The U.S. Food and Drug Administration on Tuesday rejected Ocular Therapeutix Inc.'s eye disease drug Dextenza, citing problems with manufacturing and quality control testing uncovered during a May inspection of the company's plant.
A Second Circuit panel on Tuesday rejected requests from Shell Oil Co. and BP Products North America to revisit its decision to revive the Orange County Water District’s claims that oil companies had endangered its water supply by leaking the gasoline additive methyl tertiary-butyl ether.
A Tennessee magistrate judge on Tuesday recommended partial certification of a group of residents alleging railroad operator CSX and a railway equipment company caused a train car carrying hazardous substances including acrylonitrile to derail, purportedly putting the community at risk of exposure to a potential carcinogen.
After only two months in office, U.S. Food and Drug Administration Commissioner Scott Gottlieb has unveiled a series of steps to curb the opioid crisis, including focusing on abuse-deterrent opioid options and expanding existing risk evaluation and mitigation strategies. Here, Law360 looks at three takeaways from the new standards.
Justice Stephen Breyer discusses the Supreme Court’s role as a check on executive authority and the global influence on U.S. courts, in the first of two articles based on an exclusive interview with the justice. This is part of a series of exclusive Law360 interviews with current and former Supreme Court justices.
Benjamin Moore & Co. Inc. and three other paint companies reached proposed settlements with the Federal Trade Commission over allegations that they deceptively advertised some of their paint products as free of potentially harmful chemicals, the agency announced Tuesday.
General Motors began a new round of federal trials Tuesday over 2000s-era ignition switches that could cut cars’ power without warning, telling a Manhattan jury that a modified switch was a different animal from its more infamous predecessor and had no role in an Arizona man’s crash.
A California judge ruled Tuesday that Johnson & Johnson can’t keep a gynecologist from testifying in an upcoming trial that its talcum powder products caused a woman’s ovarian cancer, but said the expert must confirm her opinion is unchanged after the judge excluded some of the expert’s evidence.
A California federal judge on Tuesday denied the Federal Trade Commission’s pending motion seeking additional testimony into claims that Volkswagen AG’s U.S. unit intentionally destroyed documents after its diesel emissions cheating scandal made headlines, a procedural move in light of the FTC’s settlements with the German automaker.
Takata Corp. plans to recall 2.7 million more air bag inflators built between 2005 and 2012 and installed in Ford, Nissan and Mazda vehicles sold in the U.S., because tests have shown predictors of future explosions, the National Highway Traffic Safety Administration said Monday.
Akin Gump Strauss Hauer & Feld LLP has brought aboard a high-ranking U.S. Food and Drug Administration official who oversaw much of the recent revolution in supply chain safety, the firm announced Tuesday.
U.S. Attorney General Jeff Sessions said Tuesday that a $35 million settlement of government allegations that Mallinckrodt PLC was a conduit for generic oxycodone pills to be peddled on the street marked a major step forward in fighting a deadly opioid epidemic.
The U.S. Food and Drug Administration scolded an Indian drug manufacturer over the poor condition of its equipment, took issue with supplements lauded as treatments for “obesity genes” and chastised an online e-cigarette store for selling to a minor.
A California federal judge Monday ordered Coca-Cola-owned fruit juice brand Odwalla Inc. and a proposed class of consumers to mediate a dispute over the company’s "no added sugar" label on its fruit drinks.
Walgreens Boots Alliance Inc. said Monday an Arizona federal court should not revive parts of a largely dismissed suit filed by a proposed class of consumers alleging Theranos Inc. misrepresented the accuracy of blood tests administered at Walgreens stores.
Bayer HealthCare Pharmaceuticals Inc. and Johnson & Johnson unit Janssen Pharmaceuticals Inc. have downplayed the risks associated with their blood thinner Xarelto, two couples allege in separate suits filed in New York state court Monday.
A California judge on Monday changed course from her prior tentative ruling and dismissed Imerys Talc from an impending trial over claims that a woman’s ovarian cancer was caused by Johnson & Johnson products made with Imerys-supplied talc, saying Imerys can’t be sued for supplying an “inherently safe” ingredient.
Endo International PLC’s recent decision to yank its painkiller Opana ER from the market, following pressure from the U.S. Food and Drug Administration to stop sales of the abuse-linked drug and as prescriptions of opioids remain high in many parts of the country, points to the need for more research in treating both pain and opioid addiction.
McGuireWoods LLP has added a product liability and mass tort litigator with experience handling cases involving automotive, pharmaceutical, medical device and chemical manufacturers, the firm said Monday.
The former commissioner of the U.S. Food and Drug Administration told an Illinois federal jury Monday that the ads AbbVie Inc. put out for its product AndroGel misleadingly promoted it for uses beyond what the regulator approved.
As in the U.S., a product liability lawsuit in Australia can be resolved through an out-of-court settlement agreement. But the mechanisms for settlement in Australian litigation differ from how cases are settled in the U.S. Knowing the settlement landscape and possible costs consequences is important for U.S.-based companies who operate or distribute in Australia, says Bettina Sorbello of DibbsBarker.
Tutorials in the form of “science days” are an increasingly common way for judges to learn more about the science behind litigation over medical and consumer products and chemical exposures. The science day held recently by a California state court judge overseeing talcum powder litigation provides valuable insights into the process, say David Schwartz of Innovative Science Solutions LLC and attorney Nathan Schachtman.
Last month, the American Bar Association published revised guidance regarding an attorney’s duty to protect sensitive client material in light of recent high-profile hacks. The first step in compliance is understanding how your data is being stored and accessed. There are three key questions you should ask your firm’s information technology staff and/or external solution vendors, says Nick Holda of PreVeil.
It is becoming clear that the disruptive nature of the autonomous vehicle will extend far beyond the automotive industry. Conversations with clients from a variety of industries have provided unique insight into what a future might look like without humans behind the wheel, say Mike Nelson and Trevor Satnick of Eversheds Sutherland.
A California state appeals court's recent decision in Orange County Water District v. Alcoa Global Fasteners is one of very few opinions in California that applies to water district claims for response costs in groundwater contamination cases. It will be influential in future cases brought by water districts in the state, says Kimberly Bick of Bick Law LLP.
Recent cyberattacks launched from internet-connected devices illustrate that the growth of such products creates an opportunity for malevolent actors. The internet of things is highly vulnerable to attacks that can cause denials of service, ransomware incidents and even physical damage to property and people, says H. Michael O'Brien of Wilson Elser Moskowitz Edelman & Dicker LLP.
In short order, the U.S. Environmental Protection Agency will issue its final inventory reset rule under the Toxic Substances Control Act. As we await publication of the final rule, Lawrence Culleen and Eric Rey of Arnold & Porter Kaye Scholer LLP note the important aspects all manufacturers, importers and processors of chemical substances should be aware of, and related practical tips to facilitate and expedite compliance.
Last month, the Northern District of Illinois denied class certification to consumers who purchased allegedly defective Whirlpool ovens, and excluded the opinions of the plaintiffs’ expert. The ruling in Kljajic v. Whirlpool Corp. demonstrates the importance of having an expert witness who can be sensitive to a case's weaknesses without creating new ones, says Jack Nolan of Weil Gotshal & Manges LLP.
One of the easiest ways to improve civil jury trials is to give juries substantive instructions on the law at the beginning of the trial rather than at its conclusion. It is also one of the most popular proposals we are recommending, say Stephen Susman, Richard Lorren Jolly and Dr. Roy Futterman of the NYU School of Law Civil Jury Project.
Lateral candidates looking to make the last — or perhaps only — move of their career cannot afford to just stand by and let a law firm’s vetting process unfold on its own, says Howard Flack, a partner at Volta Talent Strategies who previously led lateral partner recruiting and integration at Hogan Lovells.