Justia Drugs & Biotech Opinion Summaries

The case involves Terrence Jordan and Damara Sanders, who were pulled over by a state trooper for speeding. During the stop, the trooper noticed inconsistencies in their travel plans and observed Jordan's heavy breathing, which raised his suspicion. He called for a canine unit, which detected the presence of drugs. A subsequent search of the vehicle and the defendants revealed marijuana, pill presses, digital scales, plastic baggies, firearms, and a significant quantity of pills containing a fluorofentanyl-fentanyl mixture.The defendants were charged with possessing a firearm as a felon, possessing a controlled substance with the intent to distribute, and possessing firearms in furtherance of drug trafficking. They sought to suppress the evidence obtained from the traffic stop, arguing that the trooper lacked reasonable suspicion to extend the stop. The District Judge denied the motion. The defendants also proposed a lesser-included-offense instruction for simple possession of a controlled substance, which the court rejected, citing the quantity of drugs and distribution paraphernalia as evidence of intent to distribute.The United States Court of Appeals for the Sixth Circuit affirmed in part, vacated in part, and remanded for further proceedings. The court held that the trooper had reasonable suspicion to extend the stop, based on the defendants' suspicious travel plans, Sanders's implausible explanations, and Jordan's heavy breathing. The court also agreed with the district court's decision not to give a lesser-included-offense instruction, given the substantial evidence of the defendants' intent to distribute drugs. However, the court vacated the defendants' convictions for possessing firearms in furtherance of drug trafficking due to an error in the jury instructions. The case was remanded for further proceedings consistent with the court's opinion. View "United States v. Jordan" on Justia Law

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

Lawsuits brought by governmental bodies and health clinics alleged that Quest, a wholesale pharmaceutical distributor, engaged in misconduct that contributed to a nationwide epidemic of opioid abuse. The plaintiffs plead violations of the RICO Act and state statutes, common law public nuisance, and negligence, seeking damages for “significant expenses for police, emergency, health, prosecution, corrections, rehabilitation, and other services.” Some complaints clarify that the claims “are not based upon or derivative of the rights of others” and that the plaintiffs “do not seek damages for death, physical injury to person, emotional distress, or physical damages to property[.]”Quest's insurance policies covered "damages because of 'bodily injury' or 'property damage'" and explain that “[d]amages because of ‘bodily injury’ include damages claimed by any person or organization for care, loss of services or death resulting at any time from the ‘bodily injury.’” “Bodily injury” is defined as “bodily injury, sickness or disease sustained by a person, including death resulting from any of these at any time.”The insurers sought declaratory judgments that they had no duty to defend or indemnify Quest. The district court granted the insurers summary judgment. The Sixth Circuit affirmed. Based on the plain language of the policies and their overall context and purpose, the court concluded that the Kentucky Supreme Court would find that the insurers have no duty to defend because the lawsuits do not seek damages “because of bodily injury” and claim only economic damages. View "Westfield National Insurance Co. v. Quest Pharmaceuticals, Inc." on Justia Law

Ethicon manufactures a mesh sling, used to treat stress urinary incontinence, and a posterior mesh “Prolift, “designed to treat pelvic organ prolapse. In 2009, Dr. Guiler surgically implanted both devices to treat Thacker. Before the surgery, Thacker reviewed and signed an informed consent form that listed several risks, including: “infections and/or erosions of the mesh” which could require additional follow-up surgeries, urinary retention, “[p]ainful intercourse and vaginal shortening,” and treatment failure. After the surgery, Thacker’s incontinence worsened, and she suffered from shooting pain in her groin area and severe abdominal swelling and bloating. In 2010, Thacker started experiencing severe and unbearable pain during intercourse.Thacker ultimately sued Ethicon, alleging strict liability and negligence claims under the Kentucky Product Liability Act for design defect and failure to warn. The district court granted Ethicon summary judgment. The Sixth Circuit reversed. Dr. Guiler’s testimony suggested that he likely would have recommended a different course of treatment had Ethicon given adequate information. Thacker’s expert testified that no reasonable physician would have used the Pelvic Mesh Devices to treat Thacker had Ethicon given adequate information in 2009. A jury could accept that expert’s opinion that a feasible alternative design would have prevented Thacker’s injuries. View "Thacker v. Ethicon, Inc." on Justia Law

The Food and Drug Administration denied Breeze’s Premarket Tobacco Product Applications for its electronic nicotine delivery systems (ENDS). Breeze sought a stay of the FDA’s order. Under the Family Smoking Prevention and Tobacco Control Act “any person adversely affected by” the denial of a Premarket Tobacco Product Application may seek judicial review of the denial, 21 U.S.C. 387l(a)(1)(B). Breeze argued that seeking a stay from the FDA would have been impracticable because the order takes effect immediately and the FDA can take months to consider an agency-level request for a stay.The Sixth Circuit denied the requested stay, finding that Breeze had not made a strong showing that it is likely to succeed on the merits.” Breeze has not made a strong showing that it would likely succeed on its claim that the FDA’s review of its application was arbitrary or capricious nor that the FDA’s denial of its application contradicted the FDA’s nonbinding 2019 guidance. That guidance contemplated more rigorous scientific data than contained in Breeze's application that its ENDS product adequately protected public health. The FDA cited well-developed evidence showing that flavored ENDS products’ special appeal to youths harms public health to a degree not outweighed by the (far-less-supported) effects of adult cigarette smokers switching to e-cigarettes. View "Breeze Smoke, LLC v. United States Food and Drug Administration" on Justia Law

A drug manufacturer cannot distribute a drug in interstate commerce without obtaining the FDA’s approval for the uses listed on the drug’s official label, 21 U.S.C. 355(a). The Act does not prohibit doctors from prescribing FDA-approved drugs for “off-label” use but leaves the regulation of doctors to the states. Hydroxychloroquine is approved to treat malaria, lupus, and arthritis but not to treat COVID-19. In 2020, the FDA relied on then-available data and issued an Emergency Use Authorization, permitting hydroxychloroquine in the federal government’s strategic stockpile to be distributed to treat COVID-19 patients in limited circumstances.The Association, a nonprofit organization with physician members, sued, challenging restrictions barring use of hydroxychloroquine to treat COVID-19 except for hospitalized patients. The Association alleged that these restrictions violated the implied equal-protection guarantee in the Fifth Amendment; violated the First Amendment right to associate by limiting access to medication useful for meeting in groups; and violated the Administrative Procedure Act. The Association alleged an injury to itself: it was considering canceling a conference purportedly due to the restrictions. It also invoked associational standing on behalf of its physician members who could not prescribe hydroxychloroquine for COVID-19.The district court held that none of these injuries plausibly pleaded the Association’s standing to challenge the Authorization. The court dismissed the complaint for lack of subject matter jurisdiction. The Sixth Circuit affirmed. The Associaiton failed to plausibly plead that any member has been injured by the FDA’s actions. View "Association of American Physicians & Surgeons v. United States Food & Drug Administration" on Justia Law

In 2003, Clabo underwent surgery to correct pelvic organ prolapse and urinary incontinence. Clabo’s doctor implanted her with a TVT transvaginal mesh sling device that the Defendants manufactured. By 2006, she began experiencing pelvic pain, urinary issues, scarring, and pain during sexual intercourse. After being notified by her doctor that the mesh from her device had eroded through her vaginal canal, Clabo had a procedure in April 2006 to remove the TVT implant. A month later, Clabo had surgery to implant a mesh sling similar to the one she had removed. In 2011, Clabo had another surgery to have pieces of her second implant removed and other parts repaired, again due to mesh erosion. Clabo alleges that it was not until July 2012 that she finally realized, after speaking with a physician-friend, that the TVT mesh product was the likely cause of her persistent pain and suffering.In May 2013, Clabo filed suit under the Tennessee Products Liability Act. The court dismissed Clabo’s claims as barred by Tennessee’s statute of repose, which prohibits product liability claims brought more than six years after the date of the injury that gave rise to the suit, finding that Clabo’s initial injury occurred during 2006. The Sixth Circuit affirmed; the record demonstrates that Clabo’s injuries occurred outside of the statute of repose period. View "Clabo v. Johnson & Johnson Health Care Systems, Inc." on Justia Law

The counties filed suit in the Northern District of Ohio against manufacturers and distributors of prescription opioids. More than 2,700 other opioid cases have been transferred there by the Judicial Panel on Multidistrict Litigation (MDL). The first Case Management Order put the Counties’ cases on “Track One,” with a March 2019 trial date, setting a deadline in April 2018 for the Counties to amend their complaints. The Counties then asserted claims against 12 Pharmacies as “distributors” of pharmaceuticals to their own retail pharmacies, expressly declining to bring "dispenser" claims. Distributors ship pharmaceuticals wholesale; dispensers fill prescriptions. The Track One parties engaged in massive discovery.Rather than ruling on summary judgment motions, the district court granted the Counties’ motion to sever all but one Pharmacy (Walgreens) from Track One. Trial had been rescheduled for October 2019. The 11 Pharmacies settled with the Counties, agreeing to pay $260 million. The district court canceled the trial, then allowed the Counties to amend their complaints to add “dispenser” claims and ordered discovery to proceed anew. The court refused to rule on dismissal motions and ordered the Pharmacies to produce data on every prescription that they had filled for any opioid medication, anywhere in the U.S., dating back to 2006. The Sixth Circuit ordered that the amendments to the complaints be stricken, noting that the Federal Rules of Civil Procedure apply in MDL under 28 U.S.C. 1407 and had been disregarded in several instances. View "In re National Prescription Opiate Litigation" on Justia Law

About 1,300 public entities sued manufacturers, distributors, and retailers of prescription opiate drugs to recover the costs of health problems caused by the opioid crisis. Plaintiffs subpoenaed the U.S. Drug Enforcement Agency’s ARCOS database, a “comprehensive drug reporting system which monitors the flow of DEA controlled substances from their point of manufacture through commercial distribution channels to point of sale or distribution at the dispensing/retail level.” The district court noted that the ARCOS data “are not pure investigatory records compiled for law enforcement purposes, [but] simply business records of defendants; . . . the database does not include any additional DEA analysis or work-product” and concluded that Plaintiffs’ request was reasonable. The court permitted pleadings and other documents to be filed under seal or with redactions, refused a request to disclose the ARCOS data to the media, and entered a protective order.The Sixth Circuit vacated. The district court never made a finding that Defendants or the DEA made “a particular and specific demonstration of fact” justifying the Protective Order. The court expressed concern that the district court may have wanted the threat of public disclosure to motivate settlement discussions. On remand, the court may consider why pieces of ARCOS data related to specific ongoing investigations should not be disclosed but cannot enter a blanket, wholesale ban on disclosure pursuant to state public records requests. No modified protective order may specify that the ARCOS data be destroyed or returned to the DEA at the conclusion of litigation. The court must reconsider each pleading filed under seal or with redactions and make specific determinations as to the necessity of nondisclosure. View "In re National Prescription Opiate Litigation" on Justia Law

Esperion has never generated any revenue, relying solely upon investor funding. Esperion’s sole focus is the development of ETC-1002, a first-in-class oral medication for lowering LDL “bad cholesterol,” a significant risk factor in cardiovascular disease. Esperion hopes to market ETC-1002 as an alternative treatment for statin-intolerant patients and as an add-on for patients are unable to reach their recommended levels using statins alone. In 2015, Esperion had completed several clinical studies and reported that ETC-1002 was well-tolerated and demonstrated significant average LDL-cholesterol reductions. After a meeting with FDA officials regarding Phase 3 of the approval process, Esperion published a press release, stating that “[b]ased upon feedback from the FDA, approval of ETC-1002 in [specific] patient populations will not require the completion of a cardiovascular outcomes trial,” with cautionary language, suggesting that “Esperion may need to change the design of its Phase 3 program once final minutes from the FDA meeting are received.” Market reaction was mostly positive. Following its receipt of the final FDA minutes, Esperion published another press release, indicating that the “FDA has encouraged the Company to initiate a cardiovascular outcomes trial promptly.” Esperion’s stock dropped 48% the next day. Plaintiffs, the purchasers of Esperion common stock between the two press releases, brought a class action under sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and SEC Rule 10b-5. The Sixth Circuit reversed the district court holding that Plaintiffs failed to adequately plead a strong inference that Esperion’s CEO willfully or recklessly made misleading statements. Plaintiffs adequately alleged scienter. View "Dougherty v. Esperion Therapeutics, Inc." on Justia Law