Justia Drugs & Biotech Opinion SummariesArticles Posted in U.S. 9th Circuit Court of Appeals
Perez, et al v. Nidek Co., Ltd., et al
Plaintiff and others sought and received LASIK eye surgery with a Nidek EC-5000 Excimer Laser System ("Laser") to correct farsightedness. Plaintiff, on behalf of himself and a class of similarly situated individuals, claimed that, had they known that the FDA had not approved the Laser for this use, they would not have consented to the surgeries. The court held that the complaint did not state a claim under the California Protection of Human Subjects in Medical Experimentation Act, Cal. Health & Saf. Code 24171 et seq., because the surgeries were not "medical experiments" subject to the protection of the Act. Plaintiff did not have standing to sue for injunctive relief under the California Consumers Legal Remedies Act (CLRA), Cal. Civ. Code 1750 et seq., and his other substantive claim was preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301 et seq. Plaintiff's common-law fraud by omission claim was expressly preempted by the preemption provision in the Medical Device Amendments. Even if it were not, it was impliedly preempted because it amounted to an attempt to privately enforce the FDCA. Accordingly, the court affirmed the dismissal of the complaint. View "Perez, et al v. Nidek Co., Ltd., et al" on Justia Law
Posted in: Drugs & Biotech, Government & Administrative Law, Health Law, U.S. 9th Circuit Court of Appeals
Holmes, et al. v. Merck & Co., Inc.
Plaintiffs appealed the district court's grant of summary judgment in favor of Merck in their diversity action alleging wrongful death. Plaintiffs' son died after being administered a Measles, Mumps, and Rubella vaccine manufactured by Merck. On appeal, plaintiffs contended that the district court erred in applying the standards of the National Childhood Vaccine Injury Act, 42 U.S.C. 300aa-22, to their individual claims for damages. Having concluded that Section 22 of the Act generally applied to limit tort liability in a parent's claim for individual injuries, the court determined that plaintiffs' suit was a "civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine" and thus limited by the Act. Accordingly, the court affirmed the judgment. View "Holmes, et al. v. Merck & Co., Inc." on Justia Law
Connecticut Retirement Plans and Trust Funds v. Amgen Inc., et al.
Plaintiff brought this securities fraud action against defendant, a biotechnology company and several of its officers, alleging that, by misstating and failing to disclose safety information about two of the company's products used to treat anemia, they violated the Securities and Exchange Act of 1934, 15 U.S.C. 78j(b), 78t(a), and Rule 10b-5, 17 C.F.R. 240.10b-5. At issue was what a plaintiff must do to invoke a fraud-on-the-market presumption in aid of class certification. The court joined the Third and Seventh Circuits in holding that plaintiff must (1) show that the security in question was traded in an efficient market, and (2) show that the alleged misrepresentation were public. As for the element of materiality, plaintiff must plausibly allege that the claimed misrepresentations were material. In this case, plaintiff plausibly alleged that several of defendants' public statements about its pharmaceutical products were false and material. Coupled with the concession that the company's stock traded in an efficient market, this was sufficient to invoke the fraud-on-the-market presumption of reliance. Therefore, the district court did not abuse its discretion in certifying the class. View "Connecticut Retirement Plans and Trust Funds v. Amgen Inc., et al." on Justia Law