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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National Stage Applications Must Comply with Entirety of § 371 Prior to Commencement of National Stage, Unless Early Commencement Expressly Requested

Regardless of whether an application is filed before or after the amendments made to the Technical Corrections Act (TCA), the entirety of §371 must be complied with before national stage commencement of an international PCT application may begin. To commence the national stage early, an express request to do so must be made, regardless of whether pre- or post-TCA versions of §154(b)(1)(A)(i)(II) applies. The Technical Corrections Act, as amended, extends the patent term by one day for each day after the period specified, if the issue of a patent is delayed due to the failure of the PTO to provide certain notifications not later than 14 months after the date of commencement of the national stage under §371 in an international application. Prior to its amendment, the TCA stated the ...
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Pennsylvania Superior Court Issues Opinion in Tincher v. Omega Flex, Inc. Clarifying How Juries Should be Charged in Product Liability Cases

In an opinion filed February 16, 2018, the Superior Court of Pennsylvania vacated judgement in favor of the Tincher plaintiffs and remanded the case for a new trial. The central issue in the decision was the trial court’s failure to properly instruct the jury on the definition of “defect” in a product liability — design defect — case. How did we get back to Tincher again? Some readers may be wondering why we are talking about Tincher again since the Pennsylvania Supreme Court issued its landmark decision in the matter back in 2014. The following is a relatively quick synopsis of the procedural history: The Supreme Court remanded the case to the trial court to decide whether further action was needed on post-trial motions. The defendant, Omega Flex, Inc. asked ...
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Increased Enforcement and Litigation Risk for Data Breaches Involving Personal Health Information

HIPAA and HITECH have long been high priority concerns for health care and life sciences organizations. But recent developments in HIPAA enforcement and data breach litigation raises the threat level for all companies dealing with personal health information (PHI). On the enforcement front, on February 1, 2018, HHS’s Office of Civil Rights — which enforces HIPAA privacy, security, and breach notification rules — announced a $3.5 million settlement with Fresenius Medical Care North America to resolve several potential HIPAA violations. In 2013, Fresenius filed five breach reports with HHS, each arising from the theft of unencrypted laptops, desktops and USB drives, each at a different Fresenius facility. Notable about the settlement is the dollar figure compared to the number of individuals’ data exposed. Fresenius agreed to pay the fifth highest ...
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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 it was mainly limited to medical marijuana. The memo was rescinded by Attorney General Sessions in January 2018. However, whereas the Cole Memo outlined steps states could (and should) take to avoid federal prosecution, the memorandum issued by Attorney General Sessions was much more … ...
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Superior Court of Pennsylvania Issues Ruling Addressing Multiple Issues in Pharmaceutical Case

In an opinion filed January 8, 2018, Pennsylvania’s intermediate appellate court addressed multiple issues arising after a plaintiff’s verdict in a case from the In Re: Risperdal Litigation. The issues the court addressed are discussed below. Initially, the court, citing Frye, reiterated that in Pennsylvania, a party wishing to introduce novel scientific evidence must demonstrate that the relevant scientific community has reached general acceptance of the principles and methodology employed by the expert witness to testify regarding his conclusions. However, the conclusions themselves need not also be generally accepted. In this particular instance, Dr. Solomon used the differential diagnosis method to conclude that Risperdal caused the plaintiff’s gynecomastia. The Superior Court essentially affirmed that in Pennsylvania differential diagnosis is a generally accepted scientific process to establish specific causation when applied ...
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Potential Criminal Repercussions Under Medical Marijuana Laws for Physicians

Many states have their own medical marijuana laws that define who can use medical marijuana, what qualifying conditions are necessary, and what licenses are required to distribute the drug. In Arizona, the Arizona Medical Marijuana Act (AMMA, A.R.S. §36-2801) immunizes physicians from prosecution for providing written certifications that a patient is likely to receive therapeutic or palliative benefits from the medical use of marijuana to treat or alleviate a patient’s debilitating medical condition. The physician is required to specify the debilitating medical condition and sign and date the certification after completing a full assessment of the patient’s medical history. As the case below makes clear, strictly complying with statutory language is paramount to avoiding both criminal prosecution and potential professional ramifications. In State v. Gear, 239 Ariz. 343 (2016), a ...
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