There have been a number of recent developments in the coordinated multi-district federal proceedings (MDL No. 1871) pending in the United States District Court for the Eastern District of Pennsylvania against GlaxoSmithKline, the manufacturer of Avandia (rosiglitazone):
- Congestive Heart Failure Claims – Judge Rufe held hearings in late July on the drug manufacturer’s request that these cases be dismissed. GSK argues that the warnings regarding Avandia causing or exacerbating congestive heart failure (CHF) have been part of the drug’s warning label for more than a decade, and that for this reason, the defendant contends that no plaintiff can maintain a claim that these warnings were inadequate. No ruling has yet been announced on this important issue.
- Stroke Claims – On August 15, 2011, the parties proposed a schedule for briefing and argument for Daubert proceedings with regard to cases involving plaintiffs who suffered Avandia-induced strokes. A Daubert proceeding is used to attack the weight and sufficiency of expert testimony with regard to proof of causation. They can be utilized by either side in litigation in order to limit or exclude expert testimony. In order to prove causation in the Avandia litigation, the plaintiffs must prove, to the satisfaction of the judge, that there is sufficient support in the medical and scientific community that Avandia causes strokes in the general population. This evidence is usually comprised of clinical trial data, published case reports, clinical studies, and epidemiological data. Once that generic causation hurdle is met, individual plaintiffs would then have to prove, through expert testimony accepted by the Court that their particular injury was caused by use of Avandia. The parties have asked Judge Rufe to conduct this hearing on the sufficiency of the evidence regarding the generic stroke causation during the week of November 7, 2011.
- Additional Hurdles for Injured Plaintiffs – GlaxoSmithKline has also filed a number of additional motions seeking rulings from Judge Rufe that would have the result of dismissing pending Avandia cases and/or making them more difficult and costly to prosecute. These requests include capping attorneys’ fees; requiring expensive expert witness reports at earlier stages of the proceedings; dismissal of cases for failure to timely provide completed Fact Sheets, authorization forms, and Physician Certifications; and dismissal of cases where GSK contends that the statute of limitations period has expired. The MDL judge issued a “lone pine” order last year, which increased the demands on new plaintiffs filing actions in the MDL, including the requirement that they provide a Physicians Certification to substantiate use of Avandia and the timing of their Avandia-induced injury, but GlaxoSmithKline is urging the court to enter a second order which would further raise the bar for injured plaintiffs.
Judge Rufe has ordered counsel for plaintiffs to file case lists, including detailed claim information, by the end of August of 2011 and to update these lists each month. Presumably, the filing of these lists will assist the court and GSK to easily analyze its exposure and perhaps evaluate settlement and litigation strategies with regard to this latest wave of filings.
There has also been a lot of news from the various state court proceedings involving Avandia this summer:
- Pennsylvania – At this time, there are only 16 cases which remain pending in the state court proceedings in Philadelphia. Nearly 1,000 cases that were previously filed in this court have been recently settled. Judge Moss held a hearing on July 13, 2011, and discussed scheduling issues pertaining to a number of upcoming trials which are slated to occur between November of 2011 and January of 2012.
- California – Approximately 83 cases remain pending in the coordinated proceedings before Judge Berle. More than 3,100 plaintiffs have settled and dismissed their cases over the past few months. The first trial in Los Angeles is scheduled to begin on November 28, 2011, with additional trials anticipated in the first quarter of 2012. Scheduling orders have also been issued requiring the parties to begin depositions and pre-trial preparation of additional pending Avandia cases.
- New Mexico – Only 14 plaintiffs still have cases pending in New Mexico. The cases are assigned to several judges in that state. The first Avandia trial in New Mexico is scheduled for November 21, 2011, and additional trials are currently slated for March 12, 2012, and June 18, 2012. The cases of 117 New Mexico plaintiffs have now been dismissed following settlement of their individual claims with GSK earlier this year.
- Illinois – Three different state court judges in St. Clair County, Illinois are overseeing the pending Avandia cases of 940 plaintiffs. These cases are still very early on in the litigation process, and no trial dates have been scheduled yet in this jurisdiction.
- Alabama – There are currently 2 cases involving 3 plaintiffs pending in Alabama. These cases are in the early stages of litigation.
- Missouri – The cases of more than 2,100 plaintiffs are pending before several judges in this state. No trials have yet been scheduled and depositions have not yet begun.
Obviously, there are a number of upcoming trials, anticipated rulings, hearings, and other matters that could impact the viability of a number of pending cases as well as the advisability of GlaxoSmithKline continuing to litigate claims involving Avandia-induced heart attacks, strokes, and heart failure.