Previous products liability cases implicating statins have famously involved cerivastatin (Baycol), a one-time rival to Lipitor, for causing rhabdomyolysis. The drug was pulled from the market in 2001 after it reportedly caused 31 deaths. Bayer, its manufacturer, paid about $1 billion in 2005 to settle some 3,000 cases. An example of a medication causing diabetes is quetiapine (Seroquel), an antipsychotic drug manufactured by AstraZeneca, which in 2011 agreed to pay $647 million to settle more than 28,000 lawsuits.
However, the upcoming Lipitor litigation may be more difficult for the plaintiffs to win. Among some of the medico-legal questions to be addressed are:
1) Was there prior company knowledge of the risk and a failure to warn?
2) Were the patients harmed by the drug, given that diabetes is a very common disease and may be linked more to genetics and/or an underlying metabolic syndrome in those who are hyperlipidemic, hypertensive, or obese – the very same patients likely to be on a statin?
3) Is Lipitor a defective product, and is it unreasonably dangerous?
Despite the FDA-directed change in labeling, a number of scientists and the FDA itself have emphasized that the cardiac benefits of a statin drug are greater than any small increased risk of developing diabetes.
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.