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 increasingly cyber-insecure environment, and the healthcare community is seeking some relief from it. On June 25, 2018, the Centers for Medicare and Medicaid Services (CMS), a division of the Department of Health and Human Services (HHS), issued a request for public comment on the regulatory ...
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Issues Abound in Cannabis Cultivation – What Can We Expect

When cannabis began its march towards legalization, both medically and recreationally, there were many mistakes made by state agencies issuing licenses for cultivation, manufacturing and dispensing. This was the result of self-imposed deadlines, no clear path how to go about deciding who “wins” a license and who does not and various legal hurdles concerning everything from zoning to security for facilities. And as always, let’s not forget the Federal Government’s continued ban on cannabis as a Schedule I substance. Many believe other countries throughout the world have handled the legalization of marijuana in a more cohesive and comprehensive manner. However, a closer look reveals this is not necessarily the case. A perfect example is Germany. Germany previously allowed various companies to bid for cultivation rights. A number of companies were ...
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A Big Week of Changes in Cannabis Law

Despite continued animosity by U.S. Department of Justice regarding marijuana and marijuana-based products, at least one branch of the federal government decided that the time was right to approve the use of a drug made from cannabidiol. As many of you know from our earlier posts, U.K. company GW Pharmaceuticals Plc, created a drug to treat seizures associated with two types of epilepsy that typically affect children. After providing substantial evidence to the Food and Drug Administration (FDA), on Monday, June 25, 2018, the FDA approved Epidiolex. The drug is designed to treat seizures associated with Lennox-Gastaut and Dravet syndromes, in patients age two and older. These particular syndromes are resistant to various other treatments and Dravet syndrome has a mortality rate of almost 20 percent in children with syndrome, ...
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Michael Hamilton to Speak at Perrin Conferences on Opioid Litigation

Join Goldberg Segalla’s Michael A. Hamilton at Perrin Conferences Opioid Litigation Conference in Dallas, TX on Thursday June 28, 2018. This one-day conference covers medical perspectives on opioid prescription practices, opioid-related litigation across state courts, and more. Register here.
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Florida’s Second Circuit Invalidates State Legislature’s Attempt to Ban Use of Smokable Marijuana in Private

Medical marijuana has become more and more widespread and accepted throughout the country and state legislatures have drafted legislation that regulates its use.  However, when a state’s legislature oversteps its limits, the courts must be willing to respond and invalidate such measures.  That’s exactly what happened on Friday, May 25th, 2018, in People United for Medical Marijuana v. Florida Dept. of Health, Index No.: 2017-CA-1394 (2nd Judicial Circuit, Leon County). In November 2016, Floridians voted to amend their state constitution and allow individuals who suffered from certain medical conditions access to medical marijuana.  The adopted amendment became Section 29, Article X of the Florida Constitution.  The amendment allowed individuals who qualified for use to have safe access to medical marijuana, with the only restriction being an inability to smoke marijuana ...
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Potential Approval by the FDA of New Cannabis-Based Drug Used to Treat Rare Forms of Epilepsy

Despite continued animosity by U.S. Department of Justice regarding marijuana and marijuana-based products moving forward, at least one branch of the federal government has decided that the time is now right to at least consider the efficacy of certain medications that have their basis in cannabis. U.K. company GW Pharmaceuticals Plc, has created a drug to treat seizures associated with two types of epilepsy that typically affect children and recently provided “substantial evidence” of the drug’s effectiveness to the Food and Drug Administration (FDA). The FDA confirmed this fact in a report released April 17, 2018. The FDA further stated that “The risk-benefit profile established by the data in the application appears to support approval of cannabidiol.” GW Pharmaceutical’s drug is made from cannabidiol (otherwise known as CBD), a compound ...
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Massachusetts Supreme Judicial Court Expands Liability for Branded Drug Companies to Consumers of Generics

On March 16, 2018, the Supreme Judicial Court of Massachusetts, the state’s highest appellate court, issued a decision of importance for branded drug companies. In Rafferty v. Merck & Co., the Massachusetts high court held that a brand-name drug company can be liable to a consumer of a generic drug for injuries arising from the failure to update the brand-name drug’s label that results from a “reckless disregard of an unreasonable risk of death or grave bodily injury.” The background for this decision is the intersection between federal law governing drug labeling and state product liability and negligence law. The FDA pre-approval process requires a branded drug company to show that its label is accurate and adequate. Post-approval, the drug company has the authority and obligation, under certain circumstances, to ...
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Federal Law Preempts State Law Product Liability Claims Involving “Hybrid” Medical Devices

On an issue of first impression in the federal Circuit Courts of Appeals, the Third Circuit held that federal law preempts state law claims involving hybrid medical devices where any part of the device requires FDA pre-approval of the device’s safety and effectiveness. The 1976 Medical Device Amendments to the Food, Drug and Cosmetics Act brought medical devices under the regulatory authority of the Food and Drug Administration. The Amendments established a system whereby certain types of devices, termed Class 3 devices, require approval by the FDA prior to being brought to market after a finding of the device’s safety and effectiveness. The Amendments also prescribe labeling requirements, but permit off-label uses. Class 1 and 2 devices do not require pre-approval or a finding as to their safety or effectiveness, ...
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District Court’s Handling of “Prejudicial” Discovery Violation Upheld after Proceeding to Trial on ANDA Infringement Claims

On February 9, 2018, in Merck Sharp & Dohme Corp v Amneal Pharm. LLC, the U.S. Court of Appeals for the Federal Circuit held that the District Court did not abuse its discretion in proceeding to trial despite a party’s violation of a discovery order where the court took adequate steps to ensure the opposing party would not be prejudiced. In 2014, Amneal submitted an Abbreviated New Drug Application (ANDA) to the FDA disclosing a generic version of Merck’s Nasonex®. Thereafter, Merck filed an infringement suit against Amneal alleging that the active agent in Amneal’s nasal spray would necessarily convert to the patented “MFM” form over its two-year shelf-life. Pursuant to a discovery order, Amneal was obligated to exchange all “representative commercial batches” of its product. Notwithstanding this directive, Amneal ...
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Mere Hypothesis of Success is Not Reasonable Expectation of Success in Achieving the Claimed Invention

On December 18, 2017, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court’s final judgement enjoining Dr. Reddy’s Laboratories and Teva Pharmaceuticals (collectively DRL) from commercially manufacturing, using, offering for sale, selling, or importing the generic version of Genzyme’s bone marrow stimulant Mozobil®. The court found that combining the prior art in the manner suggested by DRL would not create a reasonable expectation of success in achieving the claimed invention. Genzyme, along with Sanofi Aventis, had developed a method for mobilizing and harvesting stem cells, which are immature blood cells residing in the bone marrow. Stem cells can develop into mature blood cells, including white blood cells, and are usually anchored to the bone marrow partly through a bond between a receptor (CXCR-4) located on the ...
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