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

Mealey's Drugs & Devices

August 30, 2023
IVC Device Maker Sued By Law Firm For $1.1M In Unpaid Legal Fees

PHILADELPHIA — A law firm has sued a medical device manufacturer in a Pennsylvania court alleging that the company owes it more than $1.1 million in unpaid legal fees accrued while defending the device maker in a mass tort litigation over allegedly defective inferior vena cava (IVC) filters.
August 30, 2023
Heartburn Drug MDL Judge Rejects Plaintiffs’ Objections To Final Judgment Order

WEST PALM BEACH, Fla. — The Florida federal judge overseeing the multidistrict litigation on Zantac/ranitidine overruled various objections filed in response to a tentative order granting final judgment on certain cases alleging that the heartburn drug contained a chemical that causes cancer.
August 23, 2023
High Court Briefs In Purdue Pharma/Sackler Case Due Sept. 20, Oct. 20

WASHINGTON, D.C. — The U.S. Supreme Court has ordered merits briefs in the Purdue Pharma LP bankruptcy appeal to be filed by Sept. 20 and Oct. 20.
August 29, 2023
9th Circuit Asked To Allow Restricted-Abortion States To Intervene In Mifepristone Case

SAN FRANCISCO — Seven states with bans or tight restrictions on abortions tell the Ninth Circuit U.S. Court of Appeals that a federal district court in Washington erred by denying their motion to intervene in a case involving federal regulations for the abortion drug mifepristone.
August 29, 2023
Judge Denies Merck Summary Judgment In Mumps Vaccine Antitrust Class Action

PHILADELPHIA — A Pennsylvania federal judge has largely denied a motion by Merck & Co. Inc. to dismiss an antitrust complaint by three health care providers that Merck engaged in anti-competitive behavior to thwart a competitor and caused the providers to pay more for the childhood vaccine.
August 29, 2023
Special Master Recommends $2.14M In Common Fees In Atrium C-Qur Mesh MDL

CONCORD, N.H. — A special master has recommended that the New Hampshire court overseeing the Atrium C-Qur surgical mesh multidistrict litigation pay $2.14 million in common benefit fees and $1.12 million in common benefit expenses.
August 28, 2023
5th Circuit Affirms Dismissal Of Case Alleging Heart Device Injury

NEW ORLEANS — A trial court did not err in dismissing on res judicata grounds a man’s complaint alleging that he was injured by a defective heart device, a Fifth Circuit U.S. Court of Appeals panel ruled.
August 28, 2023
D.C. Circuit: Grant Of Exclusive Patent License Not Anticompetitive

WASHINGTON, D.C. — A panel of the District of Columbia Circuit U.S. Court of Appeals ruled Aug. 25 that allegations by Federal Trade Commission drugmakers violated antitrust law by the terms of a 2017 settlement in a breach of contract action fail to state a claim.
August 28, 2023
Exactech MDL Third-Party Payer Class Action Dismissed After MSP Recovery Drops Case

BROOKLYN, N.Y. — The New York federal judge overseeing the Exactech multidistrict litigation has dismissed a third-party payer class action after the plaintiffs failed to file an amended complaint addressing the court’s lack of subject matter jurisdiction.
August 25, 2023
Judge: W.Va. Law Restricting Use Of Abortion Drug Does Not Violate Constitution

HUNTINGTON, W.Va. — A West Virginia federal judge on Aug. 24 granted motions by the West Virginia attorney general and a county prosecutor to dismiss claims filed by an abortion drug manufacturer arguing that a state law curtailing the use of the drug violated the U.S. Constitution.
August 25, 2023
9th Circuit Allows Appeal Of RICO TPP Class Certification For Actos Cancer Risk

LOS ANGELES — The Ninth Circuit U.S. Court of Appeals granted a petition by two pharmaceutical companies for permission to appeal a decision by a district court to certify a national third-party payer (TPP) class of entities that paid for the diabetes drug Actos.
August 25, 2023
Georgia High Court Won’t Review Nonpreemption Ruling In Supplement Case

ATLANTA — The Georgia Supreme Court has denied cross-petitions for certiorari in a case where the state appeals court ruling that a consumer’s claim involving a dietary supplement is not preempted by the Food, Drug and Cosmetic Act (FDCA).
August 24, 2023
2 Bankruptcy Creditors Object To Martin Shkreli’s $168M Indemnification Claim

WILMINGTON, Del. — Two creditors of drugmaker Vyera Pharmaceuticals LLC on Aug. 23 objected to two bankruptcy court claims totaling $168 million filed by former CEO Martin Shkreli, saying Shkreli cannot be indemnified by his former companies for intentional and unlawful violations of antitrust laws.
August 24, 2023
Opioid Maker Mallinckrodt To File 2nd Chapter 11 Petition, Restructure Settlement

DUBLIN, Ireland — Drugmaker Mallinckrodt PLC on Aug. 23 told shareholders that it will file a second Chapter 11 bankruptcy petition that restructures the company’s second lien funded debt and the Opioid Master Disbursement Trust II.
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.