- The Washington Times - Thursday, May 14, 2009

ANALYSIS/OPINION:

Michael Kinsley is nobody’s idea of a corporate shill. When the veteran journalist tells a congressional committee that one of its anti-corporate turns puts health at risk, his fellow liberals should know their bill is out of line.

At issue is the misnamed Medical Device Safety Act. The bill would let injured patients reap financial awards from manufacturers whose products reportedly caused harm without adequate warning on their labels about the danger. The devices in question include heart stents, pacemakers and other implants.

The bill would allow lawsuits to proceed although the Food and Drug Administration approved the labeling used on the devices. The theory is that the manufacturer should warn against and be liable for any possible harm its products could cause even if the FDA has not found the warning necessary.

Supporters of the bill cite horror stories about injured patients, while opponents say manufacturers should not be held hostage to inexpert juries in 50 different states under 50 different state laws when the experts at the FDA already have told them what the labels must say. Mr. Kinsley’s testimony on Tuesday reminded lawmakers that patients other than a plaintiff in a particular courtroom can be seriously affected, and victimized, by such trials.

Mr. Kinsley suffers from Parkinson’s disease. He testified that his disease is controlled - and his quality of life considerably enhanced - by “wires in my head and two pacemaker-type batteries in my chest,” which are the result of surgery called deep-brain stimulation.



“So here’s the problem,” he said. “We all want the government to protect us from dangerous drugs and devices. But we don’t want the government to prevent us from getting helpful or even lifesaving drugs and devices. Yet the most important drugs and devices are both. They save lives, and they can cost lives. The government’s job is to weigh the risks against the benefits … [The FDA] set* a uniform standard for everyone in every state.”

If the FDA can be overridden by any jackpot-seeking plaintiff’s attorney, Mr. Kinsley said, “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.”

This bill would kill innovation. If manufacturers know they will be subject not just to regulation by the FDA but to uncertain justice under 50 different state standards, the manufacturers are far less likely to bring that device to the market. All those other beneficiaries - the Michael Kinsleys of the world - would be harmed by a law undermining the FDA’s authority.

The Medical Device Safety Act favors litigious trial lawyers over sick patients. Its passage would amount to serious legislative malpractice.

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