Justia Drugs & Biotech Opinion Summaries

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

Defendants manufacture and distribute FDA-approved prescription eye drop medications for treating conditions such as glaucoma. Bottles are pre-packaged with a fixed volume of medication; labeling does not indicate how many doses or days of treatment a patient can extract from the bottle. The dimensions of the bottle’s dropper tip dictate the size of the drop dispensed. Scientific research indicates that a normal adult’s inferior fornix – the area between the eye and the lower eyelid – has a capacity of approximately 7-10 microliters (µLs) of fluid. If a drop exceeding that capacity is placed into an eye, excess medication is expelled, providing no pharmaceutical benefit to the patient. Expelled medication also may flow into a patient’s tear ducts and move into his bloodstream, increasing the risk of certain harmful side effects. These studies conclude that eye drops should be 5-15 µLs. Defendants’ products emit drops that are considerably larger so that at least half of every drop goes to waste. The Third Circuit reversed dismissal of a putative class action (Class Action Fairness Act, 28 U.S.C. 1332) under state consumer protection statutes. The consumers’ allegations of injury were sufficient to confer standing. Plaintiffs claim economic interests in the money they spent on medication that was impossible for them to use; their concrete and particularized injury claims fit comfortably in categories of “legally protected interests” readily recognized by federal courts. View "Cottrell v. Alcon Laboratories" on Justia Law

Serena Kwan appealed the dismissal of her second amended complaint for failing to state a claim upon which relief can be granted. In 2014, Kwan, On Behalf of Herself and All Others Similarly Situated, filed a class action against Defendants-Appellees, SanMedica International, LLC (“SanMedica”), and Sierra Research Group, LLC (“Sierra”), alleging violations of California’s Unfair Competition Law (“UCL”) and California’s Consumers Legal Remedies Act (“CLRA”). The complaint was based on an allegation that the defendants falsely represented that their product, SeroVital, provided a 682% mean increase in Human Growth Hormone (“HGH”) levels, that it was clinically tested, and that “peak growth hormone levels” were associated with “youthful skin integrity, lean musculature, elevated energy production, [and] adipose tissue distribution." The Ninth Circuit concluded the district court correctly concluded that California law did not provide for a private cause of action to enforce the substantiation requirements of California’s unfair competition and consumer protection laws. Further, the district court did not err in concluding that Kwan’s second amended complaint failed to allege facts that would support a finding that SanMedica International’s claims regarding its product, SeroVital, were actually false. Accordingly, the Court affirmed dismissal. View "Kwan v. Sanmedica Int'l" on Justia Law

The district court certified eight classes, consisting of persons in Illinois and Missouri who take eye drops manufactured by six pharmaceutical companies for treatment of glaucoma. Plaintiffs claimed that the defendants’ eye drops are unnecessarily large and wasteful, in violation of the Illinois Consumer Fraud Act, 815 ILCS 505/1, and the Missouri Merchandising Practices Act, Mo. Rev. Stat. 407.010, so that the price of the eye drops is excessive and that the large eye drops have a higher risk of side effects. There was no claim that members of the class have experienced side effects or have been harmed because they ran out of them early. The Seventh Circuit vacated with instructions to dismiss. The court noted possible legitimate reasons for large drops, the absence of any misrepresentation or collusion, and that defendants’ large eye drops have been approved by the FDA for safety and efficacy. “You cannot sue a company and argue only ‘it could do better by us,’” nor can one bring a suit in federal court without pleading that one has been injured. The plaintiffs allege only “disappointment.” View "Eike v. Allergan, Inc." on Justia Law

Plaintiff was diagnosed with drug-induced lupus, allegedly a side effect from using Solodyn, a treatment for acne. Plaintiff sued Medicis Pharmaceutical Corporation, which manufactures and distributes Solodyn, alleging that Medicis knowingly represented and omitted material facts in connection with the sale or advertisement of Solodyn in violation of the Consumer Fraud Act (CFA). Plaintiff also alleged that Medicis failed to adequately warn her of the consequences of the long-term use of Solodyn. The superior court granted Medicis’s motion to dismiss. At issue on appeal was the learned intermediary doctrine (LID), under which a manufacturer satisfies its duty to warn end users by giving appropriate warnings to the class of persons who may prescribe or administer the product. The Supreme Court reversed the superior court’s order dismissing Plaintiff’s complaint, holding (1) the LID does not prevent Plaintiff from suing Medicis; (2) Plaintiff alleged sufficient facts to survive Medicis’s motion to dismiss with regard to her products liability claim; and (3) the CFA applies to prescription pharmaceuticals, and therefore, Plaintiff alleged an actionable claim under the CFA. View "Watts v. Medicis Pharmaceutical Corp." on Justia Law

In earlier litigation, Teva challenged the validity and enforceability of GSK’s patents on lamotrigine, Lamictal’s active ingredient. Teva was first to file an FDA application, alleging invalidity or nonenforceability, and seeking approval to produce generic lamotrigine tablets and chewable tablets for markets alleged to be annually worth $2 billion and $50 million,. If the patent suit resulted in a determination of invalidity or nonenforceability—or a settlement incorporating such terms—Teva would be statutorily entitled to a 180- day period of market exclusivity, during which time only it and GSK could produce generic lamotrigine tablets. After the judge ruled the patent’s main claim invalid, the companies settled; Teva would end its patent challenge in exchange for early entry into the chewables market and GSK’s commitment not to produce its own, “authorized generic” Lamictal tablets. Plaintiffs, direct purchasers of Lamictal, sued under the Sherman Act, 15 U.S.C. 1 & 2, claiming that the agreement was a “reverse payment” intended to induce Teva to abandon the patent fight and eliminate the risk of competition in the lamotrigine tablet market for longer than the patent would otherwise permit. The district court dismissed. The Third Circuit vacated, citing Supreme Court precedent, holding that unexplained large payments from the holder of a drug patent to an alleged infringer to settle litigation of the patent’s validity or infringement (reverse payment) can violate antitrust laws. View "King Drug Co of Florence Inc, v. Smithkline Beecham Corp." on Justia Law

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

Gnosis appealed the district court's entry of judgment in favor of Merck on its Lanham Act, 15 U.S.C. 1125(a), false advertising and contributory false advertising claims; award to Merck of damages, attorneys' fees and costs, and prejudgment interest; and order that Gnosis engage in a corrective advertising campaign. Merck had filed suit against Gnosis, claiming misleading advertising in connection with its use of the pure Isomer Product chemical name and properties in its marketing materials for Extrafolate. At issue on appeal was the court's false advertising jurisprudence. The court concluded that where, as here, the parties operate in the context of a two-player market and literal falsity and deliberate deception have been proved, it is appropriate to utilize legal presumptions of consumer confusion and injury for the purposes of finding liability in a false advertising case brought under the Lanham Act; in a case where willful deception is proved, a presumption of injury may be used to award a plaintiff damages in the form of defendant's profits, and may, in circumstances such as those presented here, warrant enhanced damages; and, therefore, the court affirmed the judgment of the district court. View "Merck Eprova AG v. Gnosis S.P.A." on Justia Law

The funds filed suit alleging that, among other things, the pharmacies engaged in fraudulent, misleading, or deceptive practices in connection with the sale of merchandise by failing to pass on the funds the entire difference between the acquisition cost of the generic prescription drug dispensed and its brand name equivalent as required by Minn. Stat. 151.121, subd. 4. The district court granted the pharmacies's Rule 12 motion to dismiss the complaint. The court held that section 151.21, subd. 4 does not create a private cause of action in favor of union-sponsored health and welfare benefit funds against pharmacies for failing to pass on the difference between the acquisition cost of brand name drugs and substituted generic prescription drugs; an omission-based consumer fraud claim is actionable under Minn. Stat. 325F.69, subd. 1 when special circumstances exist that trigger a legal or equitable duty to disclose the omitted facts; the amended complaint did not allege facts that would trigger a legal or equitable duty for the pharmacies to disclose prescription-drug acquisition costs; and, therefore, the complaint failed to state a claim upon which relief can be granted under Minn. Stat. 325F.69, subd. 1. Accordingly, the court affirmed in part and reversed in part. View "Graphic Communications Local 1B, et al. v. CVS Caremark Corp., et al." on Justia Law

Plaintiffs filed three separate class action suits alleging that defendants violated Missouri law and conspired with unknown third parties to deceive customers into throwing away medications after their expiration dates, knowing that the medications were safe and effective beyond the expiration date. Defendants appealed the district court's remand order holding that defendants failed to establish the amount in controversy requirement under the Class Action Fairness Act (CAFA), 28 U.S.C. 1332(d)(2). The court concluded that each defendant's affidavit detailing the total sales of their respective medications in Missouri met the amount in controversy requirement; even if it was highly improbable that plaintiffs would recover the amounts defendants have put into controversy, this did not meet the legally impossible standard; defendants were not required to provide a formula or methodology for calculating the potential damages more accurately, as the district court held; and defendants' affidavits were not inadmissible hearsay. Therefore, the court reversed the district court's finding that it lacked subject matter jurisdiction and remanded for further proceedings. View "Raskas, et al. v. Johnson & Johnson, et al." on Justia Law