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Plavix (clopidogrel bisulfate) is a blood thinner originally approved by the Food and Drug Administration (FDA) in 1997. Today Plavix is a blockbuster product for manufacturers Sanofi-Aventis and Bristol-Myers Squibb Co., with worldwide sales of $9.5 billion in 2009 alone. However, reports abound linking Plavix with bleeding, stroke and other serious, even fatal, side effects.

Studies have shown the drug may not be as effective as advertised and that the manufacturer failed to warn patients and professionals of the dangers. Patients who suffered adverse effects while using Plavix may pursue compensation for monetary losses and physical and emotional suffering. Heirs of patients who have died after taking Plavix may also pursue compensation for their expenses and suffering. If you or a loved one has been injured by Plavix, contact an attorney to learn more.

Compensation for Plavix Side Effects

"Poor Metabolizers" – FDA Issues Black Box Warning

In March 2010, the FDA issued a black box warning (the agency's most serious warning) to alert the public that patients with certain genetic factors have been identified as "poor metabolizers" of Plavix. Plavix may not be as effective in preventing heart attack, stroke and cardiovascular death in these patients because their bodies do not effectively convert Plavix into its active form.

The FDA estimates 2 percent of Caucasians, 4 percent of blacks and 14 percent of ethnic Chinese are poor metabolizers of Plavix.

Poor metabolizers can be identified through a $500 genetic test. The FDA recommends that physicians consider a different anti-clotting drug for patients who are found to be poor metabolizers of Plavix.

Plavix is an anti-clotting medication prescribed to reduce the risk of blood clots, heart attacks and strokes for certain patients who are at risk (e.g., patients with disease of the heart or blood vessels). However, studies have linked Plavix to serious and possibly deadly side effects, including stroke, heart attack, gastrointestinal bleeding, ulcers, thrombocytopenia (low platelet count) and other blood disorders.


If you have been harmed as a result of taking Plavix, you may be entitled to recover the following damages:

  • Pain, suffering, anxiety and disability
  • Costs of medical care, treatment, and services
  • Lost wages and decreased earning power
  • Loss of love, care, affection, companionship
  • Loss of enjoyment of life (i.e., a decreased ability to participate in activities enjoyed before the injury)

Survivors of loved ones who have died while taking Plavix may be entitled to recover the following defective drug death damages:

  • Medical care and services
  • Funeral and burial expenses
  • Lost love, affection, companionship, care, protection, and guidance
  • Pain, grief, sorrow, anguish, stress, shock, and mental suffering
  • Income, gifts and other financial support lost as a result of the death

In many jurisdictions, punitive damages might also be awarded in personal injury and wrongful death cases to punish the defendant for bad acts.

Defective drug law suits require medical and legal expertise. If you or a loved one suffered harm as a result of taking Plavix, it is best to speak with a defective drug attorney about recovering compensation to help you cope with your injuries and damages.

Plavix Liability

Other Factors

Plavix side effects have been linked to certain genetic profiles, medical conditions, medications and other factors. Studies have shown:

  • Plavix may actually double the risk of heart attack, stroke or serious bleeding in patients with high cholesterol or high blood pressure.
  • The rate of heart attack and death nearly doubles during the 90 days following discontinued use of Plavix (the "rebound effect").
  • Certain Plavix users are 12 times more likely to experience recurrent ulcers or gastrointestinal bleeding than those taking aspirin and a heartburn pill.
  • The combination of Plavix and aspirin is no better than aspirin alone at preventing deaths, heart attacks, and strokes in people at high risk for cardiovascular disease. Furthermore, in patients with certain risk factors, the combination may do more harm than good.

Sources: New England Journal of Medicine, Journal of the American Medical Association

Pharmaceutical manufacturers must take comprehensive measures to ensure that drugs are safe for their intended use. Some of the responsibilities include adequately testing the product before seeking FDA approval; providing adequate warnings about drug interactions, adverse reactions and serious side effects; and providing adequate warnings about preexisting conditions and other factors which may increase the risk of harm.

The FDA has issued numerous warnings to alert the public to the potential dangers associated with Plavix use. Most recently, the FDA warned that Plavix may not be as effective in preventing blood clots, strokes and heart attacks in patients taking Prilosec or Prilosec OTC (heartburn medication) and issued a "black box" warning (see sidebar) that patients with certain genetic profiles may not get the full benefits of the drug.

Victims of Plavix have filed lawsuits alleging:

  • Plavix is defective in its design and formulation
  • The possibility of side effects outweighs the benefits
  • There are safer alternatives to Plavix available
  • Manufacturers concealed the risks associated with Plavix

Some of the lawsuits filed also note that many physicians would not have prescribed Plavix if the actual risks were known.

FDA approval of a drug does not insulate a drug manufacturer from liability for harmful defects and side effects associated with its products. When a drug manufacturer fails to take adequate steps to ensure the safety of a medication, or when a drug is unavoidably unsafe, they may be held liable for injuries and other damages based on legal theories such as strict liability, negligence, misrepresentation and failure to warn. Every state has its own laws concerning product liability, so it is important to speak with an experienced attorney to learn more about the laws in your state.

Defective Drug Attorneys

Plavix has been the subject of FDA warnings time and again. As far back as 1998, the FDA warned the public that Plavix was falsely advertised as being more effective than aspirin in treating heart disease. If you or a loved one has been harmed as a result of taking Plavix, you may wish to contact a product liability attorney about the possibility of recouping damages from Plavix manufacturers.