Justia U.S. 4th Circuit Court of Appeals Opinion Summaries

Relator filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. 3729-3733, against Omnicare, alleging that defendants violated a series of FDA safety regulations requiring that penicillin and non-penicillin drugs be packaged in complete isolation from one another. The court concluded that the public disclosure bar did not divest the district court of jurisdiction over relator's FCA claims. The court concluded that once a new drug has been approved by the FDA and thus qualified for reimbursement under the Medicare and Medicaid statutes, the submission of a reimbursement request for that drug could not constitute a "false" claim under the FCA on the sole basis that the drug had been adulterated as a result of having been processed in violation of FDA safety regulations. The court affirmed the district court's grant of Omnicare's motion to dismiss, holding that relator's complaint failed to allege that defendants made a false statement or that they acted with the necessary scienter. The court also concluded that the district court did not abuse its discretion in denying relator's request to file a third amended complaint. View "United States ex rel. Rostholder v. Omnicare, Inc." on Justia Law

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

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

Plaintiffs commenced this putative class action alleging that defendants participated in a global Internet conspiracy to sell illegal prescription drugs, in violation of the laws of the United States and Virginia. At issue on appeal was whether the district court erred in dismissing the complaint against four foreign banks for lack of personal jurisdiction. The court concluded that Rule 4(k)(2) did not justify the exercise of personal jurisdiction over the banks because exercising jurisdiction over them would not, in the circumstances here, be consistent with the United States Constitution and laws. Subjecting the banks to the coercive power of the court in the United States, in the absence of minimum contacts, would constitute a violation of the Due Process Clause. Accordingly, the court affirmed the district court's orders dismissing the complaint against the banks. View "Unspam Technologies v. Chernuk" on Justia Law

Appellants filed a class action, alleging that defendant, a chemical manufacturer, sold thiodiglycol (TDG) to Saddam Hussein's Iraqi regime, which then used it to manufacture mustard gas to kill Kurdish enclaves in northern Iraq during the late 1980's. At issue was whether appellants have alleged viable claims under the Torture Victim Protection Act (TVPA), 28 U.S.C. 1350, or the Alien Tort Statute (ATS), 28 U.S.C. 1350. The court held that the TVPA excluded corporations from liability. The court also held that the ATS imposed liability for aiding and abetting violations of international law, but only if the attendant conduct was purposeful. Appellants, however, have failed to plead facts sufficient to support the intent element of their ATS claims. Accordingly, the court affirmed the district court's grant of defendant's motion to dismiss under Rule 12(b)(6).