Justia Drugs & Biotech Opinion Summaries

Shirley Gross filed suit against PLIVA after her long-term use of the generic drug metoclopramide, produced by PLIVA, caused her permanent injuries. On appeal, plaintiff, as the personal representative of the estate of Gross, challenged the district court's denial of Gross's request to amend her complaint and her state common law tort claims against PLIVA for injuries sustained as a result of her use of a drug it manufactured. Federal Food, Drug, and Cosmetics Act, 21 U.S.C. 301 et seq. The court affirmed the district court's denial of leave to amend and held that none of plaintiff's claims regarding PLIVA's alleged failure to update its warnings were before the court on appeal; the court found that the complaint did not allege any violation of the federal misbranding laws or parallel state duties, and to the extent these claims were made on appeal, they were waived; and all of Gross's causes of action were preempted by the FDCA. Accordingly, the court affirmed the judgment of the district court. View "Drager v. PLIVA USA, Inc." on Justia Law

A number of suits have challenged the accuracy of the warning label on Pradaxa, a prescription blood-thinning drug manufactured by Boehringer. The litigation is in the discovery stage. The district judge presiding over the litigation imposed sanctions on Boehringer for discovery abuse. Boehringer sought a writ of mandamus quashing the sanctions, which included fines, totaling almost $1 million and also ordered that plaintiffs’ depositions of 13 Boehringer employees, all of whom work in Germany be conducted at “a place convenient to the [plaintiffs] and [to] the defendants’ [Boehringer’s] United States counsel,” presumably in the United States. The parties had previously agreed to Amsterdam as the location. The Seventh Circuit rescinded the order with respect to the depositions but otherwise denied mandamus. View "Boehringer Ingelheim Pharm. v. Herndon" on Justia Law

Defendant appealed his conviction of five felony counts relating to the sale of counterfeit prescription drugs. Defendant sought to introduce evidence establishing a gray market for prescription pills to argue that some of the pills that police seized from him could be genuine. The court concluded that the district court did not err in barring cross-examination regarding gray market evidence where there was no connection to the knowledge element and consequently no relevance; defendant cannot use the privilege against self-incrimination as a means to free himself from the basic rules of relevancy; if the evidence were relevant, the district court did not commit reversible error by directing the evidence to defendant's case-in-chief; and, in the alternative, the gray market evidence should be excluded under Federal Rule of Evidence 403. The court also held that, viewed in the light most favorable to the Government, the evidence sufficiently established defendant's knowledge and, therefore, defendant's sufficiency argument failed. Accordingly, the court affirmed the judgment of the district court. View "United States v. Shauaib Zayyad" on Justia Law

In 2003, Fresenius, a manufacturer of hemodialysis machines sought declaratory judgments of invalidity and non-infringement with respect to Baxter’s 434 patent, covering a dialysis machine with an integrated touch screen interface. Baxter counterclaimed for infringement. The Federal Circuit affirmed a determination that the claims at issue were not invalid, but remanded for reconsideration of an injunction and post-verdict damages. While the appeal was pending, the United States Patent and Trademark Office completed reexamination of the patent and determined that all asserted claims were invalid. The Federal Circuit affirmed. Meanwhile the district court entered judgment against Fresenius in the infringement proceedings. The Federal Circuit vacated; in light of the cancellation of the asserted claims and the fact that the infringement suit remains pending, Baxter no longer has a cause of action. View "Fresenius USA, Inc. v. Baxter Int'l, Inc." on Justia Law

This case involved disputes over licensing agreements for, inter alia, the RS 3400 blood irradiation device. At issue was whether the Federal Circuit has exclusive jurisdiction to hear an appeal of a breach of contract claim that would require the resolution of a claim of patent infringement for the complainant to succeed. The court concluded that it did not have appellate jurisdiction and resolved dispositive issues in favor of Rad Source, leaving a single dispositive issue for certification: When a licensee enters into a contract to transfer all of its interests in a license agreement for an entire term of a license agreement, save one day, but remains liable to the licensor under the license agreement, is the contract an assignment of the license agreement, or is the contract a sublicense?View "MDS (Canada) Inc., et al. v. Rad Source Technologies, Inc." on Justia Law

GSK filed suit against Abbott over a dispute related to a licensing agreement and the pricing of HIV medications. The central issue on appeal was whether equal protection prohibited discrimination based on sexual orientation in jury selection. GSK contended that a new trial was warranted because Abbott unconstitutionally used a peremptory strike to exclude a juror on the basis of his sexual orientation. The court concluded that GSK had established a prima facie case of intentional discrimination where the juror at issue was the only juror to have identified himself as gay on the record and the subject of the litigation presented an issue of consequence to the gay community. The court held that classifications based on sexual orientation were subject to a heightened scrutiny under United States v. Windsor. The court also held that equal protection prohibits peremptory strikes based on sexual orientation. The history of exclusion of gays and lesbians from democratic institutions and the pervasiveness of stereotypes about the group leads the court to conclude that Batson v. Kentucky applied to peremptory strikes based on sexual orientation. The court also concluded that a Batson challenge would be cognizable only once a prospective juror's sexual orientation was established, voluntarily and on the record. The court rejected Abbott's harmless error argument. Accordingly, the court reversed and remanded. View "SmithKline Beecham Corp. v. Abbott Laboratories" on Justia Law

Mylan manufactures generic Duragesic, a drug to treat pain. It consists of fentanyl (active ingredient) and a “transdermal system” (patch that delivers the drug). Kelly’s estate claimed that the patch caused Kelly’s death by delivering an excessive amount of fentanyl, alleging strict products liability, negligence, misrepresentation, fraud, warranty, and violation of the Michigan Consumer Protection Act. The district court dismissed, based on Mich. Comp. Laws 600.2946(5), which provides that “drug” manufacturers are immune from suit. The Sixth Circuit reversed and remanded. Michigan defines “drug” using the federal definition, 21 U.S.C. 321: (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). Michigan’s definition provides that a “drug” is not a “medical appliance or device.” Immunity might not apply to a product, like the patch, that has mechanical (rather than chemical) effect on the body. Under the federal definition a product might be neither “drug” nor “device” but a “combination product.” Whether a combination product is regulated as a drug or a device is left to the Secretary’s discretion. View "Miller v. Mylan, Inc." 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

Plaintiff filed a complaint seeking damages and injunctive relief, alleging that defendants violated, inter alia, the Lanham Act, 15 U.S.C. 1125(a)(1), and New York General Business Law 349 when defendants published a scientific article reporting research results related to plaintiff's production of surfactants. The court concluded that, as a matter of law, statements of scientific conclusions about unsettled matters of scientific debate could not give rise to liability for damages sounding in defamation. The court also concluded that the secondary distribution of excerpts of such an article could not give rise to liability, so long as the excerpts did not mislead a reader about the conclusions of the article. Therefore, the district court correctly concluded that plaintiff failed to state a claim based on publication of the article itself because the challenged statements were protected scientific opinion and plaintiff failed to adequately allege that defendants Chiesi and Cornerstone distributed misleading excerpts of the article. Accordingly, the court affirmed the judgment.View "ONY, Inc. v. Cornerstone Therapeutics, Inc." on Justia Law

Wyeth’s patents relate to the use of rapamycin for treatment and prevention of restenosis, the renarrowing of an artery. To open a blocked artery, a doctor guides a balloon catheter to the site of accumulated plaque and inflates the balloon to crush the plaque. As the balloon inflates it may cause injury to the arterial wall that leads to restenosis. The claims recite a method of treating or preventing “restenosis ... which comprises administering an antirestenosis effective amount of rapamycin.” In general, “rapamycin” may refer to a class of compounds; the parties agree that the specification discloses only one rapamycin species, sirolimus. In Wyeth’s infringement action, the district court adopted Wyeth’s proposed construction of “rapamycin,” but entered summary judgment, finding the patents invalid for nonenablement. The Federal Circuit affirmed, finding that the specification does not enable one of ordinary skill to practice the asserted claims without undue experimentation. View "Wyeth & Cordis Corp. v. Abbott Labs." on Justia Law