Last Updated Feb 11, 2011 4:03 PM EST
The ruling also highlights one of the more pernicious habits of drug companies: failing to warn American consumers about dangerous drug side effects even when companies do warn of those risks when their products are sold in foreign countries.
There's a legitimate debate to be had about whether it's worth warning people about Stevens-Johnson Syndrome (SJS) and its more severe variant, Toxic Epidermal Necrolysis (TEN). The rare but life-threatening conditions make your skin detach from your body. But it's odd that J&J believes it's OK to warn German consumers about the risk, and not Americans.
In the case, 15-year-old Christopher Trejo sued J&J after he took some Motrin and developed TEN. The U.S. Motrin packet has never specifically warned of this, and the FDA declined to require J&J to list SJS and TEN by name. Instead, the label warns of severe allergic reactions in layman's language. But, the judge said:
McNeil has known since the 1980s that ibuprofen is associated with SJS/TEN, yet never asked the FDA to include that fact in the OTC label warning, despite the fact it could have done so.
Foreign labels for Motrin have long contained more information about SJS/TEN than United States labels, e.g., a patient information leaflet inside bottles of OTC Motrin sold in Germany warns "of the side effects associated with this OTC product of rare but serious skin reactions, such as reddening and blister formation . . . which is bullous EM/SJS."While J&J did comply with everything the FDA asked it to do, that may not be enough, the ruling states:
... petitioners failed to provide adequate warnings concerning SJS and TEN (though they have long known about them), ...
[T]hrough many amendments to the FDCA and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market. [Emphasis in the original.]This notion -- that the company, not the FDA, bears final responsibility for the drug's safety warnings -- is a recent one, spurred by a 2009 U.S. Supreme Court ruling, Wyeth v. Levine. That ruling states FDA regulation merely sets the minimum safety requirements for drug sellers, and that companies may have a responsibility to go beyond that if new information arises suggesting health risks.
As for the difference between warnings on Motrin in the U.S. and Motrin in Germany, this isn't an isolated case. In Sweden, Merck (MRK)'s baldness drug Propecia warns men that one of its side effects may be permanent erectile dysfunction. The U.S. version carries a much milder warning suggesting it's temporary.
Coupled with the knock-on effects of Wyeth v. Levine, the industry could eventually conclude that if a safety warning is worth making in one country, it's worth making worldwide.
- Why Merck's Hair Loss Drug Could Make Its Income Statement Go, Um, Limp
- In Motrin Case, Court Strips Virginians of Most of Their Rights
- How a Girl Blinded by Acne Meds Could Force Generic Drugmakers to Take Safety Seriously