Leaders at the National Institutes of Health on Tuesday announced how the agency plans to spend the extra $500 million it received from the U.S. Congress to fight the opioid crisis, saying it will focus on strengthening addiction and abuse treatment and improving pain management.
Delaware’s Supreme Court late Monday upheld a $55.8 million breach of contract ruling from September 2017 that favored oncology drug developer Wellstat Therapeutics Corp., but called for revised prejudgment interest calculations under terms still likely to push the overall award above $70 million.
A Kansas federal judge on Monday ordered Humana Inc. to hand over within three weeks documents related to a multidistrict litigation accusing drugmaker Mylan NV of antitrust violations related to a surge in the price of its allergy treatment device, the EpiPen.
A media advertising consultant in California will disgorge several thousand dollars to shake the U.S. Securities and Exchange Commission's suit alleging he funneled proceeds from the sale of unregistered securities to insiders at a company that manufactures hemp health products, according to a consent judgment filed Tuesday in federal court.
The U.S. House of Representatives passed two dozen bills aimed at combating the opioid epidemic Tuesday, ranging from giving pharmacists more authority to refuse prescriptions to giving the National Institutes of Health more leeway in testing non-opioid pain treatments.
A special master in multidistrict litigation over the opioid crisis on Monday shot down “clearly overbroad” drugmaker requests for detailed medical information about patients, while also warning plaintiffs attorneys that not producing the information could jeopardize their bellwether cases.
A California state appeals court on Monday declined to revive a purported whistleblower suit alleging LabCorp had pressured a genetic counselor to alter a patient’s medical records and then fired her, saying there was nothing medical about the records or illegal about the changes the counselor was asked to make.
Shortly before a D.C. federal judge cleared AT&T’s $85 billion merger with Time Warner, the U.S. Department of Justice’s top antitrust official on Tuesday said in Washington, D.C., that consumer welfare will continue to be the cornerstone of DOJ antitrust enforcement, rejecting calls to expand the Antitrust Division’s goals to include concerns over democratic market structures or other social benefits.
A California federal judge let an Allergan PLC unit off the hook for proposed class action claims that it deceived customers with marketing materials that classified its “CoolSculpting” fat-freezing system as having been “cleared,” but not “approved” by the U.S. Food and Drug Administration.
An Illinois man accused of pocketing about $2 million from investors in his Wisconsin pharmaceutical company by lying about his work surrounding an experimental drug pled guilty to a single count of wire fraud Tuesday.
The U.S. Food and Drug Administration on Tuesday unveiled final guidance outlining its recommendations on how companies can share information with insurers about drugs and medical devices that’s not included in the labels, as well as information for uses that haven't yet been approved.
A veterinary pharmaceutical company likely didn't mislead investors about the timeline for bringing an appetite stimulant for dogs to market, a New York federal judge said in dismissing a proposed securities class action alleging that a delay in the drug's availability caused the company's stock to nosedive.
Counsel for a group of consumers who claim Zimmer Inc.’s NexGen knee implants failed as a result of flawed design told the Illinois federal judge overseeing their multidistrict litigation Tuesday that they have agreed on terms for a final confidential settlement.
Attorneys for the direct purchasers of the Lidoderm pain patch urged a California federal judge to approve more than $47 million in attorneys' fees and reimbursements out of a $166 million settlement with pharmaceutical companies Teikoku, Endo and Actavis.
Wilson Sonsini Goodrich & Rosati PC has scored a corporate attorney in Los Angeles from Squire Patton Boggs LLP with significant experience representing technology, life sciences and other growth companies in the United States and internationally, the firm announced Monday.
Federal prosecutors late Monday blasted an attempt by former executives at Insys Therapeutics Inc. to get more details about charges that they bribed doctors to boost sales of their fentanyl spray, saying the executives have more than enough information from the complaint and discovery.
Alta Partners, a private and venture capital investment firm focused on health care, has clinched its latest fund after raising $130 million from investors, with plans to focus on businesses that are developing biotherapeutics and technology enabled health care services, the firm has announced.
Following a challenge from Merck Sharp & Dohme Corp., the Patent Trial and Appeal Board said Friday that all but one claim in a patent related to Pfizer Inc.’s top-selling Prevnar 13 pneumonia vaccine were unpatentable as obvious under prior patents.
The Federal Circuit on Monday rejected Cook Medical's bid for attorneys' fees from a company that dismissed a patent suit against it over a kidney stone extraction device, in part because Cook did not say until after the litigation ended that it thought the case was unreasonable.
Drug manufacturers, distributors and pharmacies are launching counterattacks in multidistrict litigation over the devastating opioid crisis, according to newly filed documents that contain aggressive and wide-ranging assaults on bellwether suits in the historic MDL. Here, Law360 summarizes test cases filed by local governments and the drug companies’ attacks on them.
Although the U.S. Supreme Court has denied review on 12 False Claims Act-related petitions this term, at least six petitions raising FCA issues currently remain on the docket. And three of them appear to have already piqued the court’s interest, say Michael Waldman and Ralph Mayrell of Robbins Russell Englert Orseck Untereiner & Sauber LLP.
When an advertiser voluntarily participates in industry self-regulation before the National Advertising Division, it does so expecting to avoid litigation. Yet there is a consistent concern among advertisers that NAD participation may make consumer class action litigation more, rather than less, likely. Attorneys with Kelley Drye & Warren LLP examine whether NAD decisions actually provide fodder for class actions.
Litigation over e-cigarettes has thus far been limited to claims arising out of malfunctioning devices, but injury claims that result from widespread use of e-cigarettes that function exactly as intended will involve numerous interesting and contested insurance coverage issues, says Jonathan Viner of Nicolaides Fink Thorpe Michaelides Sullivan LLP.
On May 17, 1954, the U.S. Supreme Court decided Brown v. Board of Education, recognizing a moral and legal truth that should be beyond question in American society. The refusal by some of President Donald Trump's judicial nominees to say whether they believe the case was decided correctly is indicative of the narrow-minded elitism they would bring to the bench, says professor Franita Tolson of the University of Southern California's Gould School of Law.
Since the U.S. Supreme Court’s 2015 decision in Teva v. Sandoz changed the standard of review for factual findings made in the course of claim construction, the Federal Circuit has applied deference in just eight of the 24 cases that involved claim-construction extrinsic evidence. These decisions reveal some predictability, says Richard Zhang of Fisch Sigler LLP.
In deciding whether cloud computing is right for the organization or firm, an attorney must consider cloud computing’s significant impact on the electronic discovery process, say Daniel Garrie, managing partner at Law & Forensics LLC, and David Cass, chief information security officer at IBM Cloud.
Several of the opioid-related proposals under consideration in both houses of Congress would allow more practitioners to remotely prescribe treatment for opioid addiction. This would greatly increase providers' access to those suffering from addiction in rural areas, say Emily Wein and Amit Rao of Baker Donelson Bearman Caldwell & Berkowitz PC.
Receiving U.S. Food and Drug Administration approval is critical for any medical device company looking to bring new products to market. Only a handful of premarket approval applications and de novo reclassifications brave the advisory panel process each year. Gerry Prud’homme and Kristin Zielinski Duggan of Hogan Lovells offer six key points for companies preparing for an advisory panel meeting.
A growing number of recent governmental investigations and settlements calls into question the practice of pharmaceutical companies donating to independent charities that provide financial assistance with out-of-pocket drug costs to patients. In light of this emerging trend, donating to independent patient assistance programs should now be considered a high-risk activity, say attorneys with Ropes & Gray LLP.
In these politically divisive times, many ask whether our institutions and traditions can help us return to a greater consensus. In days long past, the legal profession could have been counted on to serve just such a function. But lawyers are now just as polarized as everyone else, says Samuel Samaro of Pashman Stein Walder Hayden PC.