Justia Drugs & Biotech Opinion SummariesArticles Posted in US Court of Appeals for the Seventh Circuit
Johnson v. C. R. Bard, Inc.
Hoping to minimize her risk of suffering serious complications from future blood clots, Johnson underwent surgery to implant a retrievable intravascular filter–a medical device that is placed in the inferior vena cava to prevent blood clots that develop in the lower body from flowing into the heart and lungs. Johnson’s doctor selected the Meridian filter, which was supposed to be temporary and easily removable. Johnson’s filter migrated and fractured, leaving shards embedded in the wall of her heart and elsewhere. Her surgeon was unable to remove the device safely and fully. As a result, Johnson faces an ongoing risk of infection, pain, and other complications.Johnson sued the manufacturers of the Meridian filter (Bard), claiming that they defectively designed the Meridian filter and failed to warn medical providers about the device’s risks, in violation of Wisconsin law. A jury rejected most of Johnson’s theories but returned a $3.3 million verdict in her favor on her strict liability failure-to-warn count. The Seventh Circuit affirmed, stating that its decision “should not be misinterpreted as our endorsement of some of Johnson’s counsel’s trial tactics.” There was no reversible error in instructing the jury or in permitting certain testimony, in alleged violation of expert witness disclosure requirements. View "Johnson v. C. R. Bard, Inc." on Justia Law
Astellas US Holding, Inc. v. Federal Insurance Co.
The 2005 Medicare amendment, launching prescription drug coverage, raised concerns that patient assistance plans could violate the Anti-Kickback Statute, 42 U.S.C. 1320a-7b, and the False Claims Act, 31 U.S.C. 3729, by effectively rewarding doctors and patients for choosing particular drugs. Astellas subsequently launched Xtandi, used to treat metastatic prostate cancer. Priced at $7,800 per month, Xtandi prescriptions were covered by Medicare up to about $6,000 per month. Astellas made contributions to two patient assistance plans. An Astellas marketing executive encouraged both plans to create special funds to provide co-pay assistance for only androgen receptor inhibitors like Xtandi and a few other medications. Astellas donated to the new funds but stopped after contributing about $27 million. Astellas continued contributing to broader prostate cancer funds.The Department of Justice began investigating; the Astellas marketing executive acknowledged that he had “hoped” and “expected” that the contributions would produce financial benefits for Astellas but that Astellas had made no efforts to calculate “a return on investment.” Astellas settled with the government for $100 million--$50 million for “restitution” to the government. Astellas sought indemnification from liability insurers, including Federal, which denied coverage.The Seventh Circuit affirmed summary judgment for Astellas. Under Illinois law, a party may not obtain liability insurance for genuine restitution it owes the victim of its intentional wrongdoing, but a party may obtain insurance for compensatory damages. In cases of ambiguity, Illinois favors settlements and freedom of contract. Federal wrote its insurance policy to try to extend coverage to the limit of what Illinois law would allow. Federal did not carry its burden of showing that the portion of the settlement payment for which Astellas seeks coverage is uninsurable restitution. View "Astellas US Holding, Inc. v. Federal Insurance Co." on Justia Law
Bridges v. Blackstone, Inc.
Bridges and Cunningham filed a putative class action, alleging that Blackstone (the owner of Ancestry.com) violated Section 30 of Illinois’s 1998 Genetic Information Privacy Act, which provides that no person or company “may disclose or be compelled to disclose the identity of any person upon whom a genetic test is performed or the results of a genetic test in a manner that permits identification of the subject of the test,” 410 ILCS 513/30(a). Both plaintiffs had purchased DNA testing products from Ancestry and submitted saliva samples for genetic sequencing years earlier. Blackstone subsequently purchased Ancestry in a “control acquisition”— an all-stock transaction. Because Ancestry had allegedly paired the plaintiffs’ genetic tests with personally identifiable information—including names, emails, and home addresses—Bridges and Cunningham maintained that Blackstone, as part of acquiring Ancestry, had compelled the disclosure of their genetic identities in violation of Section 30.The Seventh Circuit affirmed the dismissal of the suit for failure to state a claim. The complaint focusing exclusively on Blackstone’s acquisition of Ancestry did not adequately allege any compulsory disclosure. View "Bridges v. Blackstone, Inc." on Justia Law
Gripum, LLC v. United States Food and Drug Administration
Gripum manufactures and distributes flavored liquids for use in e-cigarette devices. Gripum submitted a “premarket tobacco product application” to the federal Food and Drug Administration (FDA) in 2021. The agency denied the application, reasoning that Gripum had failed to demonstrate public-health benefits as required by the Family Smoking Prevention and Tobacco Control Act, 21 U.S.C. 387j. The 2016 “Deeming Rule,” promulgated under the Act requires denial of an application to market a new tobacco product if the manufacturer fails to show that the product would be “appropriate for the protection of public health,” considering the risks and benefits to the population as a whole, including users and non-users, the “increased or decreased likelihood that existing users of tobacco products will stop using such products and those who do not use tobacco products will start using such products.The Seventh Circuit upheld the denial. The FDA required Gripum to show that its flavored e-cigarette products were relatively better at reducing rates of tobacco use than products already on the market. It properly applied the comparative standard mandated by the statute. Gripum failed to provide evidence specific to its products; its studies of other products did not even compare tobacco-flavored e-cigarette products to flavored products resembling Gripum’s products. View "Gripum, LLC v. United States Food and Drug Administration" on Justia Law
Terry Paulsen v. Abbott Laboratories
To treat her endometriosis, Paulsen received Lupron injections in 2004 from her physician in Georgia. Shortly afterward she began experiencing health problems, including severe bone and joint pain, memory loss, and fevers. In April 2010, Paulsen filed a personal injury suit. Paulsen voluntarily dismissed her claims in 2014. In 2015, Paulsen filed a second lawsuit asserting product liability, negligence, breach of warranty, and misrepresentation. After several amended complaints and the addition of a defendant, two claims remained: a strict liability failure-to-warn claim against AbbVie and Abbott; and a negligent misrepresentation claim against Abbott. Limited discovery was permitted.The district court subsequently applied Illinois procedural law and Georgia substantive law, reasoning that Paulsen’s injury occurred in Georgia, and Illinois lacked a stronger relationship to the action, then granted the defendants summary judgment. The court ruled that Paulsen’s strict liability failure-to-warn claim was time-barred by Georgia’s 10-year statute of repose. Georgia does not recognize a stand-alone misrepresentation claim in product liability cases. Even if this cause of action did exist, the court reasoned, Paulsen’s misrepresentation claim would fail because “the undisputed evidence show[ed] that Abbott did not make any representations regarding Lupron.” The Seventh Circuit affirmed. The court noted extensive evidence that Paulsen’s claims accrued before April 2008 and are barred by the Illinois two-year statute of limitations for personal injuries. View "Terry Paulsen v. Abbott Laboratories" on Justia Law
Donaldson v. Johnson & Johnson
Donaldson sought treatment for stress urinary incontinence and anterior pelvic organ prolapse. In 2010, to remedy these conditions, Dr. Schultheis surgically implanted in Donaldson two transvaginal polypropylene mesh medical devices. Both were manufactured by a subsidiary of Johnson & Johnson. In 2014, Donaldson sought treatment for injuries resulting from erosion of the mesh into her bladder, vagina, and adjacent tissues, causing scarring, bladder stones, and abdominal pain, among other problems. Information sheets packaged with the devices warned of the risks of erosion but Donaldson never saw the warnings and contends that Dr. Schultheis did not inform her of these risks. Dr. Schultheis testified that he was aware of the possible complications and that he believed that the benefits of the devices outweighed the risks. He also testified that, in implanting the devices, he followed all of the manufacturer’s instructions.The Seventh Circuit affirmed summary judgment in favor of the manufacturers. Although there is no doubt that Donaldson suffered severe and painful complications after the devices were implanted, she failed to produce sufficient evidence to avoid summary judgment in her case for non-specific defects under Illinois product liability law. There was no evidence eliminating abnormal use or secondary causes, or that the device failed to perform as expected. View "Donaldson v. Johnson & Johnson" on Justia Law
United States v. Elmer
Elmer owned and operated multiple healthcare-related companies including Pharmakon, a compounding pharmacy that mixes and distributes drugs—including potent opioids like morphine and fentanyl—to hospitals across the U.S.. Pharmakon conducted its own internal potency testing and contracted with a third party to perform additional testing to evaluate whether its compounded drugs had too little of the active ingredient (under-potent) or too much (over-potent). In 2014-2016, testing showed 134 instances of under- or over-potent drugs being distributed to customers. Elmer knew the drugs were dangerous. Rather than halting manufacturing or recalling past shipments, sales continued and led to the near-death of an infant. Elmer and Pharmakon lied to the FDA.Elmer was charged with conspiracy to defraud the FDA (18 U.S.C. 371); introducing adulterated drugs into interstate commerce (21 U.S.C. 331(a), 333(a)(1) & 351); and adulterating drugs being held for sale in interstate commerce (21 U.S.C. 331(k), 331(a)(1) & 351). Pharmakon employees, FDA inspectors, and Community Health Network medical staff testified that Elmer was aware of and directed the efforts to conceal out-of-specification test results from the FDA. The district court sentenced Elmer to 33 months’ imprisonment. The Seventh Circuit affirmed, rejecting challenges to rulings related to the evidence admitted at trial and Elmer’s sentence. The evidence before the jury overwhelmingly proved Elmer’s guilt. The sentence was more than reasonable given the gravity of Elmer’s crimes. View "United States v. Elmer" on Justia Law
Dolin v. GlaxoSmithKline LLC
Dolin was prescribed Paxil, the brand-name version of the drug paroxetine, to treat his depression. The prescription was filled with a generic paroxetine product. Six days later, Dolin died by suicide. Federal law preempted an "inadequate labeling" state-law claim against the generic manufacturer. Mrs. Dolin sued GSK, the manufacturer of brand-name Paxil, arguing that GSK was responsible for the labeling for all paroxetine, no matter who made and sold it, and had negligently omitted an adult suicide risk. The Seventh Circuit reversed her jury verdict, based on preemption, citing the complex regulation of drug labels and of Paxil/paroxetine’s label in particular. GSK had attempted to change the Paxil label in 2007 to add an adult suicide warning. The FDA rejected that change. The court concluded that GSK lacked new information after 2007 that would have allowed it to add an adult-suicidality warning under the existing regulations.Eight days after denying Dolin certiorari, the Supreme Court decided another case, further explaining the “clear evidence” standard for impossibility preemption for prescription drug labels. Dolin filed an unsuccessful motion under FRCP 60(b)(6), arguing that the 2018 judgment should be set aside based on a change in law so that GSK could not establish its defense of impossibility preemption. The Seventh Circuit affirmed and did not impose sanctions. The Supreme Court provided important guidance but did not break new ground that would change the result in Dolin’s case. Her motion was not frivolous. View "Dolin v. GlaxoSmithKline LLC" on Justia Law
Antrim Pharmaceuticals LLC v. Bio-Pharm, Inc.
The patent for Lexapro, an anti-depressant, was expiring, creating a potentially lucrative opportunity to sell a generic version, escitalopram. BioPharm, a generic drug manufacturer, and Antrim planned to sign an updated version of the terms for a previous venture, but never signed a contract for the escitalopram venture. The FDA approved Antrim’s Abbreviated New Drug Application for escitalopram. Bio-Pharm manufactured the first batch but never shipped it to Antrim because the companies never signed a new agreement. Antrim sued Bio-Pharm for breaching an oral contract. Bio-Pharm counterclaimed, arguing promissory estoppel or breach of the claimed oral contract. Antrim unsuccessfully argued the court should preclude testimony by Bio-Pharm’s expert on how the FDA regulates ANDA holders. BioPharm successfully argued the court should preclude testimony by Antrim’s expert on industry practices and how Bio-Pharm’s alleged breach impaired the value of Antrim’s business. The court rejected Antrim’s proposed Jury Instruction that under FDA policy an ANDA holder owns the product underlying that ANDA and denied Antrim’s motion to bar Bio-Pharm from requesting lost profits in its counterclaim, despite missing the Rule 26(a)(1) disclosure deadline.A jury ruled in favor of Bio-Pharm on Antrim’s claim and in favor of Antrim on Bio-Pharm’s counterclaim. Neither party was awarded damages. The Seventh Circuit affirmed, rejecting Antrim’s challenges to the jury instructions, evidentiary rulings, and allowing Bio-Pharm to request lost profits. View "Antrim Pharmaceuticals LLC v. Bio-Pharm, Inc." on Justia Law
Kaiser v. Johnson & Johnson and Ethicon, Inc.
Kaiser had surgery to implant the Prolift Anterior Pelvic Floor Repair System, a transvaginal mesh medical device that supports the pelvic muscles. A few years later, Kaiser began experiencing severe pelvic pain, bladder spasms, and pain during intercourse. Her physician attributed these conditions to contractions in the mesh. Kaiser had surgery to remove the device, but her surgeon could not completely extract it and informed her that the complications she was experiencing were likely permanent. Kaiser sued Ethicon, Prolift’s manufacturer, under the Indiana Products Liability Act. A jury found Ethicon liable for defectively designing the Prolift device and failing to adequately warn about its complications and awarded $10 million in compensatory damages; the judge reduced a punitive award to $10 million. The Seventh Circuit affirmed, rejecting Ethicon’s claim of federal preemption. The requirements of the FDA’s premarket-notification process do not directly conflict with Indiana law. A reasonable jury could conclude that Prolift was unreasonably dangerous and could credit the physician’s assertion that additional warnings about complications would have led him to choose a different treatment plan. The court rejected challenges to the damages and to jury instructions. Seventh Circuit precedent interprets the Indiana Product Liability Act to require a plaintiff in a design-defect case to produce evidence of a reasonable alternative design for the product but the Indiana Supreme Court disagreed in 2010. The state supreme court’s decision controls on a matter of state law. View "Kaiser v. Johnson & Johnson and Ethicon, Inc." on Justia Law