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From Products Liability Law Daily, July 3, 2013

State law products liability claims against generic drug manufacturer of sulindac preempted

By Anthony H. Nguyen, J.D.

State law products liability claims against a generic drug manufacturer alleging injuries from the use of a generic drug were preempted by federal law (Ko v. Mutual Pharmaceutical Co., Inc., July 1, 2013, Whyte, R). Generic drug manufacturers are required by federal law to use the same FDA-approved labeling as do the manufacturers of the brand-name drug. Generic manufacturers are not permitted to change their labels to add additional warnings. State law claims based on a failure to warn were, therefore, preempted, because of the conflict with FDA regulations.

Background. Mutual Pharmaceutical Company (Mutual) manufactured sulindac, a generic anti-inflammatory medication that was prescribed to Josie C. Ko (Ko). She alleged that she had suffered “internal heart organ failure—myocarditis—due to prescribed sulindac medication” from taking sulindac. The case was removed to the federal court and Mutual moved to have the matter dismissed. Subsequently, Ko filed a response to Mutual’s motion, which Mutual moved to strike because the response was signed by her husband and not Ko.

Mutual asserted two arguments in support of its motions to dismiss and strike: (1) Ko's complaint failed to state a claim showing that she was entitled to relief; and (2) any claim Ko presented was preempted by federal law under the U.S. Supreme Court's decision in PLIVA, Inc. v Mensing, (131 S.Ct. 2567 (2011)).

Deficiencies. In order to survive a motion to dismiss, the facts pled in the complaint, taken as true, must allow the court "to draw the reasonable inference that defendant is liable for the misconduct alleged." The district court noted that Ko’s complaint contained only minimal recital of a cause of action’s elements and was supported by conclusory statements. Additionally, Ko’s complaint stated that the suit against Mutual was for products liability without stating a specific cause of action. The statement that she took sulindac, and then at some unspecified time later, suffered myocarditis, was not enough to raise her claim above a speculative level. Ko’s pleadings would have been considered inadequate on these reasons alone, but the court continued in its analysis.

Strict liability. To establish a products liability claim based on a theory of strict liability, Ko would have to assert she was harmed by a product manufactured by Mutual that contained a manufacturing, design, or warning defect. The district court noted that Ko’s complaint contained no facts relating to the most crucial element of any products liability tort action, causation; nor did Ko assert clearly what the warning defect was. The court held that although Ko’s allegations satisfied the plausibility pleading standard for a claim based on strict liability, federal law still preempted her state law failure-to-warn claims.

The only information Mutual was allowed to put on its label was prescribed by federal regulations under 21 U.S.C. 355(j). Per the Supreme Court’s ruling in Mensing, generic drug manufacturers are required by federal law to use the same FDA-approved labeling as the manufacturers of the brand-name drug; and because generic manufacturers cannot change their labels to add additional warnings, any state-law claims based on a failure to warn impermissibly conflicted with the FDA regulations. Thus, preemption was warranted.

The case number is C-13-00890-RMW.

Attorneys: Josie C Ko, Pro Se. Kendra Pappas (Hassard Bonnington LLP) for Mutual Pharmaceutical Co., Inc.

Companies: Mutual Pharmaceutical Co., Inc.

MainStory: TopStory WarningsNews PreemptionNews DrugsNews CaliforniaNews

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