Justia Civil Procedure Opinion Summaries

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

Defendants produce or sell patented drug products containing the antiviral agent tenofovir alafenamide fumarate (TAF), which is used in the treatment of AIDS. Healthcare provides medical care to persons afflicted with AIDS, including providing antiviral drugs, including the TAF products that Healthcare buys from Defendants. Healthcare sought declarations of invalidity for patents purportedly covering TAF and various combination products so that it could partner with generic makers and purchase generic TAF on the expiration of the five-year New Chemical Entity exclusivity s(21 U.S.C. 355(j)(5)(F)(ii)). Healthcare filed suit two months after the FDA approved Genvoya®—the first TAF-containing product to receive FDA approval; other TAF products were still undergoing clinical trials. No unlicensed source was offering a TAF product or preparing to do so. Healthcare told the court that “none of the generic makers wanted to enter the market because there was the fear of liability.” The court ruled that Healthcare’s actions in encouraging others to produce generic TAF products and interest in purchasing such products did not create an actual controversy under the Declaratory Judgment Act. The Federal Circuit affirmed. The declaratory requirement of immediacy and reality is not met by litigation delay. Healthcare has not otherwise shown that there is a controversy of sufficient immediacy and reality to create declaratory judgment jurisdiction. Liability for inducing infringement requires that there be direct infringement. An interest in buying infringing product is not an adverse legal interest for declaratory jurisdiction. View "AIDS Healthcare Foundation, Inc. v. Gilead Sciences, Inc." on Justia Law

The district court did not err in dismissing Plaintiffs’ first amended complaint (FAC) for failure to state a claim or in denying Plaintiffs leave to file their proposed second amended complaint (PSAC) in this litigation in which Plaintiffs brought securities fraud claims against Sarepta Therapeutics, Inc. (Sarepta), Sarepta’s chief executive officer and Sarepta’s chief scientific officer (collectively, Defendants).Plaintiffs sought to represent a class of purchasers of securities that Sarepta issued between April 21, 2014 and October 27, 2014. Plaintiffs alleged that Defendants knowingly or recklessly misled investors about their target date for submitting an application to the United States Food and Drug Administration (FDA) for approval of the drug eteplirsen. The district court dismissed the FAC and denied Plaintiffs leave to file the PSAC. The First Circuit affirmed, holding (1) the district court did not err in dismissing the FAC for failure to state a claim because Plaintiffs did not adequately plead scienter in the FAC; and (2) and even assuming that the PSAC was not futile, the district court did not abuse its discretion in denying the PSAC on undue delay grounds. View "Kader v. Sarepta Therapeutics, Inc." on Justia Law

The district court did not err in dismissing Plaintiffs’ first amended complaint (FAC) for failure to state a claim or in denying Plaintiffs leave to file their proposed second amended complaint (PSAC) in this litigation in which Plaintiffs brought securities fraud claims against Sarepta Therapeutics, Inc. (Sarepta), Sarepta’s chief executive officer and Sarepta’s chief scientific officer (collectively, Defendants).Plaintiffs sought to represent a class of purchasers of securities that Sarepta issued between April 21, 2014 and October 27, 2014. Plaintiffs alleged that Defendants knowingly or recklessly misled investors about their target date for submitting an application to the United States Food and Drug Administration (FDA) for approval of the drug eteplirsen. The district court dismissed the FAC and denied Plaintiffs leave to file the PSAC. The First Circuit affirmed, holding (1) the district court did not err in dismissing the FAC for failure to state a claim because Plaintiffs did not adequately plead scienter in the FAC; and (2) and even assuming that the PSAC was not futile, the district court did not abuse its discretion in denying the PSAC on undue delay grounds. View "Kader v. Sarepta Therapeutics, Inc." on Justia Law

The Ninth Circuit affirmed the district court's judgment for EpiCept in an action brought by doctors, alleging claims for breach of contract, breach of the implied covenant of good faith and fair dealing, and fraud. The doctors' claims relate to two patents for a non-FDA approved drug (NP-2) and EpiCept's failure to develop those patents into FDA-approved drugs. The doctors' arguments mainly center on the jury's determination that the doctors materially breached their contract with EpiCept by failing to disclose that Dr. Flores treated burn patients with NP-2. The panel held that the district court did not abuse its discretion in formulating the jury instructions, or in determining that the jury's verdict was not against the clear weight of the evidence; neither the jury instructions given in this case nor the evidence presented at trial warrant the do-over the doctors demanded; the district court's response to the jury's question also did not merit a new trial because the jury's question was essentially factual and the district court's answer appropriately directed the jury to consider its original instructions and the evidence presented at trial; and because the panel affirmed the jury's finding that the doctors materially breached the contract, the district court's exclusion of the doctor's damages expert was necessarily harmless. View "Crowley v. EpiCept Corp." on Justia Law

Testosterone replacement drugs have been FDA-approved prescription drugs for more than 60 years. In recent years, manufacturers have found a new market: older men. Numerous lawsuits were filed against manufacturers alleging that the drugs increase health risks. Cases alleging that the manufacturers failed to warn doctors and patients adequately about the risks, citing state product-liability laws, were consolidated for pretrial proceedings. The district court granted a motion to dismiss brought by Depo-T’s manufacturer, finding the failure-to-warn claims preempted by federal law. The court stated that DepoT’s manufacturers could not change their drug labels to add warnings because FDA regulations prohibit them from “making a unilateral labeling change.” The Seventh Circuit affirmed. In Wyeth v. Levine, the Supreme Court held that claims against a manufacturer of a brand-name prescription drug for failure to warn adequately of the drug’s dangers were not preempted by federal law.; in PLIVA v. Mensing, the Court held that such failure-to-warn claims against manufacturers of generic drugs are preempted. The Court cited the different regulatory requirements and processes for approving and labeling prescription drugs. Depo-T “does not fit neatly into the colloquial dichotomy between brand-name and generic drugs” so the Seventh Circuit focused on whether the FDA approved public sale of its drugs through the “new drug application” or through the “abbreviated new drug application” (ANDA) and stated that the FDA-approved label defines an ANDA holder’s duty of sameness and the lines of federal preemption. View "Guilbeau v. Pfizer Inc." on Justia Law

A jury found William Scully guilty of mail and wire fraud and conspiracy to commit mail and wire fraud, conspiracy to defraud the United States through the introduction of misbranded drugs into interstate commerce, introduction of misbranded drugs into interstate commerce, receipt of misbranded drugs into interstate commerce and delivery thereof for pay, introduction of unapproved drugs into interstate commerce, and unlicensed wholesale distribution of prescription drugs. He was sentenced principally to 60 months in prison. The main issue on appeal was whether the district court properly excluded evidence relating to Scully’s advice-of-counsel defense. Because the Second Circuit found that the evidence was admissible and its exclusion was not harmless error, it vacated the district court’s judgment and remanded for further proceedings. View "United States v. Scully" on Justia Law

The Biologics Price Competition and Innovation Act, 42 U.S.C. 262, establishes a scheme for adjudicating claims of patent infringement in the FDA's approval of “biological products.” To obtain FDA approval, the sponsor of a new biological product must demonstrate that it is “safe, pure, and potent.” For a “biosimilar” product based on an approved “reference” product, a party may submit an abbreviated “subsection (k)” application that “piggybacks” on the showing made for an approved reference product but must provide the reference product's sponsor with its subsection (k) application and information that describes the manufacturing process. The parties then collaborate to identify patents for immediate litigation. The second phase is triggered by the applicant’s notice of commercial marketing and involves any patents that were included on the lists but not previously litigated. Hospira's subsection (k) application sought approval of a biosimilar of EPOGEN®, Amgen’s FDA-approved product, Although Amgen asserted that Hospira failed to disclose the composition of the cell-culture medium used during manufacturing, the parties began identifying patents. Amgen claimed that it could not assess the reasonableness of asserting infringement claims concerning other patents for culturing cells and moved to compel discovery on the composition of Hospira’s cell-culture medium in its suit on listed patents. The court denied Amgen’s motion, stating that the information had no relevance to the asserted patents. Amgen appealed that interlocutory order. The Federal Circuit dismissed, holding that it lacked jurisdiction under the collateral order doctrine and that Amgen failed to satisfy the prerequisites for mandamus. View "Amgen, Inc.. v. Hospira, Inc.." on Justia Law

The State of New Hampshire moved to enforce administrative subpoenas served on defendants Actavis Pharma, Inc., Endo Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Purdue Pharma L.P., and Teva Pharmaceuticals USA, Inc. The State was investigating defendants’ role in allegedly causing health care providers to prescribe opioids to treat chronic pain. Defendants resisted, arguing the Office of the Attorney General’s (OAG) engagement of outside counsel was unlawful. In addition, defendants moved for a protective order, seeking to “bar the Attorney General from engaging contingent fee counsel to: (a) participate in or assume responsibility for any aspect of the State’s investigation of alleged violations of the Consumer Protection Act . . . ; or (b) participate in or assume responsibility for any subsequent enforcement action pertaining to alleged CPA violations.” Defendants argued that the OAG’s fee agreements with the firm Cohen Milstein: (1) violated RSA 21-G:22 and :23 (2012) (amended 2016); (2) violated New Hampshire common law; (3) were ultra vires because the OAG did not comply with RSA 7:12 (2013) (amended 2016) or :6-f (Supp. 2016); (4) violated the doctrine of separation of powers; (5) violated the New Hampshire Rules of Professional Conduct; and (6) violated due process under the New Hampshire and United States Constitutions. The State replied that an objection to the Attorney General’s use of outside counsel was not appropriate justification for refusing to comply with lawful subpoenas, and that defendants lacked standing to raise that complaint. The trial court denied the State’s motion to enforce the subpoenas and granted the defendants’ motion for a protective order “to the extent that the OAG and Cohen Milstein’s contingency fee agreement is invalid.” The trial court determined that the defendants had demonstrated standing to bring their claims, that the fee agreement was void, and therefore denied the State’s motion to enforce the subpoenas on that basis. The New Hampshire Supreme Court concluded defendants lacked standing to challenge the outside counsel agreement. It reversed and remanded the matter for further proceedings. View "New Hampshire v. Actavis Pharma, Inc." on Justia Law

The Supreme Court's opinion in CRST Van Expedited Inc. v. E.E.O.C., 136 S. Ct. 1642, 1646 (2016), effectively overruled Branson v Nott's holding that when a defendant wins because the action is dismissed for lack of subject matter jurisdiction he is never a prevailing party. In this case, Amphastar filed a qui tam action against Aventis under the False Claims Act (FCA), 31 U.S.C 3730, alleging that Aventis obtained an illegal monopoly over the drug enoxaparin and then knowingly overcharged the United States. The district court dismissed the suit based on lack of subject matter jurisdiction. The Ninth Circuit held that Amphastar's allegations were based on publicly disclosed information, and it lacked the direct and independent knowledge needed to be an original source. Therefore, the panel upheld the district court's judgment on the merits. However, the panel held that the district court erroneously concluded that it could not award attorneys' fees, because the FCA's fee-shifting provision contained an independent grant of subject matter jurisdiction and because a party who wins a lawsuit on a non-merits issue is a "prevailing party." The panel remanded for resolution of the attorneys' fees issue. View "Amphastar Pharmaceuticals v. Aventis Pharma" on Justia Law