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

Bradley purchased ratchet straps to use exclusively on a hunting treestand. In 2008, Bradley used the straps to secure his treestand, exposed to the elements, from early September to mid-October. Bradley then stored the treestand and straps in his garage until 2011. He did not use the treestand until a few months after setting it up. He inspected the treestand and straps before climbing into the stand. Within minutes of Bradley’s ascent, the straps broke, causing Bradley to fall and sustain injuries. Bradley’s suit allegied strict product liability, negligent design and manufacture, strict liability failure to warn, negligent failure to warn, loss of consortium, and violations of the Tennessee Consumer Protection Act. The court excluded the testimony of two plaintiffs’ experts, one of whom would have testified that the straps failed to include an ultraviolet light inhibitor that would have reduced the rate of polymer degradation due to sunlight exposure and that the defendants failed to warn and instruct consumers how to recognize when the straps were no longer safe, finding the expert’s experience “with the webbing material . . . sparse.” The court dismissed the failure-to-warn claims on other grounds. The Sixth Circuit reversed, finding the expert qualified and that the court erred by not allowing Bradley to proceed under the consumer expectation test, relying on lay testimony about objective facts and circumstances surrounding the straps’ failure. View "Bradley v. Ameristep, Inc." on Justia Law

Officer Lapham responded to a call for backup; another officer had stopped a car with expired tags when a passenger—16-year-old Robert—ran from the car, broke into an abandoned house, and hid. Lapham arrived as an officer began to arrest Robert, who then tried to evade the officer’s grasp. A struggle ensued. Lapham de-holstered his taser and shot Robert. One dart hit inches above Robert’s heart, the other inches below. Robert fell to the ground. A medical team could not resuscitate him. In training, officers had been told that, “even when the taser’s darts land on the chest, the weapon is safe.” Robert’s mother settled claims against the officers and the city, then added claims against the weapon’s manufacturer, Taser. The Sixth Circuit affirmed summary judgment for Taser, finding no duty to warn the Warren Police Department about any cardiac risks at the time of sale in 2006, Michigan law precluded any post-sale duty to warn, Taser had not assumed a duty to warn by virtue of its training regimen, and plaintiff could not prove that Lapham would have ever seen a warning even if Taser had issued one. View "Mitchell v. City of Warren" on Justia Law

GE manufactures Omniscan, an FDA-approved gadolinium-based contrast agent that has been associated in some patients with development of nephrogenic systemic fibrosis (NSF), a rare and deadly condition that leads to the hardening (fibrosis) of the kidneys. Omniscan was administered to Wahl for two MRIs she received in Nashville in 2006. About one year later, she displayed the first symptoms of NSF. She was officially diagnosed with NSF in 2010. The Judicial Panel on Multidistrict Litigation consolidated all pre-trial litigation of Omniscan-related cases in the U.S. District Court for the Northern District of Ohio. In 2011, Wahl filed a complaint in that court. With the agreement of Wahl and GE, the MDL judge transferred the case, in 2013, to the Middle District of Tennessee, the “proper venue.” GE then moved for summary judgment, arguing that all Omniscan doses produced from 2004 to 2006 were marked with expiration dates two years after manufacture, so the Omniscan administered to Wahl must have expired no later than 2008; the Tennessee Products Liability Act’s statute of repose requires suits to be instituted within one year of the expiration date appearing on a product’s packaging. The Sixth Circuit affirmed summary judgment, favoring GE, applying Tennessee choice-of-law rules. View "Wahl v. Gen. Elec. Co." on Justia Law

In 1988 Sutherland received breast implants in North Carolina. She filed suit in North Carolina five years later, after learning that the silicone in her implants could be causing a variety of serious medical problems. The Silicone’s manufacturer, Dow Corning, filed for bankruptcy in Michigan, and Sutherland’s suit was transferred there. In 2012, 24 years after Sutherland received the implants, the district court concluded that Sutherland’s claim was barred by Michigan’s statute of limitations and granted summary judgment to the defendant. The Sixth Circuit reversed, reasoning that the district court should have applied North Carolina’s law instead of Michigan’s, and should have concluded that there was a genuine factual issue as to whether Sutherland’s claim was timely-filed under North Carolina law. View "Sutherland v. DCC Litig. Facility, Inc." on Justia Law

In 2005, in connection with a magnetic resonance imaging procedure (MRI), Decker received a dose of Omniscan, a gadoliniumbased contrast agent manufactured by GEHC. After taking Omniscan, Decker developed Nephrogenic Systemic Fibrosis (NSF). In 2012, the Deckers sued GEHC, as part of a multidistrict litigation (MDL). Before the Deckers’ case, hundreds of similar cases in the MDL involving GEHC had been settled. The Decker case was the first case in the MDL to go to trial. The jury returned a verdict in favor of the Deckers on a failure-to-warn claim, awarding $5 million in damages. The Sixth Circuit affirmed, rejecting claims that the district court judge should have recused himself from the trial and a motion for a new trial; made several erroneous evidentiary rulings, which were applicable to all MDL cases; erroneously denied GEHC’s motion for a new trial because insufficient evidence supported the jury’s verdict regarding the causation element of the Deckers’ failure-to-warn claim; and erroneously failed to issue two proposed jury instructions. View "Decker v. GE Healthcare Inc." on Justia Law

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