Please explain a defense strategies on this case.

PART I United States of America ex rel. Chung v. DUSA Pharmaceuticals, Inc., No. 16 cv 1614-JLR.

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The Massachusetts-based DUSA Pharmaceuticals which is a subsidiary of Sun Pharmaceutical Industries, Inc was the subject of a Qui Tam provision under the False Claim Act by the United States Department of Justice Civil Division (USA.ex rel. Chung v. DUSA. 2020). I have learned that for many years the company has been using its sales force to mislead and corrupt physicians on prescribing the product called "Levulan Kerastick" a topical cream used for minimum to moderate lesions in the face and scalp from Actinic Keratoses (Aks) (USA.ex rel. Chung v. DUSA. 2020). The lawsuit was brought in the first place by an ex-employee part of the sale representative staff under the whistleblower provision. The company used tactics that are unethical and dangerous because of greed. The DUSA sale management knowingly promoting and paying physicians to mislead and lie to physicians who prescribing the product. The company lied to prescribing physicians during the incubation periods and the clearance rates that are lower than the FDA approved rates (USA.ex rel. Chung v. DUSA. 2020). This behavior and complicity caused physicians to submit false claims to Medicare and other Federal healthcare providers which is a gross violation of the False Claim Act. In August 2020, the company agreed to settle with the federal government for $ 20.75 million in Civil penalties (USA.ex rel. Chung v. DUSA. 2020). The Whistleblower is scheduled to receive $3.5 millions under the qui Tam provision. Besides, DUSA and Sun Pharma have agreed to be part of a Corporate Integrity Agreement (CIA) with the Justice Department of United States branch of the Health and Human Services Office of the Inspector General (HHS-OIG) in which there will be a Compliance Officer acting as a third party to monitor the all activities of the companies and writing reports on progress made. The Compliance Officer would have full control over all internal documents and reports directly to the CEO of the Sun Pharma.

Questions regarding the case

In August 2020, a Pharmaceutical company called DUSA was subject to a lawsuit under the whistleblower (qui tam ) provision of the False Claim Act by an ex-employee .The employee was one of the sales representatives who promote the product "Levulan Kerastick which is a prescription cream used for the treatment of the lesion of the face and scalp.

Which employees appear to have engaged in the wrongdoing? The administration of DUSA appears to have been part of the wrongdoing, as well as the sales force, and the physicians' speakers who deliberately mislead the public and other physicians in order to get paid.

What facts did the government allege about the company? What laws did the government allege were broken? The company encouraged and promoted the product in contradiction to the instruction approved by the United Stated Food and Drug Administration (FDA) and unsupported by clinical evidence (USA.ex rel. Chung v. DUSA. 2020). The Dosage and Administration label of the product that was approved by FDA was deliberately ignored and neglected. The allegation of the lawsuit according to the DOJ is that DUSA encouraged physicians to use a less and shorter incubation period rather than what approved by the FDA via physician speaker programs. DUSA organized paid physician peer-to-peer discussion and used their sales force to disseminate and mislead responses to questions from prescribing physicians (USA.ex rel. Chung v. DUSA. 2020). The law that was broken is the Qui Tam provision of the False Claim Act.

What types of documents do you think the government may have obtained to support its case? The government has a variety of documents that can be available to support the case. For example, the emails communication that DUSA used to promote the product. The recordings of many conferences of the speaker programs and paying advertising. Also, the document provided by the whistleblower that brought the lawsuit. If you were the government lawyer prosecuting the case, who do you think you would want to interview to get more information?As the lawyer of the government, I would be interviewed by the whistleblower, the prescribing physicians who have been misled and manipulated. The sales force staff who are involved in the promotion of the product, and the DUSA senior management team who knowingly allowed the process to go on. What documents would you ask the company to provide?The company would have to provide a list of the paid physicians involved in the promotion of the drug. The amount paid to the physician speakers and the sales force over the years. The FDA approved document of the product and the clinical evidence (Richer & Cooch,2024). The company would have to provide the financial sheets for the product. What third parties might have documents you would want to obtain? The third party that I would like to have documents from are the whistleblower, the physicians who have prescribed the product, and the pharmacies where the product has been sold.

If you were defending the company, who do you think you would want to interview to get more information? If I were to defend the company from the allegation brought by the government and the whistleblower would have interviewed the whistleblower, the sales force employees, the DUSA senior management involving on the sale of the product, the physicians prescribing the product, and patients or users that have good experience with the product.

What documents would you ask the company to provide to help you build a defense? The documents that I could ask for is a compliance report of oversight regarding the product, the official FDA approved documents promoting the product, senior management reports for the product, the balance sheet of product to detect all payments and kickback if any, and the whistleblower document that generated the lawsuit.

What third parties might have documents you would find helpful? The third party that could be helpful in defending the case are patients who have good experience with the Product and the Company (DUSA), ex-employees who can vow for the internal rules and regulations of the company, and physicians who prescribed other pharmaceutical products made and sold by the company.

References:

1-John Richer and Peter Cooch, (20204) LAW 6183 unit #1, Experiencing a Simulated Investigation: Food & Drug Administration.

2-United States of America ex rel. Chung v. DUSA Pharmaceuticals, Inc., No. 16 cv 1614-JLR.Updated August 24,2020