The incretin-based therapies litigation is in full swing in the Federal District Court for the Southern District of California (San Diego). Byetta (Amylin / Eli Lilli), Januvia (Merck), Janumet (Merck), and Victoza (Norvo Nordisk) are popular diabetes drugs that have been associated with an increased risk of pancreatic cancer and thyroid cancer. Unfortunately, none of the manufacturers have seen fit to properly warn prescribing physicians and the general public of these increased risks. In fact, rather than provide objective and useful reports on the various studies linking these drugs to these potentially fatal side effects, the drug company Defendants in this litigation prefer instead to criticize those studies and the scientists behind them.
Last month, the multidistrict litigation (MDL) Court entertained a two-day science presentation by the Plaintiffs and Defendants. Lawyers on both sides of the aisle spent two full days describing how these drugs affect the human body, differentiating between medical causation and legal causation, dissecting various clinical trials and case studies, and presenting the accumulating epidemiology of incretin-based therapies. In short, there are some studies suggesting a clear and discernable association between the drugs and pancreatic cancer, while others do not.
It’s no surprise that the studies reporting no association are typically funded by the pharmaceutical industry. Interestingly, when the statistical analysis of some of these industry studies is carefully scrutinized, a number of studies actually reveal an association between the drug and increased cancer risk, despite the authors’ stated conclusion to the contrary. Other industry studies claiming no association were not adequately powered to reveal an increased incidence of pancreatic cancer and, indeed, some studies claiming no observed association were not even looking for pancreatic cancer.
When it comes to evaluating the strength and reliability of these complicated studies, it is critical to look behind the stated conclusions of the authors, and fully evaluate the data presented. That is the only way to fully appreciate whether the study was adequately powered, properly designed and accurately interpreted by the authors.
The incretin-based therapies MDL is now up to nearly a thousand cases. The first bellwether trial is still about a year away. As to be expected, and as evidenced by the first salvos from the Defendants during the science presentations, the major battles between the litigants will concentrate on the science and causation. The Plaintiffs are well-organized and hold considerable resources, and we continue to consult with and retain the foremost experts in the world to present our cases. Lawyers in the Mass Torts Section are investigating all cancer cases in patients who took these four drugs. If you need more information or have a potential claim, contact David Dearing, a lawyer in the Section, at David.Dearing@beasleyallen.com or call him at 800-898-2034. He will be glad to talk with you.
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