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| JOHNSON & JOHNSON: FIVE DECADES OF PRODUCT LIABILITY
1960’s McNeil Labs Kept Dangerous Side-Effects and Deaths Secret WASHINGTON, D. C. (AP) - April 29, 1964 - Food and Drug Commissioner George P. Larrick testified Tuesday that mistakes by his agency and the withholding of information by Johnson & Johnson subsidiary McNeil Labs kept a harmful drug on the market for five years. The drug, Flexin, was finally suspended by the FDA on Oct. 13, 1961. Larrick told a House government operations subcommittee on drug safety that a sister drug, Paraflex, made by the same company is still on the market. Larrick said that in 1955, when McNeil Laboratories submitted Flexin as a drug to relieve muscle spasm, the company had a report that one test patient who used the drug had died from hepatitis. But this information, Larrick said, was not relayed to the FDA, which approved the drug in 1956. In 1958, while asking the FDA to allow the drug to be used in the treatment of gout, McNeil Labs stated: "Flexin has produced no irreversible toxic reactions when administered to patients daily for periods of over six months. But, Larrick testified, "the facts are that at that time the firm had received reports of seven deaths from hepatitis of patients who were also taking Flexin." In 1959, be said, "the firm then knew of 39 cases of hepatitis in patients taking Flexin, including 11 fatalities, and that 20 of the cases, including six deaths had been directly ascribed to Flexin by the reporting physicians." Larrick said the FDA had reported the withholding of information by McNeil to the Justice Department. McNeil Labs was acquired by Johnson & Johnson in 1959 for $33 million.
1970’s
Rye Syndrome: Deceptive Marketing Tactics
The marketing strategy for Tylenol is a primary case example of pharmaceutical industry deceptive marketing: "After Johnson & Johnson acquired McNeil in 1959 the safer-than-aspirin pitch was complemented by a massive giveaway of the product to doctors and hospitals, creating market share by irresistible financial force." In the 1970s, Counterpunch reports, "J&J sales reps began solemnly informing healthcare professionals that aspirin had been associated with "Reye's syndrome a potentially fatal condition involving the liver and ultimately the brain of infants and children following viral illness."
J&J failed to warn about its own product’s lethal risk while succeeding in scaring the public by making exaggerated misleading claims about aspirin lethality. Meanwhile, the number of Tylenol related casualties is mounting. Counterpunch reports that according to the National Institutes of Health, last year there were approximately 2,000 acute liver failure cases, resulting in about 500 deaths according to William M. Lee, MD, of the University of Texas Southwestern Medical Center.
“Acetaminophen overdose is the leading cause for calls to Poison Control Centers (more than 100,000 /year); it accounts for some 60,000 emergency room visits annually.”
Yet, these devastating Tylenol-related statistics have been effectively concealed from the public by a media wall of silence and, according to Counterpuch, by J&J buying silence in sealed settlements: "Johnson & Johnson has paid out countless millions of dollars over the years to settle suits by Tylenol victims and minimize adverse publicity.”
Ad from July 1972 "for the millions who should not take aspirin" 
Ortho-Novum: Deadly Side-effects
On June 30, 1971, a physician prescribed Ortho-Novum 1/50 for Pauline Jane Buchan, a 23-year-old Ontario mother. She was in excellent health, a nonsmoker with no predisposition to a stroke. Yet after taking the pill only briefly - slightly less than six weeks - she suffered a stroke. It left her permanently disabled, damaging her brain and substantially paralyzing her left arm and leg. The pill had been issued with no warning that it increases the risk of a stroke - another stumbling block.
Transcutaneous Electrical Nerve Stimulator: Anti-trust Violations
Ever since J&J introduced Tylenol in the early seventies, it has played hardball with its competitors in the crowded painkiller market - Bayer, Bufferin, St. Joseph's, and the like. So the company was understandably uneasy about the advent in 1971 of an inexpensive pain-relieving device - a one-time purchase - that involved no pill-taking at all. The device, called a transcutaneous electrical nerve stimulator, soothes pain by sending an electric current into the body through electrodes attached at the pain site. Apparently impressed with the product - produced by a small company with few resources to market it - J&J bought up the entire organization. Oddly enough, though, it never promoted the stimulator. J&J's real goal was apparently not preventing pain, but preventing competition. The founders of the usurped company sued, charging that J&J had, among other things, violated the Sherman Antitrust Act. After nearly 15 years of legal battles, J&J settled out of court. - McDonald v. Johnson & Johnson
1980’s
Delfen Contraceptive Foam
1983; "Your firm failed to take appropriate measures to prevent [the over-the-counter product from] being contaminated with objectionable micro-organisms," the agency said in a "Regulatory Letter" obtained under the Freedom of Information Act. J&J subsidiary, Ortho pharmaceutical also "failed to conduct investigations of complaints, and it failed to include in the written record the reasons that investigations were not conducted," Matthew H. Lewis, the FDA's district director in Newark, told Gary Parlin, the company's president. The firm sent two reply letters to the agency, but these were unresponsive to the violations, Lewis said. Yet the FDA neither fined nor censured the company, and the press never reported the story. In this case, as in the others, J&J had little trouble dropping the corporate veil. Only now, after two decades of corporate darkness, is it finding that veil a little harder to draw. - Morton Mintz article At least seven people died after taking Tylenol that had been laced with cyanide. Contrary to statements made by J&J executives and FDA officials, the Tylenol was poisoned while under the control of J&J or Jewel Foods. J&J dragged the ensuing litigation out for nine years, settling with the victims families just one day before the case was to go before a jury.
Tylenol Toxicity: Hundreds Die Every Year
The "therapeutic ratio" of a drug compares the amount required to produce harmful effects with the amount required to provide benefit. The therapeutic ratio of acetaminophen, the active ingredient in Tylenol, is about 2:1 -and even lower if your liver has been compromised by hepatitis or alcohol. Overdoses of acetaminophen (sold as Tylenol and other brands) cause more than 450 deaths due to acute liver failure each year in the United States, and this number appears to be on the rise. In 2001, the U.S. Acute Liver Failure (ALF) Study found acetaminophen responsible for 39 percent of cases. In 2003, the number had risen to 49 percent. - Medical News Today Some of the nation's top researchers - including the National Institute of Health (NIH) and the Center for Disease Control (CDC) - have concluded that acetaminophen toxicity is the leading cause of acute liver failure in the United States. - Tylenol Dangers In 1979, despite years of overwhelming evidence, verified by an FDA Advisory committee, that any Tylenol overdose, no matter how small, can cause liver toxicity and failure, Johnson & Johnson insisted that "only a massive overdose of their painkiller can cause severe medical problems." The FDA's Advisory Review Panel recommended in 1977 that products containing acetaminophen bear warnings such as, "Do not exceed recommended dosage because severe liver damage may occur," but the FDA ignored the panel's advice for nearly three decades.
Zomax: J&J Kept Deadly Drug on the Market When Zomax was withdrawn from the market in 1983, it had been sold for only 28 months, yet its manufacturer, J&J subsidiary McNeil Pharmaceutical, had received hundreds of reports of severe allergic reactions from this prescription painkiller. The FDA believes that Zomax was probably a factor in 14 deaths. Seniors who were suffering from arthritis were the main users of this drug. 1983; Johnson & Johnson and its McNeil Pharmaceutical subsidiary have been accused of "fraudulent misconduct" in the marketing of the popular painkiller Zomax in a lawsuit filed by two former McNeil employees who claimed they lost their jobs because they refused to participate.
The former employees, Dr. James A. Dale, an assistant director of medical research, and Edward F. Lemanowicz, a senior scientist who served as liaison with the Food and Drug Administration, alleged that company officials sought to mislead the public, the FDA and the medical profession about potentially dangerous side effects associate...
Because Dr. James Dale and Sr. Scientist Edward Lemanowicz put the public's safety over Johnson & Johnson's profits, they were fired.
James A. Dale, M.D., et al. v. Johnson & Johnson, et al., No. 89-4057 (May 14, 1990) (Debevoise, J.) (allowing civil RICO suit by two former drug company executives who were discharged for failing to cooperate in company scheme to deceive consumers and regulators on the hazards of various drug products) featured in R. Bell, Impure Science: Fraud, Compromise and Political Influence in Scientific Research (1992), Chapter 6, pp. 144-82 ("Impure Profit: Marketing Medicine In Scientific Research"); Drug Data Withheld, Two Charge: Johnson & Johnson Accused of Plot, Phila. Inq. (October 6, 1989) p. B18 - Marketing Zomax
Suprol: J&J Kept Another Deadly Drug on the Market
1982/3 – 1987; One case of bad judgment? Consider Suprol, another prescription anti-inflammatory drug with potential for high profits. Like Zomax, Suprol was heavily promoted to physicians as an alternative painkiller to addictive narcotics - just the thing for folks with morning stiffness, muscle pulls, or back pain. Like Zomax, it caused a spate of serious adverse reactions that were reported with something less than candor to the FDA. Like Zomax, it caused benign tumors in rodents, meaning it posed a possible carcinogenic risk to humans. And like Zomax, Suprol remained on the market long after it should have been removed if J&J really did put safety first. - Morton Mintz article After the 1982 Tylenol murders, J&J refused to discontinue the easily tampered with capsule form of Tylenol. In 1986, the inevitable occured. Once again someone filled Tylenol capsules with cyanide. This time the poisoned capsules were shipped to stored in Bronxville, NY, and at least one person died.
1990’s
Propulsid Responsible for the Death of Dozens of Children Serious adverse-events associated with Propulsid were ignored by J&J and the FDA when the drug was launched in 1993. The government and Johnson & Johnson negotiated for five years before the company pulled Propulsid. By then, the federal government had reports of 80 heart-related deaths and 341 injuries among patients taking Propulsid.
Lucrative Drug, Danger Signals and the FDA
Dozens had died and more than 100 patients had suffered serious heart problems by March 1998 after taking Propulsid, a popular medicine for heartburn. Infants, given the drug to treat acid reflux, seemed particularly at risk. Federal officials told Propulsid's manufacturer, Johnson & Johnson, that the drug might have to be banned for children, or even withdrawn altogether. Instead, the government and the company negotiated new warnings for the drug's label - though not nearly as tough as regulators had wanted.
Propulsid had a good year anyway. Sales continued to surpass $1 billion. Johnson & Johnson continued to underwrite efforts that promoted Propulsid's use in children. Two years later, as reports of heart injuries and deaths mounted, Johnson & Johnson continued defending the safety of Propulsid, but then pulled it from the market before a government hearing threatened to draw attention to the drug's long, largely hidden, record of trouble.
That record, pieced together from newly obtained corporate and government documents, provides an in-depth view of a pharmaceutical company trying to save a lucrative drug in the face of growing evidence of harmful side effects. Documents from lawsuits against Johnson & Johnson show that the company did not conduct safety studies urged by federal regulators and their own consultants that could have revealed Propulsid's danger early on. The F.D.A., moreover, did not disclose company research that cast doubt on Propulsid's effectiveness against digestive disorders it was being used to treat, since the studies are considered trade secrets. Eventually, Johnson & Johnson to pay up to $90 million to settle lawsuits that eventually involved claims that 300 people died and as many as 16,000 were injured from taking Propulsid. Many of the documents relating to Propulsid obtained by The New York Times were filed under seal in the lawsuits. - Marketing Propulsid Salesman helped New York doctors in fatal surgery NEW YORK - 11/8/98: A 30-year-old patient went to Beth Israel Medical Center last November for routine outpatient surgery to remove a benign tumor in her uterus. Yet nothing, it turned out, would be routine that day. According to a report released by the state Thursday, the woman died of a heart attack after doctors pumped her with too much saline. State authorities said the hospital failed to meet basic standards of care, even allowing a medical equipment salesman to participate in the surgery without the woman's consent. "What we see here is what we would call a systemic failure. There were lots and lots of checks and balances that failed in that hospital," Baid Frances Tarlton, a spokeswoman for the state Department of Health. "Basically, this salesman, by participating in an operating room procedure, was practicing medicine," Tarlton said. During the procedure, the attending physicians allowed Johnson & Johnson salesman David Myers to operate a new device - the Versapoint Bipolar Hysteroscopy Electrosurgery System - which uses electrical currents to remove fibroid tumors, the report said. Myers' employer, Ethicon Inc., a division of Johnson & Johnson, denied he ever touched the equipment during the surgery. From The New Yotk Times Nov. 6, 1998: Without knowledge of the patient -- who was not identified by the Health Department -- Mr. Myers showed up at an operating room at the center dressed in scrubs and with the device, because the doctors planned to use it. Nurses in the operating room expressed concern that they were not trained in assisting with the equipment, according to the report, but the doctors told them not to worry because Mr. Myers would operate the controls, a violation of hospital policy. ....Mr. Myers regulated the electrical current to remove the fibroid by operating the controls of the device, the report says. About midway through the procedure, the report says, a nurse noticed that fluid was no longer properly draining from the patient, and she alerted the doctors several times, who told her not to worry. The woman, who went into the hospital otherwise healthy, was given several types of drugs to relieve the bloating, but her breathing gradually became shallow and infrequent, and she eventually went into cardiac arrest. Attempts to revive her failed, and she died in Beth Israel's emergency department. An autoposy found that she had died of ''excessive infusion.'' But the patient had already been logged as discharged with the help of an escort, which was corrected much later. Susan Odenthal, a spokeswoman for Ethicon, said that Mr. Myers was still working there. She denied that he ever touched any of the equipment during the procedure and that he was even in the sterile field, the area directly surrounding the patient. She added that her company was certain he had received the go-ahead to take the equipment in for use at Beth Israel. Husband Wants Doctors and Salesman Charged in Fatal Surgery: In a brief statement yesterday, Mr. Smart criticized Johnson & Johnson for its response to the state report. While Beth Israel has admitted that mistakes were made, Johnson & Johnson has denied any wrongdoing. Mr. Smith has filed malpractice lawsuits against the doctors, the hospital and Johnson & Johnson. ''As a consumer and a member of the public, I indict Johnson & Johnson,'' Mr. Smart said. ''They have lied about their product, covered up their conduct and endangered the public health.'' But Susan Odenthal, a spokeswoman for the Ethicon Inc. unit of Johnson & Johnson, which manufactured the equipment, reiterated the company's position yesterday that it had committed no wrongdoing. She said the company was seeking a meeting with state health officials to clarify ''certain facts'' within the report.
Ethicon Manufactured and Sold Contaminated Sutures The nation's biggest maker of surgical sutures is accused in a nationwide class action lawsuit of selling contaminated sutures that gave patients serious infections and caused at least one death, lawyers said Tuesday. Ethicon Inc., a Johnson & Johnson company, recalled 3.5 million packages of its Vicryl brand sutures in 1994 — under pressure from federal regulators. However, because hospitals use up sutures quickly, only one fourth were returned to the manufacturer and destroyed. "We recalled the sutures ... not because we believed the product was contaminated, but because we could not assure (its) sterility," said Susan Odenthal, director of communications at Ethicon, which makes about 80 percent of the sutures used in this country. She declined to discuss specific allegations. The company has made settlements with some plaintiffs, but Odenthal said she did not know how many. According to the lawsuit, "contaminated sutures" made by Ethicon in 1994 were used in surgeries and other medical procedures, causing serious injuries and infections. "A lot of these victims had to be rehospitalized for a significant amount of time," attorney Wendy York of Sacramento, Calif., said Tuesday. Some had to have additional surgery to clean up the infection or redo the original operation, and one Las Vegas police officer was permanently disabled. York said she represents 35 plaintiffs who developed postoperative infections along the suture lines, causing such symptoms as fevers, chronic fatigue, extreme nausea and painful swelling. Other lawyers represent additional clients, she said.York said a woman from the San Francisco Bay area died as a result of an infection. ** The lawsuit claims problems started when new sterilization system was installed at the SanAngelo, Texas, factory where Ethicon sterilizes and packages its sutures. The suit says the system began malfunctioning almost immediately. When tests showed evidence of contamination, Ethicontried to resterilize the sutures and distributed them anyway. How suture maker kept lid on infection suits Despite recall, Ethicon said product was harmless The microorganism Mycobacterium fortuitum is a cousin of tuberculosis and leprosy. It lives in dirt and water, and usually it's harmless. But when introduced into an open wound - a surgical incision, say - it can cause the most destructive of infections. Stubborn. Aggressive. So resistant to antibiotics that some experts say you must attack it like cancer, and cut away infected tissue to prevent its spread.
"It generally doesn't kill you," says Dr. Gwen Ann Huitt of Denver's National Jewish Medical and Research Center, a world leader in treating mycobacterial infections. "But it can cause terrible disfigurement and significant harm."
U.S. infection outbreaks caused by Mycobacteria fortuitum are rare, and have been of keen interest to public health officials. In 1981 the U.S. Centers for Disease Control and Prevention did an extensive probe - complete with DNA analysis - to unravel the cause of an outbreak at a single hospital in Texas.
But in 1994, when surgery patients in California, Oklahoma and Florida were felled by raging mycobacterial infections blamed in lawsuits on contaminated surgical sutures, there was no public health investigation. The difference? In 1994, when the medical supply manufacturer Ethicon Inc. ordered a massive recall of sutures because of suspected contamination, the company insisted its products were harmless to patients. The U.S. Food and Drug Administration agreed, finding no reason to notify the CDC, no need to track down surgery patients to see whether they had gotten sick. An Examiner review of lawsuits and the FDA's own records show that at least 100 U.S. patients who underwent surgery in 1994 were felled by aggressive post-operative infections they blamed on contaminated sutures. Lawyers and patients familiar with the incidents say they believe there were many more infections that were never reported.
Because no public-health investigation was conducted, it was left to individual victims themselves - and to their attorneys, if they chose to file lawsuits - to try to unravel the mystery of the outbreak of debilitating post-op infections.
Ethicon's attorneys, and the legal system, often stymied the efforts of those individual patients.
As the sutures cases played out in courtrooms around the nation, a series of pretrial confidentiality orders and secret financial settlements combined to drape a cloak of secrecy over questions of critical public importance: the extent of the outbreak, and its cause. According to court and FDA records, the sutures problem began in early 1994, when Ethicon, a $1.2 billion subsidiary of medical products giant Johnson & Johnson, installed a new sterilizer system at a plant in San Angelo, Texas. The equipment was used to sterilize Ethicon's synthetic Vicryl sutures, which dissolve in a patient's wound.
Starting in March 1994, the new sterilizer system began to malfunction occasionally, the records show. Finally, in May, the company stopped using the new equipment. But no recall was ordered until September, after prodding from FDA inspectors who had discovered that the new equipment had been shut down. In the meantime, 3.6 million suspect sutures were on the market, some for months.
While conceding that its sutures might have been contaminated, the company insisted it wasn't bad enough to infect anybody. The risk of illness was so low, Ethicon said, that it wasn't necessary for doctors who had already used the sutures to warn patients, according to a company memo. In case after case, Ethicon denied that its sutures were responsible for infections. It aggressively sought to limit or challenge evidence indicating the sutures caused the infection outbreaks. And it sought to keep secret information about both the sterilization failure at the Texas factory and the infection outbreak that had been linked to the sutures in lawsuits and FDA records.
Indeed, some patients' lawsuits stalled in the face of Ethicon's tough defense, and because of problems of proof that a public health probe might have resolved. In some cases, victims were hampered because their hospital records and charts did not detail the brand - let alone the specific lot numbers - of sutures used in their operations. If the hospital records were ambiguous about what sutures had been used, Ethicon sought to have the cases dismissed, contending that the patients' infections must have some other cause. .... In defending the suture lawsuits, Ethicon also sought sweeping secrecy orders to keep what it called trade secrets and confidential patient information from becoming public.
Among the items that Ethicon persuaded a judge in the California cases to keep secret: the identities of doctors and patients who may have filed FDA reports blaming sutures for infection outbreaks; Ethicon's own internal report on why the sterilizer units malfunctioned; the pretrial testimony by Ethicon officials about the problem. Alameda County Superior Court Judge Sandra Marguiles agreed that "disclosure of these documents would cause serious harm to Ethicon and/or physicians and their patients." .... In exchange for the payments, some patients - and their attorneys - were required to sign sweeping confidentiality agreements. According to sources familiar with the agreements, patients and lawyers are banned from discussing in public virtually any aspect of their cases.
"They had everything in there - no news, no TV, no nothing - in the confidentiality agreement," said one person familiar with the agreements.
A lawyer familiar with the cases said Ethicon's legal team had achieved virtually all that any company could hope for when confronted with a problem like that posed by the contaminated sutures: The company has limited its legal liability, and obtained virtually no publicity about the outbreak.
"It was a great PR effort that nipped this hot potato in the bud," said the lawyer, who represented a patient who settled.
Unsolved mysteries
But the piecemeal settlements, the secrecy and the lack of a public-health investigation into the outbreak combined to leave several medical mysteries unsolved.
One is the question of other infection victims. Patients contend they were told of other people who became infected, and lawyers say they strongly believe there were many others.
"There are some victims out there who probably aren't aware of the recall, who perhaps got sick and didn't know the reason why," said Connolly, the Miami lawyer. Read all.... Read Part 1: OUTBREAK - Lawsuits fly against maker of sutures alleged to be tainted LifeScan Corporate Headquarters Raided - J&J Hid Product Defects Ralph Larsen, chief executive of Johnson & Johnson, clearly remembers his whereabouts on Tuesday, March 31, 1998. ''I was at a speaking engagement in Phoenix,'' he said. ''I got a phone call that said: 'Ralph, you're not going to believe this, but we just had a raid at our LifeScan headquarters by 30 or 40 armed federal agents. They've cordoned off the building and are serving a search warrant.''' Mr. Larsen thought that the call might be an early April fool’s joke. 'It's no joke,'' the caller assured him. The raid came after management of LifeScan, a unit of Johnson & Johnson based in Milpitas, Calif., failed to notify the Food and Drug Administration of a glitch in software for the SureStep diabetes diagnostic device LifeScan makes. The defect caused some units to show an error message rather than a ''HI'' warning reading if a person's blood glucose level was very high. Because these J&J employees put the public's safety over Johnson & Johnson's profits, they were fired. The United States attorney's office in San Francisco stepped in after a whistleblower from LifeScan called the Justice Department. On Dec. 15, 2000, Johnson & Johnson pleaded guilty to three misdemeanor criminal charges and agreed to pay fines of $60 million for selling defective devices and submitting false information about the problems to the food and drug agency. - The Right Thing
2000's
Counterfeit Procrit
In 2003, several lots of J&J's Anti-anemia drug, Procrit, were found to be counterfeit. Some Hospitals and pharmacies unknowingly bought a counterfeit version of Procrit. The counterfeit drug was useless, and contaminated with bacteria. Procrit Kickbacks Two of the world’s largest drug companies are paying hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines, which regulators now say may be unsafe at commonly used doses. Neither Amgen nor Johnson & Johnson has disclosed the total amount of the payments. But documents given to The New York Times show that at just one practice in the Pacific Northwest, a group of six cancer doctors received $2.7 million from Amgen for prescribing $9 million worth of its drugs last year. J&J Knew About Deadly Side Effects of Birth Control Patch for Years Pharmaceutical giant Johnson & Johnson may have known years ago about the deadly risks of its birth control patch Ortho Evra, according to internal documents obtained by NBC News. Patient reports between 2002 and 2004 show that Ortho Evra was 12 times more likely to cause strokes and 18 times more likely to cause blood clots than the conventional birth control pill, NBC News' TODAY show revealed Wednesday. In 2005, Johnson & Johnson Vice President Dr. Patrick Caubel suddenly quit, saying in his resignation letter, "I have been involved in the safety evaluation of Ortho Evra since its introduction on the market. … The estrogenic exposure [of the patch] was unusually high, as was the rate of fatalities." His letter, which was obtained by NBC, said the research was "compelling evidence" that the company ignored. Therefore, he wrote, "it became impossible for me to stay in my position as VP." Dr. Joel Lippman, who is suing the company for unlawful termination, blew the whistle on the patch's dangerously high levels of estrogen, even before it came to market. The company, he says, "disregarded his concerns and launched the product anyway." "The company knew about much of it, if not all of it," said Dr. Wolfe. "They thought correctly that it wouldn't sell as well if you told people how dangerous it was." Wolfe petitioned the FDA two years ago to pull the patch off the market, but the FDA has yet to make a decision....Full Story
J&J Former Chief Medical Officer Blows the Whistle
Because Dr. Joel Lippman put the public's safety over Johnson & Johnson's profits, he was fired. Ortho Evra A study was released that confirmed previous studies showing an increased risk of blood clots associated with the use of Ortho Evra versus oral contraceptives. The study found that women using Ortho Evra were twice as likely to develop blood clots as those using oral contraceptive pills. Blood clots can lead to heart attacks and strokes. Johnson & Johnson misled doctors and regulators for years by altering and withholding medical data about the health risks of its Ortho Evra birth-control patch, lawyers for women suing the company claim in court papers. J&J faces lawsuits by 2,400 women who claim the patch releases high levels of estrogen that cause strokes, heart attacks, and blood clots in the legs and lungs. Internal documents and pre-trial interviews with J&J scientists show the company learned the risk in 1999 and misled the Food and Drug Administration when seeking approval in 2001 to market the device, the filings state. - J&J Altered Birth-Control Patch Data to Hide Risks
For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents. J&J Ethicon - Intergel Lippman says that in 2002 he "insisted on the recall of a product known as Intergel" which "had caused serious injuries and was related to a number of deaths." Intergel also has been the basis of numerous product liability suits, which claim the product spreads infection during surgery, rather than prevent it. Lippman says that he demanded for more than a year that Intergel be recalled, and that after "a decision to recall the product was made," he was summoned to the officer of Michael Dormer, "Chairman of Medical Devices and Diagnostics for J&J in New York City," where Dormer and four attorneys attacked him "for the decision to recall Intergel". Lippman says that he demanded, for more than a year, that Intergel be recalled, and that after "a decision to recall the product was made," he was summoned to the office of Michael Dormer, "Chairman of Medical Devices and Diagnostics for J&J in New York City," where Dormer and four attorneys attacked him "for the decision to recall Intergel". Michael Dormer resigned in 2007 after admitting to the use of bribes to secure overseas foreign business. J&J Ethicon - Panacryl Sutures Lippman also objected to the release of Panacryl, "a suture whose use resulted in numerous adverse events," and ProCeed, a "mesh product." He says that despite his objections, Ethicon refused to recall Panacryl "and Ethicon continued to receive reports of adverse events." And he says, "The FDA later required Ethicon to recall ProCeed." Halunen & Associates, along with partner firms from across the country, have filed a class action lawsuit against Ethicon based upon their allegedly defective panacryl sutures. Panacryl sutures did not dissolve in many patients. Often, additional surgeries were required to remove the infected sutures. Recovery times for patients suffering complications were as long as two years. In some cases, the sutures remained inside the patient’s body for six months before the granulomas and/or infections occurred. The Panacryl recall included 1,061,712 sutures distributed worldwide. The sutures were introduced to the market in 1999 and were removed form the market in March of 2006 after Ethicon issued a voluntary recall. The costumer notification letter issued by Ethicon, said that Panacryl suture’s “unique absorption profile could act as a foreign body”. Surgeons stated that the sutures inhibited healthy tissue growth. More worriedly, many cases of infection were reported at the site of the patient’s wound requiring additional surgeries to remove the infected sutures. Recovery times for infected patients varied from a few months to as long as one year. In some cases the sutures remain inside the patients body for one to two years before granulomas or infections occurred. In at least one case, a doctor reported problems with the sutures to the FDA and asked the Ethicon rep to have one of Ethicon's surgeons to call him. The doctor never received a call from Ethicon. J&J Ethicon's Cardiac device In the case that he claims led directly to his illegal firing, Lippman says that by April 2006 he had received three complaints that an Ethicon arterial cannula called DFK24, a life sustaining device used in heart bypass surgery, lost its tip during surgery, and had to be retrieved from the patient's aorta. He says he and the vice president of medical operations, a cardiac surgeon, decided in April that the DFK 24 must be recalled because "the risk of serious injury or intra operative death was very high." Ethicon's Quality Assurance Board decided to recall it on April 14, but Ethicon refused, and still had not recalled it when it fired him on May 15, 2006" It was subsequently reported that a recall of the DFK24 Heartport Direct Flow Arterial Cannula was initialted by Ethicon, Inc. on April 27, 2006, but the recall notice was not posted on the FDA website until June 9, 2006.
Duragesic Patch: Lethal Defects
Duragesic patches are manufactured by J&J subsidiary, Alza Corp., have received many safety warnings and have also been voluntarily recalled a number of times. The FDA issued a safety warning in December 2007 over the patches, saying improper use could cause breathing difficulties and death. That followed a July 2005 FDA alert put out after 120 patients taking the drug died. Johnson & Johnson stated in November 2007 that it faced 72 lawsuits over the patches. Most recently, in February 2008, J&J voluntarily recalled all 25-microgram-per-hour patches that are sold in the U.S. Johnson & Johnson stated they instituted the recall because manufacturing defects in the 25 microgram patches may cause leaks that can lead to fatal overdoses. It estimated that in all, about 32 million patches will be recalled. - Duragesic Patch Natrecor The controversy over Natrecor follows two recently published studies by Dr. Jonathan Sackner-Bernstein, a heart failure specialist at North Shore University Hospital in Manhasset, N.Y. The analyses, based on patient studies submitted to the F.D.A., linked the drug to worsened kidney function and hastened death. Some heart doctors, meanwhile, have raised questions about whether the drug, which some studies have linked to kidney problems and other potentially fatal effects, is safe enough to be used so frequently. Many of the questions have been fueled by articles in The Journal of the American Medical Association and another medical journal, Circulation.
What is beyond dispute is that, through Medicare, the taxpayers are footing most of the bill. Since Natrecor's introduction in 2001, the drug has become a brisk seller, generating sales of $400 million last year and has been forecast by some analysts to top $600 million this year. Dr. Packer, despite supporting Natrecor's approval in 2001, said developments since the treatment's approval had raised new questions.
"There's now additional mortality data that wasn't available at the time," Dr. Packer said. "And this is not a drug being used for a very small focus group of patients anymore. We felt comfortable for a focused group of patients. Now we've got a greater safety concern than we had then, and a greatly expanded use for patients for which we have no efficacy data."
Motrin: Stevens-Johnson-Syndrome
MALIBU, Calif., Jul 16, 2008 (BUSINESS WIRE) -- Sabrina Johnson's parents gave her Children's Motrin when she came home from school with a slight fever. Within 36 hours, she was admitted to Cedars-Sinai Hospital for the chemical burns to her eyes caused by the drug. This severe allergic reaction was the result of a rare condition called Stevens-Johnson syndrome. According to the plaintiff's attorneys, as many as 20 people had been blinded, seriously injured, or killed by Children's Motrin between its introduction to consumers in the 1990s and 2003 when Sabrina Johnson took the drug. However, the lawsuit (Los Angeles Superior Court -- Court Case No.: TC 018540) claims that Johnson & Johnson failed to warn parents and physicians of the possible side effects such as blisters, redness, and rash-like symptoms that ibuprofen could cause. Anthony R. Temple, former executive medical director for Johnson & Johnson's McNeil Consumer Products subsidiary, said he was aware of more than 40 cases of Stevens-Johnson Syndrome since Sabrina's hospitalization. According to the lawsuit, warnings about the full extent of these serious allergic side effects are still missing from the labels, despite a 2006 FDA order that McNeil Consumer Products, the manufacturer of Children's Motrin, list them on the label. - Upstart Lawyer Brings Johnson & Johnson to a Long-Awaited Justice JOHNSON & JOHNSON'S MISDEEDS GO ON AND ON... PATIENT ATTACHED TO BROOKLYN KIDNEY MACHINE DIES November 2, 1983 A patient attached to a faulty kidney dialysis machine died two weeks ago in Brooklyn, the Federal Food and Drug Administration said yesterday. The machine, at the Brooklyn Kidney Center, is the same model as one that failed in Dallas last Friday. Three people attached to the Dallas machine suffered almost simultaneous cardiac arrests and died soon afterward. Authorities said both the Dallas and the Brooklyn incidents occurred when blood being cleansed by the machines was returned overheated to the patients. But the F.D.A., the agency that regulates medical devices, said the fault in Dallas apparently was partly due to a miswiring at the factory, while in Brooklyn it apparently was a relay that failed because of a lack of maintenance. ''We are treating the two as unrelated incidents,'' said Christopher Smith, a spokesman in Washington for the F.D.A. Dr. Gross's Finding. An autopsy was performed on the patient who died at the Brooklyn center, a woman in her 50's, and according to Dr. Elliot Gross, the city's Chief Medical Examiner, the cause of death was coronary and kidney disease. Dr. Gross said it would be impossible to determine through an autopsy whether the machine had caused the death. The machines are made by Extracorporeal Medical Specialties, which has its headquarters in King of Prussia, Pa., and its factory in Tampa, Fla. The company is a subsidiary of Johnson & Johnson. Mr. Smith said there were about 110 similar machines made by Extracorporeal in 60 centers around the country. These machines cannot be recalled, he said, because kidney patients would die if they did not have access to them. He said that all the machines were being inspected and that so far the only other fault found was miswiring, similar to that in Dallas, in a machine in Ann Arbor, Mich. Mr. Smith said there had been no problems with patients in Ann Arbor. Technician Sent A spokesman for Johnson & Johnson said the Brooklyn center, at 184 Sterling Place in the Park Slope section and operated by Long Island College Hospital, had called Extracorporeal after the death on Oct. 17. A technician was sent from Extracorporeal and he found that a relay that was supposed to prevent the dialysis solution from overheating a patient's blood had failed, according to the spokesman, Lawrence G. Foster. Mr. Foster, who is corporate vice president for public relations at Johnson & Johnson, said that the relay was not one supplied by Extrcorporeal and that it had not been replaced within the past year. The directions from Extracorporeal, Mr. Foster said, were that the relay should be replaced annually. He said that the Brooklyn center had not hired Extracorporeal to maintain the machine. Machine Checked Long Island College Hospital would say only that the manufacturer had been called after an ''incident'' and had sent out a technician. When the technician departed, according to the hospital spokesman, Dale Timmons, he said the machine was in good condition. Miss Timmons said she was not authorized to say whether any repairs had been made or whether machine failure had caused the death. ''Deaths occur all the time in hospitals,'' Miss Timmons said. Repeated calls to the hospital's president, Harold Light, seeking comment, were not returned. In Dallas, Dr. Thomas Parker, the director of the Dallas Kidney Disease Center attributed the deaths there to machine failure due to miswiring at the factory and to a backup gas heater. In a statement, Johnson & Johnson said that its preliminary investigation indicated that an electrical part in the alarm system was miswired when the machine was manufactured seven years ago. Gas Heater Cited But, the statement said: ''This miswiring did not cause the dialysis treatment fluid to overheat, which was the apparent cause of death, but may have contributed to preventing the alarm system from functioning. The overheating was apparently due to a malfunction elsewhere in the system which was modified by the Dallas Dialysis Center since its installation seven years ago. This modification by the center involved a gas heater for the dialysis solution.'' The kidney centers around the country treat 70,000 people with end-stage renal disease who depend on thrice- weekly dialysis sessions at the centers to clear their blood of the impurities normally eliminated by the kidneys. The Dallas and Brooklyn dialysis machines are designed to serve several patients at one time. While three people hooked up to one machine in Dallas died after receiving the overheated blood, only one of the 13 attached to the Brooklyn machine died when it malfunctioned, Mr. Smith said. ''Those machines are not state of the art,'' Mr. Smith said of the Dallas and Brooklyn equipment, explaining that newer models were self-contained, serving only one person at a time. Johnson & Johnson sells Extracorporeal Medical Specialties In 1984, just months after Extracorporeal Medical Specialties dialysis machines malfunctioned, Johnson & Johnson sold the company. Johnson & Johnson did not take any responsibility for the malfunctions, nor did Johnson & Johnson take any responsibility for the resulting deaths. Ortho’s PR Cover-Up Ortho Pharmaceutical Corp., a wholly-owned subsidiary of Johnson & Johnson, pleaded guilty in January 1995 to one count of conspiracy to obstruct justice, one count of obstruction of justice, and eight counts of corruptly persuading employees to destroy documents relating to a federal investigation of the drug company’s Retin-A public relations campaign. The company will pay a $5 million fine and $2.5 million in restitution to the government. The charges against Ortho relate to a Food and Drug Administration (FDA), Department of Justice and grand jury investigation into an extensive public relations campaign, conducted by Ortho from 1985 to 1988, that generated publicity about Retin-A’s use in the treatment of sun-wrinkled, or “photoaged” skin, federal officials said. The FDA approved Retin-A in 1971 for the treatment of acne. But the agency has not approved Retin-A for use in the treatment of photoaging, nor has the FDA approved a new drug application that would permit Ortho to label or promote Retin-A for photoaging. Outside public relations agencies employed by Ortho conducted the extensive public relations campaign for Retin-A from 1985 through 1988. In 1988, the FDA began investigating Ortho’s involvement in Retin-A publicity. In late 1990, the Justice Department began its own investigation. On January 2, 1991, FDA investigators questioned two former Ortho employees about Ortho’s Retin-A public relations program. And on January 3, 1991, the Justice Department served a grand jury subpoena on Johnson & Johnson, Ortho’s parent, seeking documents from Johnson & Johnson and Ortho relating to the campaign to disseminate information about the use of Retin-A as a treatment for photoaging. Ortho admitted that on January 3, 1991, the day a grand jury subpoenaed documents from Johnson & Johnson, Ortho’s parent, high-ranking Ortho representatives directed and authorized employees to destroy documents and materials relating to the program to disseminate information about the use of Retin-A to treat photoaging. In compliance with this directive from high-ranking Ortho representatives, employees of the company destroyed thousands of documents, including documents showing that Ortho exercised close control and direction over the work of the public relations agencies employed by Ortho to generate Retin-A publicity. Employees also removed videotapes relating to Retin-A and photoaging from Ortho’s Main Administration Building, federal officials charged. “The destruction of documents by a major corporation to thwart a federal investigation is outrageous misconduct that simply will not be tolerated,” says Frank Hunger, head of the Justice Department’s civil division. Johnson & Johnson's 1-Day Wonder April 19, 2001 Johnson & Johnson has agreed to pay up to $860 million to settle a lawsuit that the company told consumers to throw out disposable contact lenses after one day while they could have been worn up to two weeks.
The lawsuit claimed that J&J's Acuvue and 1-Day Acuvue lenses are the same product, though 1-Day Acuvue costs much less than the two-week version. The lawsuit filed in state Superior Court in 1996 estimated that 6 million people who use contact lenses spent $1.1 billion since 1994 on lenses because of misleading advertising.
Jeff Leebaw, a company spokesman, said the company agreed to settle the lawsuit to put the matter behind it. The company has agreed to remove the words "disposable" and "for single use" from the 1-Day Acuvue packaging.
Jay Eisendorfer, a lawyer representing consumers in the class-action lawsuit, said "Johnson & Johnson, despite having one of the most prestigious names in the consumer products business, went far astray in this situation and allowed marketing people to get the better of the organization's ethical creed."
Leebaw said the company had always been "straightforward about its lenses" and criticized Eisendorfer for discussing the proposed settlement before its hearing, scheduled for Friday.
"His slurs against this company are an insult to the sensibilities of any fair-minded review of this case," Leebaw saidy.
If Superior Court Judge John Fratto agrees to the settlement after a hearing on Friday, Johnson & Johnson would be required to advertise on the Internet and with toll-free telephone numbers to tell consumers how to apply for compensation.
Leebaw said the $860 million figure would be the upper limit of the settlement, "if everybody absolutely pursued compensation in this thing." He said the company expects the actual amount paid out will be much less. Net pharmacy closing amid conflict questions
J&J's indirect control raises eyebrows
Oct. 28, 2006. 03:34 PM
DAVID BRUSER
An online drugstore owned by a major U.S. drug maker and run by a prominent Waterloo pharmacist is suddenly shutting down Monday amid questions about a possible conflict of interest.
The move comes after the Toronto Star started asking questions about the unusual arrangement that had industry observers worried.
PharmaDirect.ca is indirectly owned by New Jersey-based Johnson & Johnson and managed by pharmacist Phil Hudson — an unusual arrangement between drug maker and drug dispenser that has raised concerns about whether the traditional independence of pharmacists is being undermined by corporate interests.
Unlike typical pharmacies that sell drugs made by numerous manufacturers, PharmaDirect.ca sells to Canadians only over-the-counter drugs made by Johnson & Johnson.
Critics fear that this kind of exclusive relationship can result in consumers paying higher prices or not getting unbiased advice on the most effective drug for their needs.
"Due to changing strategic focus from the company's perspective the online pharmacy will be closed as of Oct. 30," said J&J spokesperson Lan Lai-Minh.
Industry experts have been raising ethical concerns about the unorthodox Internet drugstore in interviews with the Star in recent days.
"I haven't heard of this kind of thing before. How do you know whose interest they're putting first?" said Joel Lexchin, an emergency room doctor in Toronto, York University professor and a long-time pharmaceutical industry researcher.
"They could be seen as furthering the interests of their employer indirectly, Johnson & Johnson, and not the patients. Whether or not they are is irrelevant because there's the perception of a conflict of interest. That can take away the confidence that people should have in their pharmacists."
The Ontario College of Pharmacists, the province's regulatory body, would not talk to the Star about the online business managed by Hudson.
Hudson says he was president of the college in the mid 1990s and currently sits on one of its committees. Hudson also teaches at the University of Toronto.
Both Johnson & Johnson and Hudson had said before the shutdown announcement that they're doing nothing wrong, noting the pharmacy is fully accredited by the Ontario College of Pharmacists and operates as any independent pharmacy should.
"Nothing has ever arisen to make me question that the public interest was not being put first," Hudson has said. "As a pharmacist, that would be one of my first interests.
"At all times the primary role of the pharmacist is to have the public interest at heart. That should always be placed above self-interest."
Johnson & Johnson's ownership of PharmaDirect is not illegal. Ontario law says no corporation can own a pharmacy unless the majority of its directors are pharmacists. At PharmaDirect, two of the three directors are pharmacists who work at a Johnson & Johnson subsidiary, McNeil Consumer Healthcare in Guelph.
"This is troubling to me because I want to see independent advice," said Eleanor Friedland of the Consumers Council of Canada. "This does not look transparent."
Friedland said she'd rather buy from her pharmacist "across the street," who tells her whether there is a cheaper equivalent.
So, why not clearly label the website as a Johnson & Johnson enterprise?
"Johnson & Johnson is, firstly, not a Canadian company and the other thing is, it's to be able to provide the people a pharmacy or a name that makes sense," said J&J's Lai-Minh.
"There's no smoke and mirrors here. I don't think that knowing that Johnson & Johnson owns PharmaDirect — (and) we're not trying to hide that — is a detriment to consumers. I don't think that there's anything there that would cause a consumer to wonder."
While the site encourages consumers to call "our pharmacist" with questions, the number takes the consumer to a call centre in Guelph subcontracted by Johnson & Johnson.
A reporter posing as a potential buyer with a history of chronic headaches and with questions about possible side effects of using Imodium — a product available on PharmaDirect — reached an operator who consulted a medical textbook to advise on "contra-indications." The operator said "Pharmacist Phil," as he is identified on the PharmaDirect site, was not available at this number and that the consumer should consult his own health care professional.
At the Ontario Pharmacists' Association, where Hudson is a member, CEO Marc Kealey is troubled.
"If you're telling me that there's something missing, that is the proverbial counter (and) the access to reliable and expert information, that is unacceptable," Kealey said.
"What we strive to maintain is that you as a consumer will have access to that reliable and expert information from a pharmacist."
PharmaDirect appears to violate two of the college's guidelines on online pharmacy operations, which state that consumers should:
Avoid websites where the pharmacist cannot be directly identified, contacted or verified.
Avoid websites that ... can only be reached through a phone number that is answered by a customer service representative.
Johnson & Johnson says that the site, created six years ago, was designed to do two things: capitalize on the growing Web economy and consumers' increasing willingness and desire to buy online; and to provide a more private marketplace for products that consumers might not choose to buy in the more public setting of a bricks-and-mortar pharmacy.
They include so-called schedule III over-the-counter products — such as Monistat for yeast infections and Rogaine for hair loss — that cannot be sold in a corner store. Schedule III products are available in the regular consumer aisles of pharmacies but must be sold near the pharmacist's counter so consumers with questions can get answers. Hudson, who runs another pharmacy in Waterloo called Beechwood Wellness Centre, said his experience means he understands how to properly operate a pharmacy.
When told the Star could not reach him through the call centre, Hudson said, "I can be contacted by email. I answer probably 20-odd emails a week."
Email isn't good enough for Kealey, of the pharmacists' association.
"In most cases, people want telephonic information at the very (minimum).
Health care is all about communication." Orthopedic Surgeons' Buck-raking Exposed 11/05/2007 The top two earners were Thomas Thornhill, chair of the orthopedics department at the Harvard-affiliated Brigham and Women's Hospital in Boston, and Robert Scott, also at Brigham and Women's, who each collected $6.7 million in the first ten months of 2007 from DuPuy Orthopaedics, a unit of Johnson & Johnson. In a statement released Friday, the two men claimed the money came from consulting fees and from patent royalties on an artificial knee licensed to J&J in 1986 and an artificial hip licensed to J&J in 1991. They said in a prepared statement that they collected no royalties on DuPuy products used at their hospital, and all the consulting fees were donated to charity. Norman Scott of the Insall Scott Kelly Institute for Orthopaedics and Sports Medicine in Manhattan collected $5.5 million in payments so far in 2007 or about $25,000 a day from Zimmer Inc. The institute's website claims an affiliation with the Albert Einstein School of Medicine, but the Yeshiva University affiliate says Scott's appointment ended in 2005. A secretary at the institute refused to comment or put a call through to Scott. Richard H. Rothman of the Rothman Institute, the former chairman of the orthopedics department at the Thomas Jefferson Medical School in Philadelphia, received $2.4 million in 2007 or about $12,000 a day from Stryker, a division of Howmedica Osteonics Corp. A spokesman for the institute, contacted Sunday, refused to comment. A full list of the surgeons who collected more than $1 million in payments can be found here. With seniors accounting for nearly 70 percent of the knee and hip replacement market, Medicare spent $16 billion on the procedures last year. A typical knee replacement costs $33,000, according to Medicare records. A spokesman for Christopher J. Christie, the U.S. attorney in Newark, said the investigation into the alleged kickback scheme is ongoing. By Jim Edwards | March 3rd, 2009 @ 6:57 am How bad could that Texas lawsuit against Johnson & Johnson for mismarketing Risperdal be? Try $5,000 per visit of a sales rep to a doctor. That was the formula used in a West Virginia state court case in which the state attorney general sued J&J and its Janssen Pharmaceutica unit over false or misleading statements about Risperdal and Duragesic. The West Virginia judge assessed only $4.4 million in fines, but the formula he used — $5,000 per visit of a rep to a doctor plus $500 per letter or brochure — could have resulted in $22 million in fines. The court noted in its order, The defendants were twice put on notice by previous [FDA] warning letters that its promotional materials for Duragesic contained false or misleading statements; however … the defendants then willfully sent the false or misleading Duragesic [brochure] to West Virginia health care providers to make its medication Duragesic more appealing for sale. The wording of [the] November 2003 Risperdal letter was intentionally constructed to modify the FDA’s warning language and mislead healthcare professionals, who rely on this information when prescribing medication for their patients.
J&J faces a much bigger suit in Texas, where it has been accused of Medicaid fraud, kickbacks and improper marketing of Risperdal to children and the poor in that state. The FDA’s Risperdal warning letter is a big part of the Texas case, too. U.S. FDA warns J&J unit over antibiotic studies 2009-08-18 18:00:15 -0400 (Reuters Health) * FDA: unit did not properly monitor records, researchers * J&J says letter concerns ceftobiprole By Susan Heavey WASHINGTON (Reuters) - U.S. health regulators have warned Johnson & Johnson's drug development unit over its failure to properly oversee two clinical trials for an experimental antibiotic for treating skin infections. The U.S. Food and Drug Administration, in a letter released on Tuesday, cited "objectionable conditions" that included a failure to properly monitor the studies and ensure researchers followed the study plan, among other issues. "We conclude that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations," the agency said in a letter to Johnson & Johnson Pharmaceutical Research & Development (J&J PRD). The FDA withheld details about the drug in question and the clinical trial sites, but a spokesman for the J&J unit confirmed it involved ceftobiprole. "We will continue to work with the agency to address their concerns," said J&J PRD spokesman Ernie Knewitz. Most such warnings are handled without further regulatory action, but the FDA can impose fines, product seizures and other penalties. J&J had hoped to market the drug in the United States to combat skin infections. But in November 2008 the FDA declined to approve it and asked the company to further investigate issues at some trial sites and overall monitoring of its studies. It was not clear from the warning letter when the FDA conducted its investigation. But J&J PRD's Knewitz said it received its first notice from the agency June 12, 2008 and sent a response to the agency later that month. The unit sent two more responses in September 2008, but the company's responses were "inadequate," the FDA wrote. Among other issues, the company did not ensure that researchers conducting the studies were properly trained and experienced, the letter said. J&J chose a doctor at one site despite finding "that the investigator 'is not recommended' for lack of compliance in completing regulatory documents," according to the FDA. Knewitz said the two studies of the drug were being conducted at 150 sites worldwide and that "a handful of sites were identified by the agency as having issues." The FDA posted the letter on its website at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm177398.htm. | |
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