Products Liability Law Daily Failure to warn claim against artificial hip manufacturer moves forward
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Tuesday, September 8, 2020

Failure to warn claim against artificial hip manufacturer moves forward

By David Yucht, J.D.

Patient’s design/manufacturing defect claims were dismissed with prejudice, however.

A federal judge in Ohio found that a patient, who claimed that he was injured by the implantation of an artificial hip, failed to adequately plead his claims for design defect, manufacturing defect, and failure to conform to representations under the Ohio Products Liability Act (OPLA). Common law negligence and breach of warranty claims were dismissed because they were abrogated by the OPLA. However, the court found that the patient’s failure to warn claim was sufficiently pleaded to survive the manufacturer’s motion to dismiss (Grubbs v. Smith & Nephew, Inc., September 4, 2020, McFarland, M.).

A patient underwent total hip arthroplasty to alleviate complications related to hip degeneration. As part of this surgery, he was implanted with an artificial hip manufactured by Smith & Nephew, Inc. Sometime after this procedure, he experienced severe pain, requiring his doctor to perform revision surgery. The patient asserted that the Smith & Nephew hip loosened and separated from the hip socket, which caused the pain and necessitated the additional surgery. He sued Smith & Nephew under the OPLA claiming failure to warn, defective design, defective manufacturing, and failure to conform to representations. He also alleged liability under common law breach of warranty and negligence. The manufacturer moved for dismissal.

Abrogation of common law. The court dismissed the patient’s common law warranty and negligence claims, noting that OPLA abrogates all common law product liability causes of action. OPLA governs all product liability claims in Ohio. Since the patient’s common law breach of warranty and negligence claims fell under the OPLA’s definition of a product liability claim, they were preempted by the OPLA and, consequently, dismissed by the court.

Failure to warn. The court ruled that the patient sufficiently alleged a claim for inadequate warning. In Ohio, to establish a manufacturer’s liability for damages for product liability in general, one must show that the product was defective in manufacture or design, defective due to inadequate warnings, or defective because it did not conform to the manufacturer’s representation. Moreover, the defect must be a proximate cause of harm, and the manufacturer must have somehow been involved in the design, production, or re-building of the subject product. Concerning the inadequate warning claim, a product is defective due to inadequate warning if, when it left the manufacturer’s control, the manufacturer knew or should have known "about a risk associated with the product" but failed to provide the warning that "a manufacturer exercising reasonable care would have provided."

The manufacturer argued that the learned intermediary doctrine required dismissal of the failure to warn claim. However, the court felt that the pleadings were sufficient, even in light of the learned intermediary doctrine. The patient claimed that the manufacturer knew or should have known that its artificial hip was unsafe, but failed to adequately warn patients, including himself, and health care providers, including his physician, of the risks associated with the device.

Manufacturing defect. The court determined that the patient failed to sufficiently plead facts that supported a manufacturing defect claim. A product is defective in manufacture if, upon leaving the manufacturer’s control, it deviated materially from the manufacturer’s design specifications or standards, or materially deviated from identical units manufactured to the same specifications or standards. Here, the patient alleged that the subject artificial hip materially deviated from Smith & Nephew’s design standards or from otherwise identical units manufactured to the same performance standards and that these defects occurred while the product was still in the manufacturer’s control. The court found that these allegations simply mirrored the statutory language without pleading specific facts that supported the patient’s manufacturing defect claim. The patient failed to specifically identify the defects at issue. He did not support the manufacturing defect claim with any factual allegations showing that his artificial hip was different from any other hip of the subject model, or that it deviated in any way from the manufacturer’s standards.

Design defect. Likewise, the court ruled that the patient failed to plead an adequate claim for design defect. Under Ohio law, a product’s design is defective if, when it left its manufacturer’s control, "the foreseeable risks associated with its design" outweighed the design’s benefits. Design defect claims must contain factual allegations concerning which portions of the product failed. Here, as was the case with his manufacturing defect claim, the patient parroted the statutory elements without even indicating which portion of his device failed.

Failure to conform to representations. The court also dismissed the patient’s claim for failure to conform to representations. A product is defective for failure to conform if, when it left the manufacturer, it failed to conform to a representation made by that manufacturer. Someone seeking to recover under this theory must show that: (1) the manufacturer made a material representation concerning the quality of its product; (2) the product did not conform to that representation; (3) the plaintiff justifiably relied on that representation; and (4) this reliance caused injuries. Here, the patient did not allege what representations he was referring to, or how the product failed to conform to these representations.

Leave to amend. Despite the norm to "freely give leave" to amend, the court refused the patient’s request for leave to amend because the request was supported only by "throwaway language" instead of an adequate motion and was not submitted with a proposed revised complaint.

The case is No. 1:19-cv-248.

Attorneys: Matthew Miller-Novak (Barron Peck Bennie & Schlemmer, Co. LPA) for Harry W. Grubbs. Eric Larson Zalud (About Benesch, Friedlander, Coplan & Aronoff LLP) for Smith & Nephew, Inc.

Companies: Smith & Nephew, Inc.

MainStory: TopStory WarningsNews DesignManufacturingNews MedicalDevicesNews OhioNews

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