Life Science Compliance Update

Search Results for: Uncle Same Wants His Money - First Coast Cardiovascular Institute as a Case Study in Repaying Overpayments Can Generate Liability in FCA Liability

March

2018

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Uncle Sam Wants His Money – First Coast Cardiovascular Institute as a Case Study in Repaying Overpayments Can Generate in FCA Liability

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Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

In October 2017, First Coast Cardiovascular Institute, entered into an almost $450,000 settlement with the DOJ to resolve allegations that it violated the False Claims Act by knowingly delaying repayment of more than $175,000 in overpayments. This settlement involving First Coast is a substantive example of how failing to make timely repayment can bring substantial, additional liability under the FCA. Therefore, it is crucial to ensure timely repayment to and reconcile any overbalances with the U.S. Government.


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August

2016

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Misleading Survival Data Leads to FCA Liability in Recent Genentech Case

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Kaitlin Fallon Wildoner, Esq., Staff Writer for Life Science Compliance Update
The DOJ and FDA are starting to back off prosecuting cases involving just off-label claims, after making several unsuccessful attempts. However, the recent Genentech settlement may illuminate a path to success for the DOJ utilizing the False Claims Act. This article outlines the Genentech case, why it is different from other off-label cases, and what compliance officers can do to prevent their company from experiencing the same fate.


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April

2016

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The FDA Shield – The Medtronic Infuse Case and the Latest Tango of Preemption Versus Liability

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Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

The U.S. Supreme Court will shortly decide whether it will hear a case that will have a significant impact on the life sciences and medical device industry, specifically on the issue of whether approval by the Food and Drug Administration (FDA) of medical devices for “single limited use” shields and otherwise immunizes manufacturers from product liability suits results from non-FDA approved uses.


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March

2017

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Do DPA’s Work? – The BioMet Case Study

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Robert N. Wilkey, Esq., LSCU Staff Writer

On January 12, 2017, the U.S. Department of Justice (DOJ) announced publicly that Zimmer Biomet Holdings, Inc. (Zimmer BioMet) had agreed to pay a $17.4 million criminal penalty “in connection with a scheme to pay bribes to government officials in Mexico and for violations of the internal controls provisions of the Foreign Corrupt Practices Act (FCPA) involving the company’s operations in Mexico and Brazil.” This is not the first time BioMet faced allegations involving its business practices in foreign countries, and in 2012 entered a deferred prosecution agreement (DPA). The BioMet settlement highlights the significant liability life health science companies face when failing to adhere to DPAs and how large-scale settlements are used by the government to ensure industry compliance.


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January

2016

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Gold Mining – The FCA and the Emergence of the Data-Driven Whistleblower

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By: Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

The U.S. Department of Justice’s recently announced a $250 million settlement pursuant to the False Claims Act (FCA), involving over 500 hospitals in 43 different states as the result of a whistleblower qui tam lawsuit substantiating false billing claims. At first glance this case may appear as a typical FCA case, but the fundamental role of data-driven medical evidence as it relates to life science based compliance, highlights this case is substantively more significant. The industry should take immediate notice of the increasing role of data mining and analysis as a tool in qui tam lawsuits.


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March

2016

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Be Careful What You Sign Up For – Implied Certification and the False Claims Act (FCA)

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By: Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

The U.S. Supreme Court recently granted certiorari in the Escobar case from the 1st Circuit Court of Appeals that will significantly impact the way in which the False Claim Act (FCA) may impose civil liability. Given the overall purpose, scope, and intent of the FCA, we believe that the Court will seek to uphold rather than diminish the role of implied certification.


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June

2017

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Genentech & Escobar: Using Materiality to Escape False Claims Liability

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Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

In constructively bringing an end to a False Claims Act (“FCA”) whistleblower suit alleging Genentech, Inc.(“Genentech”) of defrauding Medicare by way of concealing substantive health care analytics data involving purported side effects of the company’s cancer drug Avastin the Third Circuit of Appeals in a recent decision determined that the Plaintiff in this matter had failed to demonstrate that any noncompliance had an impact on government payments. Specifically, the Court applied the prevailing standard in Escobar that an FCA lawsuit must demonstrate that any misrepresentation is “material” to the government’s payment decision. In dismissing this suit and invoking this heightened standard of materiality, the Third Circuit not only reinforces Escobar but places the now clear burden on FCA Plaintiffs to demonstrate that any noncompliance was material to alleged fraudulent payments.


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July

2017

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Punting on the Issue of FCA and Statistical Sampling

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Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

In a much-anticipated U.S. Court of Appeals decision, the Fourth Circuit on February 14, 2017, in evaluating the issue of whether the government has veto power over False Claims Act (FCA) settlements, particularly where liability is established by use of statistical sampling, opted to forego rendering a decision on such issue, and leaving wide open the use and appropriateness of statistical sampling in FCA related cases.


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August

2017

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A New Application of Escobar: Gilead or When Half-Truths Can Become Actionable Under the FCA

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Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

On July 7, 2017, the Ninth Circuit in a very closely watched opinion determined that the whistleblowers in this case had demonstrated viable claims under the False Claims Act (“FCA”), alleging that their employer, Gilead Sciences, Inc. (“Gilead”) had made false statements to the U.S. Food and Drug Administration (“FDA”) regarding its HIV drug, resulting in billions of dollars of illicit payments from the government to Gilead. Such judicial decision is highly significant in that it is the first substantive Circuit Court decision since the U.S. Supreme Court decision in Universal Health Care v. Escobar, which effectively raised the legal burden by whistleblowers to demonstrate claims under the FCA.


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January

2016

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Not to Say “I Told You So,” But… – Using Open Payments Data to Support Corporate Liability

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By: Kaitlin Fallon, JD, Staff Writer for Life Science Compliance Update

Many in the compliance industry have warned about the possibility of Sunshine Act Open Payments data being used against reporting companies in potential lawsuits. Those days were thought to be far off. However, a recent class action case against Insys Therapeutics Incorporated, et al., shows that the future is now and that Open Payment data can, and will, be used against you. This article explores both the recent case and likely ramifications.


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January

2016

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Not to Say “I Told You So,” But… – Using Open Payments Data to Support Corporate Liability

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ByL Kaitlin Fallon, JD, Staff Writer for Life Science Compliance Update

Many in the compliance industry have warned about the possibility of Sunshine Act Open Payments data being used against reporting companies in potential lawsuits. Those days were thought to be far off. However, a recent class action case against Insys Therapeutics Incorporated, et al., shows that the future is now and that Open Payment data can, and will, be used against you. This article explores both the recent case and likely ramifications.


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August

2016

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Railroad Retirement Board (RRB) First to Double-Down on DOJ’s Civil Penalties for FCA Violations

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Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

In early July of this year, the Railroad Retirement Board (RRB) became the first federal agency to implement the mandatory requirements under the Bipartisan Budget Act of 2015, the doubling of civil monetary penalties (“CMPs”) to be assessed for violations of the False Claims Act (FCA). Specifically, the new RRB final rules now increase the minimum per claim civil penalty from $5,500 to $10,781 and increasing the maximum per claim civil penalty from $11,000 to $21,563. Life science companies should be cognizant of such changes, where agencies such as the RRB, are significantly changing the landscape on how civil penalties are being calculated, imposed, and otherwise assessed against FCA violators.


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June

2018

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Everything Old is New Again – McKesson Accused of Skimming Cancer Meds in FCA Suit

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Carolyn Greene, Esq.

In response to concerns about the provenance of cancer drugs its providers received from McKesson, Omni has filed an FCA suit alleging that McKesson engaged in a scheme to increase profits illegally on cancer drugs. Specifically, Omni asserts that McKesson harvested and pooled overfill from single-use vials of cancer medications. McKesson then re-packaged these cancer drugs into pre-filled syringes. By collecting the overfill, Omni alleges that McKesson increased the number of doses of the cancer medications. This practice led to adulteration of the drugs themselves, as well as the submission of fraudulent claims to various government agencies for reimbursement on these extra doses of drugs created from the overfill. This case is yet another example of the re-occurring themes of overfill harvesting and “playing the spread” in conjunction with submission of fraudulent claims to the federal government for pharmaceutical reimbursement.


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July

2018

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The Sleeping Giant Awakens – Cantrell’s Consent Decree as a Study on How Not to Respond to FDA Enforcement Actions

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Carolyn Greene, Esq.

Cantrell Drug Company, a 503B outsourcing facility in Little Rock, Arkansas, has been subject to multiple FDA inspections over a five-year period. Each inspection found numerous deficiencies, many in critical areas relating to the prevention of microbiological contamination and aseptic processing. Cantrell defied FDA instructions and shipped products in interstate commerce. As a result, FDA referred the matter to the DOJ, which filed a civil enforcement proceeding seeking to enjoin Cantrell from further distribution. Ultimately, Cantrell entered into a consent decree with the FDA. This case played out much more publicly than similar situations, as Cantrell executives were posting comments on Twitter about the process. Unfortunately, the tone of the comments suggested that Cantrell did not take the FDA’s supervision seriously.


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    July

    2016

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    Dentsply v. Bates: Taking a “Bite” Out of False Claim Act (FCA) Violations for Lack of Evidence

    Written by , Posted in Enforcement

    Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

    Recently the U.S. District Court for the Eastern District of Pennsylvania dismissed Plaintiffs’ qui tam False Claim Act (FCA) claims, finding that the plaintiffs had failed to produce any evidence that Defendants “influenced” any health care provider to submit a false claim for reimbursement to the federal government.


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