Category: Dangerous Drugs

Defendant AbbVie Seeks to Delay Androgel Bellwether Selection in Multi-District Litigation Androgel lawsuits continue to be filed in federal court alleging that Defendant manufacturer AbbVie failed to adequately warn about the risk of heart attacks, blood clots and other side effects associated with the popular testosterone replacement therapy. Defendant is now seeking to delay the bellwether trial selection process in the federal multi-district litigation (MDL) which is centered in federal district court for the Northern District of Illinois before Judge Matthew Kennelly. As part of the coordinated pretrial proceedings in the MDL, the parties have been directed to exchange fact sheets containing specific information about each claim, so that a small group of Androgel injury lawsuits can be selected for a bellwether trial process. AbbVie currently faces about 800 product liability lawsuits filed in U.S. District Courts nationwide involving use of the testosterone gel Androgel, which recent studies have linked to serious and potentially life-threatening cardiovascular risks. Earlier in May, AbbVie filed a submission with the Court for the MDL with respect to Plaintiff fact sheets alleging that information about many of the cases have not been timely filed or…

The FDA has agreed to a fast-track review process for a potential reversal agent for the blood thinner Pradaxa, which has been linked to thousands of serious and sometimes fatal injuries due to uncontrollable bleeding events. Boehringer Ingelheim, the makers of Pradaxa, announced on April 23 that the FDA has announced expedited review for a drug which may be able to rapidly reverse the blood thinning effects of the anticoagulant. The decision means that the drug's review will be accelerated and, if approved, could get to patients faster than normal for new drugs. If approved by the FDA, idarucizumab, the name of the reversal agent, would be the first reversal agent to hit the market for a new generation of oral anticoagulants used to prevent strokes in patients with atrial fibrillation. The class, which includes the blockbuster drugs Pradaxa, Xarelto, and Eliquis, has been linked to uncontrollable bleeding events because they were released without antidotes that doctors can use in the event patients suffer hemorrhages or other bleeding events. The drugs have been promoted as superior replacements for generic warfarin, which has been on the market for many years, with…

The straightforward question in this case is whether a pharmaceutical company is immune from responsibility to respond in damages for lack of due care resulting in personal injury or death, except for two discreet grounds, namely, on account of drug impurities or deficient warnings.  The drug regimen which gave rise to the shorthand terms, "Fen-Phen" and "Phen-Fen" is at the center of this case.   Justice Saylor's writing for the majority argued that there is greater flexibility with regard to traditional fault-based liability, i.e., negligence, where the conduct of manufacturers and/or suppliers are squarely in issue.  For policy reasons the court has declined to extend strict liability into prescription drug arena.  However, it has not immunized other drug companies from other governing aspects of Pennsylvania tort law delineating product manufacturer duties and liabilities.   The court wisely noted the importance of direct-to-consumer advertising and the evolution of the health-care delivery system encompassing new forms of managed care.  In the situation where no warning would be sufficient, the learned intermediary doctrine should not apply to diminished duties of pharmaceutical companies, or to insulate them from liability for lack of due care.…