Immunizing Medical Device Manufacturers Means Bad News for Doctors
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Immunizing Medical Device Manufacturers Means Bad News for Doctors

Friday, March 26, 2010By Richard Alexander

Preemption is a legal concept that takes from the victims of defective medical devices the right to sue the manufacturers for damages.

Preemption is a legal doctrine that’s based on the supremacy clause of the United States Constitution. Preemption states that when federal and state laws differ, federal law takes precedence. In its rulings on medical devices, the Supreme Court has taken preemption to an absurd level by giving the manufacturers of medical devices immunity from legal action if their devices harm or kill people.

In the case of Riegel vs. Medtronic, the Supreme Court ruled that because the Food and Drug Administration, a thoroughly incompetent federal agency, had approved a device that harmed Charles Riegel, he and his wife could not seek damages from Medtronic in New York state court.

Mr. Riegel experienced severe physical trauma when an angioplasty catheter made by Medtronic burst inside a coronary artery while he was undergoing heart surgery. The ruling against him shows just how damaging preemption is to consumers and how it may become very harmful for doctors.

Riegel vs. Medtronic was really a product liability case, and product liability lawyers representing Mr. Riegel presented evidence showing that the catheter had been negligently designed, labeled, and manufactured.

The FDA’s approval meant that the agency had reviewed the design of the catheter and had approved it for specific uses. FDA approval did not, or certainly should not, give a manufacturer legal permission to sell defective products.

Subsequently, Medtronic received another permission slip to cause severe suffering and wrongful deaths when a federal judge dismissed lawsuits filed by patients who had been damaged by Medtronic's Sprint Fidelis lead, which is a wire used in pacemakers.

Before Medtronic issued a recall, many of the devices fractured and caused electrical shocks in patients. Those patients and their families faced huge medical bills that were clearly the fault of Medtronic, but the court’s ruling said that Medtronic did not have to pay for the damages that the company had caused.

Medical device manufacturers’ immunity is completely different from the legal responsibility that drug manufacturers face, even though the same FDA approves both drugs and medical devices. As the FDA’s record clearly shows, the agency frequently approves deadly drugs, so no one should put any faith in the FDA’s approval process for anything, and Congress should not declare the FDA infallible.

These rulings that support preemption are obviously bad for consumers, and they’re also very bad news for doctors and hospitals that may find themselves the targets of lawsuits.

Writing in the New England Journal of Medicine, Dr. Robert G. Hauser of the Minneapolis Heart Institute, said, “FDA approval now immunizes medical-device manufacturers from state tort liability. As a result, plaintiffs will target physicians, hospitals, and health care systems.

“Plaintiffs will assert, not unreasonably, that physicians who are qualified to use medical devices should be able to assess the quality and completeness of the data supporting a product's safety and efficacy.

“Congress must consider the long-term implications of preemption. Rather than spurring innovation, preemption may create an environment in which, for fear of liability, physicians and hospitals decline to use promising new therapies, to the detriment of patients.”

In another opinion piece in the New England Journal of Medicine entitled Why Doctors Should Worry About Preemption, Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D. wrote, “Product-liability litigation has unquestionably helped to remove unsafe products from the market and to prevent others from entering it.”

The doctors then posed and answered this question for their colleagues: Why should doctors be concerned about preemption?

“In stripping patients of their right to seek redress through due process of law, preemption of common-law tort actions is not only unjust but will also result in the reduced safety of drugs and medical devices for the American people. Preemption will undermine the confidence that doctors and patients have in the safety of drugs and devices. If injured patients are unable to seek legal redress from manufacturers of defective products, they may instead turn elsewhere.”

Elsewhere, of course, would mean medical malpractice lawsuits against doctors and hospitals.

In the proposed Medical Device Safety Act of 2009 under consideration in Congress, doctors and consumers do have some hope for the removal of preemption. The bill, sponsored by Representative Frank Pallone of New Jersey and the late Senator Edward Kennedy of Massachusetts, and cosponsored by Representative Zoe Lofgren of California’s 16th District, would repeal the immunity currently granted to medical device manufacturers.

If it passes, this bill will be good for everyone, but the usual suspects have come out in opposition to it. The Medical Device Manufacturers Association has vowed that it will not give up its license to harm and kill easily, and the association has made this anti-consumer statement: “The Medical Device Safety Act threatens to undermine the FDA approval process for Pre-Market Approval (PMA) devices by allowing state courts to challenge the validity of the scientific process. MDMA will be active in preventing passage of any legislation that threatens the innovation and access of medical technologies.”

Of course, that’s just a liar’s way of saying: “We want to continue to be able to sell defective products without having to take responsibility for the damage and deaths that they cause.”

It’s also a way of saying to doctors: “Thanks to preemption, we have no concerns about liability. You’re the ones responsible for our defective products.”

Preemption is bad for everyone, and it certainly has no place in a new healthcare system, if the goal of that system is to improve the quality of care for all Americans.

If you have suffered injury or a loved one has died because of a medical device, call us to investigate your claim and to take the right action to protect your rights.

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