Mixed Bag in New Jersey Medical Device Preemption Opinion

On May 4, 2021, New Jersey Superior Court Judge Rachelle Harz issued an opinion that may be of interest to readers who follow medical device preemption decisions. Judge Harz, who oversees the centralized multicounty litigation in New Jersey state court involving product liability claims with respect to Allergan’s Biocell line of textured breast implants and tissue expanders, agreed with the defendants in dismissing some of the claims asserted in the plaintiffs’ master long form complaint on preemption grounds, but disagreed and declined to dismiss other…
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Federal Law Preempts State Law Product Liability Claims Involving “Hybrid” Medical Devices

Matthew S. Trokenheim

On an issue of first impression in the federal Circuit Courts of Appeals, the Third Circuit held that federal law preempts state law claims involving hybrid medical devices where any part of the device requires FDA pre-approval of the device’s safety and effectiveness. The 1976 Medical Device Amendments to the Food, Drug and Cosmetics Act brought medical devices under the regulatory authority of the Food and Drug Administration. The Amendments established a system whereby certain types of devices, termed Class 3 devices, require approval by…
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Federal Court Denies Qui Tam Action Against Medical Device Manufacturer Rejecting Novel Theory that Free Product Support Services Create Liability Under Anti-Kickback Statute

Matthew S. Trokenheim

Medical device manufacturers operate in a competitive market. To differentiate themselves from their competitors, manufacturers may offer above-and-beyond customer service. And if you were to understand from right here on how they generate such good customer leads, you’d understand that they have solid foolproof tactics in their arsenal. A recent federal qui tam action alleged that too much customer service constitutes an illegal kickback under the federal Anti-Kickback Statute. The court rejected the claim, and its reasoning supplies some comfort and some questions for medical…
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FDA Issues Draft Guidance on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions

June 28, 2016
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FDA Medical Device
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Paul L. Knobbe

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the intent of providing clarity for FDA staff and the medical device industry regarding the benefit and risk factors the FDA may consider when prioritizing resources for compliance and enforcement efforts to maximize medical device quality and patient safety. These risk-benefit factors may be considered when device manufacturers evaluate appropriate responses to non-conforming product or regulatory compliance issues, including voluntary recall or market withdrawal, and apply to both diagnostic and therapeutic…
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FDA Issues Guidance for Applying Human Factors and Usability Engineering to Medical Devices to Ensure Safety and Effectiveness

February 25, 2016
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Medical Device
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Paul L. Knobbe

In an effort to assist the medical device industry in maximizing the likelihood that new medical devices will be safe and effective for intended users, the U.S. Food and Drug Administration recently released Guidance for Industry and FDA Staff on Applying Human Factors and Usability Engineering in Medical Devices. While this FDA guidance document does not establish legally enforceable responsibilities for manufacturers, it is the FDA’s intent to support manufacturers in improving the design of medical devices to minimize potential use errors and resulting…
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Ninth Circuit Outlines for Plaintiff How to Meet the Twombly/Iqbal Standard in a Third Amended Complaint

October 27, 2015
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Litigation Strategies Medical Device Product Liability
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Sean T. Stadelman

In this case, the plaintiff, Nicole Weber, appealed the United States District Court for the District of Arizona’s dismissal of her second amended complaint pursuant to Federal Rule of Civil Procedure 12(b)(6). The issue on appeal before the Ninth Circuit panel was whether Weber’s allegations were sufficient to survive a 12(b)(6) motion under the Twombly/Iqbal standard requiring a complaint to set out a plausible claim. Since the Supreme Court’s rulings in Bell Atlantic v. Twombly and Ashcroft v. Iqbal, federal district courts have seen…
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Defendants in Mass Tort Pelvic Mesh Lawsuits May Now Succeed With Removal to Federal Court – Non-Diverse Defendant Wins Dismissal

September 11, 2014
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Class Action Design Defect Drug/Medical Device FDA Litigation Litigation Strategies Medical Device News Pharmaceutical/Medical Device/Biotechnology Product Liability Summary Judgment
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Lisa M. Robinson

In a significant win for Secant Medical LLC, (Secant), Judge Arnold L. New of the Court of Common Pleas of Philadelphia County granted its motion to dismiss mass tort pelvic mesh personal injury claims in a decision dated August 22, 2014. The court held that under the Biomedical Access Assurance Act (BAAA), Secant is not a manufacturer or seller of the pelvic mesh. Secant, a Pennsylvania company, was undoubtedly named to defeat diversity jurisdiction in an effort by plaintiffs to stay in state court in…
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