Justia Drugs & Biotech Opinion Summaries

This matter stemmed from a lawsuit filed by the State of Mississippi against the defendant pharmacies. The State alleged deceptive trade practices and fraudulent reporting of inflated “usual and customary” prices in the defendant’s reimbursement requests to the Mississippi Department of Medicaid. The State argued that Walgreens, CVS, and Fred’s pharmacies purposefully misrepresented these prices to obtain higher prescription drug reimbursements from the State. Finding that the circuit court was better equipped to preside over this action, the DeSoto County Chancery Court transferred the matter to the DeSoto County Circuit Court in response to the defendants’ request. Aggrieved, the State timely filed an interlocutory appeal disputing the chancellor’s decision to transfer the case. After a thorough review of the parties’ positions, the Mississippi Supreme Court found that though the chancery court properly could have retained the action, the chancellor correctly used his discretion to transfer the case, allowing the issues to proceed in front of a circuit-court jury. As a result, the Supreme Court affirmed the chancellor’s decision. View "Mississippi v. Walgreen Co." on Justia Law

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

The Jazz patents relate to a drug distribution system for tracking prescriptions of a “sensitive drug.” “A sensitive drug is one which can be abused, or has addiction properties or other properties that render the drug sensitive.” One such sensitive drug is Xyrem®. Jazz exclusively markets Xyrem®, which the FDA has approved to treat symptoms associated with narcolepsy. The active ingredient in Xyrem®, gamma-hydroxybutyrate (GHB), may also be illicitly used as a “date-rape drug.” Under the Controlled Substances Act any approved drug product containing GHB is classified as a Schedule III depressant, so the FDA approved Xyrem® under “restricted distribution regulations contained in [21 C.F.R. 314.500] (Subpart H) to assure safe use of the product.” On inter partes review, the Patent Board found certain claims invalid as obvious. The Federal Circuit affirmed, upholding a conclusion that implementing prior art, consisting of background materials and the meeting minutes, transcript, and slides on the FDA website, on multiple computers “would have been a predictable use of a known distributed data system according to its established function.” View "Jazz Pharmaceuticals, Inc.. v. Amneal Pharmaceuticals, LLC" on Justia Law

Endo holds the approved New Drug Application for Aveed®, a testosterone undecanoate intramuscular injection. Bayer owns the 640 and 395 patents listed in the Orange Book for Aveed®. Custopharm’s predecessor submitted an Abbreviated New Drug Application (ANDA) to the FDA for approval to produce and market a generic version of Aveed® and made a Paragraph IV certification and gave notice of the certification to Endo and Bayer in October 2014. Endo and Bayer brought an action alleging infringement of the 640 and 395 patents. Custopharm stipulated to infringement; Endo and Bayer limited their asserted claims to claim 2 of the 640 patent and claim 18 of the 395 patent. After a bench trial on invalidity, the district court concluded that Custopharm had not proven that the claims were invalid under 35 U.S.C. 103. The Federal Circuit affirmed. Custopharm failed to meet its burden of showing that a skilled artisan would combine a lowered dose with the injection schedule in the manner claimed. View "Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc." on Justia Law

Alpenglow Botanicals, LLC (“Alpenglow”) sued the Internal Revenue Service (“IRS”) for a tax refund, alleging the IRS exceeded its statutory and constitutional authority by denying Alpenglow’s business tax deductions under 26 U.S.C. 280E. The federal government classified marijuana as a “controlled substance” under schedule I of the Controlled Substances Act (“CSA”), but it is legal for medical or recreational use in Colorado. This appeal was the product of the clash between these state and federal policies: Alpenglow is a medical marijuana business owned and operated by Charles Williams and Justin Williams, doing business legally in Colorado. After an audit of Alpenglow’s 2010, 2011, and 2012 tax returns, however, the IRS issued a Notice of Deficiency concluding that Alpenglow had “committed the crime of trafficking in a controlled substance in violation of the CSA” and denying a variety of Alpenglow’s claimed business deductions under section 280E. Alpenglow’s income and resultant tax liability were increased based on the denial of these deductions. Because Alpenglow was a “pass through” entity, the increased tax liability was passed on to Charles Williams and Justin Williams. The two men paid the increased tax liability under protest and filed for a refund, which the IRS denied. The district court dismissed Alpenglow’s suit under Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim upon which relief could be granted, and denied Alpenglow’s subsequent motion under Federal Rule of Civil Procedure 59(e) to reconsider the judgment. Finding no reversible error in the district court's judgment, the Tenth Circuit affirmed. View "Alpenglow Botanicals v. United States" on Justia Law

Upsher-Smith manufactures a generic form of amiodarone hydrochloride, which is FDA-approved as a drug of last resort for patients suffering from ventricular fibrillation and ventricular tachycardia, life-threatening heartbeat irregularities. As a generic manufacturer, Upsher-Smith is required to ensure that it includes the same labeling approved for its brand-name counterpart. 21 U.S.C. 355(j)(2)(A)(v), including making “Medication Guides” available for distribution to each patient with each prescription, 21 C.F.R. 208.24(b). Medication Guides explain the approved uses of a drug and its side effects “in nontechnical, understandable language.” The Guide for amiodarone warns that the drug “should only be used in adults with life-threatening heartbeat problems.” Lung damage is listed as a “serious side effect” that may continue after ceasing treatment. McDaniel sued Upsher-Smith, alleging that her husband died because he took amiodarone to treat his non-life threatening atrial fibrillation. Johnny apparently did not receive the Medication Guide when he filled his prescriptions in May and June 2015; Upsher-Smith neglected to ensure its availability. He was unaware that only adults with life-threatening heartbeat problems who had unsuccessfully sought alternative treatments should take the drug. The Sixth Circuit affirmed the dismissal of the failure-to-warn claims with prejudice, holding that they were impliedly preempted under the Federal Food, Drug, and Cosmetic Act. McDaniel failed to cite any Tennessee duty paralleling the federal duty to provide a Medication Guide, so the claims would not exist without the Act. View "McDaniel v. Upsher-Smith Laboratories, Inc." on Justia Law

Triptans are selective serotonin receptor agonists, developed in the 1980s. When Zolmitriptan became available in the U.S. in oral tablet form in 1999 under the name Zomig® it was among several triptans on the market or under development. AstraZeneca owns the 237 and 767 patents, which relate to formulations of zolmitriptan for intranasal administration, and the New Drug Application for Zomig® (zolmitriptan) Nasal Spray, approved by the FDA for treatment of migraines. The patents are listed in connection with Zomig® Nasal Spray in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). In 2012, AstraZeneca and Impax entered into an agreement, granting Impax an exclusive license to AstraZeneca’s patents covering the Zomig® products, for the payment of $130 million and additional payments at varying royalty rates. In 2014, Lannett notified AstraZeneca that it had filed an Abbreviated New Drug Application, seeking approval for a generic version of Zomig® Nasal Spray, with a Paragraph IV certification (21 U.S.C. 355(j)(2)(A)(vii)(IV)), alleging noninfringement or invalidity of the 237 and 767 patents. In the subsequent infringement suit, 35 U.S.C. 271(e)(2)(A), the district court issued its claim construction opinion, the parties stipulated to infringement, and the court held that Lannett failed to prove by clear and convincing evidence that the asserted claims were invalid or would have been obvious over prior art. The Federal Circuit affirmed, upholding the entry of an injunction. View "Impax Laboratories Inc. v. Lannett Holdings Inc." on Justia Law

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

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

Lipitor, a pharmaceutical drug, is prescribed to lower patients’ “bad” cholesterol and triglycerides. Plaintiffs, more than 3,000 women, claim that they developed diabetes as a result of taking Lipitor. The Judicial Panel on Multidistrict Litigation consolidated the lawsuits for pretrial proceedings. The parties agreed on four bellwether cases. Plaintiffs enlisted general experts, to testify that there was a causal association between Lipitor and diabetes; specific experts, to testify that Lipitor proximately caused the onset of diabetes in the bellwether plaintiffs; and an expert biostatistician, who concluded that taking Lipitor led to a statistically significant increased risk of diabetes. Plaintiffs also sought to introduce internal Pfizer emails, information from Lipitor's labeling, a statement in Lipitor's FDA New Drug Application, and information from the Lipitor website. Citing Federal Rule of Evidence 702, the court excluded the opinions of the statistician; the general causation expert, except relating to a specific dosage; and the specific causation opinions. The rulings left the plaintiffs without their bellwether cases, limited to a subset of patients who had taken an 80 mg dose. The court issued show-cause orders asking whether any plaintiff could submit evidence that would enable her claim to survive summary judgment given prior rulings. Some plaintiffs submitted evidence showing only that they were not diabetic before taking Lipitor, that they were diagnosed with diabetes after taking Lipitor, and that they lacked certain risk factors that might make them especially likely to develop the disease. After the court rejected the evidence, the plaintiffs unsuccessfully argued that the cases ought to be returned to their transferor district courts for individual resolution on the issue of specific causation. The Fourth Circuit affirmed summary judgment for the defendants. View "Plaintiffs Appealing Case Management Order 100 v. Pfizer, Inc." on Justia Law