Does the learned intermediary doctrine apply in the context of a clinical trial? According to the Southern District of Texas, it does. The case in question is Butler et al. v. Juno Therapeutics, Inc., a tragic case involving the death of a 19-year-old woman with terminal leukemia who died within days of receiving an experimental cancer drug as a participant in a clinical trial.
In 2015, Juno Therapeutics (Juno) was developing a treatment for advanced blood cancers involving Chimeric Antigen Receptor T-cell (CAR-T) therapy. CAR-T therapy is designed to modify a patient’s white blood cells to target cancer cells with the goal of improving the patient’s condition so a bone marrow or stem cell transplant can be tolerated. In October 2015, Juno entered into a Clinical Study Agreement with MD Anderson (and other hospitals) as part of a Phase 2 clinical trial (the “Rocket Study”) of a drug identified as JCAR015, a CAR-T therapy. Drs. William Wierda and Michael Rytting were the principal investigators of the Rocket Study at MD Anderson.
Some product liability suits are dead on arrival. At least, that is the position the Fifth Circuit took late last week in affirming the dismissal of a pro se plaintiff’s suit against a collection of generic and brand-name drug manufacturers.
The case in question is Johnson v. Novartis Pharmaceuticals Corporation, et al., and concerns Mr. Johnson’s purported struggles with Peyronie’s Disease (PD), a connective tissue disorder that causes painful, bent erections, after he had ingested generic forms of the prescription drugs Minocin (an antibiotic) and Tegretol (an anticonvulsant).
A review of multidistrict litigation (MDL) statistics confirms the increasing percentages of federal cases being consolidated into MDLs. According to the Judicial Panel on Multidistrict Litigation (JPML) website, as of June 2019, 202 MDLs were pending in 46 different federal districts, in 32 different states, before 160 different transferee judges. California boasts the largest number of MDLs, with 30. New York State is close behind with 26. The 141,721 cases included in these MDLs represent more than 50 percent of the federal civil docket. More than 30 percent (or 70 MDLs) of the pending MDLs are products liability cases, a significant increase from 16 percent in 2005. And, of the 70 MDLs, more than 50 are litigations involving pharmaceutical products and/or medical devices. These numbers highlight the increase in the frequency with which products liability cases are being coordinated in MDL proceedings.
The MDL statute enacted in 1968 allows for the transfer of cases “involving one or more common questions of fact … pending in different districts” to “any district for coordinated or consolidated pretrial proceedings.” 28 U.S.C. § 1407(a). After an MDL is established, later-filed cases involving the same questions of fact are seamlessly transferred to the MDL as tagalong cases. The efficiencies seen in MDL proceedings since 1968 have caused the MDL docket to grow dramatically. In the early years, the “caseload was relatively flat—in the late 1970s and throughout the 1980s, the Panel averaged only around 40 [consolidation] motions per year.” Emery G. Lee III et al., “Multidistrict Centralization: An Empirical Examination,” 12 Journal of Empirical Legal Studies, 211, 221 (2015). By the 1990s, the MDL caseload was growing rapidly. Today, the JPML reports that it considers more than 55 motions per year on average, and as of the end of 2018, MDLs accounted for 52 percent of all civil cases pending in federal court.
President Trump recently signed the SUPPORT, or Substance-Use Disorder Prevention That Promotes Opioid Recovery and Treatment, for Patients and Communities Act (the “Act”), aimed at curbing the overuse of opioids in the United States. The Act is far-reaching, and it includes changes to Medicare, Medicaid and other public health efforts. Certain sections, especially those in Title III, “FDA and Controlled Substance Provisions,” will have a direct impact on manufacturers of certain products used to treat chronic pain.