Justia Drugs & Biotech Opinion Summaries

Articles Posted in U.S. Court of Appeals for the Seventh Circuit
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The district court certified eight classes, consisting of persons in Illinois and Missouri who take eye drops manufactured by six pharmaceutical companies for treatment of glaucoma. Plaintiffs claimed that the defendants’ eye drops are unnecessarily large and wasteful, in violation of the Illinois Consumer Fraud Act, 815 ILCS 505/1, and the Missouri Merchandising Practices Act, Mo. Rev. Stat. 407.010, so that the price of the eye drops is excessive and that the large eye drops have a higher risk of side effects. There was no claim that members of the class have experienced side effects or have been harmed because they ran out of them early. The Seventh Circuit vacated with instructions to dismiss. The court noted possible legitimate reasons for large drops, the absence of any misrepresentation or collusion, and that defendants’ large eye drops have been approved by the FDA for safety and efficacy. “You cannot sue a company and argue only ‘it could do better by us,’” nor can one bring a suit in federal court without pleading that one has been injured. The plaintiffs allege only “disappointment.” View "Eike v. Allergan, Inc." on Justia Law

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Wagner, a licensed attorney proceeding pro se, took both brand‐name and generic hormone therapy drugs as prescribed by her gynecologist to treat her post‐menopausal endometrial hyperplasia. After taking the drugs, Wagner developed breast cancer. Wagner sued multiple pharmaceutical companies that designed, manufactured, promoted and distributed the drugs she took, asserting Wisconsin state law tort claims, all based upon allegations that the defendants sold dangerous products and failed to adequately warn of their risks. Defendants moved for Rule 12(c) judgment on the pleadings, arguing that federal law preempted Wagner’s claims. In response, Wagner asserted, for the first time, that the defendants delayed updating their generic brand labels to match the updated, stricter labels on the brand‐name drug. The district judge granted the motion, finding that the Food, Drug, and Cosmetics Act, 21 U.S.C. 301, preempted the state law claims. The Seventh Circuit affirmed: Wagner’s complaint lacked the requisite factual allegations to support a failure to update theory and federal law preempts her Wisconsin state‐law claims. View "Wagner v. Teva Pharmaceuticals USA, Inc." on Justia Law

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West Virginia sued pharmaceutical distributors, seeking to hold them liable for contributing to the state’s epidemic of prescription drug abuse. The complaint alleged that certain pharmacies, “pill mills,” knowingly provided citizens with hydrocodone, oxycodone, codeine, and other prescription drugs, not for legitimate uses, but to fuel and profit from their addictions. The state contends that those pharmacies ordered drugs in quantities so large that the distributors should have known they would be used for illicit purposes. H.D. Smith, a distributor, had a general commercial liability insurance policy issued by Cincinnati Insurance. The policy covered damages that H.D. Smith became legally obligated to pay “because of bodily injury,” defined as “bodily injury, sickness or disease sustained by a person, including death.” “[D]amages because of bodily injury” include “damages claimed by any person or organization for care, loss of services or death resulting at any time from the bodily injury.” Cincinnati refused to defend the suit and obtained a declaratory judgment. The Seventh Circuit reversed summary judgment. The plain language of the policy requires Cincinnati to defend a suit brought by a plaintiff to recover money paid to care for someone who was injured by H.D. Smith. West Virginia’s suit fits that description. View "Cincinnati Ins. Co. v. H.D. Smith, LLC." on Justia Law

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At his Reedsville, Wisconsin home, Dessart manufactured and sold products containing the active chemical ingredients in numerous prescription drugs, offering them for sale online with the disclaimer “for research only” to evade FDA oversight. After receiving an anonymous tip, investigating Dessart’s website, and intercepting three packages connected to Dessart’s operation, agents obtained a warrant, conducted a controlled delivery, and search Dessart’s house. He was convicted of violating the Food, Drug, and Cosmetic Act, 21 U.S.C. 331, with the intent to defraud or mislead the agency, which converted his violations from strict-liability misdemeanors into specific-intent felonies. The Seventh Circuit affirmed, rejecting arguments that the FDA’s investigator lied in procuring a search warrant and the warrant otherwise lacked probable cause; the government’s evidence was insufficient to prove that he acted with deceptive intent; and the district court erred in instructing the jury on the definition of “prescription drug.” The evidence of Dessart’s intent to mislead the FDA was ample and easily sufficient to support the jury’s verdict. View "United States v. Dessart" on Justia Law