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Claims of Negligent Design and Breach of Implied Warranty to Proceed Against Boston Scientific Mesh

Defective Medical Devices

On February 9, 2009, a North Carolina resident was implanted with the Obtryx Transobturator Mid- Urethral Sling System. She sued Boston Scientific Corp., the maker of the sling, asserting claims of strict liability because design defect, manufacturing defect and failure to warn, negligence, breach of express and implied warranties, and punitive damages. She asserts that she has experienced multiple complications as result of the implantation, including bleeding, bleeding during intercourse, dyspareunia, and vaginal pain.

Picture69Judge Goodwin, the judge presiding over the case, determined that North Carolina law applies to the tort claims because the alleged injury occurred in that state, where victim was implanted with the alleged defective device. According to Judge Goodwin, the warranty claims are also governed by North Carolina law because that is where the Obtryx device was sold, distributed, delivered and used.

Boston Scientific Corp. moved for summary judgment. Summary judgment is a procedural device during civil litigation to dispose of a case without a trial. It is used when there is no dispute as to the material facts of the case and a party is entitled to judgment as a matter of law.

Goodwin granted Boston Scientific Corp’s summary judgment on the failure to warn claim. Because the plaintiff’s implant surgeon testified that he did “not read the DFU [Directions for use] for the Obtryx transobturator sling.” Judge Goodwin held, “Thus, the facts here demonstrate, indisputably, that the surgeon failed to rely on the Obtryx DFU.” “In turn, a reasonable juror could not infer that Boston’s allegedly defective warnings proximately caused [the Plaintiff’s] injuries.”

In addition, the Judge granted Boston Scientific Corp.’s summary judgment on the breach of express warranty claim, finding the record contains no evidence to suggesting that any express warranties were provided to the Plaintiff’s surgeon because the surgeon admitted that he did “not read the DFU for the Obtryx transobturator sling”, Judge Goodwin stated.
Judge Goodwin also granted Boston Scientific Corp’s summary judgment on the negligent manufacturing claim, finding, “is devoid of any evidence regarding Boston Scientific Corp’s manufacturing process, much less any negligent action or omission that occurred during those processes.”

However, Judge Goodwin denied Boston Scientific Corp.’s Motion for Summary Judgment as to the negligent design claim, finding genuine issues of fact exist as to whether Boston Scientific Corp. acted unreasonable in designing the Obtryx. Judge Goodwin held that issues of fact also exist as to whether Boston Scientific Corp. unreasonably failed to adopt a safer, practical, feasible, and otherwise reasonable alternative design, or whether the design or formulation of the product was so unreasonable that a reasonable person, aware of the relevant facts, would not use it. The judge also denied Boston Scientific Corp.’s Summary Judgment on the claim of breach of implied warranty of merchantability, explaining that because a reasonable juror could determine that Boston Scientific Corp. negligently designed the Obtryx, a reasonable juror could likewise find that Boston Scientific Corp. breached the implied warranty of merchantability.

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