Products Liability Law Daily Wrap Up, DESIGN AND MANUFACTURING DEFECTS—MEDICAL DEVICES—D. Idaho: Bioinductive shoulder implant maker denied dismissal of claims in patient’s device degradation case, (Jan 6, 2026)

By Pankhuri Bhatnagar, B.A. LL.B.

The patient’s claims were adequately pleaded, and the manufacturer’s competing theory of medical causation could not be admitted as it was based on extrinsic literature.

In an action brought against a medical device manufacturer by a patient and her spouse for injuries allegedly caused by an implant’s premature degradation and fragmentation, the federal district court in Idaho denied the manufacturer’s motion to dismiss. The strict liability and negligence claims survived since the complaint adequately pleaded a design and manufacturing defect along with a malfunction theory supported by medical evidence, and the precise failure mechanism was not necessary at the pleading stage. The failure to warn, emotional distress, and loss of consortium claims also survived because the patient identified the product’s undisclosed risks, the manufacturer owed a duty to not cause injury to a patient’s spouse, and the couple suffered physical harm due to their emotional distress (Leete v. Smith & Nephew, Inc., No. 2:24-cv-00576-AKB (D. Idaho Dec. 31, 2025)).

Background. A woman underwent rotator cuff repair surgery in which a REGENETEN Bioinductive Patch was implanted in her shoulder. The implant was designed to remain intact during the healing period and reinforce the repair, but her pain persisted following the procedure. Imaging tests revealed synovitis, fluid, debris, and a possible cartilaginous body in her shoulder, allegedly due to the device’s premature failure and degradation. Eight months later, a revision arthroscopic surgery was performed in which 50 loose rice-shaped fragments were removed from her shoulder. The patient continued to experience restricted motion and mechanical symptoms and later underwent an additional repair surgery. She and her spouse sued several entities involved in the implant’s design, manufacture, assembly, marketing, and distribution, asserting claims for strict products liability, negligence, negligent infliction of emotional distress, and loss of consortium. The complaint identified the specific implant by catalog number, lot number, and use-by date, and alleged that similar fragmentation events had been reported in the FDA’s MAUDE database since 2019 and were known or knowable to the manufacturer. The implant manufacturer, Smith & Nephew, Inc., moved to dismiss all claims under Rule 12(b)(6).

Strict liability and negligence. The manufacturer argued that the complaint failed to identify a defect, making it unclear whether a defect caused the degradation, whether degradation itself was the defect, or whether the release of loose bodies constituted the defect. The court rejected this framing, noting that the claimants had asserted three alternative defect theories—design defect, manufacturing defect, and malfunction theory—and supported them with specific factual allegations. These included premature degradation of the implant within months of implantation despite its intended design to remain intact during healing; surgical removal of approximately fifty loose fragments; MRI findings showing debris, synovitis, and fluid; and publicly reported similar fragmentation events in the MAUDE database. The court emphasized that these were concrete, nonconclusory allegations describing a specific malfunction and its consequences.

Moreover, a plaintiff need not plead the precise internal mechanism of a medical device’s failure at the pleading stage, since such information often lies within the defendant’s control. Elliott v. Smith & Nephew, Inc., No. 1:12-CV-0070-EJL-MHW, 2013 WL 1622659 (D. Idaho Apr. 15, 2013). While Elliott involved recall allegations and matching catalog numbers, those facts only strengthened the complaint and were not prerequisites to pleading a plausible defect claim. The manufacturer’s reliance on Green v. W. L. Gore & Assocs., Inc., No. 4:19-CV-00022-DCN, 2020 WL 1666790 (D. Idaho Apr. 3, 2020) was unpersuasive as it involved a complaint devoid of any malfunction allegations, whereas here, a specific failure mode—premature degradation and fragmentation—was tied to the patient’s injuries through observable medical findings and surgical removal. Accordingly, the strict liability and negligence claims could not be dismissed for absence of an identifiable defect. Contrary to the manufacturer’s contention, strict liability under Restatement (Second) of Torts § 402A is an independent basis for recovery and is not merged with negligence concepts. Toner v. Lederle Lab'ys, a Div. of Am. Cyanamid Co., 732 P.2d 297 (Idaho 1987). As such, the claimants could assert strict liability as a separate claim.

Failure to warn. The complaint alleged that the manufacturer failed to warn of three specific hazards: the likelihood of degradation, the risk that degradation could release loose bodies, and the risk that such degradation could cause the repair to fail. Smith & Nephew argued that there was no explanation as to why the device warnings were inadequate, but the court held that at the pleading stage, identifying specific undisclosed hazards, alleging a failure to warn of those hazards, and alleging resulting injury were sufficient to state a plausible failure-to-warn claim under Idaho law.

Medical causation. The manufacturer relied on online dictionary entries and a radiology journal article to proffer that rice bodies can arise from chronic inflammation. The court rejected this approach for multiple reasons. First, the cited materials were extrinsic, not incorporated into the complaint, subject to reasonable dispute, and not appropriate for judicial notice under Rule 201 of the Federal Rules of Evidence. Second, the complaint itself alleged MRI evidence of debris and intra-operative removal of 50 fragments, contradicting the manufacturer’s alternative causation theory. Third, considering extrinsic medical literature would improperly convert the motion to dismiss into a motion for summary judgment. Hal Roach Studios, Inc. v. Richard Feiner & Co., 896 F.2d 1542, 1555 n.19 (9th Cir. 1989). Fourth, competing medical explanations are more appropriately addressed through expert discovery or summary judgment proceedings.

NIED and loss of consortium. Count Two of the complaint combined the negligent infliction of emotional distress (NIED) and loss of consortium claims, but the court construed them separately since Idaho law treats them as distinct claims. Smith & Nephew’s argument that it did not owe a duty to the spouse of the intended medical product customer was unpersuasive since Idaho recognizes a broad duty imposed upon third parties to not cause injuries that result in loss of consortium damages, as confirmed in Beebe v. North Idaho Day Surgery, LLC, 526 P.3d 650, 662 (Idaho 2023), which held that: “any tortious act of the defendant which causes injury to a plaintiff's spouse can support a plaintiff's claim for loss of consortium.” Further, both claimants claimed that they suffered physical manifestations of harm because of their emotional distress, which was sufficient for the NIED claim to survive.

The case is No. 2:24-cv-00576-AKB.

Judge: Brailsford, A.

Attorneys: Eric S. Rossman (Rossman Law Group PLLC) for Lacey L. Leete and Robert Leete. Anthony J. Monaco (Swanson, Martin & Bell, LLP) for Smith & Nephew, Inc. and Smith & Nephew PLC.

Companies: Smith & Nephew, Inc.; Smith & Nephew PLC; Arthrocare Corp.

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