Justia Drugs & Biotech Opinion Summaries

Articles Posted in US Court of Appeals for the Seventh Circuit
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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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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