The pharmaceutical industry may be breathing a collective sigh of relief over the latest court verdict involving Merck & Co.'s Vioxx, but it may not be time to pop the cork on the champagne.
Experts say the two very different jury decisions handed down so far could still have some negative implications for the pharmaceutical industryas well as for physicians.
In August, a Texas jury awarded $253 million to the widow of a man who died after taking Vioxx (rofecoxib), but in November a New Jersey jury found no fault with the company's actions in the case of a man who claimed that taking Vioxx contributed to his having a heart attack.
This latest verdict is "definitely a huge victory for Merck," with its implication that at least some of the 6,000 pending cases against the company will be dropped, said Daphne Monie, Ph.D., an analyst in the immune and inflammatory disorders group at Decision Resources Inc., a market research firm that conducts analysis of trends in the drug industry.
However, it could spell trouble for the pharmaceutical industry.
The first case shows that a jury is willing to hold the company responsible for the adverse effects of the drug, even as a different jury concluded that the company provided adequate warning to physicians and the public about risks. When taken together, the verdicts send the message that drug companies could be held liable for adverse effects even when the risks are properly disclosed, she said.
And it's possible that physicians could also become the target of lawsuits. If the precedent is set that Merck can be held liable for adverse events even when providing adequate warning about the risks, physicians may be held responsible for prescribing the drugs. At press time, Dr. Monie knew of no such cases against physicians involving Vioxx.
But Dr. Eric Matteson, a rheumatologist and professor of medicine at the Mayo Clinic in Rochester, Minn., said that cases against physicians are unlikely because Vioxx was an FDA-approved drug and there were limited warnings about its use. "I think physicians prescribed in good faith," he said.
The two very different verdicts in these cases reflect the complexity of trying to attribute cardiovascular events to exposure to a particular drug especially when other drugs and comorbidities are involved, he added.
The risk information about cyclooxygenase-2 (COX-2) inhibitors in general has made everyone a lot more cautious. It definitely seems to be slowing down the release of new COX-2s onto the market, he said, and it may have an effect on the willingness of physicians to prescribe COX-2s when the agents do become available.
Physicians should be aware that these drugs have a limited utility and that global prescribing for pain and inflammation in unselected patients is not a good practice, Dr. Matteson added.
Regardless of the recent verdicts, the courtroom is not the best place to be debating the safety of Vioxx, said Dr. W. Hayes Wilson, who is a national medical advisor for the Arthritis Foundation and chief of rheumatology at Piedmont Hospital in Atlanta.
"There is no correlation between jury verdicts and scientific literature," Dr. Wilson explained. "Scientific literature is not best evaluated in a court of law." In that context, the jurors can only decide based on the information that is presented to them.
The likely outcome of all the events surrounding the withdrawal of Vioxx is that there will be fewer choices for patients, he said.