Justia Drugs & Biotech Opinion Summaries

The Fifth Circuit affirmed the district court's dismissal of plaintiff's complaint alleging that she used defendants' prescription chemotherapy drug and now suffers from permanent hair loss. As a plaintiff in this multidistrict litigation (MDL), plaintiff was required to serve defendants with a completed fact sheet disclosing details of her personal and medical history soon after filing her short form complaint. She failed to do so in this case.The court applied the Deepwater Horizon two-factor test to the district court's dismissal of plaintiff's case and held that the district court was not required to make specific factual findings on each of the Deepwater Horizon prongs before dismissing plaintiff's case. The court explained that plaintiff exhibited a clear record of delay sufficient to meet the first prong in the Deepwater Horizon test, and lesser sanctions would not have served the best interests of justice. The court also held that the district court did not abuse its discretion in denying plaintiff's motion for reconsideration. View "Kuykendall v. Accord Healthcare, Inc." on Justia Law

Plaintiffs filed suit against Mentor, alleging causes of action for negligence and negligence per se based on Mentor's negligent failure to warn and negligent manufacturing of breast implants, strict products liability for failure to warn, and strict products liability for manufacturing defects.The Court of Appeal reversed the trial court's judgment and entered an order overruling the demurrer to the third amended complaint. The court held that the tort claims in this case survive preemption because they are premised on conduct that both violates the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetics Act and would give rise to a recovery under state law even in the absence of the MDA. The court also held that plaintiffs pleaded the requisite causal connection between their injuries and Mentor's tortious acts to survive a demurrer. Finally, the trial court erroneously sustained Mentor's demurrer to the loss of consortium claim because it was derivative of the other claims. View "Mize v. Mentor Worldwide LLC" on Justia Law

Essure--permanent birth control for women--originally was manufactured and developed by Conceptus, a California corporation. Bayer bought Conceptus. Bayer marketed Essure as safer and more effective than other birth control. Two residents of Madison County, Illinois, filed personal injury complaints, alleging that Essure caused debilitating pain, heavy bleeding that necessitated medication, and autoimmune disorders. including 179 plaintiffs from at least 25 states. Months later, the U.S. Supreme Court issued its “Bristol-Myers” decision. Bayer argued that, following Bristol-Myers, a court cannot exercise specific personal jurisdiction over an out-of-state defendant as to the claims of out-of-state plaintiffs when the conduct giving rise to the claims did not occur in the forum state. The plaintiffs argued Illinois courts had specific personal jurisdiction over Bayer because it “created the Essure Accreditation Program and the marketing strategy for Essure in Illinois,” conducted clinical trials in Illinois, and used Illinois as a testing ground for its physician training program. The appellate court affirmed the denials of motions to dismiss: Bayer “conducted a part of its general business in Illinois, and [p]laintiffs’ claims arose out of" trials conducted, in part, in Illinois.The Illinois Supreme Court reversed. The nonresident plaintiffs identified no jurisdictionally relevant links between their claims and Illinois. The nonresidents have not explained how Illinois could be a convenient location for this litigation; they were not implanted with their devices here and have identified no other activity that would connect their specific claims to Illinois. Many nonresident plaintiffs initiated duplicate actions in California, indicating that the interests of judicial economy are not furthered by permitting their claims to proceed in Illinois. A corporation’s continuous activity of some sort within a state is not enough to render the corporation subject to suits unrelated to that activity. View "Rios v. Bayer Corp." on Justia Law

This appeal stemmed from a group of fourteen diversity cases that were consolidated by the Judicial Panel on Multidistrict Litigation and transferred to the Northern District of Oklahoma. The plaintiffs in all fourteen cases were cancer treatment providers who purchased multi-dose vials of Herceptin, a breast cancer drug, from defendant Genentech, Inc. (Genentech). Plaintiffs alleged that Genentech violated state law by failing to ensure that each vial of Herceptin contained the labeled amount of the active ingredient, and by misstating the drug concentration and volume on the product labeling. After the cases were consolidated, Genentech moved for summary judgment, arguing that plaintiffs’ claims were pre-empted by federal law. The district court agreed with Genentech and granted its motion for summary judgment. Plaintiffs appealed. The Tenth Circuit disagreed with the district court's conclusion that plaintiffs' claims were preempted, and consequently, reversed summary judgment and remanded for further proceedings. View "In re: MDL 2700 Genentech" on Justia Law

Kaiser had surgery to implant the Prolift Anterior Pelvic Floor Repair System, a transvaginal mesh medical device that supports the pelvic muscles. A few years later, Kaiser began experiencing severe pelvic pain, bladder spasms, and pain during intercourse. Her physician attributed these conditions to contractions in the mesh. Kaiser had surgery to remove the device, but her surgeon could not completely extract it and informed her that the complications she was experiencing were likely permanent. Kaiser sued Ethicon, Prolift’s manufacturer, under the Indiana Products Liability Act. A jury found Ethicon liable for defectively designing the Prolift device and failing to adequately warn about its complications and awarded $10 million in compensatory damages; the judge reduced a punitive award to $10 million. The Seventh Circuit affirmed, rejecting Ethicon’s claim of federal preemption. The requirements of the FDA’s premarket-notification process do not directly conflict with Indiana law. A reasonable jury could conclude that Prolift was unreasonably dangerous and could credit the physician’s assertion that additional warnings about complications would have led him to choose a different treatment plan. The court rejected challenges to the damages and to jury instructions. Seventh Circuit precedent interprets the Indiana Product Liability Act to require a plaintiff in a design-defect case to produce evidence of a reasonable alternative design for the product but the Indiana Supreme Court disagreed in 2010. The state supreme court’s decision controls on a matter of state law. View "Kaiser v. Johnson & Johnson and Ethicon, Inc." on Justia Law

The Ninth Circuit reversed the district court's dismissal of civil Racketeer Influenced and Corrupt Organizations Act (RICO) claims based on lack of RICO standing in a putative class action brought against pharmaceutical companies. Plaintiffs filed suit alleging that the companies refused to change the warning label of their drug Actos or otherwise inform the public after they learned that the drug increased a patient’s risk of developing bladder cancer.The panel held that patients and health insurance companies who reimbursed patients adequately alleged the required element of proximate cause where they alleged that, but for defendant's omitted mention of a drug's known safety risk, they would not have paid for the drug. The panel agreed with the First and Third Circuits that plaintiffs' damages were not too far removed from defendants' alleged omissions and misrepresentations to satisfy RICO's proximate cause requirement. In this case, plaintiffs sufficiently alleged a direct relationship, and the Holmes factors weighed in favor of permitting their RICO claims to proceed. The panel explained that, although prescribing physicians served as intermediaries between defendants' fraudulent omission of Actos's risk of causing bladder cancer and plaintiffs' payments for the drug, prescribing physicians did not constitute an intervening cause to cut off the chain of proximate causation. The panel also held that plaintiffs have adequately alleged the reliance necessary to satisfy RICO's proximate cause requirement. View "Painters and Allied Trades District Council 82 Health Care Fund v. Takeda Pharmaceuticals Co." on Justia Law

Appellants Jonathan Saksek and Joshua Winter challenged a superior court decision to affirm summary judgment in favor of Appellees Janssen Pharmaceuticals, Inc., Johnson & Johnson Company, and Janssen Research and Development, LLC (collectively, “Janssen”). Saksek and Winter were two of a large number of men who filed suit against Janssen, alleging that they developed gynecomastia as a result of their ingestion of Risperdal, an antipsychotic drug manufactured by Janssen. In 2014, Janssen filed two motions for summary judgment, which were nominally directed at Saksek’s and Winter’s cases, but had language affecting all Risperdal plaintiffs: the companies sought a global ruling that all claims accrued for statute of limitations purposes no later than October 31, 2006, when Janssen changed the Risperdal label to reflect a greater association between gynecomastia and Risperdal. The trial court ruled that all Risperdal-gynecomastia claims accrued no later June 31, 2009. The superior court disagreed, ruling that all such claims accrued no later than Janssen’s preferred date (October 31, 2006). Concluding that the superior court erred in granting summary judgment at all in Saksek’s and Winter’s cases, the Pennsylvania Supreme Court vacated its decision and remanded to the trial court for further proceedings. View "In Re: Risperdal Litig." on Justia Law

Forest Laboratories, LLC ("Forest"), filed a permissive appeal pursuant to Rule 5, Ala. R. App. P., of an Alabama circuit court's order denying it summary judgment. Forest manufactured and marketed Lexapro, a drug prescribed for depression, and Forest Pharmaceuticals, Inc. ("FPI") sold and distributed Lexapro. In 2015, Elias Joubran's physician prescribed Lexapro for Elias's depression. Elias's prescription was filled with generic escitalopram that was manufactured and sold by a company other than Forest. On December 30, 2015, Elias entered the house belonging to him and his wife, Sheila Joubran; he shot and killed Sheila, then shot and killed himself. Kevin Feheley, Sr., serving as personal representative of Shiela's estate, sued Mary Jourbran in her capacity as the personal representative of Elias's estate. Forest, FPI and several fictitiously named defendants were included in the suit. The complaint alleged that, at the time of the murder/suicide, Elias was under prescription for pharmaceuticals manufactured by defendants, including Forest and FPI, and that "Forest's Lexapro[] enhanced, enabled and aggravated [Elias's] depression and violent behaviors." The Alabama Legislature enacted section 6-5-530, Ala. Code 1975, "on the heels" of the Alabama Supreme Court's decision in Wyeth, Inc. v. Weeks, 159 So. 3d 649 (2014). In addressing the Weeks decision, section 6-5-530 specifically provided that a plaintiff who is suing based on personal injury, death, or property damage caused by a product "must prove ... that the defendant designed, manufactured, sold, or leased the particular product the use of which is alleged to have caused the injury on which the claim is based" regardless of the type of claims or theory of liability the plaintiff asserts. Because this case was a permissive appeal, the questions before the Supreme Court were limited to whether 6-5-530 effectively overruled Weeks, and whether a manufacturer could be held liable for an injury caused by a product it did not manufacture. The Court determined Section 6-5-530 abrogated Weeks: a pharmaceutical manufacturer cannot be held liable for injury caused by a product it did not manufacture. Based on the Court's answer to the trial court's certified question in the permissive appeal, it reversed the trial court's order denying Forest's motion for a summary judgment and remanded this case for further proceedings. View "Forest Laboratories, LLC v. Feheley, Sr." on Justia Law

The Ninth Circuit affirmed the district court's grant of summary judgment to Allergan in an action under state law alleging that plaintiff suffered injuries when her breast implants bled silicone into her body. Through the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act (FDCA), Congress permitted FDA oversight of medical devices; the MDA expressly preempts state law regulation of medical devices; and for a state law claim regarding a Class III medical device to survive express preemption by the MDA, a plaintiff must establish that the defendant violated an FDA requirement.In this case, the panel held that plaintiff failed to show that Allergan violated a federal requirement for its Style 20 breast implant. The panel held that plaintiff failed to raise a genuine dispute of material fact that Allergan violated the FDA's pre-market approval and Current Good Manufacturing Practices. Therefore, plaintiff has now shown a violation of an FDA requirement, which she must for her state law claims to fit through the narrow exception to MDA preemption. View "Weber v. Allergan, Inc." 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