Type 2 diabetics who have experienced serious side effects as a result of taking Avandia -- or survivors of patients who suffered fatal complications caused by its use -- may be closer to compensation for the medical problems they have faced. This follows the release of a key US Supreme Court decision that establishes pharmaceutical manufacturers' responsibility for issuing accurate and timely warnings about the known side-effects and risks of the drugs they manufacture.
The US Supreme Court decision in the case of Wyeth v. Levine establishes the principle that pharmaceutical manufacturers bear the primary responsibility for drug labeling, and can be found negligent if they fail to issue adequate warnings about all the known risks to patients of a drug they manufacture and distribute. This kind of failure can render a company vulnerable to lawsuits launched by or on behalf of consumers who suffered serious injury or died because such information was not made available. In the case of Avandia, independent studies in 2007 and 2008 -- based in part on evidence available in the company's clinical trials data -- found a much higher possibility of serious side effects than had been acknowledged by GlaxoSmithKlein, including the risk of PPH, heart attacks, congestive heart failure, serious liver damage, and bone fractures in women.
Avandia, approved by the FDA in 1999, is one of a class of drugs known as PPAR antagonists, which act to increase sensitivity to insulin in peripheral tissues. These drugs work by activating or suppressing dozens of genes; their effects on the body are complex, wide ranging and not fully understood. Initial warnings issued with the drug included possible weight gain, fluid retention, back pain, headache, cough or cold, and sinus inflammation. After further clinical trials, warnings of more serious side effects were issued. These included the risk of hypoglycemia, macular and/or cardiac edema, anemia and liver damage. It was independent scientists, however -- not the company -- who subsequently discovered and made public indications of the much higher level of risk and serious side effects that accompanied use of the drug.
When a group of investors filed a class action suit against GlaxoSmithKlein in 2008, they contended that the company had failed to adequately disclose the results of its own meta-analysis. This analysis also showed the increased risk of heart attacks demonstrated in the 2007 analysis presented by Nissen and Wolski in the New England Journal of Medicine. Publication of that information in the NEJM caused the number of prescriptions for Avandia to drop sharply, affecting the value of the company and their investment in it. The investors filed for compensation for the injury to their financial health caused by the company's failure to disclose all pertinent information. The US Supreme Court ruling in favor of Levine allows patients and their families affected by the same concealment of information to seek redress based on the company's failure to warn them of the true dangers of taking the medication for the pain and loss caused by that failure.
Determining who may successfully seek compensation and on what basis is often complex task. In establishing who may be able to file suit against a company -- either individually or as part of a class action -- requires the analysis of a number of factors. These include the applicable statutes of limitations -- which vary from state to state -- the type of suffering caused and how directly it can be shown to be related to a manufacturer's failure to issue the necessary warnings in a timely manner.
For this reason anyone who may have cause to seek compensation for damage caused by taking Avandia should take steps to have their case assessed by an attorney as soon as possible. It is important to seek the help of someone both experienced in working with medical product liability cases and knowledgeable about Avandia.
Depending on the advice of your lawyer, you may decide to participate in a class action suit. This will give you access to more legal and scientific resources, lower individual costs, and may increase the likelihood of settlement -- though it may also mean lower compensation for each individual class member. An attorney can advise you whether participating in a class action suit or suing as an individual is best in your case.