Drug & Device News

After determining that the exclusion of two U.S. Food and Drug Administration (FDA) letters and other evidence left jurors with an “incomplete picture” of the facts, a Massachusetts appeals court recently reversed a defense verdict for Boston Scientific Corp. The case was brought by plaintiff Diane Albright, who allegedly was injured by a surgical mesh device known as Pinnacle, with which she was implanted in 2010 as a treatment for pelvic organ prolapse. At trial, the plaintiff was barred from offering into evidence a 2004 warning sent by the manufacturer's polypropylene supplier, as well as two 2012 FDA letters telling Boston Scientific that further studies were required.

Plaintiff's attorney Jonathan Orent, an associate in the Providence, RI, office of Motley Rice, noted that these same pieces of correspondence had been admitted in other pelvic mesh litigations, and concluded, “By not allowing us to use these documents, we weren't able to cross-examine their experts and experts' opinion about the current safety and efficacy of the Pinnacle at the time of trial.” Meanwhile, defense counsel stated several times during the course of the trial that the FDA had “cleared” the Pinnacle device for sale. After the jury returned a defense verdict, the plaintiff appealed to the intermediate-level Massachusetts Appeals Court. According to Associate Justice Gary Katzmann, who wrote for the three-judge appellate panel, “The repeated reference to the FDA's clearance aided BSC's defense, and handicapped Albright's case, on the central product safety issue in the case.” This, the court concluded, was prejudicial error requiring the case's return to Massachusetts' Middlesex County Superior Court for retrial.