Big Drug Cases Evaporate Next Fall??

I have been wanting to post this for about 2 weeks now, but I have kept putting off researching the cases myself. I finally said screw it, I will just post it the way it is. So please excuse any misreading of the cases as I am summing up some of the numerous news stories that I have heard on the topic.

A couple of recent cases and one on the way before the Supreme Court may end pharmaceutical products liability, or for that matter, it may eliminate most or all cases against drug makers for any unwarranted health effects of medications. This spring the Supreme Court in its “infinite wisdom” decided 2 cases: Riegel v. Medtronic and Warner-Lambert v. Kent. The decisions in these cases indicate that the Supreme Court is going down a road that the approval of a drug by the FDA preempts any tortuous action based on the taking of that drug. How did I come to this conclusion? Why does this matter? How does it affect you?

First the conclusion—
Riegel v. Medtronic was a 8-1 decision by the Supreme Court which I believe was written by J. Scalia was delivered on Wednesday, February 20, 2008. The lone dissenter was J. Ginsberg.
The decision made medical device makers immune from personal injuries liability if the Food and Drug Administration has approved a device before it is marketed. This decision preempts state law under the authority of the Medical Device Amendments of 1976 to (I believe) the Food, Drug and Cosmetic Act of 1938. These amendments apparently did have some preemptory language which the Supreme Court extended to cover any medical device that met the requirements.
It is yet to be seen exactly how many additional medical device cases this new preemption net will catch, though apparently there are several that were active that will be immediately affected. The case also apparently does not prevent suits for negligent manufacture. However, if a medical device is made in accord with FDA regulations, then it apparently falls under this preemption protection and any remedies are only under Federal law.

Warner-Lambert v. Kent was a 4-4 decision by the Supreme Court with C.J. Roberts abstaining because he held 5,000-50,000 shares of stock in Warner-Lambert’s Parent company. The decision was delivered on Monday, March 3, 2008.
The tie vote automatically affirms the lower court’s judgment. Here a federal appeals court had rejected the company’s argument that Supreme Court precedent barred personal injury suits that are based on a claim that a drug manufacturer obtained FDA approval through fraud. As a side note, this case in itself might have been distinguished from other cases in any case, because it seems to have been based on a relatively unusual state statute.
The affirmation obviously holds little or no precedential value, but C.J. Roberts was the one who sat out the decision. Would he have voted, based on the Medtronic case, he would have been in favor of a preemption of individual damage suits.

Wyeth v. Levine will come before the Supreme Court in the next term. The full court will be asked to decide whether FDA approval will preempt personal injury suits where the label failed to include adequate warnings. Such warnings could include things like that Vioxx could increase the risk of heart attacks or that atypical antipsychotics (like Zyprexa or Seroquel) could increase the risk of weight gain and diabetes.

This Matters Because—
All these recent designer drug cases might evaporate this fall in the midst of a ruling for the Pharmaceutical companies. This is bad for lawyers in this region of the country in general. And specifically lawyers in the Philadelphia Area, as there are several Pharmaceutical companies located in the Philly area. Plaintiffs firms out here will not be able to take the leads in some of these class action suits anymore, as they will be gone. The Defense firms will be able to make cutbacks in their health effects departments because there are not going to be nearly so many cases. AND…

More immediate to all of you, contract work on these cases will dry up. For the last 3-5 years, Pharmaceutical cases have been a bigger and bigger part of contract legal work in Philly. The Vioxx project alone had about 200 or so attorneys on it. There are several projects that are currently on-going in the city dealing with other drugs. They could end.

Philadelphia while still an attractive market for some firms because of the lower pay rates then NYC or DC, could suddenly find itself flooded with many contract attorneys out on the street scrounging for work both contract and otherwise, and without a clear market to fill the void.

How Does This Affect You—
If working on a drug case you could be put out of work. If looking for a job, you will have a lot more competition. There will no longer be as large of a net of contract work at least for awhile.

Advice—
Get off a drug case in favor of another gig, find a new job before the decision comes down. Keep your head down, hold on tight, and prey your job doesn’t end because of this.

Here are some links that you can use to look into the situation further on your own:

http://query.nytimes.com/gst/fullpage.html?res=9E04E3D8153AF932A15751C0A96E9C8B63&sec=&spon=&pagewanted=1

http://pharmexec.findpharma.com/pharmexec/News/Supreme-Court-Splits-on-Warner-Lambert-Preemption-/ArticleStandard/Article/detail/500187?contextCategoryId=43753

http://www.oyez.org/cases/2000-2009/2007/2007_06_179/

http://www.oyez.org/cases/2000-2009/2007/2007_06_1498/

http://www.oyez.org/cases/2000-2009/2008/2008_06_1249/

http://www.supremecourtus.gov/

Here is a blog by an attorney at Dechert and one from Jones Day on this type of law:
http://druganddevicelaw.blogspot.com/

Please comment. I would like to hear ideas and other interpretations. The sky is not falling yet, but it could very soon.

--The Black Sheep