Albright v. Boston Scientific Corporation (Lawyers Weekly No. 11-123-16)

NOTICE:  All slip opinions and orders are subject to formal revision and are superseded by the advance sheets and bound volumes of the Official Reports.  If you find a typographical error or other formal error, please notify the Reporter of Decisions, Supreme Judicial Court, John Adams Courthouse, 1 Pemberton Square, Suite 2500, Boston, MA, 02108-1750; (617) 557-1030; SJCReporter@sjc.state.ma.us   15-P-633                                        Appeals Court   DIANE ALBRIGHT  vs.  BOSTON SCIENTIFIC CORPORATION.[1]     No. 15-P-633.   Middlesex.     April 15, 2016. – September 13, 2016.   Present:  Cypher, Katzmann, & Massing, JJ.     Conflict of Laws.  Negligence, Defective product, Design, Adequacy of warning, Duty to warn.  Evidence, Relevancy and materiality, Rebuttal, Bias.  Error, Harmless.  Practice, Civil, Instructions to jury.       Civil action commenced in the Superior Court Department on March 8, 2012.   The case was tried before Diane M. Kottmyer, J.     Jonathan D. Orent (Dennis A. Costigan with him) for the plaintiff. Robert T. Adams, of Missouri (Susan M. Donnelly Murphy with him) for the defendant.     KATZMANN, J.  The plaintiff Diane Albright, an Ohio resident, brought this action in the Superior Court against defendant Boston Scientific Corporation (BSC), a Massachusetts-based company, seeking damages for injuries that she sustained after having BSC’s “Pinnacle Pelvic Floor Repair” kit (Pinnacle device) surgically implanted to treat her pelvic organ prolapse (POP) condition.[2]  BSC designed, manufactured, and marketed the Pinnacle device and sold it to the Ohio hospital where Albright’s surgery took place.  After a three-week trial, a jury found for BSC on Albright’s claims of defective design and inadequate warning. On appeal, Albright challenges the exclusion of the medical application caution (caution) contained within the 2004 material safety data sheet (MSDS)[3] that had been provided to BSC by its supplier of the polypropylene material used to fabricate the mesh in the Pinnacle device.  Albright offered the caution for the limited purpose of showing notice and knowledge on the part of BSC.  Albright also claims error from the exclusion of two letters that the United States Food and Drug Administration (FDA) sent to BSC in 2012.[4]  We conclude that, in the context of the case as it unfolded at trial, it was prejudicial error to exclude the proffered caution and FDA letters.  The judgment in favor of BSC shall therefore be vacated and the case remanded to the Superior Court for a new trial. Background.  There was evidence from which the jury could have found the following.[5] Surgeries.  In 2008, Albright had surgery to treat POP symptoms involving her bladder.  Dr. Jay Meyer performed a procedure[6] that did not involve the implantation of surgical mesh.  Less than twelve months later, Albright experienced a recurrence of the bulging sensation in her […]

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