Justia Drugs & Biotech Opinion SummariesArticles Posted in US Court of Appeals for the Seventh Circuit
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
Vanzant v. Hill’s Pet Nutrition, Inc.
Plaintiffs own cats with health problems. Their veterinarians prescribed Hill’s cat food. They purchased this higher-priced cat food from PetSmart stores using their veterinarian’s prescriptions before learning that the Prescription Diet cat food is not materially different from non-prescription cat food and no prescription is necessary. Plaintiffs filed a class-action lawsuit under the Illinois Consumer Fraud and Deceptive Business Practices Act. The district judge dismissed the claim as lacking the specificity required for a fraud claim and barred by a statutory safe harbor for conduct specifically authorized by a regulatory body (the FDA). The Seventh Circuit reversed. The safe-harbor provision does not apply. Under the Food, Drug, and Cosmetic Act, 21 U.S.C. 301, pet food intended to treat or prevent disease and marketed as such is considered a drug and requires FDA approval. Without FDA approval, the manufacturer may not sell it in interstate commerce and the product is deemed adulterated and misbranded. FDA guidance recognizes that most pet-food products in this category do not have the required approval and states that it is less likely to initiate an enforcement action if consumers purchase the food through or under the direction of a veterinarian (among other factors). The guidance does not specifically authorize the conduct alleged here, so the safe harbor does not apply. Plaintiffs pleaded the fraud claim with the particularity required by FRCP 9(b). View "Vanzant v. Hill's Pet Nutrition, Inc." on Justia Law
Robinson v. Davol, Inc.
Bard manufactures a surgical patch, consisting of two pieces of mesh that surround a flexible plastic ring. During a hernia repair, the patch is folded to fit through a small incision, then the plastic ring springs back into its original shape and flattens the mesh against the abdominal wall. Bard recalled several versions of the patch in 2005-2006 following reports that the plastic ring was defective. Sometimes the ring broke, exposing a sharp edge that could perforate the patient’s intestines. Other times the ring caused the patch to bend and warp, exposing the patch’s adhesive to a patient’s viscera. Before the recall, Bowersock underwent hernia repair surgery, involving a Bard patch. Roughly one year later, she died of complications arising from an abdominal-wall abscess. Her estate sued. Unlike defective patches in other injured patients, Bowersock’s patch did not adhere to her bowel or perforate her organs. Plaintiff's expert tried to present a new theory of causation: the patch had “buckled,” forming a stiff edge that rubbed against and imperceptibly perforated her internal organs. The court excluded that testimony, finding the “buckling” theory not sufficiently reliable. The Seventh Circuit affirmed summary judgment for the defense. The novel theory of causation was not peer-reviewed, professionally presented, consistent with Bowersock’s medical records or autopsy, or substantiated by other cases. View "Robinson v. Davol, Inc." on Justia Law
Dolin v. GlaxoSmithKline LLC
In 2010, a doctor prescribed Paxil, the brand‐name version of paroxetine, to treat Stewart’s depression and anxiety. His prescription was filled with generic paroxetine manufactured by another company (not a defendant). Days later, Stewart committed suicide at age 57. He had paroxetine in his system. GSK manufactured brand‐name Paxil and was responsible under federal law for the content of the drug’s label. Labels for paroxetine and similar antidepressant drugs then warned that they were associated with suicide in patients under the age of 24 but did not warn about any association between the drugs and an increased risk of suicide in older adults. It is virtually impossible to sue generic drug manufacturers for failure to warn because they are required to use the FDA-approved label used by the brand-name (original) manufacturer. Only the brand-name manufacturer can seek FDA approval to change the label. Stewart’s wife sued GSK, alleging that it negligently failed to include warnings that paroxetine was associated with suicide in patients older than 24. The jury awarded her $3 million. The Seventh Circuit reversed, holding that federal law prevented GSK from adding a warning about the alleged association between paroxetine and suicides in adults. The FDA repeatedly told GSK not to add a paroxetine‐specific suicide risk warning. View "Dolin v. GlaxoSmithKline LLC" on Justia Law
Owens v. Auxilium Pharmaceuticals, Inc.
Owens began using Testim, a topical gel containing 1% testosterone, in July 2011 when his doctor diagnosed him with hypogonadism. Owens used Testim sporadically. Although the medication guide directs users to apply a full tube of Testim to the shoulders and arms, Owens would apply part of a tube to his thighs and stomach. In July 2013, Owens was admitted to a hospital for pain in his leg. An ultrasound revealed blood clots. He was diagnosed with deep vein thrombosis (DVT). Owens was treated with blood thinners and released the following day. Owens sued, asserting strict liability, negligence, fraud, and negligent misrepresentation under Kentucky law. Each claim requires expert testimony to establish causation. Owens’s case was selected for a bellwether trial in multidistrict litigation. Owens planned to rely on testimony by Dr. Abbas that Testim had caused Owens’s DVT. That opinion assumed that Owens was applying the prescribed dose in the proper manner. When asked during his deposition about hypothetical cases that resembled Owens’s use of Testim, Abbas had no opinion. The district court excluded the testimony and granted Auxilium summary judgment. The Seventh Circuit affirmed. The court properly applied the Daubert framework when excluding Abbas’s testimony. It did not abuse its discretion by concluding that the testimony did not fit the facts of Owens’s case or by failing to consider an argument Owens never presented. Without expert testimony on causation, Owens’s claims necessarily fail. View "Owens v. Auxilium Pharmaceuticals, Inc." on Justia Law
Eli Lilly and Co. v. Arla Foods USA, Inc.
Arla, a Denmark-based global dairy conglomerate, launched a $30 million advertising campaign aimed at expanding its U.S. cheese sales, branded “Live Unprocessed.” The ads assure consumers that Arla cheese contains no “weird stuff” or “ingredients that you can’t pronounce,” particularly, no milk from cows treated with recombinant bovine somatotropin (“rbST”), an artificial growth hormone. The flagship ad implies that milk from rbST-treated cows is unwholesome. Narrated by a seven-year-old girl, the ad depicts rbST as a cartoon monster with razor-sharp horns. Elanco makes the only FDA-approved rbST supplement. Elanco sued, alleging that the ads contain false and misleading statements in violation of the Lanham Act. Elanco provided scientific literature documenting rbST’s safety, and evidence that a major cheese producer had decreased its demand for rbST in response to the ads. The Seventh Circuit affirmed the issuance of a preliminary injunction, rejecting arguments that Elanco failed to produce consumer surveys or other reliable evidence of actual consumer confusion and did not submit adequate evidence linking the ad campaign to decreased demand for its rbST. Consumer surveys or other “hard” evidence of actual consumer confusion are unnecessary at the preliminary-injunction stage. The evidence of causation is sufficient at this stage: the harm is easily traced because Elanco manufactures the only FDA-approved rbST. The injunction is sufficiently definite and adequately supported by the record and the judge’s findings. View "Eli Lilly and Co. v. Arla Foods USA, Inc." on Justia Law
Henson v. Department of Health and Human Services
Under the Food, Drug, and Cosmetics Act, “Class III” medical devices are those that support or sustain human life, that are of substantial importance in preventing impairment of human health, or that present a potential, unreasonable risk of illness or injury, 21 U.S.C. 360c(a)(1)(A), and must undergo scientific and regulatory review before they are marketed. Henson, a diabetic, sent the Food and Drug Administration requests under the Freedom of Information Act (FOIA), 5 U.S.C. 552, seeking documents related to the premarket approval process for a glucose monitoring system, claiming to have observed deficiencies with his monitor. The agency produced documents. Henson was not satisfied with the response, so he sued. The agency reprocessed Henson’s requests and provided him with responsive documents totaling 8,000 pages plus a “Vaughn index,”listing each redacted or withheld document cross-referenced with the FOIA exemption that the FDA asserted was applicable. The FDA explained that it did not respond to all of Henson’s requests because the requested materials were either outside of the Act’s scope, duplicative of Henson’s other requests, or available on the agency’s website. The Seventh Circuit affirmed the rejection of Henson’s suit on summary judgment. The agency’s search for responsive documents and the application of exemptions were reasonable. View "Henson v. Department of Health and Human Services" on Justia Law