Mealey's Drugs & Devices
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August 01, 2024
Mass Tort Cases For Drugs, Medical Devices
New developments in the following mass tort drug and device cases are marked in boldface type.
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August 01, 2024
Sanofi-Aventis Agrees To Cap Insulin At $35 In Settlement With Minnesota
NEWARK, N.J. — Minnesota Attorney General Keith Ellison and Sanofi-Aventis U.S. LLC told a New Jersey federal court that they have reached a settlement under which the drug manufacturer has agreed to make its insulin products available to consumers in Minnesota for no more than $35 for a monthly subscription.
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August 01, 2024
4th Circuit Consolidates Appeals On Whether N.C. Abortion Law Is Preempted
RICHMOND, Va. — The Fourth Circuit U.S. Court of Appeals consolidated three cases asking it to weigh in on a decision by North Carolina federal judge that found that parts of the state’s abortion laws are preempted by federal law.
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August 01, 2024
Federal Judge Asks Mich. Supreme Court To Weigh In On Learned Intermediary Doctrine
DETROIT — While denying a manufacturer’s motion to dismiss a case alleging injuries from a defective limb-lengthening device, a Michigan federal judge certified to the state Supreme Court a series of questions for clarification on how the learned intermediary doctrine applies to product liability cases.
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July 31, 2024
7th Circuit Says Defective IVC Claims Time-Barred Under Ohio Limitation Statute
CHICAGO — A lower court properly found that Ohio’s two-year statute of limitations applied to a woman’s claim that she was injured by a defective inferior vena cava (IVC) filter, the Seventh Circuit U.S. Court of Appeals ruled July 30, affirming summary judgment for the manufacturer.
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July 31, 2024
DePuy Wins Defense Verdict In Alleged Defective Hip Implant Jury Decision
PHOENIX — A jury in the U.S. District Court for the District of Arizona found in favor of a drug device manufacturer in a defective metal-on-metal hip implant case after a seven-day long trial in a case that was remanded from the multidistrict litigation hearing similar cases.
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July 31, 2024
Judge Sets Briefing Schedule In Mifepristone Case After High Court Decision
YAKIMA, Wash. — A Washington federal judge who previously enjoined the Food and Drug Administration to maintain relaxed prescribing regulations for the abortion drug mifepristone signed an order setting a briefing schedule in a case that was put on hold awaiting the U.S. Supreme Court’s decision in a related mifepristone case.
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July 31, 2024
Fla. Federal Judge Allows Woman To Amend Complaint In Transferred Bair Hugger Case
TAMPA, Fla. — Over a manufacturer’s objections, a Florida federal judge presiding over a case that was recently transferred from a multidistrict litigation ruled that a woman who alleges that a Bair Hugger Force Air Warming System caused contaminants to enter her open surgical wound may amend her complaint after finding that doing so would not be violation of any orders issued by the MDL court.
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July 31, 2024
Judge Says Federal Law Preempts Hip Device Claims, Grants Dismissal Motions
BALTIMORE — A Maryland federal judge found that a man’s claims that he was injured by a defective metal-on-metal hip implant are preempted by federal law and granted separate motions to dismiss filed by the remaining defendants.
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July 31, 2024
Judge OKs Further Discovery, Denies Motion For Summary Judgment In Device Case
LEXINGTON, Ky. — A motion for summary judgment in a product liability and personal injury suit involving a surgical implant is premature, a Kentucky federal judge ruled after finding that “additional discovery is necessary.”
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July 30, 2024
4th Circuit Sets Oral Argument Date In Dispute Over W.Va.’s Law Banning Abortion
RICHMOND, Va. — The Fourth Circuit U.S. Court of Appeals on July 29 tentatively set oral arguments from Oct. 29 to Nov. 1 in a case debating whether the West Virginia Unborn Child Protection Act (UCPA), which bans abortion in almost all cases, is preempted under federal law.
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July 30, 2024
Breast Cancer Survivors Sue Device Maker, Say Implanted Device Was Defective
BOSTON — A group of seven breast cancer survivors who allege that an implanted radiographic marker used to mark soft tissue sites during treatment was defective and caused injuries, resulting in a second surgery to remove the device, filed suit against the manufacturer, seeking compensatory and punitive damages.
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July 29, 2024
D.C. Circuit Says Drug Maker Did Not Show Error In FDA’s Refusal To Reclassify
WASHINGTON, D.C. —The U.S. Food and Drug Administration did not violate the Administrative Procedure Act (APA) by refusing to reclassify a company’s drug as a biological product, which makes approval of a generic product more difficult, the District of Columbia Circuit U.S. Court of Appeals said in an opinion unsealed July 26, affirming a lower court’s summary judgment award in favor of the FDA and the drug company’s competitor.
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July 29, 2024
Indivior To Pay $86M In Multistate Settlement For Its Role In Opioid Crisis
NEW YORK — Suboxone maker Indivior has agreed to a $86 million settlement with multiple states to settle allegations that its buprenorphine-based products that are used to treat opioid use disorder but can fuel addiction if misused helped spread “deadly opioid addictions across New York and the country,” the New York attorney general announced July 26 in a press release.
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July 26, 2024
2nd Circuit Says Plaintiffs Must Show Intent To Trigger CAFA, Affirms Remand
NEW YORK — Citing the “consistent desire” of plaintiffs asserting personal injury claims stemming from their use of Zantac “to avoid federal jurisdiction,” the Second Circuit U.S. Court of Appeals agreed that a motion to consolidate did not trigger federal jurisdiction and affirmed a district court decision to remand nine cases to state court.
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July 26, 2024
Judge Partially Grants Amazon’s Motion To Dismiss Contaminated Eye Drops Case
PHILADELPHIA — A federal judge in Pennsylvania agreed to dismiss certain claims against Amazon.com Inc. in a woman’s suit alleging that use of artificial tears that were contaminated with bacteria resulted in her eye being surgically removed.
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July 25, 2024
9th Circuit: Other States Can’t Intervene In Suit Over Mifepristone Regulations
SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals on July 24 said it was “guided . . . by the Supreme Court's recent decision on standing and the FDA's regulation of mifepristone in FDA v Alliance for Hippocratic Medicine. 602 U.S. 367 (2024)” and denied a motion filed by Idaho and other anti-abortion states to intervene in a case involving federal regulations for the abortion drug mifepristone.
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July 25, 2024
Judge Partly Dismisses Hip Replacement Patient’s Suit Over Defective Implant
SAN FRANCISCO — A California federal judge granted in part and denied in part a motion to dismiss filed by several companies involved in the manufacture and sale of a prosthetic hip replacement who are accused of causing a patient injuries and lost wages after his implant began releasing toxic metals into his body, finding that the patient’s claims, including for violation of California’s unfair competition law (UCL), are not preempted by federal authority.
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July 23, 2024
4th Circuit Finds Lower Court Erred In Excluding Testimony In Pelvic Mesh Case
RICHMOND, Va. — The Fourth Circuit U.S. Court of Appeals on July 22 found that based on answers to questions certified to the West Virginia Supreme Court of Appeals, a district court erred in excluding testimony from a woman’s expert in a pelvic mesh case and vacated a judgment that found in favor of the device manufacturer.
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July 22, 2024
Massachusetts Federal Judge Denies Barry Cadden’s Motion To Reduce His Sentence
BOSTON — A Massachusetts federal judge denied a request by New England Compounding Center (NECC) founder Barry J. Cadden to reduce his sentence of 174 months for his role in a fungal meningitis outbreak after finding that Cadden is not eligible for a sentence reduction under a recent amendment to the U.S. Sentencing Commission guidelines.
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July 18, 2024
Mass Tort Cases For Drugs, Medical Devices
New developments in the following mass tort drug and device cases are marked in boldface type.
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July 18, 2024
Judge Grants Approval To $50M Settlement To End Antitrust Claims Involving EpiPen
KANSAS CITY, Kan. — A Kansas federal judge has signed off on final approval to a settlement agreement in which Pfizer Inc. agreed to pay $50 million to settle claims that it conspired with others in an attempt to delay entry of generic competitors for the EpiPen epinephrine autoinjector (EAI) into the market.
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July 18, 2024
CPAP MDL Judge Sets Date For Medical Monitoring Settlement Hearing
PITTSBURGH — The federal judge overseeing the multidistrict litigation involving the recall of approximately 10.8 million continuous positive air pressure (CPAP) sleep apnea devices will hold a final fairness hearing on Oct. 30 on a $25 million settlement to resolve medical monitoring claims in the MDL.
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July 18, 2024
Arbitration Agreement Not Binding, But Judge Says Device Claims Preempted
LAKE CHARLES, La. — The legal screen used to set up an app to connect a medical device that detects blood glucose levels to a personal mobile device such as an iPhone did not clearly make a user aware that she was agreeing to arbitrate all claims, a Louisiana federal judge ruled, but he partially granted the manufacturer’s motion to dismiss claims as preempted by federal law.
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July 18, 2024
Judge Overseeing Diabetes And Diet Drug MDL OKs Direct Filings Of New Complaints
PHILADELPHIA — The Pennsylvania federal judge newly appointed to oversee the multidistrict litigation involving diabetes and diet drugs that consumers allege caused gastrointestinal and other injuries signed five case management orders, including an order that directs any potential plaintiff to file directly into the MDL.