Justia Drugs & Biotech Opinion Summaries

When Samantha Reckis was seven years old, she developed toxic epidermal necrolysis, a life-threatening skin disorder, after receiving multiple doses of Children’s Motrin, an over-the-counter medication with ibuprofen as its active ingredient. Plaintiffs, Samantha and her parents, sued the manufacturer and marketer of Children’s Motrin and its parent company, alleging that Samantha developed TEN as a result of being exposed to ibuprofen in the Children’s Motrin and that the warning label on the medication’s bottle rendered the product defective because it failed to warn consumers about the serious risk of developing a life-threatening disease from it. A jury found in favor of Plaintiffs and awarded Samantha a total of $50 million in compensatory damages and each of Samantha’s parents $6.5 million for loss of consortium. The Supreme Judicial Court affirmed, holding (1) Plaintiffs’ claim of failure to warn was not preempted by the Federal Food, Drug, and Cosmetic Act; (2) a pharmacologist who offered the causation evidence essential to Plaintiffs’ case was qualified to testify as to specific medical causation, and the testimony was reliable and admissible; and (3) the damages awarded to each of the plaintiffs were not grossly excessive or unsupported by the record. View "Reckis v. Johnson & Johnson" on Justia Law

Hardin suffered complete blindness and permanent, severe and painful scarring after she took Lamotrigine, the generic form of the medication Lamictal. Hardin sued the prescribing physician, the manufacturer, the store where she bought the prescription (Safeway), WKH, which produced the drug information pamphlet (monograph), and PDX, a software provider that distributes drug information to pharmacy customers. Unlike physician package inserts and patient medication guides, which are FDA-mandated, WKH monographs are not regulated or reviewed by the FDA, but are produced as part of a self-regulating action plan required under 110 Stat. 1593. The WKH monograph was the only information received by Hardin when she first filled her prescription for Lamictal. The abbreviated warning used by Safeway and provided to Hardin omitted the “Black Box” warning: “BEFORE USING THIS MEDICINE” that stated: “SERIOUS AND SOMETIMES FATAL RASHES HAVE OCCURRED RARELY WITH THE USE OF THIS MEDICINE. Hardin says that had she been provided this warning, she would not have taken the medication. WKH moved to strike Hardin’s claims against it under Code of Civil Procedure section 425.16, the “anti-SLAPP” (Strategic Lawsuit Against Public Participation ) statute.. The trial court ruled that WKH’s production of drug monographs was protected speech concerning a public issue or an issue of public interest and that Hardin had no probability of prevailing because she could not establish that WKH owed her any duty. The court denied PDX’s motion to strike, finding that the activity underlying PDX’s alleged liability was the reprogramming of its software to permit Safeway to give customers an abbreviated, five-section monograph that omitted warnings instead of the full eight-section version that included those warnings. The court of appeal affirmed. View "Hardin v. PDX, Inc." on Justia Law

Relator filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. 3729-3733, against Omnicare, alleging that defendants violated a series of FDA safety regulations requiring that penicillin and non-penicillin drugs be packaged in complete isolation from one another. The court concluded that the public disclosure bar did not divest the district court of jurisdiction over relator's FCA claims. The court concluded that once a new drug has been approved by the FDA and thus qualified for reimbursement under the Medicare and Medicaid statutes, the submission of a reimbursement request for that drug could not constitute a "false" claim under the FCA on the sole basis that the drug had been adulterated as a result of having been processed in violation of FDA safety regulations. The court affirmed the district court's grant of Omnicare's motion to dismiss, holding that relator's complaint failed to allege that defendants made a false statement or that they acted with the necessary scienter. The court also concluded that the district court did not abuse its discretion in denying relator's request to file a third amended complaint. View "United States ex rel. Rostholder v. Omnicare, Inc." on Justia Law

Pauline and her doctors were aware of Pauline’s allergy to heparin, an anti-coagulant; she wore a medical bracelet listing her heparin allergy and her medical records noted the allergy. Her estate alleges that on several occasions, the hospital’s medical staff injected Pauline with heparin “in direct contradiction to her specific directive,” which proximately caused her death. The district court dismissed, for failure to comply with the notice and heightened pleading requirements of the Tennessee Medical Malpractice Act. The court concluded that under Tennessee law the injections were not “procedures” or “treatments” for the purposes of medical battery, but were only component parts of her treatment process, which did not require consent and could form the basis for medical malpractice but not medical battery. The Sixth Circuit reversed, holding that the complaint plausibly alleged medical battery, which is not subject to the Act. View "Shuler v. Garrett" on Justia Law

The government filed suit against appellants, alleging that they violated federal laws regulating the manufacture and labeling of drugs and biological products by producing, as part of their medical practice, a substance consisting of a mixture of a patient's stem cells and the antibiotic doxycycline (the "Mixture"). The Federal Food, Drug & Cosmetic Act (FDCA) 21 U.S.C. 301 et seq., and the Public Health Service Act (PHSA), 42 U.S.C. 201 et seq., are statutes that promote the safety of drugs and biological products, respectively, by setting forth detailed requirements for how such substances are to be manufactured and labeled. The court held that, by virtue of its use of doxycycline, the Mixture was within the scope of drugs - and, by extension, biological products, - regulated by section 331(k) of the FDCA; appellants failed to establish that the Mixture was exempt from the FDCA's manufacturing and labeling requirements; the Mixture was per se adulterated where it was undisputed that appellants' facilities, methods, and controls for processing the Mixture violated federal manufacturing standards in numerous respects; because its label failed to provide the minimum information necessary to qualify for either exemption from section 352(f), the Mixture was misbranded; and the district court properly enjoined appellants from committing future violations of the FDCA's manufacturing and labeling provisions. Accordingly, the court affirmed the judgment of the district court and dismissed appellants' counterclaims. View "United States v. Regenerative Sciences, LLC, et al." on Justia Law

Johnson, a Louisiana citizen, and Lucier, a Pennsylvania citizen, suffer from birth defects allegedly caused by their mothers’ use of thalidomide. They claim that newly-accessible evidence revealed that the defendant companies were aware of the drug’s risks while marketing it to pregnant women, and that they have been engaged in a 60-year cover-up to avoid liability. After defendants removed their suit for damages to federal court, the plaintiffs moved to remand the action to state court because four of the defendants are Pennsylvania citizens. The district court denied the motion. The Third Circuit affirmed, concluding that the district court correctly analyzed the citizenship of the companies, examining the principal place of business of one company and the fact that a limited liability company assumes the citizenship of its owner.View "Johnson v. SmithKline Beecham Corp." on Justia Law

Volkman, an M.D. and a Ph.D. in pharmacology from University of Chicago, was board-certified in emergency medicine and a “diplomat” of the American Academy of Pain Management. Following lawsuits, he had no malpractice insurance and no job. Hired by Tri-State, a cash-only clinic with 18-20 patients per day, he was paid $5,000 to $5,500 per week. After a few months, pharmacies refused to fill his prescriptions, citing improper dosing. Volkman opened a dispensary in the clinic. The Ohio Board of Pharmacy issued a license, although a Glock was found in the safe where the drugs were stored. Follow-up inspections disclosed poorly maintained dispensary logs; that no licensed physician or pharmacist oversaw the actual dispensing process; and lax security of the drug safe. Patients returned unmarked and intermixed medication. The dispensary did a heavy business in oxycodone. A federal investigation revealed a chaotic environment. Cup filled with urine were scattered on the floor. The clinic lacked essential equipment. Pills were strewn throughout the premises. Months later, the owners fired Volkman, so he opened his own shop. Twelve of Volkman’s patients died. Volkman and the Tri-State owners were charged with conspiring to unlawfully distribute a controlled substance, 21 U.S.C. 841(a)(1); maintaining a drug-involved premises, 21 U.S.C. 856(a)(1); unlawful distribution of a controlled substance leading to death, 21 U.S.C. 841(a)(1) and 841(b)(1)(C), and possession of a firearm in furtherance of a drug-trafficking crime, 18 U.S.C. 24(c)(1) and (2). The owners accepted plea agreements and testified against Volkman, leading to his conviction on most counts, and a sentence of four consecutive terms of life imprisonment. The Sixth Circuit affirmed. View "United States v. Volkman" on Justia Law

At age four months, Elias received a Diptheria-Tetanus-acellular-Pertussis (DTaP) vaccine. Elias developed a seizure disorder shortly afterwards. While a petition for compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. 300aa-1, was pending, Elias died as a result of his seizure disorder at the age of seven. A special master determined that the DTaP vaccine caused Elias’ epilepsy and resulting death. The Secretary of Health and Human Services and the estate agreed to a $250,000 death benefit plus $175,000 for actual pain and suffering and past unreimbursable expenses. The estate also sought future lost earnings under section 300aa-15(a)(3)(B). The special master determined that the estate was entitled to future lost earnings. Subject to the right to seek review, the Secretary proffered, and the estate accepted the sum of $659,955.61 as a measure of the lost earnings. The Claims Court affirmed the special master’s future lost earnings award. The Federal Circuit reversed, holding that an estate cannot recover lost future earnings under section 300aa-15(a)(3)(B) when the person injured by a vaccine dies before entry of a compensation judgment. View "Tembenis v. Sec'y of Health & Humans Servs." on Justia Law

Zizic is the former CEO of BioniCare, which sold the BIO-1000, a medical device designed to treat osteoarthritis of the knee. BioniCare attempted to bill Medicare for the BIO-1000, but many claims were denied as not medically necessary. Q2A contracted with the government to review such claim denials across the nation. Q2A’s denials were reached without physician review, which is required by the Medicare Act, 42 U.S.C. 1395, HHS regulations, and its contract. A former Q2A employee testified that it implemented an internal policy to deny all BIO-1000 claims, which were reviewed by a single nurse rather than a panel of physicians; later allowed non-physician subcontractors to prepare BIO-1000 appeals for review by a single physician; and finally developed a mail merge letter that automatically denied BIO-1000 claims without any review. BioniCare’s trustee in bankruptcy became aware of and disclosed these practices. Zizic filed a qui tam suit under the False Claims Act, 31 U.S.C. 3729-33. The district court dismissed, concluding that it lacked jurisdiction because the allegations against Q2A and RTS were based on prior public disclosures and because Zizic was not an original source of that information. The Third Circuit affirmed. View "Zizic v. Q2Adm'rs LLC" on Justia Law

The National Childhood Vaccine Injury Act of 1986 established a no-fault compensation system to stabilize the vaccine market and expedite compensation to injured parties. Under the Act, a proceeding for compensation is “initiated” by service upon the Secretary of Health and Human Services and “the filing of a petition containing” specified documentation with the clerk of the Court of Federal Claims, who forwards the petition for assignment to a special master. 42 U. S. C. 300aa–11(a)(1). An attorney may not charge a fee for services in connection with such a petition, but a court may award attorney’s fees and costs incurred by a claimant in any proceeding on an unsuccessful petition, if that petition was brought in good faith. In 1997, shortly after receiving her third Hepatitis-B vaccine, Cloer began to experience symptoms that led to a multiple sclerosis (MS) diagnosis in 2003. In 2004, she learned of a link between MS and the Hepatitis-B vaccine, and in 2005, she filed a NCVIA claim. The special master concluded that Cloer’s claim was untimely because the Act’s 36-month limitations period began to run when she had her first MS symptoms in 1997.The Federal Circuit agreed. Cloer then sought attorney’s fees and costs. The Federal Circuit ruled in Cloer’s favor. The Supreme Court affirmed. Nothing in the attorney’s fees provision suggests that the reason for the subsequent dismissal of a petition, such as untimeliness, nullifies the initial filing. An NCVIA petition delivered to the court clerk, forwarded for processing, and adjudicated before a special master is a “petition filed under section 300aa–11.” The government’s contrary position is inconsistent with the fees provision’s purpose, which was to avoid limiting petitioners’ ability to obtain qualified assistance by making awards available for “non-prevailing, good-faith claims.” View "Sebelius v. Cloer" on Justia Law