Parties involved in coordinated proceedings featuring thousands of plaintiffs and a tight discovery schedule are expected to negotiate an efficient process for production of baseline data. The Plaintiff Fact Sheet (PFS)/Defendant Fact Sheet (DFS) process provides an orderly procedure for discovery specific to plaintiffs and their prescribing/treating physicians.
On October 10th, the United States Supreme Court heard arguments in Air & Liquid Systems Corp., et al. v. Devries, et al., No. 17-1104, over whether the manufacturer of a bare metal product, in this case engines on a Navy ship, may be held liable for injuries suffered from later-added asbestos-containing materials. Under maritime law, the Third Circuit said yes, if the facts show the manufacturer reasonably could have known that asbestos is hazardous and its product will be used with an asbestos-containing part, because (a) the product was originally equipped with the asbestos part, which needs to be replaced, (b) the manufacturer specifically directed that the product be used with the asbestos-containing part, or (c) the product required the asbestos-containing part to properly function.
The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent an untitled letter to Eisai Inc. on October 11, 2018, based on a sales representative’s “false and misleading” oral statements during a lunch presentation about the safety of the antiepileptic medication Fycompa®, downplaying warnings, and engaging in off-label promotion of the product.
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.
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.”
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).”