Justia U.S. 7th Circuit Court of Appeals Opinion Summaries

From 1998 to 2012 Abbott marketed the anticonvulsant medication Depakote for applications that had not been FDA-approved (off-label uses). Physicians may prescribe drugs for off-label uses, but pharmaceutical companies are generally prohibited from marketing drugs for those same applications. Qui tam actions were filed under the False Claims Act. In 2009, Abbott disclosed in an SEC filing that the Department of Justice was investigating its marketing. Abbott pleaded guilty to illegally promoting Depakote from 2001 through 2006 and agreed to pay $1.6 billion to settle the criminal and qui tam actions. Employee benefits funds filed suit 15 months later, alleging that Abbott misrepresented Depakote’s safety and efficacy for off-label uses, paid kickbacks to physicians, established and funded intermediary entities to promote the drug for off-label uses, and concealed its role in these activities, in violation of the Racketeer Influenced and Corrupt Organizations Act. The district court dismissed, finding that the statute of limitations for the RICO claim began to run in 1998, when the funds initially reimbursed a prescription for off-label use. The court refused to toll the limitations period until the guilty plea, finding that Abbott’s concealment efforts were not designed to hinder potential lawsuits. The Seventh Circuit reversed, finding that dismissal was premature without an opportunity for discovery into when a reasonable fund should have known about its injuries from off-label marketing. View "Sidney Hillman Health Ctr. of Rochester v. Abbott Labs., 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 The Seventh Circuit rescinded the order with respect to the depositions but otherwise denied mandamus.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

Baxter’s Colleague Infusion Pump, an electronic device used to deliver intravenous fluids to patients, was known to have a range of defects. The FDA sent Baxter warning letters. Baxter’s response was not satisfactory. In 2005 the FDA sought forfeiture of all Baxter‐owned Pumps. In 2006, Baxter entered into a Consent Decree to stop manufacturing and distributing all models of the Pump within the U.S., and committed to bringing the approximately 200,000 Pumps in the hands of health care professionals into compliance with the FDA Act. Baxter devoted significant resources to fixing the Pumps, but the FDA was not satisfied and ordered a product recall. In a derivative suit, plaintiffs alleged that that Baxter’s directors and officers breached fiduciary duties by consciously disregarding their responsibility to bring about compliance with the Consent Decree, causing Baxter to lose more than $550 million. Plaintiffs did not first ask Baxter’s board of directors to pursue those claims, but alleged futility. The district court dismissed, finding that Westmoreland failed adequately to plead demand futility, as required by FRCP 23.1(b)(3) and Delaware substantive law. The Seventh Circuit reversed, stating that particularized facts furnished by plaintiffs cast a reasonable doubt that the defendants’ conduct was the product of a valid exercise of business judgment. View "Westmoreland Cnty. Emps. Retirement Sys. v. Parkinson" on Justia Law

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

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

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

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.

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.

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.

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.