Faegre Drinker on Products

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Articles by Faegre Drinker on Products:


Pennsylvania Medical Device Strict Liability Claims: Relentless Repetition, Clamoring for Review

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A Pennsylvania federal court has again asked that the state’s Supreme Court clarify whether, and to what extent, medical device manufacturers are immune from strict liability claims by virtue of the “unavoidably unsafe products” exemption recognized in Restatement (Second) of Torts Sec. 402A cmt. k (“Comment k”)—only this time with a direct certification.

On Thursday, the Third Circuit Court of Appeals certified that question to the Pennsylvania Supreme Court, along with a question about which negligent design defect theory—or theories—a Pennsylvania plaintiff may assert against a medical device manufacturer.  Pet. for Certification of Questions of State Law, ECF No. 50, Ebert v. C.R. Bard, Inc., et al., No. 20-2139 (3d Cir. June 24, 2021) (“Ebert Pet.”).   Last spring, Judge Pappert of the Eastern District of Pennsylvania dismissed Ms. Ebert’s strict liability claim, finding her IVC filter “an ‘unavoidably unsafe product’” under Hahn v. Richter, 673 A.3d 888 (Pa. 1996), and she appealed that order granting summary judgment to the Third Circuit.

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District of New Jersey Adopts Local Civil Rule Requiring Disclosure of Third-Party Litigation Funding

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The U.S. District Court for the District of New Jersey has adopted new Local Civil Rule 7.1.1, requiring lawyers to disclose details about third-party litigation funding.  On June 21, 2021, Chief Judge Freda L. Wolfson signed the order formally amending the Rule to include Section 7.1.1.

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FDA Solicits Feedback to Create Consistent Process for Labeling Devices

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The Food and Drug Administration Center for Devices and Radiological Health is soliciting feedback on how materials information about medical devices should be communicated to patients and healthcare providers. On May 20, 2021, the FDA published a discussion paper titled Conveying Materials Information about Medical Devices to Patients and Healthcare Providers: Considerations for a Framework. With a goal of stimulating discussion among stakeholders, the paper outlines several factors to consider for labeling devices so that providers can make well-informed decisions about which devices may be most appropriate for their patients.

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Eleventh Circuit Holds Expert Qualified in Surgical Tool Suit Despite Lack of Experience Using the Product

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The Eleventh Circuit recently reinstated a case alleging a surgical tool caused internal burns during a hysterectomy surgery, holding that the district court erred in disqualifying an expert on the basis that he had never before used the tool.  The decision is a reminder of the importance of asserting and maintaining precise and strategic Daubert challenges.

In Moore v. Intuitive Surgical, Inc., No. 19-10869, the plaintiff underwent a laparoscopic hysterectomy in which her surgeon used a robotic miniature electrified scissor tool manufactured by the defendant.  Following surgery, the plaintiff experienced, among other things, abdominal pain and eventually learned she had sustained internal burns to her left ureter during the surgical procedure.  The tool was recalled by the manufacturer a few months after the plaintiff’s procedure, and the plaintiff filed suit.

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Not All’s Well That Ends Well: The Seventh Circuit Misapplies Daubert, but Still Delivers a Victory

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The nature of advocacy makes it hard sometimes for lawyers to focus solely on the outcome and the bottom line result.  How a court gets there may not matter much to the prevailing party in the dispute as they celebrate the win, but it may have an impact on later cases.  A recent example is the opinion in Burton et al. v. E.I. DuPont de Nemours and Co., Inc., 2021 WL 1422814 (7th Cir. Apr. 15, 2021).  The court found the winner’s circle, but it dented the car a bit along the way.

[Disclosure/disclaimer:  The author filed an amicus brief in support of defendants in the case.]

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A Cautionary Tale and a Wistful Remembrance About Settlement Security

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Our language around settlements connotes war and peace – in settling we are “buying our peace” or “ceasing hostilities.”  The old saw is that a good settlement leaves no one satisfied, but in truth, a good settlement leaves nothing significant left to do in the dispute.  In abandoning claims or defenses, we seek a measure of closure.  And in obtaining a durable settlement our client can live with, we necessarily rely, to some extent, on the regularity of the underlying proceedings, candor to the court, and some minimal level of good faith in the negotiations.

What happens when that reliance is upended and those expectations are dashed?  A recent unpublished California decision provides a cautionary tale.  It also stirred memories of a flawed settlement from three decades ago, inspiring this reverie.

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