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Drug / Device Law BlogLegal updates, news, and commentary from the attorneys of Baker Sterchi Cowden & Rice LLC

"Impossibility Preemption" Remains Alive and Well in Missouri for Generic Drug Manufacturers

April 6, 2018 | Leigh Ann Massey

“Impossibility preemption” applies to bar tort claims where it is impossible for a party to comply with both state and federal law. In the recent opinion of Raskas v. Teva Pharms. USA, Inc., No. 4:17-CV-2261 RLW, 2018 U.S. Dist. LEXIS 3507 (E.D. Mo. January 8, 2018), the Eastern District of Missouri reaffirmed application of “impossibility preemption” to generic drug manufacturers  on strict liability and negligent defective design and failure to warn claims. 

The allegations in the Raskas v. Teva complaint provide the story of a young man, Ralph Raskas, who, after seeking treatment for nausea and vomiting, ingested the medication prescribed by his physician - generic metoclopramide - and allegedly developed pain and restlessness in his legs. After being diagnosed with “drug-induced acute akathisia,” he complained of significant pain and eventually committed suicide after two prior attempts.  His father filed a wrongful death action against Teva Pharmaceuticals, USA (Teva) and Actavis Elizabeth, LLC (Actavis) - manufacturers of the dispensed generic metoclopramide - alleging that the drug caused his son’s neurological injuries and suicide. Plaintiff asserted claims for strict liability and negligent defective design and failure to warn, negligence in identifying risks associated with the drug, as well as what he contended was a failure to update the generic medication’s labeling to conform to that of its brand name equivalent. Relying upon PLIVA, Inc. v. Mensing, 564 U.S. 608 (2011), and Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013), Teva and Actavis sought dismissal of all claims against them on federal preemption grounds. 

The Raskas court began its analysis of the plaintiff’s claims by reviewing the approval requirements of the Food and Drug Administration (FDA) for both brand name and generic drugs. To gain approval of brand name drugs, a manufacturer must submit a new-drug application (NDA) that includes clinical investigative reports and all relevant information to allow the agency to determine whether the drug is safe for use. On the other hand, approval of a generic drug typically requires only that the generic be “bioequivalent” to the branded medication. In fact, a generic may receive FDA approval without any in vivo studies, solely based on in vitro studies that study dissolution of the proposed generic.  See 21 C.F.R. §§ 320.24(b)(5) and 320.22(d)(3).

Critically for the generic drug manufacturers in Raskas, 21 C.F.R. Part 314 prohibits generic drug manufacturers from 1) making any unilateral changes to a drug’s label, and 2) deviating from the drug’s approved formulation. See 21 21 C.F.R. §§ 314.94(a)(8)(iii), 314.150(b)(10), and 314.70(b)(2)(i). These federal regulatory restrictions are the basis for the “impossibility preemption” found in Raskas.

In rejecting the plaintiff’s defective design claims, the court considered Brinkley v. Pfizer, Inc., 772 F.3d 1133 (8th Cir. 2014), in which metoclopramide design defect claims were specifically precluded due to preemption because the only way the manufacturer could avoid liability under Missouri law was by redesigning the product. If a generic drug manufacturer were required to redesign the product to comply with Missouri state law, it would be impossible to comply with federal law, which requires a generic drug’s formulation to be bioequivalent to the branded medication and the generic’s labeling to be identical to that of the brand name drug. This is the definition, and a descriptive example, of impossibility preemption, which provides that “[w]here state and federal law directly conflict, state law must give way.” Mensing, 564 U.S. at 617. 

Raskas’s failure to warn claims were found to be similarly barred by impossibility preemption, because the warning labels on the generic metoclopramide manufactured by Teva and Actavis were required, under 21 C.F.R. Part 314, to be identical to those of the brand name medication Reglan®. If the failure to warn claims were allowed to proceed, generic drug manufacturers - in order to escape state tort liability - would be required to relabel their products to provide additional information or warnings, which is directly prohibited under federal regulations. The Missouri federal district court in Raskas determined it would be impossible for Teva and Actavis to comply with both state and federal law in this instance, so dismissal of the failure to warn claims against them was appropriate. 

Although the plaintiff attempted to distinguish its claims from those presented in controlling legal precedent, the court ultimately concluded that impossibility preemption applied to each of the asserted negligence, strict liability, and wrongful death claims for failure to warn or defective design. The plaintiff was, however, granted leave to amend his complaint to adequately plead an alleged claim against Teva and Actavis for failure to update their labeling to conform to that of Reglan®, the brand name medication.

The Raskas opinion may be found here in its entirety.

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