By: Kelli F. Robinson
Attorney at Law
Attorney at Law
Sirote & Permutt, PC
On January 11, 2013, the Alabama Supreme Court issued an opinion which found that a brand-name drug manufacturer can be liable for a patient’s injuries caused by a generic drug. Since its release, the opinion has received national attention due to its potential for far-sweeping consequences on healthcare.
At issue in the case before the Alabama Supreme Court was whether Weeks could bring his lawsuit against Wyeth, Inc., the brand-name drug manufacturer of Reglan now owned by Pfizer, Inc., for failing to warn of the risk of long-term use of the generic drug manufactured and distributed by Actavis Elizabeth, LLC, and Teva Pharmaceuticals USA. The U.S. District Court for the Middle District of Alabama certified the following question: “Under Alabama law, may a drug company be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture or distribution of a brand-name drug, by a plaintiff claiming physical injury from a generic drug manufactured and distributed by a different company?”
The Alabama Supreme Court cited a June 2011 U.S. Supreme Court opinion, PLIVA v. Mensing, 131 S. Ct. 2567 (2011), which found that injured patients’ state-law failure-to-warn claims against generic-drug manufacturers are preempted by federal law because the Food and Drug Administration (FDA) requires those manufacturers to use labeling that is the same as the brand-name labeling. In an 8-to-1 decision written by Justice Michael F. Bolin, the Alabama Supreme Court held that:
. . . an omission or defect in the labeling for the brand-name drug would necessarily be repeated in the generic labeling, foreseeably causing harm to a patient who ingested the generic product. A brand-name manufacturer is well aware of the expiration of its patent and well aware that a generic version of the drug will be made when the patent expires. It is recognized that generic substitutions are allowed in all 50 states. A brand-name manufacturer could reasonably foresee that a physician prescribing a brand-name drug (or a generic drug) to a patient would rely on the warning drafted by the brand-name manufacturer even if the patient ultimately consumed the generic version of the drug.
Id. at *41-42. The Alabama Supreme Court also explained that while “the brand-name manufacturer is under a continuing duty to supply the FDA with postmarketing reports of serious injury and can strengthen its warnings on its own accord. . . a generic manufacturer’s label must be the same as the brand-name manufacturer’s label, and the generic manufacturer cannot unilaterally change its warning label.” Id. at *46-47.
On February 19, 2013, the brand-name manufacturers of Reglan filed an application for re-hearing to the Alabama Supreme Court arguing that the Court’s ruling is inconsistent with rulings in the overwhelming majority of state and federal courts around the nation. The U.S. Chamber of Commerce, the Business Council of Alabama, the Alabama Policy Institute, the Pharmaceutical Research and Manufacturers of America, the Product Liability Advisory Council, and the Alabama Defense Lawyers Association all filed briefs in support of the brand-name manufacturers’ request.
Although this opinion only affects Alabama state law, it has received national attention due to its potential impact on decisions in other states. A few months ago, Congress introduced the Patient Safety and Generic Labeling Improvement Act which was promulgated in response to the U.S. Supreme Court’s PLIVA decision. Critics of the PLIVA decision claim that the U.S. Supreme Court’s decision effectively created dual drug labeling standards for brand-name and generic drug manufacturers. While brand-name drug manufacturers have to demonstrate to the FDA that a new drug is safe and effective and that the proposed label is accurate and adequate, generic drug manufacturers do not have to meet the same burden.
The bill seeks to hold generic drug manufacturers to the same standards as the brand-name manufacturers. Should the bill pass, generic drug manufacturers would also have the burden of showing that their labels are accurate and adequate.