Medical Device Litigation—Is the End Near for Comment K?
Comment k was intended to be a narrow exception to strict liability and only applied in cases where an otherwise useful product is "incapable of being made safe."
October 25, 2021 at 01:00 PM
13 minute read
On May 27, the Legal Intelligencer published an article titled "The Case for Application of Comment K to Manufacturing Defect Claims," which was written by attorneys Stephen J. Finley and Jonathan T. Woy of Gibbons P.C. The authors of "The Case for Comment K" suggest that both the language of Comment k to Section 402A Restatement (Second) of Torts and binding Pennsylvania precedent categorically exempt all medical devices from claims of strict liability. The authors suggest that, in defiance of this purported categorical bar "a number of lower state and federal courts have ignored binding precedent and relied upon 'artificial distinctions'" in erroneously permitting strict liability for certain manufacturing defect claims. Respectfully, the suggestion by Finley and Woy that Comment k insulates medical devices from all (or any) strict liability claims is incorrect as a matter of law and policy. In fact, as reflected in recent precedent, the Pennsylvania Supreme Court's landmark decision in Tincher v. Omega Flex, 104 A.3d 328 (2014), appears to have foreclosed any argument that medical devices are entitled to blanket immunity from strict liability. Contrary to the authors' suggestion, the claims limiting principle in Comment k was never meant to enjoy broad application. Rather, Comment k was intended to be a narrow exception to strict liability and only applied in cases where an otherwise useful product is "incapable of being made safe." The authors' suggestion that the text of Comment k and policy considerations warrant immunizing all medical devices from strict liability contradicts the language and purpose of Comment k. In any case, this debate should soon be settled. The Pennsylvania Supreme Court is set to decide what role, if any, Comment k plays in medical device litigation. If the current trend continues, Comment k may soon be a dead letter.
This content has been archived. It is available through our partners, LexisNexis® and Bloomberg Law.
To view this content, please continue to their sites.
Not a Lexis Subscriber?
Subscribe Now
Not a Bloomberg Law Subscriber?
Subscribe Now
NOT FOR REPRINT
© 2024 ALM Global, LLC, All Rights Reserved. Request academic re-use from www.copyright.com. All other uses, submit a request to [email protected]. For more information visit Asset & Logo Licensing.
You Might Like
View AllFederal Judge Allows Elderly Woman's Consumer Protection Suit to Proceed Against Citizens Bank
5 minute readJudge Leaves Statute of Limitations Question in Injury Crash Suit for a Jury
4 minute readSupreme Court's Ruling in 'Students for Fair Admissions' and Its Impact on DEI Initiatives in the Workplace
6 minute readMembership Has Its Privileges: Bankruptcy Court Examines LLC's Authority to File Bankruptcy
8 minute readLaw Firms Mentioned
Trending Stories
Who Got The Work
Michael G. Bongiorno, Andrew Scott Dulberg and Elizabeth E. Driscoll from Wilmer Cutler Pickering Hale and Dorr have stepped in to represent Symbotic Inc., an A.I.-enabled technology platform that focuses on increasing supply chain efficiency, and other defendants in a pending shareholder derivative lawsuit. The case, filed Oct. 2 in Massachusetts District Court by the Brown Law Firm on behalf of Stephen Austen, accuses certain officers and directors of misleading investors in regard to Symbotic's potential for margin growth by failing to disclose that the company was not equipped to timely deploy its systems or manage expenses through project delays. The case, assigned to U.S. District Judge Nathaniel M. Gorton, is 1:24-cv-12522, Austen v. Cohen et al.
Who Got The Work
Edmund Polubinski and Marie Killmond of Davis Polk & Wardwell have entered appearances for data platform software development company MongoDB and other defendants in a pending shareholder derivative lawsuit. The action, filed Oct. 7 in New York Southern District Court by the Brown Law Firm, accuses the company's directors and/or officers of falsely expressing confidence in the company’s restructuring of its sales incentive plan and downplaying the severity of decreases in its upfront commitments. The case is 1:24-cv-07594, Roy v. Ittycheria et al.
Who Got The Work
Amy O. Bruchs and Kurt F. Ellison of Michael Best & Friedrich have entered appearances for Epic Systems Corp. in a pending employment discrimination lawsuit. The suit was filed Sept. 7 in Wisconsin Western District Court by Levine Eisberner LLC and Siri & Glimstad on behalf of a project manager who claims that he was wrongfully terminated after applying for a religious exemption to the defendant's COVID-19 vaccine mandate. The case, assigned to U.S. Magistrate Judge Anita Marie Boor, is 3:24-cv-00630, Secker, Nathan v. Epic Systems Corporation.
Who Got The Work
David X. Sullivan, Thomas J. Finn and Gregory A. Hall from McCarter & English have entered appearances for Sunrun Installation Services in a pending civil rights lawsuit. The complaint was filed Sept. 4 in Connecticut District Court by attorney Robert M. Berke on behalf of former employee George Edward Steins, who was arrested and charged with employing an unregistered home improvement salesperson. The complaint alleges that had Sunrun informed the Connecticut Department of Consumer Protection that the plaintiff's employment had ended in 2017 and that he no longer held Sunrun's home improvement contractor license, he would not have been hit with charges, which were dismissed in May 2024. The case, assigned to U.S. District Judge Jeffrey A. Meyer, is 3:24-cv-01423, Steins v. Sunrun, Inc. et al.
Who Got The Work
Greenberg Traurig shareholder Joshua L. Raskin has entered an appearance for boohoo.com UK Ltd. in a pending patent infringement lawsuit. The suit, filed Sept. 3 in Texas Eastern District Court by Rozier Hardt McDonough on behalf of Alto Dynamics, asserts five patents related to an online shopping platform. The case, assigned to U.S. District Judge Rodney Gilstrap, is 2:24-cv-00719, Alto Dynamics, LLC v. boohoo.com UK Limited.
Featured Firms
Law Offices of Gary Martin Hays & Associates, P.C.
(470) 294-1674
Law Offices of Mark E. Salomone
(857) 444-6468
Smith & Hassler
(713) 739-1250