United States: Federal Pharmaceutical Regulations Pre-empt State-Tort Laws

Weeks v. Wyeth, Inc., et al., (M.D. Ala. Aug. 3, 2015)

Addressing whether federal labeling requirements imposed on generic drug manufacturers directly conflict with state-tort law claims, the U.S. District Court for the Middle District of Alabama recently determined that federal law pre-empted state-tort law claims against generic drug manufacturers in accordance with Supreme Court and circuit precedent. Weeks v. Wyeth, Inc., et al., 2015 WL 4635176 (M.D. Ala. Aug. 3, 2015) (J. Watkins, D.J.).

This case involves metoclopramide (MCP), the generic counterpart of the prescription drug Reglan®. Reglan is designed to increase the speed at which food travels through the digestive system in order to treat patients suffering from gastroesophageal reflux. The drug was approved by the U.S. Food and Drug Administration (FDA) in 1980 as a short-term therapy.

Plaintiffs Danny and Vicki Weeks sued several pharmaceutical companies, including Wyeth, the manufacturers of MCP. They alleged that Mr. Weeks developed a severe and incurable neurological disorder as a result of ingesting MCP over the course of two years as prescribed by his treating physician. The Weeks asserted that Defendants had actual knowledge of potential neurological side effects from long-term use of Reglan or MCP and that they failed to warn doctors and patients of these risks.

After the Weeks filed suit, the brand-name defendants moved to dismiss, since Mr. Weeks only ingested MCP and that liability against them, as manufacturers of Reglan, must fail. The court granted the motion with respect to the Weeks claims that the brand-name defendants owed Mr. Weeks a duty to disclose information about either Reglan or MCP, but denied the motion with respect to claims that the brand-name defendants owed Mr. Weeks' prescribing physician the same duty. While the issue of whether brand-name drug manufacturers can be held liable for harm caused by a generic product manufactured and distributed by an un-related generic manufacturer was being decided in the U.S. Court of Appeals for the 11th Circuit, the brand-name defendants moved the court to certify this question to the Supreme Court of Alabama. Ultimately, the Supreme Court of Alabama determined that liability could extend to brand-name manufacturers and developers for fraud or mis-representation made in connection with the manufacture and sale of a brand-name drug, by a plaintiff who was injured by the generic drug manufactured and distributed by a different company.

While the Supreme Court of Alabama was deciding the certification request, the generic defendants filed a motion to dismiss on the grounds that federal law pre-empted state-tort law claims against generic pharmaceutical manufacturers. The court stayed the action while the Supreme Court of Alabama addressed the certified question. Once its decision was issued, the stay was lifted and the generic defendants filed a motion for judgment on the pleadings. Despite the generic defendants having not filed answers to the Weeks' amended complaint, and consistent with other authorities, the court construed this motion under Rule 12(c) of the Federal Rules of Civil Procedure as a motion to dismiss for failure to state a claim pursuant to Rule 12(b)(6).

In addressing the generic defendants' motion to dismiss based on federal pre-emption, the court relied heavily on the Supreme Court of the United States' decision in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011) case. The facts of Mensing are similar to the current case, in which the plaintiffs alleged that long-term use of MCP caused neurological disorders and that the generic drug manufacturers were liable under state-tort laws "for failing to provide adequate warning labels." Similar to the generic defendants' arguments, the Mensing defendants argued that "federal statutes and FDA regulations required them to use the same safety and efficacy labeling as their brand-name counterparts," which means that they could not "simultaneously comply with both federal law and any state tort-law duty that required them to use a different label." The Supreme Court found that defendants in these circumstances were without means to comply with both federal and state law, and that federal law prohibited generic drug manufacturers from unilaterally changing their labels or providing additional warnings directly to physicians. Thus, the Supreme Court (in Mensing) held that federal law pre-empted the failure-to-warn state-tort claims.

The U.S. District Court for the Middle District of Alabama recognized that the scope of Mensing covers any state-law claims based on a generic drug manufacture taking unilateral action. In these cases, the state-law claims are pre-empted by federal law, since federal pharmaceutical regulations requiring a "duty of sameness" from generic companies makes them dependent on brand-name manufacturers.

If the brand-name defendants were not required to communicate a warning to physicians or patients, then the generic defendants also would not be required to warn and any state-law claim based on that unilateral action would be pre-empted by federal law. Here, the Weeks expressly alleged in their amended complaint that the brand-name defendants failed to communicate any warnings to Mr. Weeks' prescribing physician. Accordingly, the district court concluded that the Weeks' state-law tort claims are pre-empted by federal law and granted the generic defendants' motion to dismiss.

Federal Pharmaceutical Regulations Pre-empt State-Tort Laws

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