Justia U.S. 11th Circuit Court of Appeals Opinion SummariesArticles Posted in Products Liability
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
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
Harris v. R.J. Reynolds Tobacco Co.
In this "Engle progeny" case, where Florida-resident smokers sought recovery from tobacco companies for cigarette-related injuries, the Eleventh Circuit reversed the district court's denial of defendants' motion for judgment in accordance with the verdict. Plaintiff brought an individual Phase III suit on behalf of her deceased husband, seeking the benefit of the Phase I jury's findings, arguing that her husband was a member of the original class based on two medical conditions.The court concluded that plaintiff's husband had no medical condition that both was caused by cigarette addiction and manifested on or before the class cut-off date. Therefore, plaintiff's husband was not an Engle class member, and nothing in the Florida Supreme Court's treatment of Angie Della Vecchia, one of the three representative plaintiffs, requires the court to conclude otherwise. Furthermore, because plaintiff's husband was not a class member, Florida courts would not give preclusive effect to the Engle Phase I findings in this case. Neither did the court under the Full Faith and Credit Act. Without the preclusive effect of the Phase I findings, plaintiff failed to prove essential elements of her claims. In this case, plaintiff failed to demonstrate that the tobacco-company defendants acted tortiously, relying only on the Phase I findings. View "Harris v. R.J. Reynolds Tobacco Co." on Justia Law
Crawford v. ITW Food Equipment Group, LLC
Plaintiff filed suit against FEG for negligent product design after his arm was amputated when it came into contact with the unguarded blade of one of FEG's commercial meat saws, the Hobart Model 6614. Plaintiff was working as the meat-market manager at a supermarket at the time he sustained his injuries. A jury awarded plaintiff and his wife $4,050,000.The Eleventh Circuit affirmed the district court's evidentiary determinations, holding that the district court did not abuse its broad discretion in rejecting FEG's Daubert challenge to the testimony of plaintiff's expert regarding inadequate testing. The court also held that the district court did not abuse its discretion in finding that allowing the jury to consider the expert's supplemental affidavit was harmless. The court further held that there was sufficient evidence introduced at trial to satisfy Florida's risk utility test and the evidence was sufficient to uphold a verdict of negligent design. Furthermore, the evidence introduced at trial was sufficient to support a finding that FEG's saw failed the consumer expectations test. Although it may have been error for the district court not to issue FEG's requested Florida state-of-the-art instruction, the court held that it was not reversible error. Finally, the district court did not abuse its broad discretion by admitting summaries of OSHA reports of fatalities and catastrophes. View "Crawford v. ITW Food Equipment Group, 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
Cote v. Philip Morris USA, Inc.
The 1994 “Engle” Florida class action against major cigarette manufacturers, was decertified, but “Phase I findings” concerning the defendants’ conduct may be used in individual suits. Berger sued Philip Morris for smoking-related injuries. A jury awarded Berger compensatory and punitive damages. The Eleventh Circuit affirmed the denial of Philip Morris’s motions for a new trial based on improper closing argument, and for judgment as a matter of law on all claims based on due process and preemption principles. Eleventh Circuit precedent holds, categorically, that use of Phase I findings to establish Engle-progeny tort claims is constitutionally permissible. The court reversed judgment as a matter of law, in favor of Philip Morris, on intentional tort claims and remanded for the entry of judgment in Plaintiff’s favor on fraudulent concealment and conspiracy to fraudulently conceal claims and for reinstatement of the punitive damages award. Engle-progeny concealment claims arise from a sustained effort to hide the truth about the health hazards of smoking. Florida courts hold that Engle-progeny plaintiffs are not required to show reliance on a specific statement. Berger’s testimony that peer pressure influenced her decision to start smoking and that she chose her cigarette brand based on personal preferences did little to rebut the reasonable inference that Philip Morris’s disinformation campaign confused her about the health hazards of smoking; a reasonable juror could have concluded that if she had known the whole truth about smoking, she would have quit. View "Cote v. Philip Morris USA, Inc." on Justia Law