The Washington Times today takes editorial notice of Michael Kinsley’s testimony Tuesday in a House committee on the Medical Device Safety Act, legislation that would encourage litigation against manufacturers of FDA-approved devices. From “Patients in the crossfire“:

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.

And if the bill passes?

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.

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.

Balanced story in today’s Cleveland Plain Dealer on a House committee hearing scheduled this afternoon on H.R. 1346, the Medical Device Safety Act. This is the bill that would end what’s called “preemption,” the federal liability protection for FDA-approved medical devices, opening the gates wide for product liability suits in state courts.

The bill comes in response to the Supreme Court’s ruling in Riegel v. Medtronic, and has long been a priority of the trial lawyers at the American Association for Justice.

The Plain Dealer’s headline represents the pro-lawsuit arguments, “Patients injured by faulty medical devices want laws to hold manufacturers accountable,” and the story leads with the claims of the injured party. Still, the Plain Dealer provides space for manufacturers and others to comment on innovation-stifling effects of the legislation.

“This bill does not in any way improve patient safety,” said Steris spokesman Stephen Norton. “It will, however, restrict patient access to essential medical technologies, produce a chilling effect on medical innovation, create more lawsuits, and ultimately result in higher health-care costs for all Americans.”

And from Medtronic spokesman Rob Clark:

“When you regulate through litigation, which is the recipe the Medical Device Safety Act is aimed at, it places decisions in the hands of a 12-person jury that’s only looking at one particular patient, and one particular situation and not evaluating the safety and efficacy and risk benefit of that device for everyone,” Clark said.

Washington Post columnist Michael Kinsley, who is testifying at today’s House Energy and Commerce subcommittee hearing, made that important point last year when commenting on the high-profile preemption case, Wyeth v. Levine.

The flaws of litigation as a method of making important government decisions are well rehearsed. It is ungodly expensive: The lawyers typically cost more than even the most worthy plaintiff ever gets. It is arbitrary: The same issues get litigated again and again, usually with a different result each time. Most people who suffer never sue and get nothing. While the FDA has scientists, the courts have jurors, for whom ignorance of the subject at hand is not merely the norm but a virtual requirement. And because trials occur only when a risk has gone wrong, they inevitably overemphasize the risk and undervalue the benefit.

The Subcommitte on Health holding the hearing is chaired by Rep. Frank Pallone (D-NJ), sponsor of the bill, so the agenda is clear enough. We trust that agenda allows space for the argument that undermining preemption will create a chaotic, expensive and capricious regulatory system ruled not by medical experts and the disinterested FDA but by juries in the 50 different states. And that’s a regulatory regime that does not serve the public.

For more on the hearing, see our post at Point of Law.com, “Medical Device Safety Act hearing, the PR angle.” It’s an interesting witness list.