Justia U.S. 6th Circuit Court of Appeals Opinion Summaries

Payne sued Novartis for failing to warn her doctor that two of the drugs it manufactures, Aredia and Zometa, could cause serious damage to a patient’s jaw bones. The drugs are given intravenously, most often to patients with cancerous conditions, and are effective in preventing pathological fractures and other bone pains. Payne took both in 1999-2001 and had to have part of her jaw removed in 2007 because of osteonecrosis, which results in the gums being eaten away until the bone is exposed The connection between the drugs and the condition began to come to light to the medical community in the early 2000’s. The district court entered summary judgment for Novartis. The Sixth Circuit reversed. Under Tennessee law, the question of whether Novartis’s failure to warn was a cause of Payne’s injuries is for a jury to determine. Payne’s testimony, combined with that of her doctor, could establish a sufficient causal link between Novartis’s failure to warn and Payne’s jaw death. A reasonable jury could conclude that Payne would not have taken Aredia or Zometa had her doctor warned her of the risk View "Payne v. Novartis Pharm. Corp." on Justia Law

Lee was injured while shooting a revolver made by Smith & Wesson. In his product liability suit alleging a defect in the firearm, the only expert evidence regarding how a defect in the firearm could have caused the injury was excluded because the expert’s theory was not consistent with aspects of plaintiff’s own memory of what happened. Lee reserved the right to challenge that evidentiary decision and stipulated to dismissal. The Sixth Circuit reversed and remanded. Smith & Wesson identified no judicial admission on the part of Lee in his represented status as plaintiff. Lee as a witness testified as to what he remembered. A tort plaintiff should be able to testify honestly to his memory of what happened and still have his lawyer argue that on the evidence as a whole it is more probable than not that the memory was faulty. If no jury could reasonably conclude that the plaintiff’s memory was faulty, dismissal would be warranted. View "Lee v. Smith & Wesson Corp." on Justia Law

In 1957, the FDA approved propoxyphene for the treatment of mild to moderate pain, under the trade name Darvon. In 1972, the manufacturer obtained FDA approval to market another product combining propoxyphene with acetaminophen, under the name Darvocet. Because the new drug application (NDA) process is onerous, Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984, (Hatch-Waxman Act) to make available more low cost generic drugs. Generic drugs require an abbreviated new drug application (ANDA) showing that the drug is equivalent to and that labeling proposed is the same approved for the brand-name drug. Several companies obtained approval to market generic versions of Darvon and Darvocet. Complaints about perceived risks associated with propoxyphene began in 1978; eventually the United Kingdom withdrew it from the market. Two FDA advisory committees recommended withdrawal from the market, but the FDA ordered the NDA holder to change the label to include “Black Box” warnings and to undertake a clinical trial to assess the risks of a particular cardiac complication. In 2010, the FDA determined that the risks of propoxyphene outweighed its benefits and ordered its removal from the market. Plaintiffs in 68 consolidated cases alleged that they ingested propoxyphene products prior to its withdrawal and that manufacturers continued marketing propoxyphene after they knew or should have known that risks exceeded benefits. The district court dismissed. The Sixth Circuit affirmed, except with respect to one plaintiff.View "Germain v. Teva Pharm, USA, Inc" on Justia Law

Mylan manufactures generic Duragesic, a drug to treat pain. It consists of fentanyl (active ingredient) and a “transdermal system” (patch that delivers the drug). Kelly’s estate claimed that the patch caused Kelly’s death by delivering an excessive amount of fentanyl, alleging strict products liability, negligence, misrepresentation, fraud, warranty, and violation of the Michigan Consumer Protection Act. The district court dismissed, based on Mich. Comp. Laws 600.2946(5), which provides that “drug” manufacturers are immune from suit. The Sixth Circuit reversed and remanded. Michigan defines “drug” using the federal definition, 21 U.S.C. 321: (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). Michigan’s definition provides that a “drug” is not a “medical appliance or device.” Immunity might not apply to a product, like the patch, that has mechanical (rather than chemical) effect on the body. Under the federal definition a product might be neither “drug” nor “device” but a “combination product.” Whether a combination product is regulated as a drug or a device is left to the Secretary’s discretion. View "Miller v. Mylan, Inc." on Justia Law

The plaintiffs allege that they ingested metoclopramide, the generic equivalent of the prescription drug Reglan, and, as a result, developed a serious neurological disorder, tardive dyskinesia. The labeling for the drugs recommends short-term use for heartburn and acute and recurrent bloating: up to 12 weeks in adults for heartburn. Reglan and metoclopramide have not been shown to be either efficacious or safe for long-term treatment; the drugs affect the brain’s movement center, typically causing involuntary, repetitive movements. Overuse can result in symptoms including tardive dyskinesia, dystonia, and akathisia, Parkinsonism, and Reglan-induced tremors. Reglan and metoclopramide have also been associated with central nervous system disorders, depression with suicidal ideation, visual disturbances, and other problems. The plaintiffs sued both the generic and brand-name manufacturers, alleging various product-liability claims. The district court dismissed, finding the metoclopramide claims preempted by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301-399f, and that the brand-name manufacturers are not liable because none of the plaintiffs ingested Reglan. The Sixth Circuit affirmed and denied the plaintiffs’ motion to certify a proposed question to the Tennessee Supreme Court. View "Speed v. Wyeth Pharm., Inc." on Justia Law

A three-year-old child found a cigarette lighter in his father’s truck and used it to loosen a button on his shirt. His shirt caught fire and he spent three weeks in the hospital, where he was treated for second and third degree burns to his face and chest and underwent several skin graft surgeries. A BIC cigarette lighter was found at the scene and delivered to the police. Who found the lighter, and where, is unclear. In a suit against the manufacturer, the jury found the lighter was not defective or unreasonably dangerous in a way that causally contributed to the injuries. The Sixth Circuit affirmed, rejecting arguments that the court allowed inadmissible evidence of the failure of the Consumer Product Safety Commission to take action concerning the lighter and that the court erred by permitting BIC’s counsel to argue that the parents were to blame and refusing to instruct the jury to disregard such arguments. The court noted that the lighter admitted in evidence is presumed to be the one that caused the fire; it was worn, and the child safety guard had been removed. View "Cummins v. Bic USA, Inc." on Justia Law

In 2010, P&G began marketing Pampers disposable diapers with “Dry Max technology.” Two months later, the Consumer Product Safety Commission began investigating whether the diapers caused severe diaper rash. The district court consolidated several law suits. In August 2010, the CPSC and Health Canada released reports, finding no connection between the diapers and diaper rash. Despite a pending motion to dismiss and before any formal discovery, the parties reached a settlement agreement, under which they agreed to seek class certification under Rule 23(b)(2), so that absent class members could not opt out. P&G agreed: to reinstate a refund program; to add to its label a sentence suggesting that consumers consult Pampers.com or call; to add basic diaper rash information to its website; and to contribute $300,000 to a pediatric resident training program and $100,000 to fund a program “in the area of skin health.” Named plaintiffs would release all of their Pampers-related claims and receive $1000 “per affected child.” Unnamed class members would not receive any award, would benefit only from the one-box refund, but would release “equitable” claims against P&G, and be permanently barred from future class actions against P&G. Class counsel would receive $2.73 million. The district court certified the class. The Sixth Circuit reversed, noting that the per-child payments provided a disincentive for named plaintiffs to care about the adequacy of relief afforded unnamed class members. View "Greenberg v. Procter & Gamble Co." on Justia Law

Tennessee resident Lombard acquired a 1997 Lincoln Town Car in 2004. The car was partially manufactured, and its final assembly completed, in 1996 at Ford’s Wixom, Michigan plant. In March 2007, the Lincoln, which was licensed, registered, and insured in Tennessee, allegedly caught fire in Lombard’s driveway, causing damage to the car, Lombard’s residence, and personal property. Lombard’s insurers reimbursed Lombard for his losses and, as subrogees, sued Ford, asserting products liability, breach of warranty and negligence claims, alleging that the fire was due to a defective cruise control system. The district court dismissed, finding that Tennessee law governed and that Tennessee’s statute of repose for products liability actions bars the claims. The Sixth Circuit affirmed, after examining Michigan choice of law rules. The conclusion that Michigan’s interests do not “mandate” that Michigan law be applied despite Tennessee’s interests was not erroneous. View "Std. Fire Ins. Co. v. Ford Motor Co." on Justia Law

Crouch was piloting his Piper Lance II single-engine airplane with Hudson as passenger. After losing engine power at an altitude of 5000 feet, and finding it impossible to reach an airport, Crouch made a forced landing in a field near Bardstown. The plane’s engine was manufactured in 1978 and overhauled in 2005, with installation of a rebuilt magneto that allegedly detached, causing the crash. Both occupants survived but suffered serious permanent injuries, including paraplegia. The district court dismissed, on summary judgment, their allegations that the aircraft engine manufacturer was liable for negligently failing to warn airplane owners and operators, and failing to notify regulatory authorities, of defects in the engine and its components, finding that the allegations failed to make out a claim in avoidance of the applicable period of repose under the General Aviation Revitalization Act, 49 U.S.C. 40101. The Sixth Circuit affirmed. Plaintiffs did not show or even allege that a revised overhaul manual contained a substantive alteration that caused harm and the evidence did not support a theory that defendants withheld information. View "Crouch v. Honeywell Int'l, Inc." on Justia Law

Fulgenzi was prescribed the generic drug metoclopramide (FDA approved in 1980), sold originally under the brand name Reglan, a drug approved for short-term treatment of patients suffering from gastroesophageal reflux disease. In her suit, claiming failure to adequately warn of risks, she alleged that taking the drug caused her to develop tardive dyskinesia, an often-irreversible neurological disorder that causes involuntary movements, especially of the lower face. In 2009, the Supreme Court held that with respect to branded drug manufacturers, state failure-to-warn suits were not preempted by the federal Food Drug and Cosmetic Act , 21 U.S.C. 301. In 2011 the Court held that such suits could not go forward against generic drug manufacturers, as it is impossible to comply simultaneously with their state duty to adequately warn and their federal duty of sameness (federal law requires generic drug labels to be the same as their branded counterpart). The district court dismissed. The Sixth Circuit reversed, noting that after the branded-drug manufacturer of metoclopramide strengthened warnings on its label, the generic manufacturer failed to update its label as required by federal law, rendering compliance with both federal and state duties no longer impossible. View "Fulgenzi v. PLIVA, Inc." on Justia Law