Justia Drugs & Biotech Opinion Summaries

Accutane was a prescription medication developed by defendants and approved by the FDA to treat recalcitrant nodular acne. Accutane’s alleged role as a cause of gastrointestinal disease ultimately resulted in a series of lawsuits against defendants. The case before the New Jersey Supreme Court here involved over two thousand plaintiffs who alleged they developed Crohn’s disease as a result of taking Accutane. In the years since many earlier Accutane cases were decided, epidemiological studies were published, all of which concluded that Accutane was not causally associated with the development of Crohn’s disease. Defendants filed a motion seeking a hearing on the association between Accutane and Crohn’s disease. The issue presented for the New Jersey Supreme Court’s consideration reduced to the admissibility of scientific evidence under the New Jersey Rules of Evidence. Plaintiffs claimed that a causal connection existed between Accutane and Crohn’s disease. The Supreme Court discerned little distinction between “Daubert’s” principles regarding expert testimony and New Jersey’s, and Daubert’s factors for assessing the reliability of expert testimony “will aid New Jersey trial courts in their role as the gatekeeper of scientific expert testimony in civil cases.” The Court reconciled the standard under N.J.R.E. 702, and relatedly N.J.R.E. 703, with the federal Daubert standard to incorporate its factors for civil cases. Here, the trial court properly excluded plaintiffs’ experts’ testimony. Moreover, the Court reaffirmed that the abuse of discretion standard must be applied by an appellate court assessing whether a trial court has properly admitted or excluded expert scientific testimony in a civil case. In this matter, the trial court did not abuse its discretion in its evidential ruling and, therefore, the Appellate Division erred in reversing the trial court’s exclusion of the testimony of plaintiffs’ experts. View "In re: Accutane Litigation" on Justia Law

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

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

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 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

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