By Pamela C. Maloney, J.D.
Lack of specificity with regard to manufacturing defect and failure to warn claims results in dismissal of patient’s claims against mesh device implant maker.
Although a question of fact remained as to whether the two-year statute of limitations barred a patient’s manufacturing defect and failure to warn claims against the manufacturer of a pelvic mesh product, the complaint lacked specificity with regard to how the product deviated from the FDA-approved manufacturing process or how a warning would have changed the prescribing physician’s conduct in implanting the device, the U.S. District Court for the Southern District of Texas ruled, dismissing the claims. The court did grant the patient leave to amend her complaint (Miles v. Boston Scientific Corp., July 9, 2020, Miller, G.).
A patient who had been surgically implanted with Advantage Fit, a pelvic mesh product manufactured by Boston Scientific Corp., to treat her stress urinary incontinence filed a products liability lawsuit against the manufacturer, alleging that the medical device contained manufacturing defects and that Boston Scientific had failed to warn her or her treating physician about the known risks of serious injuries associated with the device. Boston Scientific moved to dismiss both claims, arguing that they were barred by the two-year statute of limitations and that the complaint failed to state a claim for manufacturing defect or failure to warn.
Statute of limitations. Although the patient’s implantation surgery occurred more than 13 years before she filed her lawsuit, both parties agreed that because her injuries stemmed from an implanted device, the discovery rule exception deferred accrual of her cause of action until the patient knew, or should have known through the exercise of reasonable care and diligence, the nature of her injuries. The manufacturer claimed that the patient’s cause of action accrued in 2012, the year in which she knew or had reason to know of her injuries based on the publicly available information cited in her complaint. The patient countered that the nature of her injuries and their relationship to the pelvic mesh device were not discovered and could not have been discovered through reasonable care and due diligence, until after November 1, 2017. The court acknowledged that evidence of extensive media coverage could qualify as "sufficient facts" to cause a reasonably prudent person to make further inquiry. However, it was not clear from the facts set out in the patient’s complaint whether the statute of limitations and the discovery rule exception applied to bar the claims. Concluding that further factual development was necessary, the court refused to dismiss the claims on the basis of the manufacturer’s statute of limitations defense.
Manufacturing defect. In support of its motion to dismiss the manufacturing defect claim, the manufacturer argued that the patient had failed to alleged how the device deviated from its specifications or planned output of other units at the time it left the manufacturer in a way that rendered it unreasonably dangerous and also had failed to allege how a manufacturing defect had caused her injuries. In her complaint, the patient set forth several defects in the device, including its use of polypropylene material, arms, and anchors, and its propensity to contract or shrink, elongate and deform, and degrade and fragment inside the body. The complaint also stated that the device implanted in her was not reasonably safe for its intended use and that it was defective with respect to its manufacture, in that it deviated materially from the manufacturer’s design and manufacturing specifications in such a manner as to pose unreasonable risks of serious bodily harm. She further alleged that she had experienced significant mental and physical pain and suffering, permanent injury, and had undergone medical treatment and/or corrective surgery and hospitalization as a result of the device’s implantation. Although the patient had alleged the specific manufacturing defect in the device, she failed to plead with sufficiency the causal connection between the failure of the specific manufacturing process and the specific defect in that process which caused her injuries. She also failed to plead how the manufacturing process failed or deviated from the device’s FDA-approved manufacturing process. Finally, the patient never claimed that the device had been recalled. Absent these details, the patient failed to plead a necessary element of a manufacturing defect claim and, therefore, the manufacturer’s motion to dismiss the claim was granted, but the patient was given leave to amend her complaint.
Failure to warn. Under Texas law, which applies the learned intermediary doctrine to medical products liability claims, the manufacturer only has a duty to warn the prescribing physician of a product’s dangers. However, a manufacturer could still be found liable for injuries sustained by the ultimate user if the physician’s warning was defective and the failure to warn was a producing cause of a patient’s injury or condition. The patient alleged that the manufacturer knowingly had provided incomplete and insufficient training and information to physicians regarding the use of the mesh implant and had failed to provide sufficient or adequate warnings and instructions regarding its dangers and adverse effects. According to the court, these allegations were vague and conclusory in that they did not identify the warning her doctor had received nor how the warnings received had been inadequate. She also failed to allege how a different warning would have changed her physician’s actions or how the failure to warn was a cause of her injuries. Thus, the manufacturer’s motion to dismiss the failure to warn claim was granted and the patient was given leave to amend.
Fraud/negligent misrepresentation. The court also dismissed the patient’s claims for fraudulent concealment and negligent misrepresentation, both of which were premised on the fact that the manufacturer had promoted the device as safe despite knowing that it was not fit for its intended purposes and caused serious medical problems. Although the patient had alleged that she had relied on those representations, the complaint failed to specify the time, place, or contents of the alleged fraudulent or false representations, or the identity of the person making those representations. Furthermore, the fraud-based and negligent misrepresentation claims were premised on the patient’s allegations that the manufacturer knowingly had omitted material facts about the device’s risks. As such, these allegations merely recited her failure to warn claims and, because the learned intermediary doctrine applied, her fraud-based and negligent misrepresentation claims must be dismissed for the same reasons as her failure to warn claim had been dismissed. The court also granted the patient leave to amend these claims.
The case is Civil Action No. H-19-4319.
Attorneys: Breanne Vandermeer Cope (Common Sense Counsel LLP) for Gayle Miles. Michele Yennie Smith (MehaffyWeber PC) and Kate E. Middleton (Faegre Drinker Biddle & Reath LLP) for Boston Scientific Corp.
Companies: Boston Scientific Corp.
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