VIOXX: WHAT TO DO IF YOU THINK YOU HAVE A LEGAL CLAIM

If you or a family member were a Vioxx user for a significant period of time, you may have a products liability claim against the manufacturer of the product, Merck & Company. An enormous number of Vioxx claims are expected to be filed based on the factual circumstances surrounding the marketing of what is now acknowledged to be a defective product coupled with the potential for serious or fatal injury to some patients.

Merck, which obtained FDA approval to market Vioxx in 1999, voluntarily took the drug off the market in September of 2004. Merck withdrew Vioxx based on the results of an internal three-year study of 2,600 patients, half of whom received a 25 milligram dose of Vioxx and half of whom received a placebo. The company said these patients, treated with Vioxx to thwart the resurgence of colorectal polyps, a common precursor to cancer, showed no undesirable effects during the first 18 months of the study begun in 2000.

After 18 months, however, there was a pattern of increased risk of stroke and heart attack. Peter Kim, President of Merck Research Laboratory said that "while the cause of these results is uncertain at this time, they suggest an increased risk of confirmed cardiovascular events beginning after 18 months of continuous therapy".

How much are former Vioxx patients at risk? While the answer to this question is unknown at present, acting FDA Commissioner Dr. Lester M. Crawford stated that "(a)although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo." Dr. Crawford added that FDA will closely monitor other drugs in this class for similar side effects, and that "all of the NSAID drugs have risks when taken chronically, especially of gastrointestinal bleeding, but also liver and kidney toxicity.

What Dr. Crawford did not say is that half of all heart attack victims die as a result. Doubling the risk of a catastrophic or fatal event is obviously significant, particularly for patients who may have already suffered those type of injuries while on Vioxx.

The FDA itself has come under fire recently for approving Vioxx in the first place, over the objection of some of its own scientists. FDA approved Vioxx in 1999 for the reduction of pain and inflammation caused by osteoarthritis, as well as for acute pain in adults and for the treatment of menstrual pain. It was the second of a new kind of NSAID (Cox-2 selective) approved by FDA. Subsequently, FDA approved Vioxx to treat the signs and symptoms of rheumatoid arthritis in adults and children.
At the time that Vioxx and other Cox-2 selective NSAIDs were approved, it was hoped that they would have a lower risk of gastrointestinal ulcers and bleeding than other NSAIDs (such as ibuprofen and naproxen). Vioxx is the only NSAID demonstrated to have a lower rate of these side effects.

In November of 2004 an expert with the FDA accused the agency in Congress of having pressed him to withhold results of a study showing potential dangers of the anti-inflammatory drug Vioxx. "I was pressured to change my conclusions and recommendations, and basically threatened that if I did not change them, I would not be permitted to present the paper at the conference," said David Graham, Associate Director for Science with the Office of Drug Safety at the FDA. Dr. Graham testified at a Senate hearing about his 2001-2004 study. "One drug safety manager recommended that I should be barred from presenting the poster at the meeting and also noted that Merck needed to know our study results," he said.

Whatever happened behind the scenes as Vioxx came to market is sure to be an evolving story, one with potential ramifications for the population of Vioxx patients who were injured by the drug. If it can be shown that Merck knew about the injurious side effects when the drug was still on the market, then claimants will have potential claims for punitive damages.

For those who took Vioxx, it is important to get a prompt medical evaluation to assess whether any cardiovascular damage may have occurred. If none has occurred, the possibility of pursuing a claim will be reduced though perhaps not foreclosed altogether. Claims may exist for those who suffer cardiovascular events within a short period of time after discontinuing Vioxx, though claims will be more difficult to prove as the time period between ingestion of Vioxx and an adverse event increases. The clearest claims will involve those who suffered heart attacks or strokes while on Vioxx. Counsel should be retained in those situations to conduct an investigation and determine whether Vioxx was a contributing factor to the injurious events.

Counsel can be hired to pursue Vioxx claims on a contingent fee basis, whereby attorney's fees are only owed if a recovery is secured on behalf of the claimant. I would expect most contingency agreements to be in the one-third to 45% range.

For more information, you may contact the undersigned dlt@swtlaw.com or call (404) 688-6800.

THIS ARTICLE IS FOR INFORMATION PURPOSES ONLY AND DOES NOT CONSTITUTE LEGAL ADVICE. FOR ADVICE ABOUT A SPECIFIC LEGAL MATTER CONTACT COUNSEL OF YOUR CHOOSING.