Vioxx payout signals new FDA era.

Merck & Co. has announced that it will pay $4.85 billion into a fund to settle claims that its cyclooxygenase-2 inhibitor rofecoxib (Vioxx) was responsible for causing myocardial infarction and stroke in patients who took the drug for pain.

The Vioxx saga spurred a sea change in the way the Food and Drug Administration handles drug safety issues, and resulted in a raft of new reforms that were signed into law in October.

Dr. Steven Nissen, one of the first to sound the alarm about Vioxx's potential cardiovascular risk, said in an interview that he believes the FDA reform bill is one of Vioxx's most important legacies. Chief among the reforms is the agency's new ability to unilaterally change a drug's labeling. "With Vioxx, it took 14 months for the FDA to reach agreement with the company on the exact language of the warning," he said.

He also said he was encouraged by the establishment of a clinical trial results registry that will be open to the public. "Not everything that was known about rofecoxib ended up in the public domain," Dr. Nissen noted.

As principal investigator, Dr. Nissen is delving further into the knowns and unknowns about COX-2s with the 20,000-patient PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen or Naproxen) study. He said he expects interim data by 2011.

In the meantime, Merck hopes to close the door on the Vioxx litigation with its settlement fund. Payouts will begin only if 85% of plaintiffs enter into the settlement. That seemed likely, as many of the key plaintiffs' attorneys were involved in the negotiations that led to the settlement.

"It's been a long hard fight in achieving justice for the many injured victims of Vioxx nationwide, and I believe this global resolution is the best and fairest way to resolve this litigation," said Christopher A. Seeger, a co-lead counsel for the New Jersey state Vioxx actions and the federal cases, in a statement.

If the settlement is not accepted, Merck said it would continue to fight the suits on a case-by-case basis. But accepting the payout may be the best course of action for patients seeking redress from Merck. The statute of limitations (which varies by jurisdiction) on product liability suits has expired in 42 states, Puerto Rico, and the District of Columbia. Merck withdrew Vioxx from the market on Sept. 30, 2004.

The company has been successful at trial, with juries deciding in favor of the company 12 times and in favor of the plaintiffs 5 times. Another 5,550 claims have been dismissed. Merck has spent $1.2 billion in its defense, and had planned on spending at least $1.9 billion to cover the ongoing litigation.

With the settlement, "Merck does not admit liability or causation, and in fact, Merck continues to believe that it acted responsibly," company senior vice president and general counsel Bruce Kuhlik said in a conference call.

The settlement would cover 45,000-50,000 pending claims. All claims will be individually evaluated by the company. Merck expects that another 10,000-15,000 plaintiffs won't be eligible because they did not suffer a stroke or a heart attack. Claimants have to have filed suit on or before Nov. 8, 2007, and they must meet three criteria: They must have had an MI or ischemic stroke, they must have taken at least 30 pills, and they must have ingested the pills in "sufficient number" within 14 days of the injury.

Merck believes that its settlement precludes any future litigation, he added. First, attorneys with pending claims who accept the settlement have to forswear future claims. And anyone who seeks future redress will have to produce contemporaneous medical records demonstrating an MI or stroke; they can't hire experts to testify to the injury after the fact.

The settlement does not apply to 300 cases involving 800 plaintiff groups outside the United States, the company said.

BY ALICIA AULT

Associate Editor, Practice Trends