By Pamela C. Maloney, J.D.
In three of seven multi-district suits concerning the use of transvaginal surgical mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), a federal district court in West Virginia dispensed with Boston Scientific Corp’s (BSC) motions for summary judgment, finding that the learned intermediary doctrine blocked two of the three patients’ failure-to-warn claims. The court also greenlighted the patients’ negligent design claims, but granted BSC’s motion on the strict liability design and manufacturing defect claims (Howard v. Boston Scientific Corp., Contreras v. Boston Scientific Corp., Waltman v. Boston Scientific Corp., April 11, 2016, Goodwin, J.).
After determining under the governmental interest test for the California patients (Howard and Contreras) and the most significant relationship test for the Texas patient (Waltman) that California law applied to all three cases, the court turned to the substantive issues presented in each case.
Learned intermediary doctrine. The learned intermediary doctrine, which is part of any failure-to-warn analysis in California, provides that manufacturers of prescription drugs and medical devices satisfy their duty to warn if they provide adequate warnings to prescribing physicians, rather than to patients. Under the doctrine, in order for a patient to prevail on a failure-to-warn claim, the patient must demonstrate that the prescribing physician would have acted differently had he or she received adequate warnings. Thus, if a doctor did not read the warning, or read the warning but did not rely on it in prescribing the drug or in using the medical device, then the chain of causation was broken and the patient’s strict liability and negligent failure-to-warn claims must fail.
Neither Howard nor Contreras provided any evidence to establish causation. There was no evidence that Howard’s implanting physician had read the Directions for Use (DFU) that accompanied the device. Further, even assuming that he had read the DFU, there was no evidence that he would have taken a different course of action had he been given an adequate warning. Similarly, a review of the deposition testimony of Contreras’s implanting physician failed to reveal that she would have changed her course of treatment. Because neither patient could establish proximate causation, the manufacturer’s motion for summary judgment was granted on these failure-to-warn claims.
However, the court’s review of the record presented in Waltman raised genuine issues of fact with regard to (1) whether the manufacturer’s warning was adequate and (2) whether the alleged inadequate warning proximately caused the patient’s injuries. Thus, the court denied the manufacturer’s motion for summary judgment on the patient’s claim of strict liability for failure to warn.
Design defect claims. Although California does not recognize strict liability for defective design, the patients could pursue negligent design claims, despite the manufacturer’s argument to the contrary. The manufacturer failed to present any other argument to support its contention that negligent design claims were not recognized.
Manufacturing defect. With respect to the manufacturing defect claims, none of the patients presented evidence showing the existence of a manufacturing defect in the particular product implanted during their surgeries and, thus, summary judgment was warranted on those claims.
Attorneys: Jeffery J. Larrimore (Mueller Law) for Linda Howard and Jeffrey Howard. Jayne Conroy (Simmons Hanly Conroy LLC) for Evelyn Contreras and Pablo Contreras. Clayton A. Clark (Clark Love & Hutson) and Derek H. Potts (The Potts Law Firm) for Bonnie D. Waltman and Jeff Waltman. A. Bradley Bodamer (Shook, Hardy & Bacon LLP) for Boston Scientific Corp.
Companies: Boston Scientific Corp.
MainStory: TopStory WarningsNews DesignManufacturingNews WestVirginiaNews CaliforniaNews
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