The U.S. Food and Drug Administration on Friday sketched out a gentler vision for oversight of lab tests that have proliferated rapidly in recent years, two months after the agency shied away from stronger regulation.
Toyota Motor Corp. on Thursday announced that it will recall 543,000 more vehicles in the U.S. to replace front passenger air bags manufactured by Takata Corp. which the automaker said contain potentially fatal defects.
A California judge on Thursday declined to set a trial date for a woman who alleges she has only six months to live due to ovarian cancer caused by Johnson & Johnson talcum powder, saying she must ensure an early trial won't complicate the coordinated proceeding containing hundreds of plaintiffs.
A California federal judge overseeing a false-labeling class action over Bayer AG's One-A-Day vitamins declined Wednesday to intervene in a discovery dispute about alleged defense production delays and accusations that Bayer’s lead counsel engaged in witness-coaching.
Investors seeking a refund of their $96 million stake in troubled biotech venture Theranos Inc. won a recommendation Wednesday for extended use of documents collected in their Delaware Chancery Court lawsuit, but lost a bid to limit demands for records involving Walgreen Co., another Theranos lawsuit opponent.
Baxter Healthcare Corp., a producer of intravenous solutions, has agreed to pay $18 million to resolve a False Claims Act suit and bypass criminal charges in North Carolina federal court relating to alleged violations of maintenance regulations for sterile drug products, the U.S. Department of Justice said Thursday.
A Volkswagen executive arrested in Miami this month in connection with the German automaker's “clean diesel” emissions fraud scandal was ordered Thursday by a Florida federal judge to be detained and extradited to Michigan, where he has been indicted, according to the U.S. Department of Justice.
Noble Energy Inc. on Thursday told the Texas Supreme Court it’s wrongly on the hook to ConocoPhillips Co. for $63 million in environmental cleanup costs under an indemnity agreement a predecessor company didn't know existed when it bought property.
A Tennessee surgical center argued in multidistrict litigation Thursday that since several health agencies recklessly did not act against a compounding pharmacy linked to a deadly 2012 meningitis outbreak — despite knowing the risks the pharmacy posed — a jury should be allowed to allocate fault accordingly.
The Navajo Nation shot back Wednesday at a U.S. Environmental Protection Agency contractor’s attempt to escape a liability suit over the Gold King Mine spill, saying the contractor was directing remediation activities and conducting operations at the site when the disaster occurred.
Lamorak Insurance Co. told the Second Circuit Thursday that a New York district court judge “rewrote" its contract with Olin Corp., saying the plain language of the policy dictates that the chemical producer must collect on earlier policies with other insurers before Lamorak has to pay out for the cleanup of contaminated sites.
The National Football League’s teams made another move Wednesday to dismiss a long-running proposed class suit filed by ex-players who accuse the NFL and its doctors of encouraging them to abuse painkillers, arguing that the Racketeer Influenced and Corrupt Organizations Act claims against the teams are barred by time limitations.
The estate of an 8-year-old girl who died after a shifter in their Chevrolet Suburban allegedly failed told a Connecticut federal judge on Wednesday that General Motors LLC shouldn't be allowed to say that the mother committed a crime by not being in the car at the time.
The U.S. Environmental Protection Agency on Wednesday proposed banning the toxic chemical trichloroethylene when it’s used as a vapor degreaser, a move that will affect several industries including petroleum refineries, soap manufacturers and machine shops.
Ford on Thursday announced it will expand a recall of vehicles equipped with possibly defective air bag inflators manufactured by Takata by more than 800,000, taking the total number of cars, trucks and SUVs under the automaker’s recall campaign to over 3 million.
Takata Corp. may plead guilty to criminal wrongdoing and pay out about $1 billion to end a U.S. Department of Justice investigation into its potentially deadly air bag inflators as soon as Friday, according to media reports on Thursday.
A Pennsylvania state judge has ruled that a sports equipment distributor who was sued over head injuries an All-American high school lacrosse player allegedly suffered from a defectively designed helmet didn't act recklessly and isn't on the hook for penalty damages.
Apple Inc. escaped a customer’s suit alleging the tech giant hides the fact that damaged iPhones covered by service plans are replaced with secondhand phones after a California federal judge said Wednesday that the customer had only received new replacement phones and failed to show she relied on the company's supposed misrepresentations.
Fiat Chrysler installed and failed to disclose engine software that allowed about 100,000 Jeep Cherokee and Dodge Ram trucks to produce excessive emissions of nitrogen oxide, the U.S. Environmental Protection Agency said Thursday.
Biosimilar names will have to include meaningless suffixes, the U.S. Food and Drug Administration said in final guidance Thursday, brushing off concerns about confusion.
A decade’s worth of multiple bar association initiatives, conferences, corporate law summits, detailed research reports and opinion pieces on the pay gap has seemingly fallen on the deaf ears of BigLaw. However, recent events presage substantial movement toward pay equity in law firms, say Stephanie Scharf of Scharf Banks Marmor LLC, Michele Coleman Mayes, general counsel for the New York Public Library, and Wendi Lazar of Outten & Golden LLP.
The media has been full of stories lately about the death of facts and the rise of “fake news.” It is reasonable to wonder if people sitting on juries will be able to function appropriately in this post-fact world, says Ross Laguzza of R&D Strategic Solutions LLC.
Air transportation of lithium ion batteries recently garnered significant attention due to reports of the Samsung Galaxy Note 7’s batteries overheating, catching fire and even exploding. Jonathan Todd and David Krueger of Benesch Friedlander Coplan & Aronoff LLP examine the current regulatory regime relating to air transport of lithium batteries, the forces shaping its future, and relevant emerging trends in hazardous materials compliance.
Pro se litigation can be a time-consuming cost of doing business, particularly for large, well-known companies. Though pro se cases occasionally include interesting, even amusing, claims, like all litigation, they must be taken seriously. In this article, attorneys from Shook Hardy & Bacon LLP detail several practical approaches to dealing with the problems posed by pro se litigants.
Federal courts do not often consider and interpret product safety laws administered by the U.S. Consumer Product Safety Commission. A Wisconsin federal court recently ruled for the CPSC against Spectrum Brands Inc. for failing to timely report a product problem. The opinion may have major ramifications for the product safety community, say attorneys from Mintz Levin Cohn Ferris Glovsky and Popeo PC.
I recently asked a panel of four federal court judges whether they expect courts to start taking a more active role in e-discovery. They answered with a resounding yes. However, their responses left me wondering whether courts are actually taking a more active role in discovery since the Federal Rules of Civil Procedure amendments took effect in December 2015, says Cristin Traylor of McGuireWoods LLP.
The U.S. Food and Drug Administration’s approach to laboratory developed tests has had more plot twists than — and has gone on nearly as long as — some of TV’s most popular soap operas. Gail Javitt of DLA Piper offers a brief recap of the past several decades, a look at the FDA's most recent announcement on the subject, and prognostication on what 2017 may bring.
On Nov. 29, the U.S. Environmental Protection Agency announced that it will review the hazard and exposure risks caused by asbestos, in response to recent amendments to the Toxic Substances Control Act. But as always, asbestos presents unique challenges to regulators, both because it is naturally occurring, and because of disagreements about which minerals fit the definition, says J. Michael Showalter of Schiff Hardin LLP.
On Dec. 1, 2016, the annual updates to the Federal Rules of Civil Procedure went into effect. Revisions include the end of the three-day “mail rule” extension for electronically served discovery, an amendment regarding service of internationally based corporate defendants, and a technical change regarding venues in maritime law actions, say Patrick Reilly and Eldin Hasic of Faegre Baker Daniels LLP.
As expected, U.S. Consumer Product Safety Commission civil penalty settlement amounts increased again this year. 2016 ended up setting records, both for the total dollar amount of civil penalty settlements and for the much-publicized largest single civil penalty settlement amount in CPSC history, says John Celeste of Miles & Stockbridge PC.