Justia Drugs & Biotech Opinion Summaries

Wife, suing on behalf of her deceased husband, (plaintiff) filed tort claims and a breach of warranty claim against pharmaceutical companies, alleging that the prescription Mirapex that husband used to treat his Parkinson's disease lead him to compulsively gamble. At issue was whether the district court properly granted summary judgment to defendants because plaintiff's claims were time-barred. The court held that the district court correctly determined that plaintiff's claim accrued more than two years before he brought his suit and thus was time-barred. The court also held that because husband became aware of the effect of the Mirapex more than two years before he filed suit, the continuing tort doctrine did not save his claim; that the open courts provision did not operate to save plaintiff's claim; that the district court did not err in determining that the facts were sufficiently developed to establish a concrete injury in 2006 for the purpose of determining ripeness; that the affidavits at issue did not raise a genuine issue of fact as to whether husband's behavioral problems and side effects were so severe as to render him legally incompetent and therefore, the tolling provisions of section 16.0001 of the Texas Civil Practice and Remedies Code were unavailable; and that plaintiff had not satisfied the requirement that purchasers gave notice of a breach of warranty claim prior to filing suit and therefore, the district court did not err in granting summary judgment to defendant on that claim. Accordingly, the judgment was affirmed. View "Gazal v. Boehringer Ingelheim Pharmaceuticals, et al." on Justia Law

Plaintiff, a pharmaceutical company, owns a patent that claims conjugated estrogen pharmaceutical compositions for use in hormone replacement therapies. Plaintiff alleged infringement of the patent based on defendant's Abbreviated New Drug Application for a generic version of plaintiff's hormone replacement therapy product, arguing the doctrine of equivalents. The district court entered summary judgment for defendant. The Federal Circuit affirmed. Plaintiff failed to rebut the presumption of prosecution history estoppel based on unforeseeability. The doctrine of prosecution history estoppel prevents a patent owner from recapturing, through the doctrine of equivalents, subject matter surrendered to acquire the patent. Because plaintiff narrowed the scope of the patent's claims in response to a prior art rejection, a presumption of prosecution history estoppel applies. View "Duramed Pharm., Inc. v. Paddock Labs, Inc." on Justia Law

These consolidated lawsuits involved state tort law claims based on certain drug manufacturers' alleged failure to provide adequate warning labels for the generic drug metoclopramide. State tort law required a manufacturer that was, or should be, aware of its drug's danger to label it in a way that rendered it reasonably safe. On the other hand, federal drug regulations, as interpreted by the FDA, prevented the manufacturers from independently changing their generic drug safety labels. At issue was whether such federal drug regulations applicable to generic drug manufacturers directly conflicted with, and thus preempted, the state law claims. The Court concluded that the federal drug regulations preempted the state law claims because, if manufacturers had independently changed their labels to satisfy their state law duty to attach a safer label to their generic metoclopramide, they would have violated the federal requirement that generic drug labels be the same as the corresponding brand-name drug labels. Thus, it was impossible for the manufacturers to comply with federal and state law. Even if the manufacturers had fulfilled their federal duty to ask for FDA help in strengthening the corresponding brand-name labels, assuming such a duty existed, they would not have satisfied their state tort law duty. State law demanded a safer label, it did not require communication with the FDA about the possibility of a safer label. Therefore, the Court held that when a party could not satisfy its state duties without the Federal Government's special permission and assistance, which was dependent on the exercise of judgment by a federal agency, that party could not independently satisfy those state duties for preemption purposes. The Court also noted that Congress and the FDA retained authority to change the law and regulations if they so desired. Accordingly, the case was reversed and remanded for further proceedings. View "PLIVA, Inc., et al. v. Mensing; Actavis Elizabeth, LLC v. Mensing; Actavis, Inc., v. Demahy" on Justia Law

Vermont's Prescription Confidentiality Law, Vt. Stat. Ann., Tit. 18, 4631(d), restricted the sale, disclosure, and use of pharmacy records that revealed the prescribing practices of individual doctors. Respondents, Vermont data miners and an association of brand-name drug manufacturers, sought declaratory and injunctive relief against state officials, contending that section 4631(d) violated their rights under the Free Speech Clause of the First Amendment. At issue was whether section 4631(d) must be tested by heightened judicial scrutiny and, if so, whether Vermont could justify the law. The Court held that the Vermont Statute, which imposed content-based and speaker-based burdens on protected expression, was subject to heightened judicial scrutiny. The Court also held that Vermont's justifications for section 4631(d) did not withstand such heightened scrutiny and therefore, affirmed the Second Circuit's judgment that section 4631(d) unconstitutionally burdened the speech of pharmaceutical marketers and data miners without adequate justification. View "Sorrell, et al. v. IMS Health Inc., et al." on Justia Law

A citizen of Illinois brought suit against several non-Illinois companies and one Illinois company, alleging failure to warn with respect to side effects of Yazmin birth control pills. The defendants removed to federal court, claiming improper joinder. The district court dismissed the Illinois pharmacy owner, restoring diversity, and dismissed the suit after the plaintiff abandoned the case. The Seventh Circuit affirmed, applying the "learned intermediary doctrine" and reasoning that the pharmacy had no duty to warn, absent knowledge of a particular susceptibility. The "common defense" exception does not serve as a basis for remand because the plaintiff alleged that the other defendants concealed information.

Plaintiffs, two scientists, brought a suit to enjoin the National Institutes of Health ("NIH") from funding research using human embryonic stem cells ("ESCs") pursuant to the NIH's 2009 Guidelines ("Guidelines"). At issue was whether the preliminary injunction was properly granted where the district court concluded that plaintiffs were likely to succeed in showing that the Guidelines violated the Dickey-Wicker Amendment, an appropriations rider that barred federal funding for research in which a human embryo was destroyed. The court vacated the preliminary injunction and held that plaintiffs were unlikely to prevail because Dickey-Wicker was ambiguous and the NIH seemed reasonably to have concluded that, although Dickey-Wicker barred funding for the destructive act of deriving an ESC from an embryo, it did not prohibit funding a research project in which an ESC would be used.