The New Jersey Supreme Court has booted a lawsuit that sought to force Merck to pay for electrocardiograms and follow-up medical care, because the plaintiffs had not suffered any injury. The ruling, which is a big win for the drugmaker, reverses a decision by an appellate court, which found that a trial court dismissal in 2005 was premature.
The Supreme Court decided that individuals can't pursue claims for medical monitoring under New Jersey's Product Liability Act unless they can show they first suffered an injury. "...it is not disputed that plaintiffs do not allege a personal physical injury. Thus, we conclude that because plaintiffs cannot satisfy the definition of harm to state a product liability claim under the Product Liability Act, plaintiffs’ claim for medical monitoring damages must fail.” (Please see page 17 of the ruling).
"The NJ Supreme Court has made it clear that you cannot bring a medical monitoring claim unless you allege you were injured by a product. The plaintiffs in this suit sought to recover from Merck even though VIOXX has been off the market for almost four yars and they do not claim that it ever injured them," says Ted Mayer of Hughes Hubbard & Reed, Merck's lawyer, in a statement.
In its defense, Merck also aruged there is no medical science supporting the plaintiffs’ position that they need to be monitored for cardiovascular conditions almost four years after VIOXX was voluntarily taken off the market.
5 Comments
Makes perfect sense. As I have said before, one by one these claims on the gravy train keep getting thrown out. Unfortunately, the damage has been done to:
- Thousands of patients who can no longer access valuable product with a favorable (not perfect) risk/benefit profile
- Thousands of patients who will either not benefit or will have to wait longer for therapies because everyone has become so risk-averse
- The thousands of people without jobs
- Thousands of patients who will miss the chance to experience Vioxx-induced heart attacks and sudden death over a four year period
http://www.consumeraffairs.com/news04/vioxx_estimates.html The Food and Drug Administration (FDA) estimates that Vioxx may have contributed to 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003
So far, no one has taken me up on the challenge of actually reading and responding to the specific charges upheld in the New Jersey verdict upheld in the federal court of appeals there. (The McDarby decision that Ed posted).
PG's estimates are low - sound like they come from David Graham's Vioxx/Celebrex study. Other studies have put the Vioxx deaths at between 50,000 and 80,000.
As far as Paul's comments, the following:
- I would love to hear your response to the court decison above, particularly how you react to Merck's insistence on the "cardioprotective" effects of Naproxen which even their internal folks knew was horse hockey. But marketing played that card to the bitter end, even while they aggressively tried to camoflage/distract from the CV issues they knew were there.
If there is another way to read the evidence, I'd be genuinely interested in hearing it. So would many folks at Merck who knew the truth at the time. Perhaps you know some of them. I do.
Vioxx would still be on the market if Merck hadn't wildly overreached and oversold. Maybe it's time to place responsibility where it belongs.
- As far as jobs, every other major pharma company - Pfizer, Lilly, Wyeth, et. al. - have gone through similar or larger job cuts.
Blame all the problems on the lawyers if you want. It will bring you no closer to reality.
Thanks Justice,
I agree with you that blaming all the problems on the lawyesr will not bring us closer to reality. However, blaming all the problems on Merck will not do that either.
The answer is somewhere in between. This the crux of all these arguments. Come good common-sense discussion would help a great deal, but it ain't gonna happen because there are too many emotions, biases and egos involved.
Justice says: "As far as jobs, every other major pharma company - Pfizer, Lilly, Wyeth, et. al. - have gone through similar or larger job cuts."
Very true. However, most people in the industry argue that it was the Vioxx situation that prompted the FDA to become more conservative in its approval of new drugs, which has contributed to the job losses throughout the industry. At my company (you can figure out the one) we have recieved 6 negative decisions from the FDA ("nonapprovable" or "approvable") over the past year while only recieving 3 positive decisions (for minor products). Due largely to these delays, we just eliminated ~3000 jobs and anticipate another ~2000 jobs being lost in the coming months. We conducted clinical trials and submitted the FDA documents based on the criteria in front of us in a pre-Vioxx era. Now, due to no fault of our own, the ground has shifted and FDA is rejecting things that it would have approved just a few short years ago. It's is having a devistating impact on pharma research. My company alone has eliminated ~200 researchers. We are shifting our research resources away from primary care indications and instead towards specialty indications that hopefully will face less FDA backlash.
Note that these research positions being eliminated aren't being replaced at other companies. Combine my company with the other big pharma out there and you'll find thousands of research positions simply vanishing. These people aren't going to universities or biotech companies. They are becoming lawyers, scientific sales reps, writers, etc. They are no longer contributing to the advancement of science.
We certainly can't blame all our problems on Merck or the FDA -- but I sure put most of the blame in their laps.