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

Mealey's Drugs & Devices

May 08, 2024
Judge Dismisses 2nd Dispute Over Attorney Fees In Benicar MDL

CAMDEN, N.J. — A New Jersey federal judge on May 7 applied the doctrine of collateral estoppel in dismissing with prejudice claims that an improper amount of attorney fees were awarded to a law firm for its work in the Benicar multidistrict litigation.
May 08, 2024
New Expert Offers Same Opinions As Excluded Experts, ASD-ADHD MDL Defense Says

NEW YORK — The opinions of an expert retained by newly named plaintiffs in the acetaminophen autism spectrum disorder-attention deficit hyperactivity disorder (ASD-ADHD) multidistrict litigation who allege that prenatal exposure to acetaminophen causes autism or attention deficit hyperactivity disorder “are a classic example of ‘made for litigation’ opinions that require heightened judicial scrutiny,” the defendants argue in a motion to exclude.
May 07, 2024
2nd Circuit Issues Mandate Regarding Dismissal Of FCA Claims Affirmed On Appeal

NEW YORK — The Second Circuit U.S. Court of Appeals on May 6 issued a mandate regarding its ruling affirming a district court’s dismissal of a relator’s claim against a pharmaceutical company for violations of the federal False Claims Act (FCA) but vacating and remanding the lower court’s dismissal of state law claims, finding that the district court correctly found that the relator failed to show that the pharmaceutical distributor acted willfully pursuant to the FCA when allegedly giving customers business management tools in exchange for their agreements to purchase drugs.
May 07, 2024
FDA Issues Final Rule Designating In Vitro Diagnostic Products As Medical Devices

SILVER SPRING, Md. — The U.S. Food and Drug Administration on May 6 issued a final rule amending a regulation “to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act . . . including when the manufacturer of the IVD is a laboratory.”
May 06, 2024
Opioid MDL Judge Denies Request To Certify Questions To Georgia Supreme Court

CLEVELAND — The Ohio federal judge overseeing the opioid multidistrict litigation denied a request by Publix Super Markets Inc. to certify to the Georgia Supreme Court a series of questions for the high court to determine how the state’s public nuisance law applies, noting that he previously denied its request to certify a similar question.
May 06, 2024
Generic Opioid Drug Manufacturer Agrees To $272.5M Multistate Settlement

NEW YORK — The New York attorney general on May 3 announced that generic opioid manufacturer Amneal Pharmaceuticals has agreed to a multistate settlement for its role in the nationwide opioid crisis by failing to monitor and report suspicious orders.
May 03, 2024
Federal Judge Enters Judgment Against Endo Health For Mislabeling Opioid Drug

DETROIT — A Michigan federal court judge on May 2 entered a forfeiture money judgment of $450 million against Endo Health Solutions Inc. (EHSI) in favor of the United States, representing the proceeds obtained by the company as a result of its violation of the Food, Drug and Cosmetic Act (FDCA) by marketing its opioid drug Opana ER as crush- and tamper-resistant.
May 02, 2024
Federal Judge Finds Parts Of North Carolina’s Abortion Law Are Preempted

GREENSBORO, N.C. — A North Carolina federal judge ruled that portions of a state law governing pregnancy termination that “frustrate the congressional goal of establishing a comprehensive regulatory framework under which the FDA determines conditions for safe drug distribution” are preempted but let stand parts of the law that focus on the practice of medicine and a patient’s informed consent.
May 02, 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 02, 2024
Judge In Exactech MDL Selects 3 Bellwether Plaintiffs, Tells Parties To Find The 4th

BROOKLYN, N.Y. — The federal judge overseeing the Exactech orthopedic device multidistrict litigation has selected three cases to serve as the bellwether trials, with the first slotted to begin in June 2025.
May 02, 2024
Skin Cancer Drugmaker Loses Bid To Toss Negligence Case In Calif. Federal Court

LOS ANGELES — A California federal judge denied a drug manufacturer’s motion to dismiss a product liability suit filed by the family of a woman who died from an adverse drug reaction to a prescription skin cancer treatment drug, finding that the claims are not preempted by federal law and that the label did not adequately warn of the dangerous effects of the drug.
May 01, 2024
Hearing Set For Final Approval Of Opioid Third-Party Payers’ Claims Settlement

SAN FRANCISCO — McKinsey & Co. Inc. told the opioid promotion multidistrict litigation court that it has filed certain documents in compliance with the Class Action Fairness Act (CAFA) in preparation for a hearing scheduled for July to approve a $78 million settlement to end third-party payers (TPP) claims.
May 01, 2024
Oklahoma Federal Judge Dismisses Some Claims In Underfilled Drug Vial Cases

OKLAHOMA CITY — The Oklahoma federal judge overseeing cases involving claims that a company underfilled vials of the breast cancer drug Herceptin found that the plaintiffs have not stated a claim for relief under California’s unfair competition law (UCL) and false advertising law (FAL) and dismissed those claims.
April 30, 2024
Bard Denies Claims Made By Woman Alleging Defective IVC Filter Caused Damage

SEATTLE — C.R. Bard Inc. and Bard Peripheral Vascular Inc. filed an answer to a woman’s complaint in a Washington federal court, denying her allegations that its inferior vena cava (IVC) filter was defective and caused her significant injuries.
April 30, 2024
Insulin Manufacturers, PBMs Hit With RICO Suit Alleging Conspiracy

HARTFORD, Conn. — A union health benefit plan sued the top three insulin manufacturers and a host of pharmacy benefit managers (PBMs) in a Connecticut federal court, alleging that they conspired to artificially inflate the price of the prescription drug in violation of the Racketeer Influenced and Corrupt Organizations Act (RICO).
April 29, 2024
Publix: Georgia County Misses Point Of Motion To Certify Questions In Opioid Case

CLEVELAND — Publix Super Markets Inc. says Cobb County, Ga.’s opposition to its motion to certify to the Georgia Supreme Court a series of questions for the high court to determine how the state’s public nuisance law applies in the opioid multidistrict litigation actually demonstrates the need for the high court to weigh in.
April 29, 2024
Hernia Mesh MDL Judge OKs Dismissal Of 28 Cases After Agreements Reached

ATLANTA — The judge overseeing the Ethicon Physiomesh hernia patch multidistrict litigation granted a motion to dismiss with prejudice 28 cases after the parties told the court in a joint motion that they have settled all claims in those cases.
April 29, 2024
CPAP MDL Parties Reach $1.1B Settlement To End Injury, Medical Monitoring Claims

PITTSBURGH — Philips Respironics and the plaintiffs in the multidistrict litigation involving personal injuries caused by deteriorating sound insulation in Philips’ continuous positive airway pressure (CPAP) devices, which led to a recall of approximately 10.8 million sleep apnea devices, on April 29 announced an agreement for $1.1 billion to settle all personal injury claims and the medical monitoring class action.
April 26, 2024
MDL Judge Grants Final Approval To Economic Claims Settlement For CPAP Devices

PITTSBURGH — The federal judge overseeing the multidistrict litigation involving the recall of approximately 10.8 million continuous positive air pressure (CPAP) sleep apnea devices on April 25 granted final approval of a $506 million settlement to end all economic claims in addition to an award of $95 million for attorney fees and costs in connection with the settlement.
April 26, 2024
Indivior Proposes Plan For Phased Discovery In Suboxone MDL

CLEVELAND — Indivior Inc., a defendant in the Suboxonefilm multidistrict litigation, filed a supplemental proposal for phased discovery on general causation following a request from the judge overseeing the MDL during a conference meeting.
April 26, 2024
CGL Insurer Dismissed From Coverage Dispute Arising From Opioid Epidemic

SPARTANBURG, S.C. — Parties filed a stipulation in a South Carolina federal court dismissing one commercial general liability insurer without prejudice from the insurers’ lawsuit seeking a declaration that they have no duty to defend or indemnify against governmental entities’ underlying lawsuits alleging that their insured caused or contributed to the opioid crisis by improperly marketing, distributing and selling opioid medications.
April 25, 2024
Diabetes And Diet Drug MDL Names Co-Lead Counsel, Plaintiffs’ Committee Members

PHILADELPHIA — The federal judge overseeing the multidistrict litigation involving diabetes and diet drugs that consumers allege caused gastrointestinal and other injuries appointed counsel to lead the plaintiffs.
April 25, 2024
Pharmaceutical Company Says FDA’s Approval Of Generic Drug Violated FDCA

WASHINGTON, D.C. — A pharmaceutical company moved for summary judgment in its suit against the U.S. Food and Drug Administration, asking a federal judge in the District of Columbia to order that the FDA vacate its approval of the abbreviated new drug application (ANDA) for generic tasimelteon and recall the drug.
April 23, 2024
Judge Adopts Magistrate’s Recommendation To Deny Motion To Amend Taxotere Complaint

NEW YORK — A New York federal magistrate judge’s report and recommendation denying a motion to amend a complaint is “supported by the already vast body of case law denying Taxotere plaintiffs’ motions to amend,” a federal judge said in adopting the report.
April 23, 2024
SoClean Says MDL’s Plan For Third-Party Complaints Violates Federal Rules

PITTSBURGH — A manufacturer of equipment that uses ozone to clean or disinfect medical devices and accessories objected to a special discovery master’s report and recommendation filed in a multidistrict litigation involving the recall of approximately 10.8 million Philips continuous positive air pressure (CPAP) sleep apnea devices and respirators, arguing that the procedures outlined for handling third-party litigation are inadequate.