Search Results (1132)
Documents on Antitrust & Trade Regulation, Pharmaceuticals, Health Care
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|FDA Voices Privacy Concerns and Promotes Medical Device Cybersecurity with New Guidance, Collaborative Information-Sharing|
Laurie A. Clarke, Alexis Slagle Gilroy, Colleen Heisey, Kevin D. Lyles, Mauricio F. Paez; Jones Day;
December 16, 2014, previously published on November 2014Cybersecurity of medical devices poses unique challenges for industry and regulators, because of potential risks in device malfunction, disruption of medical care, and compromised patient data, as well as the challenge of balancing countervailing needs, such as patient safety and ensuring that...
|Jury Finds for Drug Manufacturers in First Post-Actavis "Reverse Payment" Trial|
Jonathan Berman, Benjamin H. Cheng, Aimee E. DeFilippo, Kevin D. McDonald; Jones Day;
December 16, 2014, previously published on December 2014In the first "reverse payment" trial since the U.S. Supreme Court’s Actavis decision held that "reverse payment" settlements potentially could be found anticompetitive under a rule of reason analysis, a federal jury in Massachusetts has returned a verdict in favor of the...
|Will Evaporated Cane Juice Be Sweet for Class Action Plaintiffs?|
Mark Mansour, Stephanie L. Resnik, Emily K. Strunk; Jones Day;
December 10, 2014, previously published on November 2014The past few years have seen a remarkable growth in the number of class actions directed at food labels. Noteworthy about these cases is not merely how many have been filed but their nature as well. There's nothing novel about alleging that a product label (including a food label) is false or...
|"Right to Try" Becomes a Reality in Michigan|
Jennifer B. Van Regenmorter; Foster, Swift, Collins & Smith, P.C.;
November 28, 2014, previously published on November 13, 2014On Friday, October 17, Governor Rick Snyder signed the Right to Try Act, which allows patients to try experimental drugs and other treatments before they have been approved by the Food and Drug Administration (FDA). The law gives patients with advanced illnesses access to drugs that successfully...
|OIG Proposes New Anti-Kickback Law and CMP Safe Harbors|
Robert P. Charrow, Francis J. Serbaroli; Greenberg Traurig, LLP;
November 28, 2014, previously published on November 10, 2014Whenever the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) issues proposed regulations regarding exceptions to the Anti-Kickback Statute (AKS), and the Civil Monetary Penalty (CMP) provisions of the Social Security Act, it’s news. When the OIG proposes...
|Antitrust Alert: U.S. Federal Court Provides Guidance on Treating Joint Ventures as a "Single Entity" for Antitrust Purposes|
Thomas Demitrack, Kathryn M. Fenton, Peter A. Julian, Toby G. Singer; Jones Day;
November 12, 2014, previously published on October 2014The United States District Court for the Southern District of Ohio has unsealed its summary judgment opinion in The Medical Center at Elizabeth Place v. Premier Health Partners. The Court granted summary judgment in favor of the defendants-four hospital systems that operated pursuant to a joint...
|Public Justice and AAJ Contest Dismissal of Big-Pharma Fraud Case|
Jordan Elias; Lieff, Cabraser, Heimann & Bernstein, LLP;
November 10, 2014, previously published on October 21, 2014Public Justice (represented by Lieff Cabraser) and the American Association for Justice today filed an amicus brief in the U.S. Court of Appeals for the Second Circuit urging the reinstatement of civil RICO claims that Sanofi-Aventis profited from a scheme to market and sell its antibiotic Ketek by...
|Federal Judge Rules That Integrated Healthcare System Comprised of Separately Owned Hospitals Incapable of Conspiring Under Section One of The Sherman Act|
Robert B. Craig; Taft Stettinius & Hollister LLP;
November 5, 2014, previously published on October 29, 2014In recent years, some competing hospital systems have achieved the benefits of merging without a change in ownership of their assets by undertaking highly integrated joint ventures so that the combination essentially becomes a single enterprise with a complete unity of interest. Such “virtual...
|Louisiana Federal Judge Dramatically Reduces $9 Billion Punitive Damage Award To $37 Million|
Sutherland Asbill Brennan LLP;
November 5, 2014, previously published on October 30, 2014On Monday, U.S. District Judge Rebecca Doherty (Western District of Louisiana) cut a total punitive damage award from $9 billion to $36.875 million, an award 244 times smaller than the jury had determined. The case involved the first trial in an MDL involving the potentially unsafe effects of a...
|Competition Bureau Releases Updated IP Guidelines|
Jonathan Bitran, Dominic Thérien; McCarthy Tétrault LLP;
October 28, 2014, previously published on October 20, 2014On September 18, 2014, the Competition Bureau (Bureau) released updated Intellectual Property Enforcement Guidelines (IPEGs). These IPEGs are an update of the original guidelines released in 2000 and result from recent consultations; the Bureau has announced that it will soon conduct another...