As threatened, a Texas judge did a Texas-size thing: he dismissed a Vioxx lawsuit brought by a woman who claimed the painkiller caused a heart attack. And he cited a state law that limits failure-to-warn claims against a manufacturer. The rationale is that Merck properly provided all info appropriately to the FDA, which has a rule saying its jurisdiction trumps state courts.

The concept is called pre-emption, and essentially this gives companies some immunity against product liability claims, because the FDA has already deemed a product to be safe. An exception would occur when, say, a company knowingly hid or falsified info that would have led the FDA to make a different decision about approving a drug.

Relying on the U.S. Supreme Court, state court judge Randy Wilson ruled that the decision about the safety of a drug can only be made by the FDA, not a Texas jury. However, as Merck notes, the FDA has never made any such determination. Wilson certified the decision for an expedited appeal to the Texas Court of Civil Appeals.

The implications are potentially far-reaching, and not just for Merck. For one, state court judge Randy Wilson has effectively cast a legal cloud over some 1,000 Vioxx cases in Texas. And since drugmakers are regularly citing pre-emption in product-liability cases, this decision is going to be cited in mass torts in other states with similar laws.

Merck believes there are about 2,000 Vioxx cases pending in other jurisdictions that may be subject to this Texas law. And the drugmaker notes the failure-to-warn claim is the main theory argued by plaintiffs’ lawyers in the Vioxx cases. Plaintiffs have asserted other alleged theories and the effect of the ruling on cases that include such other theories remains to be determined.

“The Texas Legislature enacted its law to ensure that jurors are not asked to second-guess the doctors and scientists at the FDA who conduct an extensive review,” says Merck lawyer Ted Mayer. “The nation’s highest court has affirmed that the FDA’s role is paramount and that state law cannot be allowed to undermine the FDA’s statutory responsibility to ensure the safety and availability of prescription medications for all Americans.”

Further reading…
Merck statement;
A good primer for anyone who isn’t an attorney can be found on Drug & Device Law.

[tags]Merck, Pre-emption, Vioxx[/tags]