Mealey's Drugs & Devices
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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.
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February 13, 2024
Lilly Agrees To Cap Insulin Costs At $35 In Minnesota Settlement Agreement
NEWARK, N.J. — Eli Lilly and Co. has agreed to make its insulin products available to consumers in Minnesota for no more than $35 for a monthly subscription as part of a settlement agreement reached with the state.
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February 13, 2024
JPMDL Rejects Objections To Transfer Of 3 Cases In Bard Port Catheter MDL
WASHINGTON, D.C. — The U.S. Judicial Panel on Multidistrict Litigation (JPMDL) denied a motion filed by a port catheter device maker to vacate two conditional transfer orders, rejecting its argument that including a trio of complaints “would expand the scope” of the multidistrict litigation.
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February 13, 2024
Judge Grants Summary Judgment In Taxotere Case, Says Woman On Notice Of Injury
PEORIA, Ill. — An Illinois federal judge found that a woman was on notice that Taxotere, a chemotherapy used to treat breast cancer, was the possible cause of her permanent hair loss and that her complaint was filed after the statute of limitations expired.
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February 12, 2024
Insured Seeks Rehearing, Certification Of Questions In Opioid Coverage Dispute
SAN FRANCISCO — A prescription drug distributor insured on Feb. 9 asked the Ninth Circuit U.S. Court of Appeals to reconsider its ruling that there is no coverage owed for underlying lawsuits prompted by the opioid epidemic because the underlying claims “describe exclusively deliberate conduct,” arguing that a panel rehearing or rehearing en banc is warranted so the panel can certify two “undecided, critical questions of California law” to the California Supreme Court.
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February 09, 2024
Mifepristone Maker Argues W.Va.’s Law On Abortion Conflicts With Federal Law
RICHMOND, Va. —The West Virginia Unborn Child Protection Act (UCPA), which bans abortion in almost all cases, is preempted under federal law because Congress has made it clear that only the U.S. Food and Drug Administration may determine “which restrictions are necessary to ensure mifepristone’s safe use while minimizing burdens,” GenBioPro Inc., the maker of generic mifepristone, tells the Fourth Circuit U.S. Court of Appeals in its opening brief.
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February 09, 2024
Defective Medical Device Suit Partially Dismissed In Alabama Federal Court
MONTGOMERY, Ala. — An Alabama federal judge on Feb. 7 granted a manufacturer’s partial motion to dismiss a complaint filed by a man who alleges that a vascular access device used during chemotherapy was defective.
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February 08, 2024
Man Alleges Defect In Da Vinci Robot Device Led To His Wife’s Death
WEST PALM BEACH, Fla. — A man sued the manufacturer of the da Vinci robot in a Florida federal court, alleging that it concealed a defect in the multiarmed, remote controlled surgical device that caused a small cut in his wife’s intestines that led to her death.
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February 07, 2024
FDA, Danco Oppose States’ Intervention In Abortion Drug Case In High Court
WASHINGTON, D.C. — Three anti-abortion states on Feb. 6 replied to oppositions filed by the U.S. Food and Drug Administration and by Danco Laboratories LLC, the manufacturer of Mifeprex-brand mifepristone, on the states’ motion to intervene in a U.S. Supreme Court case involving the abortion drug with the FDA arguing “that the states waited far too long to seek intervention.”
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February 07, 2024
SoClean Moves To Dismiss Countersuit By Philips In Foam Degradation Dispute
PITTSBURGH — SoClean Inc., which sells machines that use ozone to clean and disinfect CPAP devices and accessories, asks a Pennsylvania federal court to dismiss counterclaims filed by Koninklijke Philips NV and its affiliates that allege that SoClean’s sale of the products violated federal law.
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February 06, 2024
Hernia Mesh MDL Judge Cancels Plans For 4th Bellwether Trial, Denies Remand
COLUMBUS, Ohio — The Ohio federal judge overseeing the Davol hernia mesh multidistrict litigation said the “usefulness of another lengthy and expensive trial is dubious at best” and vacated the scheduling order for the fourth bellwether trial but denied a motion by the plaintiffs to begin the remand process.
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February 06, 2024
JPMDL Centralizes Suboxone Cases In Northern District Of Ohio
WASHINGTON, D.C. — The U.S. Judicial Panel on Multidistrict Litigation (JPMDL) agreed that cases alleging that Suboxone film, a prescription drug used to treat opioid use disorder, causes extensive dental decay involve common question of facts and ordered the cases to be centralized in the U.S. District Court for the Northern District of Ohio before Judge J. Philip Calabrese.
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February 06, 2024
JPMDL Centralizes Diabetes Drug Cases In Eastern District Of Pennsylvania
WASHINGTON, D.C. — The Judicial Panel on Multidistrict Litigation (JPMDL) agreed to centralize cases alleging that diabetes and diet drugs caused consumers to suffer gastrointestinal and other injuries and assigned the multidistrict litigation to Judge Gene E.K. Pratter of the U.S. District Court for the Eastern District of Pennsylvania.
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February 05, 2024
New Plaintiffs In ASD-ADHD MDL Argue Their Expert Can Prove Causation
NEW YORK — A group of plaintiffs who allege that prenatal exposure to acetaminophen causes autism (ASD) or attention deficit hyperactivity disorder (ADHD) responded to an order from the judge overseeing the multidistrict litigation, arguing that because their cases were filed after she ruled that general causation experts are inadmissible under Federal Rule of Evidence 702, they should be allowed to present their own experts.
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February 05, 2024
FDA: 111 More Deaths Reportedly Connected To Philips CPAP Devices
SILVER SPRING, Md. — The U.S. Food and Drug Administration released an update on medical device reports (MDRs) associated with the alleged breakdown of polyester-based polyurethane (PE-PUR) foam used in continuous positive air pressure (CPAP) devices, bi-level positive air pressure (Bi-PAP) devices and ventilators made by Philips Respironics, noting that 111 additional deaths have been reported.
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February 05, 2024
Hikma, Ad Agency Reach Settlements For Role In Opioid Crisis
NEW YORK — Hikma Pharmaceuticals has agreed to a $150 million multistate settlement for its role in the opioid epidemic, New York Attorney General Letitia James announced on behalf of the participating states; the attorney general also announced a separate $350 million settlement that resolves allegations that Publicis Health LLC, an advertising agency working with Purdue Pharma LP, “helped create and maintain a public nuisance.”
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February 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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February 01, 2024
CPAP MDL Judge Allows Plaintiffs To File Amended Master Personal Injury Complaint
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 has adopted and rejected certain recommendations from the special master and granted a motion to allow the plaintiffs to modify the master complaint for personal injuries (master PI complaint).
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February 01, 2024
Judge Allows 3rd Amended Complaint To Proceed In Defective Hip Device Case
FRANKFORT, Ky. — A Kentucky federal judge denied a “metal-on-metal” hip replacement device maker’s motion to dismiss a third amended complaint alleging injuries caused by a defective design.
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February 01, 2024
EBay Agrees To $59M Settlement For CSA Violation In Pill Press Machine Sales
WASHINGTON, D.C. — The U.S. Department of Justice announced Jan. 31 that eBay Inc. will pay $59 million to settle allegations that it violated the Controlled Substances Act (CSA) by selling thousands of pill presses and encapsulating machines through its website.
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January 31, 2024
Philips To Stop Selling CPAP Products Until FDA Consent Decree Is Finalized
WASHINGTON, D.C. — Koninklijke Philips NV said in a U.S. Securities and Exchange Commission filing that it has agreed to terms of a consent decree with the U.S. Food and Drug Administration related to the recall of approximately 10.8 million continuous positive air pressure (CPAP) sleep apnea devices and respirators and that as part of the decree, it will pause its sale of sleep therapy devices or other respiratory care devices in the United States.
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January 30, 2024
Man Appeals Dismissal Of Suit Alleging Injury From Shingles Vaccine
PHILADELPHIA — A man who alleges that his shingles vaccine caused him to develop Guillain-Barré syndrome (GBS) has filed a notice of appeal in the Third Circuit U.S. Court of Appeals, contending that the Pennsylvania federal judge overseeing the Zostavax multidistrict litigation erred in dismissing his case after finding his experts on specific causation unqualified to testify.
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January 30, 2024
Court: Pennsylvania Attorney General Can Enter Sweeping Opioid Settlement Agreement
HARRISBURG, Pa. — The attorney general for Pennsylvania had the authority to settle all claims that were part of a $26 billion nationwide settlement reached with various drug manufacturers for their role in the opioid crisis, including claims brought by district attorneys under the Unfair Trade Practices and Consumer Protection Law (UTPCPL), the Pennsylvania Commonwealth Court held, noting that it was a case of first impression.
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January 30, 2024
U.S. Supreme Court Sets Oral Argument Date For Abortion Drug Debate
WASHINGTON, D.C. — Oral arguments in the U.S. Supreme Court will be held March 26 on whether the Fifth Circuit U.S. Court of Appeals erred in upholding a district court’s stay of the Food and Drug Administration’s 2016 amendments to mifepristone’s approval and the agency’s 2021 decision not to enforce its regulations during the COVID-19 pandemic, the high court announced Jan. 29.
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January 30, 2024
9th Circuit Stays Mandate Reversing Court’s Dismissal In FCA Drug Pricing Suit
SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals granted a 90-day stay of the mandate reversing and remanding a district court’s dismissal of a relator’s qui tam suit alleging violations of the False Claims Act (FCA) against pharmaceutical companies related to their alleged fraud by artificially inflating drug prices.