Pennsylvania court dismisses off-label promotion claims as preempted

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A recent opinion out of the Philadelphia Court of Common Pleas reinforces the notion that claims asserted by private plaintiffs based on alleged off-label promotion of FDA regulated medications are preempted by federal law. See Caltagirone v. Cephalon, Inc., 2017 WL 1135576 (Pa. C.P. March 23, 2017).

The case involved Actiq, an opioid medication that was approved by the FDA in 1998 to treat cancer pain.  Actiq is a form of Fentanyl and is highly addictive.  The decedent, Joseph Caltagirone, began treatment with Dr. Thomas Barone for migraine headaches in 2005 and was prescribed Actiq from 2005 through 2011.  The prescription of Actiq for the pain of migraines was a known off-label use.  Mr. Caltagirone was first admitted to a facility for detoxification in April, 2006, and was in an out of drug treatment programs during the next four years for addictions to multiple schedule II opiates and other illicit drugs.  Mr. Caltagirone died on May 15, 2014 at age 39 of

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Expert Drowns in Whirlpool

On May 9, Judge Amy St. Eve of the United States District Court for the Northern District of Illinois (i) denied certification to various classes of consumers who purchased allegedly defective Whirlpool ovens, and (ii) excluded the opinions of Albert de Richemond, plaintiffs’ expert for proof of a common defect among theRead the full article →