Court Shields Medical Device Manufacturers

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February 25 2008
Supreme Court Shields Medical Device Manufacturers from Consumer Lawsuits
by Mike Adams

(NaturalNews) The U.S. Supreme Court has ruled that medical device manufacturers cannot be sued for injuries caused by their products if those products were pre-approved for use by the FDA.

The court ruled that Charles Riegel, who was injured in 1996 when a balloon catheter made by Medtronic Inc. burst while being inserted into one of his coronary arteries during an angioplasty, could not sue the company for damages. In doing so, the Supreme Court upheld a ruling by a U.S. appeals court and an earlier ruling by a trial court in New York.

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Hiding behind a legal technicality

Medtronic, which no longer makes the balloon catheter in question, said that the fault was with the doctor, who used the device contrary to the operating instructions. The company also said that the doctor made an error in using that type of product for a patient in Riegel's condition. But rather than ruling in Medtronic's favor merely for the one specific instance, the court dismissed the case entirely, saying that federal law prohibits suing device manufacturers in state courts if the device was approved as safe by the FDA. The decision is expected to have ramifications for a large number of pending lawsuits against manufacturers of devices such as breast implants, defibrillators, artificial heart pumps and valves, drug-coated stents, spinal cord stimulators, and prosthetic hips and knees.

Because there is no federal law that allows consumers to sue medical device manufacturers for damages, state courts have become a common venue for such suits.

The legal reasoning behind the court's decision centered on the wording of the 1976 Medical Device Amendments law. The law, which set in place an FDA pre-approval process for medical devices, explicitly prohibited states from putting in place "any requirement" that is "different from, or in addition to" FDA requirements. In an 8-1 majority, the court ruled that allowing citizens to sue device companies in state courts amounts to "a requirement" that undermines the FDA approval process.

Writing for the majority, Justice Antonin Scalia wrote that the FDA may approve devices "that present great risks if they nonetheless offer great benefits in light of available alternatives." In other words, there is no requirement that devices actually achieve any reasonable level of safety for all patients. To receive FDA approval and be immunized from lawsuits, medical devices merely have to keep alive slightly more people than they kill.

It would be inappropriate to empower juries second-guess these FDA decisions without full access to data about the benefits of technologies, Scalia said. This is the Supreme Court's way of saying that medical device safety is define solely by the FDA, and if the FDA says something is safe, the fact that such devices actually kill people does not in any way disprove the device's safety.

A jury "sees only the cost of a more dangerous design, and is not concerned with its benefits; the patient who reaped those benefits are not represented in court," he wrote. This is a clever way of saying that products that kill some consumers -- but not all -- are safe enough to be granted blanket immunity because there are some survivors. It's a ridiculous position, of course, and it's never applied to natural remedies.

Note that if an herb kills even ten people in the entire country, the FDA immediately leaps to the conclusion that the herb is "unsafe at any dose." (Google the history of the FDA's ephedra ban for details.) But medical devices and pharmaceuticals are held to an entirely different standard: They must only avoid killing more people than they kill! The fact that some people survived the treatment is apparently sufficient to justify all those who died! This is precisely what Justice Scalia is saying in this decision.

A whisper of sanity from Justice Ginsburg

Dissenting Justice Ruth Bader Ginsburg disagreed with the logic that the ability to sue companies constitutes an unfair "requirement."

"Congress, in my view, did not intend [for the 1976 law] to effect a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices," she wrote.

The purpose of the law, according to Ginsburg, was to prevent states from imposing confusing additional regulatory processes on top of the new federal standard. Prior to 1976, the absence of a federal regulatory process for medical devices had spurred many states to initiate their own.

Senator Edward Kennedy, one of the sponsors of the 1976 law and head of the Health, Education, Labor and Pensions Committee, agreed with Ginsburg's analysis. "In enacting legislation on medical devices, Congress never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices," Kennedy said. "Congress obviously needs to correct the court's decision. Otherwise, FDA approval will become a green light for shoddy practices by manufacturers."

The Supreme Court ruling applies only to medical devices pre-approved under the process set in place by the 1976 law, not to devices grandfathered in under a separate process, in which the FDA decides that a product is "substantially equivalent" to one that was already on the market prior to 1976. In 1996, the Supreme Court ruled that manufacturers of those devices can indeed be sued by states.

Devices that undergo the FDA pre-approval process, and thus are exempted from lawsuits under the current ruling, tend to be more technologically advanced, expensive and risky than older devices.

Under the new ruling, device manufacturers that fail to follow FDA specifications can still be sued in state courts. In addition, lawsuits or prosecutions can be brought against companies for violations of state laws that are the same as federal laws, just not state laws with different requirements.

Supreme Court's decision will unleash a wave of shoddy medical devices that could kill tens of thousands

Allison Zieve, the lawyer who represented Riegel's family, said that the court's ruling will have a dangerous effect on the quality of medical devices. Because the threat of lawsuits is a primary incentive for manufacturers to make sure their products are as safe as possible, the removal of this threat will lead to more dangerous devices staying on the market.

"By minimizing the incentive, the Supreme Court's decision poses a risk to the safety of medical devices," she said.

This is crucial to understand: When medical device manufacturers are granted blanket immunity that protects them from all lawsuits, they no longer have any reason to make their products safe. They only need to seek FDA approval, not genuine product safety, and FDA approval is a political process, not a scientific one, so achieving such approval for unsafe medical devices is simply a matter of paying off the right people, fudging the right scientific studies, and filling out the paperwork. The FDA grants its approval to deadly products on a regular basis. (Just look at Vioxx, Rezulin, and all the other deadly drugs approved by the FDA...)

Remember: The FDA serves the interests of corporations, not the American people. When it comes down to a question of public safety vs. corporate profits, the FDA favors the corporations in nearly every case. Now, with the U.S. Supreme Court handing medical device manufacturers blanket immunity, the American public has absolutely no legal recourse for the harm caused by dangerous medical devices, even if they are defective!

What's next? Immunity for Big Pharma of course

The Bush administration, which supported Medtronic in the current case, has announced its intentions to seek similar lawsuit immunity for drug companies. This would make it impossible for consumers to sue drug companies for the harm caused by pharmaceutical side effects, unleashing a new era of blanket immunity for the very corporations that are now poisoning the American population with dangerous and deadly synthetic chemicals.

Drugs are regulated under a different law than medical devices: the Food, Drug, and Cosmetic Act of 1938. Unlike the 1976 medical device law, the Food, Drug and Cosmetic Act does not explicitly prohibit alternate state regulations. But according to the Bush administration, the ban is implicit.

The Supreme Court will consider whether to grant this immunity to drug companies on Monday, in the case of Warner-Lambert Co. V. Kent. (See http://www.law.cornell.edu/supct/cert/0... ) If the drug companies win this case, it will unleash a chemical holocaust on the American people, where the most dangerous chemicals imaginable are patented, marketed and sold to unsuspecting consumers, with absolutely no legal recourse for those harmed or killed by such products. The American people will find themselves chemically and financially enslaved to the drug companies, poisoned by an evil conspiracy of greed between Big Pharma and the FDA while being stripped of their right to justice thanks to the U.S. Supreme Court.

Hint: The coming collapse of America is accelerating, and the people running this country will not stop until every right is stripped, every person is drugged, every dollar is stolen and every wage earner is forever indebted to a system of disease management that is intentionally designed to prevent health and keep the population in a state of chronic disease (and mental weakness).

The U.S. Supreme Traitors

That the U.S. Supreme Court would take away the rights of consumers to sue medical device manufacturers for the harm caused by their dangerous devices is not even the issue here: It's the fact that the U.S. Supreme Court is WILLING to take away such consumer rights! It means the Constitution is deemed irrelevant, and its last-ditch protectors have now sold out to the corporations. The U.S. Supreme Court is now operating as a band of traitors who have surrendered the future of this nation to the corporations. Today, it's with medical device manufacturers, tomorrow it's with pharmaceuticals, and in another year, it could be for any product or service that is "approved" by a government regulator.

Essentially, the U.S. Supreme Court has announced its intent to enslave the U.S. population and grant total power to the corporations and the corrupt, centralized regulators (like the FDA and USDA) influenced by those corporations.

You've just lost your country, folks. Good luck trying to get it back. The corruption is now so deep that the U.S. Supreme Court no longer protects the People. The very concept of "We the People" is now history. The new message to the People is simple this: Take your medicine. Don't ask questions. Pay your taxes. Do what you're told, vote for who you're told, and don't demand any more rights.

And if you're killed by a medical device, rest in peace with the knowledge that someone else wasn't.