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Mealey's Drugs & Devices

April 10, 2024
Pharma Companies Seek High Court Review Of Ruling Reversing FCA Suit Dismissal

WASHINGTON, D.C. — Pharmaceutical companies accused of violating the False Claims Act (FCA) by artificially inflating drug prices filed a petition for writ of certiorari in the U.S. Supreme Court, seeking review of the Ninth Circuit U.S. Court of Appeals’ reversal of a district court’s dismissal of a qui tam suit against them, arguing, in part, that the panel “created a circuit split by holding that a relator can avoid the public disclosure bar by ‘stitching together’ public disclosures.”
April 09, 2024
McKinsey MDL Judge OKs $39.5M Settlement Agreement With Tribal Plaintiffs

SAN FRANCISCO — The California federal judge presiding over the McKinsey & Co. opioid promotion multidistrict litigation has signed off on a $39.5 million settlement reached between the consulting company and a group of Native American tribes.
April 09, 2024
2nd Circuit Agrees Statute Of Limitations Bars Defective Medical Device Suit

NEW YORK — The Second Circuit U.S. Court of Appeals agreed that a woman’s product liability and breach of warranty claims against two medical device companies were properly dismissed by a district court and denied the woman’s appeal of the summary judgment award.
April 04, 2024
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.
April 04, 2024
Oral Arguments Set For Theranos’ Elizabeth Holmes Fraud Conviction Appeal

SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals will hear oral arguments on June 11 in Theranos Inc. founder Elizabeth Holmes’ appeal of her conviction; Holmes argues that there was insufficient evidence to convict her of defrauding investors in her blood testing startup and that she was prevented from presenting exculpatory evidence.
April 04, 2024
Dispute Over Attorney Fees In Benicar MDL Stays In Federal Court, Judge Says

CAMDEN, N.J. — A New Jersey federal judge refused to send a dispute involving the proper amount of attorney fees that should have been awarded to a law firm for its work in the Benicar multidistrict litigation back to state court, denying a motion to remand filed by a group of plaintiffs.
April 03, 2024
Alaska Judge Finds Public Nuisance Laws Don’t Apply In Opioid Suit

ANCHORAGE, Alaska — An Alaska Superior Court judge found that the state’s argument that the actions of various pharmacies in the sale and distribution of opioids created a public nuisance “is a bridge too far to take” and granted final judgment to dismiss the case.
April 03, 2024
Proposed Co-Lead Counsel Named For Diabetes And Diet Drug MDL; 1 Firm Objects

PHILADELPHIA — Attorneys involved “in the vast majority of complaints on file have reached agreement on a proposed leadership structure for the cases consolidated” in the multidistrict litigation involving diabetes and diet drugs that consumers allege caused gastrointestinal and other injuries, according to a motion filed in the U.S. District Court for the Eastern District of Pennsylvania.
April 03, 2024
Kentucky Federal Judge Allows Defective Hip Device Case To Move Forward

FRANKFORT, Ky. — A Kentucky federal judge denied a “metal-on-metal” hip replacement device maker’s motion to dismiss portions of a woman’s third amended complaint for failure to state a claim, allowing a case that has been transferred from the Pinnacle hip implant products liability multidistrict litigation pending in the Northern District of Texas to proceed.
April 02, 2024
Parties In Exactech MDL Debate Need For In Camera Meeting To Discuss Settlement

BROOKLYN, N.Y. — Counsel for plaintiffs in the Exactech orthopedic device multidistrict litigation said the parties “are nowhere close to reaching any proposed settlement” and urged the judge overseeing the cases to reject a request from the device manufacturer for an in camera, off-the-record conference.
April 01, 2024
La. Federal Judge Selects Bellwether Cases In Taxotere Eye Injury MDL

NEW ORLEANS — The judge overseeing multidistrict litigation for cases alleging that a chemotherapy drug caused eye injuries announced March 29 the six cases that will be included in the bellwether pool.
April 01, 2024
9th Circuit Sets Argument Date For Appeal Of Theranos’ Balwani Trial, Sentence

SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals will consider during oral arguments on June 11 whether a lower court erred in admitting lay witness testimony, among other arguments, during the trial of former Theranos Inc. Chief Operating Officer Ramesh “Sunny” Balwani, according to a March 31 docket entry.
March 29, 2024
FCA Suit Against Allergan Tossed, But Judge Allows ‘Last Opportunity’ To Amend

CHICAGO — An Illinois federal judge dismissed without prejudice relators’ third amended qui tam complaint against Allergan asserting violations of the federal False Claims Act (FCA) and numerous state false claims laws regarding allegations that Allergan paid unlawful kickbacks to physicians to prescribe opioid drugs for off-label uses, finding it “appropriate” to allow the relators “one chance to fix the deficiencies the Court has identified.”
March 28, 2024
MDL Judge Finds Some Claims In All Gardasil Cases Barred By Vaccine Act

STATESVILLE, N.C. — The federal judge overseeing the Gardasil multidistrict litigation partially granted the drug manufacturer’s motion for partial judgment on the pleadings for claims asserted by two women who claim injuries caused by the vaccine, also declaring that the ruling will apply to all cases in the MDL.
March 27, 2024
5th Circuit Affirms Dismissal Of Woman’s Defective Mesh Device Claims

NEW ORLEANS — The Fifth Circuit U.S. Court of Appeals on March 26 rejected a woman’s argument on appeal that a trial court erred in adopting a magistrate judge’s recommendation to grant summary judgment to a medical device manufacturer in an injury case, agreeing that she failed to assert the required facts to prove her claims.
March 26, 2024
Justices Hear Arguments On Restrictions To Access To Abortion Drug Mifepristone

WASHINGTON, D.C. — Oral arguments were held March 26 before the U.S. Supreme Court with the government arguing that a group of anti-abortion advocates lack standing in the case that challenges the U.S. 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, and Justice Ketanji Brown Jackson questioning the “significant mismatch in this case between the claimed injury and the remedy that's being sought.”
March 26, 2024
California Woman Alleging Hair Loss From Cancer Drug Cannot Amend Complaint

SAN FRANCISCO — A woman whose case was remanded from the Taxotere hair loss multidistrict litigation cannot amend her complaint, a California federal judge ruled, finding that similar attempts have been unsuccessful in the MDL and other remanded cases.
March 25, 2024
4th Circuit Sends Certified Question To W.Va. High Court On Opioid Nuisance Claim

RICHMOND, Va. — The Fourth Circuit U.S. Court of Appeals has certified a question to the West Virginia Supreme Court of Appeals to address the dispute over whether the state’s public nuisance law applies to the sale and distribution of opioids.
March 25, 2024
Opioid MDL Rejects Calls To Disqualify Motley Rice Over Previous Government Work

CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation ruled “that disqualification of Motley Rice is unnecessary and inappropriate in the circumstances of this case,” rejecting calls 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 MDL.
March 25, 2024
Executives Convicted Of Off-Label Marketing File Petition With High Court

WASHINGTON, D.C. — Two former Acclarent Inc. executives convicted of distributing and misbranding medical devices sold in interstate commerce filed a petition for a writ of certiorari with the U.S. Supreme Court asking it to review the First Circuit U.S. Court of Appeals’ decision that affirmed their convictions, arguing that the U.S. Food and Drug Administration’s “intended use” regulations violate their constitutional rights.
March 25, 2024
Suboxone MDL Judge Allows New Cases To Be Filed Directly In Ohio Federal Court

CLEVELAND — The judge overseeing the Suboxone film multidistrict litigation filed a case management order allowing users of the prescription drug that treats opioid use disorder who allege that the drug caused extensive dental decay to file directly in the U.S. District Court for the Northern District of Ohio for inclusion in the MDL.
March 18, 2024
Panel Refuses To Disturb No Coverage Ruling In Suit Arising From Opioid Epidemic

SAN FRANCISCO — A panel of the Ninth Circuit U.S. Court of Appeals unanimously voted to deny a prescription drug distributor insured’s petition seeking rehearing of the panel’s Jan. 26 ruling that there is no coverage owed for lawsuits prompted by the opioid epidemic because the underlying claims “describe exclusively deliberate conduct.”
March 18, 2024
High Court: FDA, Danco Can Divide Time For Oral Arguments In Abortion Drug Case

WASHINGTON, D.C. — The U.S. Supreme Court on March 15 granted a motion filed by the U.S. solicitor general to allow counsel for the U.S. Food and Drug Administration and Danco Laboratories LLC, the manufacturer of Mifeprex-brand mifepristone, to divide time for oral arguments in a case on whether the Fifth Circuit U.S. Court of Appeals erred in upholding a district court’s stay of the FDA’s 2016 amendments to mifepristone’s approval and the agency’s 2021 decision not to enforce its regulations during the COVID-19 pandemic.
March 15, 2024
Judge Won’t Strike ‘Allegedly Scandalous Material’ In FCA Suit Against Medtronic

KANSAS CITY, Kan. — A Kansas federal judge denied Medtronic’s request to strike purportedly false allegations in a qui tam suit alleging that Medtronic and its related company and a hospital violated the False Claims Act (FCA) by participating in a scheme to provide medically unnecessary treatment resulting in the submission of false claims for payment to federal health care programs, finding that “the court has no grounds to strike” “the allegedly scandalous material.”
March 14, 2024
Mass Tort Cases For Drugs, Medical Devices

New developments in the following mass tort drug and device cases are marked in boldface type.