The Wayne, N.J.-based company said it is asserting counterclaims which allege that Abiomed engaged in false advertising to promote that its Impella device was superior to Datascope’s intra-aortic balloon pumps.
Datascope said that, simultaneously, Maquet will be expanding the infringement case by alleging that most Impella models infringe upon 3 Maquet patents, bringing the total number of patents in the suit to 6.
In Datascope’s counterclaims, the company asserts that Abiomed “engaged in a pattern of intentional and widespread false advertising regarding Impella compared with IABP in violation of federal and state law,” according to a press release.
In the suit, it is alleged that Abiomed falsely advertised that the Protect II trial and a related “hypothesis-generating” post hoc analysis of data from the trial demonstrated that the Impella significantly reduced major adverse events compared with IABPs.
Datascope added that “recent developments” supported Datascope’s position that Abiomed’s superiority claims were unlawful. The company said that in Health Quality Ontario’s Feb. 2017 in-depth tech assessment concluded that “percutaneous ventricular support with Impella does not lower death rates; nor is it safer or cheaper than usual treatment with balloon pumps,” according to a press release.
The company goes on to allege that Abiomed disseminated false representations regarding the US FDA’s approval of IABP, the cost-effectiveness of it’s Impella compared to IABP, and other features of the Impella device. In the suit, the company claims that Abiomed advertised that IABP was not FDA-approved as safe and effective for treating acute myocardial infarction, cardiogenic shock or for use during high-risk PCI, which Datascope claims is false.
Last July, after being threatened with a patent infringement lawsuit if it didn’t agree to a licensing deal with Maquet, Abiomed responded by asking a Massachusetts judge for a judgment of non-infringement in May 2015.
Maquet sent a letter to Danvers, Mass.-based Abiomed in December 2015, alleging infringement of a trio of patents by the Impella line of transcatheter heart pumps and seeking a licensing deal – and threatening a patent infringement action in the alternative.
In a Jan. 19 response, a lawyer for Abiomed said the Maquet patent claims were “devoid of any merit” and denied any infringement.