Health Law Daily FDC Act preempts off-label promotion claims but not fraud and consumer protection claims
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Tuesday, January 29, 2019

FDC Act preempts off-label promotion claims but not fraud and consumer protection claims

By Jeffrey H. Brochin, J.D.

Claims based solely on "off-label" promotion of the opioid pain killer Subsys® for non-cancer pain conditions were preempted by the FDC Act, while those based on independent state-law grounds were allowed to proceed.

A federal district court in Ohio has ruled that a patient who was prescribed the pain killer Subsys® for his general pain relief and who subsequently suffered addiction and serious side effects, was preempted by the federal Food, Drug and Cosmetic Act (FDC Act). The court found preemption as to the negligence and inadequate warning claims arising from "off-label" promotion of the opioid. However, the FDC Act did not preempt his negligent misrepresentation, fraud, consumer protection, false advertising, and design defect claims (Kelley v. Insys Therapeutics, Inc., January 25, 2019, Carr, J.).

Patient use and side effects. An Ohio patient began taking Subsys in September, 2013 when his pain management doctor recommended it to treat the pain in his lower back, knee, and carpal tunnel. Subsys is a potent painkiller which is allegedly stronger than morphine and heroin and was approved by the FDA in January, 2012 for the management of breakthrough cancer pain. Therefore, the patient’s prescription was for an "off-label" use. He became highly dependent on the drug, and in July, 2016, his wife found him in unresponsive and with respiratory failure from an accidental Subsys overdose. He also suffered hypoxia, aspiration pneumonia, renal failure, multi-organ system failure, liver failure, altered mental status, and stroke, and was hospitalized in intensive care until August, 2016.

He subsequently filed a products liability suit against the drug manufacturer, Insys Therapeutics, Inc., citing statutory and common-law strict liability claims and common-law claims for negligence, negligent misrepresentation, fraud, false advertising, and unjust enrichment, as well as claims pursuant to the Ohio Consumer Sales Practices Act (OCSPA). The manufacturer responded with their motion to dismiss primarily based on FDC Act preemption.

Implied FDC Act preemption. The court noted that the FDC Act impliedly preempts claims based solely on off-label use and promotion. However, the court further clarified that not all claims involving allegations of off-label promotion are preempted: if independent state law grounds support such claims, then the FDC Act does not preempt them. The court examined the negligence claim and ruled that the FDC Act did in fact preempt that claim because the patient had alleged that the manufacturer breached a duty by selling Subsys in an "off-label" manner rather than for uses approved by the FDA.

Failure to warn claim preempted. Similarly, because the patient’s failure to warn claim was based on the manufacturer’s failure to warn of the increased risks and danger of harm inherent in Subsys for individuals without cancer—meaning, those using Subsys for an off-label purpose—the FDC Act again preempted the inadequate warning claims based on the same reasoning as the negligence claim. Accordingly, both claims were dismissed.

Independently grounded claims. The court next examined the claims for negligent misrepresentation, fraud, consumer protection, and false advertising, and determined that they relied on the independent ground that the manufacturer promoted Subsys in a fraudulent way. Here, the patient alleged more than off-label promotion, alleging that the manufacturer willfully deceived him and others as to the health risks and consequences of the use of Subsys, failed to disclose material facts regarding the safety of Subsys, and misrepresented its appropriate use. Because off-label promotion was not the basis for these claims, the FDC Act did not preempt them, and, because the design defect claim alleged more than off-label promotion, it too was not preempted.

The case is No.: 3:18-cv-01774-JGC.

Attorneys: Dennis P. Mulvihill (Wright & Schulte LLC) for Michael Kelley and Julie Kelley. Adam P. Schwartz (Carlton Fields Jorden Burt, PA) and Gerald R. Kowalski (Spengler Nathanson PLL) for Insys Therapeutics, Inc., Insys Pharma, Inc. and Insys Manufacturing, LLC.

Companies: Insys Therapeutics, Inc.; Insys Pharma, Inc.; Insys Manufacturing, LLC

MainStory: TopStory CaseDecisions FDCActNews AdvertisingNews DrugBiologicNews LabelingNews PrescriptionDrugNews PLDrugNews SafetyNews OhioNews

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