FDA approval of medical device excises Lanham Act claim

Rita Medical Systems, Inc. v. Resect Medical, Inc., 2006 WL 2038328 (N.D. Cal.)

Plaintiff Rita makes ablation-technology products used to treat patients with tumors. Ablation involves the surgical excision of tissue. Defendant Resect also makes instruments for surgical resection using ablation. Resect was founded by Rita’s former director of product development. Rita brought a bunch of claims against Resect; this opinion just deals with the Lanham Act and cognate state law claims.

Some hospitals use Resect’s InLine Bipolar Coagulator together with Rita's radiofrequency ("RF") generators. Rita apparently discourages the use of the devices in tandem, contending that the compatibility of the two devices is uncertain and untested. Rita maintains that there have been several accidents involving the use of the devices together.

According to Rita, Resect has nevertheless made and continues to make purported misrepresentations touting the compatibility of the InLine with Rita's RF generators. Rita also argues that its reputation is being tarnished, as physicians believe Rita is responsible for the malfunctioning and incorrectly assume the InLine and the RF generators are produced by the same company.

The parties disagree over whether this is a false association or false advertising case; it sounds like both to me.

Resect submitted a §510(k) premarket notification to the FDA in order to be allowed to market the InLine. If the FDA determines that a device is substantially equivalent to a device on the market prior to 1976, the applicant is free to market the device. The §510(k) notification specifically stated that the InLine was designed for use with “a standard FDA cleared RF generator, the RITA System Model 1500 or 1500X.” The FDA determined that the InLine was substantially equivalent to legally marketed predicate devices and allowed Resect to sell the InLine.

According to the court, this “casts doubt on the viability of plaintiff’s Lanham Act claim,” because the Lanham Act can’t be used to challenge FDA determinations, and the FDA has comprehensive regulatory authority over medical devices. Only the FDA can enforce the FDCA. “The FDA authorized Resect to market the InLine as described – that is, configured with Rita’s RF generators.” Evaluating Rita’s Lanham Act claim that, contrary to Resect’s advertising, the InLine isn’t compatible with Rita’s generators, would be tantamount to a review of the FDA approval.

This analysis seems problematic to me, not least because the device at issue is a grandfathered one. When the FDA has found a new drug safe and effective, individual competitors can reasonably be precluded from challenging that determination via the Lanham Act. But when the FDA has just made a substantial equivalence finding that entitles the maker to skip the approval process, saying that the FDA’s hands-off means a Lanham Act hands-off seems risky and unnecessary. Moreover, as far as I can tell, the FDA didn’t evaluate the statement that the InLine was designed for use with the Rita generator. I’m not sure that evaluating its equivalence with an earlier device would include evaluating its compatibility with other devices.

Other FDA preemption cases have asked whether the claims at issue can be evaluated without interpreting FDA regulations; it seems as if the plaintiff’s claims here could be.

Even if the FDA doesn’t preempt the claim, the court found that its approval made Rita unlikely to succeed because it served as evidence Resect’s claims were true. Rita also didn’t have sufficient evidence of incompatibility to show a fair chance of success on its claims. Two failed surgeries weren’t enough, because it wasn’t clear why the failures occurred, and even two negative incidents aren’t “statistically significant enough to conclude that defendants made representations.” (NB: Apparent misuse of the concept of statistical significance.) Moreover, the evidence of the incidents was inadmissable hearsay from Rita employees, rather than testimony from the invovled physicians. Unlike the preemption argument, the failure of proof seems unproblematic.

In the end, Rita didn’t have enough reliable evidence that Resect’s product was incompatible, or that customers believe that Rita’s generators are responsible for the resultant machine failures, or that they wrongly believe that Rita makes the InLine devices.