A Pennsylvania federal judge on Monday tossed the non-negligence claims in two suits alleging Novartis Pharmaceuticals Corp.’s bone drug Zometa caused jaw injuries, saying strict products liability claims could not be brought against the drug company under Pennsylvania law.
New rules and guidance from the U.S. Food and Drug Administration have made lots of waves with drug and device makers in 2014, sparking debate about future oversight of off-label promotion, social media interactions and the rapidly evolving field of clinical software. Here are six issues attorneys are watching closely.
Vascular Solutions Inc. will pay $520,000 to resolve a whistleblower's False Claims Act suit accusing the company of inducing physicians to bill federal health programs like Medicare for an unapproved treatment of varicose veins, the U.S. Department of Justice said Monday.
A drugmaker potentially breached the Anti-Kickback Statute by supplying discounts that could encourage use of other items and services covered by Medicare and Medicaid, but the company enacted safeguards that reduced the risk of fraud and made sanctions unnecessary, according to an Office of Inspector General opinion posted Monday.
A group of physicians’ associations and manufacturers urged the Centers for Medicare and Medicaid Services on Monday to let them take a look at the context for physician payment data due to be disclosed under the Physician Payments Sunshine Act in September.
The Internal Revenue Service published final regulations Monday establishing how branded prescription drug manufacturers or importers who have at least $5 million in sales to various government programs like Medicaid and Tricare should calculate an annual fee established by the Affordable Care Act.
GlaxoSmithKline PLC and Teva Pharmaceutical Industries Ltd. on Friday urged the Third Circuit to reject the Federal Trade Commission's request to participate in oral arguments in the Lamictal pay-for-delay litigation, saying the antitrust watchdog was not the "independent" observer it claimed to be.
Three Democratic senators asked the U.S. Food and Drug Administration in a letter Monday to provide information on the agency’s plans to curb the overuse of antibiotics in food animal production in light of research showing the practice can lead to the creation of antibiotic-resistant bacteria.
BakerHostetler has recruited to its Los Angeles office a trademark and copyright expert, and previous Foley & Lardner LLP chairwoman, who specializes in U.S. and global procurement, prosecution, transactions, enforcement and disputes in the hospitality, entertainment and pharmaceutical industries, the firm announced Monday.
Del Monte Fresh Produce NA Inc. on Friday was hit with a suit in California federal court accusing its newly introduced “Nature Made” food products of ripping off the trademark for Pharmavite LLC’s popular line of vitamins and supplements with the same name.
A $5.8 million breach of contract complaint filed Monday in Pennsylvania federal court by the Cancer Treatment Centers of America alleges that Avax Technologies Inc. has failed to deliver on its promise of a "unique cancer vaccine" that could help CTCA's patients.
CVC is close to winning an auction for Epicor Software, while 21st Century Fox would offer board seats to sweeten its $80 billion Time Warner bid. France's Danone may sell its medical nutrition business to U.S.-based Hospira, making it the latest in a wave of inversion deals. China's banking regulator is also allowing five cities to launch asset management companies to gobble up bad loans.
Virtus Pharmaceuticals LLC refused Friday to drop its attempt to block Norton Rose Fulbright from representing Nestle Health Science-Pamlab Inc. in its unfair competition suit seeking to keep Virtus from selling some of its prescription products, saying the magistrate judge erred by holding the firm should not be disqualified.
I was fortunate to take a class at the Harvard School of Negotiation by the authors of “Getting to Yes,” and I would recommend that book to any dealmaker. It has really shaped my negotiating style, says Josef Volman of Burns & Levinson LLP.
The Federal Circuit on Thursday refused to halt an order requiring Endo Pharmaceuticals Inc. and Mylan Pharmaceuticals Inc. to negotiate a settlement in their infringement row over Endo’s patent for migraine medication Frova, saying Endo hadn't met the standard for a stay.
Recent U.S. Supreme Court rulings on what is patent-eligible have "created chaos" in the law, and the patent system would be better off if the justices stepped back and avoided the contentious issue for a few years, former Federal Circuit Chief Judge Paul Michel said in an exclusive interview with Law360.
DLA Piper has picked up a life sciences partner from Hogan Lovells LLP whose practice has focused on complex intellectual property transactions and corporate partnering issues, technology licenses and commercial contracts, DLA Piper confirmed Friday.
The Obama administration on Thursday took a firm stance on so-called inversion transactions, calling the deal structure unpatriotic and urging a ban, which cast uncertainty on whether pending deals would advance and what costs already-combined companies could face, experts say.
A Florida federal judge has trimmed a proposed class action against toiletry and dietary supplement maker Chattem Inc. accusing it of making misleading claims that its ACT mouthwash rebuilds tooth enamel.
The First Circuit is set to hear arguments Thursday about whether a group of consumers, insurers and others who paid for Nexium can sue as a class over alleged pay-for-delay deals over the heartburn drug even though many of them may not have overpaid because of the patent settlements, in a case that could have implications beyond the pharmaceutical world.
While the RoHS-1 Directive did not apply to medical devices, the RoHS-2 Directive does, implying that manufacturers intended for the EU market have to assess and document whether their products comply with the latest directive’s chemical restrictions, say Lucas Bergkamp and Nicholas Herbatschek of Hunton & Williams LLP.
Given commercial realities and the possibility that the intended tax savings could be limited or eliminated by the effect of retroactive or even prospective legislation, a potential inversion transaction should only be pursued if the nontax reasons for the combination are sufficiently compelling, say attorneys with Morrison & Foerster LLP.
This year, the U.S. Supreme Court decided on six patent cases that will have significant consequences for companies as they work to advance their strategy for protecting their intellectual property, say J. Michael Martinez de Andino and George Davis of Hunton & Williams LLP.
It happens all the time. When a dispute arises, two parties find themselves in arbitration, realizing that they might have had more leverage to dictate the terms of the process when they were negotiating the arbitration provision — but missed the opportunity, says Daniel McCloskey of Duane Morris LLP.
In this e-discovery era, why aren't more litigants using Federal Rule of Evidence 502(d) orders and affording themselves basic protection of their most sensitive information? Or, if they are moving for such orders, why are they doing it wrong? asks John Rosans of Katten Muchin Rosenman LLP.
Most ominous in China's draft Food Safety Law is the pledge to strengthen the "link" between food safety regulation and criminal penalties, indicating criminal prosecutions could likely continue increasing once the law is adopted, say attorneys at Covington & Burling LLP.
Potential bids by U.S. suitors for U.K. target companies in the pharmaceutical and health care sectors seem to be a recurring theme this year
Although challenges remain for generics, it is clear at the 30-year mark that the promise of Hatch-Waxman has been realized, quite possibly beyond the dreams of Senator Orrin Hatch and Congressman Henry Waxman, say Alan Klein and Solomon David of Duane Morris LLP.
The prosecution of FedEx Corp. for allegedly failing to heed signs that illegal Internet pharmacies were using its facilities represents a significant expansion of the U.S. Department of Justice’s efforts to outsource law enforcement to private third parties and then go after these third parties when they fail to meet an undefined standard of compliance, rather than focus on the criminals, say attorneys with Bingham McCutchen LLP.
A growing trend in the Southern District of New York akin to a sua sponte rocket docket can provide defendants with an opportunity to set the tone of discovery and shift the burden and risks of the schedule to their adversaries, say Isaac Greaney and Jackie Lu of Sidley Austin LLP.