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HTMLFDA 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;
Legal Alert/Article
December 16, 2014, previously published on November 2014
Cybersecurity 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...


HTMLJury Finds for Drug Manufacturers in First Post-Actavis "Reverse Payment" Trial
Jonathan Berman, Benjamin H. Cheng, Aimee E. DeFilippo, Kevin D. McDonald; Jones Day;
Legal Alert/Article
December 16, 2014, previously published on December 2014
In 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...


HTMLWill Evaporated Cane Juice Be Sweet for Class Action Plaintiffs?
Mark Mansour, Stephanie L. Resnik, Emily K. Strunk; Jones Day;
Legal Alert/Article
December 10, 2014, previously published on November 2014
The 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...


HTML"Right to Try" Becomes a Reality in Michigan
Jennifer B. Van Regenmorter; Foster, Swift, Collins & Smith, P.C.;
Legal Alert/Article
November 28, 2014, previously published on November 13, 2014
On 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...


HTMLOIG Proposes New Anti-Kickback Law and CMP Safe Harbors
Robert P. Charrow, Francis J. Serbaroli; Greenberg Traurig, LLP;
Legal Alert/Article
November 28, 2014, previously published on November 10, 2014
Whenever 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...


HTMLAntitrust 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;
Legal Alert/Article
November 12, 2014, previously published on October 2014
The 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...


HTMLPublic Justice and AAJ Contest Dismissal of Big-Pharma Fraud Case
Jordan Elias; Lieff, Cabraser, Heimann & Bernstein, LLP;
Legal Alert/Article
November 10, 2014, previously published on October 21, 2014
Public 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...


HTMLFederal 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;
Legal Alert/Article
November 5, 2014, previously published on October 29, 2014
In 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...


HTMLLouisiana Federal Judge Dramatically Reduces $9 Billion Punitive Damage Award To $37 Million
Sutherland Asbill Brennan LLP;
Legal Alert/Article
November 5, 2014, previously published on October 30, 2014
On 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...


HTMLCompetition Bureau Releases Updated IP Guidelines
Jonathan Bitran, Dominic Thérien; McCarthy Tétrault LLP;
Legal Alert/Article
October 28, 2014, previously published on October 20, 2014
On 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...


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