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From Health Law Daily, September 19, 2014

Generic manufacturer avoids liability by fulfilling “duty of sameness”

By Harold M. Bishop, JD

State failure to warn and design defect claims brought against a generic manufacturer of enoxaparin sodium shots failed because the U.S. Supreme Court has held that federal law: (1) prevents a generic manufacturer from unilaterally altering the labels of its generic drug; and (2) requires a generic drug to have the same design (i.e., active ingredients, route of administration, dosage form, strength, and labeling) as the brand-name drug on which it is based. In this case, the generic manufacturer’s labeling and design both fulfilled the “duty of sameness” with regard to the brand-name drug and were therefore unassailable (Mitchell v Sandoz, Inc., September 18, 2014, Russell, T).

Background. Cindy Mitchell, proceeding pro se, alleged that after taking “lovenox (generic) enoxaparin shots” from February of 2013 through September of 2013, she suffered a gastrointestinal bleed resulting in her hospitalization from September 16, 2013 ,until September 21, 2013. Mitchell stated that “the only side effect that she was aware of was abnormal bruising.” She sought compensation and an order that enoxaparin sodium shots be taken off the shelf. The Court construed her complaint as alleging a failure to warn and a design defect claim under the Products Liability Act of Kentucky (PLA) (Ky. Rev. Stat. sec. 411.300).

Enoxaparin sodium is a prescription injection and is the generic bioequivalent of the drug Lovenox®. Lovenox is indicated to help reduce the risk of deep vein thrombosis—also known as DVT blood clots—to help avoid potential pulmonary embolism in patients undergoing abdominal surgery, hip-replacement surgery, knee-replacement surgery, or medical patients with severely restricted mobility during acute illnesses. Sandoz Inc. (Sandoz) is a generic drug manufacturer that manufactured and distributed enoxaparin sodium shots.

Motion to dismiss. Sandoz moved to dismiss all the claims alleged against it based on federal preemption, arguing that the Food, Drug, and Cosmetic Act (FDC Act), 21 U.S.C. sec. 301 et seq., conflicts with the PLA, making it impossible for the manufacturer of a generic drug to comply with both state and federal law. Sandoz explained that under federal law, generic manufacturers cannot unilaterally alter their labeling or formulas. Therefore, state laws that impose heightened warning labels are in direct conflict with federal law.

Analysis. The court’s analysis of the Sandoz motion was guided by two recent Supreme Court decisions: PLIVA, Inc. v Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v Bartlett, 133 S. Ct. 2466 (2013). In Mensing, the Court held that state-law failure-to-warn claims against generic drug manufacturers are preempted by federal law. The Supreme Court extended that holding to reach to state tort claims of design defects in Bartlett (see Design-defect lawsuits against generic drug manufacturers preempted by federal lawJune 24, 2013).

The court noted that the Sixth Circuit Court of Appeals (which encompasses the Kentucky district courts) has applied the Mensing and Bartlett decisions to both state law claims for failure-to-warn and design defect.

Findings. The court found that to the extent Mitchell alleged that Sandoz should have changed its labeling in order to better reflect the potential risks of the drug, her claim was preempted. Federal law prevents Sandoz from unilaterally altering the labels of its generic drug.

Second, to the extent that Mitchell alleged Sandoz should have altered the design of the drug, federal law also prohibited Sandoz from taking action. The FDC Act requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as the brand-name drug on which it is based.

Therefore both claims were preempted. The case was dismissed.

The case number is 5:14-CV-00018.

Attorneys: Cindy Mitchell, pro se. W. Kennedy Simpson (Thompson Miller & Simpson PLC) for Sandoz Pharmaceutical.

Companies: Sandoz Pharmaceutical

MainStory: TopStory CaseDecisions PreemptionNews PLDrugNews FDCActNews DrugBiologicalNews GenericDrugNews LabelingNews KentuckyNews

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