The first of the Pradaxa lawsuits to go to trial in multidistrict litigation (MDL) will be the complaint filed by Suzanne Mackiewicz. This plaintiff filed her lawsuit on behalf of her father, Malachy Higgins, deceased. Mackiewicz expects to have her day in court on September 8, 2014. During her trial, she will testify that the defendants, Boehringer Ingelheim, marketed a defective medication, Pradaxa, which allegedly led to the death of her father.
Currently, there are over 2,000 Pradaxa lawsuits pending in the MDL, which is proceeding in the U.S. District Court for the Southern District of Illinois before the Honorable Judge David R. Herndon. The U.S. Judicial Panel on Multidistrict Litigation (JPML) established the MDL to improve the efficiency of pretrial proceedings in cases with similar allegations and statements of fact. The MDL also prevents the possibility of conflicting rulings and duplicative discovery.
Each plaintiff in the MDL retains the right to an individual trial. The first four cases to go to trial, including that of Mackiewicz, are known as bellwether trials. Following the resolution of these initial trials, the remaining cases will be remanded to their home districts for resolution if settlements aren’t reached beforehand.
Pretrial schedule established
Judge Herndon issued a new Case Management Order on April 9, 2014, which established the pretrial schedule for the Mackiewicz complaint. The plaintiff must submit her witness list by July 2 and the defendants must do the same by July 9. Witness deposition is expected to be completed no later than July 31. The parties have been instructed to file any motions in limine no later than August 8. These motions are used for the purpose of excluding specific issues or evidence in trial. On September 8, the selection of the jury will begin and the parties are expected to make their opening statements on September 15. The trial may extend over a period of several weeks before a jury verdict or settlement is reached.
Outcome may influence other trials
In an MDL, the bellwether trials serve an important purpose. They often establish a trend in litigation by allowing the parties to evaluate the reactions of the jury to various evidence and testimony. Although the outcome of the Mackiewicz trial is not binding on any other complaint in the MDL, the defendants may be more apt to discuss settlement offers with other plaintiffs if the jury returns a substantial verdict for this first case.
Like other Pradaxa lawsuits in the MDL, this wrongful death lawsuit claims that Pradaxa is defective in design and manufacture because it lacks an antidote to quell uncontrolled bleeding. Pradaxa (dabigatran) is a blood-thinning medication that was first marketed after its October 2010 approval by the FDA. It was intended to reduce the risk of stroke in patients with certain risk factors. Pradaxa was marketed as a better alternative to older generations of blood-thinners, namely warfarin (Coumadin). Warfarin required regular monitoring of patients and dietary restrictions; Pradaxa was marketed as more convenient because these measures were not necessary.
However, unlike warfarin, Pradaxa has no antidote. If a patient suffers from internal bleeding while using the drug, doctors are helpless to remedy the situation. Since its approval late in 2010, the drug has been the subject of thousands of adverse event reports submitted to the FDA, including serious injuries from uncontrollable bleeding and over 500 deaths.
- Drugs.com, Pradaxa, http://www.drugs.com/pradaxa.html
- FDA, Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events, http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm282820.htm