Justia Products Liability Opinion SummariesArticles Posted in US Court of Appeals for the Eleventh Circuit
Terrance Nelson Cates v. Zeltiq Aesthetics, Inc.
This appeal arises from a dispute about CoolSculpting, a medical device intended to minimize the appearance of fat. When Plaintiff tried CoolSculpting, he developed a rare condition called Paradoxical Adipose Hyperplasia (“PAH”), which enlarges the targeted fat tissue. Needless to say, Plaintiff was unhappy that CoolSculpting maximized the fat he wanted to minimize. So Plaintiff sued Zeltiq Aesthetics, Inc., the manufacturer of the CoolSculpting system, for failure to warn and design defects under Florida law. The district court granted Zeltiq summary judgment. On failure to warn, the district court concluded that Zeltiq’s warnings about PAH were adequate as a matter of law. On design defect, the court determined that Plaintiff failed to provide expert testimony that the risk of CoolSculpting outweighed its utility. Plaintiff challenged both of the district court’s rulings on appeal. The Eleventh Circuit affirmed. The court explained that Zeltiq warned medical providers in its user manual and training sessions about the exact condition Plaintiff experienced: PAH is an increase of adipose tissue in the treatment area that may require surgery to correct. Accordingly, the district court properly concluded Zeltiq’s warnings were adequate as a matter of law. Further, the court held that it is convinced that Plaintiff’s defect claim fails under either test. View "Terrance Nelson Cates v. Zeltiq Aesthetics, Inc." on Justia Law
John D. Carson v. Monsanto Company
Plaintiff used Roundup on his lawn for thirty years until 2016, when he was diagnosed with malignant fibrous histiocytoma, a form of cancer. He sued Monsanto, Roundup’s manufacturer, in the district court. He alleged that Monsanto knew or should have known that Roundup was carcinogenic but did not warn users of that danger. The question on appeal is whether, under an express preemption provision, a federal agency action that otherwise lacks the force of law preempts the requirements of state law. The district court ruled that a provision of the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. Section 136v(b), expressly preempts some of Plaintiff’s claims under Georgia law because the Environmental Protection Agency had approved a label for Roundup that lacked a cancer warning and the Agency classifies Roundup’s main ingredient—glyphosate—as “not likely to be carcinogenic.” Plaintiff argued that his suit is not preempted. The Eleventh Circuit concluded that the question at issue must be answered by recourse to ordinary principles of statutory interpretation, and the court remanded this appeal to the panel to decide whether Plaintiff’s suit is preempted. The court explained that a conflict between a state-law rule that has the force of law and a federal agency rule that does not have the force of law is not the type of conflict between state and federal legal obligations that the Supremacy Clause addresses. But this reasoning does not extend to express-preemption cases the meaning of the express-preemption provision—not conflicting federal and state legal obligations—triggers preemption. View "John D. Carson v. Monsanto Company" on Justia Law
Mark Henderson v. Ford Motor Company
Plaintiff, through his estate, sued Ford Motor Company, inter alia, for wrongful death and product liability pursuant to the Alabama Extended Manufacturer’s Liability Doctrine (AEMLD). He alleged that a faulty seatbelt design in his 2003 Ford Mustang caused his fatal injury. At trial, the jury returned a verdict in favor of Ford. Plaintiff now appealed, arguing that the district court erroneously ruled on several evidentiary issues, a motion for judgment as a matter of law (JMOL), and a motion for a new trial. Ford filed a cross-appeal in anticipation of a possible reversal, challenging the district court’s denial of its motion to exclude expert testimony at trial. The Eleventh Circuit affirmed the rulings challenged by Plaintiff. As for Ford’s cross-appeal, the court dismissed for lack of standing. Here, the working seatbelt from the crash was admitted into evidence alongside expert testimony opining that the driver likely caused the excess webbing. A reasonable jury could have weighed this evidence against the evidence introduced by Plaintiff and “might reach different conclusions” about whether Plaintiff was contributorily negligent. Id. Therefore, JMOL is not proper, and the court affirmed the district court’s denial of Plaintiff’s motion. Further, the court explained that although Ford has identified cases where the court has addressed a victorious Plaintiff’s cross-appeal, the court is not bound by a prior decision’s sub silentio treatment of a jurisdictional question. View "Mark Henderson v. Ford Motor Company" on Justia Law
John D. Carson v. Monsanto Company
Plaintiff regularly used Roundup on his lawn for about 30 years until 2016. Around 2016, Plaintiff was diagnosed with malignant fibrous histiocytoma, which he believes was linked to the compound glyphosate, the main chemical ingredient in Roundup. Plaintiff filed suit against Monsanto, the manufacturer of Roundup. In his four-count complaint, Plaintiff alleged strict liability for a design defect under Georgia law (Count I); strict liability for failure to warn under Georgia law Count II); negligence under Georgia law (Count III); and breach of implied warranties under Georgia law (Count IV). On appeal, the Eleventh Circuit was tasked with deciding whether the district court erred in concluding that Plaintiff’s failure to warn claim was preempted under Federal Insecticide, Fungicide, and Rodenticide Ac (FIFRA) because the Environmental Protection Agency’s (EPA) had classified glyphosate as not likely to be carcinogenic to humans and approved the Roundup label. The Eleventh Circuit concluded it did and reversed the district court’s ruling. The court held that Plaintiff’s Georgia failure to warn claim is not preempted by the federal requirements under the FIFRA or the EPA actions pursuant to it. View "John D. Carson v. Monsanto Company" on Justia Law
Sheila A. Knepfle v. J & P Cycles, LLC, et al
Plaintiff appealed from the district court’s grant of summary judgment in favor of a mixed group of domestic and foreign corporations, (collectively, “the defendants”), in a product liability action stemming from a motorcycle accident and allegedly defective helmet. Plaintiff contended that the district court erroneously excluded the testimony of her expert witness, after finding his testimony based on novel and untested theories unreliable. In the district court proceedings, defendant HJC Corporation (“HJC”), a foreign corporation organized under the laws of, and principally operating within, South Korea, moved separately for summary judgment based on a lack of personal jurisdiction. The district court denied this motion as moot, after granting summary judgment to all the defendants on the merits. The Eleventh Circuit affirmed the district court’s grant of Defendants’ motion to exclude Plaintiff’s expert’s testimony. Because the district court properly excluded Plaintiff’s expert’s testimony, the court affirmed the district court’s grant of summary judgment in favor of Defendants. The court reversed its denial of HJC’s motion for summary judgment. The court concluded that the district court erred by failing to conduct a veil piercing or alter-ego analysis with respect to HJC and HJCA for personal jurisdiction purposes. The court agreed with HJC that the district court erred by failing to address HJC’s jurisdictional motion before reaching the merits of Defendants’ summary judgment motion. View "Sheila A. Knepfle v. J & P Cycles, LLC, et al" on Justia Law
Lalitha E. Jacob, MD v. Mentor Worldwide, LLC
Plaintiff received MemoryGel Silicone Gel Breast Implants made by Mentor Worldwide, LLC. After one of her implants ruptured, she sued Mentor pro se, alleging negligence and negligence per se, strict liability failure to warn, and strict liability manufacturing defect. The district court dismissed her complaint without prejudice and later dismissed her amended complaint with prejudice as preempted and foreclosed by Florida law. Plaintiff appealed the district court’s dismissal of the manufacturing defect claims in Counts I and III of her initial complaint. The Eleventh Circuit reversed the district court’s ruling and held that Plaintiff’s manufacturing defect claims are sufficiently pleaded to survive a motion to dismiss. The court explained that construing her pro se pleadings liberally, Plaintiff’s manufacturing defect claims are sufficiently pleaded to survive Mentor’s motion to dismiss. She plausibly alleged that Mentor violated a duty it owed to her, not the government. Specifically, she alleged that the implants’ manufacturing process differed from the specifications agreed to by the FDA and that Mentor used materials that differed from those approved by the FDA, violating both state law and the device-specific regulatory controls the FDA approved under 21 C.F.R. Section 820.30. These allegations are enough to state a plausible claim against Mentor under Rule 12(b)(6), and the district court erred by holding otherwise. View "Lalitha E. Jacob, MD v. Mentor Worldwide, LLC" on Justia Law
Donna Brown v. Philip Morris USA, Inc.
Plaintiff, a lifelong smoker, sued Philip Morris USA, Inc., seeking damages for the injuries she sustained as a result of smoking Philip Morris’s cigarettes, specifically her development of peripheral vascular disease (“PVD”), a debilitating disease that eventually required the amputation of both of her legs, among other injuries. A jury returned verdicts against Philip Morris for Brown’s claims for strict liability, negligence, fraudulent concealment, and conspiracy to fraudulently conceal, and awarded Brown $8,287,448 in compensatory damages and $9 million in punitive damages.Philip Morris appealed the District Court’s denial of its renewed motion for judgment as a matter of law on the fraud claims, arguing that Plaintiff presented insufficient evidence to show that she relied to her detriment on statements made by Philip Morris that concealed material information about the health effects or addictive nature of smoking, or that such reliance was a legal cause of her smoking-related disease.The Eleventh Circuit affirmed Plaintiff’s jury verdicts for her negligence and strict liability claims, but reversed and remanded on Plaintiff's fraud claims based on the reasoning in Prentice v. R.J. Reynolds Tobacco Co., No. SC20-291, 2022 WL 805951 (Fla. 2022). Engle-progeny plaintiffs bringing a fraudulent concealment or conspiracy to fraudulently conceal claim must prove reliance on one or more specific statements by an Engle defendant. Plaintiff relied on evidence of Philip Morris’s disinformation campaign, which is no longer sufficient under Prentice. View "Donna Brown v. Philip Morris USA, Inc." on Justia Law
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
Salinero v. Johnson & Johnson
Plaintiff and her husband filed suit against Ethicon and its parent company, Johnson & Johnson, in the Southern District of Florida for failure to warn of the adverse health consequences of an Artisyn YMesh implant. After defendants successfully moved for summary judgment, plaintiff and her husband appealed, asking the court to create a "financial bias" exception to the learned intermediary doctrine.The Eleventh Circuit affirmed and concluded that it was Erie bound to follow the decisions of the Florida courts. Without any indication from Florida's appellate courts that they would create a "financial bias" exception to the learned intermediary doctrine insofar as it applies to physicians, the court held that the learned intermediary doctrine is available and that, under the facts of this case, it plainly entitles defendants to summary judgment on the failure-to-warn claim. In this case, the treating physician was both aware of the risks surrounding the mesh implant and stood by his decision to use it to treat plaintiff's prolapse. The court explained that, under Florida law, an inadequate warning could not be the proximate cause of plaintiff's injuries and, therefore, the learned intermediary doctrine bars a failure-to-warn claim. View "Salinero v. Johnson & Johnson" on Justia Law
Cote v. Philip Morris USA, Inc.
The Eleventh Circuit affirmed the district court's order denying Philip Morris's motion for a new trial or to reduce the punitive damages award in favor of Judith Berger, concluding that the punitive damages award is not unconstitutionally excessive and does not violate due process. In this case, a jury awarded Judith $6.25 million in compensatory damages and approximately $20.7 million in punitive damages for smoking-related injuries. The court concluded that Philip Morris's argument that the punitive damages award is unconstitutionally excessive is not barred by the court's decision in Cote I. The court also concluded that the punitive damages award is not unconstitutionally excessive in light of the degree of reprehensibility of Philip Morris's conduct; the ratio of the punitive damages award to the actual or potential harm suffered by Judith; and the difference between the punitive damages award and the civil penalties authorized or imposed in comparable cases. View "Cote v. Philip Morris USA, Inc." on Justia Law