On September 13, 2016, the Massachusetts Appeals Court decided Albright v. Boston Scientific Corporation by vacating a jury’s verdict in favor of Boston Scientific Corporation (BSC) and remanding the matter to the Superior Court for retrial. No. 15-P-633, 2016 WL 4736686 (Mass. App. Ct. Sept. 13, 2016).
By way of background, the Plaintiff, Diane Albright, sued BSC alleging that she suffered serious injuries following a March 2010 surgery in which she had a Pinnacle Pelvic Floor Repair device implanted to correct a pelvic organ prolapse. Id. at *1. That is, after Ms. Albright’s surgery she “developed painful bladder syndrome and other complications” due to the implant’s degradation. Id. at *2. BSC designed, manufactured, and marketed the device in question. Subsequently, Ms. Albright tried her case before a Middlesex County jury, which found in BSC’s favor with respect to Ms. Albright’s defective design and inadequate warning claims.
The plaintiff appealed arguing that the trial justice erred when she (1) excluded from evidence a medical application caution found within a 2004 and 2007 Material Safety Data Sheet (MSDS) concerning the polypropylene material used to form the mesh within the device and (2) prevented the jury’s consideration of two 2012 FDA letters to BSC. Id. at *1. The first letter ordered BSC to conduct a postmarket surveillance study of its Pinnacle devices. In its second letter to BSC, the FDA agreed to the postmarket surveillance study’s suspension following receipt of BSC’s representation that it planned to cease manufacturing and marketing the implant in the United States. Id. at *7.
After reviewing the trial court record, the appeals court agreed with the plaintiff’s position. It reasoned that the medical application caution “was relevant, material evidence for the limited purpose of showing that BSC, which had received the MSDS well before 2009, had notice or knowledge of the content of the caution.” Id. at *6. Thus, the medical application caution was not hearsay for the sole purpose of showing that BSC had notice or knowledge of the foreseeable risks associated with the Pinnacle implant. Id. Likewise, the appeals court concluded that the two FDA letters were admissible “for the limited purpose of cross-examining BSC’s witnesses, who had testified, without qualification, that the Pinnacle device was safe as of the time of trial.” Id. at *7. Such a limited purpose use of the FDA letters, the court found, would constitute reasonable cross-examination to show bias or to rebut BSC witness opinion testimony.