Justia Drugs & Biotech Opinion SummariesArticles Posted in US Court of Appeals for the Eleventh Circuit
Blackburn v. Shire US Inc.
Blackburn, who has Crohn’s disease, was prescribed LIALDA, an anti-inflammatory drug specifically aimed at the gut. LIALDA is not FDA-approved to treat Crohn’s, but it is approved to treat ulcerative colitis, Crohn’s “sister” disease. Blackburn was subsequently diagnosed with advanced-stage kidney disease. Blackburn does not claim that Shire, LIALDA’s manufacturer failed to warn of the risk of kidney disease; he and his doctor knew that the drug might impair his kidney function. Blackburn contends that Shire should have more explicitly warned his doctor about how regularly to monitor his kidney function after prescribing LIALDA. He contends that, if LIALDA’s warning label had been better, his physician would have discovered the effect on his kidneys sooner and prevented his injury.The Eleventh Circuit identified two unsettled, dispositive questions of Alabama law, which it certified to the state’s highest court. May a pharmaceutical company’s duty to warn include a duty to provide instructions about how to mitigate warned-of risks? May a plaintiff establish that an improper warning caused his injuries by showing that his doctor would have adopted a different course of testing or mitigation, even though he would have prescribed the same drug? View "Blackburn v. Shire US Inc." on Justia Law
Catalyst Pharmaceuticals, Inc. v. Becerra
The Eleventh Circuit held that the statutory phrase "same disease or condition" contained in the Orphan Drug Act is not ambiguous. This case arose from Catalyst's lawsuit against the FDA alleging multiple violations of the Administrative Procedure Act related to its approval of Ruzurgi, which Catalyst claims violated the company's exclusivity of its own drug, Firdapse, to treat Lambert-Eaton Myasthenic Syndrome. Jacobus intervened shortly afterwards. The court concluded that the district court erred by finding this statutory phrase ambiguous and then deferring to the FDA's interpretation of it. Accordingly, the court reversed the district court's grant of summary judgment in favor of defendants and Jacobus and remanded with instructions to grant summary judgment in favor of Catalyst. View "Catalyst Pharmaceuticals, Inc. v. Becerra" on Justia Law
Belcher Pharmaceuticals, LLC v. Hospira, Inc.
Belcher filed suit against its competitor, Hospira, under the Lanham Act, alleging that the labels of two of Hospira's drug products falsely implied that the products and their uses were FDA-approved, and that Hospira's misrepresentations allowed it to cut into the sales of Belcher's drug. The district court granted summary judgment to Hospira.The Eleventh Circuit concluded that the Lanham Act can peacefully coexist with the Food, Drug, and Cosmetic Act for many drug-related claims, including this one. Although Belcher's Lanham Act claim was not precluded by the FDCA, the court concluded that it also was not supported by evidence of any misleading statements on Hospira's labels. The court explained that, because Belcher never showed that Hospira made representations that misled consumers about the FDA's approval of its drug products, Hospira is entitled to summary judgment. Accordingly, the court affirmed the district court's judgment. View "Belcher Pharmaceuticals, LLC v. Hospira, Inc." on Justia Law
United States v. US Stem Cell Clinic, LLC
The FDA filed suit against the Clinic, alleging that the Clinic's stem cell procedure violates the Federal Food, Drug, and Cosmetics Act. The Clinic offers a procedure, which purportedly treats all kinds of chronic conditions, in which they remove fat tissue from a patient, isolate the portion containing stem cells, and inject that portion back into the patient. The district court granted summary judgment for the FDA and enjoined the Clinic from offering its procedure until it can demonstrate to the FDA that its stem cell therapy is safe and effective.The Eleventh Circuit affirmed, concluding that the Clinic's stem cell procedure does not fall within the "same surgical procedure" exception or the "361 HCT/P" exception to regulation under the FDCA. The procedure does not fall within the same surgical procedure exception because the biological material implanted into the patient is not the same as that removed. Furthermore, the procedure does not fall within the 361 HCT/P exception because the Clinic intends the stem cells to perform functions after the procedure beyond the basic functions the stem cells performed prior to the procedure. View "United States v. US Stem Cell Clinic, LLC" on Justia Law
Hubbard v. Bayer Healthcare Pharmaceuticals Inc.
In 2012, 41-year-old Karen Hubbard suffered a catastrophic stroke caused by a blood clot to her brain--a venous sinus thrombosis, a type of venous thromboembolism (VTE). She had been taking Beyaz, a birth control pill manufactured by Bayer. While she first received a prescription for Beyaz on December 27, 2011, Karen had been taking similar Bayer birth control products since 2001. The pills are associated with an increased risk of blood clots. The Beyaz warning label in place at the time of Karen’s Beyaz prescription warned of a risk of VTEs and summarized studies.The Eleventh Circuit affirmed summary judgment in favor of Bayer. Georgia’s learned intermediary doctrine controls this diversity jurisdiction case. That doctrine imposes on prescription drug manufacturers a duty to adequately warn physicians, rather than patients, of the risks their products pose. A plaintiff claiming a manufacturer’s warning was inadequate bears the burden of establishing that an improved warning would have caused her doctor not to prescribe her the drug in question. The Hubbards have not met this burden. The prescribing physician testified unambiguously that even with the benefit of the most up-to-date risk information about Beyaz, he considers his decision to prescribe Beyaz to Karen to be sound and appropriate. View "Hubbard v. Bayer Healthcare Pharmaceuticals Inc." on Justia Law
Debernardis v. IQ Formulations, LLC
The Eleventh Circuit vacated the district court's dismissal of plaintiffs' claims against defendants based on lack of standing. The court held that plaintiffs plausibly alleged that they suffered an economic loss when they purchased supplements that were worthless because the Federal Food, Drug, and Cosmetic Act (FDCA) prohibited sale of the supplements. The court explained that Congress, through the FDCA and the Dietary Supplement Health and Education Act (DSHEA), banned adulterated supplements to protect consumers from ingesting products that Congress judged to be insufficiently safe.In this case, the complaint's allegations establish that plaintiffs purchased adulterated dietary supplements that they would not have purchased had they known that sale of the supplements was banned. The court also held that plaintiffs sufficiently alleged sufficient facts to show that their injuries were fairly traceable to defendants. Accordingly, plaintiffs had Article III standing to pursue their claims. View "Debernardis v. IQ Formulations, LLC" on Justia Law
Taylor v. Mentor Worldwide, LLC
After plaintiff filed suit against Mentor and Mentor Corporation for compensatory and punitive damages for injuries she suffered as a result of the surgical implantation of a polypropylene mesh sling manufactured by Mentor to treat her stress urinary incontinence, a jury found Mentor liable and awarded $400,000 in compensatory and $4 million in punitive damages. The district court upheld the jury's verdict with respect to liability and compensatory damages, but concluded that the punitive damages award exceeded Florida's statutory cap, reducing the punitive damages award to $2 million.The Eleventh Circuit affirmed, holding that the trial court acted well within the bounds of its discretion in allowing the jury to consider an expert's testimony relating to specific causation and Mentor was not entitled to judgment as a matter of law. The court also held that, in this case, which was focused on the physiological response to a design defect in a medical device, the dose-response relation was not implicated and there was no abuse of discretion in admitting the testimony. The court considered Mentor's remaining evidentiary challenges and held that the district court at no point exceeded the bounds of its discretion. Therefore, Mentor was not entitled to a new trial. Finally, the court affirmed the district court's reduction of the punitive damages award where evidence that Mentor knew of a high incidence of injury was not sufficient for finding a specific intent to harm. View "Taylor v. Mentor Worldwide, LLC" on Justia Law
United States v. Hi-Tech Pharmaceuticals, Inc.
This case arose from the FDA's seizure from Hi-Tech a substantial quantity of products containing 1,3-dimethylamylamine or DMAA, which is used in fitness products aimed at bodybuilders and other athletes. The district court granted the FDA's motion for summary judgment, holding that the seizure of DMAA was both substantively and procedurally proper.The Eleventh Circuit affirmed and held that DMAA is not an "herb or other botanical" and is not a "constituent" of an herb or other botanical under the Dietary Supplement Health and Education Act of 1994. Furthermore, the court held that DMAA is not generally recognized by qualified experts, as adequately shown through scientific procedures, to be safe under the conditions of its intended use. The court also held that the district court did not abuse its discretion when it declined to reopen discovery, and Hi-Tech was afforded the full range of procedural due process available in federal court. View "United States v. Hi-Tech Pharmaceuticals, Inc." on Justia Law
Hi-Tech Pharmaceuticals, Inc. v. HBS International Corp.
Hi-Tech filed suit alleging that the label of a protein-powder supplement distributed by HBS misled customers about the quantity and quality of protein in each serving, violating both the Georgia Uniform Deceptive Trade Practices Act and the federal Lanham Act. The district court dismissed the complaint.The Eleventh Circuit affirmed the district court's dismissal of the state law claim because it was preempted by the Food, Drug, and Cosmetics Act (FDCA). However, the court reversed the district court's dismissal of the Lanham Act claim, and rejected HBS's arguments that the FDCA barred the claim under the Lanham Act. In this case, Hi-Tech's Lanham Act claim would only require a court to determine whether the protein-content representations on the HexaPro label were misleading to consumers in the context of the label's failure to specify the sources of the nitrogen measured by the federal test. Therefore, this inquiry would not require a court to interpret or apply the FDCA to determine whether or not the marketing of the supplement was deceptive. View "Hi-Tech Pharmaceuticals, Inc. v. HBS International Corp." on Justia Law
Jones Total Health Care Pharmacy, LLC v. DEA
The Eleventh Circuit denied the petition for review of the DEA's denial of Jones Pharmacy and SND Healthcare's application for certificates of registration to dispense controlled substances under the Controlled Substances Act (CSA), 21 U.S.C. 801 et seq. The court held that substantial evidence supported the DEA's determination that Jones Pharmacy's owner did not credibly accept full responsibility; the DEA's refusal to consider Jones Pharmacy's remedial measures did not render its decision arbitrary or capricious in this case; and the chosen sanction was not arbitrary or capricious. View "Jones Total Health Care Pharmacy, LLC v. DEA" on Justia Law