Bayer's Legal Woes: 125 Suits Over Yaz; FDA Allegedly Not Told of Trasylol Study
Bayer faces more than 125 lawsuits over its Yaz contraceptive and new cases are being filed around the country at a rate of up to up to six a day, according to Courthouse News Service.
The cases all claim the same thing: That the new progesterone ingredient that Bayer used for Yaz causes more dangerous blood clots to form than previous formulations. BNET noted in July that drospirenone allegedly causes a buildup of potassium that slows down the heart rate, allowing clots to form.
A new White Plains, N.Y., case alleges a slightly more detailed theory of causation involving dehydration:
Drospirenone blocks the hormone aldosterone, and can cause dehydration from increased potassium secretion and increased absorption sodium and water.
Studies have reported that the resulting electrolyte imbalance can lead to potentially fatal hyperkalemia arrhythmia and deep-vein thrombosis …
Separately, even though Bayer removed anti-bleeding drug Trasylol from the market in 2007, new lawsuits keep arriving. Three were filed in Wisconsin recently. One alleges that Bayer failed to tell the FDA that a 67,000-patient study showed Trasylol increased the risks of renal failure, heart attack and stroke:
After a 19-member advisory panel studied the matter, it recommended to the FDA that Bayer’s warnings on Trasylol did not need to be strengthened, the complaints say.
But just days after the panel’s recommendation, a professor at Harvard’s School of Public Health contacted the FDA about a 67,000 patient study he helped to perform at Bayer’s request. The study confirmed that Trasylol increased the risk of renal failure, heart attack and stroke, the plaintiffs claim. In addition, it suggests that patients who receive Trasylol are at an increased risk of death, kidney failure and congestive heart failure.
Bayer knew of the study and its results, but failed to disclose the data to the FDA, according to the complaints.
- Previous items on Bayer and contraception:
- On Yaz, Bayer Believes “a Multiple of a Rare Event Is Still a Rare Event”
- BMJ: Ingredient in Bayer’s Yaz Causes More Blood Clots Than Rivals
- Suits Claim Bayer’s Yaz Caused 50 Deaths; Novel Theory of Blood Clot Causation
- Bayer’s Trasylol Killed Too Many People; Lawsuits Arrive
Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.
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