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SF Health Plan Seeks Class Cert. In McKesson AWP Suit
Thursday, Jul 02, 2009
San Francisco city officials have asked the federal court overseeing their suit accusing McKesson Corp. of conspiring to inflate the average wholesale price of hundreds of drugs to certify a class of all governmental entities in California, including the state itself, that overpaid for the drugs.
Former HealthSouth CFO Headed To Prison
Thursday, Jul 02, 2009
Following the U.S. Supreme Court's refusal to take up the case, the former finance chief of HealthSouth Corp. has been ordered to report to federal prison for three months for allegedly helping to carry out a massive accounting fraud scheme that nearly torpedoed the company.
Guidant Judge Rejects 3rd Party Payor Claims Again
Thursday, Jul 02, 2009
A federal judge has refused to reconsider a 2007 dismissal of proposed class action claims third-party health care providers brought against Guidant Corp. over its recalled implantable heart defibrillators, noting that much of the request was "an attempt to relitigate old issues."
Expanded Discovery Allowed In Actavis Digitek MDL
Thursday, Jul 02, 2009
A federal judge has allowed for expanded discovery and has refused Actavis Group's bid to quash a subpoena in the multidistrict product liability case accusing Actavis of selling a defective or adulterated heart medication.
2nd Circ. Revives Antitrust Suit Over Hospital Access
Thursday, Jul 02, 2009
A federal appeals court has vacated a lower court's ruling of summary judgment for a surgeon and his practice — defendants in an antitrust case over access to operating rooms at state-run Westchester Medical Center in New York — finding that they are not necessarily immune from unfair competition claims even though the hospital is.
Last Acculink Claim Against Abbott Nixed
Thursday, Jul 02, 2009
A federal judge has thrown out the lone remaining claim in a product liability lawsuit brought by a man who was partially blinded during a stent procedure in which Abbott Laboratories' blood clot-capturing Acculink system failed to prevent a stroke.
Wyeth Wins Sanctions Against Firm In Prempro MDL
Thursday, Jul 02, 2009
A judge in charge of the multidistrict litigation over Wyeth Pharmaceuticals Inc.'s hormone replacement pill Prempro has followed through on his threat to sanction Bailey & Galyen, a law firm representing hundreds of plaintiffs, for its failure to timely produce completed client fact sheets.
Apotex Launches Suit Over Eisai’s Aricept Patents
Thursday, Jul 02, 2009
Canadian generics maker Apotex Inc. has fired off a declaratory judgment action asserting it is not infringing Eisai Co. Ltd.’s patents, in a move to secure federal approval for its generic version of the Tokyo company’s Alzheimer’s drug Aricept.
Bayer Hits Teva With Suit Over Levitra Patent
Thursday, Jul 02, 2009
Teva Pharmaceutical Industries Ltd. is facing a suit by two Bayer AG units over the Israeli generics maker’s plans to launch a generic version of erectile dysfunction drug Levitra.
9th Circ. Vacates Marlyn Supplement Recall Order
Thursday, Jul 02, 2009
A federal appeals court has upheld a decision that granted a preliminary injunction against Marlyn Nutraceuticals Inc. in a trademark infringement case over the dietary supplement Wobenzym, but it threw out a recall order.
Eli Lilly Wins Dismissal Of Another Zyprexa Case
Wednesday, Jul 01, 2009
A judge has dismissed another lawsuit from the multidistrict litigation alleging Eli Lilly & Co. failed to warn of the health risks associated with the blockbuster antipsychotic drug Zyprexa.
FDA Panel Pushes Acetaminophen Painkiller Ban
Wednesday, Jul 01, 2009
Popular prescription painkillers including Abbott Laboratories' Vicodin and Endo Pharmaceuticals Holdings Inc.'s Percocet may soon be pulled from the market, after a narrow majority of U.S. Food and Drug Administration advisory panel members reportedly voted Tuesday to eliminate the drugs because they contain acetaminophen, which has been linked to liver damage and death.
Forest, Lundbeck Lose Bid To Limit Lexapro Claims
Wednesday, Jul 01, 2009
A federal judge has rejected the latest bid from H. Lundbeck A/S and its partner Forest Laboratories Inc. to pare down a patent dispute related to the antidepressant citalopram, ruling that a lone letter from one of the companies' suppliers did not yield enough evidence to drop part of Infosint SA's infringement claims.
Alzheimer's Institute Sues Pfizer Over Mice Patents
Wednesday, Jul 01, 2009
A biotechnology patent-holding company has sued Pfizer Inc. alleging the drugmaker infringed patents related to components of Alzheimer’s disease research, including nucleic acid coding for the so-called Swedish mutation and genetically engineered mice expressing the mutation.
FDA Mandates Labels For Pfizer, GSK Smoker Drugs
Wednesday, Jul 01, 2009
The U.S. Food and Drug Administration has required Pfizer Inc. and GlaxoSmithKline PLC to put boxed warnings on their smoking-cessation aids amid reports linking the medications to suicides.
Ohio Court Says Law Bars Off-Label Abortion Pill Uses
Wednesday, Jul 01, 2009
Responding to a request from a federal appeals panel, Ohio's highest court ruled Wednesday that a state law requires doctors prescribing mifepristone — also known as the RU-486 abortion pill — to follow the usage approved by U.S. regulators, including an admonition not to dispense the drug more than 49 days into a pregnancy.
Federal Preemption Shifting, Not Dead: Experts
Wednesday, Jul 01, 2009
In the wake of the U.S. Supreme Court case Wyeth v. Levine, President Barack Obama released a memo signaling a more cautious approach to federal preemption than that of the last Bush administration. But legal experts say Obama has merely given a nod to state sovereignty, not rung the death knell for federal preemption.
NLRB Erred In Nursing Home Case Ruling: DC Circ.
Wednesday, Jul 01, 2009
The National Labor Relations Board erred when it ruled a company that purchased a California nursing home was not entitled to implement new terms and conditions for employment workers at the facility, a federal appeals court has ruled.
Abbott Hit With $1.7B Verdict In IP Suit Over Humira
Tuesday, Jun 30, 2009
A jury in the U.S. District Court for the Eastern District of Texas has hit Abbott Laboratories with possibly the largest patent verdict in U.S. history, awarding Johnson & Johnson subsidiary Centocor Inc. $1.67 billion and finding that Abbott's flagship arthritis drug Humira infringed a Centocor patent.
Solvay, Unimed Hit With AndroGel Suit In Pa.
Tuesday, Jun 30, 2009
Safeway Inc. and Walgreen Co. have sued five drug companies — including Solvay Pharmaceuticals Inc. and its unit Unimed Pharmaceuticals LLC — over an alleged scheme to block generic competition for the drug AndroGel, marking another private suit over AndroGel in the wake of the Federal Trade Commission taking Solvay to court in January.
FDA Enforcement Crackdown Requires Reforms
An increase in the number of FDA enforcement actions will improve public health and level the commercial playing field only if the enforcement actions are tethered to the statutes and regulations that govern FDA-regulated firms, say Sheldon T. Bradshaw and D. Kyle Sampson of Hunton & Williams LLP.
HITECH And Federal Breach Notification Rules
The American Recovery and Reinvestment Act of 2009 received a lot of attention for its tax and spending provisions, however the legislation also makes very significant changes to certain aspects of health care regulation, in particular the privacy and security of health information, say Jacqueline Klosek and Christopher Brancati of Goodwin Procter LLP.
Wyeth Places Heavier Burden On Implied Preemption
The U.S. Supreme Court issued a landmark ruling in March in Wyeth v. Levine, deciding that FDA approval of drug labels does not automatically preempt state tort claims. The justices' analyses of the impossibility doctrine of implied preemption impact the viability of FRCP 12(b)(6) motions, as well as discovery plans, say Joseph J. Leghorn and Kathleen S. Kizer of Nixon Peabody LLP.
Inequitable Conduct Still A Thorny Issue
Last month’s denial by the U.S. Supreme Court of a petition for certiorari filed by Aventis Pharma SA signals continued uncertainty regarding the state of the law of inequitable conduct, says Rachel K. Zimmerman of Merchant & Gould PC.
Making The Most Of Rule Of Evidence 502
It is foreseeable that, if used strategically, the new Federal Rule of Evidence 502 should alleviate the burdens of costly electronic discovery and post-production privilege review and should ultimately reduce the billions of dollars spent each year in litigation to protect against the inadvertent disclosure of privileged materials, says Otilia Gabor of Miles & Stockbridge PC.
A Stark Lesson For Doctor-Hospital Arrangements
An appeals court recently found that a hospital system’s relationship with its exclusive anesthesiology providers failed to meet federal requirements, handing hospitals and physicians a sharp reminder of the importance of ensuring that all arrangements between hospitals and physicians are appropriately documented, says Victoria Heller Johnson of Fox Rothschild LLP.
The Latest FTC Clinical Integration Advisory
As the new administration articulates its position on how to balance the care and cost benefits of the clinical integration of independent health care providers with the potential for harm to competition from joint contracting, this confluence of health care policy and antitrust law only promises to get more interesting, say David W. Simon and Heather Holden Brooks of Foley & Lardner LLP.
Blackwell V. Wyeth: The Application Of Frye
If you are like me, the Daubert requirements on the admissibility of expert testimony play a far more active role in your practice than the older, and somewhat more limited, Frye analysis. But the recent opinion from the Maryland Court of Appeals in Blackwell v. Wyeth gave me pause to reconsider Frye's place in the product liability practitioner’s toolbox, says Brian Casto of Miles & Stockbridge PC.