Mealey's Drugs & Devices
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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.
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January 30, 2024
Judge Overrules Discovery Objections In FCA Suit, Says Scope Should Be Nationwide
SAN DIEGO — A California federal judge affirmed a magistrate judge’s discovery order and overruled Abbott Laboratories’ objections to the geographical scope of discovery in a suit alleging violations of the False Claims Act (FCA) and state false claims laws regarding an alleged kickback scheme to induce hospitals and physicians to use an Abbott cardiac medical device, finding that the complaint sufficiently alleges a “nationwide scheme.”
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January 30, 2024
Now Is Not Time To Start Remand Process, Hernia Pelvic Mesh Makers Tell MDL Court
COLUMBUS, Ohio — A motion by plaintiffs in the hernia mesh multidistrict litigation urging the court to begin the process of remanding cases is “premature, unreasonable, and counter-productive to its stated goals,” C.R. Bard Inc. and Davol Inc. argue in their opposition to a proposed case management order.
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January 30, 2024
Law Firm Tells Court To Reject Motion To Disqualify For Previous Governmental Work
CLEVELAND — Motley Rice LLC has rejected an argument from OptumRx that the law firm’s separate representation of other governmental investigations into the pharmacy benefits manager (PBM) means that it should be disqualified from representing parties in the opioid multidistrict litigation.
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January 30, 2024
Plaintiffs In ASD-ADHD MDL Ordered To Explain Why Cases Shouldn’t Be Dismissed
NEW YORK — The New York federal judge overseeing the acetaminophen autism spectrum disorder-attention deficit hyperactivity disorder (ASD-ADHD) multidistrict litigation told the plaintiffs who allege that prenatal exposure to acetaminophen causes autism or attention deficit hyperactivity disorder that they must explain why their cases should not be dismissed in light of a ruling that found the general causation experts are inadmissible under Federal Rule of Evidence 702.
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January 30, 2024
Suboxone Film Caused Permanent Tooth Decay, Kentucky Man Alleges
LEXINGTON, Ky. — The manufacturer of Suboxone film used to treat opioid use disorder failed to disclose that the drug can cause permanent damage to teeth, a Kentucky man who used the product for 10 years alleges in a state federal court.
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January 30, 2024
Judge: False, Misleading Claims Over Cough Drop Label Preempted By Federal Law
WHITE PLAINS, N.Y. — A New York federal judge granted a cough drop manufacturer’s motion to dismiss, finding that a woman’s putative class action alleging that the over-the-counter (OTC) product label is false and misleading is preempted under the Food, Drug and Cosmetic Act (FDCA).
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January 29, 2024
Panel: Opioid Suits Describe ‘Exclusively Deliberate’ Conduct, No Coverage Owed
SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals on Jan. 26 held that underlying allegations brought against a prescription drug distributor insured “describe exclusively deliberate conduct” and, therefore, there is no coverage owed, affirming a lower federal court’s summary judgment ruling in favor of insurers in their lawsuit disputing coverage for the underlying lawsuits prompted by the opioid epidemic.
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January 26, 2024
Shkreli Lifetime Ban From Drug Industry Affirmed By Appeals Court
NEW YORK — The Second Circuit U.S. Court of Appeals has affirmed a lifetime ban on former drug executive and convicted securities fraudster Martin Shkreli from the pharmaceutical industry.
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January 25, 2024
Johnson & Johnson To Pay $149.5 Million To Washington In Opioid Settlement
SEATTLE — Washington and Johnson & Johnson have reached an agreement in which the opioid manufacturer and raw material supplier will pay $149.5 million to the state for its role in fueling the opioid epidemic, the state announced Jan. 24.
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January 24, 2024
FDA, Danco Urge High Court To Reverse 5th Circuit’s Abortion Drug Decision
WASHINGTON, D.C. — The U.S. Food and Drug Administration and Danco Laboratories LLC, the manufacturer of Mifeprex-brand mifepristone, on Jan. 23 filed separate opening briefs in the U.S. Supreme Court, arguing that 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.
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January 24, 2024
N.C. Federal Judge Finds Claims Against Drugmaker Preempted, Dismisses Case
ASHEVILLE, N.C. — A North Carolina federal judge granted a motion to dismiss a second complaint filed by a woman who alleges that her arthritis medication damaged her kidneys after finding that her claims are preempted by the Food, Drug and Cosmetic Act (FDCA).
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January 19, 2024
Settlement Reached In Class Alleging Injuries From Ankle Monitoring Device
DENVER — A man seeking to represent a class of individuals who allege that they were injured by an alcohol tracking ankle monitor and the device’s manufacturer notified a Colorado federal court that the parties have reached a confidential settlement to resolve all claims.
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January 17, 2024
High Court Told ‘Chaos’ Will Ensue ‘In A World Without Chevron’ Deference
WASHINGTON, D.C. — The U.S. Supreme Court was told Jan. 17 that “chaos” will ensue “in a world without Chevron” deference by government attorneys, who urged it to apply stare decisis and uphold Chevron, which is being challenged in two cases arising out of federal fishing regulations.
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January 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.