South Carolina Lawyer Blog

Trasylol, a defective drug manufactured by Bayer AG, may have claimed as many as “1,000 lives per month” in the time before it was recalled, according to a doctor who presented a study to the FDA in September 2006. It wasn’t until November 2007, however, when the Canadian Data Safety Monitoring Board had stopped a Trasylol trial after a data analysis indicated that the 30-day mortality risk in the study’s patients was nearing “statistical significance”, that Bayer suspended sales of the drug in the US at the FDA’s request.

Trasylol is a drug used to prevent bleeding during heart bypass surgery, and before it was removed from the market, about a third of all bypass patients had received Trasylol. The initial reports from the Canadian study suggested an increased risk of death for Trasylol users compared with two other antifibrinolytic drugs. There had also been reports linking Trasylol with kidney problems, amputations, heart attacks and strokes.

Dr. Dennis Mangano, who presented his study to the FDA which found that Trasylol increased the risk of kidney failure requiring dialysis, as well as death, believes Trasylol should have been taken off the market when he published his study in 2006. Bayer executives, in fact, attended Mangano’s presentation in order to defend Trasylol. What they did not tell the FDA was that their own Trasylol study, known as the 13 drug report, confirmed Mangano’s findings. That study, which analyzed a database of hospital patients who were given the drug, suggested the drug’s use could also increase the likelihood of serious kidney damage, congestive heart failure and strokes. Even after learning about the 13 drug report, however, the FDA allowed Trasylol to remain on the market, adding only a warning label to its packaging explaining that the drug placed patients at high risk of kidney failure. Between the study’s publication and November 2007 when Bayer removed Trasylol, close to half a million patients received the drug.

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Merck & Co., manufacturer of the painkiller Vioxx, said Friday November 9th that it will pay $4.85 billion to end thousands of state and federal lawsuits over its painkiller Vioxx in one of the largest drug settlements ever.

Vioxx was developed to treat arthritis, but was pulled from the market on September 30, 2004 after its researchers determined that continued use of the product doubled risk of heart attacks and strokes. At the time that the medication was recalled, Merck & Co. was pulling in about $2.5 billion a year in sales of the drug. To qualify for a settlement, plaintiffs must have filed claims by a certain date and meet several criteria, including medical proof that they suffered a heart attack or stroke, that they received at least 30 Vioxx pills and that they received enough pills to support a presumption that they were ingested within two weeks before injury.

Company officials stressed that the agreement is not a class action settlement and that it is not admitting fault. They estimated the deal, if accepted, would end 45,000 to 50,000 personal injury lawsuits involving U.S. Vioxx users who suffered a heart attack or ischemic stroke, the type in which blood flow to the brain is blocked.

The agreement becomes binding only if 85 percent of the plaintiffs in key categories agree to the deal: all pending heart attack and ischemic stroke cases, all cases involving deaths and all cases alleging more than 12 months of Vioxx use. Potential claimants will have to have prior medical documentation of a heart attack or stroke, and they will not be able to later opt out of the settlement. Also, all law firms involved in the “steering committees” directing pretrial discovery and other coordination of both state and federal cases must get every one of their clients to settle.

The numbers involved in this settlement are staggering. While $4.85 Billion may seem like an astronomical number, it is interesting to note that upon announcement of the terms of the agreement, Merck & Co. stock went up 2 percent, to $55.90 – trading near their 52 week high of $58.36. The Food and Drug Administration approved Vioxx in 1999, and in the years following its release, the drug was used by over 84 million people around the world. Although studies conducted around the time that the drug was approved for distribution showed that there were hypertension related side effects associated with Vioxx, the drug was made available across the globe.

The South Carolina prescription drug lawyers at the Louthian Law Firm can help you if you or a loved one has suffered any serious side effects as the result of a taking prescription drugs. Contact us immediately to discuss your case with a dedicated legal professional. Our attorneys can begin helping you as soon as you contact us, and may be able to recover for you the monetary compensation that you deserve for your serious injuries.

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After hearing testimony that the drug increases the risk of suicidal thoughts, even in patients without a history of depression, Federal health officials unanimously rejected the weight loss drug, rimonabant, manufactured by Sanofi-Aventis SA. The panel said that the company failed to show the drug is safe.

Judging from the back-to-back 14-0 votes by the expert panel it is unlikely the Food and Drug Administration will approve the drug. The agency usually follows its panel’s advice, but it isn’t required to do so.

“There is a reasonable suspicion we better learn some more and watch this affair more closely before we launch into massive use of this drug,” said panelist Dr. Jules Hirsch, a senior physician at New York’s Rockefeller University.

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FDA Commissioner Andrew von Eschenbach said at a congressional hearing Wednesday that
the FDA is going to require stronger warnings about heart failure on the diabetes drugs Avandia and Actos.

The FDA is directing GlaxoSmithKline to add a "black box" warning to Avandia and ordering Takeda Pharmaceuticals to do the same for its competing diabetes drug Actos, strengthening existing warnings about a condition in which the heart does not adequately pump blood. The issue is separate from an analysis in the New England Journal of Medicine that said Avandia increased the risk of heart attack.

The concerns about Avandia prompted Democratic lawmakers to call for increased regulation of the pharmaceutical industry. Rep. Henry Waxman, D-Calif criticized the FDA for not alerting consumers sooner about the drug's potential dangers.

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Chicago Tribune staff reporter Bruce Japsen reported that gifts which are showered on doctors by drug and medical device makers have become so pervasive that they are a standard part of virtually every United States physician’s practice.
“Despite self-policing initiatives launched by organized medical groups and the drug and device makers to curb the cozy relationship between physicians and industry, 94 percent or virtually all physicians have at least one type of relationship with the drug industry, according to a study which was scheduled to be published in the New England Journal of Medicine.”
Drug marketing and conflict of interest between doctors and medical product companies have come under scrutiny because of their impact on cost and because of safety issues involving heavily promoted drugs. Eric Campbell, the studies lead researcher and co-author who is an associate professor of medicine at the Institute for Health Policy at Massachusetts General Hospital and Harvard Medical School, says that “relationships with industry are a fundamental part of the way medicine is practiced today.” He went on to say that consumers have a reason to be concerned about what the study found.
The American Medical Association guidelines, which are voluntary, say that any gift to a physician should “primarily entail a benefit to patients and should not be of substantial value”. When physicians accept gifts they should be worth less than $100 and “benefit patients.” Studies suggest that many doctors do not always follow the AMA guidelines.

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