Cases & Deals

PLAC files amicus brief in violation of state consumer protection action arguing that the criteria for collateral estoppel was not met due to no agency adjudication

Clients Product Liability Advisory Council

Jones Day prepared and filed an amicus brief to the West Virginia Supreme Court on behalf of the Product Liability Advisory Council (PLAC) in an action alleging a violation of the state consumer protection statute. The Attorney General of West Virginia sued Janssen Pharmaceutica alleging that its marketing and promotion of two drugs was false and misleading in violation of the state consumer protection statute. Janssen had earlier issued "Dr. Doctor" letters to advise physicians of its concession to revisions that the FDA staff had demanded in the marketing and promotional materials, even though Janssen disagreed with the FDA staff. The West Virginia trial court held that Janssen's acquiescence to the FDA staff's position amounted to an admission of liability and that Janssen was estopped from contesting liability under the state consumer protection law. It entered summary judgment against Janssen, finding that the promotional and marketing materials were false and misleading as a matter of law. After a hearing on damages, it awarded the State millions of dollars in penalties under the statute. On behalf of the Product Liability Advisory Council, our amicus brief argued that the company's decision not to contest the FDA staff's position was not an admission of liability and did not meet the criteria for either collateral estoppel or res judicata in the absence of any agency hearing, adjudication and right of appeal. The amicus brief also argued that the concession to the FDA staff was an inadmissible settlement and that Janssen's letters to physicians were inadmissible subsequent remedial measures. The West Virginia Supreme Court agreed with PLAC that the criteria for collateral estoppel were not met, because there was no agency adjudication. It reversed the trial court's summary judgment and award of damages for the State.

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