Justia Drugs & Biotech Opinion SummariesArticles Posted in U.S. 7th Circuit Court of Appeals
Unted States v. Hardimon
A chiropractor pleaded guilty to defrauding health insurers and to money laundering and was sentenced to 70 months (the bottom of the guidelines range) and to pay restitution of almost $2 million. At the guilty-plea hearing the judge asked the defendant whether he was “currently under the influence of any drugs, medicine, or alcohol,” and the defendant answered: “prescription medications.” He told the judge that he was taking medicines for “high anxiety, depression, adult attention hyperactivity disorder, and depression,” but stated that he was “thinking clearly.” He waived his right to appeal, but six weeks later moved to retract the plea, claiming that he had been taking psychotropic drugs, rendering his plea involuntary. The judge denied the motion because the defendant had presented no evidence that switching from Prozac to Lexapro could have the dramatic effects he claimed it had, and because at the plea hearing he had been alert and responsive and exhibited no signs of confusion. The Seventh Circuit affirmed. View "Unted States v. Hardimon" on Justia Law
Abbott Labs., Inc. v. Alexander
In 2010-2011 several hundred plaintiffs filed 10 lawsuits in Illinois state courts against Abbott, for personal injuries they allege were caused by Depakote, a prescription. Plaintiffs moved the Supreme Court of Illinois to consolidate and transfer their cases to St. Clair County, pursuant to Illinois Supreme Court Rule 384; the Supreme Court has not ruled. Abbott removed each of the cases to federal court, asserting that the motion to consolidate brought the cases under the “mass action” provision of the Class Action Fairness Act, 28 U.S.C. 1332(d)(11)(B)(i), which allows the removal of any case where 100 or more people propose to try their claims jointly. Cases filed in St. Clair and Madison counties were removed to the Southern District of Illinois and cases filed in Cook County were removed to the Northern District; plaintiffs moved to remand in both courts. The Northern District denied plaintiffs’ motion to remand. The Seventh Circuit held that removal was proper, rejecting plaintiffs’ argument that they did not propose a joint trial because their motion to consolidate did not address how the trials of the various claims in the cases would be conducted, other than proposing that they all take place in St. Clair County. View "Abbott Labs., Inc. v. Alexander" on Justia Law
On-Site Screening, Inc. v. United States
Plaintiff sought to develop a rapid, self-administered test to determine a person’s HIV status. The development process included collection of human blood and saliva samples. Plaintiff sued the United States under the Federal Tort Claims Act for the destruction of its blood and saliva specimens by the Food and Drug Administration. The specimens had been seized during a criminal investigation and the freezer in which they were stored broke down. The district court entered summary judgment that the suit arose from a law enforcement officer’s detention of property, excepting the claims from the FTCA waiver of sovereign immunity, 28 U.S.C. 2680(c). The Seventh Circuit affirmed. The government presented uncontroverted evidence that the officer detained the specimens as a law enforcement officer View "On-Site Screening, Inc. v. United States" on Justia Law
Posted in: Constitutional Law, Drugs & Biotech, Government & Administrative Law, Health Law, U.S. 7th Circuit Court of Appeals
Plumbers & Pipefitters Local Union 719 Pension Fund v. Zimmer Holdings Inc.
Zimmer manufactures orthopaedic reconstructive devices. One product, a replacement hip socket, was subject to a report of high failure rates. Zimmer announced preliminary findings in 2008, attributed the failures to improper surgical technique, stopped selling the product in the U.S. while preparing new instructions for implantation, and returned the item to the market. Owners of Zimmer stock sued, claiming that the problem was poor design or quality control, that Zimmer pretended otherwise to avoid hurting the price of its stock, and that Zimmer delayed revealing quality-control problems at its plant until after its 2008 quarterly report and earnings call. Zimmer had projected 10% to 11% revenue growth for the year and net earnings of $4.20 to $4.25 per share; months later it cut this projection to 8.5% to 9% growth and net earnings of $4.05 to $4.10 per share. The district court dismissed under the pleading standards of the Private Securities Litigation Reform Act of 1995, 15 U.S.C. 78u-4. The Seventh Circuit affirmed, holding that plaintiffs failed to establish scienter. The FDA has never concluded that the product was defectively designed or made and never issued a warning or caution; quality control issues at pharmaceutical and medical-device producers are endemic. View "Plumbers & Pipefitters Local Union 719 Pension Fund v. Zimmer Holdings Inc." on Justia Law
Schaefer-LaRose v. Eli Lilly & Co.
Plaintiffs in consolidated cases claim that, during their tenures as pharmaceutical sales representatives employed by Lilly and Abbott, they were misclassified as exempt employees and denied overtime pay in violation of the Fair Labor Standards Act, 29 U.S.C. 201-19. The employers argued that the administrative exemption and the outside sales exemptions removed the sales representatives from overtime protections. The two district courts reached opposite conclusions. After considering an amicus brief from the Department of Labor, the Seventh Circuit held that, under regulations of the Department of Labor, the pharmaceutical sales representatives are classified properly within the administrative exemption to overtime requirements. The court did not address the outside sales exemption. The sales representatives were compensated on a salary basis and their work is directly related to the general business operations of the pharmaceutical companies; they were required to exercise a significant measure of discretion and independent judgment, despite the constraints placed on them, and on all representatives of the pharmaceutical industry, by the regulatory environment in which they work. View "Schaefer-LaRose v. Eli Lilly & Co." on Justia Law
United States v. Boro
Based on his role in operating an online pharmacy that did not require prescriptions, defendant was convicted of conspiracy to import controlled substances, 21 U.S.C. 963 and 18 U.S.C. 2, conspiracy to possess controlled substances with the intent to distribute 21 U.S.C. 846 and 18 U.S.C. 2, and conspiracy to launder money, 18 U.S.C. 2; 1956-1957 with intent to promote the importation of controlled substances. The Seventh Circuit affirmed, upholding admission of expert testimony by a pharmacologist who testified about the classification of various drugs, their side effects, and the medical supervision needed to prescribe them. Although the testimony had only minimal relevance, the threshold for relevance under Rule 401 is quite low. Parts of the testimony related to side effects and birth defects should have been excluded under Rule 403 because the probative value was negligible, but the error was harmless given the weight of the evidence. View "United States v. Boro" on Justia Law
United States v. Muoghalu
Defendant was the pharmacy director of a medical center and had influence over decisions concerning which drugs to stock. Levato was the local business manager of a pharmaceutical company. Levato agreed to pay defendant $18,000 not to switch away from his company's drug, and made computer entries recording nine nonexistent speeches given by defendant for the pharmaceutical company; defendant later received another $14,000 for more fictitious speeches. After investigation by an FDA agent, Levato and defendant were indicted. Levato plead guilty and testified against defendant. Defendant was convicted of solicitation and receipt of kickbacks and sentenced to 22 months in prison. The Seventh Circuit affirmed. Memoranda prepared by the Department of Health and Human Services, discovered by the prosecution after trial, did not constitute exculpatory material withheld by the prosecution. The court noted that the documents would have strengthened the prosecution case. View "United States v. Muoghalu" on Justia Law
Posted in: Criminal Law, Drugs & Biotech, Health Law, U.S. 7th Circuit Court of Appeals, White Collar Crime
Turek v. General Mills, Inc.
Plaintiff claims that fiber identified on the nutrition label (required by 21 U.S.C. 343(q)(1))of "chewy bars" made and sold by defendants is inferior to unprocessed fiber and can be harmful. The district judge held that the suit was precluded by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 343-1(a)(5), which forbids states to impose "any requirement respecting any claim of the type . . . made in the label or labeling of food that is not identical to the requirement of section 343(r)." The Act does not create a private right of action; suit was filed under the Illinois Consumer Fraud and Deceptive Business Practices Act, 815 ILCS 505, and the Deceptive Trade Practices Act, 815 ILCS 510. The Seventh Circuit affirmed the dismissal. The labeling of the challenged products is compliant with the statute and FDA regulations. The disclaimers that the plaintiff wants added are not identical to the labeling requirements imposed by federal law, and so they are barred. The court further noted that plaintiff failed to state claim under Illinois law. View "Turek v. General Mills, Inc." on Justia Law
Affymax, Inc. v. Ortho-McNeil-Janssen Pharmaceuticals, Inc.
In 1992 two companies began a joint venture to develop peptide compounds. The agreement provides that inventions created by joint efforts are jointly owned, but inventions attributable to a single party are owned by that party and that disputes will be arbitrated. In court-ordered arbitration, a panel decided that a certain group of patents are jointly owned, but that another group is owned by defendant. The district court confirmed those rulings, but vacated a ruling in defendant's favor on foreign patents. Holding that appeal is authorized by 9 U.S.C. 16(a)(1)(E), and that the dispute does not concern patent law, but is a contract issue, the Seventh Circuit reversed. The Federal Arbitration Act authorizes a court to vacate an award for any of four reasons, 9 U.S.C. 10(a); a conclusion that the arbitrators disregarded the law by failing to discuss the foreign patents separately from the domestic patents did not justify vacating the award. The judge mistakenly inferred from silence that the arbitrators must have had an extra-contractual ground; the arbitrators had no reason to discuss the foreign patents separately from the domestic patents. View "Affymax, Inc. v. Ortho-McNeil-Janssen Pharmaceuticals, Inc." on Justia Law
Posted in: Arbitration & Mediation, Contracts, Drugs & Biotech, Patents, U.S. 7th Circuit Court of Appeals
Walton v. Bayer Corp.
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.