New Jersey Judge Pops Hopes of Hundreds of Plaintiffs in Accutane Trial
An April 2, the judge in the Accutane mass tort litigation currently being litigated in the Superior Court of New Jersey, Atlantic County, issued a ruling that directly affects hundreds of plaintiffs in the lawsuit, and could impact hundreds more.
Accutane is a prescription medicine that was used to treat a certain kind of severe acne from 1982 to 2009. After it had been on the market for some time, serious questions began to be raised about the drug’s safety, linking Accutane to irritable bowel syndrome (IBD), severe stomach pain and rectal bleeding. Lawsuits followed, and drug maker Hoffman-LaRoche removed the product from the market in 2009. Variations of the drug made by Roche and other companies are still on the market in the U.S. and elsewhere.
The current litigation in New Jersey has been ongoing for a decade. The cases were designated as a mass tort and consolidated into a multicounty litigation (MCL) in the Atlantic County courthouse on May 2, 2005. Judge Carol Higbee was assigned to handle the MCL and was the judge in charge of the litigation until last October, when the cases were transferred to Judge Nelson Johnson, after Judge Higbee was elevated to the New Jersey Appellate Court. It is Judge Johnson’s April 2nd ruling that has sent shockwaves through the world of the Accutane litigation.
The plaintiffs in the Accutane cases had been alleging that the warnings on the Accutane label were insufficient, which would make Accutane basically a defective product under products liability law. Judge Johnson ruled in his April 2nd order that the warnings on the Accutane label after April 10, 2002 were adequate as a matter of law. Therefore, any plaintiffs who started using Accutane on or after that date cannot succeed on their claim.
This ruling will have an immediate impact for over 800 New Jersey plaintiffs who fit into that category, and the decision may also impact plaintiffs in the case from other states as well. Judge Johnson’s ruling was based on the New Jersey Product Liability Act, which creates a legal presumption that labeling is adequate if the manufacturer is in compliance with FDA regulations. Plaintiffs in other states with similar laws, or that require a heavier burden of proof than New Jersey, may also see their cases dismissed. Plaintiffs from Michigan and Texas, for instance, may also be out of luck based on this latest ruling.
A key component of the ruling is the application of the “learned intermediary doctrine” in New Jersey, which says that the drug labels are meant to be read by the prescribing doctors and not by patients. Under this doctrine, labels do not have to be written in such plain and clear language, because it is expected a doctor with medical training could understand the risks, even if the average patient could not.
This ruling may not apply to plaintiffs from other states with different laws. Also, New Jersey plaintiffs who took Accutane prior to April 10, 2002 may still pursue their claims unhindered by this ruling. It remains to be seen how many of the more than 6,700 cases in the mass tort litigation will be affected.
