MDXG: Undisclosed Adverse Reaction Contradicts Product Safety Claims
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“Let’s not forget the proven safety profile of MiMedx allografts and the fact that we have distributed over 1 million grafts without a single reported adverse reaction. While a number of competitors have begun selling new products that utilize different processing and configuration techniques, we believe MiMedx birth tissue products provide the greatest safety for the patients.”
–Chris Cashman, MiMedx Chief Commercialization Officer
MiMedx aggressively markets its placenta-based products to patients despite not having obtained any FDA approval (read previous report). Instead, former CEO Parker Petit has said that “mother nature did safety and efficacy testing on the tissue”. MiMedx operates in a regulatory gray area for biologics known as “enforcement discretion” under which, as recently explained by the Wall Street Journal, “the FDA allows such product to be sold, provided its use doesn’t raise safety concerns”. MiMedx boldly claims on its website that it has “distributed more than 1 million allografts to date with zero reported adverse reactions attributed to our products”. The company has previously been accused by other short sellers of covering up adverse events, which MiMedx vehemently denied on its now-deleted short selling commentary page.
Yet, according to a lawsuit filed earlier this month, an Epifix patient suffered an adverse reaction so severe that she was left permanently maimed. We view this as highly problematic because undisclosed adverse reactions, especially of this character, could potentially cause the FDA to pull MiMedx products from the marketplace.
The lawsuit was filed by a patient against Dr. Shar Hashemi and the Nerve, Bone & Joint Institute on August 6, 2018 in Virginia Circuit Court for Fairfax County (Available Here Case No. 2018 11634). The patient states that Dr. Hashemi performed a hand surgery on her to relieve carpal tunnel and used MiMedx’s Epifix allograft “to minimize scar tissue formation”. The suit contends Hashemi’s use of Epifix was reckless and experimental (Note: you should assume that defendants deny all allegations referenced in this suit).
The suit states that “the introduction of the EpiFix into the surgical wound caused an inflammatory reaction which is depicted in the photograph attached” (posted above). We showed the photo to two individuals with medical backgrounds who immediately identified this as a severe and highly unusual reaction. According to the suit, the Epifix “caused neurological and muscular injuries which persist to this day and are reflected in pain upon use of the hand and impaired function”. Not only did this lead to “discoloration and disfigurement which is permanent”, but the “introduction of Epifix into the surgical wound has exacerbated the management of the patient’s Lyme Disease, which in turn has restricted the palliative treatments she can receive”.
The suit alleges that Epifix caused the inflammatory reaction after Hashemi improperly applied the Epifix by inserting it into the surgical wound as opposed to applying it externally. But even if the product was misused, the severe adverse reaction the patient experienced is troubling because it appears consistent with a systemic response. This reaction is concerning because it could have resulted from an unidentified allergen in the product, which is precisely why robust clinical trials are required to gain FDA approvals. If the product is completely sterile and safe, we question why an improper application would catalyze such a severe response? Especially since other MiMedx products derived from the same placental tissues as Epifix are specifically intended to be injected inside patients. We also can’t rule out the possibility that the Epifix had a contaminant and are concerned by the undisclosed form 483 issued by FDA inspectors in 2016 which stated that MiMedx’s micronized manufacturing process, among other things, “fails to address bacteriostasis and fungistatis testing”, “endotoxin validation is inadequate”, and “lacks validation of particle size, distribution, product identity, safety, and potency”.
The FDA, according to our understanding, uses a risk-based architecture for evaluating adverse events and its guidance suggests that incidents with systemic effects on patients are of elevated concern. The FDA states that “an adverse reaction means any noxious and unintended response to any HCT/P for which there is a reasonable possibility that the HCT/P caused the response”, a threshold that this incident certainly appears to meet. The lawsuit states that MiMedx “became aware” of “the patient outcome in this case”, which indicates the event was reported to MiMedx and that the company knew of this adverse reaction. We therefore believe the evidence presented in this lawsuit directly contradicts MiMedx’s claim of having “zero” adverse reactions.
Had this patient not filed suit, these details never would have been revealed to the public. This causes us to question how many other adverse events may also have not been disclosed? We urge the company’s newly created Ethics Committee Chaired by Luis Aguilar to immediately investigate this issue.