Category Archives: News

Update on Medical Cannabis for Veterans

As we recently noted in our last blog post, Senators Nelson and Schatz from Florida and Hawaii introduced The Veterans Medical Marijuana Safe Harbor Act.  The legislation provided our military veterans access to medical cannabis if they were found to be suffering from chronic pain, PTSD and other serious medical conditions, as well as funding clinical trial research within the Department of Veterans Affairs. As quickly as it was introduced and actually approved in the Senate by a vote of 85-9, it was also quickly…

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Health Care Organizations Seek Regulatory Changes To Improve Access To Cybersecurity Tools

Cybersecurity presents thorny problems specific to healthcare organizations. Not only are their protection of personal health information strictly regulated by the HIPAA and HITECH laws, but such organizations are also more frequently the targets of cyberattacks due in part to the highly personal information collected by such organizations, and in part due to the relative lack of resources available to battle cyber-threats. One set of healthcare regulations not directly related to cybersecurity, the Stark anti-kickback law, has potentially hindered healthcare organizations in adapting to an…

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The End of Marijuana as a Schedule I Banned Substance?

On January 4, 2018, Attorney General Jeff Sessions rescinded what is commonly referred to as “The Cole Memorandum.” The Cole Memo was drafted in 2013 by United States Deputy Attorney General James M. Cole and governed federal prosecution of offenses related to marijuana/cannabis. Under the memo, U.S. attorneys generally refrained from prosecuting state-licensed cannabis businesses unless they violated state as well as federal law. For the most part, this was not an issue, as those states which had legalized marijuana heavily regulated its use, and…

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Appeals Courts Vacate Half a Billion in Verdicts Against Johnson & Johnson

Johnson & Johnson (J&J) has successfully challenged two talc verdicts and has mitigated nearly $500 million in damages in less than a week. The largest verdict to date, the $417 million  Echevarria verdict, was reversed and a new trial has been ordered. This decision comes at the heels of J&J convincing a St. Louis appeals court to vacate a separate $72 million verdict. Superior Court Judge Maren Nelson concluded that the evidence presented during Echevaria’s trial didn’t support the large verdict.  Judge Nelson wrote that…

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Federal Court Denies Qui Tam Action Against Medical Device Manufacturer Rejecting Novel Theory that Free Product Support Services Create Liability Under Anti-Kickback Statute

Medical device manufacturers operate in a competitive market. To differentiate themselves from their competitors, manufacturers may offer above-and-beyond customer service. A recent federal qui tam action alleged that too much customer service constitutes an illegal kickback under the federal Anti-Kickback Statute. The court rejected the claim, and its reasoning supplies some comfort and some questions for medical device companies going forward. The federal Anti-Kickback Statute, 42 USC sec. 1320a-7b (AKS), makes it unlawful to knowingly and willfully solicit any remuneration (e.g. bribe, kickback, rebate, etc.)…

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Drug Promotion on Social Media By Consumers: Can It Be Regulated?

Kim Kardashian recently used social media to promote the use of a prescription drug. In her Instagram post, Ms. Kardashian told her followers that a physician recommended use of the drug Diclegis to alleviate her symptoms of morning sickness. Ms. Kardashian is not the only public figure to recently deal with morning sickness as the Duchess of Cambridge also dealt with this issue, reported here. Having experienced positive results following the use of this drug, Ms. Kardashian posted her intent to pair with the

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Defendants in Mass Tort Pelvic Mesh Lawsuits May Now Succeed With Removal to Federal Court – Non-Diverse Defendant Wins Dismissal

In a significant win for Secant Medical LLC, (Secant), Judge Arnold L. New of the Court of Common Pleas of Philadelphia County granted its motion to dismiss mass tort pelvic mesh personal injury claims in a decision dated August 22, 2014.  The court held that under the Biomedical Access Assurance Act (BAAA), Secant is not a manufacturer or seller of the pelvic mesh. Secant, a Pennsylvania company, was undoubtedly named to defeat diversity jurisdiction in an effort by plaintiffs to stay in state court in…

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This Week’s Life Science Headlines

        Litigation

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This Week’s Life Science Headlines

        Litigation

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This Week’s Life Science Headlines

        Litigation

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