§ 510(k) Safety and Effectiveness – A Changing Landscape for Punitive Damages?

The Central District of California recently issued an opinion that breathes new life into the argument that the § 510(k) substantial equivalence process for Class II medical devices involves an FDA finding of safety and effectiveness. It is part of a trend of recent federal cases giving credence to the § 510(k) process, which could have significant implications for punitive damages claims brought against manufacturers of Class II devices.

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Clinical Trial Activity Is Not an Exception to the Rule

Defendants and courts have seen a variety of arguments set forth in attempts to demonstrate specific personal jurisdiction. One argument seen with increasing frequency in medical products cases is that specific jurisdiction exists over an out-of-state defendant for the claims of non-resident plaintiffs because the defendant conducted clinical trials of the product at issue in the forum state. Courts have consistently rejected this argument.

For example, in Moore v. Bayer Corp., 2018 WL 4144795 (E.D. Mo. Aug. 29, 2018), three Missouri plaintiffs joined 95 non-Missouri plaintiffs to sue Bayer and four of its subsidiaries in Missouri state court. All plaintiffs alleged that they had suffered personal injuries as a result of being prescribed and implanted with the medical device Essure. The non-resident plaintiffs argued that specific jurisdiction existed because Bayer worked on the regulatory approval of Essure in Missouri. Plaintiffs alleged that “Missouri was one of eight principal sites in the United States chosen to conduct pre-market clinical trials of Essure. Missouri hospitals and physicians were used in these clinical investigations, and the Missouri study results were used to support the FDA approval process of Essure.” After analyzing Bristol–Myers Squibb Co. v. Superior Court of California, San Francisco County, 137 S. Ct. 1773 (2017) [BMS], the court held that “[t]he injury claims of the non-Missouri plaintiffs lack an adequate connection to Bayer’s activities in Missouri for specific jurisdiction. The non-Missouri plaintiffs were not prescribed Essure in Missouri, they did not have the device implanted in Missouri, and they were not injured in Missouri.” The court went on to state that “[t]he non-Missouri plaintiffs do not allege to have taken part in Missouri clinical trials nor do they allege to have personally reviewed or relied on the resulting data.”

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NJ Top Court Tosses More Than 500 Suits Against Acne Medication Maker

On October 3, 2018, the New Jersey Supreme Court dismissed 532 cases against Hoffmann-La Roche Inc. and Roche Laboratories Inc., the manufacturer of the prescription acne medication Accutane, holding that the laws of New Jersey – the location of Roche’s principal place of business– and not the respective laws of plaintiffs’ home states governed the adequacy of the warnings underlying plaintiffs’ failure to warn claims.  The Court held that because the medication’s warnings were FDA-approved, “they enjoy a ‘rebuttable presumption’ of adequacy under New Jersey’s Products Liability Act ([NJ]PLA).”

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New Jersey MCL Update: Three New Consolidated Litigations in New Jersey

August was a busy month for multi-county litigation (MCL) in New Jersey: the Supreme Court of New Jersey designated three new MCLs and terminated one in a matter of just three days. Newly added to the MCL docket are the Physiomesh Flexible Composite Mesh litigation, Zostavax litigation, and Taxotere litigation. Meanwhile, the Pompton Lakes Environmental Contamination litigation has been terminated. Here is a brief update on these four litigations.

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New Study Shows Link Between Increased Product Liability Litigation And Decreased Technological Innovation

It’s an argument both manufacturers and the defense bar have been making for years: an increased risk of liability for new products will deter manufacturers from developing new technologies. Yet despite the apparent logic of such an argument, there was scant empirical evidence backing up this claim . . . until last month.

Researchers Alberto Galasso of the University of Toronto and Hong Luo of Harvard Business School recently published a working paper that examines the impact of increased litigation for medical implant manufacturers in the early 1990s. The paper, titled “How Does Product Liability Risk Affect Innovation? Evidence From Medical Implants,” shows how this increase led to a decrease in downstream innovation in medical implants and demonstrates how tort reform—specifically the 1998 Biomaterials Access Assurance Act (BAAA)—subsequently reversed this trend and spurred further innovation for raw material manufacturers.

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