Justia Drugs & Biotech Opinion Summaries

Articles Posted in Massachusetts Supreme Judicial Court
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The Supreme Judicial Court held that a previously enacted municipal bylaw that permits only nonprofit entities to operate medical marijuana dispensaries is preempted by a statutory provision specifically eliminating that restriction.In 2012, marijuana was legalized for medical use, and the licensing of medical marijuana dispensaries was limited to nonprofit entities. In 2017, the marijuana laws were amended to allow for-profit entities to dispense medical marijuana. Subsequently, CommCan, Inc., a dispensary, converted from a nonprofit to a for-profit corporation. At issue was what impact the conversion had on CommCan's eligibility for a special permit previously issued by the town of Mansfield planning board. The judge found no error in the board's decision to grant CommCan a special permit and concluded that the town's bylaw requiring medical marijuana dispensaries to be operated by nonprofit entities was preempted by the 2017 act. The Supreme Judicial Court affirmed, holding that the town's bylaw was preempted by state law to the extent it required all medical marijuana dispensaries to be nonprofit organizations. View "West Street Associates LLC v. Planning Board of Mansfield" on Justia Law

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In this case involving claims of personal injury and product liability against the manufacturer of a medical device the Supreme Judicial Court reversed the decision of the superior court judge denying the manufacturer's motion to dismiss, holding that plaintiffs asserting parallel state law claims may do so with no greater degree of specificity than otherwise required under Iannacchino v. Ford Motor Co., 451 Mass. 623, 636 (2008).Plaintiff sued Genzyme Corporation, asserting that Synvisc-One, a class III medical device subject to premarket approval under the Medical Device Amendments (MDA), 21 U.S.C. 360c et seq., was negligently manufactured, designed, distributed, and sold by Genzyme. Genzyme filed a motion to dismiss on the grounds that the allegations were preempted by federal regulation. The trial judge denied the motion to dismiss. The Supreme Judicial Court reversed, holding that while all of Plaintiff's state law claims properly paralleled the federal requirements, none of them was sufficiently pleaded under Iannacchino to survive Genzyme's motion to dismiss. View "Dunn v. Genzyme Corp." on Justia Law

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In this case involving the indictments of Dr. Frank Stirlacci and his office manager, Jessica Miller, for violations of the Controlled Substances Act and for submitting false health care claims to insurance providers, the Supreme Judicial Court affirmed in part and reversed in part the superior court's judgment dismissing several of the indictments, holding that there was sufficient evidence to indict Shirlacci on twenty-six counts of improper prescribing and to indict both defendants on twenty of the twenty-two counts of submitting false health care claims.The charges against Defendants included twenty-six counts each of improper prescribing, twenty counts each of uttering a false prescription, and twenty-two charges each of submitting a false health care claim. The trial judge dismissed the indictments for improper prescribing and uttering false prescriptions and dismissed six of the indictments against each defendant for submitting false health care claims. The Supreme Judicial Court reversed in part, holding (1) the evidence was sufficient to indict Stirlacci on all counts of improper prescribing, but Miller's status as a nonpractitioner precluded her indictment on improper prescribing; (2) there was insufficient evidence to indict either defendant for uttering false prescriptions; and (3) there was sufficient evidence to indict both defendants on twenty counts of submitting false health care claims. View "Commonwealth v. Stirlacci" on Justia Law

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A plaintiff who alleges that he was injured from his use of a generic drug because of a failure to warn of the drug’s side effects cannot bring a common-law general negligence claim against the brand-name manufacturer that created the warning label. The plaintiff, however, may bring a common-law recklessness claim against the brand-name manufacturer if it intentionally failed to update the label on its drug, knowing or having reason to know of an unreasonable risk of death or grave bodily injury associated with its use. Further, a plaintiff who is injured by a generic drug due to a failure to warn cannot bring a claim under Mass. Gen. Laws ch. 93A, 9 against a brand-name manufacturer that did not advertise, offer to sell, or sell that drug because such failure did not occur in the conduct of “trade or commerce” as defined in section 1(b).In the instant case, the trial judge dismissed Plaintiff’s claims against Merck & Co, Inc. asserting negligence for failure to warn and a violation of Mass. Gen. Laws ch. 93A, 9. The Supreme Judicial Court vacated the order dismissing Plaintiff’s common-law claim and remanded with instructions that Plaintiff be granted leave to amend his complaint and affirmed the order dismissing Plaintiff’s chapter 93A claim. View "Rafferty v. Merck & Co., Inc." on Justia Law

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A plaintiff who alleges that he was injured from his use of a generic drug because of a failure to warn of the drug’s side effects cannot bring a common-law general negligence claim against the brand-name manufacturer that created the warning label. The plaintiff, however, may bring a common-law recklessness claim against the brand-name manufacturer if it intentionally failed to update the label on its drug, knowing or having reason to know of an unreasonable risk of death or grave bodily injury associated with its use. Further, a plaintiff who is injured by a generic drug due to a failure to warn cannot bring a claim under Mass. Gen. Laws ch. 93A, 9 against a brand-name manufacturer that did not advertise, offer to sell, or sell that drug because such failure did not occur in the conduct of “trade or commerce” as defined in section 1(b).In the instant case, the trial judge dismissed Plaintiff’s claims against Merck & Co, Inc. asserting negligence for failure to warn and a violation of Mass. Gen. Laws ch. 93A, 9. The Supreme Judicial Court vacated the order dismissing Plaintiff’s common-law claim and remanded with instructions that Plaintiff be granted leave to amend his complaint and affirmed the order dismissing Plaintiff’s chapter 93A claim. View "Rafferty v. Merck & Co., Inc." on Justia Law