Federal prosecutors have ended their civil and criminal investigation into allegations of off-label marketing of Medtronic Inc.’s Infuse bone graft product, the company said Wednesday, days after a whistleblower False Claims Act suit accusing it of paying kickbacks to promote off-label use was unsealed.
Facing mounting legal bills after a deadly explosion at a Connecticut power plant site in 2010, a group of energy companies and contractors filed suit Monday against Aon, alleging the insurance giant failed to meet its contractual obligation to provide adequate coverage for defense costs.
An Alabama federal judge on Wednesday granted mining giant Drummond Co.'s request to compel certain documents from Travelers Casualty & Surety Co. in a coverage battle over litigation costs related to pollution from the company's coke production operations.
A Texas appeals court Tuesday upheld a jury’s $5.4 million verdict against Pasadena Refining System Inc. in a lawsuit brought by a contractor burned while making repairs at its refinery, but held that PRSI was covered under an insurance policy held by the contractor's employer.
Senators introduced revised legislation Tuesday to reauthorize user fee programs at the U.S. Food and Drug Administration, adding provisions to extend government grants for drugs used in rare diseases and calling for greater public input on development of new medical products.
The Third Circuit on Wednesday refused to revive two putative class actions alleging former pharmaceutical giant Schering-Plough Corp. marketed off-label uses for certain drugs, saying the suits both failed to allege a link between the company's marketing and any actual injuries.
Creditors with claims for asbestos-related health problems proposed the initial reorganization plan for Specialty Products Holdings Corp. on Monday, hoping to jump-start a case stalled by the difficulty of estimating the bankrupt company’s massive asbestos liability.
A California homeowner on Tuesday asked a Minnesota federal court to nix class certification in a multidistrict litigation accusing Uponor Inc. of duping consumers into buying faulty plumbing systems, arguing class members making California law claims were not fairly represented in settlement talks.
Tishman Construction Corp. on Monday urged the Second Circuit to affirm that it can't be held liable for negligence by Consolidated Edison Co. of New York Inc. and its insurers over the collapse of 7 World Trade Center following the 9/11 terrorist attacks.
Secretary of Defense Leon Panetta on Tuesday placed new flight restrictions on the U.S. Air Force's most advanced jet, Lockheed Martin Corp.'s F-22 Raptor, until the military can solve persistent problems with the aircraft's oxygen system.
The Fourth Circuit on Tuesday upheld the award of black lung benefits to the widow of a former Harman Mining Co. coal miner, finding that an administrative law judge was entitled to refer to the preamble of certain regulations when evaluating a medical expert's credibility.
The Fifth Circuit on Tuesday affirmed the Clean Water Act and permit violation convictions and sentences of wastewater treatment provider Jeffrey Pruett and his two companies, ruling on a question of first impression that only ordinary negligence is required for criminal penalties tied to negligent violations of CWA permits.
A bill requiring the California Public Utilities Commission to consider safety recommendations by a federal transportation agency in order to prevent incidents like the fatal 2010 gas pipeline explosion in San Bruno cleared a state Senate panel on Tuesday.
A Florida real estate developer on Monday agreed to pay $4.8 million to a class of condominium owners who claim that Chinese-manufactured drywall used in the construction of the homes caused health problems and property damage.
A California appeals court on Monday upheld a decision that Golden Eagle Insurance Corp. did not have to cover Lemoore Real Estate and Property Management Inc.'s $29 million settlement over a fatal fire in one of its buildings because of a professional services exclusion in the insurance policy.
The National Highway Traffic Safety Administration on Thursday opened an investigation into the Hyundai Motor Group's 2012 Elantra after a consumer complained that the improper deployment of his car's air bag lacerated his ear and face.
Glam metal rocker and reality TV star Bret Michaels on Monday settled his suit against Tony Awards Productions and CBS Entertainment over a head injury he sustained at the 2009 Tony Awards that he says nearly killed him.
A California judge on Monday trimmed a malpractice suit against Greene Broillet & Wheeler LLP and other former attorneys who represented a girl who lost a high-profile case against Johnson & Johnson alleging her use of Children's Motrin caused her to go blind.
The Natural Resources Defense Council on Monday asked the Second Circuit to reopen a suit aimed at forcing the U.S. Food and Drug Administration to regulate anti-bacterial agents triclosan and triclocarban, saying their use in soaps could lead to the rise of so-called superbugs.
Forty-one attorneys general Friday threw their weight behind legislation that would effectively overturn a U.S. Supreme Court ruling shielding manufacturers of generic drugs from lawsuits over harm caused by inadequate warning labels.
While a contract's force majeure clause may be boilerplate, the Food Safety Modernization Act provides new reasons to pay greater attention — new provisions of the FSMA, when taken together, greatly increase the probability that your supply chain, or your ability to comply with your contractual obligations, will be disrupted by some regulatory action by the U.S. Food and Drug Administration, say Michael Plunkett and Corinne Marie Pouliquen of Blank Rome LLP.
The Institute of Medicine has issued a report entitled “Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad." Some of IOM’s goals, including the application of current food-tracing requirements to medicines, biologics and even medical devices, suggest that supply-chain tracing may be of increased importance over the next three to five years, says Amy Goerss of Hodgson Russ LLP.
After hearing argument in two cases that have far-reaching implications for corporations doing business in politically volatile regions, the U.S. Supreme Court has determined in one case that corporations are not liable under the Torture Victim Protection Act — but it left open for exploration whether the Alien Tort Statute can or should be used as a vehicle for litigating alleged wrongdoing occurring in foreign countries, say Timothy Nelson and Jennifer Spaziano of Skadden Arps Slate Meagher & Flom LLP.
An e-discovery review usually requires significant manpower and a certain level of expertise to be done properly, and many in-house legal departments turn to litigation support and discovery management providers as an alternative for first-pass document review. Regardless of who performs it, proper preparation and planning in advance of a review is the key to its success, says Stacy Jackson of IE Discovery.
A holding by the New York Appellate Division, First Department, that breach of implied and express warranty claims against a defendant in the Reeps family's product liability lawsuit should be dismissed may be the most important in the case, because it clarifies that service providers, as opposed to product sellers, cannot be held liable under strict product liability or breach of warranty theories of liability, says William Ruskin of Epstein Becker Green PC.
Creating new approaches to fee agreements is something to embrace rather than fear — and when structured and managed correctly, it can be financially advantageous. Take, for example, fixed-fee arrangements, result-based billing and portfolio billing, say Bill Rudnick and Keith Maziarek of DLA Piper.
With its holding that the Consumer Product Safety Improvement Act of 2008 extends to reported violations of food safety standards, the U.S. Administrative Review Board has created multiple layers of protection for food industry whistleblowers and further demonstrated its tendency to espouse a broad and expansive view of whistleblower protections generally, says Michael Slocum of Epstein Becker Green PC.
It is clear from Dobbs v. Wyeth and Levine v. Wyeth that the most persuasive evidence for the impossible preemption argument is an actual prior rejection by the U.S. Food and Drug Administration of the very warning language at issue. Absent this type of evidence, it is easy for a court to find that impossibility preemption is just impossible to prove, say Randall Christian, Jason Casell and Darlene Ghavimi of Bowman and Brooke LLP.
A U.S. senator has proposed a bill intended to undo the perceived inequality in the U.S. Supreme Court's 2011 Pliva v. Mensing decision. If the bill succeeds, it would not only place a heavy burden on generic manufacturers contrary to the intent of the Hatch-Waxman Act, but it would also ignore the reality of how prescription drugs are used in the health care system, say James Huston, Julie Park and Erin Bosman of Morrison & Foerster LLP.
The Tenth Circuit's recent decision in U.S. ex rel. Wickliffe v. EMC Corp. highlights a tool rarely used by the government in qui tam actions brought under the federal False Claims Act — dismissing the case over a relator’s objection — and provides guidance to approaches defense counsel may take with regard to this powerful procedural tool, say Lawrence Kraus and Christina Taylor of Foley & Lardner LLP.