If J&J misled FDA, can patients sue?

Drug companies appear to be close to gaining a long-coveted prize: A shield against patient lawsuits. The Bush administration has been arguing in favor of it, saying that only the FDA has the expertise to regulate pharma. And the Supreme Court will rule during its next term on a case that could make FDA approval pre-empt any liability claims.

In the meantime, Johnson & Johnson is using the argument in a case over the Ortho Evra birth control patch. Company documents show that J&J knew the patch delivered more estrogen to patients than low-dose birth-control pills did--knew this even before the FDA approved the product in 2001. A 1999 trial showed the patch delivering 30 to 38 micrograms into the bloodstream daily. But the company marketed the product as delivering 20 micrograms daily. High doses of estrogen are known to raise the risk for blood clots that can cause heart attack and stroke. Families and patients have sued, alleging a variety of health problems, including death, ensued after women began using the patch--and that the company either hid or altered data to mislead the FDA and patients.

The FDA didn't warn women of the product's dangers until 2005, after receiving reports of at least 50 deaths associated with the drug. As one FDA official admitted during the Zyprexa trial last month, the agency doesn't always ask for strong warnings even on risky drugs because companies typically oppose them. "We at the FDA know what we can and cannot obtain," the official said, according to the New York Times. Plus, the fiddling J&J did with the estrogen numbers--a "correction factor"--was only disclosed once in its 435-page approval app for the patch.

Nevertheless, patients shouldn't be allowed to sue, the company's lawyers say, because the agency approved the product and its label: "FDA is responsible for making those decisions." We'll see how that defense fares.

- read the NYT story
- see the item at PharmaGossip

Suggested Articles

Compared with the FDA "boxed warning," the EMA version puts a smaller restriction on the higher dose but broadens the cautionary language.

Shionogi's newest antibiotic Fetroja has now earned the FDA's approval, but will a mortality-rate warning scuttle the drug's chances?

Novartis' Sandoz doubled down in Japan as Lupin retreated. Dr. Reddy's posted a loss tied to its Zantac recall. Aslan's varlitinib failed again.