Tuesday, January 20, 2009

Whose Product Liability?

"A federal judge threw out lawsuits on behalf of thousands of patients with heart-defibrillator wires that have been shown to fracture and dispatch potentially lethal shocks, concluding that a recent Supreme Court opinion made the dismissals inevitable. U.S. District Judge Richard H. Kyle in Minneapolis dismissed the lawsuits, citing the February decision that federal law 'pre-empts' product-liability lawsuits under state law, effectively precluding such cases. That decision triggered an effort in Congress to change the law, one that will almost certainly intensify under the new Democratic Congress. ... Medtronic Chief Executive Bill Hawkins lauded the decision as supporting 'the principle that the U.S. Food and Drug Administration is the appropriate body to determine the safety and efficacy of innovative technologies.' ... The lead was marketed based not on any multiyear study in hundreds of human patients, but rather on 'bench testing' of the product in a laboratory to determine how easily it might fail by putting multiple stresses on it. ... Judge Kyle took the unusual step in his opinion of noting his apparent discomfort with the result. 'The Court recogizes that at least some plaintiffs have suffered injuries from using Sprint Fidelis leads, and the Court is not unsympathetic to their plight,' he wrote. Neverthless, he said, the plaintiffs' remedy 'lies with Congress'," my emphasis, Thomas Burton at the WSJ, 7 January 2009.

Hawkins is a fool, or worse. Lower courts must follow clear Supreme Court precedent, which is all Kyle did. Kyle asks Congress to reverse Wyeth. It is ususual for a District Judge to say in effect, "I disagree with the Supremes, but am stuck. Congress, reverse these fools". Those who think we can develop nuclear warheads using only computer simulations should read this. If Mr. Obama wants, he can become our "Andrew Jackson". Obama? He can push legislation and overturn Wyeth. Then when our "constitutional scholar" signs it in the Oval Office, with all Supremes present, he hands John Roberts (JR) the pen in front of tens of millions. We'll see how long it takes even corrupt, arrogant, superior, JR to get the hint and return (publicly) to Hogan & Hartson! See my 16 November 2008 post, link: http://skepticaltexascpa.blogspot.com/2008/11/product-liability-and-supremes.html. See also my 26 January 2008 post, link: http://skepticaltexascpa.blogspot.com/2008/01/supreme-injustice.html.


Anonymous said...

IA... what was with Roberts at the swearing in?

Stage fright?

Or stage slight?

Printfaster said...

There are some big medical equipment companies in the Mpls-St. Paul area. Often the judges in that area are keenly aware of the economic impact of burdening the manufacturers.

There is another side to medical equipment problems, and that is that all equipment fails. That is a guaranty. The question is what is acceptable, and what are the acceptable remedies. I for one would not like to produce any product that can engender huge or numerous lawsuits. Kind of like the Sarbox approach where overspending on legal defense becomes the rule.

Hard to find a balance, I guess that is what judges are about, and politicians avoid.

Independent Accountant said...

Have you Medtronic in mind? You are correct, all equipment has some failure rate. People are allergic to all kinds of things, some are allergic to peanut butter. Do we ban peanut butter from schools because one kid in say 1,000 is allergic to it? Should we stop producing pacemakers because they will fail from time-to-time? Of course not. Now here's the rub. Suppose Company X produces a pacemaker. It tests it and finds it has a failure rate of 1 per 5,000 years of use. It gets FDA approval for sale. After two years and 10,000 pacemakers sold, it finds 20 failures, should it get sued?
In my world yes! With 20,000 years of exposure, X's pacemakers should have had ex ante four failures. With 20 failures, 16 "surplus" ex ante failures, should we compensate the victims of these pacemakers failures? Using "Hand's negligence formula", 16/20 or 80% of each's damage should be born by X, not the users. Compensating victims of product failure is not an exact science. The Supreme's decision is: victims go to hell.
Learned Hand, 1872-1961, was the third best jurist this country ever produced in my opinion.
Gerald Gunther, a Stanford Law Professor wrote a fine biography of Hand in 1994.