Reflecting on Supreme Court ruling on medical equipment
The Supreme Court ruled in an 8-1 decision in February that medical device makers in the United States cannot be sued for devices that have received approval from the US Food and Drug Administration.
In Riegel v Medtronic, plaintiff Charles Riegel sued the Fridley, Minn, company after a balloon catheter burst in his coronary artery during angioplasty in 1996. Riegel, who passed away in December 2004, suffered serious injuries as a result of the rupture, and alleged that the device was designed, labeled, and manufactured in a manner that violated New York common law.
In an opinion delivered by Justice Antonin Scalia, the Supreme Court ruled that state product-liability suits are barred to the extent that they would impose requirements different from federal regulatory standards.
According to the Associated Press, the case has significant implications for the $75 billion-a-year health care technology industry. Imaging Economics spoke with Dean Janes, chairman and CEO of medical device manufacturer Imaging3 Inc, Burbank, Calif, to learn how the court ruling affects his business and the industry as a whole.
IE: Tell me about your professional background. What kind of expertise do you have on this topic?
Janes: I am a biomedical engineer with more than 24 years' experience. I've worked for Kaiser Medical Physics in Southern California as an in-house senior x-ray imaging engineer and as a national technical support engineer for Toshiba America Medical for cardiac catheter labs and angiography suites. I have filed three FDA 510(k)s for Imaging3 and have assisted on several others for different manufacturers. The Dominion is one such device that we are awaiting FDA approval on. The Dominion is a patented diagnostic imaging device that produces readings in three dimensions and real time.
IE: In terms of your specific company, how is the Supreme Court's ruling significant?
Janes: It offers a layer of protection from undue litigation. The standards already in place are far more stringent than any others in existence throughout the world. Imaging3 is happy to maintain compliance with these standards and has done so since 1995. We obviously do not expect problems with our medical imaging devices, but it is nice to know we have some protection through this ruling.
IE: How does the ruling affect the medical device manufacturing industry as a whole?
Janes: From a business standpoint, this ruling is very important as our society continues toward ever-increasing litigation. Companies spend a great deal of time and money developing cutting-edge technology to better medicine and patient care with far greater scrutiny and standards than the rest of the world. However, even with the most altruistic intentions, mechanical and electronic devices can fail beyond the expectations of testing and design plans. Holding companies to an even higher standard than what currently exists will just increase costs even more, making health care less affordable and/or decreasing the quality due to manufacturers not desiring to enter a high-risk market. This would be especially burdensome if overseas companies aren't required to maintain equal standards.
IE: Do you agree with the court's opinion? Why should or shouldn't the requirements for FDA approval be paramount to state laws?
Janes: I agree with the decision and it would be far too burdensome for companies to manufacture and sell devices with different and varying standards on a state by state basis, which is why we have a federal government agency like the FDA to set national standards as in their 21CFR. Currently, states cannot be less stringent in their legal requirements than the 21CFR federal requirements. This would also put an undue burden on states, as they would have to create or augment state agencies to mirror the FDA approval standards, adding costs to local medical systems.
IE: In the aftermath of the ruling, analysts have labeled it a win for business and a blow to consumers. Do you agree with this perspective?
Janes: I agree with the win for business. In my opinion, the consumer is already very well protected. FDA approval is a very difficult and sometimes expensive process. The FDA is staffed with very intelligent and professional experts in the many specific fields of medicine and physics. However, in this society we tend to believe too much in perfect technology, which simply does not exist. We already could have medicines and medical devices in the marketplace that could save lives tomorrow if we didn't require such stringent standards and approval. But the risk would be more significant. If I created a device that could cure cancer tomorrow, I would have to test it for 2 to 4 years—many people would die from cancer in that time frame. The fact is that more people would die for the lack of my miracle machine than from the machine itself
IE: As reported by The New York Times, some have suggested that the industry's newer technologies—sophisticated and profitable Class III devices such as defibrillators, pacemakers, and stents—may be so different from pre-1976 devices that they require a more thorough safety and effectiveness review. How do you account for their position, and do you agree with their sentiment?
Janes: I completely disagree; manufacturing capabilities of today make the 1970s look like the Stone Age. Engineers are far better trained; we have tools engineers in the 1970s could only dream about, which allow us to computer generate a design as well as test it prior to even building it. Machining, tooling, and fabrication processes are far more accurate than ever before, allowing more accurate, faster, and more efficient production of devices utilizing stronger and lighter composite materials. This not only equates to a more efficient manufacturing process but allows more time to be spent on design and testing than ever before, with final product specifications actually measuring up to the design standards.
IE: Is there anything else that you'd like to add about this ruling—what it represents now and for the future?
Janes: I didn't grow up to be an engineer to create products that hurt people—as I believe is the case with most, if not all, engineers. When I create a device, I want it to be safe enough to use on my own family, a feeling shared by all of Imaging3 employees. The FDA does a very good job in setting standards for manufacturing as well as for their approval process. Yet, the FDA is overworked and understaffed. More money should be spent from the budget for the FDA as they have a more significant impact on your individual health, safety, and well-being.
Snip: "The decision, for example, does not foreclose lawsuits claiming that a device was made improperly, in violation of F.D.A. specifications. Cases may also be brought under state laws that mirror federal rules, as opposed to supplementing them."
February 21, 2008 Justices Shield Medical Devices From Lawsuits By LINDA GREENHOUSE
WASHINGTON — Makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the Food and Drug Administration approved the device before it was marketed and it meets the agency’s specifications, the Supreme Court ruled on Wednesday.
The 8-to-1 decision was a victory for the Bush administration, which for years has sought broad authority to pre-empt tougher state regulation.
In 2004, the administration reversed longstanding federal policy and began arguing that “premarket approval” of a new medical device by the F.D.A. overrides most claims for damages under state law. Because federal law makes no provision for damage suits against device makers, injured patients have turned to state law and have won substantial awards.
The Bush administration will continue its push for pre-emption in another F.D.A. case that the court has accepted for its next term, on whether the agency’s approval of a drug, as opposed to a device, pre-empts personal injury suits. Drugs and medical devices are regulated under separate laws.
The case before the court concerned only medical devices that had gone through the premarket approval process specified by the Medical Device Amendments of 1976. Most devices now available reached the market through a different process, under which the F.D.A. found them to be “substantially equivalent” to those marketed before the 1976 law took effect.
The Supreme Court ruled in 1996 that this less rigorous approval process does not pre-empt state damage suits against the manufacturers of “grandfathered” devices.
Devices subject to the premarket approval process, and thus affected by the court’s opinion, tend to be more technologically advanced, expensive and, in some instances, risky.
Examples of devices that have been the subjects of recent lawsuits include an implantable defibrillator, a heart pump, a spinal cord stimulator, a drug-coated stent, an artificial heart valve, and prosthetic hips and knees.
It was not immediately clear how many of the thousands of lawsuits against medical device manufacturers would be affected, though some pending cases will almost certainly be nullified.
The decision, for example, does not foreclose lawsuits claiming that a device was made improperly, in violation of F.D.A. specifications. Cases may also be brought under state laws that mirror federal rules, as opposed to supplementing them.
Next Monday, the court will hear another F.D.A. pre-emption case, on whether a state case can be based on the claim that a drug maker committed fraud by misrepresenting or withholding information from the agency during the approval process. The administration is supporting the manufacturer in that case, Warner-Lambert Co. v. Kent, No. 06-1498, which concerns the diabetes drug Rezulin.
Writing for the majority in Wednesday’s case, Riegel v. Medtronic Inc., No. 06-179, Justice Antonin Scalia said that permitting state juries to impose liability on the maker of an approved device “disrupts the federal scheme,” under which the F.D.A. has the responsibility for evaluating the risks and benefits of a new device and assuring that it is safe and effective for its intended use.
A jury, looking only at the injured plaintiff, will tend to weigh only the dangers of a device and “is not concerned with its benefits,” Justice Scalia said, adding, “the patients who reaped those benefits are not represented in court.”
The decision affirmed the dismissal of a lawsuit by a patient who was injured during an angioplasty when a balloon catheter burst while being inserted to dilate a coronary artery. The device won F.D.A. premarket approval in 1994, two years before the incident. The patient, Charles R. Riegel, died after the lawsuit was filed, and the case was carried on by his widow, Donna.
The medical device statute contains a pre-emption clause that bars states from imposing “any requirement” related to a medical device that is “different from, or in addition to” a federal requirement. The question of statutory interpretation at the heart of the case turned on what Congress meant by “any requirement.”
Justice Scalia said that state tort law, by imposing duties of care on product makers, amounted to such an additional requirement. He said the 1976 law “speaks clearly to the point at issue,” regardless of the federal government’s previous or current positions.
Justice Ruth Bader Ginsburg, the solitary dissenter, said the court had misconstrued Congress’s intent in adding the pre-emption clause to the 1976 law. The purpose, she said, was to prevent individual states from imposing their own premarket approval process on new medical devices. Devices were not regulated under federal law at the time, and California and other states had stepped in to fill the vacuum by setting up their own regulatory systems.
That was all that Congress had in mind, Justice Ginsburg said, not “a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.” She said that Congress had passed the 1976 law “to protect consumer safety,” not to oust the states from “a domain historically occupied by state law.” The decision was at odds with the “central purpose” of the 1976 law, Justice Ginsburg added.
Crucial Democratic lawmakers appear to agree with Justice Ginsburg, including Senator Edward M. Kennedy, Democrat of Massachusetts, who heads the Health, Education, Labor and Pensions Committee and was the sole Senate sponsor of the 1976 legislation in question.
“In enacting legislation on medical devices, Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices,” Mr. Kennedy said in a statement. He added: “Congress obviously needs to correct the court’s decision.”
Representative Henry Waxman, the California Democrat who is chairman of the House Committee on Oversight and Government Reform and was on the House panel that approved the 1976 bill, expressed a similar view.
“The Supreme Court’s decision strips consumers of the rights they’ve had for decades,” Mr. Waxman said. “This isn’t what Congress intended, and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”
The Food, Drug and Cosmetic Act of 1938, under which the F.D.A. regulates pharmaceuticals, does not contain a pre-emption clause. Nonetheless, the administration is arguing in the case the court has accepted for its next term, Wyeth v. Levine, No. 06-1249, that pre-emption is implicit in the structure of the statute.
The Supreme Court’s interest in pre-emption is not limited to the medical arena. In a similar case decided on Wednesday, this one unanimously, the court ruled that the federal law that deregulated the trucking industry in 1980 pre-empted two recent laws adopted by the State of Maine to regulate the shipment of tobacco products into the state.
The state laws were intended to prevent children who were not of legal age to buy cigarettes from ordering them over the Internet. The laws placed responsibility on shippers and delivery companies to verify the recipient’s identity and age.
Justice Stephen G. Breyer, writing for the court in this case, Rowe v. New Hampshire Motor Transport Association, No. 06-457, said the state law “produces the very effect that the federal law sought to avoid, namely, a state’s direct substitution of its own governmental commands for competitive market forces” in a deregulated environment.
Barnaby Feder contributed reporting from New York and Gardiner Harris from Washington.
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