Justia Massachusetts Supreme Court Opinion SummariesArticles Posted in Drugs & Biotech
Dunn v. Genzyme Corp.
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
Commonwealth v. Stirlacci
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
Rafferty v. Merck & Co., Inc.
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
Reckis v. Johnson & Johnson
When Samantha Reckis was seven years old, she developed toxic epidermal necrolysis, a life-threatening skin disorder, after receiving multiple doses of Children’s Motrin, an over-the-counter medication with ibuprofen as its active ingredient. Plaintiffs, Samantha and her parents, sued the manufacturer and marketer of Children’s Motrin and its parent company, alleging that Samantha developed TEN as a result of being exposed to ibuprofen in the Children’s Motrin and that the warning label on the medication’s bottle rendered the product defective because it failed to warn consumers about the serious risk of developing a life-threatening disease from it. A jury found in favor of Plaintiffs and awarded Samantha a total of $50 million in compensatory damages and each of Samantha’s parents $6.5 million for loss of consortium. The Supreme Judicial Court affirmed, holding (1) Plaintiffs’ claim of failure to warn was not preempted by the Federal Food, Drug, and Cosmetic Act; (2) a pharmacologist who offered the causation evidence essential to Plaintiffs’ case was qualified to testify as to specific medical causation, and the testimony was reliable and admissible; and (3) the damages awarded to each of the plaintiffs were not grossly excessive or unsupported by the record. View "Reckis v. Johnson & Johnson" on Justia Law