Justia Drugs & Biotech Opinion Summaries

Several plaintiffs alleged that they suffered injuries, such as renal, bone, or tooth damage, from taking a drug manufactured by Gilead Sciences, Inc. known as tenofovir disoproxil fumarate (TDF). Plaintiffs conceded that TDF was not defective but claimed that Gilead had developed an alternative drug, tenofovir alafenamide fumarate (TAF), which was equally effective and less toxic. Plaintiffs argued that Gilead unreasonably delayed bringing TAF to market, allegedly to maximize profits, and that this delay deprived them of a safer drug option, causing their injuries.In the San Francisco City and County Superior Court, Gilead moved for summary judgment, asserting that negligence liability could not attach for injuries caused by a nondefective product. The trial court denied Gilead’s motion. Gilead then petitioned the Court of Appeal, First Appellate District, Division Four, which partially granted the petition. The Court of Appeal directed summary adjudication on the fraudulent concealment claim but allowed the negligence claim to proceed. It held that drug manufacturers may owe a duty of reasonable care to users of a nondefective drug in deciding whether and when to commercialize a safer alternative.The Supreme Court of California reviewed the case and reversed the Court of Appeal’s judgment. The court held that, even assuming drug manufacturers might owe a broader duty of care beyond marketing nondefective drugs, the factors set forth in Rowland v. Christian justify an exception in this context. Specifically, the court determined that a manufacturer’s decision to delay commercialization of a safer drug during early development stages is too remote and unforeseeable to establish a duty of care, and imposing such liability would unduly burden innovation and public health. The Supreme Court directed the trial court to grant summary judgment for Gilead on all claims. View "Tenofovir Cases" on Justia Law

Buyers of over-the-counter nasal decongestants containing oral phenylephrine brought numerous class actions against drug manufacturers and retailers, alleging that for years these companies sold and advertised decongestant products they knew to be ineffective. The plaintiffs claimed that scientific studies, particularly since 2016, had shown oral phenylephrine to be no better than a placebo at relieving congestion, yet the companies continued to market their products as effective decongestants and complied with Food and Drug Administration (FDA) labeling requirements. The FDA, despite mounting evidence, did not remove oral phenylephrine’s designation as an effective decongestant under its regulations.The Judicial Panel on Multidistrict Litigation consolidated nearly one hundred class actions and transferred them to the United States District Court for the Eastern District of New York. Plaintiffs filed a complaint asserting New York statutory and common-law claims as well as a federal RICO claim. The district court granted the defendants’ motion to dismiss, holding that the Federal Food, Drug, and Cosmetic Act (FDCA) expressly preempted the state law claims because the drugs’ labels complied with FDA requirements, and that the plaintiffs lacked standing to bring the RICO claim. The court also dismissed a Lanham Act claim brought by one pharmacy plaintiff.On appeal, the United States Court of Appeals for the Second Circuit held that the FDCA expressly preempts most of the state law claims because the federal regime requires manufacturers to follow the FDA-approved labeling, but it vacated the dismissal for claims regarding “Maximum Strength” labeling and brand-name drugs approved via the New Drug Application process, remanding those for further proceedings. The court affirmed dismissal of the RICO claim, adopting the indirect purchaser rule, and upheld denial of the pharmacy’s motion for reconsideration regarding its Lanham Act claim. View "Yousefzadeh v. Johnson & Johnson Consumer Inc." on Justia Law

A plaintiff alleged that she suffered serious eye injuries, including blindness in one eye, after receiving an injection of a pharmaceutical product manufactured by the defendant. The specific unit used was from a lot later recalled due to the possible presence of silicone particulates. The plaintiff had a history of eye conditions and prior treatments but argued that her injuries followed the use of the recalled product. She presented two experts on causation: a retained ophthalmologist who provided a report and deposition, and her treating physician, who did not provide a written expert report.The Superior Court, Law Division, denied the defendant’s motions to bar the experts’ testimony and for summary judgment. The court did not conduct the “gatekeeping” inquiry regarding expert reliability required by New Jersey law. The defendant appealed, and the Appellate Division reversed. It found the experts’ opinions to be inadmissible net opinions, lacking evidentiary support for the proposed theory of causation and methodology. The Appellate Division thus also reversed the denial of summary judgment, holding the plaintiff had not established causation.The Supreme Court of New Jersey reviewed the case and held that its decision in In re Accutane Litigation requires trial courts to resolve disputes about the reliability of expert testimony by undertaking a “rigorous” gatekeeping analysis, potentially including a hearing under N.J.R.E. 104. The Supreme Court found the record insufficient for this determination and ordered a remand so the trial court could conduct the proper reliability inquiry. The Court held the retained expert’s report was not a net opinion but left open whether the treating physician’s testimony could be admitted, depending on whether a proper expert report is served. The Supreme Court reversed the Appellate Division’s judgment and remanded the matter to the trial court for proceedings consistent with its opinion. View "Beavan v. Allergan U.S.A., Inc." on Justia Law

The City of Boston, along with its Public Health Commission and Housing Authority, brought suit against two pharmacy benefit managers (PBMs), OptumRx and Express Scripts, alleging that the PBMs had worked with opioid manufacturers to misrepresent the risks of opioid drugs. The City claimed that this conduct violated Massachusetts public nuisance law and resulted in harm to the City. The PBMs removed the case to federal court and argued that the suit was untimely because it was brought after the three-year statute of limitations had expired. The City responded by asserting that its complaint sufficiently alleged a continuing nuisance and that the statute of limitations should be tolled due to the PBMs’ fraudulent concealment of their wrongdoing.The United States District Court for the District of Massachusetts granted the PBMs’ motion to dismiss, finding that the City either knew or should have known of its injuries and of the PBMs’ alleged role before 2021, based on public records and prior litigation, and thus failed to file suit within the statutory period. The district court further ruled that the City had not adequately pled a continuing nuisance, as it did not allege any specific, recent unlawful acts within the limitations period, and rejected the City’s claim of fraudulent concealment, determining that the City had the means to discover the facts needed for its claim. The district court also denied a motion by the PBMs to disqualify the City's law firm, Motley Rice.On appeal, the United States Court of Appeals for the First Circuit affirmed both the dismissal of the City’s state law claim and the denial of the motion to disqualify Motley Rice. The court held that the action was time-barred and that the City had not met the requirements for tolling the statute of limitations or for pleading a continuing nuisance under Massachusetts law. View "The City of Boston v. OptumRx, Inc." on Justia Law

A licensed veterinarian developed and manufactured undetectable performance enhancing drugs (PEDs) for use in professional horse racing, selling them to trainers who administered them to horses to gain a competitive edge. His salesperson assisted in these activities, operating a company that distributed the drugs without prescriptions or FDA approval. The drugs were misbranded or adulterated, and the operation involved deceptive practices such as misleading labeling and falsified customs forms. The PEDs were credited by trainers for their horses’ successes, and evidence showed the drugs could be harmful if misused.The United States District Court for the Southern District of New York presided over two separate trials, resulting in convictions for both the veterinarian and his salesperson for conspiracy to manufacture and distribute misbranded or adulterated drugs with intent to defraud or mislead, in violation of the Food, Drug, and Cosmetic Act. The district court denied motions to dismiss the indictment, admitted evidence from a prior state investigation, and imposed sentences including imprisonment, restitution, and forfeiture. The court calculated loss for sentencing based on the veterinarian’s gains and ordered restitution to racetracks based on winnings by a coconspirator’s doped horses.On appeal, the United States Court of Appeals for the Second Circuit held that the statute’s “intent to defraud or mislead” element is not limited to particular categories of victims; it is sufficient if the intent relates to the underlying violation. The court found no error in the admission of evidence from the 2011 investigation or in the use of gain as a proxy for loss in sentencing. However, it vacated the restitution order to racetracks, finding no evidence they suffered pecuniary loss, and vacated the forfeiture order, holding that the relevant statute is not a civil forfeiture statute subject to criminal forfeiture procedures. The convictions and sentence were otherwise affirmed. View "United States v. Fishman" on Justia Law

The case involves hundreds of plaintiffs who allege that they were injured by the drug Fosamax, manufactured by Merck Sharp & Dohme Corp. (Merck), due to inadequate warnings about the risk of atypical femoral fractures. The plaintiffs claim that they would not have taken the drug if they had been properly warned. Merck contends that it proposed a label change to the Food and Drug Administration (FDA) to address this risk, but the FDA rejected the proposed change due to insufficient scientific support.The United States District Court for the District of New Jersey granted summary judgment in favor of Merck, concluding that the plaintiffs' state law claims were preempted by federal law. The court found that Merck had fully informed the FDA of the justifications for the proposed warning and that the FDA had rejected the proposed label change, thus preempting the state law claims. The court relied on the FDA's Complete Response Letter and other communications to determine that the FDA's rejection was based on a lack of sufficient scientific evidence linking Fosamax to atypical femoral fractures.The United States Court of Appeals for the Third Circuit reviewed the case and vacated the District Court's judgment. The Third Circuit concluded that the District Court erred in its preemption analysis by giving too little weight to the presumption against preemption. The appellate court found that the FDA's Complete Response Letter was ambiguous and that the District Court placed too much reliance on informal FDA communications and an amicus brief to interpret the letter. The Third Circuit emphasized that the presumption against preemption is strong and that Merck did not meet the demanding standard of showing that federal law prohibited it from adding any and all warnings that would satisfy state law. The case was remanded for further proceedings. View "In re: Fosamax" on Justia Law

The case involves four plaintiffs who took docetaxel, a chemotherapy drug, as part of their treatment for early-stage breast cancer and subsequently suffered permanent chemotherapy-induced alopecia (PCIA). The plaintiffs allege that the manufacturers of the drug, Hospira, Inc., Hospira Worldwide, LLC, and Accord Healthcare, Inc., violated state law by failing to warn them that docetaxel could cause PCIA.The case was initially heard in the United States District Court for the Eastern District of Louisiana, where the defendants moved for summary judgment on the basis that the plaintiffs' state law failure-to-warn claims were preempted by federal law. The district court denied the motion, and the defendants appealed.The United States Court of Appeals for the Fifth Circuit was tasked with determining whether federal law preempts the plaintiffs' state law failure-to-warn claims against the defendant drug manufacturers. The court found that the district court had erred in its interpretation of what constitutes "newly acquired information" under the changes-being-effected (CBE) regulation, which allows manufacturers to file a supplemental application with the FDA and simultaneously implement a labeling change before obtaining FDA approval. The court held that the district court failed to enforce the requirement that newly acquired information must "reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA."The court vacated the district court's judgment on the plaintiffs' failure-to-warn claims and remanded the case for further consideration of one outstanding issue: whether the Bertrand Abstract, a scientific study, constituted "newly acquired information" that revealed a greater risk of PCIA than previously known. If the Bertrand Abstract does not meet this standard, the court held that the defendants would not be liable to the plaintiffs on their state law failure-to-warn claims. View "Hickey v. Hospira" on Justia Law

A group of individuals filed a lawsuit against Genzyme Corporation, a drug manufacturer, for injuries allegedly caused by the company's mishandling of a prescription drug shortage between 2009 and 2012. The lawsuit was filed several years after the events in question occurred and would typically have been considered too late under the applicable statutory limitations periods. However, the plaintiffs argued that previous class actions, a savings statute, and a tolling agreement between the parties allowed the lawsuit to proceed. The district court partially agreed and rejected Genzyme's argument that the delay in filing required dismissal of the lawsuit. However, it dismissed the claims of all but four plaintiffs for lack of standing, and dismissed the remaining claims on the merits.On appeal, the United States Court of Appeals for the First Circuit found that all plaintiffs have standing and the court has jurisdiction to proceed with the case, at least with respect to the plaintiffs' individual claims. However, it concluded that four plaintiffs waited too long before filing this lawsuit, and their claims are time-barred. For the remaining plaintiffs, the court vacated the judgment dismissing their claims and remanded the case to the district court for further proceedings. View "Wilkins v. Genzyme Corporation" on Justia Law

In the case before the Court of Appeal of the State of California First Appellate District Division Four, the plaintiffs, thousands of individuals who suffered adverse effects from the use of a prescription drug, TDF, made by Gilead Life Sciences, Inc., brought a claim of negligence and fraudulent concealment against Gilead. The plaintiffs alleged that while Gilead was developing TDF, it discovered a similar, but chemically distinct and safer potential drug, TAF. However, Gilead allegedly decided to defer development of TAF because it was concerned that the immediate development of TAF would reduce its financial return from TDF. Gilead sought summary judgment on the ground that in order to recover for harm caused by a manufactured product, the plaintiff must prove that the product was defective. The trial court denied Gilead's motion for summary judgment in its entirety.In reviewing this case, the appellate court held that the trial court was correct to deny Gilead's motion for summary judgment on the negligence claim. The court reasoned that a manufacturer's duty of reasonable care can extend beyond the duty not to market a defective product. The court found that the factual basis of the plaintiffs' claim was that Gilead knew TAF was safer than TDF, but decided to defer development of TAF to maximize its profits. The court held that if Gilead's decision to postpone development of TAF indeed breached its duty of reasonable care to users of TDF, then Gilead could potentially be held liable.However, the appellate court reversed the trial court's decision regarding plaintiffs' claim for fraudulent concealment. The court concluded that Gilead's duty to plaintiffs did not extend to the disclosure of information about TAF, as it was not available as an alternative treatment for HIV/AIDS at the time the alleged concealment occurred. Consequently, the court granted in part and denied in part Gilead's petition for a writ of mandate, directing the superior court to vacate its order denying Gilead's motion for summary judgment and to enter a new order denying summary adjudication of the negligence claim but granting summary adjudication of the fraudulent concealment claim. View "Gilead Tenofovir Cases" on Justia Law

This case involves a pharmaceutical manufacturer, Gilead Life Sciences, Inc., and its development and sale of a drug, tenofovir disoproxil fumarate (TDF), to treat HIV/AIDS. The approximately 24,000 plaintiffs allege that they suffered adverse effects from TDF, including skeletal and kidney damage. Gilead developed a similar but chemically distinct drug, tenofovir alafenamide fumarate (TAF), which could potentially treat HIV/AIDS with fewer side effects. The plaintiffs claim that Gilead delayed the development of TAF to maximize profits from TDF.The plaintiffs do not claim that TDF is defective. Instead, they assert a claim for ordinary negligence, arguing that Gilead's decision to delay the development of TAF breached its duty of reasonable care to users of TDF. They also assert a claim for fraudulent concealment, arguing that Gilead had a duty to disclose information about TAF to users of TDF.The Court of Appeal of the State of California, First Appellate District, Division Four, partially granted Gilead's petition for a writ of mandate and held that the plaintiffs could proceed with their negligence claim. The court concluded that a manufacturer's legal duty of reasonable care can extend beyond the duty not to market a defective product. However, the court reversed the trial court's decision denying Gilead's motion for summary adjudication of the plaintiffs' claim for fraudulent concealment. The court held that Gilead had no duty to disclose information about TAF to users of TDF, as TAF was not available as an alternative treatment at the time. View "Gilead Tenofovir Cases" on Justia Law