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Originally Published MDDI July 2005

WASHINGTON WRAP-UP

Are PMAs Legally Safer Than 510(k)s?

Courts have ruled that FDA premarket approval decisions may protect products from product liability claims.

James G. Dickinson

More Device Review Staff for FDA| Crawford Aide in Breast Implant Controversy| Public Citizen Seeks to Block Cyberonics Stimulator| MRL External Defibrillators Recalled

Conventional wisdom has been that 510(k) product clearances are the way to go, if you have a choice. After all, they officially take only 90 days to get through FDA. And so, 510(k) applications are what the majority of medical device makers submit.

But in a May 6, 2005, Washington Legal Foundation legal backgrounder, attorney John Powers said that premarket approval (PMA) applications are safer. Powers, of Hancock & Estabrook (Syracuse, NY), said that FDA approval—rather than clearance—may be the key. FDA approval has been ruled in the courts to confer protection from certain types of product liability claims. So, he says, the litigation savings alone from averted product liability actions justify going the PMA route.

In many cases, Powers writes, such savings may lessen, or even surpass, the expense of pursuing PMA approval. Additional economic incentives realized from preemption may compel device manufacturers to rely on the PMA process as the primary product approval process. If this happens, he says, the public will benefit in the long run because, on the whole, more new products would be subject to greater FDA scrutiny. Thus, those products should be considerably safer.

Powers says that, in addition to the 510(k) exception, manufacturers should examine Section 360(k) of the Medical Device Amendments of 1976 (MDA). That section preempts states from regulating medical devices that are specifically regulated by FDA. By the late 1980s, he says, device manufacturers were testing this provision's scope. They asserted that it preempted state common law tort and product liability claims concerning devices regulated under the MDA.

Two issues are critical to the interpretation of this provision, Powers says. The first is whether a state common law jury verdict awarding damages could constitute a state requirement. The second is whether the FDA approval process establishes a device-specific federal requirement that would trigger the preemption of later common law design-defect claims for the same device.

Powers also referred to a split 1996 U.S. Supreme Court decision. That decision held that a state common law jury verdict could possibly constitute a state requirement under the MDA preemption provision. But, the decision said, even if it did, the 510(k) approval of a device does not create a parallel federal requirement about the safety or effectiveness of that device that would preempt later design-defect lawsuits. The court said the 510(k) approval process is focused on equivalence, rather than safety.

Last August, the U.S. Court of Appeals for the Third Circuit said the MDA preempts common law design-defect product liability claims when FDA approved the accused device through the PMA process. The Third Circuit agreed with prior decisions from four other appeals court circuits about what FDA PMA approval represents. The courts said it constitutes approval of a product's design, testing, intended use, manufacturing methods, performance standards, and labeling that is specific to the product. Thus, it preempts any state law civil claims regarding alleged defects or inadequacies in those areas.

More Device Review Staff for FDA

FDA expects to add about 150 more staff to conduct and support medical device reviews this fiscal year. According to CDRH's FY 2004 user fee annual report, the center collected $27.2 million in fees in 2004. That's $4.8 million (15%) less than revenue projections had anticipated. The shortfall was attributed to a number of factors. Among them, the center received fewer applications and supplements that paid the higher fees. In addition, there was an increase in applications that qualified for fee exemptions.

A Medical Device User Fee and Modernization Act (MDUFMA) provision calls for funding shortfalls to be made up by October 1, 2005. Without a legislative amendment to eliminate the provision, the program will expire on that date, the report says. However, the director of the Office of Management and Budget says that the administration will request resources for the program in FY 2005, 2006, and 2007. Those resources, if granted, will meet the levels required by MDUFMA, the report says.

FDA's report says the user fee program's biggest challenge this year is to add the additional staff and infrastructure needed to meet MDUFMA goals.

Crawford Aide in Breast Implant Controversy

A key figure in Lester Crawford's stalled bid to be confirmed as FDA commissioner is now embroiled in a separate controversy involving silicone breast implants.

Six women's advocacy groups have written the Senate Health, Education, Labor and Pensions (HELP) Committee. Each is calling for an investigation based on an e-mail sent from FDA scientific policy director Susan Bond. She sent the e-mail to Crawford and CDRH director Daniel Schultz five weeks before an advisory committee met to review two PMA applications on silicone breast implants.

The e-mail contained silicone breast implant background information prepared by an “outsider who is interested in seeing us come out okay on the [breast implant] issue,” wrote Bond. It was biased toward approval, the groups claim. They believe the e-mail may have exerted “inappropriate influence over the agency to act in the interest of industry.”

Bond is at the center of anonymous allegations that have held up Crawford's confirmation vote. An FDA employee purportedly sent a letter to committee chairman Mike Enzi (R-WY) in April. It alleged an affair between Crawford and Bond, waste of government resources, and irregular promotion of Bond to her present position.

In May, FDA's General and Plastic Surgery Devices advisory committee voted to recommend approval of Mentor's silicone breast implants. The day before, the committee had rejected a PMA application from a rival company, Inamed.

The advocacy groups claim that Bond's e-mail proves that FDA had a “predetermined interest in approval even before the panel met.” They say that for Bond to send the document from an outsider without providing this person's identity is “especially questionable.”

The groups also call into question other irregularities associated with the advisory panel's review. They question why experts inside and outside of FDA were not invited to present their data. They also note that FDA's own data on breast implant ruptures were not provided to the panel. The HELP commit-tee is reportedly reviewing the matter.

Public Citizen Seeks to Block Cyberonics Stimulator

Public Citizen Health Research Group says the vagus nerve stimulator should not be approved for use in patients with treatment-resistant depression. In a letter to CDRH director Daniel Schultz, Public Citizen questioned the device's effectiveness. It also questioned the soundness of the studies submitted by Cyberonics to support the new indication. The product is currently approved for treating epilepsy patients.

“The principle is simple: If it doesn't work, it shouldn't be approved,” said Public Citizen deputy director Peter Lurie. “FDA would never approve a drug under these conditions. They certainly shouldn't approve this device.”

The device consists of a pulse generator that is implanted in the base of a patient's neck. The generator delivers electrical signals to the left cervical vagus nerve, which connects to the heart, gastrointestinal tract, brain, and other parts of the body. It is programmed to be on for 30 seconds and off for 5 minutes. The device was approved in 1997 for use in epilepsy patients.

A Public Citizen news release says that in 2003, Cyberonics asked FDA to approve use of the device in patients with chronic or recurrent depression. The patients would have to be 18 or older and would have to have failed to respond to two or more antidepressant treatments. The next year, FDA sent a “major deficiency letter” that cited serious flaws in the company's data. The company responded, and an advisory committee later voted 5–2 to conditionally approve the device for this indication. FDA, however, overruled the committee's recommendation, Public Citizen said. The agency cited concerns about the device's effectiveness and data showing worsening depression in many patients.

The company submitted more data, and FDA reversed itself in February. It told the company that the device was approvable. Public Citizen said the company has submitted data about only a single randomized, controlled trial. In that trial, all patients had the device implanted, but only half had the device turned on. That trial failed to convincingly demonstrate the device's effectiveness, Public Citizen said. Cyberonics also produced long-term, nonrandomized data comparing patients with the device with another patient group, but an FDA statistician called that analysis “highly questionable,” the advocacy group said.

“FDA should not let justified empathy for this patient population lead to the unjustified approval of a device,” said Nicholas Stine, a Public Citizen researcher who worked on the letter. He said it does not come close to meeting the agency's approval standards and may do more harm than good.

MRL External Defibrillators Recalled

MRL Inc. has recalled 597 AED20 automatic external defibrillators. The units have the potential to display an error code that may prevent adequate defibrillation. “The AED20 may display a ‘Defib Comm' error message on the device display during use,” the company says. This message may result in a failure of the device to analyze the patient's ECG and deliver the appropriate therapy. If this happens, the defibrillator may be prevented from resuscitating a patient, the company says. This problem occurs when an impact to the exterior of the AED20 causes a circuit board connector to perforate an insulation shield. The perforated shield allows an electrical short between the connector and the external housing of the AED20.

So far, the company has received 12 complaints associated with the error code. In one instance, the short may have prevented patient resuscitation. MRL says the devices were manufactured between February and July last year. FDA has classified the recall as a Class 1, its most severe rating, because of the potential for the error to cause serious harm or death.

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