Justia U.S. 8th Circuit Court of Appeals Opinion SummariesArticles Posted in Drugs & Biotech
United States v. Heard
In the case before the United States Court of Appeals For the Eighth Circuit, the defendant, Kaycee Heard, appealed his 180-month sentence for involvement in a drug-trafficking conspiracy that transported oxycodone and fentanyl pills from Michigan to North Dakota for distribution. Heard pleaded guilty to conspiring to distribute and possess with intent to distribute controlled substances, and his sentence exceeded his Guidelines range of 135 to 168 months. Heard's appeal centered around three key claims: the district court miscalculated his criminal history score, wrongly applied a Guidelines enhancement for his role in the conspiracy, and issued an unreasonable sentence.The Court of Appeals rejected all three of Heard's claims. First, the court found that the district court was correct to assess a criminal history point for a two-year probation term Heard served under Michigan’s Holmes Youthful Trainee Act. Despite Heard's argument that this sentence should not have counted towards his criminal history score as no conviction was entered and the underlying charges were dismissed, the Appeals Court ruled that Heard's admission of guilt by pleading guilty meant the probation term was correctly counted as a "prior sentence".Second, the Appeals Court upheld the district court's application of a three-level enhancement for Heard's role in the conspiracy, finding that Heard had exhibited sufficient managerial or supervisory authority to warrant this enhancement. The court pointed to evidence that Heard had recruited co-conspirators, used a co-conspirator’s apartment as a stash house, directed a co-conspirator to travel to get pills for distribution, and received proceeds from the pills’ sale.Finally, the court found Heard's sentence to be both procedurally and substantively reasonable. The district court had varied up from the Guidelines range based on Heard's conduct in pretrial detention, including his participation in a prison riot and assaults on two inmates. The Appeals Court found no clear error in the district court's determination that Heard had participated in the riot, and concluded that the 180-month sentence was within the realm of reasonableness given Heard's drug trafficking and pretrial detention misconduct. The court also rejected Heard's claim that his sentence created unwarranted disparities with his co-conspirators, stating that the need to avoid unwarranted sentence disparities refers to national disparities, not differences among co-conspirators. The court therefore affirmed the district court’s judgment. View "United States v. Heard" on Justia Law
United States v. Riaski
In this appeal before the United States Court of Appeals For the Eighth Circuit, the defendant, Linda Riaski, who was convicted of one count of conspiracy to distribute methamphetamine and one count of possession of a firearm in furtherance of a drug trafficking crime, appealed the denial of her request for a hearing under Franks v. Delaware. The case involves a search warrant that was issued based on an affidavit prepared by Deputy Sheriff Jerry Brisky, who relied on information provided by a confidential informant (CI). The CI claimed to have observed Riaski packaging methamphetamine for distribution and to have seen Riaski with a black 9 millimeter handgun. The search of Riaski's residence resulted in the discovery of methamphetamine and firearms.Riaski's appeal was based on the argument that the district court erred in denying her request for a Franks hearing to challenge the validity of the search warrant. She claimed that the affidavit supporting the search warrant was misleading because it omitted information about the CI’s credibility, her criminal history, her drug use, the financial arrangement between her and Deputy Brisky, and certain facts alleged in Riaski’s own affidavit.The court affirmed the district court's decision, holding that Riaski failed to make a substantial preliminary showing that Deputy Brisky intentionally or recklessly omitted facts with the intent to mislead the issuing judge, and that the affidavit, even if supplemented by the omitted information, could still support a finding of probable cause. The court reasoned that the omitted information about the CI's criminal history and drug use would not have altered the probable cause determination, as the affidavit had already provided a basis for the CI’s reliability, disclosing that she previously had provided accurate information and had made controlled purchases under Brisky’s supervision. The court also found that the omission of the details and existence of the agreement between Brisky and the CI did not render the affidavit misleading. The judgment was affirmed. View "United States v. Riaski" on Justia Law
United States v. Ready
In this case before the United States Court of Appeals for the Eighth Circuit, the defendant, Bradley Ready, appealed his sentence following his guilty plea for possession with intent to distribute methamphetamine and possession of a firearm as an unlawful user of a controlled substance. The court affirmed the district court's decision.During a search of Ready's residence, law enforcement officers found drug paraphernalia, scales, a loaded hunting rifle, and three bags of methamphetamine. Ready was subsequently charged and pleaded guilty to both counts. At sentencing, the U.S. Probation Office recommended grouping the drug and gun counts together and applying a two-level enhancement due to the possession of a dangerous weapon. Ready objected to this enhancement, but the district court overruled this objection.On appeal, Ready argued that the district court erred in applying the enhancement for possession of a dangerous weapon and applied the wrong standard in determining his eligibility for safety valve relief. The appellate court found no error in the district court's conclusions.The appellate court held that the district court did not err in applying the enhancement for possession of a dangerous weapon, as it was not "clearly improbable" that the rifle found in Ready's bedroom was connected to the distribution of methamphetamine from his home. The court also held that the district court did not err in its application of the standard for determining Ready's eligibility for safety valve relief. Therefore, the district court's judgment was affirmed. View "United States v. Ready" on Justia Law
Levitt v. Merck & Co.
Plaintiff filed a personal injury action against Merck after she suffered cardiovascular injuries allegedly from taking a medication called Vioxx. The Eighth Circuit reversed the district court's dismissal of plaintiff's claims. The district court held that plaintiff's claims accrued prior to September 2001 and thus her September 29, 2006 suit was time-barred. In Missouri, the statute of limitations for personal injury claims is five years after the cause of action accrues.The court held that there was a genuine issue of fact as to whether the evidence was such that a reasonably prudent person was on notice of a potentially actionable injury before September 29, 2001. The court predicted that the state supreme court would conclude that mere knowledge in the medical community of a possible link between Vioxx and heart problems did not, as a matter of law, place a reasonably prudent person in plaintiff's position on notice of a potentially actionable injury. View "Levitt v. Merck & Co." on Justia Law
Mancini v. Boehringer Ingelheim Pharmaceuticals
Plaintiff filed suit against pharmaceutical companies, alleging that they were liable for substantial gambling and other financial losses that resulted from obsessive compulsive behavior, a side effect of taking a dopamine agonist called Mirapex for his Parkinson's disease. The Eighth Circuit affirmed the district court's grant of summary judgment dismissing all claims as barred by the applicable California statute of limitations. The court rejected plaintiff's contention that the statute should be tolled because he was insane when the cause of action accrued; rejected plaintiff's contention that each ingestion of the drug gave rise to a separate and distinct claim under the continuing violations doctrine; and held that the district court did not abuse its discretion in denying a motion to stay defendants' motion for summary judgment. View "Mancini v. Boehringer Ingelheim Pharmaceuticals" on Justia Law
Lager v. CSL Behring
The Eighth Circuit affirmed the dismissal of relator's False Claims Act (FCA), 31 U.S.C. 3729 et seq., suit based on the public disclosure bar. Relator alleged that CSL Behring conspired with pharmacies to submit false claims to the United States for reimbursement for prescription drugs. The Eighth Circuit concluded that, viewed collectively, the public disclosures provided enough information about the participants in the scheme to directly identify the defendants and the subject drugs; the disclosures would have set the government squarely on the trail of the defendants' participation in the purported fraudulent reporting; and the essential elements of relator's claims -- the purported fraud -- were publicly disclosed prior to him filing suit. View "Lager v. CSL Behring" on Justia Law
Kokocinski v. Collins, Jr.
Plaintiff filed a shareholder derivative action on behalf of Medtronic, Inc., against current and former directors and officers of Medtronic, and against Medtronic as a nominal defendant. Plaintiff's complaint alleged various bad acts and false and misleading statements stemming from Medtronic's alleged improper promotion to physicians of the "off-label" use of its "Infuse" product. The district court dismissed the action based on a report by a special litigation committee (SLC). The court concluded that defendants' motion to terminate the litigation based on the SLC report could not be construed as a motion under Rule 12(b)(6) nor one arising under Rule 56; the court agreed with the district court and the Eleventh Circuit that the closest fit for a motion to terminate in the Federal Rules was Rule 23.1(c); the proper standard of review was for an abuse of the district court's discretion; the district court did not err in deferring to the SLC under Minnesota's business judgment rule (BJR) where the SLC possessed a disinterested independence, and the SLC's investigative methodologies and procedures were adequate, appropriate, and pursued in good faith; and the district court did not abuse its discretion by denying plaintiff's motion for discovery. Accordingly, the court affirmed the judgment. View "Kokocinski v. Collins, Jr." on Justia Law
Anderson v. K-V Pharma. Co.
Plaintiffs acquired shares of K-V Pharmaceutical stock during the period in which the company launched and marketed Makena, its new prescription drug, designed to reduce the risk of pre-term labor for at-risk pregnant women. It had acquired rights to the drug from the FDA, under the Orphan Drug Act, 21 U.S.C. 360. In a putative class action, the plaintiffs alleged that K-V and three of its officers made materially false or misleading statements or omissions related to the product launch. The district court dismissed, holding the challenged statements were protected by the safe-harbor provision of the Private Securities Litigation Reform Act of 1995 (PSLRA), 15 U.S.C. 78u-4(b), and that the plaintiffs failed to adequately plead scienter under the PSLRA. The district court also denied the plaintiffs the opportunity to amend the complaint as it related to allegations from confidential witnesses. The Eighth Circuit affirmed. K-V’s statements fell within the PSLRA’s safe-harbor provision as forward-looking statements accompanied by meaningful cautionary language and are not actionable as a basis for a securities fraud action. View "Anderson v. K-V Pharma. Co." on Justia Law
Madel v. Dep’t of Justice
Madel sued the Department of Justice and Drug Enforcement Administration for a response to Freedom of Information Act, 5 U.S.C. 552, requests that sought information on oxycodone transactions in Georgia by five private companies. DEA withheld some documents as confidential commercial information. The district court granted summary judgment to DEA, finding it produced all non-exempt information. The court denied declaratory and injunctive relief and attorney fees. The Eighth Circuit reversed and remanded. Rejecting a claim that DEA did not justify withholding the five documents under FOIA Exemption 4, the court concluded that DEA showed that substantial competitive harm was likely. DEA did not make “barren assertions” that the documents were exempt, but linked each document to identifiable competitive harms. The court remanded for consideration of FOIA’s segregability requirement. DEA did not show “with reasonable specificity why documents withheld pursuant to a valid exemption cannot be further segregated.” Its Declaration does not address how disclosure of the data from, for example, 2007, leads to the proffered substantial competitive harms of a competitor “target[ing] specific markets” or “forecast[ing] potential business of new locations.” View "Madel v. Dep't of Justice" on Justia Law
Townsend v. Bayer HealthCare Pharm. Inc.
Townsend worked as an Arkansas pharmaceutical sales representative for Bayer, selling Mirena, a contraceptive device. Townsend visited physicians, including Dr. Shrum. Townsend learned Shrum was importing from Canada a version of Mirena that was not FDA-approved, at half the cost of the approved version. Shrum had submitted Medicaid claims at the same rate as the approved version and bragged about $50,000 in extra profit. Townsend sought guidance from his superiors. Bayer told Townsend not get involved. Townsend called the Medicaid Fraud Hotline, although he feared losing his job. Shrum was charged with Medicaid fraud. Meanwhile, Bayer changed its method of reimbursing sales expenses. Not understanding the change, Townsend’s wife spent funds intended for those expenses, causing Townsend’s account to be closed temporarily. Although Townsend's account had been reactivated, Bayer fired him, claiming his closed account prevented him doing his job. Townsend sued, citing anti-retaliation provisions of the False Claims Act, 31 U.S.C. 3730(h).). A jury awarded Townsend back pay, doubled to $642,746, and $568,000 in emotional distress damages. The court denied front pay and ordered Bayer to reinstate Townsend. The Eighth Circuit affirmed on all issues except the emotional distress damage award and remanded to allow Townsend the option of accepting a remittitur of $300,000, or a new trial on emotional distress damages. View "Townsend v. Bayer HealthCare Pharm. Inc." on Justia Law