SILVER SPRING, Md. — The Food and Drug Administration on Sept. 23 issued a Drug Safety Communication that it is requiring manufacturers of benzodiazepines to update the black box warnings for that class of drugs for their risk of abuse, misuse, addiction, physical dependence and withdrawal reactions.
SILVER SPRING, Md. — The Food and Drug Administration on Sept. 24 said certain patients may be at a higher risk of adverse health effects of mercury from metal dental fillings (amalgam).
SILVER SPRING, Md. — The Food and Drug Administration on Sept. 19 recommended that breast implant manufacturers include a black box warning on product labels about the risks of the devices.
OKLAHOMA CITY — Johnson & Johnson on Oct. 8 told the Oklahoma Supreme Court that it should reverse a trial court’s public nuisance verdict and its order to pay $465 million to fund the first year of a remediation plan (Oklahoma v. Johnson & Johnson, et al., No. 118,484, Okla. Sup.).
New developments in the following mass tort drug and device cases are marked in boldface type.
ATLANTA — A Georgia federal judge on Sept. 29 granted preemption summary judgment in a Pradaxa bleeding death case after finding that there was no new evidence that the Food and Drug Administration should have considered to strengthen the drug’s warnings about bleeding risks (Kimberly A. Lyons, et al. v. Boehringer Ingelheim Pharmaceuticals, Inc., No. 18-4624, N.D. Georgia, Atlanta Div., 2020 U.S. Dist. LEXIS 184234).
WEST PALM BEACH, Fla. — In a 2-1 decision, a Florida state appeals panel on Oct. 7 affirmed a defense verdict in a wrongful death case involving a surgical suction device even though the trial judge erred in allowing the defendant to exercise a peremptory strike against the first alternate juror when one original juror left (Lisa Cavanaugh, et al. v. Stryker Corporation, et al., No. 4D19-523, Fla. App., 4th Dist., 2020 Fla. App. LEXIS 14345).
AUSTIN, Texas — The Texas Supreme Court on Oct. 9 reversed an appeals court ruling reversing summary judgment for a plaintiff law firm in a fen-phen fee dispute and remanded the case to the appellate court to consider the law firm’s other arguments in the case (George Fleming, et al. v. Rebecca Wilson, et al., No. 19-0230, Texas Sup., 2020 Tex. LEXIS 931).
DUBLIN, Ireland — Mallinckrodt PLC on Oct. 12 announced an agreement in principle of a proposed settlement to resolve opioids-related claims for $1.6 billion, according to a company press release.
CINCINNATI — The Sixth Circuit U.S. Court of Appeals on Oct. 8 denied a mandamus petition by the Ohio Board of Pharmacy (OBOP) to order the opioids multidistrict litigation court to rescind its order to provide the names and addresses of opioid prescribers and dispensers to retail pharmacies in an upcoming bellwether trial (In Re: National Prescription Opiate Litigation [In Re: State of Ohio Board of Pharmacy], No. 20-3875, 6th Cir.).
SILVER SPRING, Md. — The Food and Drug Administration on Oct. 5 notified AMAG Pharma USA Inc. and five other drug companies that the agency is proposing to withdraw approval of Makena-brand hydroxyprogesterone caproate because a post-marketing clinical trial failed to verify that the drug has a clinical benefit and because the drug is not shown to be effective under its conditions for use.
SILVER SPRING, Md. — The Food and Drug Administration on Sept. 22 warned Nephron Pharmaceuticals Corp. to stop unapproved advertising that budesonide nasal asthma spray treats respiratory symptoms of COVID-19 infections.
WASHINGTON, D.C. — The U.S. Supreme Court on Oct. 8 held in abeyance for 40 days an application by the Food and Drug Administration to stay a district court preliminary injunction permitting the mailing of an abortion pill due to the COVID-19 pandemic (Food and Drug Administration, et al. v. American College of Obstetricians and Gynecologists, et al., No. 20A34, U.S. Sup., 2020 U.S. LEXIS 4833).
WASHINGTON, D.C. — The U.S. Supreme Court on Oct. 5 denied review of an implantable opioids pump case, letting stand a circuit court ruling that the plaintiff failed to show that any of three explanted devices were defective and that defendant Medtronic Inc. had a duty to analyze adverse event reports (Rebecca Lawrence v. Medtronic, No. 19-8689, U.S. Sup.).
WASHINGTON, D.C. — The U.S. Supreme Court on Oct. 5 denied a certiorari petition by GlaxoSmithKline LLC (GSK) to reverse a preemption ruling involving the diabetes drug Avandia based on an interpretation by the Third Circuit U.S. Court of Appeals of a 2019 Supreme Court preemption decision (GlaxoSmithKline LLC v. United Food and Commercial Workers Local 1776, et al., No. 19-1444, U.S. Sup.).
WASHINGTON, D.C. — The U.S. Supreme Court on Oct. 5 denied review of lower court rulings that a drug plaintiff’s state law failure-to-warn claim is “impliedly preempted” by federal law (Rita McDaniel, et al. v. Upsher-Smith Laboratories, Inc., No. 19-1246, U.S. Sup.).
PHILADELPHIA — In a Sept. 30 holding, the Third Circuit U.S. Court of Appeals tossed a $448 million disgorged profits award against the owners of a patent covering AndroGel but found that a Pennsylvania federal judge erred when he dismissed antitrust allegations by the Federal Trade Commission against the testosterone drug makers to the extent that those allegations relied on a reverse payment theory (Federal Trade Commission v. AbbVie Inc., et al., Nos. 18-2621,-2748, -2758, 3rd Cir., 2020 U.S. App. LEXIS 31048).
WASHINGTON, D.C. — Two plaintiffs on July 23 filed a motion asking the Judicial Panel on Multidistrict Litigation (JPMDL) to centralize 63 cases in which plaintiffs allege that the bladder drug Elmiron causes serious eye injury that patients have not been warned about (In Re: Elmiron [Pentosan Polysulfate Sodium] Products Liability Litigation, MLD Docket No. 2973, JPMDL).
New developments in the following mass tort drug and device cases are marked in boldface type.
CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation on Sept. 22 denied a motion by pharmacy defendants to reconsider his earlier denial of two of their dismissal motions or to certify questions to the Sixth Circuit U.S. Court of Appeals and the Ohio Supreme Court (In Re: National Prescription Opiate Litigation, MDL Docket No. 2804, No. 17-md-2804, N.D. Ohio, E. Div.,