MiMedx Group, Inc., a leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies, has filed a federal lawsuit against Organogenesis, Inc., manufacturer of Apligraf and Dermagraft, two skin substitute products that compete with MiMedx's EpiFix allograft.
In June 2013, the MiMedx allografts were suddenly and unexpectedly removed from the 65IIA Federal Supply Schedule (FSS) of the Veterans Administration (VA). Immediately after the removal, MiMedx challenged that action, and in a matter of just days, the VA determined that the action to remove the MiMedx allografts was not warranted and they were fully restored to the FSS. In addition, the VA issued an apology letter to MiMedx for the action. The company then inquired through a Freedom of Information Act (FOIA) request to the VA to ascertain the origin of this unusual and abrupt action. This FOIA response was received by MiMedx on December 3, 2014. Through the FOIA response, it was determined that Organogenesis provided material misinformation to the VA in order to improperly influence the VA to take action against MiMedx products. The lawsuit alleges that Organogenesis engaged in malicious actions that tortiously interfered with MiMedx's contractual relationship selling into the VA. MiMedx's investigation of Organogenesis's improper tactics is ongoing, and MiMedx will continue to pursue any and all remedies available to it to address the unlawful actions undertaken by Organogenesis.
Parker H. "Pete" Petit, chairman and CEO, stated, "For quite some time, we have had suspicions that Organogenesis was perpetrating improper influences at certain Federal agencies. Recently, these suspicions were confirmed when we obtained the FOIA response from the VA related to the June 2013 temporary removal of our allografts from the FSS. It was extremely disappointing to finally learn from the FOIA information the extent to which Organogenesis had used its law firm to misinform the VA in its desperate attempt to have the VA remove allografts from the FSS. The misinformation was appalling."
"The measures taken by Organogenesis in the VA matter, as well as in different matters involving at least one other Federal agency, substantiate an unfortunate pattern of attempts on the part of Organogenesis to influence Federal agencies with biased, misleading and inaccurate information in order to damage MiMedx. Of course, these past practices make us suspicious of the influence of Organogenesis on the actions taken by the Food and Drug Administration (FDA) through their Untitled Letter of August 28, 2013. We will continue to pursue this matter until we are certain that no improper interaction and influences on the part of Organogenesis have taken place at other Federal agencies to otherwise improperly and unfairly harm MiMedx," added Petit. Mr. Petit further stated, "Of course, we have no issues with having our products compete with Organogenesis products in the marketplace, but these types of improper actions are well beyond the boundaries of legitimate business practices."
In addition to tortious interference, MiMedx's suit against Organogenesis asserts unjust enrichment. The damages sought in the lawsuit were not specified. The lawsuit was filed in the United States District Court for the Northern District of Georgia.
"Also, to put this in perspective, please review our press release of May 20, 2014, regarding a previous attempt on the part of Organogenesis to disrupt our business activities," concluded Petit.