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

Mealey's Drugs & Devices

June 06, 2024
Judge Limits Testimony In Design Defect Case, Grants Partial Summary Judgment

BOSTON — A Massachusetts federal judge partially dismissed a woman’s suit against a surgical stapler device manufacturer after finding that certain testimony from expert witnesses is inadmissible under the standards of Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals Inc.
June 06, 2024
Laboratory, Trade Association Challenge FDA’s Final FDCA Regulation Rule

SHERMAN, Texas — A national trade association representing leading laboratories and two of its members sued the U.S. Food and Drug Administration and others in a Texas federal court challenging a recently published final rule that laboratory-developed tests will be regulated as medical devices under the federal Food, Drug and Cosmetic Act (FDCA).
June 06, 2024
Pharmacy Benefit Managers Lose Motion To Dismiss Alaska’s Opioid Charges

ANCHORAGE, Alaska — A group of pharmacy benefits managers (PBMs) lost in large part a bid to dismiss charges that they helped fuel the opioid epidemic in Alaska when a federal judge there ruled that the public nuisance and violation of the Alaska Unfair Trade Practices and Consumer Protection Act (CPA) claims can continue.
June 05, 2024
Federal Judge OKs Walgreens Settlement With San Francisco For Opioid Crisis

SAN FRANCISCO — A California federal judge on June 4 granted final approval to a $229,610,002 settlement between San Francisco and Walgreen Co. to end claims that the pharmacy chain contributed to the public nuisance that fueled the opioid epidemic in the city.
June 05, 2024
U.S. High Court Extends Response Deadline In Review Of 9th Circuit FCA Suit Ruling

WASHINGTON, D.C. — The U.S. Supreme Court on June 3 granted a 30-day extension for the qui tam plaintiff in a district court decision to respond to pharmaceutical companies’ petition seeking review of the Ninth Circuit U.S. Court of Appeals’ reversal of a district court’s dismissal of a suit accusing them violating the False Claims Act (FCA) by artificially inflating drug prices, arguing in part that the Ninth Circuit “created a circuit split by holding that a relator can avoid the public disclosure bar by ‘stitching together’ public disclosures.”
June 05, 2024
Innovasis, Executives Agree To Settle FCA Violation Claims For $12 Million

DALLAS — A spinal device manufacturer and two of its executives have agreed to pay $12 million to settle allegations that they paid kickback to surgeons to use their devices in violation of the False Claims Act (FCA), according to an unsealed settlement agreement filed in a Texas federal court.
June 04, 2024
Valsartan MDL Judge Orders Parties To Finalize Settlement Terms With Drugmaker

CAMDEN, N.J. — The New Jersey federal judge presiding over the valsartan/losartan/irbesartan hypertension drugs multidistrict litigation ordered the plaintiffs and the maker of the valsartan and losartan medications to finalize the terms of the valsartan settlement of personal injury, economic loss and medical monitoring claims by June 30 and to meet with a magistrate judge to continue settlement negotiations to resolve the losartan economic loss claim.
June 04, 2024
Judge Won’t Reconsider Order That Taxotere Plaintiffs Show Proof Of Diagnosis

NEW ORLEANS — The federal judge overseeing the Taxotere hair loss multidistrict litigation rejected a request to vacate her order that plaintiffs must show proof of a diagnosis of permanent chemotherapy-induced alopecia (PCIA).
June 03, 2024
Hernia Mesh MDL Judge Grants Dismissal Of 14 Cases After Agreements Reached

ATLANTA — Another 14 cases in the Ethicon Physiomesh hernia patch multidistrict litigation have been dismissed with prejudice after the parties told the court in a joint motion that they have settled all claims in those cases.
May 29, 2024
COMMENTARY: Review Of Expert Causation Testimony Under Federal Rule Of Evidence 702: An Early Assessment Of The 2023 Amended Rule

By William L. Anderson and Mark A. Behrens
June 03, 2024
4th Bellwether Plaintiff Selected For Exactech MDL

BROOKLYN, N.Y. — The federal judge overseeing the Exactech orthopedic device multidistrict litigation announced the name of the fourth bellwether plaintiff after the parties conferred to select a consensus pick.
May 31, 2024
Novo Nordisk Sues Pharmacy For Selling Compounded Drugs Containing Semaglutide

HOUSTON — Novo Nordisk Inc. on May 30 filed a complaint in a Texas federal court, asking that a pharmacy be enjoined from “selling misbranded injectable, non-FDA approved drugs that claim to contain semaglutide.”
May 31, 2024
Magellan To Plead Guilty, Agrees To $42M Settlement For Faulty Lead Tests

BOSTON — A Massachusetts medical device company has agreed to pay $42 million and plead guilty in a deferred prosecution agreement to resolve claims that it misled consumers and the U.S. Food and Drug Administration by concealing a malfunction in the company’s lead tests that produced inaccurately low test results.
May 29, 2024
Lilly Appeal Of Attorney Fees Consolidated With Others In False Claims Act Judgment

CHICAGO — The Seventh Circuit U.S. Court of Appeals on May 28 ordered that an appeal filed by Eli Lilly & Co. over a district court’s award of attorney fees and expenses be consolidated with other appeals stemming from a $193 million judgment after the company was found to have underpaid Medicare drug rebates owed to the United States.
May 28, 2024
5th Circuit Holds Generic Drugmakers Not Required To Change Label

NEW ORLEANS — The Fifth Circuit U.S. Court of Appeals on May 24 found that three generic drug manufacturers did not have newly acquired risk information that could have been added to the label of a chemotherapy drug that allegedly caused permanent chemotherapy-induced alopecia (PCIA) in cancer patients with the possible exception of one abstract presented at a December 2013 conference and remanded the case to the trial court to consider the incidence rate of minimal cases in that study.
May 28, 2024
Illinois Jury Returns Defense Win In 1st Zantac Trial

CHICAGO — An Illinois state jury rejected a woman’s claim that the heartburn drug Zantac caused her to develop colon cancer, signifying a win for the drug manufacturers in the first case to go to verdict.
May 24, 2024
Hawaii Wins $916M Judgment Against Bristol-Myers, Sanofi For Plavix Warnings

HONOLULU — A Hawaii state court judge ordered Bristol Myers Squibb Co. (BMS) and Sanofi-Aventis U.S. LLC to pay more than $916 million for violating the state’s unfair trade practices law by failing to warn patients of East Asia and Pacific Island ancestry that their genetic variants rendered the antiplatelet drug Plavix ineffective for them in a case that was remanded from the state Supreme Court.
May 24, 2024
Acella Pharmaceutical Agrees To $41M Settlement For Faulty Thyroid Hormone Drugs

GAINESVILLE, Ga. — A Georgia federal judge granted final approval to a $41 million settlement to end claims that a pharmaceutical company made and sold thyroid hormone pills that were subpotent and awarded $5 million in attorney fees.
May 24, 2024
Man Asks Court To Order FDA To Respond To Petition To Update SSRI Warning Labels

WASHINGTON, D.C. — A professor researching the risk of sexual dysfunction after stopping selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) drugs filed a complaint asking a District of Columbia federal court to declare that the U.S. Food and Drug Administration failed to respond to a citizen petition requesting that the warning labels be changed and to order the FDA to issue a decision within 30 days.
May 23, 2024
Pa. Federal Judge Overseeing Diabetes And Diet Drug MDL Dies; Schedule Altered

PHILADELPHIA — A case management order has been vacated and a scheduled Science Day canceled for the multidistrict litigation involving diabetes and diet drugs that consumers allege caused gastrointestinal and other injuries, following the recent death of U.S. Judge Gene E.K. Pratter of the Eastern District of Pennsylvania, who was appointed to oversee the MDL in February.
May 21, 2024
GenBioPro: W.Va.’s Law Banning Abortion Does Not Protect Citizens’ Health

RICHMOND, Va. — GenBioPro Inc., the maker of generic mifepristone, one of two drugs used to induce early termination of pregnancy, on May 20 told the Fourth Circuit U.S. Court of Appeals that the West Virginia Unborn Child Protection Act (UCPA), which bans abortion in almost all cases, is not protected by the state’s power to guard its citizens’ health.
May 20, 2024
Texas High Court: Judicial Estoppel Bars Fen-Phen Lawyer’s Arguments In Fee Case

AUSTIN, Texas — The Texas Supreme Court on May 17 found that a plaintiff law firm in a long-running fen-phen fee dispute is “judicially estopped from establishing an essential component” in its motion for summary judgment, affirming a ruling by the state appeals court that reversed the summary judgment order of the trial court.
May 17, 2024
McKinsey MDL Judge Allows Claims Over Neonatal Abstinence Syndrome To Move Forward

SAN FRANCISCO — The California federal judge presiding over the McKinsey & Co. opioid promotion multidistrict litigation on May 16 partially granted and partially denied McKinsey’s motion to dismiss an amended complaint filed on behalf of minors born with neonatal abstinence syndrome (NAS).
May 16, 2024
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
May 16, 2024
Paragard IUD MDL Judge Makes Changes To Plaintiff Counsel Leadership

ATLANTA — The Georgia federal judge overseeing the Paragard IUD (intrauterine device) multidistrict litigation revised the plaintiffs’ leadership structure in a recent order, removing eight members from the Plaintiffs’ Steering Committee (PSC), among other changes.