Another Motrin Failure-To-Warn Decision Rejects Pre-emption Defense

Massachusetts’ supreme court says no “clear evidence” showed “FDA would not have approved a warning on OTC ibuprofen labels stating that redness, rash, and blisters may lead to a life-threatening disease.” McNeil’s failed appeal of a verdict in Children’s Motrin litigation adds to rulings that reject federal pre-emption against failure-to-warn complaints.

A recent ruling against Johnson & Johnson and its McNeil PPC Inc. subsidiary in litigation about Children’s Motrin labeling further muddies the waters about OTC firms’ reliance on federal pre-emption against personal injury claims under state law.

More from United States

New Medicare Negotiation Program ‘Iterations’ Inevitable, Former CMS Official Blum Says

 
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Jonathan Blum, who was principal deputy administrator during the Biden Administration, explained the agency’s approach to setting up the price negotiation program and said changes likely will be implemented by the Trump Administration.

US FDA Rare Disease Innovation Hub’s Goals Align With Trump, Leader Says

 
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The hub’s goals of efficiency, centralization and coordination fit with the Trump Administration’s current focus for the FDA, Amy Comstock Rick, director of strategic coalitions, told the Biopharma Congress.

Pharma Still Nervous While Riding Trump’s Tariff Rollercoaster

 

The rollout of Trump’s plan has been a policy whiplash, but despite a 90-day pause on tariffs, the US president still appears to be holding a grudge with industry over drug pricing.

US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

More from North America

US Pharma Tariff Reprieve May Be Ending

 

Sector-specific tariffs, including on pharmaceuticals, could be announced as early as this week.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Trump’s US FDA Takeover Similar To Flat Earth Proponents Running NASA, Woodcock Says

 
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The former principal deputy commissioner said the “decapitation” of senior leadership will make resolving internal disputes more difficult, which will slow application reviews. Woodcock also called the FDA layoffs a slow-moving catastrophe.