Originally published August 1996
The sky did not fall on June 26, 1996. As noted on page 12 of this issue, the Supreme Court's ruling on that date in the Medtronic, Inc. v. Lohr case was indeed unfavorable to medical device manufacturers. But the concept of preemption of liability claims--the notion that the FD&C Act invalidates not only state regulations and statutes affecting devices but also product liability claims--was a relatively new and untested idea. It was a good try, but I don't think the industry lost much.
With preemption as a strategy to combat product liability abuses pretty much ruled out, perhaps attention will be focused once again where it belongs--on tort reform. Last May, the Common Sense Product Liability Legal Reform Act of 1996 succumbed to a veto, but a key component of that act for device companies--the Biomaterials Access Assurance Act--is very much alive. It would essentially eliminate the danger of suppliers being sued for providing materials used in a device they neither designed nor manufactured. With passage of this law, makers of critical materials would presumably resume supplying them to device companies. Chances seem good that President Clinton would sign this bill.
This law would do much to strengthen the device industry and particularly its relationships with materials suppliers, which have, alas, fallen into counterproductive and sometimes inane practices. Although I would like to think these two parties would be standing together against abuses of the liability laws, at the news of the Lohr ruling the suppliers to the device industry let out a collective "Whew!" As representatives of one suppliers group put it, the Supreme Court decision was good for suppliers. Litigious consumers, they reasoned, won't come after them if device companies are not given immunity through preemption.
The relationship between suppliers and device companies implied by this reaction reminds me of the two hikers who were being chased by an angry bear. Asked by his partner why he was stopping to change into running shoes, since he had no hope of outrunning the bear, the other hiker replied, "I only have to outrun you."
In the past week, I've witnessed a similar instance of counterproductive relationships between suppliers and manufacturers. One of MD&DI's sister publications received notification from a major materials supplier that in a new product report the publication had named one of the supplier's trademarked materials in a banned implantable application. When we inquired further, we were told that the supplier had already contacted the manufacturer of the product in question. The manufacturer denied having sent us the information, and speculated that we had used outdated source material.
This response was nonsense, of course. But then, everything about the situation is ridiculous. The material is perfectly good, the product is perfectly good, the business between the two companies benefits both them and the patient--and yet, all their energies are devoted to either preventing the use of the material or denying that it is actually used.
I understand, of course, the legal necessity for this wasteful behavior--I would no doubt do exactly the same. But how tragically absurd that the U.S. liability system has driven them to this extreme.
It's time for both the device industry and its suppliers to put aside any regret or pleasure about the loss of preemption and focus on fighting for the passage this year of the Biomaterials Access Assurance Act. Failure to pass it will only heighten the waste and stupidity of two great and innovative industries unable to cooperate for their greater good, and that of all consumers.