Lawtitudes Blog

Much has been made of the considerable verdict reached in New Jersey last week on behalf of an Idaho postal worker and his wife who was awarded $47.5 million after the jury found that Vioxx contributed to his 2001 non- fatal heart attack. More importantly, the jury found that Merck & Co. was reckless in promoting Vioxx- now withdrawn from the market—but once heavily promoted for arthritis relief. The award breaks down to $18 million in actual damages to Frederick Humeston and $2 million dollars in loss of consortium damages to his wife. The balance of $27.5 million was awarded against Merck for punitive damages arising form the manufacturer’s “intentional and reckless “ conduct and handling of the marketing and promoting of the once block buster drug.

Thousand of claimants around the country—and many of their counsel—have anxiously awaited this New Jersey verdict (Humeston v Merck & CO., Inc. No ATL-L-2272-03 (N.J. Super4. Ct., Atlantic Cty.) with the expectancy that a second dazzling verdict would bring the manufacturing giant to its knees—or at least to its senses. Not so.

This was a fine result—but one that will most certainly be appealed both on the compensatory and punitive elements. But we must also remember that this is simply one verdict reached on the facts of an individual case. And Merck has long taken the view—one with which it has not deviated– that it will try each case individually.

Not a bad idea, given that the company maintains that many of the cases are specious, with proof of ingestion, oftentimes speculative, and underlying pre 0065isitng medial coronary risk factors the true culprit of the devastating injuries these Vioxx claimants sustained.

Accordingly, each case must still be litigated individually notwithstanding that there are thousands waiting for their day in court. And it would seem that it will take a lot more than one or two (what the company believes are aberrant) verdicts before the global dockets will be resolved.

In other words, it may still take years.

Interestingly- and consider the timing– just 10 days after the Humeston verdict was announced– the FDA implemented a ground breaking rule which limits the role of advisors to the agency. Expert advisors to the FDA—primarily physicians- who receive $50,000 or more from a company or a competitor whose product is being discussed will no longer be permitted to serve on the FDA committees or advisory boards within the FDA which are responsible for approval or removal of a drug form the marketplace. In the New York Times article which first published the FDA rules (by Gardiner Harris, March 22, 2007, pg 1) the newspaper cites to the most famous current example of the conundrum: Bextra, another dangerous Cox-2 drug which continued for a while to remain on the market as Vioxx was removed. This drug, some suggest, is even more dangerous than Vioxx was and is the subject of much litigation around the country. . There is no question that the legal evidence will ultimately bear out that Bextra was dangerous for many of its unsuspecting users, and that physicians knew little or nothing of these risks, but that these risks knowable and known to Pfizer and some of the advisors on the FDA. We now learn that ten of the 32 advisors, who voted in 2005 to allow Bextra to remain on the market, had taken money from Pfizer. The new rules would not have allowed their votes to be counted. To understand the significance of this, if the vote had been taken toady under the revised ruling the voted by the FDA would have been to immediately take the drug off the market. Rather than to permit it to remain. And while Bextra was ultimately discontinued, there were undoubtedly live of some users which were devastated in the interim.

Truth be known- a great deal of the choice should always be with the consumer. Pain is pain—and quality of life for some is worth the risk. But the problem has always been the risk-benefit analysis, and the public and their doctors should know the risks—and be able to weigh them when making an informed choice about treatment and quality of life. This the companies failed to do, seeking block buster status and reaping corporate profits without regard for public health and knowledge.

This entry was posted on Monday, March 26th, 2007 at 11:22 am and is filed under Pharmaceutical Liability . You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.