A former U.S. Food and Drug Administration's compliance director told a California judge Monday that the agency had reviewed the instructions and brochures for Johnson & Johnson subsidiary Ethicon's pelvic mesh devices and never found them misleading, as a bench trial over the state's claims that J&J falsely marketed the devices entered its eighth week.
A D.C. federal judge erred badly by striking down a new requirement for drugmakers to disclose product prices in television advertisements, the U.S. Department of Health and Human Services told the D.C. Circuit on Monday.
A New York lawyer representing medical marijuana patients in a suit against the U.S. Department of Justice launched a congressional campaign Monday, telling supporters that any effort to legalize cannabis federally must address the human rights issues in play.
A Massachusetts federal judge handed Keryx Biopharmaceuticals Inc. a win in a proposed shareholder class action on Monday, ruling that the sole remaining plaintiff bought his shares of the company after vital information about its kidney drug had already been disclosed.
An Illinois woman on Friday hit Allergan Inc. with a proposed class action claiming that it knew about links between its textured silicone breast implants and a rare form of cancer long before the implants were recalled globally.
The U.S. Department of Justice on Monday sued a Philadelphia-based pharmacy in Pennsylvania federal court, alleging that its owner and pharmacist billed Medicare for prescriptions that it never purchased or dispensed to patients to pad their pockets with at least $1 million.
The Rhode Island federal judge handling Loestrin buyers' fraud and antitrust claims against drugmakers Warner Chilcott and Watson Pharmaceuticals directed both sides to answer questions related to the pharma companies' market power ahead of next week's potentially packed case hearing.
A trio of state lawmakers is pushing to legalize medical marijuana in Wisconsin, proposing a bill that would allow patients with certain medical conditions to access the drug if they are referred by a doctor, join a state registry and have no felony record.
Four biotechnology companies set price ranges Monday on initial public offerings that could raise a combined $526 million to develop drugs that fight cancer and other diseases, signaling a busy start for October’s IPO market.
Canfield Scientific Inc. has told the Federal Circuit that the Patent Trial and Appeal Board disregarded an abundance of reasons the biotech company put forth to prove that a Melanoscan LLC patent covering a skin cancer detection device was invalid as obvious.
A Florida federal judge has thrown out an employee's suit claiming Johnson & Johnson Vision Care Inc. refused to consider her for an executive position because she's a woman, finding that she hadn't shown the company's stated reasons for passing her over were a smokescreen for bias.
A Florida federal judge on Friday dismissed Johnson & Johnson from a suit alleging a pelvic mesh product from its Ethicon unit severely injured a woman, after agreeing with the pharmaceutical giant that the plaintiff failed to provide any legal ground to back up her claims against J&J.
Two e-cigarette companies would be banned from using actors and social media influencers under the age of 30 in their marketing and be "severely restricted" in other areas of their California advertising and promotional strategies under a lawsuit settlement announced Friday by the Los Angeles city attorney.
A Connecticut judge has upheld a jury's finding that Boehringer Ingelheim's blood thinner Pradaxa caused a man's internal bleeding, but in a surprise twist, the post-verdict ruling could spell the end of thousands of other consolidated Pradaxa suits.
A top House Democrat has filed legislation aimed at cutting drug prices by outlawing a pharmaceutical industry practice known as “product hopping,” which pushes patients onto new, exclusively sold drugs when the companies’ patents on existing ones are set to expire.
Allergan was slammed Friday with a proposed securities class action in New Jersey federal court seeking to block its blockbuster merger with AbbVie until the company provides its shareholders with certain information related to the proposed $63 billion deal.
Johnson & Johnson's decision this year to risk a $17 billion penalty in the nation's first opioid-crisis trial added one of the most dramatic chapters yet to the company's increasingly remarkable willingness to spurn settlements and litigate financially perilous cases all the way.
A Tennessee federal judge on Friday certified a class of thousands of Lovenox buyers in a suit from a Nashville hospital and a union health plan accusing Momenta and Sandoz of conspiring to monopolize the blood clot drug and its generic version.
A woman who claims she’ll live in pain for the rest of her life because of Johnson & Johnson’s allegedly faulty pelvic mesh implant can keep $15 million of an earlier $20 million verdict, a Pennsylvania appeals court said Friday, rejecting calls by J&J to kill the award entirely.
Seven law firms will steer four initial public offerings slated to price during the week of Sept. 23, led by an estimated $1.1 billion offering by home exercise startup Peloton Interactive and Hollywood talent agency Endeavor Group's potential $600 million IPO.
Camber Capital Management on Friday became the second activist investor this month to seek a shake-up at Amag Pharmaceuticals Inc., saying in a securities filing that the Massachusetts-based drugmaker’s stock is undervalued and suggesting board changes may be appropriate.
The U.S. Food and Drug Administration on Friday laid out a proposed rule setting requirements for companies seeking approval of their e-cigarette products, including keeping records on the legal marketing of their products.
The law under which a Massachusetts federal jury convicted two pharmacists at the New England Compounding Center actually didn't apply to their responsibilities at the company, their attorneys told a Massachusetts federal judge in court Friday as they moved for acquittal.
Two pharmaceutical companies admitted that they broke U.K. competition law when they agreed to fix the quantities and prices of the supply of an antidepressant drug, Britain’s antitrust regulator said Friday.
A divided D.C. Circuit panel on Friday revived a former Howard University veterinarian's suit alleging she was fired for alerting the National Institutes of Health to inhumane lab conditions, saying the trial court took "too narrow a view" of the False Claims Act, which protects workers who report fraud in government contracts.
As an early advocate of the American Bar Association's year-old well-being pledge, we launched an integrated program to create and sustain a supportive workplace culture with initiatives focused on raising mental health awareness, embracing creativity and giving back to the community, says Casey Ryan at Reed Smith.
Recent case law developments and analysis of U.S. Patent and Trademark Office data reveal that the legal status of cannabis in the U.S. may have depressed inventing vis-a-vis Canada and that design patents are a missed opportunity for cannabis companies, says Joshua Glucoft of Irell & Manella.
The Committee on Foreign Investment in the United States' critical technologies pilot program has had relatively minor impact on the U.S. biotech industry in the last year, but proposed rules unleashed by the Foreign Investment Risk Review Modernization Act will soon reshape the relationship between the government and the biotech industry, says Richard Matheny of Goodwin.
Our firm drives a holistic concept of well-being through educational opportunities, such as a series of expert-led workshops intended to address mental health and substance abuse issues that we vowed to fight when we signed the American Bar Association's well-being pledge one year ago, says Krista Logelin at Morgan Lewis.
A recent report by the U.S. Government Accountability Office on Medicare Part D drug prices provides novel insights concerning the variability of negotiated discounts across drugs and insurers, and reveals several factors that may be responsible for the fluctuation in rebating across health insurance plans, say consultants at Analysis Group.
Signing the American Bar Association's well-being pledge last year was a natural progression of our firm's commitment to employee wellness, which has included developing partnerships with professionals in the mental health space to provide customized programming to firm attorneys and staff, say Annette Sciallo and Mark Goldberg at Latham.
Sales of products containing CBD are booming, but companies selling them are still faced with a regulatory quagmire, struggling to understand how to legally promote, label and distribute CBD consumables in light of gridlock at the U.S. Food and Drug Administration and inconsistent state laws, say attorneys at DLA Piper.
One year ago, our firm signed the American Bar Association's well-being pledge and embraced a commitment to providing on-site behavioral health resources, which has since become a key aspect of our well-being program, say Meg Meserole and Kimberly Merkel at Akin Gump.
Recent actions by the U.S. Food and Drug Administration and lawsuits filed by drug manufacturers indicate that it is more important than ever for outsourcing facilities to comply with FDA policies regarding bulk drug substances allowed for use in compounding, say attorneys at Ropes & Gray.
As a result of the Federal Circuit's recent holding in Genetic Veterinary Sciences v. Laboklin that consenting to a cease-and-desist letter was sufficient to provide specific personal jurisdiction, foreign patent holders should pay careful attention to their license agreements and their enforcement and commercial activities within the U.S., say Daniel Melman and Sarah Benowich of Pearl Cohen.
After our firm signed the American Bar Association’s well-being pledge one year ago, we launched two key programs that included weekly meditation sessions and monthly on-site chair massages to help people address both the mental and physical aspects of working at a law firm, says Marci Eisenstein at Schiff Hardin.
The Federal Circuit's recent patent decisions in Ajinomoto v. U.S. International Trade Commission and Eli Lilly v. Hospira — on the tangential relation exception to the doctrine of equivalents — indicate that prosecution history estoppel may be becoming more favorable to patentees, says Sarah Kagan of Banner Witcoff.
As jurisdictions around the world adapt and modernize to capture revenue that would otherwise escape taxation under frameworks put in place long before today’s technology existed, digital health companies face rising tax uncertainty, say Kathleen Gregor and Elizabeth Smith of Ropes & Gray.
The early and prompt provision of samples from all electronically stored information sources as a part of ESI protocol search methodology is consistent with the Federal Rules of Civil Procedure and may allow for significant cost savings during discovery, says Zachary Caplan at Berger Montague.
In Nalpropion v. Actavis — a recent abbreviated new drug application case in the Federal Circuit centered on patent claim interpretation, the written description requirement and the substantial equivalence rule — the dissent reached a conclusion that is more consistent with years of jurisprudence than the majority's, says Daniel Pereira of Oblon McClelland.