Articles Posted in Drugs & Biotech

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Arla, a Denmark-based global dairy conglomerate, launched a $30 million advertising campaign aimed at expanding its U.S. cheese sales, branded “Live Unprocessed.” The ads assure consumers that Arla cheese contains no “weird stuff” or “ingredients that you can’t pronounce,” particularly, no milk from cows treated with recombinant bovine somatotropin (“rbST”), an artificial growth hormone. The flagship ad implies that milk from rbST-treated cows is unwholesome. Narrated by a seven-year-old girl, the ad depicts rbST as a cartoon monster with razor-sharp horns. Elanco makes the only FDA-approved rbST supplement. Elanco sued, alleging that the ads contain false and misleading statements in violation of the Lanham Act. Elanco provided scientific literature documenting rbST’s safety, and evidence that a major cheese producer had decreased its demand for rbST in response to the ads. The Seventh Circuit affirmed the issuance of a preliminary injunction, rejecting arguments that Elanco failed to produce consumer surveys or other reliable evidence of actual consumer confusion and did not submit adequate evidence linking the ad campaign to decreased demand for its rbST. Consumer surveys or other “hard” evidence of actual consumer confusion are unnecessary at the preliminary-injunction stage. The evidence of causation is sufficient at this stage: the harm is easily traced because Elanco manufactures the only FDA-approved rbST. The injunction is sufficiently definite and adequately supported by the record and the judge’s findings. View "Eli Lilly and Co. v. Arla Foods USA, Inc." on Justia Law

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Under the Food, Drug, and Cosmetics Act, “Class III” medical devices are those that support or sustain human life, that are of substantial importance in preventing impairment of human health, or that present a potential, unreasonable risk of illness or injury, 21 U.S.C. 360c(a)(1)(A), and must undergo scientific and regulatory review before they are marketed. Henson, a diabetic, sent the Food and Drug Administration requests under the Freedom of Information Act (FOIA), 5 U.S.C. 552, seeking documents related to the premarket approval process for a glucose monitoring system, claiming to have observed deficiencies with his monitor. The agency produced documents. Henson was not satisfied with the response, so he sued. The agency reprocessed Henson’s requests and provided him with responsive documents totaling 8,000 pages plus a “Vaughn index,”listing each redacted or withheld document cross-referenced with the FOIA exemption that the FDA asserted was applicable. The FDA explained that it did not respond to all of Henson’s requests because the requested materials were either outside of the Act’s scope, duplicative of Henson’s other requests, or available on the agency’s website. The Seventh Circuit affirmed the rejection of Henson’s suit on summary judgment. The agency’s search for responsive documents and the application of exemptions were reasonable. View "Henson v. Department of Health and Human Services" on Justia Law

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Dalton’s doctor implanted Teva’s Intrauterine Device (IUD) in her uterus for long-term birth control. Dalton became dissatisfied with the IUD and asked her doctor to remove it. The doctor did so by grasping its strings with a forceps and pulling the IUD down. A piece broke off either before or during the removal and lodged in her uterus. Dalton’s doctor advised that removing the remaining portion of the IUD would require a hysterectomy. Dalton sued Teva, asserting “strict liability,” “strict products liability failure to warn,” and “manufacturer’s defect.” Dalton failed to timely disclose any expert witness and serve the expert witness report required by FRCP 26(a)(2). The district court granted Teva summary judgment. The Seventh Circuit affirmed. Claims under the Indiana Products Liability Act, which governs all consumer actions against a manufacturer for physical harm caused by a product, require proof that the injury was proximately caused by whatever defect or breach of duty underlies the claim. The Act requires expert testimony when an issue “is not within the understanding of a lay person.” Dalton did not establish how a lay juror faced with a broken IUD could identify the cause of the break—maybe the IUD was damaged after coming into the possession of the physician, maybe human error resulted in damage during implantation or removal. This case is far removed from situations in which a causation issue is so obvious that a plaintiff may forgo expert testimony. View "Dalton v. Teva North America" on Justia Law

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Joas underwent knee replacement at a Wisconsin hospital and received a Zimmer NexGen Flex implant. Within a few years, he began experiencing pain in his new knee. X-rays confirmed that the implant had loosened and required a surgical fix. Joas brought multiple claims against Zimmer. His case was transferred to a multidistrict litigation, where it was treated as a bellwether case. Applying Wisconsin law, the presiding judge granted Zimmer summary judgment. The Seventh Circuit affirmed, declining to reinstate a single claim based on a theory of inadequate warning. The court predicted that the Wisconsin Supreme Court would follow the majority of states and adopt the “learned intermediary” doctrine, which holds that the manufacturer of a medical device has no duty to warn the patient as long as it provides adequate warnings to the physician. In addition, Joas has not identified any danger that Zimmer should have warned him about. Joas has no evidence to support causation. Joas did not select the NexGen Flex implant, so the information would not have caused him to change his behavior. His doctor selected the product, making his decision based on his own past experience, not on any marketing materials or information provided by Zimmer. View "Joas v. Zimmer, Inc." on Justia Law

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Testosterone replacement drugs have been FDA-approved prescription drugs for more than 60 years. In recent years, manufacturers have found a new market: older men. Numerous lawsuits were filed against manufacturers alleging that the drugs increase health risks. Cases alleging that the manufacturers failed to warn doctors and patients adequately about the risks, citing state product-liability laws, were consolidated for pretrial proceedings. The district court granted a motion to dismiss brought by Depo-T’s manufacturer, finding the failure-to-warn claims preempted by federal law. The court stated that DepoT’s manufacturers could not change their drug labels to add warnings because FDA regulations prohibit them from “making a unilateral labeling change.” The Seventh Circuit affirmed. In Wyeth v. Levine, the Supreme Court held that claims against a manufacturer of a brand-name prescription drug for failure to warn adequately of the drug’s dangers were not preempted by federal law.; in PLIVA v. Mensing, the Court held that such failure-to-warn claims against manufacturers of generic drugs are preempted. The Court cited the different regulatory requirements and processes for approving and labeling prescription drugs. Depo-T “does not fit neatly into the colloquial dichotomy between brand-name and generic drugs” so the Seventh Circuit focused on whether the FDA approved public sale of its drugs through the “new drug application” or through the “abbreviated new drug application” (ANDA) and stated that the FDA-approved label defines an ANDA holder’s duty of sameness and the lines of federal preemption. View "Guilbeau v. Pfizer Inc." on Justia Law

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The FDA approved Depakote for treating seizures, migraine headaches, and conditions associated with bipolar disorder. Physicians may prescribe it for other "off-label" uses, but a drug’s manufacturer can promote it only as suitable for uses the FDA has found safe and effective. Abbott, which makes Depakote, encouraged intermediaries to promote Depakote’s off-label uses for ADHD, schizophrenia, and dementia, hiding its own involvement. Abbott pleaded guilty to unlawful promotion and paid $1.6 billion to resolve the criminal case and False Claims Act suits, 31 U.S.C. 3729–33. Welfare-benefit plans that paid for Depakote’s off-label uses sought treble damages under the Racketeer Influenced and Corrupt Organizations Act, 18 U.S.C. 1964, for a class comprising all third-party payors. Following a remand, the court dismissed the suit on the ground that the plaintiffs could not show proximate causation, a RICO requirement. The Seventh Circuit affirmed, reasoning that the Payors are not the most directly, injured parties. Patients suffer if they take Depakote when it is useless and may be harmful and costly. Physicians also may lose, though less directly. Because some off-label uses of Depakote may be beneficial to patients, it is hard to treat all off-label prescriptions as injurious to the Payors; if they did not pay for Depakote they would have paid for some other drug. In addition, some physicians were apt to write off-label prescriptions whether or not Abbott promoted such uses. Calculation of damages would require determining the volume of off-label prescriptions that would have occurred absent Abbott’s unlawful activity. View "Sidney Hillman Health Center of Rochester v. Abbott Laboratories, Inc." on Justia Law

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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