A panel of lawmakers heard witness testimony on a measure that would allow consumers to sue companies under state law for injuries sustained by sophisticated medical devices.

Supporters of the Medical Device Safety Act of 2009 (HR 1346) said at Tuesday’s House Energy and Commerce Committee’s Health Subcommittee hearing that the bill would ensure product safety and consumer protection, while opponents argued that the bill would stifle life-saving medical innovation and impose unnecessary regulation on medical device companies.

The legislation responds to a Supreme Court ruling issued last year that states that under the Medical Device Amendments of 1976, certain medical devices that must go through Food and Drug Administration (FDA) pre-marketing approval are preempted from being sued for liability under state law.

But the Supreme Court decision gives medical device companies blanket immunity, said Rep. Frank Pallone Jr., D-N.Y., who introduced the bill.

“This decision in my opinion ignores congressional intent,” Pallone said.

The legislative intent of the original Medical Device Amendment was to give the FDA power to regulate approval for medical devices — it didn’t do away with state liability actions, said Rep. John D. Dingell, D-Mich., who co-sponsored the bill.

“Unfortunately, the U.S. Supreme Court . . . decided to create legislative intent where there was none,” Dingell said.

The Supreme Court ruling also leaves patients injured by medical devices no remedies, said David C. Vladeck, a law professor at Georgetown University Law Center who testified at the hearing.

The ruling has already resulted in 1,400 injury cases being thrown out of court, said Committee Chairman Henry A. Waxman, D-Calif., another co-sponsor of the bill. It’s the possibility of litigation that is one of the most powerful incentives to safety, Waxman said.

The system of concurrent FDA regulation and state tort litigation acted as complementary forms of discipline in the marketplace and deterred excessive risk by manufacturers while compensating people who were injured at no fault of their own, Vladeck said.

“Immunity removes incentive to manufacturers to fix devices quickly and get defective devices off the market,” Vladeck said.

But Republican lawmakers contended that the constant threat of litigation would stifle medical innovation.

“Eliminating pre-emption will stifle innovation in my opinion, will increase the risk among manufacturers who are on the cutting edge medical device development, prove detrimental to patients in dire need of innovative solutions to complex hard-to-treat medical conditions,” said Rep. Nathan Deal, R-Ga.

And the ruling doesn’t prevent consumers from suing companies if devices are improperly manufactured or if companies withhold information or mislead the FDA, Deal said.

“Pre-emption is not a get out of jail card for bad actors,” added Rep. Michael C. Burgess, R-Texas.

The bill would also result in a haphazard system of a patchwork of standards where lay jurors, not FDA experts, are deciding standards, Burgess said.

The measure could also result in people not having access to medical devices depending on where they live, according to Rep. Joe Pitts, R-Pa.

“Manufacturers could pull products from the market or refuse to sell them in certain states as a result of court cases,” Pitts said.

It’s an issue of benefits outweighing the risks — no device will be 100 percent effective and legislation won’t achieve the goal of having only safe medical devices on the market, Pitts said.

And the devices addressed by the Supreme Court ruling that must obtain pre-marketing approval — the most rigorous process for medical devices — constitute only two percent of all devices each year, according to Deal.

The class of devices that receive pre-market approval — like pacemakers and replacement heart valves — have the most federal oversight and undergo a rigorous pre-approval process including an average of 1,200 hours of review per application, according to the Feb. 2008 ruling.

“This decision is extremely limited in scope,” Pitts said about the Supreme Court decision.

But this percentage figure is “fuzzy math” since such devices aren’t stethoscopes or tongue depressors, but rather, life-sustaining devices that affect more than 10 million Americans, said Dr. William H. Maisel, director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Massachusetts.

And right now, under another court ruling, medical device manufacturers who know that a device can be harmful after receiving FDA approval are pre-empted from litigation, according to Vladeck.

Individuals directly affected by medical devices also testified.

Bridget Robb, a single mother from Pennsylvania who said she was shocked 31 times by defective heart device, said the medical device industry should be accountable for their products as with any other industry.

“I find it discouraging and demoralizing that I have no recourse for my injuries,” Robb said

But medical devices and medication have allowed Michael Kinsley, who has Parkinson’s disease to work and travel, according to the Washington Post columnist.

“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 lifesaving devices” — but those are the same devices, Kinsley said.

“The government’s job is to weigh the risks against the benefits,” Kinsley said in his written statement.

At a press conference the day before the subcommittee took up the issue, the Advanced Medical Technology Association warned that the legislation would imperil innovation. It highlighted the cases of patients “you won’t likely hear at the hearing” — those whose lives it said have been improved by medical devices. Among the speakers was a former U.S. Army officer who said he sustained severely debilitating injuries when his parachute failed to open but was able to walk and function again after treatment with a neurostimulator to ease severe pain. The former officer said he is now skydiving again.


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