Man unsure of the safety of his medicine

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From Products Liability Law Daily, April 8, 2015

Manufacturer ignores warning signs, risks punitive damages

By Anthony H. Nguyen, J.D.

A reasonable jury could find that Boston Scientific Corporation, a medical device manufacturer, actually knew of a defect and danger at the time its transvaginal surgical mesh device left its possession and control, based on safety warnings, a federal district court in West Virginia ruled. The same jury could also find Boston Scientific’s failure to conduct clinical testing was indication of conscious disregard to consumer safety and a “bad faith” decision to market, the court said. The district court denied Boston Scientific’s motion for partial summary judgment on the award of punitive damages because, under controlling state law, a genuine dispute of material fact existed as to whether the actions were malicious (Stidham v. Boston Scientific Corp., April 7, 2015, Goodwin, J.).

Background. Anne Stidham was surgically implanted with the Uphold Vaginal Support System™ (Uphold) and the Solyx™ SIS System (Solyx), manufactured by Boston Scientific, to treat her pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in late 2010. Stidham alleged that as a result of implantation of the Uphold and the Solyx systems, she experienced multiple complications, including pain, mesh extrusion, recurrence of prolapse, dyspareunia, neuromuscular problems, and vaginal scarring.

Stidham alleged the following claims against Boston Scientific: (1) negligence; (2) strict liability for design defect, manufacturing defect, and failure to warn; (3) breaches of express and implied warranties; and (4) punitive damages. Stidham’s spouse alleged a claim for loss of consortium. Boston Scientific moved for summary judgment on the grounds that the Stidhams’ claim for punitive damages was “without evidentiary or legal support.”

The question before the district court was whether the Stidhams produced enough evidence to create a genuine dispute of material fact as to whether Boston Scientific engaged in culpable conduct that met the punitive damages standard. To resolve the punitive damages issue, the district court addressed the issue of which state’s law applied.

Choice of law. The Stidhams argued that Maryland tort law was applicable in their lawsuit, whereas Boston Scientific argued that Massachusetts tort law was the controlling choice. The court held that because Stidham received the Uphold and Solyx implantation surgery in Maryland, the choice-of-law principles of Maryland would guide the court’s choice-of-law analysis. In tort actions, Maryland adhered to the rule that a court must apply “the law of the state in which the alleged tort took place.” In rejecting Boston Scientific’s arguments, the court noted that federal courts, and especially the Fourth Circuit, had expounded on Maryland’s view such that “the law of the place of injury applies” is considered the place where the injury was suffered, not where the wrongful act took place. As such, the court found that because Stidham’s alleged injuries were suffered and sustained in Maryland, not Massachusetts, the laws of Maryland applied to the Stidhams’ punitive damages claim.

Actual malice. Maryland courts permit an award of punitive damages in products liability cases when an injured party can prove “actual malice,” that: (1) the manufacturer had actual knowledge of a defect, and (2) the manufacturer consciously or deliberately disregarded the foreseeable harm resulting from that defect. Boston Scientific argued that the Stidhams had failed to present evidence of malice in marketing and selling the Uphold and Solyx devices. Boston Scientific argued that the surgical mesh had FDA approval, with full knowledge of potential benefits and risks. The Stidhams countered that Boston Scientific should have known that the polypropylene resin used in Uphold and Solyx was not intended for implantation in humans. In support, the Stidhams pointed to a material safety data sheet (MSDS) authored by Chevron Phillips, which supplied Boston Scientific with the polypropylene resin, and included a warning about not using the resin in “medical applications involving permanent implantation in the human body.”

In addition to the MSDS, Chevron signed an agreement with Boston Scientific that cautioned Boston Scientific to make its own determination of the safety and suitability of the polypropylene material in products. The court noted that an internal Boston Scientific document indicated no sponsored clinical studies on either the Uphold or the Solyx devices were done. Furthermore, Boston Scientific never warned via its Directions for Use that the Uphold and the Solyx were made of a component that was not safe for permanent implantation in the human body.

The court held that a reasonable jury could find that Boston Scientific actually knew of the defect and danger at the time Uphold or Solyx left its possession and control based on the MSDS warning. As such, the same jury could also find that Boston Scientific’s failure to conduct clinical testing was indication of Boston Scientific operating with conscious disregard to consumer safety and a “bad faith” decision to market. Under Maryland law, there was a genuine dispute of material fact as to whether Boston Scientific’s actions were malicious and warranted an award of punitive damages. Boston Scientific’s motion for partial summary judgment was denied.

The case is No. 2:12-cv-06759.

Attorneys: Jeffery J. Larrimore (Mueller Law) for Anne Stidham. A. Bradley Bodamer (Shook Hardy & Bacon) for Boston Scientific Corp.

Companies: Boston Scientific Corp.; Chevron Phillips

MainStory: TopStory DamagesNews MedicalDevicesNews MassachusettsNews WestVirginiaNews MarylandNews

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