Plavix

Hemorrhages, strokes, heart attacks and gastrointestinal bleedings are among the most dangerous side effects of Plavix. Several studies published in many clinical journals showed convincing evidence that this medication may double the risk of these potentially fatal adverse reactions compared to acetylsalicylic acid (ASA). Although it was advertised as a safer drug on the stomach than Aspirin, BMS’s anticoagulant may increase the risk of recurring internal bleeds and ulcers by 12 times than ASA alone. The antiplatelet agent is so dangerous, that a clinical trial issued by National Institute of Neurological Disorders and Stroke to investigate its effectiveness, had to be stopped before it was completed because of the unexpected increase in mortality faced by the study’s subjects.

The manufacturers also encouraged the off-label prescription of clopidogrel to all patients who had a risk factor for cardiovascular diseases or stroke, such as obese or diabetic patients. However, these indications go well beyond the scope approved by the FDA and may actually lead to severe internal bleeding, bone marrow damage and other serious side effects. Plavix is, in fact, associated with other complications such as Thrombotic thrombocytopenic purpura (TTP), a rare and potentially fatal condition that causes blood clots to form inside the body’s smallest vessels. The increased risk of suffering an injury caused by one of these adverse reactions is not justified when there’s no properly evaluated benefit. The unscrupulous marketing tactics allegedly advocated by the manufacturers’ sales representatives thus endangered many patients’ lives just to increase their profit margins.

Back in 1998, shortly after Plavix first obtained clearance from the U.S. Food and Drug Administration (FDA), the regulatory agency identified several violations inside the promotional material used to advertise the product. The marketing material included false and misleading information that understated the drug’s side effects while overstating its safety. In May 2001, federal regulators issued a second warning letter, requiring manufacturers to stop making unsubstantiated claims about the blood thinner’s alleged superiority over Aspirin. Clopidogrel’s advertisement did, in fact, selectively avoided presenting all the unfavorable information to healthcare providers and patients as well. The pharmaceutical company ignored all warnings and kept presenting the public with misleading data that failed to communicate any risk associated with the antiplatelet agent up until 2009.

Bristol- Myers Squibb and Sanofi-Aventis deceptive marketing

The first Plavix litigation against BMS was filed in 2014, by Hawaii state officials who claimed the pharmaceutical companies failed to disclose critical information about Plavix’s lack of effectiveness. It seems that the blood thinner may, in fact, perform poorly in at least 30 percent of the population due to a peculiar genetic predisposition that prevents patients from properly metabolizing it. BMS and Sanofi-Aventis allegedly knew about poor metabolizers for at least 12 years, yet they never warned the public according to their product liability lawsuits. In addition, the state accused the Big Pharma of deceptively labeling and marketing the anticoagulant as safe and effective in both younger and elderly patients.

On June 29, 2016, a federal judge in New Jersey reinstated a Plavix whistleblower lawsuit filed by Elisa Dickson, a Sanofi-Aventis sales representative. In her False Claims Act complaint, the woman accused the company of instructing her to fraudulently promote this medicine as a superior alternative to ASA in patients who suffered to stroke.

On August 30, 2016, the California Supreme Court ruled that 8 Plavix litigations should proceed in San Francisco Superior Court. Those complaints allege that BMS and McKesson Corp. falsely advertised the anticoagulant as a better counterpart to Aspirin, despite its increased risk of serious, life-threatening side effects including heart attacks and internal bleedings. Allegations also include misrepresentation, failure to warn and at least 18 counts of wrongful deaths. These cases involved a total of 678 plaintiffs, but it has been reported that more than 5,000 other claims have been filed already across the United States and a lot more can join the litigation.

BMS is currently trying to dodge federal jurisdiction by presenting the argument that the company is headquartered in New York and New Jersey only. According to the pharmaceutical corporation’s plea, most California claims brought unrelated claims that included drug distributor McKesson Corp. However, BMS has at least five offices and 250 sales representative in California, so the Supreme Court ruled that the lawsuits could move forward.