Four related appeals have just been decided largely in favor of the plaintiffs in mass tort litigation pending in Philadelphia involving the name-brand drug Reglan and its generic bioequivalent, metoclopramide.
The Food and Drug Administration (“FDA”) approved metoclopramide under the brand name Reglan in 1980, and five years later, generic manufacturers started producing the drug. The drug stimulates digestive function by speeding up the movement of food through the system, and it is prescribed to treat chronic digestive problems such as diabetic gastroparesis and gastroesophageal reflux.
In the years following FDA approval, long-term use of metoclopramide was linked to tardive dyskinesia, a severe and usually permanent neurological disorder characterized by involuntary and uncontrollable movements of the head, neck, face, arms, and trunk including facial grimacing and tongue thrusting. Studies showed that as many as twenty-nine percent of the people who took the drug for several years developed tardive dyskinesia. Changes to the label were made in 1985, 2004, and 2009, to strengthen warnings of the dangers associated with use of the drug for more than twelve weeks. Plaintiffs in the mass tort litigation commenced civil actions against both the name-brand manufacturers and generic manufacturers, seeking damages for personal injuries and deaths due to their ingestion of either the name brand metoclopramide, Reglan, or its generic bioequivalent.
While the Reglan mass tort litigation has been pending, the United States Supreme Court decided Mensing v. Wyeth, Inc. The Mensing Court thoroughly discussed the differences in the federal regulations governing name-brand drug manufacturers, and those pertaining to generic drug manufacturers. While regulations allowed a name-brand manufacturer to change the warning on its label by utilizing a process known as “Changes Being Effected” (“CBE”), that procedure was not available to generic manufacturers. Rather, a generic manufacturer could only change its label to conform to an updated name-brand label or in response to an FDA directive.
The Mensing Court reasoned that since a generic manufacturer is responsible under federal law for ensuring that its warning label is the same as the brand name’s label, and it cannot unilaterally change its label to attach a stronger label as required by state law, it was impossible for generic drug manufacturers to comply with both federal and state law. Thus, state law tort claims based on generic drug manufacturers’ failure to provide adequate warning labels for generic metoclopramide were preempted by federal law.
In reliance on Mensing, the Generic Defendants in the Reglan litigation filed preliminary objections to the master complaints seeking dismissal of all claims against generic manufacturers of metoclopramide on federal pre-emption grounds. The trial court overruled the preliminary objections and held that Generic Defendants failed to sustain their heavy burden of proving with certainty that no legal recovery was possible. A split three-judge panel of the Pennsylvania Superior Court has now largely affirmed that ruling and remanded the cases for further proceedings.
On appeal, the Generic Defendants contended that the Plaintiffs’ claims were essentially failure to warn claims requiring them to change the label, and that the pre-emption issue is indistinguishable from that in Mensing. The court agreed with the Generic Defendants that all pre-2007 negligent failure-to-warn claims were preempted. However, the court refused to dismiss any of the other asserted claims at this stage.
As to post-2007 conduct, the court held that the impact of the Food and Drug Administration Amendments Act of 2007 (hereinafter the “FDAAA” or the “Act”) had not yet been adequately examined by the parties or trial court. Thus, the court of appeals refused to dismiss even failure-to-warn claims based on post-2007 conduct.
As to the other claims, the court of appeals agreed with the Plaintiffs that the allegations did not frame every issue in terms of a failure to strengthen the label. The claims asserting strict liability and negligence for defective design were premised upon Generic Defendants’ sale and marketing of a drug they knew was unreasonably dangerous or defective. The product was alleged to be unreasonably dangerous when it left the manufacturer’s hands, and was expected to and did reach the consumer without substantial change. Moreover, Plaintiffs alleged that the generic manufacturers continued to market their dangerous drugs despite the fact that there were safer and less expensive alternatives available. The court of appeals found that these allegations suggest that the drug, even when used as recommended and with appropriate warnings, was defective and unreasonably dangerous:
Such averments do not necessarily implicate labeling, but assert absolute liability based on the sale of a defective or unreasonably dangerous product. The ability or duty to redesign a product is not an element of this cause of action. See Restatement (Second) of Torts § 402A cmt. f (1965) (“The rule stated in this Section applies to any person engaged in the business of selling products for use or consumption. It therefore applies to any manufacturer of such a product, to any wholesale or retail dealer or distributor, …”). Thus, according to [Plaintiffs], Generic Defendants can comply with federal law, which does not permit them to unilaterally alter a drug’s design, and state law, which extends liability to a manufacturer of a defectively designed drug without regard to whether it may redesign its drug.
Hassett v. Dafoe, — A.3d —- (Pa.Super. July 29, 2013).
The court of appeals noted that the Supreme Court’s recent decision in Mutual Pharmaceutical Co. v. Bartlett, –––U.S. ––––, 133 S.Ct. 2466 (U.S. June 24, 2013) expressly left open the issue of whether § 402A strict products liability design defect claims would be pre-empted. Thus, Bartlettt did not address, or reject, the argument that under § 402A strict products liability it is unnecessary for a plaintiff to demonstrate that a defendant should or could have altered the design or the warnings. Instead, the Bartlett Court concluded that under New Hampshire’s law, § 402A imposed a duty upon a product manufacturer to “design his product reasonably safely for the uses which he can foresee.” That duty was satisfied either by changing the design or the labeling. Since Mutual, a generic manufacturer of sulindac, had no ability to change the design, the Court concluded that it was required to change the labeling to avoid liability under state law, an impossibility after Mensing.
The Reglan Plaintiffs argued that Mensing does not pre-empt strict liability design defect claims under those states’ laws which subject distributors and retailers of defective products to strict liability even though they have no control over the design of the product. The court of appeals agreed with the Plaintiffs that such an argument “appears to have some vitality after Mensing and Bartlett.” The court noted that although federal labeling statutes may pre-empt state failure to warn claims, such statutes do not necessarily pre-empt claims based upon the marketing of defective products, a lack of due care in testing, or a product’s failure to conform to express and implied warranties.
The court of appeals also refused to dismiss Plaintiffs’ claims asserting breach of express and implied warranties at this stage. These claims seek to impose liability against Generic Defendants for failing to deliver products that conformed to the properties described in the label and promotional materials. The court of appeals agreed with Plaintiffs that such a claim is not premised on the inadequacy of the label but rather on the product’s failure to live up to or conform to its label and advertising.
Whereas the only warranties identified in Mensing were those contained in labeling, i.e., package inserts shipped with the drug from the factory, the claims asserted herein implicate warranties arising from advertising and promotional materials that arguably do not fall within the definition of labeling under the federal act.
The Plaintiffs also alleged fraud and misrepresentation in the advertising and promotion of both name brand and generic drugs. The Plaintiffs alleged that both name-brand manufacturers and Generic Defendants intentionally, knowingly, and fraudulently misrepresented material facts regarding the safety of the drugs in their advertising and promotional materials, not just their labels, and that physicians and the public relied upon those misrepresentations. The court of appeals agreed with Plaintiffs that such allegations of false advertising and promotion are not failure to warn claims based on the label that pre-empted by Mensing.
In summary, the court of appeals held that only pre-2007 failure-to-warn claims based solely on a label that was in conformity with the name-brand label are pre-empted under Mensing. As to all remaining claims, the court affirmed affirm the trial court’s overruling of preliminary objections in the nature of a demurrer and remanded for further proceedings.
Heygood, Orr & Pearson and Dangerous Drugs
The attorneys with the law firm of Heygood, Orr & Pearson have based their careers on the notion that the manufacturers of defective drugs and medical devices should be held accountable for their actions. Our firm has represented hundreds of individuals who have been harmed by hazardous products such as the fentanyl pain patch, defective hip and knee implants, Yaz birth control, Actos, Avandia, and Accutane.
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* Michael Heygood, James Craig Orr, Jr. and Eric Pearson were selected to the Super Lawyers List, a Thomson Reuters publication, for the years 2003 through 2013.