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Mealey's Drugs & Devices

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.
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.
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.
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.
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.
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.
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.
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.
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.”
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.
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.
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.
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.
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.