Justia Drugs & Biotech Opinion Summaries

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This case deals with the importation of two transcatheter heart valve systems by Meril Life Sciences Pvt. Ltd. and Meril, Inc. (collectively, "Meril") into the United States for a medical conference in San Francisco. The plaintiff, Edwards Lifesciences Corporation and Edwards Lifesciences LLC (collectively, "Edwards"), a competitor medical device company, alleged that this act constituted patent infringement. Meril argued that the importation was covered by the "safe harbor" provision of 35 U.S.C. § 271(e)(1), which exempts certain activities from being considered patent infringement if they are reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.The district court granted summary judgment in favor of Meril, and Edwards appealed to the United States Court of Appeals for the Federal Circuit. The Court of Appeals affirmed the decision of the district court, noting that the undisputed evidence showed that the importation of the valve systems was reasonably related to submitting information to the United States Food and Drug Administration. The court rejected Edwards' arguments that the district court had disregarded contemporaneous evidence, applied the safe harbor with an objective standard, and relied improperly on declarations from Meril employees. The court affirmed the district court's conclusion that there was no genuine dispute of material fact and that Meril was entitled to judgment as a matter of law. View "EDWARDS LIFESCIENCES CORPORATION v. MERIL LIFE SCIENCES PVT. LTD. " on Justia Law

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This case was before the United States Court of Appeals for the Fourth Circuit where the City of Huntington and Cabell County Commission (plaintiffs) brought a suit against AmerisourceBergen Drug Corporation, Cardinal Health, Inc., and McKesson Corporation (defendants), three distributors of opioids. The plaintiffs alleged that these companies perpetuated the opioid epidemic by repeatedly shipping excessive quantities of opioids to pharmacies, thus creating a public nuisance under West Virginia common law. The district court ruled in favor of the distributors, holding that West Virginia’s common law of public nuisance did not cover the plaintiffs’ claims.After a bench trial in 2021, the district court held that the common law of public nuisance in West Virginia did not extend to the sale, distribution, and manufacture of opioids. The court found that the application of public nuisance law to the sale, marketing, and distribution of products would invite litigation against any product with a known risk of harm, regardless of the benefits conferred on the public from proper use of the product. The court also rejected the plaintiffs’ proposed remedy, a 15-year “Abatement Plan” developed by an expert in opioid abatement intervention. The court held that this relief did not qualify as an abatement as it did not restrict the defendants' conduct or their distribution of opioids but generally proposed programs and services to address the harms caused by opioid abuse and addiction.The plaintiffs appealed the decision to the United States Court of Appeals for the Fourth Circuit, which certified the following question to the Supreme Court of Appeals of West Virginia: Under West Virginia’s common law, can conditions caused by the distribution of a controlled substance constitute a public nuisance and, if so, what are the elements of such a public nuisance claim? View "City of Huntington v. Amerisourcebergen Drug Corporation" on Justia Law

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In this case, the United States Court of Appeals for the Tenth Circuit dealt with the appeal of Youlian Zhong, who contested her mandatory minimum sentences for crimes related to her participation in a conspiracy to manufacture and distribute large quantities of marijuana. Zhong argued that the district court erred in finding that she did not qualify for the statutory safety valve for mandatory minimum sentences.Zhong and her husband, Housheng Xian, were found guilty of conspiring to grow more than 1,500 marijuana plants in their residence, intending to process and sell the marijuana. They were convicted on three counts: conspiring to manufacture and possess with the intent to distribute 1,000 and more marijuana plants, manufacturing and possessing with intent to distribute 1,000 or more marijuana plants, and using and maintaining their house for the purpose of manufacturing and distributing marijuana.Before sentencing, Zhong and Xian requested a non-guideline sentence of time served plus five years of supervised release, arguing that they met the requirements of the safety valve provisions. However, the court found that they did not provide all necessary information to the government, particularly regarding their mens rea, or intent, for the crimes for which they were convicted.On appeal, the Tenth Circuit affirmed the lower court's decision. The appeals court held that a defendant must provide the government with information sufficient to prove the mens rea required for the crimes of conviction to meet the requirement of providing “all information and evidence” concerning the offense for the safety valve provision to apply. The court concluded that Zhong did not provide sufficient information about her intent to commit the crimes for which she was convicted, and thus, did not meet her burden to prove that she qualified for safety-valve relief. View "United States v. Zhong" on Justia Law

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The United States Court of Appeals for the Second Circuit heard a case initiated by Adam Hart, who filed a qui tam action under the False Claims Act (FCA) against pharmaceutical distributor McKesson. Hart alleged that McKesson provided business management tools to its customers for free in exchange for commitments to purchase drugs, which he claimed violated the federal anti-kickback statute (AKS) and several analogous state laws. The district court dismissed Hart's FCA claim, determining he failed to allege McKesson acted "willfully" as required by the AKS.On appeal, the Second Circuit held that to act "willfully" under the AKS, a defendant must knowingly act in a way that is unlawful. The court found that Hart failed to provide sufficient facts to meet this standard. However, the court disagreed with the district court's assertion that Hart's state claims were premised solely on a violation of the federal AKS. Consequently, the Second Circuit affirmed the dismissal of Hart’s federal FCA claim, vacated the dismissal of the remaining state claims, and remanded for further proceedings. View "United States, ex rel. Hart v. McKesson Corp." on Justia Law

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The case involves Andre Dubois, who was convicted on several federal firearm offenses. These offenses arose when Dubois attempted to ship a box containing firearms from Georgia to Dominica. The United States Court of Appeals for the Eleventh Circuit was asked to address five issues on appeal.Firstly, the court dismissed Dubois's argument that a recent Supreme Court case overturned the precedent upholding a ban on felons possessing firearms. The court held that the Supreme Court case did not abrogate the precedent, and therefore Dubois's argument failed.Secondly, the court affirmed that there was sufficient evidence for a reasonable jury to find that Dubois knew he was in possession of a firearm.Thirdly, the court found that Dubois's prior conviction for possession with intent to distribute marijuana under Georgia law qualified as a "controlled substance offense" under the federal Sentencing Guidelines, triggering a higher base offense level.Fourthly, the court rejected Dubois's argument that the application of a sentencing enhancement for possession of a stolen gun violated his due process rights.Finally, the court held that the district court had not erred in imposing a $25,000 fine on Dubois, as there was sufficient evidence to suggest that he could afford to pay the fine.Therefore, Dubois's convictions and sentence were affirmed. View "USA v. Dubois" on Justia Law

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A group of individuals filed a lawsuit against Genzyme Corporation, a drug manufacturer, for injuries allegedly caused by the company's mishandling of a prescription drug shortage between 2009 and 2012. The lawsuit was filed several years after the events in question occurred and would typically have been considered too late under the applicable statutory limitations periods. However, the plaintiffs argued that previous class actions, a savings statute, and a tolling agreement between the parties allowed the lawsuit to proceed. The district court partially agreed and rejected Genzyme's argument that the delay in filing required dismissal of the lawsuit. However, it dismissed the claims of all but four plaintiffs for lack of standing, and dismissed the remaining claims on the merits.On appeal, the United States Court of Appeals for the First Circuit found that all plaintiffs have standing and the court has jurisdiction to proceed with the case, at least with respect to the plaintiffs' individual claims. However, it concluded that four plaintiffs waited too long before filing this lawsuit, and their claims are time-barred. For the remaining plaintiffs, the court vacated the judgment dismissing their claims and remanded the case to the district court for further proceedings. View "Wilkins v. Genzyme Corporation" on Justia Law

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The case concerns an appeal by Andrew Ocanas Garza against his conviction and a 235-month sentence for drug trafficking and firearm possession. Garza argued that the court incorrectly used his 2016 felony drug offenses for sentencing enhancement, contending that the 2018 amendment to the Agricultural Improvement Act altered marijuana’s definition, potentially excluding the substance he was previously convicted for trafficking. He also claimed that the court erred by not suppressing an unMirandized statement he made about having a gun in his bedroom during the execution of a search warrant.The United States Court of Appeals for the Fifth Circuit affirmed the District Court's ruling. The Appeals Court held that Garza waived his right to challenge the admission of the Bedroom Gun statement by bringing it up during the trial. The Court also rejected Garza's argument concerning the sentencing enhancement based on his 2016 drug convictions. The Court applied the "backward-looking" test, which determines whether the prior convictions were felonies at the time of conviction and were final at the time of sentencing for the current crimes. The Court found that Garza's 2016 convictions met these criteria, making them applicable for sentencing enhancement. The Court also noted that even if the District Court had erred in applying the sentencing enhancement, the error was harmless, as the same sentence would have been imposed. View "United States v. Garza" on Justia Law

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In a multi-district litigation involving diabetes drug saxagliptin, the plaintiffs claimed that the drug caused their heart failure. They presented a single expert to show the drug could cause heart failure. After a Daubert hearing and expert motions, the United States Court of Appeals for the Sixth Circuit found that the expert's testimony was unreliable due to methodological flaws and therefore excluded it. Subsequently, the district court granted summary judgment for the defendants, rejecting the plaintiffs' claim that other evidence created a genuine issue of material fact. The court also refused the plaintiffs' request for ninety days to find a replacement expert. On appeal, the plaintiffs challenged the district court's exclusion of their expert, its grant of summary judgment, and its refusal to give them more time to find another expert witness. The Court of Appeals affirmed the district court's decisions, stating that the plaintiffs' claims lacked merit. The court found that the expert's reliance on one study to the exclusion of all others was unreliable, that his use of animal data was unreliable due to his admitted lack of qualifications to analyze such studies, and that he did not reliably apply the Bradford Hill criteria - a scientific framework used to analyze whether an association between two variables is causal. The court also found that all jurisdictions require expert testimony to show general causation in complex medical cases such as this one. As the plaintiffs failed to identify a reliable general causation expert, the court granted summary judgment for the defendants. The court also found no good cause to grant the plaintiffs more time to find a replacement expert. View "In re Onglyza (Saxagliptin) and Kombiglyze (Saxagliptin and Metformin) Products Liability Litigation" on Justia Law

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In the case before the United States Court of Appeals For the Eighth Circuit, the defendant, Kaycee Heard, appealed his 180-month sentence for involvement in a drug-trafficking conspiracy that transported oxycodone and fentanyl pills from Michigan to North Dakota for distribution. Heard pleaded guilty to conspiring to distribute and possess with intent to distribute controlled substances, and his sentence exceeded his Guidelines range of 135 to 168 months. Heard's appeal centered around three key claims: the district court miscalculated his criminal history score, wrongly applied a Guidelines enhancement for his role in the conspiracy, and issued an unreasonable sentence.The Court of Appeals rejected all three of Heard's claims. First, the court found that the district court was correct to assess a criminal history point for a two-year probation term Heard served under Michigan’s Holmes Youthful Trainee Act. Despite Heard's argument that this sentence should not have counted towards his criminal history score as no conviction was entered and the underlying charges were dismissed, the Appeals Court ruled that Heard's admission of guilt by pleading guilty meant the probation term was correctly counted as a "prior sentence".Second, the Appeals Court upheld the district court's application of a three-level enhancement for Heard's role in the conspiracy, finding that Heard had exhibited sufficient managerial or supervisory authority to warrant this enhancement. The court pointed to evidence that Heard had recruited co-conspirators, used a co-conspirator’s apartment as a stash house, directed a co-conspirator to travel to get pills for distribution, and received proceeds from the pills’ sale.Finally, the court found Heard's sentence to be both procedurally and substantively reasonable. The district court had varied up from the Guidelines range based on Heard's conduct in pretrial detention, including his participation in a prison riot and assaults on two inmates. The Appeals Court found no clear error in the district court's determination that Heard had participated in the riot, and concluded that the 180-month sentence was within the realm of reasonableness given Heard's drug trafficking and pretrial detention misconduct. The court also rejected Heard's claim that his sentence created unwarranted disparities with his co-conspirators, stating that the need to avoid unwarranted sentence disparities refers to national disparities, not differences among co-conspirators. The court therefore affirmed the district court’s judgment. View "United States v. Heard" on Justia Law

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In the case before the Court of Appeal of the State of California First Appellate District Division Four, the plaintiffs, thousands of individuals who suffered adverse effects from the use of a prescription drug, TDF, made by Gilead Life Sciences, Inc., brought a claim of negligence and fraudulent concealment against Gilead. The plaintiffs alleged that while Gilead was developing TDF, it discovered a similar, but chemically distinct and safer potential drug, TAF. However, Gilead allegedly decided to defer development of TAF because it was concerned that the immediate development of TAF would reduce its financial return from TDF. Gilead sought summary judgment on the ground that in order to recover for harm caused by a manufactured product, the plaintiff must prove that the product was defective. The trial court denied Gilead's motion for summary judgment in its entirety.In reviewing this case, the appellate court held that the trial court was correct to deny Gilead's motion for summary judgment on the negligence claim. The court reasoned that a manufacturer's duty of reasonable care can extend beyond the duty not to market a defective product. The court found that the factual basis of the plaintiffs' claim was that Gilead knew TAF was safer than TDF, but decided to defer development of TAF to maximize its profits. The court held that if Gilead's decision to postpone development of TAF indeed breached its duty of reasonable care to users of TDF, then Gilead could potentially be held liable.However, the appellate court reversed the trial court's decision regarding plaintiffs' claim for fraudulent concealment. The court concluded that Gilead's duty to plaintiffs did not extend to the disclosure of information about TAF, as it was not available as an alternative treatment for HIV/AIDS at the time the alleged concealment occurred. Consequently, the court granted in part and denied in part Gilead's petition for a writ of mandate, directing the superior court to vacate its order denying Gilead's motion for summary judgment and to enter a new order denying summary adjudication of the negligence claim but granting summary adjudication of the fraudulent concealment claim. View "Gilead Tenofovir Cases" on Justia Law