Justia Drugs & Biotech Opinion Summaries

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

Hoping to minimize her risk of suffering serious complications from future blood clots, Johnson underwent surgery to implant a retrievable intravascular filter–a medical device that is placed in the inferior vena cava to prevent blood clots that develop in the lower body from flowing into the heart and lungs. Johnson’s doctor selected the Meridian filter, which was supposed to be temporary and easily removable. Johnson’s filter migrated and fractured, leaving shards embedded in the wall of her heart and elsewhere. Her surgeon was unable to remove the device safely and fully. As a result, Johnson faces an ongoing risk of infection, pain, and other complications.Johnson sued the manufacturers of the Meridian filter (Bard), claiming that they defectively designed the Meridian filter and failed to warn medical providers about the device’s risks, in violation of Wisconsin law. A jury rejected most of Johnson’s theories but returned a $3.3 million verdict in her favor on her strict liability failure-to-warn count. The Seventh Circuit affirmed, stating that its decision “should not be misinterpreted as our endorsement of some of Johnson’s counsel’s trial tactics.” There was no reversible error in instructing the jury or in permitting certain testimony, in alleged violation of expert witness disclosure requirements. View "Johnson v. C. R. Bard, Inc." on Justia Law

Medytox’s patent is directed to the use of an animal-protein-free botulinum toxin composition that exhibits a longer-lasting effect compared to an animal protein-containing botulinum toxin composition and purportedly can be used to treat both cosmetic and non-cosmetic conditions. Galderma requested post-grant review of claims 1–10, which the Patent Trial and Appeal Board granted. Medytox filed a non-contingent motion to amend seeking to cancel claims 1–10 and substitute claims 11–18 and requested that the Board issue a Preliminary Guidance. Galderma argued that the claims added new matter because the claims covered compounds with a 16-week responder rate between 50-100% but the specification only disclosed responder rates of up to 62%.Reversing its Preliminary Guidance, the Board found that the substitute claims impermissibly introduced new matter with the inclusion of the responder rate limitation and failed to meet the requirements for revised motions to amend; that the proposed substitute claims were unpatentable for a lack of written description; and that the full scope of the claims was not enabled.The Federal Circuit affirmed, upholding the Board’s claim construction of the responder rate limitation as a range. The Board provided adequate explanation for its enablement finding. The Board’s revision of its claim construction of the responder rate limitation made between its Preliminary Guidance and final decision was not arbitrary and capricious, depriving Medytox of a full and fair opportunity to litigate. View "Medytox, Inc. v. Galderma S.A." on Justia Law

The First Circuit affirmed the decision of the district court granting summary judgment to Vitamin Shoppe and ruling that the Food, Drug, and Cosmetic Act (FDCA) preempted Plaintiffs' state law tort claims, holding that Plaintiffs' state law claims were expressly preempted by the FDCA.Plaintiffs purchased three dietary supplements containing glutamine as a main ingredient. Plaintiffs brought this action against the products' manufacturers claiming that the labels on the supplements contained statements that were false and misleading under state law. The district court granted summary judgment in favor of Vitamin Shoppe, holding that the FDCA preempted Plaintiffs' state law claims. The First Circuit affirmed, holding (1) the statements on Vitamin Shoppe's labels were structure/function claims under 343(r)(6), and Vitamin Shoppe complied with the FDCA's requirements to make such claims; and (2) therefore, Plaintiffs' state law claims challenging the statements about glutamine were expressly preempted by the FDCA. View "Ferrari v. Vitamin Shoppe Industries LLC" on Justia Law

Bridges and Cunningham filed a putative class action, alleging that Blackstone (the owner of Ancestry.com) violated Section 30 of Illinois’s 1998 Genetic Information Privacy Act, which provides that no person or company “may disclose or be compelled to disclose the identity of any person upon whom a genetic test is performed or the results of a genetic test in a manner that permits identification of the subject of the test,” 410 ILCS 513/30(a). Both plaintiffs had purchased DNA testing products from Ancestry and submitted saliva samples for genetic sequencing years earlier. Blackstone subsequently purchased Ancestry in a “control acquisition”— an all-stock transaction. Because Ancestry had allegedly paired the plaintiffs’ genetic tests with personally identifiable information—including names, emails, and home addresses—Bridges and Cunningham maintained that Blackstone, as part of acquiring Ancestry, had compelled the disclosure of their genetic identities in violation of Section 30.The Seventh Circuit affirmed the dismissal of the suit for failure to state a claim. The complaint focusing exclusively on Blackstone’s acquisition of Ancestry did not adequately allege any compulsory disclosure. View "Bridges v. Blackstone, Inc." on Justia Law

In 2008, as part of the defendants’ application for approval of Onglyza and Kombiglyze XR, two diabetes drugs with saxagliptin as the active ingredient, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee required that defendant AstraZeneca perform a cardiovascular outcomes study. “SAVOR” was a randomized, double-blind, placebo-controlled study that consisted of 16,492 patients with type 2 diabetes who were at high risk of cardiovascular disease. The study concluded that saxagliptin did not increase or decrease the risk of these occurrences but noted a higher risk of hospitalization. Following SAVOR, the FDA required warning labels for medications containing saxagliptin, referring to the potential increased risk of heart failure. Researchers conducted additional studies and did not find an association between saxagliptin and an increased risk of hospitalization for heart failure.Patients who took drugs with saxagliptin filed approximately 250 related cases. Most of these cases were filed in federal court and consolidated into federal multidistrict litigation. A Judicial Council coordination proceeding (JCCP) was established for the California state court cases. The court of appeal affirmed summary judgment in favor of the defendants. The court upheld the exclusion of the plaintiffs’ general causation expert, who opined that saxagliptin can cause heart failure. View "Onglyza Product Cases" on Justia Law