Michael Kinsley on Preemption, Medical Devices

From the hearing now under way, Energy and Commerce Subcommittee Hearing on H.R. 1346, the Medical Device Safety Act of 2009, the prepared testimony of liberal columnist Michael Kinsley, who notes the benefits he has received as a Parkinson’s sufferer from FDA-approved medicines and a medical device, an implant that provides Deep Brain Stimulation. As a journalist, Kinsley has also covered the impact of litigation on health care.

In his testimony, Kinsley remarks upon the dual approach toward drug and medical device regulation, one embodied by the FDA, the other by litigation.

The other system is tort law, administered by thousands of non-expert judges and jurors in 50 state courts. The same issue can and does get relitigated dozens of times. Differences in state law or just the randomness of juries produce dozens of different answers. Some plaintiffs hit the jackpot; most victims never even sue. The direct cost is horrendous: delivering a dollar to a victim costs far more than a dollar in expenses—mostly lawyers’ bills.

The indirect cost is immeasurable. Lawsuits focus on the victim of some medical product. By their nature, they undervalue the benefit that same product has brought to other users, or even to the victim herself.

Forced to choose between these two systems for making essentially the same decision, I believe that anyone sensible would choose the FDA. But in real life, the situation is even crazier: we have both systems simultaneously. And basically, whichever one draws a more restrictive line, wins. Add to this the fact that product manufacturers have no idea when or how the standard might change, and you have a perfect arrangement for discouraging drug and device manufacturers from developing new products, like the ones that allow people like me to go about our business, which is making trouble for people like you.

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  • […] session in May on H.R. 1346, the Medical Device Safety Act. (We blogged about the hearing here, here and here.) The goal of the bill is to end legal protections gained by the device manufacturers when […]

  • fred santitoro says:

    I agree that the system is not perfect. however we must keep the drug companies and device mfg on their toes.. thheir attitude is that of the bottom line and they do not care if anyone gets hurt in the process.. They must be held accountable and people who have been hurt should be compensated.. I myself have sprint fidellis leads model 6949which failed 31 days after being implanted in june of 2006 I received A shock which caused me to black out. The doctor tried to blame me for the failure, but replaced the lead 2 days later. A nurse in the recovery room told me then that the lead was factured, but the doctor never relayed this to me.. After getting out of the hospital, I asked for a copy of my medical records for original implant and the reimplant.. At the time I saw that the lead that was taken out was 6949 and they replaced it with 6949..Also it was stated that the factured lead was sent to a lab to be examined.. In 10/07 the company recalled the lead and notified the doctor and patients that there was a problem.. Till this date 5/12/09 I have not heard from the doctor nor the company but i have read that they will supply a new lead but will not reimburse for the doctor or hospital costs.. Further replacement is not suggested as death may occur during the procedure.. So I will have to live the rest of my life not knowing when the devise that was supposed to help me, will kill me.. But as Mr. kinsley suggests the manufacturer should not be held libable because he does not have a problem.. I wonder if he would feel that way if his device fails..

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