Plavix lawyers at Pintas & Mullins Law Firm report that dozens of plaintiffs have filed suit against manufacturers Sanofi and Bristol-Myers Squibb over the blood-thinner Plavix (clopidogrel). Patients in the U.S. and abroad are claiming the drug made them develop autoimmune diseases and suffer severe hemorrhages.
U.S. plaintiffs took their claims to New York state court recently after taking Plavix to recover from strokes, stent placements, and other medical events requiring blood-thinning medications. Patients require blood-thinners to keep blood from creating dangerous, potentially fatal clots in veins and arteries.
Our Plavix attorneys recently reported that the consumer watchdog group Public Citizen requested that the FDA place a Black Box Warning, the agency’s most severe caution, on the drug’s labels. Public Citizen cited several studies which found that patients taking Plavix for long periods of time (at least one year) not only failed to improve in health, but had an increased risk of fatal internal bleeding as well. Plavix already includes a Black Box warning, implemented in 2010, which tells consumers that 2 to 14% of the population cannot properly metabolize the drug and will not benefit from its use.
Indeed, recent medical breakthroughs have shown that nearly a third of the millions of patients taking Plavix have a genetic variant of the enzyme needed to convert the drug to its active form. This means that one-third of those paying $4 a pill for Plavix are not benefiting from it, and are unnecessarily at an increased risk from blood clots and fatal bleeding episodes. Had the drug been subjected to a more rigorous approval process, this surely would have been made known sooner.
The complaints filed by plaintiffs in New York are all common in that they accuse Plavix of being defective and dangerous for human health. They also accuse Sanofi and Bristol-Myers of advertising a drug unfit and unsuitable for consumption, and for placing profits over patient safety in expediting Plavix’s approval in the U.S.
Plavix submitted an application to the FDA for approval after only one clinical study had been conducted. After a rare priority regulatory review, the FDA approved Plavix in 1997, however, several members of the federal panel expressed concerns about the drugs’ actual benefits. They were not convinced that Plavix was any more effective than over-the-counter Aspirin. As additional studies were conducted on the drug, this concern was brought to light and eventually confirmed.
Despite this, by 2012, Plavix was the world’s second-best-selling medicine, due in no small part to Sanofi and Bristol-Myers’ deep pockets and masterful (and illegal) marketing campaigns. In July 2013, over three dozen Plavix users and their families sued the drug makers over allegations that they pushed physicians to over-prescribe the drug. They claim that the companies knowingly ignored clinical evidence that Plavix was no more beneficial than Aspirin and carried severe, life-threatening risks.
These lawsuits also include the master complaint filed against Plavix in 2012 on behalf of those who died or became severely ill after using the blood thinner. This master complaint argues that Plavix was improperly labeled and failed to warn patients of the dangers associated with its use.
Other lawsuits regarding Plavix stem from accusations of off-label marketing. These suits allege that the drug makers created and acted on a scheme to market Plavix as superior to its competitors despite this falsehood. This fraudulent marketing caused several government health programs, such as Medicare, to pay for prescriptions they otherwise would not have.
Further compounding its legal woes, Sanofi and Bristol-Myers are also accused of manipulating clinical trial data to support its marketing claims of superiority. Plaintiffs claim the companies also knowingly downplayed the drugs’ side effects and health risks, which include the risk of developing haemophilia, a rare autoimmune disease.
Plavix attorneys at Pintas & Mullins Law Firm have decades of experience in pharmaceutical litigation and are currently reviewing cases concerning Plavix injuries and wrongful death. If you or a loved one was prescribed Plavix and suffered a serious bleeding episode, you may be entitled to compensation for your medical bills and lost wages, and should contact an experienced attorney as soon as possible.