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Abrams v. MiMedx Group. Inc.

United States District Court, N.D. Georgia, Atlanta Division

August 13, 2014

SPENCER ABRAMS Individually and on Behalf of All Others Similarly Situated, et al., Plaintiffs,
v.
MIMEDX GROUP, INC., et al., Defendants

For Spencer Abrams, Individually and on Behalf of All Others Similarly Situated, Plaintiff: John C. Herman, LEAD ATTORNEY, Robbins Geller Rudman & Dowd, LLP - GA, Atlanta, GA; Robert J. Robbins, LEAD ATTORNEY, PRO HAC VICE, Robbins Geller Rudman & Dowd, LLP, Boca Raton, FL.

For Jerry Freeman, Plaintiff: Adam Scott Katz, Katz Litigation Group, LLC, Atlanta, GA.

For Patricia Gladowski, Individually and on Behalf of All Others Similarly Situated, Plaintiff: David Andrew Bain, LEAD ATTORNEY, Law Offices of David A. Bain, LLC, Atlanta, GA; Joseph E. White, III, LEAD ATTORNEY, PRO HAC VICE, Saxena White, P.A, Boca Raton, FL; Katharine M. Ryan, LEAD ATTORNEY, Ryan & Maniskas, LLP, Wayne, PA.

For William M. Guyer, Individually and on behalf of all other persons similarly situated, Plaintiff: Jeremy A. Lieberman, LEAD ATTORNEY, Pomerantz Grossman Hufford Dahlstrom & Gross, LLP, New York, NY; Marc I. Gross, LEAD ATTORNEY, PRO HAC VICE, Pomerantz Haudek Block Grossman & Gross, New York, NY.

For MiMedx Group, Inc., Parker H. Petit, Michael J. Senken, William C. Taylor, Defendants: Lisa R. Bugni, Alston & Bird, LLP - Atl, Atlanta, GA; Todd Richard David, Alston & Bird, Atlanta, GA.

For Douglas Trask, Movant: Brian E. Cochran, Brian O. O'Mara, LEAD ATTORNEYS, Robbins Geller Rudman & Dowd, LLP - SD, San Diego, CA; John C. Herman, Robbins Geller Rudman & Dowd, LLP - GA, Atlanta, GA.

For Tim Kelly, Movant: Laurence Rosen, Phillip Kim, Sara Fuks, LEAD ATTORNEYS, The Rosen Law Firm, New York, NY; Lauren S. Antonino, The Antonino Firm, LLC, Atlanta, GA.

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OPINION AND ORDER

THOMAS W. THRASH, JR., United States District Judge.

This is a securities fraud class action. The Plaintiffs allege that MiMedx Group, Inc., a developer of therapeutic biomaterials, falsely stated that its injectable products qualified for an FDA exemption from drug regulation, and that the Defendants failed to disclose an FDA investigation of the products. The Defendants argue that they properly disclosed the risks associated with marketing the injectable products without FDA approval, and that the Plaintiffs did not incur economic losses from any alleged misrepresentations.

I. Background

MiMedx Group, Inc., develops and markets biomaterials and bioimplants to help the healing process. Two of its injectable products, AmnioFix and EpiFix, are at issue in this case. These products seek to hasten the healing process and reduce the

Page 1273

development of scar tissue.[1] The Plaintiffs contend that MiMedx misled its shareholders by stating that AmnioFix and EpiFix would be qualified as " human cells, tissues, and cellular and tissue-based products" under FDA regulations.[2] These products, also called " 361 HCT/Ps," are exempt from FDA regulation of drugs, devices, or biological products. To obtain 361 HCT/P status, the cell or tissue-based product can only be " minimally manipulated." Tissue products are more than " minimally manipulated," according to FDA regulations and guidelines, when the tissue's original characteristics have been altered during processing.[3] MiMedx allegedly did not inform investors that AmnioFix and EpiFix could not meet the " minimal manipulation" criterion for exemption under Section 361 although MiMedx pulverizes or grinds the amniotic tissues and cells in making the ...


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