US Supreme Court ruling favours device firms in liability lawsuits

The US Supreme Court has ruled that medical device companies cannot be liable for damages caused by their products if the products have FDA premarket approval (PMA) and meet the agency's specifications.

Two Democratic members of Congress - Senator Edward Kennedy and Representative Henry Waxman - responded immediately to the ruling by saying that Congress would have to change the law "to correct the court's decision".

"Congress never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices," Senator Kennedy, chairman of the Senate committee on health, education, labour and pensions, said in a statement. "Congress obviously needs to correct the court's decision. Otherwise, FDA approval will become a green light for shoddy practices by manufacturers."

But Linda Horton, a partner at Washington DC-based law firm Hogan and Hartson, told Clinica that while the court's opinion was welcome, she said that it helps "only a fraction of the medical devices evaluated by the FDA". She said: "As few as 1% of the medical devices that enter the US market each year do so under a PMA. The other 99% are the subject of a 510(k) that is "cleared" by the FDA on the basis of substantial equivalence to a predicate device."

The case in question concerned device giant Medtronic and the widow of a New York man, Charles Riegel, who underwent coronary angioplasty in 1996, shortly after suffering a myocardial infarction.

Mr Riegel's right coronary artery was diffusely diseased and heavily calcified, so his doctor inserted Medtronic's Evergreen balloon catheter into his coronary artery, in an attempt to dilate it, even though the device's labelling stated that its use was contraindicated for patients with diffuse or calcified stenoses.

The label on the device also warned that the catheter should not be inflated beyond its rated burst pressure of eight atmospheres. Mr Riegel's doctor inflated the catheter five times, to a pressure of 10 atmospheres. On its fifth inflation, the catheter ruptured. Mr Riegel developed a heart block, was placed on life support and had to undergo emergency coronary bypass surgery.

After his ordeal, he and his wife, Donna, brought a lawsuit to the US District Court for the Northern District of New York. They alleged that the catheter's design, labelling and manufacture violated New York common law, causing Mr Riegel to suffer severe and permanent injuries.

The court said that the Medical Device Amendments of 1976 (MDA) pre-empted the state's common law, barring common law claims challenging the safety and efficacy of devices that had received premarket approval from the FDA.

The Riegels appealed and their case continued through the courts, as Riegel vs Medtronic. Mr Riegel died in 2004, of unrelated causes, and his wife took over the case. At its final destination, the Supreme Court, on February 20, decided in an 8-1 decision, that the Court of Appeals judgement against the Riegels was correct.

The Supreme Court's ruling was based on the fact that the MDA says that no state-level legislation "may establish or continue in effect with respect to a device "any requirement" relating to the safety or effectiveness that is different, or in addition, to federal requirements".

The dissenting opinion was from Justice Ruth Bader Ginsburg who said that the Court's broad reading of the law meant that "regardless of the strength of a plaintiff's case, suits will be barred ab initio". She added: "The constriction of state authority ordered today was not mandated by Congress and is at odds with the MDA's central purpose: to protect consumer safety."

How a pre-emption clause for medical devices came to appear in the MDA is not too clear. However, what is clear is that Congress enacted the MDA following a series of high-profile device failures that had caused extensive injuries and loss of life. In particular, an intrauterine birth control device called the Dalkon Shield, which was used by about 2.2 million women in the US between 1970 and 1974, had been linked to 16 deaths and 25 miscarriages by the middle of 1975, triggering thousands of tort claims.

The proliferation of more complex devices, and the failings of some of these, led several states to adopt regulatory measures, including California, which enacted a law in 1970 requiring premarket approval of medical devices.

Congress then stepped in with its MDA legislation, imposing a regime of federal oversight that the Supreme Court, in its February 20 ruling, described as "rigorous". (the FDA spent on average 1,200 hours on each application).

Justice Antonin Scalia pointed out that "it is implausible that the MDA was meant to grant greater power [to set state standards different from or in addition to federal standards] to a single state jury than to state officials acting through state administrative or legislative lawmaking processes".

"That perverse distinction is not required or even suggested by the broad language Congress chose in the MDA, and we will not turn somersaults to create it," Justice Scalia said.

However, Hogan and Hartson's Linda Horton points out that states are still given some ability to act. "The court recognised that they can create remedies for the public for products that fail to meet FDA requirements. However, their judges and juries cannot issue a verdict for a plaintiff that would contradict, or add to, what is required of the device through its PMA approval."

US medical device industry association, AdvaMed, gave the court's ruling a warm welcome. "The FDA - and not a patchwork of state regulations or multiple jury verdicts - should determine the safety and effectiveness of medical technology," AdvaMed's president, Stephen Ubl, said.

"We are pleased this ruling will allow the FDA to continue its science-based approach to approvals and prevents the inconsistencies in standards and delayed patient access to products that would occur if juries or others were to impose additional regulatory hurdles.

"The ruling also expressly recognizes the rigorous pre-market approval process which entails extensive pre-clinical and clinical testing and thorough expert FDA review and risk analysis to ensure their safety and effectiveness. In addition, PMA-approved devices must comply with other rigorous post-market requirements including quality systems regulations, adverse event reporting and post-market surveillance. This is why many consider the FDA approval the gold standard for safe and effective medical devices."

Bearing in mind Congressmen Kennedy's and Waxman's reaction to the ruling, the issue will not go away, particularly because of the information provided by the dissenting justice, Ginsberg, who is of the opinion that Congress, in enacting the MDA, did not intend to give such protection to device manufacturers.