Do kids still do connect-the-dots? Back before tablets, smart phones, laptops, and even computers, when you went on a long car trip you passed the time playing license plate bingo, punch buggy, annoying your parents, and maybe you had an “activity book.” An actual paperback book filled with coloring pages, mazes, word scrambles, seek-a-word, and — connect-the-dots. The great thing about connect-the-dots puzzles was watching the image get revealed as you moved your crayon from one number to the next. Voila! If you did it right, you ended up with a recognizable picture. Like a hot air balloon or a rabbit in the woods. If you missed some numbers or left some blank, you got something that maybe, almost, kind of, could be either a rabbit or a hot air balloon. That’s fine for a kid to use his imagination and guess what the picture was supposed to be. That’s not fine when plaintiffs ask the court to do the same.
Which is what the court told plaintiff in United States v. Siemens Medical Solutions USA, Inc., 2025 U.S. Dist. LEXIS 9511 (E.D.N.Y. Jan 17, 2025). The case was brought by a plaintiff-relator alleging defendant, the manufacturer of laboratory tests, violated the False Claims Act (“FCA”) by not shipping those tests in containers that would ensure they maintained FDA-mandated temperature ranges during transport. Id. at *6.-7. Plaintiff alleged defendant was aware its products were being shipped inappropriately and that, therefore, its labeling regarding shelf-life and product stability were inaccurate. Id. This in turn, claimed plaintiff, caused other to submit false clams to the government “which did not disclose . . . the compromised reliability, safety, and efficacy” of the devices. Id. at *8.
Putting aside the sprawling nature of a transportation-based FCA claim and the myriad of issues it would raise, here the court only needed to analyze plaintiff’s claims under Federal Rule of Civil Procedure 9(b). FCA claims are fraud-based, and therefore, subject to Rule 9’s heightened pleading requirements. Id. at *16. Plaintiff must allege the who, what, when, where, and how of the alleged fraud. In the context of an FCA claim brought on “information and belief” that false claims were presented, plaintiff must
(1) make plausible allegations that the bills or invoices actually submitted to the government were uniquely within [the defendant’s] knowledge and control, and (2) adduce specific facts supporting a strong inference of fraud.
Id. at *17 (citations omitted). Plaintiff here failed on both counts.
First, plaintiff merely pointed to adverse event reports found on the FDA’s MAUDE database to demonstrate that defendant’s devices malfunctioned. But that is as far as the allegation went. Nowhere did plaintiff allege any facts about what caused the malfunctions. Rather it asked the court “to presume” the adverse events were caused by the devices’ storage or shipping conditions. Id. at *18. Some devices were reported as malfunctioning during the same period of time plaintiff alleges defendant was not adhering to proper shipping conditions. And?? Rule 9 is not satisfied by setting out a set of circumstances and asking the court to connect to the dots.
Second, the FCA’s “focus remains on those who present or directly induce the submission of false or fraudulent claims.” Id. at *15. Yet plaintiff failed to allege that defendant’s shipping practices compromised any tests for which claims were actually submitted to the federal government. Id. at *20. That alone was enough to dismiss the complaint.
The court is giving plaintiff another stab at connecting the dots, but plaintiff has had years to fill in the gaps and complete the picture. We doubt a little more time is going to get the job done.