The defense response to so many plaintiff allegations amounts to: so what? What difference did the complained of conduct make? Think of medical causation. Or think of warning causation in the context of a learned intermediary. In securities cases or, closer to our DDL hearts, False Claims Act cases, the ‘so what’ arrives dressed in the garb of materiality.
The recent False Claims Act case of United States ex rel. Yu v. Grifols, USA, LLC, 2021 U.S. Dist. LEXIS 235240 (S.D.N.Y. Dec. 8, 2021), turns on materiality. The plaintiff — really the relator, as will be explained below — was a former quality assurance manager at the defendant’s Los Angeles facility, which manufactured a drug that was used to treat chronic autoimmune disorders. He morphed into a whistle-blower, alleging that there were a number of “discrepancies” in the company’s system, that those discrepancies deviated from current Good Manufacturing Practices (cGMP), that those discrepancies could lead to inaccurate testing and adulterated product, and that the company’s failure to disclose the discrepancies cheated the government out of money. He filed a False Claims Act. He was listed as the Relator who was bringing the case on behalf of the government. That is why the case is titled “United States ex rel. Yu.” But the government declined to intervene, which usually signals a weakness in the case. The court seemed to agree that the case was weak. It was so weak, in fact, that it was dismissed.
First, the court...
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