AstraZeneca owes $192 million for refusing to pay royalties for an Array cancer drug after entering an $8.5 billion collaboration with Merck to develop and commercialize the compound, according to a lawsuit removed to New York federal court Monday.
Counsel for a woman suing C.R. Bard Inc. over pelvic mesh products told a New Jersey state jury Monday that the business knew the devices were unsafe and failed to warn doctors about potential risks, but a company attorney countered that they were safe and that adequate warnings had been provided.
Chinese video-streaming giant iQiyi Inc. has launched an estimated $2.3 billion initial public offering, leading six companies that set price ranges on Friday and Monday for IPOs estimated to raise nearly $3.1 billion combined and hit the market later this month.
The New Jersey Appellate Division on Monday refused to revive a product liability case alleging a medical mesh caused a host of complications for a hernia patient, ruling the patient’s expert witnesses couldn’t prove the product caused the problems.
A customer can’t sue Rite Aid Corp. for charging patients with private insurance higher co-pays than cash-paying customers who enroll in its generic-drug discount program because there’s nothing legally requiring it to match the prices, the pharmacy told a California federal court Friday, hoping to ditch a potential class action.
The Oglala Lakota Sioux tribe on Friday hit two dozen drug makers and distributors with a suit in South Dakota federal court, adding to the torrent of litigation over the companies’ alleged roles in contributing to the abuse of opioids among tribe members and others.
The U.S. Department of the Treasury urged the Fifth Circuit in an appeal filed Friday to resurrect a temporary rule invalidated by a Texas federal court after it sank a planned $160 billion merger between Pfizer Inc. and Irish counterpart Allergan PLC, saying that it had fulfilled its obligations in promulgating the rule.
Clyde & Co. has lured a former Curtis Mallet-Prevost Colt & Mosle LLP partner to serve as head of arbitration at its Paris office, bringing her extensive experience handling commercial concerns — including matters involving mergers and acquisitions, energy, and pharmaceuticals — as well as investor-state disputes.
President Donald Trump unveiled a four-part plan Monday for curbing the opioid crisis with a wide-ranging mix of policies, including tougher criminal enforcement, stricter border security, expanded addiction treatment and a nationwide educational campaign.
Illumina Inc. asked a California federal judge to permanently stop Roche’s Ariosa Diagnostics Inc. from using its patents for prenatal testing technology, arguing in a filing on Friday that Ariosa’s parent company’s clout could tarnish Illumina’s testing reputation irreparably.
Allergan and the Native American tribe that acquired patents for the drug company's Restasis medication urged the Federal Circuit on Friday to stop the Patent Trial and Appeal Board’s review of the patents, days after generic-drug makers ripped their claims of immunity as “manipulative.”
The U.S. Supreme Court declined Monday to take up two matters with implications for consumers, rejecting requests to review a pair of decisions, one reviving litigation accusing a law firm of pursuing a debt-collection action in the wrong venue and the other upholding the denial of class certification in a junk-fax suit.
The New Jersey Appellate Division on Monday revived a widower’s lawsuit over his wife’s fatal heart attack from diet drugs after finding that a doctor barred by a lower court as an expert witness was still qualified to render an opinion, despite not specializing in weight loss treatment.
One of the architects of an Impax Laboratories Inc. deal panned as a pay-for-delay scheme by big retailers and a class of consumers told a Massachusetts federal jury Monday that the 2008 agreement with Medicis Pharmaceuticals Corp. actually rushed the generic version of an acne medication to the market ahead of schedule.
The U.S. Supreme Court on Monday declined to take up a False Claims Act case alleging the government was sold aircraft parts that were falsely certified to meet contractual requirements, tossed under the FCA’s first-to-file bar after two purported relators attempted to substitute themselves for the original relator.
The U.S. Supreme Court on Monday refused to hear Teva Pharmaceuticals USA Inc.'s challenge to the revival of allegations the drugmaker and GlaxoSmithKline LLC's inflammatory bowel disease medication, when taken with other drugs, increased the risk of a rare cancer that killed the plaintiffs' son.
Three western Pennsylvania municipalities are joining the flood of litigation against opioid manufacturers, crossing the state Friday to file a class action in Philadelphia that accuses Purdue Pharma LP, Johnson & Johnson and others of deceptive marketing.
The U.S. Supreme Court told a Colorado-based marijuana company on Monday that it would not hear its lawsuit against the Internal Revenue Service alleging the agency lacked authority to investigate criminal activity.
The U.S. Department of Justice’s unusual decision to name a private equity firm as a defendant in a False Claims Act suit against one of the firm’s portfolio companies is an issue all private equity firms should be aware of, although the alleged circumstances of the case may mean similar complaints will be few and far between, attorneys say.
Two years after the U.S. Securities and Exchange Commission put Silicon Valley on notice about complying with Wall Street’s rules, the agency has delivered a pair of enforcement actions that show its focus on the California region hasn’t lessened and may even heat up.
There's no reason for limiting unbundled legal services to family law or even pro se litigants. Wider adoption, especially by litigators, presents an opportunity to correct law's distribution and pricing problem, to make justice practically available to all, and to dethrone litigation as the "sport of kings," says New York-based trial lawyer David Wallace.
Recent cases demonstrate that, despite the U.S. Supreme Court’s ruling in Escobar, False Claims Act materiality questions remain and continue to be litigated. Gilead filed a petition for certiorari a few months ago, and it is a key case to watch, say attorneys with Morrison & Foerster LLP.
Like medical professionals, lawyers often resist policies to reduce errors due to the culture of perfectionism that permeates the industry. Autonomy is key to the legal professional's prestige and the outward demonstration of competence is key to maintaining autonomy, says Peter Norman of Winnieware LLC.
Many bad drug and device law decisions lately have come from appellate courts, with the Eleventh Circuit in particular creating obstacle courses for both defense practitioners and judges. This month's Rowe v. Mentor Worldwide LLC ruling is an example. All the claims would have been dismissed if not for a pesky, unsound and inconsistent Eleventh Circuit case, says Stephen McConnell of Reed Smith LLP.
It is undisputed that in his first year in office President Trump was able to confirm a significant number of judges to the federal bench. How it happened — and whether it's a good thing — are debated here by Sen. Chuck Grassley, R-Iowa, and Sen. Dianne Feinstein, D-Calif.
The U.S. Patent and Trademark Office’s January 2018 updates to the Manual of Patent Examining Procedure seem to provide guidance that is at odds with Federal Circuit and Patent Trial and Appeal Board precedent on whether Dynamic Drinkware applies to published patent applications, say Eric Steffe and David Holman of Sterne Kessler Goldstein & Fox PLLC.
The recent Third Circuit opinion in Shuker v. Smith & Nephew got the most important issue right — when you have a multicomponent medical device, premarket approval preemption is to be addressed on a component-by-component basis. This is an important question, because surgeons engaging in off-label use do mix and match parts with different regulatory backgrounds, says Michelle Yeary of Dechert LLP.
The U.S. Supreme Court may soon revisit a seminal decision on products liability law for pharmaceutical manufacturers. If the court grants Merck & Co.'s request for certiorari in Fosamax, it could signal that lower courts, as well as branded manufacturers, will finally receive guidance on Levine’s "clear evidence" standard, say attorneys with Morrison & Foerster LLP.
Because the cosmetics industry closely borders the highly regulated drug market, cosmetics companies must be wary when marketing on platforms like Instagram. Crossing the line between a "drug" and a "cosmetic" can cause a major headache with the U.S. Food and Drug Administration, says Dominick DiSabatino of Loeb & Loeb LLP.
Following recent developments in litigation over a dietary supplement between ChromaDex and Elysium Health, several points are worth noting, one of which includes whether this is the time for a voluntary, higher-level collaboration between the dietary supplement industry and the U.S. Food and Drug Administration, say attorneys with Wilson Sonsini Goodrich & Rosati PC.