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Key Terms

medicare regulatory

Medicare is a large government-run health insurance program that primarily covers people aged 65 and older and certain younger people with disabilities. For investors it matters because Medicare acts like a huge customer and rule-maker for hospitals, drugmakers and medical-device companies—its coverage decisions, payment rates and regulatory policies can change demand, revenue and profit margins across the healthcare sector, similar to how a major client or regulator can shape a business’s prospects.

u.s. food and drug administration ('fda') regulatory

The U.S. Food and Drug Administration (FDA) is the federal agency that reviews and clears drugs, medical devices, vaccines, and food safety for use in the United States. Think of it as a gatekeeper or building inspector for health products: its approvals allow companies to sell broadly, while rejections, delays or safety warnings can shrink sales and raise costs, so investors monitor FDA decisions as they directly affect a product’s market access and a company’s financial outlook.

fda regulatory

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

Ex-MiMedx Employee Jake Heikkinen Files Counterclaims Alleging Schemes 'To Bilk Medicare' and 'Incentivize and Pressure Healthcare Providers' per Mintz Attorneys

MARIETTA, Ga., Sept. 4, 2024 /PRNewswire/ -- The third of 10 defendants who were sued earlier this year by MiMedx Group, Inc. (NASDAQ: MDXG) today filed counterclaims against the company. Jake Heikkinen, a former MiMedx employee, states in the filing that he left the placental biologics company because of "MiMedx's schemes to bilk Medicare and other government and third-party taxpayers" and "'to incentivize and pressure healthcare providers to treat wounded veterans, diabetics, chronic wound sufferers and other patients with medically unnecessary or unsuitable products—all to the detriment of patients and the federal government." Heikkinen also formally presented his answers and defenses to MiMedx's lawsuit which claimed that the 10 former employees, who all recently left the company, allegedly breached their contractual obligations to MiMedx. The filing describes the MiMedx suit as a "blatant intimidation tactic."

Specifically, the counterclaims by Heikkinen allege that MiMedx "engaged in and has directed members of its sales team including Mr. Heikkinen to engage in, predatory sales practices aimed at increasing its revenue by incentivizing fraud on the United States government, including Medicare fraud." The filing also states, "These examples are only the most recent in a long line of disreputable and unlawful business practices that MiMedx has engaged in."

The claims reference a warning letter issued by the FDA to MiMedx's CEO, Joseph H. Capper, concerning its AXIOFILL product on December 20, 2023, and assert that this former employee and others felt "that the company had wasted the sales team's time claiming that there were no issues regarding AxioFill" even after receiving the letter, and that MiMedx's "lack of communication and transparency" regarding the facts were disturbing.

The claims filed by Heikkinen's attorneys at Mintz and Fellows Labriola allege that he left MiMedx after "MiMedx tried to compel its employees to continue selling a product that the U.S. Food and Drug Administration ('FDA') determined could not lawfully be marketed without prior FDA approval."

Today's counterclaims come on the heels of two other complaints filed this month on behalf of former MiMedx employees, Lora Whooley, and Caralyn Gargan. To read the Whooley claim, please click here HERE, and to read the Gargan claim, please click HERE.

Caralyn Gargan's
https://peachcourt.com/Redirect?id=CIPG3FVQ

Lara Whooley's Counter Claim:
https://peachcourt.com/Redirect?id=SGQEOGT4

View original content:https://www.prnewswire.com/news-releases/third-defendant-fights-back-against-mimedx-claiming-disreputable-and-unlawful-business-practices-302238574.html

SOURCE Mintz