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

Articles Posted in Drugs & Biotech

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BBC, owner of the FLANAX trademark in Mexico, and its sister company, Bayer, filed suit against Belmora, owner of the FLANAX trademark in the United States, contending that Belmora used the FLANAX mark to deliberately deceive Mexican-American consumers into thinking they were purchasing BCC’s product. The court concluded that the Lanham Act’s, 15 U.S.C. 1125, plain language contains no unstated requirement that a section 43(a) plaintiff have used a U.S. trademark in U.S. commerce to bring a Lanham Act unfair competition claim; the Supreme Court’s guidance in Lexmark International, Inc. v. Static Control Components, Inc. does not allude to one, and the court's prior cases either only assumed or articulated as dicta that such a requirement existed; and therefore, the district court erred in imposing such a condition precedent upon Bayer’s claims. The court also concluded that BCC has adequately pled a section 43(a) false association claim for purposes of the zone of interests prong; BCC's allegations reflect the claim furthers the section 45 purpose of preventing the deceptive and misleading use of marks in commerce within the control of Congress; and BCC has also alleged injuries that are proximately caused by Belmora’s violations of the false association statute. Therefore, the court held that BCC has sufficiently pled a section 43(a) false association claim to survive Belmora’s Rule 12(b)(6) motion. Because these statements are linked to Belmora’s alleged deceptive use of the FLANAX mark, the court is satisfied that BCC’s false advertising claim, like its false association claim, comes within the Act’s zone of interests. The court inferred that the alleged advertisements contributed to the lost border sales pled by BCC, and that the claim also satisfies Lexmark’s proximate cause prong. Further, the court agreed with Bayer that the district court erred in overturning the TTAB’s section 14(3) decision because it read a use requirement into the section that is simply not there. Accordingly, the court vacated and remanded. View "Belmora LLC v. Bayer Consumer Care AG" on Justia Law

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BBC, owner of the FLANAX trademark in Mexico, and its sister company, Bayer, filed suit against Belmora, owner of the FLANAX trademark in the United States, contending that Belmora used the FLANAX mark to deliberately deceive Mexican-American consumers into thinking they were purchasing BCC’s product. The court concluded that the Lanham Act’s, 15 U.S.C. 1125, plain language contains no unstated requirement that a section 43(a) plaintiff have used a U.S. trademark in U.S. commerce to bring a Lanham Act unfair competition claim; the Supreme Court’s guidance in Lexmark International, Inc. v. Static Control Components, Inc. does not allude to one, and the court's prior cases either only assumed or articulated as dicta that such a requirement existed; and therefore, the district court erred in imposing such a condition precedent upon Bayer’s claims. The court also concluded that BCC has adequately pled a section 43(a) false association claim for purposes of the zone of interests prong; BCC's allegations reflect the claim furthers the section 45 purpose of preventing the deceptive and misleading use of marks in commerce within the control of Congress; and BCC has also alleged injuries that are proximately caused by Belmora’s violations of the false association statute. Therefore, the court held that BCC has sufficiently pled a section 43(a) false association claim to survive Belmora’s Rule 12(b)(6) motion. Because these statements are linked to Belmora’s alleged deceptive use of the FLANAX mark, the court is satisfied that BCC’s false advertising claim, like its false association claim, comes within the Act’s zone of interests. The court inferred that the alleged advertisements contributed to the lost border sales pled by BCC, and that the claim also satisfies Lexmark’s proximate cause prong. Further, the court agreed with Bayer that the district court erred in overturning the TTAB’s section 14(3) decision because it read a use requirement into the section that is simply not there. Accordingly, the court vacated and remanded. View "Belmora LLC v. Bayer Consumer Care AG" on Justia Law

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Relators filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. 3729 et seq., against Purdue, alleging that the company was involved in a fraudulent scheme regarding the equianalgesic ratio of OxyContin. The court declined realtors' invitation to read United States ex rel. Siller v. Becton Dickinson & Co., so as to render it internally inconsistent and at odds with the public disclosure bar’s purpose. Indeed, by foreshadowing the court’s conclusion in this case, Siller itself eschews the interpretation relators urge. Here, relators’ claims are based on facts their counsel learned in the course of making the prior public disclosure of Purdue’s allegedly fraudulent scheme. The court held, consistent with its reasoning in Siller and the public disclosure bar’s purpose, that the district court correctly dismissed the relators’ suit. View "United States ex rel. May v. Purdue Pharma L.P." on Justia Law

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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

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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

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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

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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

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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).