Mealey's Drugs & Devices : Mealey's : Legal News & Analysis

Mealey's Drugs & Devices

August 24, 2023
Preliminary Injunction To Maintain Access To Abortion Drug Denied By Federal Judge

CHARLOTTESVILLE, Va. — With no evidence that the Food and Drug Administration intends to limit access to the abortion drug mifepristone, a Virginia federal judge denied a motion for a preliminary injunction filed by a group of abortion providers that sought to enjoin the FDA from “‘altering the status quo’” in relation to access to the drug.
August 22, 2023
Judge Partly Dismisses Insurer’s Coverage Suit Against Medical Product Manufacturer

CONCORD, N.H. —A federal judge in New Hampshire granted a medical product manufacturer insured’s motion to dismiss the portion of commercial general liability insurer’s declaratory judgment lawsuit pertaining to 10 underlying class action lawsuits alleging that the insured manufactured and marketed continuous positive airway pressure (CPAP) and bi-level positive airway pressure devices that were not safe, healthy or effective, finding that the insurer’s coverage claim as to these underlying suits is untimely.
August 22, 2023
Georgia Supreme Court: Hospital Authority Can’t Challenge Opioid Settlement Law

ATLANTA — Finding that the text of the preemption provision in the Georgia Settlement Act “could not be plainer,” the Georgia Supreme Court on Aug. 21 ruled that a state entity cannot continue asserting claims against opioid manufacturers and distributors that entered into a global settlement with the state.
August 22, 2023
Teva, Glenmark Sign Deferred Prosecutions For Generic Price Fixing, Pay $305M

PHILADELPHIA — A U.S. attorney on Aug. 21 filed two deferred prosecution agreements with drugmakers Teva Pharmaceuticals USA Inc. and Glenmark Pharmaceuticals Inc. USA in which the defendants agree to pay a total of $305 million in criminal penalties and donate generic drugs to resolve criminal complaints that they conspired to fix prices and allocate market share for three generic drugs.
August 21, 2023
Indivior Settles Suboxone Antitrust End-Payer Class For $30 Million

PHILADELPHIA — Seven end-payer plaintiffs on Aug. 19 asked a Pennsylvania federal court to preliminarily approve a $30 million agreement that would settle a 10-year-old complaint that drugmaker Indivior Inc. engaged in anti-competitive behavior that caused the plaintiffs to pay higher prices for Suboxone brand buprenorphine, a drug used to treat opioid use disorder.
August 21, 2023
Ex-Insys CEO John Kapoor Must Repay Company $5.97M For His Criminal Legal Defense

WILMINGTON, Del. — A federal bankruptcy judge has recommended that Insys Therapeutics Inc. founder and CEO Dr. John N. Kapoor repay the company $5.97 million in legal advances for his criminal defense of racketeering charges.
August 18, 2023
Judge: Exclusions Do Not Bar Coverage For Claims Arising From Opioid Epidemic

GREENSBORO, N.C. — A federal judge in North Carolina on Aug. 17 ruled in favor of a wholesale pharmaceutical drug distributor insured in its lawsuit seeking coverage for underlying allegations that it failed to detect and investigate suspicious prescription opioids orders by pharmacies, rejecting the insurer’s argument that the policy’s contract and professional services exclusions bar coverage.
August 17, 2023
Investor Class Certified In Securities Case Against Medical Device Manufacturer

NEWARK, N.J. — A federal judge in New Jersey granted class certification for investors who bought shares of a medical device maker they allege concealed defects with its infusion pump product, made changes to it without Food and Drug Administration approval and made misleading statements to investors, finding that the investors met the Federal Rules of Civil Procedure requirements for class certification.
August 17, 2023
5th Circuit: Abortion Drug Stays On Market, But FDA Rule Changes Violate APA

NEW ORLEANS — In a 2-1 ruling, the Fifth Circuit U.S. Court of Appeals on Aug. 16 said a group of anti-abortion plaintiffs is too late in challenging the 2000 Food and Drug Administration’s approval of the abortion drug mifepristone, but the panel said the plaintiffs made a “substantial showing” that the FDA’s 2016 and 2021 changes loosening restrictions on the drug violate the Administrative Procedure Act (APA).
August 16, 2023
4th Circuit Vacates District Court Dismissal Of FCA Suit Against Walgreens

RICHMOND, Va. — The Fourth Circuit U.S. Court of Appeals on Aug. 15 vacated and remanded a district court decision dismissing a suit filed by federal and state governments alleging violations of the False Claims Act (FCA) and Virginia law, saying the court erred in finding that the governments did not “plausibly allege facts that establish materiality” regarding Walgreens’ alleged misrepresentation that certain patients met Medicaid eligibility requirements for hepatitis C drugs.
August 16, 2023
Ozempic, Mounjaro Makers Didn’t Warn Of Gastroparesis, Diabetic Woman Says

LAKE CHARLES, La. — A Louisiana women has filed a complaint against the makers of Ozempic and Mounjaro diabetes drugs alleging that the defendants failed to warn her about the risk of gastroparesis, or delayed stomach emptying.
August 16, 2023
8th Circuit: Pharmacies OK Denying Ivermectin, Hydroxychloroquine For COVID

ST. LOUIS — The Eighth Circuit U.S. Court of Appeals has affirmed that Minnesota law does not recognize a right of “self-determination” that overrides the judgment of the Food and Drug Administration, medical organizations and two pharmacies that ivermectin and hydroxychloroquine cannot be dispensed off-label to treat COVID-19.
August 16, 2023
Panel Refuses To Rehear D&O Coverage Suit Over Insured’s Settlement With Government

CHICAGO —The Seventh Circuit U.S. Court of Appeals refused to reconsider its finding that a directors and officers liability insurer owes the insured its $10 million policy limit for the $100 million the insured paid the U.S. government to settle potential claims that it violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), standing by its affirmation of a federal court’s summary judgment ruling in favor of the insured.
August 15, 2023
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
August 15, 2023
7th Circuit Affirms $3.3M Bard IVC Filter Verdict; 510(k) Properly Excluded

CHICAGO — The Seventh Circuit U.S. Court of Appeals affirmed a $3.3 million inferior vena cava (IVC) filter verdict against C.R. Bard Inc., ruling that the trial court did not err by excluding evidence about the device’s 510(k) approval or by reopening the plaintiffs’ case to hear testimony from the reluctant implanting physician.
August 15, 2023
CGL Insurers Dispute Coverage For Claims That Insured Contributed To Opioid Crisis

SPARTANBURG, S.C. — Commercial general liability insurers filed suit in a South Carolina federal court seeking a declaration that they have no duty to defend or indemnify against governmental entities’ underlying lawsuits alleging that their insured caused or contributed the opioid crises by improperly marketing, distributing and selling opioid medications.
August 15, 2023
Colorado Appeals Court: Split Verdict In Skin Resurfacing Case Not Inconsistent

DENVER — The Colorado Court of Appeals affirmed a $2.87 million judgment in a dermal resurfacing device injury case, finding that the learned intermediary doctrine did not bar verdicts for negligent marketing and misrepresentation and that the plaintiff’s claim of off-label marketing was not an attempt to enforce federal regulation of the device.
August 15, 2023
8th Circuit: Pelvic Mesh Expert’s Expanded Opinion Was Untimely

ST. LOUIS — The Eighth Circuit U.S. Court of Appeals has affirmed the exclusion of a plaintiff’s causation expert and summary judgment for the defendant in a pelvic mesh case, finding that the expert’s original opinion was insufficient, that an attempted supplement was untimely and that the plaintiff did not ask for a sanction other than summary judgment.
August 15, 2023
Brain Scan Maker, Founder Pay $445,000 For Giving Unfit Medicare Billing Codes

PHILADELPHIA — A medical device company and its co-founder will pay $445,000 to settle a False Claims Act complaint accusing them of promoting false billing codes for their eVox brain mapping device, according to a press release from the U.S. Attorney’s Office for the Eastern District of Pennsylvania.
August 15, 2023
Texas Settles Whistleblower Drug Fraud Claims Against Drugmakers For $42M

AUSTIN, Texas — The Texas Attorney General’s Office said in a press release that its Civil Medicaid Fraud Division has settled whistleblower claims involving the prescription drug Vyvanse against drugmakers Shire PLC, Baxter International Inc., Baxalta Inc., Viropharma Inc., Takeda Pharmaceuticals USA Inc. and Takeda Pharmaceuticals America for more than $42 million.
August 15, 2023
Teva, Acute-Care Hospitals Reach $126M Opioid, $49M Antidote Settlement

TEL AVIV, Israel — Drugmaker Teva Pharmaceutical Industries Ltd. told stockholders that it and acute care hospitals have reached an agreement in principle on the financial terms of a $126 million, 18-year settlement plus up to $49 million worth of the company’s naloxone overdose reversal drug for up to seven years.
August 15, 2023
Judge Tosses Qui Tam Action Alleging Government Misled By Merck’s Mumps Vaccine

PHILADELPHIA — A Pennsylvania federal judge found that “no reasonable jury could conclude that the alleged false claims were material to the [Centers for Disease Control and Prevention’s] purchasing decisions” and dismissed a qui tam action filed by two former Merck & Co. Inc. employees who allege that Merck violated the False Claims Act, 31 U.S.C. §§ 3729–3733, in its sale of its MMR-II and ProQuad mumps vaccines to the centers.
August 14, 2023
Federal Insulin Pricing Cases Centralized In MDL Before Judge Martinotti In New Jersey

WASHINGTON, D.C. — The Judicial Panel on Multidistrict Litigation (JPMDL) has centralized 13 federal insulin pricing lawsuits in a multidistrict litigation and assigned the MDL to Judge Brian R. Martinotti of the U.S. District Court for the District of New Jersey.
August 11, 2023
Judge In Acetaminophen Autism/ADHD MDL Denies J&J’s Interlocutory Appeal

NEW YORK — The New York federal judge overseeing the acetaminophen autism spectrum disorder-attention deficit hyperactivity disorder (ASD-ADHD) multidistrict litigation has denied a motion by Johnson & Johnson Consumer Inc. (JJCI) for certification of an interlocutory appeal of her orders denying two motions to dismiss on the grounds of preemption and lack of causation.
August 11, 2023
Pa. Federal Judge Pares Claims Against Manufacturer For Defective Breast Implant

PITTSBURGH — A woman asserting that a defective breast implant caused her to develop a rare cancer saw part of her complaint dismissed when a Pennsylvania federal judge ruled that she failed to adequately make a claim against the parent company and a subsidiary and that certain of her claims against the manufacturer are preempted by federal law.