Justia U.S. 11th Circuit Court of Appeals Opinion Summaries

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

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

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

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

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

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

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

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

Plaintiff filed suit against defendants for unintentional and intentional torts arising from the death of her mother. Plaintiff alleged that her mother's illnesses were caused by her addiction to cigarettes manufactured by defendants. The jury found for plaintiff and defendants appealed.The Eleventh Circuit affirmed the district court's judgment and rejected defendants' due process arguments because, consistent with precedent, the use of the Engle findings to establish the conduct elements of the progeny plaintiffs' tort claims was a constitutionally permissible application of res judicata. The court rejected defendants' contention that their Seventh Amendment rights were violated because the court concluded that the jury was not asked or required to reexamine the Engle findings. The court also rejected defendants' contention that the damages award should have been apportioned based on the mother's comparative fault, because the district court neither misinterpreted nor misapplied Florida law and plaintiff did not waive her statutory right to full, unapportioned damages. View "Searcy v. R.J. Reynolds Tobacco Co." on Justia Law

The Eleventh Circuit affirmed the district court's judgment against three tobacco companies in favor of plaintiff for compensatory and punitive damages. This case was one of thousands of Engle progeny suits initiated by smokers in Florida against tobacco companies and remained pending for several years while awaiting resolution of other appeals. With the benefit of those decisions, the court carefully reviewed the record and considered the parties' written and oral arguments, affirming the judgment awarded to plaintiff on her claims of negligence, strict liability, fraudulent concealment, and civil conspiracy. The court held that the district court's instructional error was harmless; the district court did not abuse its discretion in denying the companies' motion for mistrial after plaintiff's medical incident; the court rejected the companies' challenges to the punitive damages award; and the court rejected challenges to the district court's comparative fault findings and federal preemption and due process limits on the Engle jury's findings. View "Burkhart v. R.J.Reynolds Tobacco Co." on Justia Law