SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals on July 9 affirmed dismissal of a whistle-blower’s claims against two drug companies for off-label promotion of two drugs, saying the relator failed to sufficiently allege that he had “direct and independent” knowledge of the defendants’ alleged fraud.
SILVER SPRING, Md. — Acting Food and Drug Administration Commissioner Janet W. Woodcock on July 9 ask the Department of Health and Human Services inspector general to conduct an independent review of interactions between drug maker Biogen and the FDA while the agency was considering whether to approve the Alzheimer’s drug Aduhelm.
NEW ORLEANS — The Fifth Circuit U.S. Circuit Court of Appeal on July 7 said a district court did not err in dismissing kickback qui tam lawsuits against two drug companies, agreeing that the United States controls such complaints and that the government showed during a hearing that the cost of the litigation would be burdensome in relation to the expected recovery even if the relator prosecuted the cases themself.
WASHINGTON, D.C. — St. Jude Medical LLC has agreed to pay $27 million to resolve allegations that it caused false claims to be submitted to three federal health care programs by failing to disclose a deadly battery defect in implantable heart devices St. Jude used to make, according to a settlement agreement disclosed July 8 by the U.S. Justice Department.
WASHINGTON, D.C. — Medical device manufacturers Alere Inc. and Alere San Diego Inc. (collectively, Alere) will pay $38.75 million to settle claims with the U.S. Department of Justice alleging that Alere violated the False Claims Act (FCA) by billing, and causing customers to bill, Medicare for rapid point-of-care devices, known as INRatio blood coagulation monitors, that the companies knew were defective, the department announced in a press release on July 8.
WHITE PLAINS, N.Y. — The Sackler family that controls OxyContin maker Purdue Pharma LP has agreed to a $4.32 billion settlement with 15 state attorneys general that also includes the disclosure of millions more documents including attorney-client communications and having the family name removed from charitable institutions, according to a bankruptcy court mediator’s report filed July 7 and to July 8 announcements by three of the settling attorneys general.
New developments in the following mass tort drug and device cases are marked in boldface type.
CHARLESTON, W.Va. — The West Virginia Supreme Court of Appeals on June 11 said the state’s 2015 comparative fault statute does not apply to opioid public nuisance claims by the state, cities, counties and hospitals but said the state’s Mass Litigation Panel erred by not safeguarding the right of opioid manufacturers, distributors and pharmacies to try issues common to the public nuisance claims by a jury.
SPRINGFIELD, Ill. — The Fourth District Illinois Appellate Court on June 3 affirmed that two Medtronic Inc. representatives did not voluntarily undertake medical care of a drug pump patient and that claims that they failed to fully inform doctors were preempted by federal law.
MADISON, Wis. — A Wisconsin federal jury on June 17 found medical device maker C.R. Bard Inc. strictly liable for failing to warn a woman about the risk that the company’s Meridian inferior vena cava (IVC) filter could fracture inside her and awarded her $3.3 million in compensatory damages.
PORTLAND, Ore. — An Oregon federal jury on June 22 found that a former sales executive for drug maker AstraZeneca Pharmaceuticals LP was terminated because she reported that the company may be promoting drugs for off-label uses and awarded her $2.38 million in back pay and noneconomic damages.
BOISE, Idaho — The Idaho Supreme Court on June 9 affirmed summary judgment in an electrostimulator burn case, agreeing with a trial court that the plaintiff failed to present expert evidence of a device defect and injury causation and raised other theories that are inapplicable or were first raised on appeal.
SEATTLE — Two shareholders of a pharmaceutical company that develops certain treatments for neurological diseases sued the company and its CEO in Washington federal court on June 25, alleging that the company’s use of doctoral research that had previously been conducted by the CEO in developing their treatments was tainted by the CEO’s “scientific misconduct” and that, as a result, the company’s positive statements regarding its business and financial condition were false and misleading pursuant to federal securities law.
PHILADELPHIA — The Third Circuit U.S. Court of Appeals on June 24 asked the Pennsylvania Supreme Court how it would rule on questions of negligent design and the strict liability involving a C.R. Bard Inc. inferior vena cava (IVC) filter lawsuit that was the subject of a defense summary judgment ruling at the trial court level.
MIAMI — A panel of the 11th Circuit U.S. Court of Appeals on June 24 upheld findings by a Florida federal judge that a false advertising plaintiff failed to establish that the existence of a specific representation or statement by a drug maker caused consumers to believe that a product was approved by the Food and Drug Administration.
NEW YORK — Johnson & Johnson has agreed to pay $230 million to the state of New York — and possibly an additional $30 million — to settle state court opioid lawsuits by the state and two counties, the parties announced June 26.
BROOKLYN, N.Y. — Retired Senior Judge Jack B. Weinstein died June 15 at age 99, just over one year after permanently stepping down after 53 years on the bench, according to the U.S. District Court for the Eastern District of New York.
HACKENSACK, N.J. — A New Jersey state court judge on June 8 issued an initial case management order after the state supreme court on May 28 designated state court cases involving the chemotherapy drug Tasigna as a multicounty litigation (MCL).
ATLANTA — The 11th Circuit U.S. Court of Appeals on June 2 affirmed summary judgment enjoining a stem cell clinic from treating patients until it can prove that its therapy is safe and effective.
HACKENSACK, N.J. — The New Jersey state court judge overseeing the state’s Allergan Biocell breast implant multicounty litigation (MCL) on May 4 found some claims to be preempted by federal law and others not preempted.