Supreme Court Ought to Re-examine Second-Guessing of FDA-Approved Drug Labeling by State Tort Law

John-Adams-Courthouse-exterior
John-Adams-Courthouse-exterior

The U.S. Supreme Court’s 2009 decision in Wyeth v. Levine placed significant limits on the ability of brand-name drug manufacturers to defend against failure-to-warn state tort-law claims. Even though manufacturers invariably label their products precisely as the Food and Drug Administration (FDA) has mandated, Wyeth held that state courts could penalize manufacturers for failing to include additional health warnings on their labels. The Court explained that it was possible for manufacturers to simultaneously comply with both FDA and state-court-determined labeling requirements because FDA’s “Changes Being Effected” (CBE) regulation permits brand-name companies to unilaterally change the FDA-mandated label and then seek FDA’s after-the-fact approval of the changes. But as the Court recognized, the CBE regulation limits the circumstances under which unilateral label changes are permissible—and when a unilateral change is not permitted, any tort claim premised on a state-law duty to make such a change is still preempted.

Unfortunately, many lower courts have failed to recognize this important limitation imposed by Wyeth on tort liability. At its January 8, 2016 conference, the U.S. Supreme Court will consider a certiorari petition that provides it with an opportunity to clear up the confusion among the lower courts regarding when federal law preempts failure-to-warn claims against the manufacturers of drugs bearing FDA-mandated labels. The Court should seize that opportunity by granting review in Johnson & Johnson v. Reckis, a case in which the Massachusetts Supreme Judicial Court upheld a $140 million judgment against a manufacturer of ibuprofen—a generic over-the-counter pain-relief medication sold under such brand names as Advil and Motrin.

FactsReckis involves claims that ibuprofen is inadequately labeled because the label available to consumers does not explicitly warn them that its use can, in rare cases, lead to toxic epidermal necrolysis (TEN), a life-threatening skin disorder. Instead, as mandated by FDA, ibuprofen’s consumer labeling includes warnings to stop use and seek immediate medical help if an allergic reaction occurs, but it makes no mention of TEN or the possibility of “life-threatening disease.” Those more explicit warnings are reserved for the labeling available to prescribing physicians.

In 2000, FDA itself drafted the precise language to be used on all ibuprofen labels. A seven-year-old girl in Massachusetts developed TEN in 2003 after being given ibuprofen by her parents. Her father testified that he would have ceased administering the drug once he noticed that she developed a rash following the second dose, if the label had included explicit references to TEN and “life-threatening disease.” A state-court jury concluded that the manufacturer was negligent in failing to unilaterally change its product label to include such additional warnings.

The CBE Regulation. Wyeth v. Levine held that state law may impose sanctions on a brand-name drug manufacturer for not unilaterally changing its labeling in the manner demanded by a tort plaintiff, but only if the change would have been permissible under FDA’s CBE regulation. Wyeth explicitly identified one circumstance under which the regulation does not permit a manufacturer to unilaterally change its label: where there is “direct evidence” that FDA would not grant after-the-fact approval to the unilateral label change. Unfortunately, the Court did not explain what constitutes “direct evidence,” and later lower-court decisions have adopted widely disparate interpretations of the phrase.

Indeed, although the Massachusetts state courts discerned no such “direct evidence” in Reckis, other courts have arrived at the opposite conclusion with respect to ibuprofen labeling. A group of doctors petitioned FDA in 2005 to require the precise additional warnings later demanded by the Reckis plaintiffs, but FDA rejected the petition—reasoning that the change would confuse consumers without providing any additional useful information. Other courts have cited that rejection as constituting the requisite “direct evidence” that FDA would not have approved a request from the manufacturers to change the label.

“Newly Acquired Information.” The CBE regulation includes another important limitation on unilateral label changes, a limitation on which the Wyeth case did not focus. The regulation permits a brand-name drug manufacturer to act unilaterally only if a labeling change “reflect[s] newly acquired information.” If, based on a desire to comply with labeling requirements that might be imposed by a state-court jury, a manufacturer seeks to make a label change that does not “reflect newly acquired information,” it may not act unilaterally but rather must obtain advance permission from FDA for the change. Hence, in that circumstance, federal law preempts (bars) a tort claim alleging that a manufacturer should have changed its label to include a warning demanded by the plaintiff—because it would have been impossible for the manufacturer to make the change on its own without violating the CBE regulation.

To date the “newly acquired information” requirement has received scant attention from the courts, but the Reckis petition squarely raises it. As Washington Legal Foundation argued in a brief urging the Court to grant the petition, there is no basis for imposing a $140 million penalty on manufacturers for failing to unilaterally change the ibuprofen label FDA itself drafted in 2000, if they acquired no new information about the dangers of TEN between 2000 and the date on which the plaintiffs’ daughter developed TEN in 2003. The possibility that use of ibuprofen could lead to the onset of TEN in extremely rare cases was well known among medical professionals as early as the 1970s. Despite that knowledge, FDA determined in 2000—when it drafted the language mandated for use on ibuprofen labels directed at consumers—that the label should not make explicit reference to TEN or include frightening “life-threatening disease” language.

The Supreme Court should grant review to instruct lower courts that federal law preempts state-law tort claims whenever, as here, there is no evidence that the manufacturer possessed newly acquired information that would have justified a unilateral label change. Indeed, the U.S. Court of Appeals for the First Circuit—the federal appeals court with jurisdiction over appeals arising from federal courts in Massachusetts—has adopted that precise understanding of the CBE regulation. In other words, the claims of the Reckis plaintiffs would have been rejected on preemption grounds had they been heard by a Massachusetts federal court instead of a Massachusetts state court. Certiorari is warranted to resolve that split in authority as well.

The Reckis plaintiffs dispute WLF’s interpretation of the CBE regulation. In urging the Supreme Court not to hear their case, they argue that the “newly acquired information” language is inapplicable here because it was not inserted into the CBE regulation until 2008, several years after their daughter developed TEN. But that argument overlooks that FDA, ever since it first adopted the CBE regulation in 1982, has consistently interpreted it as permitting a manufacturer to undertake a unilateral label change only when it is acting on the basis of important, new information. When it adopted the “newly acquired information” wording in 2008, FDA explained that it was merely making its understanding more explicit, not changing the regulation’s meaning.

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In sum, the certiorari petition filed in Johnson & Johnson v. Reckis provides the Supreme Court with an excellent opportunity to clear up widespread confusion regarding when state tort law is permitted to impose sanctions on brand-name drug manufacturers for failing to add label warnings that FDA had previously determined to be unwarranted. Thousands of tort claims filed each year seek recovery from drug manufacturers based precisely on asking state courts to second-guess the FDA. The Supreme Court needs to step in to clarify that federal law preempts such claims whenever it was impossible for the defendant manufacturers to have made the requested unilateral label changes without violating federal law.

Also published by Forbes.com on WLF’s contributor page

2 thoughts on “Supreme Court Ought to Re-examine Second-Guessing of FDA-Approved Drug Labeling by State Tort Law

  1. Pingback: Regulatory Recon: FDA Investigating New Complaints Against Theranos, Sun Pharma Gets Warning Letter (21 December 2015) - Background Check Group

  2. Pingback: Supreme Court and constitutional law roundup - Overlawyered

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