Products Liability Law Daily Hysterectomy patient pleads valid claims against device manufacturer for design defect and failure to warn
Friday, January 8, 2021

Hysterectomy patient pleads valid claims against device manufacturer for design defect and failure to warn

By Robert B. Barnett Jr., J.D.

The claims were adequately supported by allegations that the risks and a better design were known for more than 20 years.

A patient’s suit against the manufacturer of a medical device used in hysterectomies that can inadvertently spread undiagnosed cancer cells, as it allegedly did in her, adequately pleaded a claim for a strict liability design defect because she sufficiently pleaded the existence of an alternative design then in use in similar products that would have prevented the well-known risk of spreading cancer, a West Virginia federal district court has ruled. In addition, she adequately alleged a claim for strict liability failure to warn because she sufficiently pleaded that the manufacturer failed to warn the surgeon of the risks of spreading cancer, failed to suggest preventative pre-surgery steps to be taken to reduce the risk of spreading the cancer, and failed to suggest other forms of treatment for her condition (Ward v. LiNA Medical, USA, Inc., January 5, 2021, Copenhaver, J.).

Background. In May 2018, the patient underwent a hysterectomy to treat a worsening bowel problem. The surgeon used a power morcellator to perform the procedure. The power morcellator has fast-spinning blades that mince the uterus into smaller pieces for easier removal laparoscopically. Since the 1990s, however, the medical community has been aware that, if a patient has undetected cancer cells in her uterus, the power morcellator can spread them unintentionally when it minces, with the possibility of converting a stage 1 case of cancer to a stage 4 case. Among the solutions recommended to avoid this risk has been to perform a pre-surgery biopsy to look for cancer cells and to use a containment bag with the morcellator that would prevent the spread.

In this case, when the patient’s cancer spread was diagnosed, her doctor acknowledged (on tape) that he screwed up by failing to discuss the risks with her before the procedure. In a combination medical malpractice/products liability case, she sued both the medical providers and LiNA Medical USA, Inc., the manufacturer of the power morcellator. She asserted seven causes of action against the manufacturer, which filed a motion to dismiss three of them: strict liability design defect, strict liability failure to warn, and breach of the warranty of merchantability and fitness.

Design defect. The design defect claim asserted two theories: (1) the morcellator was unreasonably dangerous because the risks outweighed the benefits; and (2) safer alternative designs involving the containment bag were known and available. The two theories were tied together, as the unreasonably dangerous nature seemed to depend on the absence of the containment bag. The manufacturer argued that including containment bags was not the norm at the time the device was manufactured and was not recommended by experts. The court, however, rejected that argument, noting that the complaint alleged that the risks were well-known prior to 2017, when the device was manufactured. Even if it were not the norm, the court said, the complaint would still have been sufficient because the measure of adequacy did not depend on industry norms or expert recommendations alone. The patient alleged that a safer alternative had been available since the early 1990s. Whether that proves to be true is a matter for discovery. For now, her allegations were sufficient to sustain a claim for strict liability design defect.

Failure to warn. The manufacturer sought dismissal of the failure to warn claim because, in 2016, West Virginia had become a learned intermediary doctrine state, which meant that the duty to warn rested with the surgeon. West Virginia law, however, has a statute stating that medical device manufacturers will not be liable for failure to warn unless they provide inadequate warning to the medical professionals (W. V. §55-7-30(a)). As a result, regardless of the learned intermediary doctrine, manufacturers must adequately notify medical professionals. The manufacturer here then argued that, however inadequate its warnings may have been, any warning would have been meaningless because the surgeon never gave the patient any warning at all. The court rejected this theory, accepting the patient’s argument that the surgeon may have been more compelled to warn the patient had he been adequately warned himself. Whether that proves to be true will be fleshed out in discovery. Therefore, the patient’s allegations that the warnings were wholly inadequate, given what was known at the time, were sufficient at this stage to support a claim for strict liability failure to warn.

Implied warranty. The court also denied the motion to dismiss as it applied to the claim for breach of the implied warranty of merchantability and fitness because, in products liability actions, the claim is coextensive with the strict liability claims. If the strict liability claims survive the motion to dismiss, so does the breach of implied warranty claim.

Accordingly, the court denied the manufacturer’s motion to dismiss in its entirety.

The case is No. 2:20-cv-00334.

Attorneys: Robert M. Bastress III (DiPiero Simmons McGinley & Bastress, PLLC) for Mary Ann Ward. Robert A. Lockhart (Cipriani & Werner, P.C.) for LiNA Medical USA, Inc. d/b/a LiNA Medical, LiNA Medical ApS d/b/a LiNA Medical and LiNA Medical Polska SP. Z.O.O. d/b/a LiNA Medical.

Companies: LiNA Medical USA, Inc. d/b/a LiNA Medical; LiNA Medical ApS d/b/a LiNA Medical; LiNA Medical Polska SP. Z.O.O. d/b/a LiNA Medical

MainStory: TopStory DesignManufacturingNews MedicalDevicesNews WarningsNews WestVirginiaNews

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