Justia Drugs & Biotech Opinion Summaries

The case involves doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF) by removing fat tissue from patients, processing it to concentrate stem cells, and then re-administering it to the same patients. The FDA inspected the clinics and found that the doctors were manufacturing and administering unapproved drug products, leading to a lawsuit alleging violations of the Food, Drug, and Cosmetic Act (FDCA).The United States District Court for the Central District of California held a bench trial and ruled in favor of the defendants. The court concluded that the SVF was not a "drug" under the FDCA and that the same-day SVF treatment fell under the "same surgical procedure" (SSP) exception, which exempts certain procedures from FDA regulation. The district court found that the cells in the same-day SVF were not altered chemically or biologically and that the procedure did not introduce any foreign material into the body.The United States Court of Appeals for the Ninth Circuit reviewed the case and reversed the district court's judgment. The appellate court held that the SVF constitutes a "drug" under the FDCA based on the plain text of the statute, which defines drugs as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body. The court also rejected the defendants' argument that their same-day SVF treatment was exempt from FDA regulation under the SSP exception. The court concluded that the SSP exception applies only if the removed and implanted human cells, tissues, and cellular and tissue-based products (HCT/Ps) are the same, and in this case, the removed fat tissue and the implanted SVF are not the same.The Ninth Circuit reversed the district court's judgment and remanded the case for further proceedings. View "USA V. CALIFORNIA STEM CELL TREATMENT CENTER, INC." on Justia Law

The case involves hundreds of plaintiffs who allege that they were injured by the drug Fosamax, manufactured by Merck Sharp & Dohme Corp. (Merck), due to inadequate warnings about the risk of atypical femoral fractures. The plaintiffs claim that they would not have taken the drug if they had been properly warned. Merck contends that it proposed a label change to the Food and Drug Administration (FDA) to address this risk, but the FDA rejected the proposed change due to insufficient scientific support.The United States District Court for the District of New Jersey granted summary judgment in favor of Merck, concluding that the plaintiffs' state law claims were preempted by federal law. The court found that Merck had fully informed the FDA of the justifications for the proposed warning and that the FDA had rejected the proposed label change, thus preempting the state law claims. The court relied on the FDA's Complete Response Letter and other communications to determine that the FDA's rejection was based on a lack of sufficient scientific evidence linking Fosamax to atypical femoral fractures.The United States Court of Appeals for the Third Circuit reviewed the case and vacated the District Court's judgment. The Third Circuit concluded that the District Court erred in its preemption analysis by giving too little weight to the presumption against preemption. The appellate court found that the FDA's Complete Response Letter was ambiguous and that the District Court placed too much reliance on informal FDA communications and an amicus brief to interpret the letter. The Third Circuit emphasized that the presumption against preemption is strong and that Merck did not meet the demanding standard of showing that federal law prohibited it from adding any and all warnings that would satisfy state law. The case was remanded for further proceedings. View "In re: Fosamax" on Justia Law

Marcus Millsap was convicted by a jury of conspiracy to violate the Racketeer Influenced and Corrupt Organizations Act (RICO), aiding and abetting attempted murder in aid of racketeering, and conspiracy to distribute and possess with intent to distribute 500 grams or more of methamphetamine. Millsap was involved with the New Aryan Empire, a white-supremacist organization engaged in drug trafficking. He assisted the organization's president, Wesley Gullett, in drug operations and attempted to retaliate against Bruce Hurley, a police informant, by offering money to have him killed. Gullett attempted to kill Hurley but failed, and Hurley was later murdered by an unknown perpetrator.The United States District Court for the Eastern District of Arkansas sentenced Millsap to life imprisonment. Millsap appealed, arguing that his indictment should have been dismissed due to a violation of the Interstate Agreement on Detainers Act, and that the district court made several errors regarding evidentiary issues and juror intimidation. He also challenged his sentence if the convictions were upheld.The United States Court of Appeals for the Eighth Circuit reviewed the case. The court found that the Interstate Agreement on Detainers Act did not apply because Millsap was transferred to federal custody via a writ of habeas corpus ad prosequendum before a detainer was lodged. The court also held that there was no sufficient showing of juror intimidation to justify a mistrial. The court found the evidence sufficient to support Millsap's convictions on all counts, including his association with the drug-trafficking enterprise and his involvement in the attempted murder of Hurley.The court also ruled that the district court did not err in admitting co-conspirator statements and other evidence, and that any potential errors were harmless. The court upheld the district court's application of sentencing enhancements and the calculation of Millsap's criminal history points. Consequently, the Eighth Circuit affirmed the judgment of the district court. View "United States v. Millsap" on Justia Law

The case involves Juan Rodriguez and Junito Melendez, who were convicted of conspiracy to distribute and possess with intent to distribute more than 500 grams of cocaine. Melendez was identified as the front man of the operation, interacting with customers and suppliers, while Rodriguez managed backend operations from his residence. The operation involved acquiring cocaine from suppliers, cooking some into crack cocaine, and selling it. The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) began investigating the defendants in 2018, leading to the seizure of Melendez's iPhone and subsequent wiretaps that provided evidence of their drug activities.In the United States District Court for the District of Massachusetts, a jury found both defendants guilty of the conspiracy charges. Melendez was also found guilty of distributing 500 grams or more of cocaine and had a prior conviction for a serious drug felony. He pleaded guilty to conspiracy to commit Hobbs Act robbery. The district court sentenced Rodriguez to 52 months and Melendez to 156 months in prison. Melendez's sentence included enhancements for drug quantity and his role as an organizer or leader in the conspiracy.The United States Court of Appeals for the First Circuit reviewed the case. The court affirmed the district court's decisions, finding no error in the denial of motions to suppress evidence from Melendez's iPhone and wiretaps, the admission of certain evidentiary testimony, and the jury instructions. The court also upheld the sentencing enhancements for Melendez, concluding that the evidence supported the drug quantity attributed to him and his role as an organizer in the conspiracy. The court found that any potential errors were harmless and did not affect the overall outcome of the case. View "United States v. Rodriguez" on Justia Law

Manish Kumar was involved in a scheme to smuggle misbranded prescription drugs and controlled substances into the United States from March 2015 to August 2019. Kumar, an Indian national, was a partner in Mihu, a New Delhi-based company that sold generic versions of drugs like Viagra, Cialis, Adderall, and tramadol without FDA approval or proper prescriptions. Kumar managed call centers in India where representatives made false statements to U.S. customers, claiming the drugs were FDA-approved and that no prescriptions were needed. Kumar was arrested in August 2019 on unrelated identity theft charges and later charged in Massachusetts with conspiracy to smuggle drugs, distribute controlled substances, and make false statements. He pled guilty to all charges in October 2022.The United States District Court for the District of Massachusetts sentenced Kumar to 87 months in prison. The court applied a fraud cross-reference in the Sentencing Guidelines and accepted the government's estimate of the loss amount involved in the offense, which was approximately $3.8 million. Kumar objected to both the application of the fraud cross-reference and the loss amount calculation, arguing that the evidence was insufficient.The United States Court of Appeals for the First Circuit reviewed the case. The court held that the fraud cross-reference was correctly applied because the false statements made by call center representatives were within the scope of Kumar's conspiracy and were made in furtherance of the criminal activity. The court also found that the sentencing court did not clearly err in its loss amount calculation, as it relied on detailed government estimates and supporting data. The First Circuit affirmed Kumar's 87-month sentence. View "United States v. Kumar" on Justia Law

The case involves BioPoint, Inc., a life sciences consulting firm, which accused Catapult Staffing, LLC, and Andrew Dickhaut of misappropriating trade secrets, confidential business information, and engaging in unfair trade practices. BioPoint alleged that Catapult, with the help of Dickhaut and Leah Attis (a former BioPoint employee and Dickhaut's fiancée), used BioPoint's proprietary information to recruit candidates and secure business from BioPoint's clients, including Vedanta and Shire/Takeda.The U.S. District Court for the District of Massachusetts handled the initial proceedings. The jury found Catapult liable for misappropriating BioPoint's trade secrets concerning three candidates and two clients, and for tortious interference with BioPoint's business relationship with one candidate. The jury awarded BioPoint $312,000 in lost profits. The judge, in a subsequent bench trial, found Catapult liable for unjust enrichment and violations of the Massachusetts Consumer Protection Law (chapter 93A), awarding BioPoint $5,061,444 in damages, which included treble damages for willful and knowing conduct, as well as costs and attorneys' fees.The United States Court of Appeals for the First Circuit reviewed the case. The court largely affirmed the lower court's findings but reduced the judge's award by $157,068, as it found that BioPoint could not recover both lost profits and unjust enrichment for the same placement. The court also reversed the district court's imposition of joint-and-several liability on Andrew Dickhaut, ruling that he could not be held liable for profits he did not receive. The case was remanded for further proceedings to determine Dickhaut's individual liability. View "BioPoint, Inc. v. Dickhaut" on Justia Law

Law enforcement executed a search warrant at Ryan Dewayne Myrick’s apartment, discovering 69.01 grams of methamphetamine, drug packaging, a digital scale, and other paraphernalia. In his vehicle, they found additional drug packaging. Myrick was charged with conspiracy to distribute methamphetamine and possession with intent to distribute. He pleaded guilty to the latter charge, admitting to possessing 69.01 grams of methamphetamine, with the intent to distribute at least 50 grams. The government agreed to dismiss the conspiracy charge and recommend a reduction for acceptance of responsibility, contingent on Myrick’s continued demonstration of acceptance.The United States District Court for the Southern District of Iowa reviewed the case. The Presentence Investigation Report (PSR) recommended holding Myrick responsible for 4.5 kilograms or more of methamphetamine, resulting in a base offense level of 38. It also suggested a two-level enhancement for maintaining a premises for drug distribution and a three-level reduction for acceptance of responsibility. Myrick objected to the drug quantity and the premises enhancement, while the government objected to the reduction for acceptance of responsibility. The district court overruled Myrick’s objections and sustained the government’s, resulting in a total offense level of 40 and an advisory Guidelines range of 360 months to life. Myrick was sentenced to 300 months of imprisonment and 5 years of supervised release.The United States Court of Appeals for the Eighth Circuit reviewed the case. Myrick challenged the district court’s drug quantity determination, the premises enhancement, and the denial of a reduction for acceptance of responsibility. The appellate court found no clear error in the district court’s findings, including the credibility of witness testimony and the application of relevant conduct principles. The court affirmed the district court’s judgment, upholding Myrick’s sentence. View "United States v. Myrick" on Justia Law

The case involves Jamie Christopher Henderson, who was convicted and sentenced following a jury trial for conspiracy to distribute cocaine and cocaine base, possession with intent to distribute cocaine base, and possession of firearms in furtherance of his drug trafficking crimes. Henderson appealed his convictions and sentence, arguing that the evidence was insufficient to support these convictions, and that his sentence is procedurally and substantively unreasonable.The case originated from an incident on April 30, 2019, when law enforcement officers executed a search warrant at Henderson’s residence. They witnessed Henderson toss items underneath a vehicle, including a gun. The officers recovered a loaded handgun, a plastic bag with cocaine and crack cocaine, a cigarette lighter, and a glass crack pipe from underneath the vehicle. Henderson was arrested. Inside the trailer, police found a loaded rifle, a loaded handgun, cocaine powder and crack cocaine in a toilet tank, and a second loaded handgun in a kitchen trash can. They also seized three digital scales and a digital video recorder containing footage from security cameras showing Henderson and other men, armed with multiple handguns and a rifle, standing in the front yard of the residence as cars and people would approach it.Henderson was charged with conspiracy to distribute cocaine and cocaine base, possession of a firearm in furtherance of the drug-distribution conspiracy, possession with intent to distribute cocaine and cocaine base, possession of a firearm in furtherance of the possession-with-intent offense, and possession of a firearm as a felon. He pleaded not guilty. At trial, the Government presented the testimony of the law enforcement officers, Henderson’s videotaped confession, the security footage from the trailer, and a letter Henderson had written to his brother. Henderson presented the testimony of his mother and daughter who claimed that Henderson was a drug user, thief, and liar—but not a drug dealer. The jury convicted Henderson on all counts.The United States Court of Appeals for the Fourth Circuit affirmed the convictions and sentence. The court found that there was substantial evidence to support the conviction and that the sentence was not procedurally or substantively unreasonable. The court noted that Henderson faced a heavy burden in challenging the sufficiency of the evidence and that the court's role was limited to considering whether there was substantial evidence to support the conviction. The court found that there was abundant independent evidence that Henderson was engaged in a large-scale drug trade, which supported the trustworthiness of his confessions. The court also found that the district court did not err in calculating the quantity of drugs attributable to Henderson for sentencing purposes. The court concluded that Henderson's sentence was substantively reasonable and that he failed to overcome the presumption of reasonableness that applies to a below-Guidelines sentence. View "United States v. Henderson" on Justia Law

A nurse practitioner, Lisa Hofschulz, and her ex-husband, Robert Hofschulz, were convicted of conspiracy and multiple counts of distributing drugs in an unauthorized manner, including one count resulting in a patient's death. The charges stemmed from their operation of a "pain clinic" that functioned as a front for an opioid mill, dispensing opioid prescriptions for cash-only payments. Robert Hofschulz was also convicted for his role in assisting Lisa Hofschulz in running the opioid mill.The Hofschulzes were initially tried in the United States District Court for the Eastern District of Wisconsin. They were found guilty on all counts, with Lisa Hofschulz receiving a minimum 20-year prison term for the count of unlawful distribution resulting in death, and Robert Hofschulz receiving concurrent terms of 36 months in prison on each of his five convictions. The Hofschulzes appealed their convictions on three grounds: they claimed the jury instructions were inconsistent with a Supreme Court decision, that the judge wrongly permitted the government’s medical expert to testify about the standard of care, and that the evidence was insufficient to support their convictions.The case was then reviewed by the United States Court of Appeals for the Seventh Circuit. The court found no instructional error, stating that the district judge had correctly instructed the jury that the government must prove beyond a reasonable doubt that the Hofschulzes intended to distribute controlled substances and intended to do so in an unauthorized manner. The court also found that the judge had correctly permitted the government’s medical expert to testify about the standard of care in the usual course of professional pain management. Lastly, the court dismissed the Hofschulzes' challenge to the sufficiency of the evidence, deeming it frivolous. The court affirmed the convictions of the Hofschulzes. View "United States v. Hofschulz" on Justia Law

The case involves Amarin Pharma, Inc., Amarin Pharmaceuticals Ireland Limited, and Mochida Pharmaceutical Co., Ltd. (collectively, “Amarin”) and Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC (collectively, “Hikma”). Amarin markets and sells icosapent ethyl, an ethyl ester of an omega-3 fatty acid commonly found in fish oils, under the brand name Vascepa®. In 2012, the U.S. Food and Drug Administration (“FDA”) approved Vascepa for the treatment of severe hypertriglyceridemia. In 2019, following additional research and clinical trials, the FDA approved Vascepa for a second use: as a treatment to reduce cardiovascular risk in patients having blood triglyceride levels of at least 150 mg/dL.In the United States District Court for the District of Delaware, Hikma moved to dismiss Amarin’s complaint for failure to state a claim. The court granted Hikma’s motion, concluding that Amarin’s allegations against Hikma did not plausibly state a claim for induced infringement.The United States Court of Appeals for the Federal Circuit reversed the decision of the district court. The court held that Amarin had plausibly pleaded that Hikma had induced infringement of the asserted patents. The court noted that the case was not a traditional Hatch-Waxman case or a section viii case, but rather a run-of-the-mill induced infringement case arising under 35 U.S.C. § 271(b). The court concluded that the totality of the allegations, taken as true, plausibly plead that Hikma “actively” induced healthcare providers’ direct infringement. View "AMARIN PHARMA, INC. v. HIKMA PHARMACEUTICALS USA INC. " on Justia Law