Labs In Court

 Commercial Labs Trade Accusations of False Advertising of TSI Assays

Case: The nasty litigation between Quidel and Siemens continued with both sides accusing the other of false and deceptive advertising. The touchstone of the suit are ads run by Siemens referring to Quidel’s TSI and TBI detection assay IMMULITE as a “TSI only” product. The latest installment raises the question of whether Quidel has “unclean hands,” a legal doctrine that means a plaintiff can’t sue a defendant for the same wrongs the plaintiff is committing itself. Specifically, Siemens charged Quidel of making two false claims about its own Thyretain TSI assay:

  • Thyretain, which is a qualitative assay, can be billed under the higher-reimbursing CPT code 84445 reserved for quantitative assays; and
  • Thyretain can deliver test results in three to four hours which belies the fact that tested cells must be cultured overnight.

 Quidel defended both claims and asked the federal district court to toss Siemens’ unclean hands defense. The court refused.

 Significance: All that’s at stake with the unclean hands defense at this point is whether there’s enough evidence to warrant a trial. Siemens will still have to prove the claim at trial. In fact, all of the other rulings in the case have also revolved around summary judgment. Thus after protracted litigation and lord knows how many hundreds of thousands of dollars in legal fees, the companies have yet to reach the merits and, barring a settlement, are now looking at a huge and very risky trial [Quidel Corp. v. Siemens Med. Sols. USA, Inc., 2020 U.S. Dist. LEXIS 63405]. For more about the case and labs’ general liability risks for deceptive advertising, see Lab Compliance Advisor (LCA), Nov. 28, 2019.


(-00000g2)