FDA rule would help bolster drug makers' defense

Ann Knef Jan. 25, 2006, 8:52am

Warning: Massive pharmaceutical litigation could lead to capital drainage and less investment in the research and development of new life-saving drugs.

That's why Merck & Co., the target of thousands of Vioxx lawsuits across the country, for instance, should embrace the Food and Drug Administration's re-assertion that drug labeling pre-empts contradictory state law.

"What's the point of the FDA's multi-year, billion dollar approval process if fundamental safety questions can then be re-litigated again and again before scientifically illiterate juries?" posed a recent Wall Street Journal commentary.

Merck & Co. faces more than 9,200 Vioxx lawsuits in state and federal courts by plaintiffs alleging Vioxx caused strokes, heart attacks and death. Among other things, plaintiffs claim that Merck failed to warn consumers that the drug could pose cardiac risks.

Vioxx, an arthritis pain-reliever, was removed from the market in September 2004 by Merck.

Three Vioxx trials have brought mixed results. In August 2005, a Texas jury awarded $253 million to the widow of a man who died while taking Vioxx. The award was later reduced because of the state's law capping punitive damages.

In November, Merck won a major victory when a New Jersey jury found that the drug maker properly warned consumers about the risks of the medication. In December, a federal judge in Texas declared a mistrial after a jury failed to reach a unanimous verdict.

Local litigation

Since 2000, Merck has been sued 57 times in Madison County's Civil Law Division, where plaintiffs seek in excess of $50,000 in damages.

Thirty-eight of the cases are Vioxx-related; three of them are Vioxx class action lawsuits. None of the cases are close to going to trial. One has been set next year.

In St. Clair County, there have been approximately 50 Vioxx lawsuits filed since October 2004.

The 49th suit was filed against Merck, including co-defendants Walgreens and Osco, on Jan. 18.

In the new suit, 11 plaintiffs claim that their or next of kin's use of Vioxx caused strokes andheart attacks.

The plaintiffs are represented by Jeffrey J. Lowe of St. Louis, Charles Lampin of St. Peters,. Mo., John Carey and Joseph P. Danis of Carey & Danis in St. Louis, T. Evan Schaeffer of Schaeffer & Lamere in Godfrey and Evan Buxner of the Walther Glenn Law Office in St. Louis.

"The Vioxx manufactured and supplied by Merck was unaccompanied by proper and adequate warnings regarding all adverse side effects associated with the use of Vioxx," the suit claims.

"The warnings given by Merck did not accurately reflect the symptoms, type, scope or severity of the side effects."

Defense boost

Though higher courts will ultimately decide, the effect of the FDA's rule will bolster pharmaceuticals' defense against personal injury claims, which often cite that consumers were not warned about a drug's risks.

Drug makers could argue that they were not required to inform consumers about potential risks if the FDA determined that the safety concern did not warrant mention on the drug's label.

In a Jan. 25 WSJ opinion, "May Cause Anxiety (in Lawyers)," the writer chastised Sen. Ted Kennedy and Rep. Maurice Hinchey for their support of the plaintiff's bar which opposes the policy.

The writer points to Dowhal v. SmithKline Beecham , a case in which the plaintiff alleged that nicotine replacement products should warn about the potential for birth defects.

"It's hard to think of a case that better illustrates the moral bankruptcy of the Kennedy-Hinchey-trial lawyer position here than Dowhal," the writer states.

"The kind of labeling and litigation environment they are fighting to preserve would probably have the effect, among others, of more women continuing to smoke during pregnancy. Overwarning on medication can be as much of a risk to public health as underwarning."

"It should be unacceptable to leave companies subject to the double jeopardy of FDA approval followed by tort law second guessing."

Merck was contacted for comment, but did not return a phone call.

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