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Editor: Robert Blanchard
Profession: Attorney at Law

Category: Ortho Evra Legal News

Some experts predict that the drug company that manufactures Ortho Evra, Johnson and Johnson, will hide behind the doctors in any litigation regarding the increased health risks associated with the patch. Using what's known as a "learned intermediary" defense, the pharmaceutical companies will say "we told the doctors." According to an article on law.com which quotes Alan Klein, a drug products lawyer in Philadelphia:

under the learned-intermediary doctrine, J&J need only prove that prescribing physicians had adequate notice of health risks.

Klein points out that because J&J advertised Ortho Evra directly to the public, it has an additional duty to warn consumers of any dangers. But that duty, set out by Perez v. Wyeth, 161 N.J. 1 (1999), is presumed satisfied if the company complies with FDA labeling and advertising regulations, he says.

The issue in this case will be, what did J&J know at the time they marketed the patch," Klein says. "I think what happened here, after the patch went on the market, is that there were additional clinical trials that found the patch released more estrogen than they estimated and it led to reports of adverse events.

Is it likely that all doctors were fully informed that one study showed up to 6 times higher risk of DVT (deep vein thrombosis) with the use of the patch vs. the pill Ortho Tricyclen. Furthermore, how many women would have chosen not to use the patch had they been fully appraised of these risks.