Much has been written about the U.S. Supreme Court decision in Riegel v. Medtronic Inc., 128 S.Ct. 999 (2008), in which the Court found preempted the design and warnings claims made by plaintiff concerning a medical device regulated by the FDA pursuant to the MDA. And MassTortDefense thought it might be interesting to also not how some lower courts are dealing with the decision.

In Despain v. Bradburn, No. 07-714, 2008 WL 1067202, (Ark., April 10, 2008), the Arkansas state supreme court revisited the attempt of plaintiff to recover damages allegedly suffered as the result of a defective hearing device. Despain alleged that the hearing device was defective because of the way it reacted to a strong magnetic field and that defendant failed to adequately warn Despain of this danger. “He does not allege that any particular part of the device should have been designed in any specific [other] manner.”

Previous Ruling

The Arkansas Court had just ruled in February that the lower court had erroneously granted summary judgment for defendant in plaintiff’s state law tort suit. See 2008 WL 324356, Ark., February 07, 2008. The state supreme court expressly ruled that the Medical Device Amendments (MDA) to the federal Food, Drug and Cosmetic Act did not preempt Despain’s claims. The state high court, noting a perceived presumption against preemption, asserted that the general state common-law requirements in this suit were not specifically developed “with respect to” medical devices. Accordingly, they are not the kinds of requirements that Congress and the FDA feared would impede the ability of federal regulators to implement and enforce specific federal requirements.

But Riegel

A few weeks later, the U.S. Supreme Court reached the opposite conclusion. Common law liability is premised on the existence of a legal duty, and thus a tort judgments establishes that the defendant has violated a state-law obligation. 128 S.Ct. at 1108. An award of damages can be, and is designed to be, a potent method of governing conduct and controlling policy. State law that requires a manufacturer to change a design, making the product safer but less effective than the design approved by the FDA disrupts the federal scheme, whether it be through tort judgments mandated by application of the common law or a specific state regulation. State juries, however, do not conduct an FDA-like risk-benefit analysis. A jury sees only the cost of the more dangerous design, and is not concerned with its benefits, as the patients who reaped the benefit of the existing demand are not before the court. Id.

Rehearing
The defendant petitioned for rehearing in light of Riegel. The Arkansas high court, in an opinion by Justice Glaze, granted the petition. The earlier opinion had reasoned that the defendant had not provided evidence of any federal device-specific requirements related to the hearing device and nothing in the complaint would have required specific changes in the way the device was designed or manufactured. Those arguments had been rejected.
Chief Justice Hannah, joined by Justice Brown, concurred in the opinion granting the petition for rehearing, noting that the U.S. Supreme Court is, of course, “the court of last resort” on questions of whether United States Congressional acts preempt state law.

Now the more interesting part of the opinion…. C.J. Hannah, concurring, expressed “deep concern” with Riegel. While clearly the MDA preempts states from setting up regulatory systems that compete with the regulatory systems set up by the federal government under the MDA, the state’s common law on tort is no such regulatory system. “It does not compete with the MDA,” according to the Chief Justice. He disagreed with the core premise underlying the Riegel decision that common-law tort damages constitute requirements preempted under the MDA because the award of damages may affect how medical devices are designed, manufactured, and sold. He though unfounded the “fear that changes made by medical device providers as a consequence of tort damage suits will be made based on what must be done to avoid future tort damages as opposed to increasing safety and effectiveness.” He disagreed with the Supreme Court’s belief “that the FDA is more reliable than juries in dealing with the issue of defective medical devices.”

He suggested the need for actual evidence to show that a state used its common-law tort damages as a means to set requirements for the safety and effectiveness of medical devices. “Arkansas does not use common-law tort damages as a means to set requirements for the safety and effectiveness of medical devices. Arkansas has no special tort law that applies only to medical devices. The tort law that applies to medical devices in Arkansas applies to any other causes of action in tort.”

The justice was “also compelled to express dismay at the summary abandonment of venerable principles of state common law that have been developed over many generations. By a conclusory and incomplete analysis, our law is dismissed. In the place of well-reasoned judicial decisions reaching back to the England of Blackstone, injured plaintiffs are told that instead of looking to their common law for redress they must look to a regulatory agency that has no power to grant them any redress.”

After extolling the virtues of the venerable common law, the opinion argues that preemption undermines “the MDA, which was enacted to protect the public against defective and unsafe medical devices through federal regulation.” He then deplores the “injury done to the ….principles of federalism [which] will not be so easily healed.”

The opinion concludes with a prediction that the United States Congress will step in to amend the MDA and “heal the injury caused in this case.” (Indeed, Senator Kennedy and Representative Waxman have already proposed that Congress reverse the decision. See Medical Device Safety Act of 2008.)

While the Arkansas court got the ultimate decision right, the language of the concurrence ought to be of continuing concern to product makers. MassTortDefense was once involved in a case in which a trial judge refused to grant a valid motion in limine because the preemption doctrine “boggles the mind and boils the blood.” The resistance to the notion that federal law is the supreme law of the land continues in many legal circles. Notions of “federalism” – read states’ rights– the asserted importance of the common law, and the desire to compensate injured plaintiffs may compel many lower courts to resist the guidance of the Supreme Court, to narrow the scope of the such preemption rulings, to force defendants to fight for every application of the rule, and to look with skepticism at attempts to base preemption motions on the policies and reasoning of the Supreme Court decision.