FDA Warns Against Sales Representative’s “False and Misleading” Oral Statements Regarding Prescription Medicine

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.

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§ 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. Continue reading

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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