Bristol-Myers Squibb developed and sells Plavix, the antiplatelet drug used to prevent blood clots in patients with certain types of medical conditions. Although the company made billions of dollars on the drug, Plavix lawsuits may cost it even more. The company has been accused in many of these lawsuits of numerous counts of wrongdoing, including marketing a drug it knew to be harmful and less effective than safer alternatives.
The U.S. Food and Drug Administration (FDA) approved Plavix for certain uses in 1997 and Bristol-Myers Squibb heavily marketed it before the patent ran out. Now there are generic versions of Plavix on the market and available from other drug companies. In spite of the known risks and the questions about its effectiveness in actually preventing deaths, Plavix remains for sale under several different names.
Plavix and Its Uses
Bristol-Myers Squibb developed the drug clopidogrel in the 1990s and got it approved for several uses for patients in 1997 under the brand name Plavix. As a drug that prevents the formation of blood clots, Plavix is like a blood thinner, but works in a different way from other classes of these same drugs. It acts on platelets, the small fragments in the blood that clump together to form clots. Clopidogrel prevents these platelets from aggregating, so clots are not likely to form. This not only prevents clots, but also helps improve circulation. There is no way to reverse this process and there is no antidote, as there is for some other types of blood thinners.
The FDA approved Plavix for specific uses, but generally as a drug that prevents death by preventing blood clots that may cause strokes or heart attacks. It is approved to be used along with aspirin, which also acts as a blood thinner, for people with specific conditions: previous heart attack or stroke, severe chest pains, and peripheral artery disease. It may also be used for people who have had certain types of surgery: angioplasty with or without stent insertion and coronary artery bypass grafts.
Possible Side Effects
The most concerning and fairly common side effect of Plavix is, like other types of blood thinners, excessive and dangerous bleeding. However, there are other possible side effects, like shortness of breath, dizziness and lightheadedness, fatigue and weakness, headaches, nausea, vomiting, diarrhea, and stomach pain.
Rare but serious is a condition called TTP, which stands for thrombotic thrombocytopenic purpura. It is characterized by the formation of platelet clots in various small blood vessels throughout the body. This can cause blood flow to be restricted, but also takes platelets out of the bloodstream, which makes the risk of excessive bleeding even greater and potentially fatal.
Signs of TTP include small, red or purple spots on the skin, bruises, fever, fatigue, pale skin, jaundice, a racing heart rate, shortness of breath, headaches, changes in speech patterns, low urine volume, and confusion. If not treated it can cause seizures and ultimately lead to seizures and death.
The Risks of Bleeding Leads to Lawsuits
By far the most serious concern with taking Plavix is bleeding. This is especially a risk with Plavix because it is taken with another medication that restricts clotting, aspirin. Another factor that makes bleeding with Plavix so dangerous is that the effect of the medication is irreversible. There is no antidote to stop excessive and possibly fatal bleeding once it starts.
Signs of excessive bleeding while on Plavix and aspirin include tarry and bloody stool, black or bloody urine, vomit that resembles coffee grounds or that has noticeable blood, patches of blood pooling under the skin, severe bruising, a severe sudden headache, excessive nosebleeds, and any other kind of bleeding that seems unusual and can’t be stopped.
People who have suffered from serious bleeding while on Plavix, as well as the loved ones of patients who died from bleeding have filed Plavix lawsuits against Bristol-Myers Squibb. They feel that the lack of an antidote, the combination with aspirin, and other factors combined to make the risks of using Plavix worse than the benefits.
Effectiveness Controversy Strengthens Plavix Lawsuits
Since Plavix came out in 1997 research has found that it may not even be as effective as Bristol-Myers Squibb claimed it was in marketing and advertising. Recent research led up to a 2015 announcement from the FDA that stated that using Plavix in combination with aspirin is not any more effective than using it alone, but that this combination does increase the risk of bleeding. It also stated that using Plavix for 12 months, which increases the risk of bleeding, is no more effective than using it for six months.
These findings strengthen lawsuits against Bristol-Myers Squibb because it means that the company put patients at risk by pushing the use medication combination that was not as effective as the company claimed it was. This risky combination of drugs, which can and has caused people to die from bleeding, was no more effective at preventing death than a safer alternative. This fact could mean that Plavix lawsuits will be found in favor of the plaintiffs.
Examples of Plavix Lawsuits
Two lawsuits were filed over the deaths of patients in Chicago in 2013. By this time, there was already some evidence that Plavix with aspirin was not as effective as safer alternatives. Plaintiffs in the cases argued that Bristol-Myers Squibb offered a drug that was not more effective, that it promoted this drug that was more expensive to maximize profits, and that it misrepresented the safety and effectiveness to convince patients and doctors to choose Plavix over competitors.
In Hawaii, the state Attorney General started a lawsuit against Bristol-Myers Squibb over Plavix in 2014. Representing the state government, the Attorney General claimed that the company used deceptive and unfair marketing practices to sell Plavix to Hawaiian residents. A particular problem in this case is that some people do not metabolize Plavix well due to genetic factors. For these people Plavix won’t work.
This genetic factor is more common in people of Pacific Islander and East Asian descent, large proportions of the Hawaiian population. The state claims that Bristol-Myers Squibb unfairly marketed Plavix here, knowing that it wouldn’t be effective in a significant percentage of the population.
More recently, New Jersey also filed a lawsuit over Plavix under the state’s False Claims Act. If you took Plavix and it didn’t work for you or if you suffered from bleeding, you could make a case that Bristol-Myers Squibb did not warn you of these risks and that the company promoted it in an unethical way. A lawyer can help you take the next steps.