Justia Drugs & Biotech Opinion Summaries

Abbott Laboratories and Abbott Laboratories, Inc. (collectively, "Abbott"), petitioned the Alabama Supreme Court for a writ of mandamus to direct the Mobile Circuit Court to dismiss all claims asserted by the Mobile County Board of Health and the Family Oriented Primary Health Care Clinic (collectively, "Mobile Health") against Abbott on the basis that those claims are barred by the rule of repose or by the applicable statute of limitations. Mobile Health alleged that Abbott had participated in the marketing of a specific prescription drug, OxyContin. Mobile Health alleged that this marketing campaign "precipitated" an "opioid crisis" in the United States, and specifically in Alabama, because it caused an astronomical increase in the use of opioids by patients who quickly became dependent upon the drugs. Mobile Health asserted that it brought this action because of the burdens it had to bear as a result of the "opioid epidemic." The Alabama Supreme Court concluded the applicable statutes of limitations barred Mobile Health's claims against Abbott. Therefore, the Court granted Abbott's petition for a writ of mandamus, and directed the circuit court to enter an order dismissing Mobile Health's claims against Abbott. View "Ex parte Abbott Laboratories and Abbott Laboratories, Inc." on Justia Law

The People of the State of California, by and through the Santa Clara County Counsel, the Orange County District Attorney, the Los Angeles County Counsel, and the Oakland City Attorney, filed suit against various pharmaceutical companies involved in the manufacture, marketing, distribution, and sale of prescription opioid medications. The People alleged the defendants made false and misleading statements as part of a deceptive marketing scheme designed to minimize the risks of opioid medications and inflate their benefits. The People alleged this scheme caused a public health crisis in California by dramatically increasing opioid prescriptions, opioid use, opioid abuse, and opioid-related deaths. In their suit, the People allege causes of action for violations of the False Advertising Law, and the public nuisance statutes. After several years of litigation, the defendants served business record subpoenas on four nonparty state agencies: the California State Board of Registered Nursing (Nursing Board), the California State Board of Pharmacy (Pharmacy Board), the Medical Board of California (Medical Board), and the California Department of Justice (DOJ). The Pharmacy Board, the Medical Board, and the DOJ served objections to the subpoenas. The Nursing Board filed a motion for a protective order seeking relief from the production obligations of its subpoena. After further litigation, which is recounted below, the trial court ordered the state agencies to produce documents in response to the subpoenas. In consolidated proceedings, the state agencies challenged the trial court's orders compelling production of documents. After review, the Court of Appeal concluded the motions to compel against the Pharmacy Board and Medical Board were untimely, and the defendants were required to serve consumer notices on at least the doctors, nurses, pharmacists, and other health care professionals whose identities would be disclosed in the administrative records, investigatory files, and coroner’s reports. Furthermore, the Court concluded the requests for complete administrative records and investigatory files, were overbroad and not reasonably calculated to lead to the discovery of admissible evidence. "The requests for complete administrative records and investigatory files also ran afoul of the constitutional right to privacy and the statutory official information and deliberative process privileges." The trial court was directed to vacate its orders compelling production of documents, and to enter new orders denying the motions to compel and, for the Nursing Board, granting its motion for a protective order. View "Board of Registered Nursing v. Super. Ct." on Justia Law

To fight his hair loss, Greenberg bought an $8 bottle of biotin. The product label states that biotin “helps support healthy hair and skin” and has an asterisk that points to a disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” A Supplement Facts panel on the bottle states that the biotin amount in the product far exceeds the recommended daily dosage. Greenberg filed a putative class action under California’s Unfair Competition Law, alleging that the labels are deceptive because most people do not benefit from biotin supplementation.The panel affirmed summary judgment in favor of the manufacturer and distributors. The plaintiff’s state law claims were preempted by the federal Food, Drug, and Cosmetic Act (FDCA), under which the FDA requires that dietary supplement labels be truthful and not misleading; 21 U.S.C. 343(r)(6)(B) authorizes several categories of statements, including disease claims and structure/function claims. The FDCA includes a preemption provision to establish a national, uniform standard for labeling. The challenged statement was a permissible structure/function claim. There was substantiation that biotin “helps support healthy hair and skin”; that statement was truthful and not misleading. The label had the appropriate disclosures and did not claim to treat diseases. The state law claims amounted to imposition of different standards from the FDCA. View "Greenberg v. Target Corp." on Justia Law

The Supreme Court made permanent a preliminary writ of prohibition preventing the circuit court from allowing Plaintiffs' claims against Janssen Pharmaceuticals, Johnson & Johnson, and Janssen Research & Development (collectively, Defendants) in the Circuit Court of the City of St. Louis, holding that the circuit court abused its discretion by refusing to transfer the claims of those injured outside of the City of St. Louis.Multiple plaintiffs filed this action stating various causes of action arising from the sale and use of Risperdal, a prescription drug. Defendants filed a motion to dismiss based on improper venue and forum non conveniens for all plaintiffs not injured in the City of St. Louis. The circuit court overruled the motion. Defendants then filed a petition for a writ of prohibition or mandamus asking that the claims of the plaintiffs whose injuries allegedly occurred in Missouri counties other than the City of St. Louis be transferred. The Supreme Court granted a writ of prohibition, holding (1) Mo. R. Civ. P. 52.05(a) cannot be used to confer venue in a forum that is otherwise improper, and newly enacted Mo. Rev. Stat. 508.013.1 did not alter the result on these facts; and (2) the circuit court's failure to transfer the claims of those injured outside of the City of St. Louis was an abuse of discretion. View "State ex rel. Janssen Pharmaceuticals, Inc. v. Honorable Michael Noble" on Justia Law

In 2003, Clabo underwent surgery to correct pelvic organ prolapse and urinary incontinence. Clabo’s doctor implanted her with a TVT transvaginal mesh sling device that the Defendants manufactured. By 2006, she began experiencing pelvic pain, urinary issues, scarring, and pain during sexual intercourse. After being notified by her doctor that the mesh from her device had eroded through her vaginal canal, Clabo had a procedure in April 2006 to remove the TVT implant. A month later, Clabo had surgery to implant a mesh sling similar to the one she had removed. In 2011, Clabo had another surgery to have pieces of her second implant removed and other parts repaired, again due to mesh erosion. Clabo alleges that it was not until July 2012 that she finally realized, after speaking with a physician-friend, that the TVT mesh product was the likely cause of her persistent pain and suffering.In May 2013, Clabo filed suit under the Tennessee Products Liability Act. The court dismissed Clabo’s claims as barred by Tennessee’s statute of repose, which prohibits product liability claims brought more than six years after the date of the injury that gave rise to the suit, finding that Clabo’s initial injury occurred during 2006. The Sixth Circuit affirmed; the record demonstrates that Clabo’s injuries occurred outside of the statute of repose period. View "Clabo v. Johnson & Johnson Health Care Systems, Inc." on Justia Law

The Second Circuit affirmed the district court's grant of summary judgment in favor of defendants and dismissal of plaintiffs' products liability claims after precluding, pursuant to Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), the opinions of plaintiffs' expert witnesses as to general causation.The court concluded that, not only was it appropriate for the district court to take a hard look at plaintiffs' experts' reports, the court was required to do so to ensure reliability. Furthermore, plaintiffs' contention that the district court impermissibly focused on plaintiffs' experts' conclusions instead of their methodologies is similarly unavailing. Even assuming that the district court required experts to back their opinions with studies definitely supporting their conclusions, the district court did not err in doing so. Therefore, the district court appropriately undertook a rigorous review of each of plaintiffs' experts, and based on that review reasonably found that the experts' methods were not sufficiently reliable and that their conclusions were not otherwise supported by the scientific community.The court also concluded that the district court correctly granted summary judgment in favor of defendants where no reasonable juror could find that it was more likely than not that general causation had been established based on plaintiffs' admissible evidence. The court was not persuaded that the district court erred in holding that there is a general causation requirement across all states. Furthermore, the court rejected plaintiffs' contention that the district court prevented them from obtaining and presenting evidence of general causation. In this case, plaintiffs failed to explain how admitting portions of the expert reports would have established general causation; the district court did not abuse its broad discretion in excluding differential-diagnosis evidence; and the district court did not abuse its broad discretion in managing discovery. View "In Re: Mirena IUS Levonorgestrel-Related Products Liability Litigation" on Justia Law

Quidel Corporation (Quidel) petitioned for a writ of mandate and/or prohibition to direct the trial court to vacate its order granting summary adjudication. Quidel contended the trial court incorrectly concluded a provision in its contract with Beckman Coulter, Inc. (Beckman) was an invalid restraint on trade in violation of Business and Professions Code, section 16600. Quidel argued the trial court improperly extended the holding from Edwards v. Arthur Andersen LLP, 44 Cal.4th 937 (2008) beyond the employment context to a provision in the parties’ 2003 BNP Assay Agreement (the Agreement). In its original, published opinion, the Court of Appeal concluded it was not, granted the petition and issued a writ instructing the trial court to vacate the December 2018 order granting summary judgment on the first cause of action. The California Supreme Court then granted review of the Court of Appeal's opinion and ordered briefing deferred pending its decision in Ixchel Pharma, LLC v. Biogen, Inc., S256927. On August 3, 2020, the Supreme Court issued Ixchel Pharma, LLC v. Biogen, Inc., 9 Cal.5th 1130 (2020), which held “a rule of reason applies to determine the validity of a contractual provision by which a business is restrained from engaging in a lawful trade or business with another business.” The Quidel matter was transferred back to the Court of Appeals with directions to vacate its previous opinion and reconsider the case in light of Ixchel. The appellate court issued a new opinion in which it concluded the trial court’s decision was incorrect. The trial court was directed to vacate the December 7, 2018 order granting summary adjudication on the first cause of action. View "Quidel Corporation v. Super. Ct." on Justia Law

After the State of Hawaii filed suit against several pharmaceutical companies in state court for allegedly deceptive drug marketing related to the medication Plavix, the companies turned to federal court, seeking an injunction against the state court litigation based on a violation of their First Amendment rights.The Ninth Circuit agreed with the district court that the state court litigation is a quasi-criminal enforcement proceeding and that Younger v. Harris, 401 U.S. 37 (1971), bars a federal court from interfering with such a proceeding. The panel explained that, even though the state proceeding is being litigated by private counsel, it is still an action brought by the State of Hawaii. The panel stated that what matters for Younger abstention is whether the state proceeding falls within the general class of quasi-criminal enforcement actions—not whether the proceeding satisfies specific factual criteria. Looking to the general class of cases of which this state proceeding is a member, the panel concluded that Younger abstention is appropriate here. In this case, the State's action has been brought under a statute that punishes those who engage in deceptive acts in commerce, and the State seeks civil penalties and punitive damages to sanction the companies for their allegedly deceptive labeling practices. Because the companies' First Amendment concerns do not bring this case within the scope of Younger's extraordinary circumstances exception, they have no bearing on the application of Younger. Accordingly, the panel affirmed the district court's dismissal of the action. View "Bristol-Myers Squibb Co. v. Connors" on Justia Law

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

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