Drugs, Devices & Discovery: Using Fee-Shifting to Resolve the Twombly/Iqbal Problem for Parallel Claims Under the FDCA.

The Supreme Court's decisions in Twombly and Iqbal ushered in a new federal pleading standard, requiring plaintiffs to state a "plausible" claim to relief before they can access discovery. Plausibility pleading, however, presents a unique burden for plaintiffs who have been injured by a Class III medical device. In Riegel, the Supreme Court held that state-law claims against device manufacturers are preempted unless they "parallel" federal requirements. However, the relevant federal requirements are located in the manufacturer's premarket approval agreement, which is confidential. Thus, it is nearly impossible for plaintiffs to allege a plausible claim against a Class III device manufacturer because they do not know what to plead in the first place. The Seventh Circuit tried to remedy this Catch-22 by lowering the pleading standards for parallel claims. However, its approach misapplies Twombly and Iqbal and overburdens device manufacturers. Instead of tinkering with pleading standards, this paper advocates a different approach. Congress should create a one-way fee-shifting mechanism that allows plaintiffs to access premarket approval agreements if they agree to pay the defendant's discovery fees (should their claim prove unsuccessful). Fee-shifting is a middle-ground approach that would better compensate plaintiffs without overdeterring device manufacturers.

High-Throughput Adaptable SARS-CoV-2 Screening for Rapid Identification of Dominant and Emerging Regional Variants.

OBJECTIVES: Emerging severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant strains can be associated with increased transmissibility, more severe disease, and reduced effectiveness of treatments. To improve the availability of regional variant surveillance, we describe a variant genotyping system that is rapid, accurate, adaptable, and able to detect new low-level variants built with existing hospital infrastructure. METHODS: We used a tiered high-throughput SARS-CoV-2 screening program to characterize variants in a supraregional health system over 76 days. Combining targeted reverse transcription-polymerase chain reaction (RT-PCR) and selective sequencing, we screened SARS-CoV-2 reactive samples from all hospitals within our health care system for genotyping dominant and emerging variants. RESULTS: The median turnaround for genotyping was 2 days using the high-throughput RT-PCR-based screen, allowing us to rapidly characterize the emerging Delta variant. In our population, the Delta variant is associated with a lower cycle threshold value, lower age at infection, and increased vaccine-breakthrough cases. Detection of low-level and potentially emerging variants highlights the utility of a tiered approach. CONCLUSIONS: These findings underscore the need for fast, low-cost, high-throughput monitoring of regional viral sequences as the pandemic unfolds and the emergence of SARS-CoV-2 variants increases. Combining RT-PCR-based screening with selective sequencing allows for rapid genotyping of variants and dynamic system improvement.