A New Jersey judge handling hundreds of lawsuits over Wyeth’s hormone replacement drug Prempro has ruled that a federal law does not bar state lawsuits alleging drugmakers did not adequately warn about a product’s risks.
The ruling, released last week by Superior Court Judge Bryan Garruto in New Brunswick, is at least the third by state or federal judges concluding that such product liability suits against drugmakers are not pre-empted by part of the U.S. Food, Drug and Cosmetic Act.
“It’s a very important decision,” said Esther Berezofsky, attorney for Ellen Deutsch, whose lawsuit blames Prempro for her breast cancer.
The ruling allows Deutsch’s key claim against Wyeth to proceed but also likely will help plaintiffs across the country suing drugmakers, Berezofsky said.
Since at least early 2006, drugmakers have been arguing that product liability suits are pre-empted, or barred, because federal law gives the Food and Drug Administration the exclusive right to determine whether a drug’s label, or detailed package insert, contains adequate warnings about any health risks.
Berezofsky said the ruling in this case backs up earlier ones in New Jersey state court involving Merck & Co.’s withdrawn painkiller Vioxx and in federal court in New York involving Eli Lilly and Co.’s anti-psychotic drug Zyprexa.
“The point is, a drug being approved by the FDA does not protect the drug companies from being sued,” she said. “The FDA regulations (on label warnings) are a floor, not a ceiling,” and drug companies can strengthen warnings or add new ones.
Wyeth spokesman Christopher Garland said the company would not comment because the Deutsch case is ongoing.
Deutsch, who took Prempro from 1996 through 2002 and also took an older Wyeth menopause treatment, Premarin, before that, alleges the drugs caused breast cancer. The Livingston, N.J., resident, in her early 60s, is in treatment for the cancer, which has spread to her bones, Berezofsky said.
Deutsch’s lawsuit is set to go to trial July 9, making it the first trial over the drug in New Jersey.
About 250 Prempro lawsuits are pending in New Jersey and about 10,000 have been filed nationwide.
Garruto also issued other pretrial rulings in the Deutsch case, including one stating that a doctor’s prescribing a drug does not preclude a patient from suing over alleged harm. Berezofsky said plaintiffs lawyers have been arguing against such motions because drug companies now advertise directly to patients, who might choose not to take a drug their doctor had prescribed if they knew all of its risks.
In a third ruling against Wyeth, Garruto wrote that a plaintiff bringing a product liability suit can separately sue for fraud or misrepresentation under New Jersey’s Consumer Fraud Act. In Deutsch’s case, though, he dismissed her consumer fraud claim because she had not provided evidence of what she paid for the hormone replacement drugs.
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