been substantially impaired. One claiming to be a non-participating bystander would be hard put to explain the receipt of such a conspiratorial writing. The acceptance of the letter and the envelope into evidence as one exhibit, stapled together, with no testimony or other evidence linking the two documents, was error and prejudicial to Wilhelmina Weinstein's defense. The harm accruing from this error being unquestionable, the conviction of appellant Wilhelmina Weinstein must be vacated and the case against her remanded for a new trial.

56

3. Admissibility of Coconspirator Hearsay.

57

The appellant Solomon Richman argues that hearsay statements, by alleged coconspirators, admitted against him at trial were inadmissible under Fed.R.Evid. 801(d)(2)(E) because they were not statements made during the course and in furtherance of a conspiracy. Appellant Richman argues there was insubstantial independent evidence to support the admission of the hearsay statements of the appellant's alleged coconspirators. United States v. Alvarez, 696 F.2d 1307, 1310 (11th Cir.), cert. denied, 461 U.S. 907, 103 S.Ct. 1878, 76 L.Ed.2d 809 (1983); United States v. James, 590 F.2d 575, 578-81 (5th Cir.), (en banc), cert. denied, 442 U.S. 917, 99 S.Ct. 2836, 61 L.Ed.2d 283 (1979).

58

In James our predecessor court held that a trial judge must determine admissibility of coconspirator hearsay based upon substantial and independent evidence (a) that a conspiracy existed, (b) that the defendant and the declarant both were members of the conspiracy, and (c) that the hearsay statements sought to be admitted were made in furtherance of the conspiracy. James, 590 F.2d 578-81. Moreover, even if the requirements of James are not met and coconspirator hearsay is improperly admitted, that admission may nevertheless be harmless error. United States v. Phillips, 664 F.2d 971, 1026-27 (5th Cir. Unit B 1981), cert. denied, 457 U.S. 1136, 102 S.Ct. 2965, 73 L.Ed.2d 1354 (1982).

59

The hearsay testimony of which the appellant Richman principally complains came in through testimony by Boudewijn Van Pamelen7 about statements made to him by Wilhelmina Weinstein. This testimony was generally to the effect that Van Pamelen met (then) Wilhelmina Harich in Germany in 1974 and that she accompanied him to the United States. Van Pamelen testified that during the time Wilhelmina Harich Weinstein cohabited with him she told him that pharmaceutical products were transferred from the Church of God to third parties and eventually to the GABAR corporation for resale in the United States.

60

The government urges that there was sufficient proof of a conspiracy under James to establish the admissibility of these coconspirator hearsay statements. Alternatively, the government argues that any error in admitting the alleged hearsay was harmless because testimony so allowed was cumulative. See e.g., United States v. Means, 695 F.2d 811 (5th Cir.1983).

61

The June 9th letter from Richman to Philip Weinstein links Richman to Weinstein, hence to the conspiracy and Wilhelmina Weinstein, the declarant of Van Pamelen's testimony. However, we note that the statements of which the appellant Richman principally complains are not, on their face, in furtherance of the conspiracy. As such, the central requirement of James would appear to be unsatisfied in the instant case.

62

We need not decide that question, however, because the statements at issue are, in our view, cumulative. At least in a nonconstitutional sense, therefore, see e.g., Kotteakos v. United States, 328 U.S. 750, 764-65, 66 S.Ct. 1239, 1247-48, 90 L.Ed. 1557 (1946), any error from their admission must be deemed harmless. Means, 695 F.2d at 818; Phillips, 664 F.2d at 1027, n. 84. Additionally, although appellant Richman does not expressly raise the point, we note that it is still an open question in this circuit whether erroneous admission of coconspirator hearsay may constitute a violation of the constitutional right to confrontation of witnesses. We need not now decide that issue because the evidence presented in the admissible June 9, 1977 letter from Richman to Philip Weinstein was overwhelmingly probative of guilt. It is our view that the cumulative admission of potentially erroneous hearsay statements linking Solomon Richman to the conspiracy at issue were, beyond a reasonable doubt, not determinative of the outcome of this trial as to the appellant Richman. Accordingly, any constitutional error in the admission of these statements was harmless in a constitutional sense as well. Chapman v. California, 386 U.S. 18, 24, 87 S.Ct. 824, 828, 17 L.Ed.2d 705 (1967).

63

We come then to the heart of this case, the sufficiency of the evidence as to RICO conspiracy and underlying overt acts as to each appellant. In order to make this evaluation we must examine, first, the elements of the charged offenses, RICO conspiracy and the essential predicate acts thereto.

64

Count One of the superseding indictment charged all appellants with conspiracy to violate the RICO statute. Fifty-seven overt acts were alleged to have been committed in furtherance of that conspiracy. Count II charged Philip Weinstein with wire fraud. Count III charged Philip Weinstein and Wilhelmina Harich Weinstein with mail fraud. Count IV charged Solomon Richman and Philip Weinstein with wire fraud. Count V charged Solomon Richman, Philip Weinstein and Wilhelmina Harich Weinstein with wire fraud. Counts VI and VII charged Solomon Richman and Philip Weinstein with wire fraud. Counts VIII through XIII of the indictment charged income tax evasion against various appellants herein.

65

Proof of a RICO conspiracy charge puts upon the government the burden to show beyond a reasonable doubt that each appellant herein objectively manifested an agreement to participate, directly or indirectly, in acts violating the substantive provisions of RICO. A substantive violation of RICO requires proof of the following elements:

66

(1) The existence of an enterprise which affects interstate or foreign commerce, (2) that the defendant 'associated with' the enterprise; (3) that the defendant participated in the conduct of the enterprises' affairs; and (4) that the participation was through a pattern of racketeering activity, [that is that the defendant committed] at least two acts of racketeering activity designated in 18 U.S.C. Sec. 1961(1).

67

Phillips, 664 F.2d at 1011.

68

Breaking this definition into its component parts, we examine first the meaning of a RICO enterprise within the meaning of the statute. In United States v. Turkette, 452 U.S. 576, 101 S.Ct. 2524, 69 L.Ed.2d 246 (1981), the Supreme Court held that the existence of an enterprise "is proved by evidence of an ongoing organization, formal or informal, and by evidence that the various associates function as a continuing unit." Id. at 583, 101 S.Ct. at 2528. Turkette left intact this circuit's holding in United States v. Elliott, 571 F.2d 880 (5th Cir.), cert. denied, 439 U.S. 953, 99 S.Ct. 349, 58 L.Ed.2d 344 (1978). United States v. Cagnina, 697 F.2d 915, 921 (11th Cir.), cert. denied, --- U.S. ----, 104 S.Ct. 175, 78 L.Ed.2d 157 (1983) ("Turkette does not prevent this court from adhering to Elliot [Elliott]."). Elliott made it clear that the definitive factor in determining the existence of a RICO enterprise was an association of individuals, however loose or informal, which furnishes a vehicle for the commission of two or more predicate crimes (the pattern of racketeering activity requisite to the RICO violation). Elliott, 571 F.2d at 898. In United States v. Hewes, 729 F.2d 1302 (11th Cir.1984), we held "that a RICO enterprise exists where a group of persons associates, formally or informally, with the purpose of conducting illegal activity." Hewes, 729 F.2d at 1311.

69

A pattern of racketeering activity is defined in the statute as

70

[A]t least two acts of racketeering activity, one of which occurred after the effective date of this chapter and the last of which occurred within ten years (excluding any period of imprisonment) after the commission of a prior act of racketeering activity.

71

18 U.S.C. Sec. 1961(5). Racketeering activity is in turn identified in 18 U.S.C. Sec. 1961(1) as being various acts, the commission of which constitute violations of federal or state law. Proof of RICO conspiracy requires proof of an agreement to violate a substantive RICO provision. United States v. Carter, 721 F.2d 1514, 1528 (11th Cir.1984), cert. denied, --- U.S. ----, 105 S.Ct. 89, 83 L.Ed.2d 36 (1984).

72

With these principles in mind we review the evidence in this case to determine whether the requisite showing of conspiracy to violate a substantive RICO provision was made. In doing so we inquire whether, viewed most favorably to the government, Glasser v. United States, 315 U.S. 60, 80, 62 S.Ct. 457, 469, 86 L.Ed. 680 (1942); Hewes, 729 F.2d at 1320 (11th Cir.1984), the evidence would permit a reasonable trier of fact to conclude that the defendant is guilty beyond a reasonable doubt. United States v. Bell, 678 F.2d 547, 549 (5th Cir. Unit B 1982) (en banc), aff'd, 462 U.S. 356, 103 S.Ct. 2398, 76 L.Ed.2d 638 (1983). We review the evidence as to each appellant.

73

The appellant Wilhelmina Weinstein argues that the evidence demonstrated merely that she was a secretary for the operations of AMI, AMC and Philip Weinstein, that she made no decisions of policy, and that she at no time agreed to conspire to violate RICO. We have carefully reviewed the evidence of Wilhelmina Weinstein's participation in the conspiracy and conclude that it was sufficient to make out a question of fact on that issue. However, we have held the envelope portion of government's Exhibit 230, the GABAR letter of June 9, 1977, to have been improperly admitted into evidence and to have been prejudicial. Because we vacate Wilhelmina Weinstein's conviction on this ground, we decline to review further her claims as to sufficiency of the evidence.

74

In order to make out its case against appellant Kowitt, the government bears the burden of proving beyond a reasonable doubt that he knew, actually or constructively, that the pharmaceutical products he obtained were acquired through misrepresentations to the manufacturers. In reviewing the sufficiency of the evidence as to this showing we must take care, under the peculiar facts of this case, to ascertain whether the jury was allowed to draw improper inferences of fraud from the peculiar and necessarily clandestine practices of the diversion industry. Diversion itself is not contended to be illegal. Evidence that Kowitt removed labels from the pharmaceuticals he obtained from his suppliers proves no crime. Evidence that Kowitt requested certain pharmaceutical products for which he had a ready market and from which he could make a quick profit, evidence that Kowitt demanded goods packaged in English, evidence that Kowitt tendered payment upon delivery for pharmaceutical goods--none of these facts are probative of guilt. At most, this evidence serves as a basis only for the inference that Stanley Kowitt was an exacting customer of an entity which he may or may not have known to be committing fraud.

75

Upon an exhaustive review of this 4,000 plus page record, we conclude that the essential evidence supporting the jury's finding that Stanley Kowitt participated knowingly in a scheme involving fraudulent misrepresentation was the conversation testified to by Peter Fixler which took place between Fixler and Kowitt. In this conversation Stanley Kowitt told Peter Fixler "make sure whoever was buying the pharmaceuticals that they tell the pharmaceutical company that ... birth control pills were not going to countries that did not allow them, so maybe Spain or the Roman Catholic countries. That would make the pharmaceutical companies wise." The question for our determination is thus whether this evidence is enough. We hold that it is.

76

While we have evaluated the evidence in this case as required by Glasser, supra, we have nevertheless scrutinized the evidence pointing to Kowitt's participation in RICO and underlying counts with particular care lest evidence of disapproved business practices be confused with evidence of the crimes charged. Kowitt and his codefendants were not charged with conducting business in a fashion disapproved by pharmaceutical manufacturers. They were charged with violating RICO through mail and wire fraud, federal crimes. Neither federal attorneys nor courts may be used to assist business houses in policing their requirements for product distribution. However, the fact that Kowitt and his coappellants were admittedly distributing the obtained products through diversion contrary to the wishes of the pharmaceutical manufacturers provided a sufficient and strong motive for the commission of fraud. It is the duty of the court to make certain defendants were not convicted merely because they did that which was disapproved, while yet admitting evidence of disapproval as a motive for the fraud alleged. Our critical review of the evidence in this case and of the trial judge's instruction to the jury has satisfied us that the district court was aware of this potential confusion. We believe that his instructions properly directed the jury's attention to the requirement of law that the government prove mail and wire fraud above and beyond participation in disapproved marketing practices.

77

There was abundant proof that fraudulent misrepresentations to pharmaceutical manufacturers furthered Kowitt's interests. Evidence therefore established Kowitt's motive for fraud. Moreover, Fixler's testimony established that Kowitt counselled his suppliers as to the content of their fraudulent misrepresentations. This evidence proved Kowitt's participation in fraud. We hold the evidence against Kowitt sufficient to sustain his conviction.

78

C. Appellants Philip Weinstein, Solomon Richman, and Robert

79

Falvo

80

Our review of the record in this case reveals ample evidence upon which a rational trier of fact could conclude that the appellants Philip Weinstein, Solomon Richman, and Robert Falvo agreed to participate and participated in a conspiracy in violation of RICO. Sufficient evidence therefore exists as to each of these.V. ERRORS IN THE INDICTMENT

81

1. Count II.

82

Count II of the indictment charged mail fraud. Of the appellants in this case, only Philip Weinstein was named in that count. However, the trial court charged the jury on Count II not only against Philip Weinstein, but also against Robert Falvo, Stanley Kowitt, Solomon Richman, and Wilhelmina Weinstein. We vacate the judgments of conviction on Count II as to the appellants Wilhelmina Weinstein, Robert Falvo, Stanley Kowitt and Solomon Richman.

83

2. Fifth amendment violation.

84

The appellant Wilhelmina Weinstein argues that the jury's improper consideration of her guilt as to the Count II mail fraud charge resulted in a misconstruction of the indictment, effecting a material amendment to the indictment requiring reversal of her conviction on all remaining counts in this case. She relies upon Stirone v. United States, 361 U.S. 212, 80 S.Ct. 270, 4 L.Ed.2d 252 (1960), as authority for this result. In light of our disposition of Wilhelmina Weinstein's conviction, we are not required to reach this issue. In the interest of clarity on remand, however, we address it briefly.

85

It is well established that "the erroneous amendment of one count does not destroy other counts of the indictment nor invalidate the judgment of conviction thereon ... in the absence of a showing of prejudice." C. Wright, Federal Practice and Procedure: Crim.2d Sec. 127 n. 16 and accompanying text (citing Chow Bing Kew v. United States, 248 F.2d 466 (9th Cir.), cert. denied, 355 U.S. 889, 78 S.Ct. 259, 2 L.Ed.2d 188 (1957); Carney v. United States, 163 F.2d 784 (9th Cir.), cert. denied, 332 U.S. 824, 68 S.Ct. 165, 92 L.Ed. 400 (1947)). Thus, while it is clear that the conviction of appellant Wilhelmina Weinstein on the improperly amended Count II must be vacated, see e.g. United States v. Fischetti, 450 F.2d 34 (5th Cir.1971), cert. denied, 405 U.S. 1016, 92 S.Ct. 1290, 31 L.Ed.2d 478 (1972); C. Wright, supra, section 127 n. 1 (and accompanying text), there is no basis in law for the proposition that this improper amendment on Count II affected the validity of the remaining convictions under other counts of the indictment. VI. MISJOINDER AND SEVERANCE

86

The appellant Philip Weinstein argues that failure to grant a severance of his prosecution from the trial of his codefendants violated his sixth amendment right to cross-examine a substantial government witness as to credibility and veracity on the required elements of the charged offense. He urges reversal on this ground, relying on United States v. Lindstrom, 698 F.2d 1154, 1163-64 (11th Cir.1983); and United States v. Callahan, 551 F.2d 733, 737 (1977), aff'd after remand, 579 F.2d 398 (6th Cir.1978).

87

The witness appellant Weinstein wanted to cross-examine was David Pollard. Early in the trial the court excluded testimony adduced by the government from Pollard that Robert Falvo and Frank Dante, an associate of Robert Falvo, were attempting to extort a share of the profits derived from the pharmaceutical diversion enterprise from the other participants in that scheme. The gravamen of Philip Weinstein's contention is that he should have been allowed to cross-examine Pollard (a) to impeach his testimony, and (b) to dispel any impression that Weinstein voluntarily aided extortion attempts. He argues that, by denying his motion to sever or for a mistrial on this issue made during the cross-examination of Pollard, the district court denied him the opportunity to cross-examine Pollard on these points and thus worked a deprivation of sixth amendment right.

88

The government answers Philip Weinstein's claim on this issue by noting that his proffered ground for severance at trial was that he sought further examination of Pollard to show that Pollard was himself part of the alleged extortion attempt instigated by Frank Dante and Robert Falvo. This testimony would have gone to Pollard's credibility. Robert Falvo's attorney pointed out to the trial court that the court's prohibition of evidence on extortion prevented this line of inquiry. Under these circumstances the district court observed that it could perceive no obvious prejudice to Weinstein from the limitation of cross-examination on Pollard's testimony as to extortion. Philip Weinstein's trial counsel specifically denied that it was the defense theory Weinstein was a victim of Falvo. Thus, the government urges that the district court's limitation of testimony as to extortion was a reasonable measure against prejudice. That limitation did not bar Weinstein from putting on his defense, but simply disallowed him from showing to the jury that Pollard was himself a part of the scheme he (Pollard) depicted and thus a less credible witness.

89

To overturn a district court's denial of severance under Fed.R.Crim.P. 14, the defendant must demonstrate clear and compelling prejudice. United States v. Sans, 731 F.2d 1521, 1533 (11th Cir.1984); Hewes, 729 F.2d at 1319; United States v. Cannington, 729 F.2d 702, 710 (11th Cir.1984). We hold that no such clear and compelling prejudice has been shown.

90

The appellant Solomon Richman argues he was misjoined in violation of Fed.R.Crim.P. 8(b) and that the trial court's denial of his motion to sever was prejudicial and is a ground for reversal of his conviction.

91

Rule 8(b) provides for the joinder of two or more defendants in the same indictment if it is alleged that they participated in the same criminal transaction upon which the prosecution is brought. It is Richman's position that, because it is not alleged he participated in the activities of Opus Christi or the Church of God, the indictment failed to show the substantial identity of facts or participants necessary for proper joinder under Rule 8(b). Richman relies upon United States v. Sutherland, 656 F.2d 1181 (5th Cir.1981), cert. denied, 455 U.S. 949, 102 S.Ct. 1451, 71 L.Ed.2d 663 (1982); and United States v. Bledsoe, 674 F.2d 647 (8th Cir.), cert. denied, 459 U.S. 1040, 103 S.Ct. 456, 74 L.Ed.2d 608 (1982). The government argues that, taken as a whole, the indictment charged the appellants with a single enterprise operated for the purpose of obtaining pharmaceutical products through false pretenses. The common thread linking Richman to this attempt was his alleged participation in the scheme to obtain preferential pharmaceutical prices by fraud. These allegations are mirrored in the RICO conspiracy indictments. The government relies upon United States v. Hewes, 729 F.2d 1302 (11th Cir.1984), and United States v. Phillips, 688 F.2d 52 (8th Cir.1982).

92

As we view this issue, it merely restates the appellant Richman's underlying and repeated contention that there existed no evidence linking him to a conspiracy to defraud pharmaceutical manufacturers. Because we hold the evidence sufficient to sustain a conspiracy indictment and conviction against appellant Richman, there is necessarily a "sufficient common link" to demonstrate the existence of a common scheme or plan. As such, Rule 8(b) is satisfied. See United States v. Kopituk, 690 F.2d 1289, 1313-14 (11th Cir.1982), cert. denied, 461 U.S. 928, 103 S.Ct. 2089, 77 L.Ed.2d 300 (1983).

93

The appellants Wilhelmina and Philip Weinstein and appellant Robert Falvo argue that remarks made by the prosecutor and government witnesses were improper and prejudicial and should have resulted in a dismissal of the indictment or, alternatively, a mistrial.

94

The appellant Falvo contends that the prosecutor deliberately and repeatedly attempted to interject evidence of extortion into the trial proceedings. The district court, although it warned the prosecutor against this conduct, denied a motion for mistrial on this ground. Four instances of alleged prosecutorial misconduct are urged. In opening, the prosecutor referred to one of the characters in the alleged conspiracy as a "strong man." The trial judge cautioned the prosecutor against such characterizations. The court also offered to give an instruction to the jury but none was sought. The government argues, that at the time these statements were made, the district court had not yet determined to exclude all evidence of extortion. As such, the government argues it should not be charged with knowing that the phrase "strong man" was an improper characterization.

95

As a second ground of alleged error, the prosecutor included in his closing argument reference to appellant Falvo as being the person "pulling the strings." This comment was the subject of the trial judge's reprimand before the jury to the prosecutor for making an argument from material stricken from the jury's consideration. The judge instructed the jury "to disregard any evidence or any comment on testimony about Mr. Falvo pulling strings."

96

A third ground of error is urged as testimony from one of the government's witnesses that Frank Dante "looked like a person out of the Untouchables, like [a] Frank Nitty-type character." Here, also, the district court instructed the jury to "disregard the last answer. Stereotypes are not evidence, and you are to disregard them entirely."

97

Finally, another government witness testified that, in a meeting about their business relationships, Robert Falvo used foul language and made strong statements about the witness's wife. There was no curative instruction on this testimony. A motion for mistrial, apparently on the basis of this testimony was denied.

98

The appellants Philip and Wilhelmina Weinstein revisit these same instances of alleged improper remarks by the prosecutor. In essence they urge the district court's determination that the inferences of Mafia activities and extortion which arose from the impermissible testimony were so damaging that the trial court abused discretion in refusing to grant a mistrial.

99

Reversal on the basis of prosecutorial misconduct requires that the misconduct be "so pronounced and persistent that it permeates the entire atmosphere of the trial." United States v. Alanis, 611 F.2d 123, 126 (5th Cir.), cert. denied, 445 U.S. 955, 100 S.Ct. 1607, 63 L.Ed.2d 791 (1980), (quoting United States v. Blevins, 555 F.2d 1236 (5th Cir.1977), cert. denied, 434 U.S. 1016, 98 S.Ct. 733, 54 L.Ed.2d 761 (1978)). See also United States v. Newbern, 731 F.2d 744, 754 (11th Cir.1984). Moreover, a prejudicial remark may be rendered harmless by curative instructions to the jury. United States v. Nickerson, 669 F.2d 1016, 1020 (5th Cir. Unit B 1982); United States v. Lichenstein, 610 F.2d 1272, 1282 (5th Cir.), cert. denied, 447 U.S. 907, 100 S.Ct. 2991, 64 L.Ed.2d 856 (1980). Finally, considerable weight must be given to the trial court's assessment of the prejudicial effect of the remarks in question. Nickerson, 669 F.2d at 1020; Blevins, 555 F.2d at 1240.

100

While we emphatically disapprove the remarks made by the prosecutor in this case, we believe that the trial court provided an opportunity to cure any potential prejudice in three of the four instances to which appellants allude. The fourth instance was, in our view, harmless. We are also mindful that we evaluate these allegedly improper remarks in the context of a four week trial; we believe the trial judge, whose vantage was superior to ours, to have correctly concluded the allegedly improper remarks were not so pronounced and persistent as to permeate the entire atmosphere of the trial. We therefore hold the trial judge correctly denied motions for mistrial on the basis of improper prosecutorial remarks.

101

Robert Falvo argues the district court erred in denying his motion to dismiss the indictment on the basis of an unconscionable delay in prosecution. He alleges prejudice to his defense accruing from the death of an associate of Falvo's, Frank Dante, between 1979 and the date of prosecution. A government prosecutor testified at a pretrial hearing in his case that the government was ready to indict Falvo as early as 1979. The five-year statute of limitations, 18 U.S.C. Sec. 3282 (1982), had not expired at the time this prosecution was commenced.

102

Statutes of limitations provide the primary guarantee against stale criminal charges. United States v. Lovasco, 431 U.S. 783, 789, 97 S.Ct. 2044, 2048, 52 L.Ed.2d 752 (1977); United States v. Marion, 404 U.S. 307, 317-19, 92 S.Ct. 455, 462-63, 30 L.Ed.2d 468 (1971); United States v. Hendricks, 661 F.2d 38, 38-39 (5th Cir.1981). Additionally, to succeed on a motion for dismissal of an indictment based upon unconscionable delay a defendant must demonstrate both a substantial prejudice to his right of a fair trial and an intentional delay on the part of the government made in order to gain tactical advantage over the accused. Tiemens v. United States, 724 F.2d 928, 929 (11th Cir.1984). As we have observed, "this standard is an exceedingly high one...." Id. We hold that Falvo has demonstrated neither that the government delayed for tactical advantage, nor that he sustained sufficient prejudice to overcome the high standard upon which we review his claims. Accordingly, the judgment of the district court as to prosecutorial misconduct by unconscionable delay is affirmed.

103

In summary, in case number 83-5260 we hold that the convictions of Wilhelmina Weinstein, Solomon Richman, and Robert Falvo, are VACATED as to Count II of the indictment charging wire fraud. The conviction of Wilhelmina Weinstein is VACATED as to all remaining counts. In all other respects the judgment in 83-5260 is AFFIRMED.

104

In case number 83-5570 the conviction of Stanley Kowitt is VACATED as to Count II of the indictment charging wire fraud. In all other respects the judgment in 83-5570 is AFFIRMED.


1

Wilhelmina Harich Weinstein is the wife of Philip Weinstein. Because the counts with which this action is concerned commenced prior to that marriage, during part of the time at issue here she was known as Wilhelmina or Wilma Harich. Unless otherwise noted in text, she will be referred to herein as Wilhelmina Weinstein or Wilhelmina Harich Weinstein

 
 
 
 
 
 
Fraud Case Exposes Corruption Encouraged by Drug Pricing Politics
 

By Jim Edwards | January 15th, 2009 @ 3:53 am

 

Roche has emerged as both victim and enabler in a big corruption case whose basis was the arcane pricing policies of U.S. drugs. In the case, two brothers who ran a medical supplies company were sentenced to nine years in prison for skimming contracts and avoiding taxes.

 

They had contracts with Roche, Johnson & Johnson and Wyeth to take drugs and supply them to hospitals. However, because drug companies charge different prices in different countries, the brothers were able to divert cheap pills bound for Puerto Rico and sell them to U.S. pharmacies, keeping the markup (and ripping off Roche).

 

The price differences exist because drug companies have lobbied for them. Consumer advocates want the U.S. ban on importating drugs ended so that drug prices will be forced into international price competition.

 

The Miami Herald has done a wonderful job of detailing the case. Rather than summarize it, I’ve digested it here with a focus on drug pricing and the role of Roche, J&J and Wyeth. It’s an eye-opener.

 

In August 2004, Roche Healthcare abruptly stopped using Pharmed, resulting in the company losing $300 million in annual revenue. Roche gave no explanation for its move, but in recent court testimony it was revealed that a Roche audit discovered the brothers had been engaging in a complex plot that used Roche supplies in violation of their contract.

 

About the same time, Pharmed’s original supplier, Johnson & Johnson, also ended its relationship with the brothers, accusing them of ”unjust enrichment” in collecting $22 million in rebates to which they were not entitled.

 

Assistant U.S. Attorney Stephen Schlessinger told Judge Seitz that in 1999, Roche agreed to let Pharmed distribute its supplies, but only outside the United States.

 

The cost of the drugs was low because Roche, like most companies, sells its drugs considerably cheaper in other countries, either because those countries have rigid price controls or because consumers in poor countries can’t afford U.S. prices. One example: The highly popular Lipitor, a Pfizer product which fights cholesterol, costs $392 at Drugstore.com for 90 40mg tablets in the United States, but can be had for $138 in India and $199 in Europe.

 

In the Roche case, Pharmed honored the contract by shipping the drugs to a warehouse in Puerto Rico, a major distribution spot for goods going to the Caribbean and Latin America. But the Roche supplies didn’t wind up there. Instead, they were forwarded to a Pharmed warehouse in Delaware, where they were resold to American customers at U.S. prices, allowing Pharmed a huge profit and ‘’systematically violating its contract” with Roche, the prosecutor said.

 

Meanwhile, both prosecutors and defense attorneys agree, the brothers were skimming 2.5 percent of all the money received from Roche and transferring it to three dummy corporations for “marketing expenses.”

 

Their plan unraveled in 2004, after a Texas company that had bought Roche drugs through Pharmed told Roche it wanted to return some of the supplies — confirming that Pharmed’s Roche products were ending up in the United States. Roche auditors visited Pharmed and verified the diversion. Roche immediately ended its relationship with Pharmed, which caused a loss of $300 million in annual revenue.

 

Roche had never even filed a civil lawsuit against Pharmed.

 

Kainen [the brothers' attorney] suggested in court that Roche may have avoided airing the matter in public because it would reveal that it was ”gouging the American public” by charging high prices for drugs.

 

What’s more, Kainen said the brothers had told him that a Roche national sales manager knew all about the drug diversion. Roche went along with the scheme because at the end of each month or each quarter it needed to move supplies that were nearing their expiration date, and ”Pharmed was always willing to take the product,” the defense attorney said.

 

It was only after a ”corporate culture change” at Roche that the company decided not to permit such contract abuses, the defense attorney told the judge.

 

Roche’s director of public affairs, Darien E. Wilson, responded in an e-mail: “The defense attorney statements regarding Roche are absolutely and categorically false. It is important to note that Roche cooperated fully with and supported the IRS for several years in its investigation into Pharmed. We also cooperated with the U.S. attorney’s office, providing complete information.”

 

Ultimately, no criminal charges were filed against the brothers in the Roche drug diversion.

 

… the gray market maneuvering is something that has come up several times before with Pharmed, which collapsed in bankruptcy in October 2007 after losing its contracts with Roche and Johnson & Johnson.

 

Back in 1987, Wyeth Pharmaceuticals sued the brothers for using shell companies to improperly obtain drug discounts. That case was settled out of court. In 1999, AmerisourceBergen, a large medical supply wholesaler, sued Pharmed, accusing the company of setting up a shell company and warehouse a few miles from its main facility for the purpose of obtaining improper discounts. That case, too, was settled for an undisclosed amount.

 

In the fraud against Kendall Regional Medical Center, the scheme at first had co-conspirators in the hospital submitting orders to Pharmed only for J&J products — products that the hospital paid for but were never delivered.

 

Why focus on J&J since the transactions were utterly fictitious? Because Pharmed received rebates from J&J for goods sold to hospitals. Eventually, J&J decided something was wrong. It accused Pharmed of taking $22 million in rebates that it was not entitled to. That case was settled in arbitration. The results are not known.

 
 
 
 
 
 
Soaring rise, rapid fall for Pharmed
 
Before its spectacular collapse, Pharmed Group was one of the great South Florida success stories, a medical supply company created by two brothers who started with nothing and built the eighth-largest Hispanic-owned business in America. In 2003, their profit was $48 million.
 

What happened to this once fabulous company, where brothers Carlos and Jorge de Céspedes often showed up for work in a Ferrari, Bentley or Porsche? How could it have crumbled so quickly?

 

Court documents show that in its last two years, Pharmed lost a huge amount of business after a major supplier and a major customer accused the company or its executives of shady business practices in civil lawsuits.

 

In the 1980s, the company faced similar accusations, according to a government investigator, a former Pharmed manager and a civil lawsuit. In the 1990s, a major supplier of the company accused Pharmed in a civil lawsuit of fraud and violating accepted business practices. Twice, Pharmed or its executives have been involved in criminal investigations.

 

The de Céspedes brothers insist that they have done nothing wrong. In fact, three of the lawsuits containing the most serious allegations were settled out of court for undisclosed terms. A fourth is still open, involving a Pharmed executive, but not the brothers themselves. The subject matter of that lawsuit is also under criminal investigation.

 

For more than a quarter century, the company operated in the highly competitive world of medical supply distribution, where firms buy products from manufacturers and sell to hospitals, doctors and pharmacies. It's a field where many companies have been accused of questionable pricing practices -- and Pharmed was no exception.

 

Most people, however, knew the highly visible brothers more for their personal charm and extravagant lifestyle.

 

LIVING THE LIFESTYLE

 

They often showed up in matching Bentleys at Chispa, their restaurant in Coral Gables. The basketball arena at Florida International University is named for Pharmed. Carlos is vice president of the Cuban American National Foundation. They bought a stake in the Charlotte Bobcats basketball team. They have frequently given inspiring speeches at business gatherings -- talking about how they started out as virtual orphans in Pedro Pan camps during the 1960s exodus from Cuba of unaccompanied children.

Within the industry, however, they have a different reputation.

 

As far back as the mid-1980s, says C. Richard "Rick" Allen, now deputy director of the Georgia Drugs and Narcotics Agency and then an agent, the brothers were under investigation concerning charges of defrauding drug manufacturers by obtaining supplies at low prices under false pretenses. The investigation died when the feds abruptly stopped a national investigation called Pharmoney.

 

In the 1990s, AmerisourceBergen Drug alleged in a civil lawsuit that Pharmed committed fraud. The case was settled out of court.

 

In 2006, Johnson & Johnson accused Pharmed of fraudulently taking $22 million in rebates. That case went to arbitration; the results have not been made public.

 

Last year, the HCA hospital chain filed a civil lawsuit, accusing a Pharmed executive of bribing hospital workers in a "scheme" that an HCA lawyer said went "all the way to the top" of the Pharmed organization, according to a court transcript.

 

The brothers' response: "This is totally untrue. We would not suggest that because Kendall Regional employees were involved in a scheme that it goes all the way to the top of HCA management."

 

The issues in the HCA suit are also being reviewed in a federal criminal investigation.

 

BROTHERS' STATEMENTS

 

The brothers did not respond directly to a detailed list of questions for this report, but they issued two statements about the company, of which they are the sole owners:

 

They attributed their bankruptcy to "a combination of factors: Overall changes in the healthcare economy. Changes in the industry model for our sector that squeezed out suppliers that were neither giant organizations nor tiny . . . niche players. . . . The loss of some very important customers."

 

About the accusations in the lawsuits: "We are a litigious society, but in our 27 years of operation prior to the bankruptcy, in our dealings with well over 1,000 vendors, we have been party to just a handful of civil suits, where were settled to our satisfaction. I am curious to know how many times The Miami Herald has been sued in the past 27 years."

 

In a separate e-mail, Carlos de Céspedes wrote, "My brother and I are tremendously proud of what we have been able to accomplish in Miami. Weve built a number of successful businesses that have employed many hundreds of people, paid a lot of taxes and supported a great many important community causes. . . .

 

"As to the various old legal and employee disputes about which you have inquired, " he wrote, "we would say simply that every business has its share of disputes and complications. Some of the matters you asked about had nothing to do with us or Pharmed.

"We have successfully resolved matters involving us and are disappointed The Herald would dredge them up simply to portray us in an unflattering light. You do not have sufficient information to understand most of these matters, and we are not going to comment on them in deference to the others involved."

 

The story of one of the area's most successful families is a distinctly South Florida saga involving two recurring themes -- the success of ambitious Cuban immigrants and an even older one, the collapse of once-great businesses into bankruptcy, a trend that started with real-estate firms of the 1920s.

 

"It was a rag-to-riches story, " says Miguel De Grandy, a lobbyist for Pharmed. "As a Cuban American, I personally feel proud, Cuban American exiles should feel proud of what they did."

 

This report was put together from court documents and interviews, including many interviews the brothers gave to The Miami Herald over the years.

 

EARLY CHALLENGES

 

Sons of a dental surgeon from the Havana suburb of Marianao, Carlos was 11 and Jorge 8 when they arrived in Miami in 1961 as part of the Pedro Pan exodus, in which 14,000 children left the island unaccompanied by parents who feared that the Castro government was about to send the children to camps for indoctrination.

 

The brothers stayed first with a family friend. He died within three months, and they were transferred to a Pedro Pan camp in Florida City. They say that change so traumatized them that unlike other children, the brothers rejected offers to leave the camp for foster homes.

 

They remained in the camps for five years. Jorge was bruised by the experience. "For many, many years, I couldn't open up to anyone other than my brother, " he once said. He felt abandoned by his parents and sought a therapist's help.

 

Carlos viewed the camp time as a tough preparation for the American business world. After five years without parents, he said, "we weren't afraid of anything."

 

The experience turned them into entrepreneurs: Jorge earned a quarter each for writing "Hi, Mom" letters for other kids, who needed to send the letters to get their $1.40 weekly allowance.

 

At Monsignor Pace High School, Carlos earned $1.15 an hour cleaning up. At the end of the school year, he rescued old textbooks from lockers and resold them the next fall in the parking lot to new students.

 

Carlos went to Emory University, Jorge to Florida International. In the 1970s, they became pharmaceutical salesmen for SmithKline Beecham.

 

BUSINESS LAUNCHED

 

In 1980, sensing an untapped market for selling medical supplies to Latin America, they started Pharmed by installing an answering machine in a small storage room in Carlos' home.

 

"In six months, we had sold $700,000, " Carlos told The Herald. "We had no occupational license, nothing. I went to my accountant, and he said, 'You're going to jail.' I said, 'No, that's why I came to you.

 

Their first domestic customer was Jackson Memorial Hospital. Their first supplier was Johnson & Johnson. The company sold everything from sutures and pharmaceuticals to batteries and cleaning supplies.

 

In wholesale medical distribution, middlemen resell products to hospitals and others, generally making 4 percent to 8 percent in profit. It is fiercely competitive, and success depends on high volume.

 

A few big national names, led by Cardinal Health and McKesson, dominate the field. Thousands of smaller distributors hustle for what's left.

 

Pricing is complex. Hospitals generally negotiate deep discounts through group purchasing organizations or get low prices because drug makers know that patients likely will keep using a drug they are introduced to in the hospital.

 

Many distributors have tried to take advantage of the price differences. "Some distributors realized that if they needed 10 cases for the hospitals that qualified for the group purchasing price, they could order 20 cases and then sell the other 10 cases elsewhere at higher prices, increasing their profits, " says Joe Colonna, a consultant on medical-supply purchasing.

 

Distributors saw this as a business strategy. Manufacturers who later sued distributors over these practices called it fraud. Generally, those disputes have been handled in civil suits, but in the 1980s, law-enforcement agencies launched Pharmoney, a four-year national criminal investigation.

 

Allen, the deputy director of the Georgia Drugs and Narcotics Agency, said he first heard of Pharmed during the investigation of another Miami firm, Bravo Export Management.

 

In January 1987, the feds charged Bravo with illegally selling drugs bought at a hospital discount to a California wholesaler. Bravo ordered the drugs in the names of two other Miami companies, Belo Medical Center and South Florida Health Alliance, "an alleged hospital purchasing group, " according to the criminal indictment.

 

State corporation records show the South Florida Health Alliance was incorporated by the de Céspedes brothers. The indictment charges that a fraudulent invoice used in the scheme was sent to Jose M. Valdivia at Belo Medical Center. Valdivia was then Carlos' father-in-law. The address of Belo Medical Center was also the address of Pharmed Sales International at the time.

 

Bravo Export pleaded guilty and paid a $75,000 fine. Then the investigation stopped. In testimony before a House subcommittee in Washington in 1990, Allen said: "There were close to 100 guilty pleas. But there were also 40 to 50 other cases which were pending. In many of which the subjects had expressed a willingness, or at least an interest in entering a guilty plea."

 

One of the pending cases was Pharmed, Allen told The Miami Herald. But the investigation ended. The Justice Department gave no explanation.

 

In 1987, Wyeth Pharmaceuticals sued Belo Medical Center, South Florida Health Alliance and the de Céspedes brothers over allegations of improperly obtaining drug discounts. After nine years, the case was settled out of court in a confidential agreement.

 

ALLEGATIONS DISMISSED

 

Alfred Botet, a Pharmed manager in the 1980s, says the company was doing things then that would lead to accusations in lawsuits over the next two decades. He says he quit because he was convinced the company "wasn't on the up and up."

 

Botet said the company warehouse had four bays and four entrances. "Strange things happened. . . . The inventories started getting mixed up, " and there was "really no control" in separating hospital-bound supplies from other supplies.

 

He said he saw pallets of supplies leave the warehouse for hospitals and then come back. "Lots of goods were never delivered." He said large hospitals at the time had bad inventory control and couldn't keep track of goods.

 

Botet said he went to the Miami-Dade state attorney's office with his views about Pharmed. "But nothing came of that, " he said.

The Miami Herald asked the brothers about all of Botet's allegations. They did not respond.

 

In 1999, similar accusations came up when AmerisourceBergen, a large medical supply wholesaler, sued Pharmed. The allegation involved setting up a corporation to get price breaks. According to court records, Pharmed Vice President Rene Portela and Pharmed contract consultant Charles J. Sanchez incorporated Quality One Medical Group, which then signed papers promising its goods would go only to hospitals. Quality One set up a warehouse a couple of miles from Pharmed's Doral center.

 

In a deposition, Portela said Carlos de Céspedes asked them to create the corporation, which placed orders with AmerisourceBergen. When the goods were delivered to the Quality One warehouse, a Pharmed truck came "immediately" to take them to the Pharmed warehouse, Portela stated.

 

AmerisourceBergen claimed it shipped goods worth $1.2 million to Quality One and didn't get paid. The company called Portela and demanded payment. "That's when I really got scared, " Portela said. "And then I asked them [Pharmed] what was going on."

 

Court documents show Pharmed eventually paid $735,091 -- the cost of the goods if they would have gone to a hospital. Amerisource sued for the difference -- $443,624.

 

Pharmed's defense in court documents: Amerisource knew or should have known that Quality One planned to resell the items to Pharmed. In 2002, the case was settled out of court on undisclosed terms.

 

PROTECTED BY THE LAW

 

Colonna, the consultant, says that even when distributors are accused of charging inappropriate prices, manufacturers can't force them out of business because federal law makes it illegal for suppliers to gang up on a distributor like Pharmed.

 

Meanwhile, Pharmed grew and prospered, setting up distribution centers in Tampa and Cleveland.

 

"Our status as a minority company has really helped, " Carlos said in 2002. One example: Arjo, an Illinois firm that makes patient-lifting devices, used Pharmed as its distributor for HCA hospital sales because the chain requested it, to boost its business with minorities.

 

Ludvig Anderberg, Arjo's chief financial officer, says that in most cases, Arjo shipped the devices directly to the hospitals, but HCA paid Pharmed for the devices, and Pharmed took its profit before paying Arjo. When Pharmed declared bankruptcy, Arjo was out $1.4 million.

 

Pharmed was aggressive in making sure its minority status was recognized. At one point, it sued SmithKline Beecham and its South Florida representative, Leo Gonzalez, accusing the firm of prejudice in not using a Hispanic supplier in South Florida. The company replied that it already had enough distributors and that prejudice had nothing to do with it. The case was eventually dismissed at the request of all parties.

 

BROTHERS PROSPER

 

The brothers were doing very well. Jorge earned $16.3 million in 2001, according to his income-tax return -- introduced in a lawsuit. In 2003, their best year, Pharmed had $584 million in revenue. The following year, Hispanic Magazine listed Pharmed as the eighth-largest Hispanic-owned business in the United States.

 

The brothers thought about taking Pharmed public but decided against it. "I have a Ferrari, " Carlos said in 2002. "I don't want an old lady who has 10 shares asking: 'Why does he have a Ferrari?

 

Carlos and his wife, Martha, bought a home on the waterfront in Coconut Grove that is now worth $2.4 million, plus a $500,000 condo in Miami Beach. Jorge and his wife, Yvonne, own a home in Southwest Ranches now worth $1.8 million and a $500,000 Hollywood oceanfront condo.

 

The brothers formed a venture-capital company, The Astri Group, which started the Gables restaurant and hired Miami-Dade Commissioner Jose "Pepe" Diaz.

 

The brothers promised to donate $1 million to Florida International University, which prompted the school to name its basketball facility Pharmed Arena. FIU officials say that so far, Pharmed has contributed a third of the promised amount.

 

BELOW THE SURFACE

 

Behind the scenes, however, problems were developing. In August 2004, Roche Healthcare, the company's largest supplier, abruptly stopped using Pharmed, resulting in a $300 million reduction in annual revenue.

 

In bankruptcy filings, Pharmed said it lost the business because Roche "eliminated the use of distributors." Roche won't say why it stopped using Pharmed, but spokeswoman Kim Cayz says: "We obviously work with distributors."

 

The next big blow came in January 2005, when Johnson & Johnson ended its 25-year relationship.

 

J&J filed a demand for arbitration, accusing Pharmed of fraud and the brothers of "unjust enrichment" in collecting $22 million in rebates to which they were not entitled.

 

Colonna, the consultant, says suppliers began to offer rebates in an attempt to stop the questionable pricing practices they viewed as being so prevalent in hospital discounts. He says manufacturers told distributors, "You have to prove to me where the surgical gloves are going to get the better price. In that case, I will then rebate you the difference.

 

Without Roche and J&J, Pharmed revenue plummeted from $584 million in 2003 to $146 million in 2005. The once highly profitable firm ended up losing $19 million that year.

 

Pharmed sued J&J for "reprehensible, intentional, malicious" defamation. A judge sent the case to arbitration. J&J won't comment.

 

DIAZ INVESTIGATION

 

As Pharmed struggled, Commissioner Diaz co-sponsored in 2006 an ordinance requiring Jackson Memorial Hospital to give preference to local suppliers. For the four previous years, he received at least $475,000 in salaries, loans and bonuses from companies controlled by the brothers.

 

Diaz has been under investigation by federal authorities looking into possible "honest services fraud" in his role as a public servant because Diaz took a fishing trip to Cancun with Carlos de Céspedes and Miami developer Sergio Pino. Diaz later voted for a major Pino development plan.

 

Federal investigators would not comment on the status of the investigation.

 

Carlos said he didn't know about the ordinance beforehand. But he applauded local companies getting more work, and he hired De Grandy to lobby public hospitals for more business.

 

Quietly, the company was selling off assets. In September 2006, it sold the inventory of its Ohio operation for $3.4 million. The Tampa center was closed. Last March, Pharmed sold some warehouses in Doral for $8.1 million.

 

Embarrassing lawsuits were cropping up, such as Citicorp Vendor Finance's demand for $130,000 in unpaid phone equipment.

The final blow came last May, when the HCA hospital chain stopped using Pharmed as a supplier -- a further loss of $21 million in annual revenue.

 

In June, HCA sued seven people, including a Pharmed assistant vice president, Erika Urquiza, 36, but not Pharmed itself or the brothers. The lawsuit alleges that Urquiza paid kickbacks to two employees of HCA's Kendall Regional Medical Center, who then ordered supplies from Pharmed that never were delivered. HCA paid Pharmed $3.5 million for the supplies, the lawsuit states.

 

The lawsuit claims Urquiza and her husband Luis used Gator Sports Collectibles to pay the hospital employees. State records show the company was incorporated by Charles J. Sanchez, who has been listed as the officer/registered agent of many companies started by the de Céspedes brothers, including Quality One, the corporation named in the AmerisourceBergen lawsuit.

 

In the incorporation papers for Gator Sports, Sanchez gave an address that was the same as Pharmed's headquarters in Doral. Sanchez and Luis Urquiza both say Sanchez incorporated the company as a favor to the Urquizas, not the brothers.

 

In the lawsuit, HCA states "the Pharmed Scheme Defendants have made extraordinary efforts to hide their ill-gotten gains, and they continue to do so."

 

Court documents contain e-mails between Urquiza and hospital employee Victor Garcia that hint others were involved. Garcia frequently asked Urquiza when he was going to get paid. "I beg and plead every day, " Urquiza responded at one point.

 

On March 19, Urquiza sent an e-mail to Sandra Johannes: "ANYTHING? $$$"

 

Within a minute, Johannes responded: "Not today, but yes." Her e-mail was signed with her name and title, executive assistant. Two former employees say she is the executive assistant to the brothers.

 

Three days later, Urquiza received the money.

 

Urquiza's attorney is George M. Evans, who has represented Pharmed in numerous corporate matters, including the lawsuit brought by Wyeth. Evans said, "Due to the ongoing investigation, my clients have been instructed not to respond to your questions."

 

NO TALK OF DEFEAT

 

The brothers insist they are not finished. In their recent statement to The Miami Herald, they said: "Our recent business reversals are disappointing, but we fully intend to put these matters behind us and build new businesses that will also contribute to Miamis economy and quality of life."

 

In fact, they recently updated the corporate registration of one of their companies, Belo Medical Center Purchasing.

 

Meanwhile, Pharmed is vanishing in bankruptcy court. Most of its remaining supplies have been sold for $916,000. Last Monday, the headquarters and warehouse were auctioned off for $10.8 million. The sale is expected to close Friday.

 

Miami Herald staff writer Jay Weaver contributed to this report

 
 
 
  
 
 
 
DANGEROUS DOSES
 
On May 19, 2008, Jose Grillo was sentenced to 12 years in prison after pleading guilty to charges of racketeering, product tampering, and organized scheme to defraud. Grillo was indicted in 2003 for his role in uplabeling 120,000 doses of Epogen/Procrit and has been held in a Miami jail since then.
Click
here to read the press release.

On May 6, 2008, in a unanimous opinion, a New York appellate court rejected the claims of Dr. Paul Perito, who subpoenaed Katherine Eban to testify about information related to the investigation chronicled in her book, Dangerous Doses. The court held that journalistic privilege granted under New York's "Shield Law" precluded Dr. Perito from obtaining non-confidential but unpublished information from Eban. Perito was arrested in 2004 in connection to a $60 million counterfeit drug scheme.
Click here to read the court's opinion.
Click
here to read the NY Law Journal article about the case.

On February 12, 2008, Robert Neil Spence, a former Vice President at Cardinal Health, pleaded guilty to felony charges of mail fraud and tax evasion for taking kickbacks from Michael Carlow in exchange for purchasing medicine from him. In July 2008, he was sentenced to four years probation and required to pay the IRS over $76,000.00 in restitution.

On March 3, 2007, Michael Allyn Carlow was sentenced in a Missouri state court to five years in prison and ordered to pay $3.4 million in restitution for his role in the $42 million dollar conspiracy to sell counterfeit Lipitor.
Click 
here to read the DOJ press release of Carlow's sentencing.

On January 26, 2007, Paul Louis Kriger pleaded guilty to conspiring to sell stolen pharmaceuticals.
Click
here to read the DOJ press release.

On January 23, 2007, Quality King Distributors Inc., was sued by Parlux Fragrances Inc., which alleged a variety of schemes related to gray market distribution.
Click
here to read the lawsuit.

On January 9, 2007, four co-defendants were indicted for their role in a multi-million dollar conspiracy to sell counterfeit, illegally imported and misbranded Lipitor and other drugs.
Click here to read the DOJ press release.

On November 3, 2006, Michael Allyn Carlow pleaded guilty to his role the a $42 million dollar conspiracy to sell counterfeit Lipitor.
Click
here to read the DOJ press release of Carlow's sentencing.

On October 23, 2006, Julio Cesar Cruz was sentenced to 13 years and six months in federal prison without parole for conspiracy to sell counterfeit Lipitor and other drugs.

On October 18, 2006, Douglas C. Albers, the owner of Albers Medical Distributors, Inc., pleaded guilty to selling counterfeit and misbranded Neupogen to a California firm in September 2001.
Click
here to read Albers's plea.

On March 29, 2006, Robert Neil Spence, a former employee of Cardinal Health Company, was indicted for allegedly taking kickbacks from Michael Carlow.
Click
here to read the indictment.

On March 23, 2006, Martin J. Bradley III was convicted on charges that include racketeering, money laundering, failure to disclose interest in foreign bank accounts and wire fraud to pay unlawful kickbacks. His father, Martin J. Bradley Jr., and the coorporation Biomed Plus were also found guilty.
Click
here to read the DOJ press release of Bradley's indictment.
Click
here to read the SavannahNOW article about his conviction.

On August 31, 2005, Michael Allyn Carlow--along with 11 others--was indicted in the Western District Court of Missouri for his alleged role in a $42 million conspiracy to sell counterfeit and misbranded Lipitor.
Click
here to read the indicment.
Click
here to read the DOJ press release.

On May 26, 2004, Dr. Paul Perito and Nicholas Just, formerly co-owners of the strip club Playpen South, were arrested for allegedly trafficking in pharmaceuticals, including mislabeled cancer and AIDS drugs.
Click
here to read the affidavit of probable cause.

On July 21, 2003, Jose Grillo, who allegedly counterfeited life-saving medicine, was arrested and charged with organized scheme to defraud and buying and selling prescription drugs from an unauthorized person.
Click here to read the Florida indictment.

On July 20, 2003, Michael Allyn Carlow, who allegedly trafficked in adulterated medicine, was arrested and charged with racketeering, conspiracy to commit racketeering, organized scheme to defraud and grand theft.
Click here to read the Florida indictment.

On June 24, 2003, the House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations held hearings, A System Overwhelmed: The Avalanche of Imported, Counterfeit, and Unapproved Drugs into the U.S. Click here to read the transcripts.

On February 27, 2003 Florida's Seventeenth Statewide Grand Jury issued a scathing report on the state's drug supply and the grave danger it posed for patients.
Click here to read the report.
 
 
 
 
 
 
 

The 'Safety' Scam

 

  COUNTERFEIT DRUGS FLOODING THE COUNTRY: THE UNTOLD STORY

 

Yes, there IS a drug safety issue, but not the one that consumed Congressional spin-meisters last week. Sun-Sentinel's investigative reporter Bob LaMendola wrote a block-buster expose on June 29th that's been totally ignored.

 

Counterfeit drugs that find their way to South Florida Rx supplies, and from there throughout the US, pose a deadly threat to patients according to Sun-Sentinel report.

 

Vials of medicine prescribed for a 16-year-old boy recovering from a liver transplant arrived in the mail from a national pharmacy chain.The shots were painful and didn't seem to work. But Tim continued to take the medication, unaware it contained only 5 percent of the active ingredient.

 

"You think you're out of the woods and you get hit again," said the boy, whose family has asked that their last name not be used to protect their privacy. "It was horrible."

 

Tim, who lives on Long Island, is the face of an alarming national scandal. The U.S. pharmaceutical supply, long considered the safest in the world, has become tainted with fake, expired, stolen and diluted drugs. In stories last month, the South Florida Sun-Sentinel reported that more than $100 million in counterfeit and suspect prescription drugs passed through unscrupulous wholesalers in Broward, Palm Beach and Miami-Dade counties in the past two years, an unknown quantity reaching patients throughout the country. A statewide grand jury and law enforcement task force are investigating more than 50 people in South Florida, including convicted felons whom the state gave licenses to peddle medicines. Health officials nationwide fear patients have suffered and even died as a result of taking bad drugs. Quantifying the problem is difficult because doctors and pharmacists often attribute patients' failure to improve on their medical condition.

 

Tim's family never imagined medicine they bought from a division of a large pharmacy chain would not be authentic. Nor could they imagine how the drug companies would pass the buck, never explaining how the fake drug had slipped through. All told, more than 2,000 boxes of counterfeit Epogen, used to boost red blood cells in kidney, cancer and AIDS patients, may have been sold to unwitting patients like Tim.

 

The drugs traveled through a maze of wholesalers and distributors in at least five states, according to federal court and state health records. The Sun-Sentinel traced the counterfeit Epogen to several wholesalers in South Florida. No answers for the family. A year after Tim took the counterfeit drug, his family still doesn't know where it came from, and no one has been arrested.

 

"Everybody's pointing to the next guy," said his father, Kevin. "It's enraging."  Doctors told Tim he needed a new liver after cirrhosis destroyed his. The February 2002 surgery left him anemic, tired and weak. The Epogen was supposed to help him get stronger. But Tim noticed no improvement from the first shipment of the drug he received from CVS ProCare. Instead, several hours after each weekly shot, Tim said his "whole body went into, like, a charley horse."

 

"It breaks your heart," his father said, recalling how Tim would tell him, "I was praying you wouldn't give me another shot."

Doctors were baffled, Kevin said. After Tim had been taking Epogen for two months, the family got a frightening call from CVS. A second shipment that had just arrived might be counterfeit, the drugstore informed them.

 

The family discovered the lot numbers on Tim's vials matched those of the fake batch. They also discovered the Epogen Tim had been taking was not full strength. Kevin called CVS for answers and was told the company buys its drugs from AmerisourceBergen, one of the nation's three biggest distributors. AmerisourceBergen referred him to the manufacturer, Amgen in California, who sent him back to AmerisourceBergen. He discovered that big distributors do not always buy directly from manufacturers. They buy from smaller wholesalers as well. Authorities say that's where fake, diluted and expired drugs enter the supply. AmerisourceBergen has filed a federal lawsuit in Phoenix against Dialysist West, an Arizona wholesaler that sold the distributor 2,082 boxes of Epogen for $8.5 million. Anywhere from half to all of that Epogen contained only 5 percent of the active ingredient but had been relabeled to say it was full strength, according to the suit. Records filed in the case show how convoluted a drug's route from manufacturer to patient can be.Dialysist West bought the lower-strength Epogen from three wholesalers: AmeRx Inc., of Oakland Park; CSG Distributors, of Knoxville, Tenn.; and Optia Medical of North Salt Lake, Utah.

 

CSG bought the Epogen from Premier Medical Distributors, a defunct Fort Lauderdale wholesaler. Premier purchased the drugs from Infinity Medical, an unlicensed wholesaler in Miami, which bought the vials from McKesson Inc., another of the Big Three distributors, according to court records and lawyers involved in the case.

 

Wholesale denial

 

All of the wholesalers deny counterfeiting the drug.

 

"I know it was not my client," said Debra Hill, a Phoenix lawyer for CSG.

 

Susan Cavaliere, in charge of purchasing for AmeRx, said, "I logged it, I looked at it and I thought it was a good product."

Cavaliere wouldn't say where she bought the drugs, except that they passed through "three or four" licensed wholesalers before AmeRx.

 

Some Epogen with the same lot numbers as the diluted batch came from the Stone Group and Breckenridge, two Boca Raton wholesalers, state health records show. Florida health regulators have determined that much of the paperwork showing where they bought their drugs was faked. The true source of the counterfeit Epogen may never be known.

 

"What burns me is you're not talking about some mom and pop drugstore," Kevin said. "You're talking about AmerisourceBergen, a $40 billion-a-year company, Amgen and CVS. In the meantime, nobody knows anything."

 

In addition to the drug companies, Kevin contacted the U.S. Food and Drug Administration and offered to hand over his vials for testing. The FDA declined for months, until he persuaded Sen. Hillary Clinton, D-New York, to intervene. Two FDA agents then came to his home and later confirmed that both batches were 5 percent strength, he said. Tim, now 17, improved after he began getting full-strength Epogen last summer. He plans to study economics at Iona College in New Rochelle, N.Y., in the fall. His family now scrutinizes all prescriptions and wonders whether the drugs are authentic.

 

"It just adds so much stress," said Kevin. "On top of everything else, he's got to worry about this because he's going to be on medication the rest of his life."

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Law enforcement raids target violent LA street gang
By JEREMIAH MARQUEZ, Associated Press Writer
Last Updated 8:35 pm PST
Thursday, November 10, 2005

LOS ANGELES (AP) - Police and federal agents carried out raids Thursday against alleged members of a notorious street gang accused of conspiracy and drug trafficking, arresting at least 18 people and seizing stashes of crack cocaine.

Nearly 1,000 law enforcement officers conducted sweeps targeting the Black P-Stones street gang - a Bloods set known for its violent history in Los Angeles and Chicago - in parts of Los Angeles' Baldwin Village area, Hawthorne and Inglewood, FBI officials said.



Eight defendants were indicted on federal charges of conspiracy and distributing cocaine base, with the remaining 10 facing various state counts. Another eight indicted on federal charges still were being sought, said J. Stephen Tidwell, assistant director in charge of the FBI's local office.

The gang allegedly made one of its homes in Baldwin Village, a lower-income community in South Los Angeles that's seen 28 murders and more than 1,500 assaults in the last five years, officials said. Also seized Thursday were weapons, including an AR-15 assault rifle and an AK-47.

"We are sending the gang a very clear message: You are not untouchable," police Chief William Bratton said.

The sweep, dubbed "Operation Stone Cold," was conducted by the FBI, the Los Angeles Police Department and other agencies as part of a joint investigation aimed at "combating homegrown gang enterprises terrorizing the streets," Tidwell said.

Hoping to break up the gang, authorities targeted its leadership. Law enforcement officials said they plan to maintain a large presence in Baldwin Park and other neighborhoods in the coming months in an effort to keep the group from regenerating.

"We won't forget about this gang," Tidwell said. "We'll continue to make sure we've ... dismantled it."

Though the gang was believed to have partly originated in Chicago during the 1960s, there have been no sweeps there as part of the crackdown, officials said.