On March 19, the U.S. Supreme Court heard arguments in the fourth in a series of recent "pre-emption" cases involving prescription drugs and medical devices.
The issue raised in these cases is whether federal law pre-empts individuals from suing pharmaceutical companies or medical-device manufacturers under state law for defects in the design, or inadequacies in the labeling, of a drug or device that has been approved by the U.S. Food and Drug Administration.
Individually, each of the three prior decisions is defensible. Collectively, the prior decisions have created an untenable situation that is confusing, and neither advances patient safety nor promotes drug and device development.
Follow the bouncing ball. In 2008 in Riegel v. Medtronic, the Supreme Court held that individuals could not sue medical-device manufacturers under state law. One year later in Wyeth v. Levine, the high court ruled that individuals could sue a brand-name pharmaceutical manufacturer under state law. In 2011, in Pliva v. Mensing, the court ruled that individuals could not sue the manufacturer of a generic drug under state law.
These wholly different rulings exist because the sale of medical devices, brand-name prescription drugs and generic-brand drugs are governed by different federal laws — the Medical Device Amendments to the federal Food, Drug, and Cosmetics Act (FDCA), the FDCA and the Hatch-Waxman Act.
The consequences of these different decisions have served the interests of neither individuals who have suffered unwarranted harm nor companies that have manufactured the products. People across the country now have different legal rights if their pharmacists filled their prescriptions with a generic rather than brand version of the same drug.
Which brings us to the current case of Mutual Pharmaceutical Co. v. Bartlett. The facts of this case are tragic. Karen Bartlett was prescribed the generic drug sulindac. She experienced a very rare but severe reaction to the drug, which resulted in burns over nearly two-thirds of her body and several permanent disabilities.
She brought suit against the generic manufacturer, Mutual Pharmaceutical, for designing an "unreasonably dangerous" product. Contrary to what the FDA had decided in allowing the product to be sold, the jury found that the dangers of taking sulindac outweighed the benefits to the public at large and awarded Bartlett $21 million in damages.
Mutual appealed, asserting that the state law claims were barred under Hatch-Waxman because, as a generic manufacturer, it could not comply simultaneously with federal and state law. Under federal law, the generic manufacturer was required to produce an exact duplicate of the brand-name drug and was not at liberty to change how the drug was made or labeled, whereas the jury found it liable for not modifying the drug to reduce its risks.
On appeal, the U.S. Court of Appeals for the First Circuit reasoned that Bartlett could sue Mutual under state law; there was no conflict between federal and state law because Mutual had the choice not to sell the drug at all.
JURY TRUMPS FDA?
This reasoning is hard to understand and conflicts with Mensing. A right that cannot reasonably be exercised is no right at all. If Mutual is effectively barred from selling its drugs as a result of court decisions holding it liable for the design or labeling of a drug that by operation of federal law it cannot control, the state law claims have trumped the federal FDA decision in violation of the Constitution’s supremacy clause.
The First Circuit’s decision effectively substituted a jury’s decision for the judgment of the FDA regarding the balance of benefits and risks of a drug. As a matter of policy, do we want a jury of six or 12 laypeople with no medical experience making decisions about the appropriate design or labeling of a drug based on evidence in one case over the judgment of medical professionals assessing information involving hundreds of patients culled from multiyear clinical data?
Based on its prior decision in Mensing, the Supreme Court may decide that the state law claims against the generic manufacturer are pre-empted because they have no choice but to comply with the FDA design and labeling requirements.
But this decision would be equally unsatisfactory. Justice should not turn on whether a person took a brand or generic drug. Drugs and devices have inherent risks, but consumers need an avenue for seeking compensation if they suffer unwarranted harm. In the emerging age of consumer-driven health care, we want to encourage — not dissuade — consumers from selecting lower-cost generics.
Any Supreme Court decision in this case will not unify the law. Congress needs to step in and create a unified medical device and brand/generic drug system that does not draw arbitrary distinctions, upholds the authority of the FDA over matters of design and labeling, and preserves for consumers avenues to seek reasonable compensation for unwarranted harm.
David L. Ferrera is a partner in the Boston office of Nutter McClennen & Fish specializing in drug and medical-device litigation.