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On January 4, 2018, Attorney General Jeff Sessions rescinded what is commonly referred to as “The Cole Memorandum.”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 The memo was rescinded by Attorney General Sessions in January 2018.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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Sixth Circuit Discourages False Claims Act Claims Based On Off-Label Promotion

On October 27, 2017, in U.S. ex rel. Ibanez v. Bristol-Myers Squibb Co., 874 F.3d 905 (6th Cir. 2017) (Ibanez), the Sixth Circuit Court of Appeals affirmed the dismissal of a qui tam action under the False Claims Act (FCA) alleging that Bristol-Myers Squibb engaged in a nationwide scheme to promote off-label uses of its anti-psychotic drug Abilify. In its decision, the Sixth Circuit highlights the challenges for a relator asserting FCA claims based on off-label promotion in a manner that should be construed to discourage similar claims. The FCA prohibits knowingly presenting, or causing to be presented, a false or fraudulent claim to the government for payment. According to the Sixth Circuit, because the claim is subject to the requirement under Rule 9(b) that fraud claims be plead with ...
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Federal Law Preempts State Law Regarding Discrimination Lawsuit Brought by Employee Terminated due to Medical Marijuana Use

In our last two posts related to this issue, we’ve discussed how states have interpreted and applied their own laws regarding medical marijuana use in the context of employment discrimination lawsuits when faced with opposing federal law under the Federal Controlled Substances Act. In Noffsinger v. SSC Niantic Operating Company LLC, 2017 WL 3401260, the Connecticut Supreme Court held that any person who used marijuana for medicinal purposes in compliance with Connecticut law may maintain a cause of action against an employer who refused to employ them for this reason. In Barbuto v. Advantage Sales and Marketing, LLC, 78 N.E.3d 37 (2017), the Massachusetts Supreme Court concluded that a plaintiff may seek a remedy through claims of handicap discrimination in violation of Massachusetts General Law chapter 151B after she was terminated ...
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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 “reviewing all of the evidence in the light most favorable to Echevarria, the best that can be said is that that there was (and is) an ongoing debate in the scientific and medical community about whether talc more probably that not causes ovarian cancer and ...
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Seventh Circuit Bars RICO Claims by Third-Party Payors Against Drug Companies Based on Off-Label Promotion

On October 12, 2017, in Sidney Hillman Health Center of Rochester v. Abbott Laboratories, —F.3d —-, 2017 WL 4544834 (7th Cir. 2017), the Seventh Circuit affirmed the dismissal of a civil RICO class action by third-party payors against drug manufacturer Abbott Laboratories. The decision appears to completely foreclose payors’ suits against drug companies for off-label promotion under the Racketeer Influenced and Corrupt Organizations Act (RICO) and potentially signals a bar against tort claims of any kind by payors against drug companies for off-label promotion practices. In 2012, Abbott paid $1.6 billion to settle qui tam actions filed against it under the False Claims Act for off-label promotion of its drug Depakote (divalproex sodium). It is alleged to have used intermediaries to encourage the prescribing of the drug for off-label purposes. ...
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Lone Pine Orders: Not Just for Multi-Plaintiff Litigation?

So-called “Lone Pine” orders derive from Lone Pine v. Lore, 1986 WL 637507 (N.J. Sup. Ct. Law Div. Nov. 18, 1986), and have often been used by state and federal courts to promote efficiency in discovery by requiring plaintiffs to provide some medical or scientific proof that their exposure to a product caused their injuries before requiring the parties to engage in the usual full-blown and expensive discovery process. In most instances, Lone Pine orders are employed in cases involving large numbers of plaintiffs as a case management tool to “weed out” those cases for which causation cannot be established. But what if you have a single-plaintiff or one-off case that involves a novel claim, for which you anticipate that the plaintiff may ultimately be unable to establish that her ...
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State Law Wins (Again) Over Federal Law When Firing Someone for the Legal Use of Medical Marijuana

We recently discussed Noffsinger v. SSC Niantic Operating Company LLC, 2017 WL 3401260, wherein the Connecticut Supreme Court analyzed whether federal law precluded enforcement of a Connecticut law that prohibited employers from firing or refusing to hire someone who used marijuana for medicinal purposes. The Connecticut Supreme Court held that any person who used marijuana for medicinal purposes in compliance with Connecticut law may maintain a cause of action against an employer who refused to employ them for this reason. The issue continues to come up in various forms in a number of states and was recently addressed by the Massachusetts Supreme Court. As many people know, in 2012, Massachusetts approved a medical marijuana act whose stated purpose is “that there should be no punishment under state law for qualifying ...
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FDA Clarifies Trading Partners Under the Drug Supply Chain Security Act

The Federal Food and Drug Administration (FDA) recently published several draft guidelines to aid industry and State and Local governments in understanding how to define entities in the drug-supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). DSCSA — enacted as part of the Drug Quality and Security Act of 2013 — delineates the steps manufacturers, re-packagers, wholesale distributors, dispensers (i.e. pharmacies), and third-party logistics providers need to take to develop an electronic, interoperable system that tracks a drug at a unit level through its trajectory in the drug-supply chain. DSCSA includes provisions that speak to product verification and identification, data sharing, record keeping, and unified licensure standards for wholesale distributors and third-party logistics providers. Since it became law in 2013, industry members and practitioners have raised ...
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