Convicted securities fraudster Charles McCall, the former chairman of health care company McKesson Corp., this month asked the U.S. Supreme Court to overturn his 2009 jury verdict, claiming a lower court judge improperly instructed the jury to consider whether McCall "recklessly disregarded" warnings about accounting improprieties at the company.
U.S. antitrust regulators on Friday moved to block Omnicare Inc.’s proposed $440.8 million deal for PharMerica Corp. over concerns that a merger of the country’s two largest long-term care pharmacies would raise drug prices, particularly for Medicare patients, and hurt competition.
The Obama administration told the U.S. Supreme Court on Friday that the Patient Protection and Affordable Care Act could survive almost intact even if the central mandate requiring all individuals to have health insurance were deemed unconstitutional.
Teva Pharmaceutical Industries Ltd. unit Cephalon Inc. will voluntarily recall a batch of its leukemia drug Treanda after glass fragments were found in one of its vials, Teva said Friday.
Allergan Inc. lodged a patent infringement suit in Texas federal court on Friday seeking to stop Hi-Tech Pharmacal Co. Inc. from launching a generic version of Allergan's glaucoma medication Lumigan.
The federal government on Friday nixed Texas' request to delay the implementation of new health care reform rules limiting what insurance companies can spend on overhead, finding that the restrictions would not destabilize the Texas health care market.
The U.S. Food and Drug Administration on Friday reopened the comment period for its proposed amendments to its regulations on direct-to-consumer TV and radio ads for prescription drugs, citing the entry of a new consumer perception study into the discussion.
An Oklahoma federal jury slapped Medtronic Inc. with an almost $10 million verdict on Thursday in a suit brought by a cardiologist alleging the medical technology company infringed a patent covering a catheter design used in angioplasty.
Cooley LLP confirmed Friday that partner Suzanne Sawochka Hooper is leaving the firm to become general counsel for Irish biopharmaceutical company Jazz Phamaceuticals PLC, a longtime client that she represented during its recent merger with Azur Pharma PLC.
Aetna Inc. is cooperating with a California insurance department probe into possible fraud against its members by medical centers affiliated with 1-800-Get-Thin that perform weight loss surgery using Allergan Inc.’s Lap-Band, the insurer confirmed Friday.
With technology giants expected to jostle for bankrupt Eastman Kodak Co.'s enviable collection of patents, attorneys say building a strong patent portfolio is not only critical for companies wanting to protect their innovations and set themselves apart from rivals, it gives them more leverage in litigation.
Health Management Associates Inc. shareholders filed a class action in Florida federal court Friday claiming stock prices plummeted after it was revealed the hospital group had used Medicare fraud to inflate prices and hidden a wrongful-termination whistleblower suit by an employee who uncovered the alleged fraud.
The European Commission has dropped its claims that Servier SAS provided false and misleading information during an investigation, but will continue its probe of whether the French pharmaceutical company reached anti-competitive deals with generic-drug makers, the regulator said Friday.
A Pennsylvania federal jury on Thursday reached a verdict that Varian Medical Systems Inc. willfully infringed a University of Pittsburgh patent for a device used in radiation cancer treatments.
A Wisconsin federal judge reopened a lawsuit Thursday in which genetic research company Affymetrix Inc. seeks to add an inventor to two Illumina Inc. patents related to microarray technology, and shot down a renewed dismissal bid from Illumina.
Pharmaceutical giants AstraZeneca AB, Merck Sharp & Dohme Corp. and KBI Inc. reached a settlement Thursday with Indian drugmaker Lupin Ltd. in a patent dispute over stomach acid reflux drug Nexium.
Johnson & Johnson unit Cordis Corp. sued the U.S. Patent and Trademark Office on Thursday, alleging the agency violated the law by refusing to let Cordis subpoena Boston Scientific Corp. and Abbott Laboratories as part of a re-examination of two Cordis stent patents.
Pfizer Inc. on Wednesday was sued in Puerto Rico by a putative class of employees who say the drugmaker channeled their retirement investments into company stock while hiding the inevitable losses that would occur when the harmful effects of their arthritis drugs came to light.
Graceway Pharmaceuticals LLC filed a Chapter 11 plan Wednesday in Delaware bankruptcy court that calls for the liquidation of substantially all its remaining assets and the resolution of all claims against the company.
The former head manager of the Cincinnati offices of the Centers for Disease Control and Prevention was sentenced Wednesday to four years in federal prison for taking bribes in exchange for construction contracts.
2011 was yet another busy legislative and regulatory year for health and other welfare benefits, keeping benefits practitioners and plan sponsors on their toes for most of the year. Major legislation, regulations and other federal guidance that either became effective or was issued in 2011 have had — or will have — a profound effect on health plans and other welfare benefits, say John Hickman and Ashley Gillihan of Alston & Bird LLP.
In Samaan v. St. Joseph Hospital, the First Circuit cited Daubert in its delivery of an opinion about the duty borne by trial courts to keep out flawed analyses by credentialed experts that is as keen in its reasoning as it is sharp in its prose, says David Oliver of Vorys Sater Seymour and Pease LLP.
Although the Biologics Price Competition and Innovation Act was signed into law in 2010 as part of the Patient Protection and Affordable Care Act, biosimilars law is not a settled matter. The debate between supporters and opponents is still ongoing regarding many aspects of the PPACA, and the BPCIA could be subsumed into this political battle, says Brian Dorn of Merchant & Gould PC.
The new standards set forth in the U.S. Food and Drug Administration's updated draft guidance on the 510(k) program could have meaningful impact on discrete aspects of the substantial equivalence process and, ultimately, on the availability of the 510(k) pathway for a fair number of devices that would otherwise not have raised any questions under existing guidance and practice, say attorneys with Hogan Lovells.
A new provision that was slipped into the IRS's annual announcement of procedures for exempt organization determinations and letter rulings provides a way for governmental entities to voluntarily terminate their Section 501(c)(3) status. This is important for governmental hospitals that otherwise could be faced with new exemption requirements and penalties, says Elizabeth Mills of Proskauer Rose LLP.
The IRS has clarified the requirement under the Affordable Care Act to report the cost of employer-sponsored health coverage on annual W-2 forms. This applies to most employers, including federal, state and local government entities, churches and other religious organizations, and employers not subject to continuation coverage requirements under COBRA, say attorneys with Proskauer Rose LLP.
The U.S. Food and Drug Administration has warned several state-licensed health care practitioners that the agency believes their advertising violates federal law. This and other recent actions indicate the agency continues to seek to expand its authority over the practice of medicine and pharmacy, say attorneys with Holland & Knight LLP.
At the end of every year, we look back over the past 12 months, the highs and the lows, the thrill of victory and the agony of defeat. We're doing that, and handing out lumps of coal in the process, specifically to the 10 worst prescription medical product liability decisions of 2011, says James Beck of Dechert LLP.
Given the increased resources being devoted by the federal government to intellectual property prosecutions, it may be time for IP holders to consider referring some cases to federal law enforcement officials, say Michael Buchanan and Frank Cavanagh of Patterson Belknap Webb & Tyler LLP.
During the Federal Insurance Office's first public hearing, the agency's director outlined an ambitious agenda for the office that includes representing U.S. interests in international prudential regulatory matters and studying the access to and affordability of insurance. But despite underscoring the need to improve industry regulation, the FIO will not directly regulate insurance, say Lawrence Mirel and Xavier Baker of Wiley Rein LLP.