The Eighth Circuit on Monday upheld a victory for Eli Lilly & Co. in a lawsuit claiming it failed to adequately warn of the risks of long-term use of the antipsychotic drug Zyprexa, backing a lower court's exclusion of expert testimony.
GlaxoSmithKline PLC has bumped up its stake in its Indian pharmaceuticals subsidiary GlaxoSmithKline Pharmaceuticals Ltd., revealing Sunday that it spent 64 billion rupees ($1.05 billion) to increase its clout in a market expected to see significant growth.
I will never forget stories I heard of what it was like to be a woman attending law school in the early 1960s, which included being called up to the front of the class to answer the professor’s questions on designated "Ladies’ Days," says Yuliya Oryol, chairwoman of Nossaman LLP's puplic pensions and investments practice group and administrative partner for the firm's San Francisco office.
The path to success for women is the same as it is for men — building relationships, delivering an excellent work product and earning the trust of your clients by serving as both a legal and strategic business adviser. I must confess, however, that I also had to learn to drink scotch and play golf, says Linda Goldstein, chairwoman of Manatt Phelps & Phillips LLP's advertising, marketing and media division.
Hoffman-LaRoche Inc. on Friday urged a New Jersey jury to reject claims its drug Accutane causes inflammatory bowel disease, summating a case that was buttressed by new scientific evidence following an appellate reversal of a $10 million verdict awarded to the plaintiff in 2008.
A Pennsylvania trial jury on Friday returned a $3 million verdict against a Johnson & Johnson unit in a case accusing the company of failing to warn a woman of the risk of birth defects when using its anti-epilepsy drug Tomapax during pregnancy.
Abbott Laboratories shareholders asked an Illinois federal judge on Thursday to bless a settlement resolving a derivative suit that alleged Abbott's directors cost the company $1.6 billion because they did nothing to stop the marketing of its anti-seizure drug Depakote for off-label uses.
A Massachusetts federal judge on Friday requested further briefing on whether he should reconsider portions of an order that granted victories to drugmakers Ranbaxy Inc. and Teva Pharmaceutical Industries Ltd. in a pay-for-delay class action involving the heartburn drug Nexium.
The owner of China’s Juneyao Airlines is in talks with Boeing and Airbus to clinch 20 planes in a deal that could be worth nearly $2 billion, while the likes of Blackstone and Bain Capital are eyeing up Northwestern Mutual Life Insurance Co.’s $3 billion indexing and management firm.
Thousands of comments poured in by Friday’s deadline for public input on proposals to eliminate Medicare Part D protections that guarantee access to certain drugs, and federal regulators appeared to be on the ropes amid an onslaught of opposition.
Eli Lilly & Co. argued Thursday that the first federal bellwether trial over the bladder cancer risks of diabetes drug Actos should exclude evidence about its fines for marketing the antipsychotic drug Zyprexa, saying it’s not relevant to negligent marketing claims over Actos.
A California federal judge refused Thursday to send to state court a lawsuit against Novartis Pharmaceuticals Corp. over a jaw injury allegedly caused by the bone drugs Aredia and Zometa, despite the plaintiff's plan to combine the suit with another naming a California-based physician and hospital as defendants.
A male in-house counsel once told me I had not been "nice" to him when I approached him about a business opportunity and would therefore not get the business. To add insult to injury, one of my male partners told me I should be flattered by the interest paid to me by the in-house counsel, says Paulette Brown, chief diversity officer at Edwards Wildman Palmer LLP.
Several people have told me that they had a lot of trepidation when they found out they would be working for a woman. To be effective, you need to be able to eliminate or address the conscious or unconscious bias colleagues may have about having a female boss, says Nancy Mitchell, chairwoman of Greenberg Traurig LLP's New York business reorganization and financial restructuring practice.
Private equity-backed medical device company Biomet Inc. is looking to raise $100 million in an initial public offering and plans to use the proceeds to reduce "outstanding indebtedness," according to documents filed Friday with the U.S. Securities and Exchange Commission.
The U.S. Supreme Court should make clear that any of its findings in Pom Wonderful LLC’s juice labeling dispute with The Coca-Cola Co. will affect only food-labeling regulations under the Food, Drug and Cosmetic Act and not pharmaceutical labeling, the Generic Pharmaceutical Association said Monday.
Agilent Technologies Inc. urged a California federal judge on Thursday to toss Genetic Technologies Ltd.'s lawsuit accusing Agilent of selling a DNA-testing device that infringes GT's patent on genetic analysis technology, arguing that GT's patent is invalid because it's based on an unpatentable natural phenomenon.
AbbVie Deutschland GmbH & Co. urged a Federal Circuit panel on Thursday to resurrect two of its antibody patents, alleging that “presumptively prejudicial” jury instructions doomed its infringement suit against a Johnson & Johnson subsidiary.
The FDA warned Thursday that Johnson & Johnson antibacterial drug Doribax poses a higher risk of death when used in patients who develop pneumonia while on ventilators compared to other antibacterial medications, prompting changes to the warning label.
The American Pharmacists Association, CVS Caremark Corp. and others urged the U.S. Food and Drug Administration on Thursday to rethink its controversial plan to let generic-drug makers independently change their warning labels, saying the proposed rule could burden consumers with increased costs for generic medicines and expose pharmacists, doctors and others to tort liability.
Unfortunately, the U.S. Patent and Trademark Office's recent memorandum to its patent examiners outlining patent eligibility under Section 101 was not subject to public notice or comment. The memorandum is flawed and, as written, may result in flawed examination of patent applications, says David Gass of Marshall Gerstein & Borun LLP.
The D.C. Circuit recently upheld a district court's ruling that autologous stem cells are a medical procedure subject to regulation by the U.S. Food and Drug Administration under the Federal Drug and Cosmetic Act and Public Health and Safety Act. The decision will further embolden the FDA to regulate stem cell therapies, so industry would be well advised to prepare for greater regulatory scrutiny, says Stacie Ropka of Axinn Veltrop & Harkrider LLP.
Most notable about China's most recent conditional merger approval decision were the faster speed of the review and the Ministry of Commerce's increased use of economic analysis. The decision on Thermo Fisher Scientific Inc.'s acquisition of Life Technologies Corp. also highlights MOFCOM's willingness to impose remedies that go beyond what other jurisdictions require, say attorneys with Jones Day.
Cloud users must know how to use the cloud responsibly to prevent later difficulties with document production. When negotiating a cloud service agreement, users should look for certain services that will prove useful when responding to discovery requests, such as comprehensive search options, instant suspension of the auto-delete function, and preservation of metadata and embedded data, say attorneys with Sidley Austin LLP.
The U.S. Supreme Court has agreed to review the Sixth Circuit’s decision in Indiana State District Council of Laborers v. Omnicare Inc., which parts ways with the Second, Third and Ninth circuits and holds that “subjective falsity” is not required for opinion-based Section 11 claims. Although the circuit split is hogging all the attention, everyone seems to be overlooking the fact that the Sixth Circuit in Omnicare ignored its own precedent, says Drew Dropkin of King & Spalding LLP.
The U.S. Department of Health and Human Services recently issued a report on the 340B Drug Discount Program to gain a better understanding of how contract pharmacy arrangements operate. While the report does not provide any recommendations in response to the inconsistencies in contract pharmacy arrangement operations, covered entities should develop policies and protocols for performing self-audits and explore the availability of independent auditing services, say attorneys at Epstein Becker & Green PC.
Although the U.S. Food and Drug Administration's recently issued draft guidance begins to shed light on the FDA’s views regarding the custom device exemption from premarket approval, a number of key open questions remain, and the exemption likely will continue to be rarely used, say Scott Danzis and Melissa Whittingham of Covington & Burling LLP.
Despite the current circuit split on whether a qui tam relator must identify specific claims in order to satisfy Rule 9(b), the U.S. Department of Justice has asked the U.S. Supreme Court to deny certiorari in U.S. v. Takeda Pharmaceuticals North America Inc. But even if the court does not agree to review this case, it appears highly likely that the court will eventually be called upon to resolve the split, says Scott Grubman, an associate at Rogers & Hardin LLP and a former federal prosecutor.
In stark contrast to the changing environment for the majority of lawyers today, the evolution for the general counsel is driven less by necessity than by opportunity. Today’s GC may touch every aspect of his or her organization to solve challenges and propel the company forward, keeping the GC far ahead of what is expected of the average lawyer, says James Merklinger, vice president and general counsel of the Association of Corporate Counsel.
In U.S. v. Omnicare Inc., the Fourth Circuit recently joined the growing chorus of courts that have refused to extend the reach of the False Claims Act to all manner of regulatory violations. And even though this case involved pre-Fraud Enforcement and Recovery Act conduct, the ruling also may have provided some much-needed perspective to the 2009 FERA amendments to the FCA, say attorneys with Fried Frank Harris Shriver & Jacobson LLP.