Justia Drugs & Biotech Opinion Summaries

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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

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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

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After Boehringer developed a drug called Pradaxa to help reduce the risk of stroke, the FDA approved the drug and its label. Betty Knight suffered complications from taking the drug and eventually died. Betty's children filed suit against Boehringer asserting a variety of state-law claims alleging Boehringer failed to adequately warn about the risks associated with taking Pradaxa. Boehringer argued that federal law preempted the claims, the district court agreed with plaintiffs, and then the jury returned a mixed verdict. Boehringer appealed, claiming that plaintiffs' fraud claim based on the physician label was preempted.The Fourth Circuit reversed the district court's order denying Boehringer's post-trial motion for judgment as a matter of law. The court held that there is no bright-line, one-size-fits-all line marking the moment when an analysis reveals new information. A careful review of the record is needed to determine whether a conclusion has been reached. Applying careful review here, the court concluded that Boehringer did not have "newly acquired information" regarding an optimal Pradaxa blood concentration level which would have warranted a unilateral change to the physician label. Therefore, the state-law fraud claim is preempted. View "Knight v. Boehringer Ingelheim Pharmaceuticals, Inc." on Justia Law

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Johnson & Johnson and other pharmaceutical defendants sought mandamus relief from an Alabama circuit court order that refused to transfer venue of the underlying lawsuit to the Jefferson County, Alabama circuit court, on grounds that venue in Conecuh County was not proper as to all plaintiffs, or alternatively, on the basis that convenience of the parties and/or the interest of justice required it. In 2019, the plaintiffs filed a complaint at the Conecuh Circuit Court against numerous defendants that, they averred, manufactured, marketed, distributed, and/or dispensed opioid medications throughout Alabama in a manner that was misleading, unsafe, and resulted in drug addiction, injury, and/or death to Alabama citizens. The complaint asserted claims of negligence, nuisance, unjust enrichment, fraud and deceit, wantonness, and civil conspiracy. The manufacturer defendants moved to transfer the case to Jefferson County, reasoning that because 8 of the 17 plaintiffs either had a place of business in Jefferson County or operated hospitals in Jefferson County or adjacent counties, logic dictated that a large percentage of the witnesses for those plaintiffs (i.e., prescribing doctors, hospital administrators, etc.) and their evidence were located in or around Jefferson County. After a review of the circuit court record, the Alabama Supreme Court determined defendants did not demonstrate a clear, legal right to transfer the underlying case from Conecuh to Jefferson County. Therefore, the petition was denied. View "Ex parte Johnson & Johnson et al." on Justia Law

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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

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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

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The Supreme Court held that the seven District Attorneys General who sued several drug companies under the Tennessee Drug Dealer Liability Act lacked standing and that the two Baby Doe plaintiffs who sued under the Act and alleged facts showing that the drug companies knowingly participated in the illegal drug market by facilitating the marketing or distribution of opioids stated a claim against the drug companies under the Act.The District Attorneys and the Baby Doe plaintiffs brought this action alleging that the defendant drug companies knowingly participated in the illegal drug market by intentionally flooding East Tennessee communities with prescription opioid medications. The Baby Doe plaintiffs alleged that they were harmed by exposure to opioids in utero and the District Attorneys claimed that the opioid epidemic had damaged the communities in their districts. The trial court dismissed the case, ruling that the Act did not apply. The court of appeals reversed. The Supreme Court affirmed in part and reversed in part, holding (1) the District Attorneys lacked standing to bring an action under the Act as individual plaintiffs; and (2) the Baby Doe plaintiffs stated a claim against the drug companies based on allegations of intentional and purposeful participation in the illegal opioid market. View "Effler v. Purdue Pharma L.P." on Justia Law

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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

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AndroGel, a testosterone replacement therapy, generated billions of dollars in sales, The Federal Trade Commission sued the owners of an AndroGel patent under Section 13(b) of the Federal Trade Commission Act, 21 U.S.C. 301, alleging that they filed sham patent infringement suits against Teva and Perrigo and entered into an anticompetitive reverse-payment agreement with Teva. The FTC accused the defendants of trying to monopolize and restrain trade over AndroGel. The District Court dismissed the FTC’s claims to the extent they relied on a reverse-payment theory but found the defendants liable for monopolization on the sham-litigation theory. The court ordered the defendants to disgorge $448 million in profits but denied the FTC’s request for an injunction.The Third Circuit reversed in part. The district court erred by rejecting the reverse-payment theory and in concluding that the defendants’ litigation against Teva was a sham. The court did not err in concluding the Perrigo litigation was a sham and that the defendants had monopoly power in the relevant market. The FTC has not shown that monopolization entitles it to any remedy. The court did not abuse its discretion in denying injunctive relief. The court erred by ordering disgorgement because that remedy is unavailable under Section 13(b). View "Federal Trade Commission v. AbbVie Inc" on Justia Law

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Pharmacy benefit managers (PBMs) reimburse pharmacies for the cost of drugs covered by prescription-drug plans by administering maximum allowable cost (MAC) lists. In 2015, Arkansas passed Act 900, which requires PBMs to reimburse Arkansas pharmacies at a price at least equal to the pharmacy’s wholesale cost, to update their MAC lists when drug wholesale prices increase, and to provide pharmacies an appeal procedure to challenge MAC reimbursement rates, Ark. Code 17–92–507(c). Arkansas pharmacies may refuse to sell a drug if the reimbursement rate is lower than its acquisition cost. PCMA, representing PBMs, sued, alleging that Act 900 is preempted by the Employee Retirement Income Security Act (ERISA), 29 U.S.C. 1144(a).Reversing the Eighth Circuit, the Supreme Court held that Act 900 is not preempted by ERISA. ERISA preempts state laws that “relate to” a covered employee benefit plan. A state law relates to an ERISA plan if it has a connection with or reference to such a plan. State rate regulations that merely increase costs or alter incentives for ERISA plans without forcing plans to adopt any particular scheme of substantive coverage are not preempted. Act 900 is a form of cost regulation that does not dictate plan choices. Act 900 does not “refer to” ERISA; it regulates PBMs whether or not the plans they service fall within ERISA’s coverage. Allowing pharmacies to decline to dispense a prescription if the PBM’s reimbursement will be less than the pharmacy’s cost of acquisition does not interfere with central matters of plan administration. The responsibility for offering the pharmacy a below-acquisition reimbursement lies first with the PBM. Any “operational inefficiencies” caused by Act 900 are insufficient to trigger ERISA preemption, even if they cause plans to limit benefits or charge higher rates. View "Rutledge v. Pharmaceutical Care Management Association" on Justia Law