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Mealey's Drugs & Devices

February 29, 2024
Drugmaker, Woman Square Off On ACA’s Impact On Mirena Class Action

SAN JOSE, Calif. — The Patient Protection and Affordable Care Act (ACA) mandates that insurers cover contraceptive drugs at no out-of-pocket cost, so a woman’s lawyers should have known that she couldn’t have suffered an economic injury sufficient for standing to pursue her claims that she wouldn’t have paid for the drug had she known about its cancer risks, the manufacturer says in seeking sanctions and opposing her motion to amend. But in reply, the woman says all the evidence in the case suggests that she does have an injury and that adding named plaintiffs who can more readily produce evidence of their own injury won’t prejudice the company.
February 29, 2024
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
February 26, 2024
Anti-Abortion Advocates Tell Court Changes To Abortion Drug Access Caused Harm

[This story has been updated to reflect the addition of amicus curiae briefs filed in support of the respondent.]
February 29, 2024
MDL Judge Orders Taxotere Plaintiffs To Show Proof Of Diagnosis In Lone Pine Order

NEW ORLEANS — Plaintiffs in the Taxotere hair loss multidistrict litigation who are eligible for remand must show proof of a diagnosis of permanent chemotherapy-induced alopecia (PCIA), the MDL judge ruled.
February 29, 2024
Couple Sue Manufacturer Of Embryo Culture Media For Loss Of Embryos

OAKLAND, Calif. — A couple sued the manufacturer of embryo culture media in a California federal court alleging that none of their fertilized eggs survived to the blastocysts stage due to a defective solution that was used in the procedure and seek compensatory and punitive damages.
February 29, 2024
Amici Urge 4th Circuit To Reverse District Court Ruling Limiting Abortion Drug

RICHMOND, Va. — “Mifepristone, when used as part of a two-drug medication abortion regimen, is one safe and common course of treatment that is used with pregnancy loss or obstetrical complications leading to fetal demise. Medication abortion, including the use of mifepristone, thus is an important part of reproductive care,” groups of obstetricians, gynecologists and clinicians tell the Fourth Circuit U.S. Court of Appeals in an amicus curiae brief.
February 29, 2024
CPAP MDL Judge Rejects Special Master Report On Medical Monitoring Claims

PITTSBURGH — The federal judge overseeing the multidistrict litigation involving the recall of approximately 10.8 million Philips continuous positive air pressure (CPAP) sleep apnea devices and respirators declined to adopt a special master’s report and recommendation to partially grant a motion to dismiss plaintiffs’ second amended medical monitoring complaint.
February 28, 2024
Hospitals Allege Harm From Opioid Epidemic Caused By Drugmakers, Distributors

CLEVELAND — A group of hospitals filed a complaint in a federal court in Ohio against drug manufacturers and distributors alleging that the hospitals have been “directly and monetarily damaged by the opioid epidemic.”
February 28, 2024
ASD-ADHD MDL Judge Sets Deadlines To Object To Causation Experts, Tosses Cases

NEW YORK — The New York federal judge overseeing the acetaminophen autism spectrum disorder-attention deficit hyperactivity disorder (ASD-ADHD) multidistrict litigation on Feb. 27 ordered that any objections on whether testimony by a newly named causation expert is admissible under Federal Rule of Evidence 702 be filed by July 1.
February 27, 2024
FDA Withdraws Pepaxto Approval After Low Survival Rate In Myeloma Patients

SILVER SPRING, Md. — The U.S. Food and Drug Administration has withdrawn its approval of Pepaxto-brand melphalan flufenamide, a drug approved in February 2021 under an accelerated approval process to treat patients with multiple myeloma.
February 27, 2024
MDL Suboxone Judge Sets Deadlines For Lead Counsel Applications

WASHINGTON, D.C. — The judge overseeing the Suboxone film multidistrict litigation ordered counsel interested in a leadership position in the MDL to submit an application by March 1 in preparation for an initial status conference that is scheduled for March 7.
February 27, 2024
Judge: PREP Act Applies To Class Action Alleging Injuries From COVID-19 Drug

LOS ANGELES — Patients and their family members who allege injuries after being prescribed and ingesting an antiviral drug used to treat severe COVID-19 symptoms saw their putative class action dismissed by a California federal judge who found that the manufacturer has immunity under the Public Readiness and Emergency Preparedness Act (PREP Act).
February 27, 2024
Diabetes And Diet Drug MDL To Meet To Discuss Lead Counsel, Division Of Cases

PHILADELPHIA — The federal judge overseeing the multidistrict litigation involving diabetes and diet drugs that consumers allege caused gastrointestinal and other injuries announced plans for an initial in-court conference to discuss, among other topics, plans to appoint lead counsel.
February 23, 2024
Philips Says Motion To Dismiss Is Premature In Foam Degradation Dispute

PITTSBURGH — Koninklijke Philips N.V., Philips North America LLC and Philips RS North America LLC (collectively, Philips) told a federal court to defer ruling on a motion to dismiss filed by a management service company for SoClean Inc, a manufacturer of equipment that uses ozone to clean or disinfect medical devices and accessories that Philips alleges contributed to the breakdown of the polyester-based polyurethane (PE-PUR) foam used in the devices, and instead focus “on SoClean’s motion to dismiss for failure to state a claim, since SoClean. (unlike [the management service]) makes no personal jurisdiction challenge.”
February 23, 2024
Vaccine Injury Case Properly Dismissed As Untimely, Federal Circuit Says

WASHINGTON, D.C. — The Federal Circuit U.S. Court of Appeals found no error in a decision by the U.S. Court of Federal Claims that held that equitable tolling did not apply to a vaccine injury case and that the petition was untimely.
February 21, 2024
Hernia Mesh MDL Judge Sets Schedule For Mediation, Resolution Of Claims

COLUMBUS, Ohio — The Ohio federal judge overseeing the Davol hernia mesh multidistrict litigation ordered the parties to attend mediation in hopes of reaching a global settlement after he canceled the fourth bellwether trial.
February 20, 2024
High Court Won’t Resolve Dispute On Right To Appeal Partially Dismissed Case

WASHINGTON, D.C. — The U.S. Supreme Court on Feb. 20 denied a petition for a writ of certiorari filed by a woman who appealed the dismissal of her case against the maker of Zantac and asked the high court to settle a jurisdictional question on whether her design defect claim was dismissed when the multidistrict litigation court dismissed the claim in a master complaint.
February 20, 2024
High Court Denies States’ Motion To Intervene In Abortion Drug Case

WASHINGTON, D.C. — The U.S. Supreme Court in its Feb. 20 order list denied a motion by three states to intervene in the case involving the abortion drug mifepristone and also granted leave for former commissioners of the U.S. Food and Drug Administration to file a brief as amici curiae out of time but denied a similar motion by the American Bar Association.
February 20, 2024
ASD-ADHD MDL Judge To Consider Causation Expert Retained By New Plaintiffs

NEW YORK — The New York federal judge overseeing the acetaminophen autism spectrum disorder-attention deficit hyperactivity disorder (ASD-ADHD) multidistrict litigation on Feb. 16 ordered the parties to file by Feb. 23 their proposed schedule for briefing on whether testimony by a newly named causation expert is admissible under Federal Rule of Evidence 702.
February 15, 2024
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
February 15, 2024
Gardasil Vaccine MDL Reassigned To Judge Bell In Western District Of N.C.

WASHINGTON, D.C. — The Gardasil vaccine multidistrict litigation has been reassigned to U.S. Judge Kenneth D. Bell of the Western District of North Carolina, the chair of the U.S. Judicial Panel on Multidistrict Litigation (JPMDL) announced in a one-page order.
February 15, 2024
Arizona Federal Judge Grants Final Approval In Theranos Suit Against Walmart

PHOENIX — An Arizona federal judge has entered final approval of a $44 million settlement agreement with pharmacy chain Walgreens to resolve class claims involving tests conducted in Arizona and California pharmacies by the now-defunct Theranos Inc. blood testing company.
February 14, 2024
6th Circuit Finds No Error In Expert Exclusion That Ended Onglyza MDL

CINCINNATI — The federal judge presiding over the Onglyza multidistrict litigation “had three good reasons to find” that testimony by an expert retained to opine that the drug is capable of causing heart failure was inadmissible, a Sixth Circuit U.S. Court of Appeals panel said Feb. 13, affirming the final judgment entered in the case.
February 14, 2024
Fla. Federal Judge Gives Woman 1 Last Chance To Amend Defective Hip Complaint

FORT MYERS, Fla. — A federal judge in Florida on Feb. 13 granted a woman one final attempt to amend her complaint to separate any commingled strict liability failure to warn claim from the negligence claim in a defective “metal-on-metal” hip replacement device case.
February 13, 2024
Amended Master Personal Injury Complaint Filed Under Seal In CPAP MDL

PITTSBURGH — Plaintiffs in the multidistrict litigation involving the recall of approximately 10.8 million Philips continuous positive air pressure (CPAP) sleep apnea devices and respirators on Feb. 12 filed under seal a second amended master long-form complaint for personal injuries after the Pennsylvania federal judge overseeing the case in January adopted in part recommendations from the special master and dismissed certain claims with leave to amend.