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

Mealey's Drugs & Devices

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.
April 22, 2024
Walgreens To Pay $110 Million To Philadelphia For Role In City’s Opioid Crisis

PHILADELPHIA — Philadelphia announced April 19 that it has reached a $110 million settlement with Walgreen Co. to settle claims that its failure to monitor suspicious opioid prescriptions or ensure that it dispensed opioid pain medications for a legitimate medical purpose caused harm to the city.
April 19, 2024
Endo Health Pleads Guilty In Michigan Federal Court To Mislabeling Opioid Drug

DETROIT — Endo Health Solutions Inc. (EHSI) on April 18 pleaded guilty in a Michigan federal court to violating the Food, Drug and Cosmetic Act (FDCA) by marketing its opioid drug Opana ER as crush and tamper resistance.
April 18, 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 18, 2024
Federal Circuit Defines ‘Surgical Intervention’ In Vaccine Injury Act Appeal

WASHINGTON, D.C. — The Federal Circuit U.S. Court of Appeals found that a lower court “relied upon a legally erroneous construction of ‘surgical intervention’” and reversed and remanded a decision that a claim was ineligible for compensation under the National Childhood Vaccine Injury Act.
April 17, 2024
Settlement With Eli Lilly Over Insulin Costs Falls Apart In National Class Action

NEWARK, N.J. — A proposed settlement between Eli Lilly & Co. and class members in which the drugmaker would pay $13.5 million for an insulin price claims fund and ensure that class members will have prices for certain Lilly insulins capped at $35 a month for four years is off the table, lawyers for the plaintiffs told a New Jersey federal judge.
April 17, 2024
Taxotere MDL Judge Denies Motions For Reconsideration Of Dismissed Cases

NEW ORLEANS — The Louisiana federal judge overseeing the Taxotere hair loss multidistrict litigation denied 10 motions for reconsideration filed by plaintiffs whose cases were dismissed for failure to comply with a court-ordered deadline to properly serve their complaints.
April 17, 2024
FDA Recalls Heart Devices Linked To Injuries, Death

SILVER SPRING, Md. — The U.S. Food and Drug Administration has announced a recall of nearly 14,000 HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS), citing reports that buildup in components can obstruct the device and make it less effective in helping the heart pump blood.