Device manufacturer’s misrepresentations result in $12.5M FCA settlement

Medical device manufacturer AngioDynamics, Inc., settled with the United States for $12.5 million following allegations that the company caused health care providers to submit false claims related to the use of the LC Bead® and the Perforator Vein Ablation Kit® (PVAK) to Medicare, Medicaid, and other federal health care programs. The government alleged that the manufacturer both provided instructions to use inaccurate billing codes and misrepresented Medicare billing policy related to the devices. The settlement came as a result of a suit filed under the whistleblower provision of the False Claims Act (FCA) (31 U.S.C. § 3729).

LC Bead allegations

The medical device manufacturer will pay $11.5 million—$10.9 million paid to the federal government and $600,000 paid to state Medicaid programs—to resolve allegations that the company caused the submission of false claims for procedures involving an unapproved drug delivery device marketed with false and misleading promotional claims. The government alleged that between 2006 and 2011, AngioDynamics served as the distributor for the manufacturer of the LC Bead and marketed the product for use as a drug delivery device in combination with chemotherapy drugs. Employees of the manufacturer routinely claimed that this use of the LC Bead was “better,” “superior,” “safer,” and “less toxic” than alternative treatment, despite lack of clinical evidence to support the statements and despite the FDA’s repeated declination to approve the product. Knowing that many insurers did not provide coverage for certain LC Bead procedures, the company instructed health care providers to use inaccurate billing codes for claims related to these uses.

PVAK allegations

AngioDynamics will also pay $1 million to resolve allegations that the company caused the submission of false claims in connection with the use of PVAK, used to close or collapse malfunctioning veins and which was approved by the FDA only for use in treating superficial veins and not for perforator veins. The manufacturer voluntarily recalled the PVAK and reissued the product under the name “the 400 micron kit.” Despite the recall and rebranding, certain AngioDynamics employees took part in a continued campaign to market the device to treat perforator veins, falsely representing to providers that Medicare would cover this use

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Draft guidance seeks to make drug labels clear, concise, more consistent

In an effort to assist applicants in writing the Indications and Usage section of labeling for human prescription drug and biological products, the FDA issued a new draft guidance. The FDA’s intent is to make information in prescription drug labeling easier for health care practitioners to access, read, and use. The goal of the guidance is to help ensure that the labeling is clear, concise, useful, and informative and, to the extent possible, consistent in content and format within and across drug and therapeutic classes (Notice, 83 FR 31759, July 9, 2018).

Indications

The Indications and Usage section should clearly communicate the scope of the approved indication, including the population to which the determination of safety and effectiveness is applicable. The guidance includes information on how and when evidence may support approval of an indication that is broader or narrower in scope than the precise population studied.

The indication should begin “Drug X is indicated” and be followed by the disease, condition, or manifestation of the cease or condition being treated, prevented, mitigated, cured, or diagnosed, and when applicable other information necessary to describe the approved indication. The other information may include selected patient subgroups or disease sub populations for whom the drug is approved, adjunctive or concomitant therapy or therapeutic modalities to use before initiation drug therapy, or specific tests needed to select patients in whom to use the drug.

Limitations of use

Limitations of use should be presented separately from the indication and should only be included when the awareness of such information is important for practitioners to ensure the safe and effective use of the drug. Limitations of Use are appropriate for drugs for which there is reasonable concern or uncertainty about effectiveness or safety in a certain clinical situation, drugs approved without evidence of benefits known to occur with other drugs in the same class, or drugs with dose, duration, or long-term use considerations.

Language

Certain products have statutory or regulatory required or recommended language for the Indications and Usage section. The guidance includes preferred wording and wording to generally avoid. For example, the guidance explains why it is better to use the phrase “reduce the risk” or “reduce incidence of” rather than using “prevent” in the indication. It also discusses when the terms “only” and “also indicated” should be avoided. Finally, product should be identified by the proprietary name or trade name if it has one, and other information such as the dosage form, and route of administration should not be included in the indication.

 

No abuse of discretion pill mill trial procedure, sentencing vacated and remanded

The trial court did not abuse its discretion when it admitted expert testimony deemed admissible under Daubert, a federal appellate court has ruled. The testifying physician relied upon several sources that are generally accepted by the medical community when he reviewed the prescribing physician’s patient files, and he applied his methodology reliably. The court also did not err when it gave the pattern jury instructions on deliberate ignorance without tailoring the instruction to the facts of the case, nor when it refused to give the physician’s proposed jury instructions. However, the trial court did err when it applied the firearms increase in the course of sentencing the physician (U.S. v. Roland, June 14, 2018, per curiam).

Pill mill operations

In August 2014, an Atlanta-area physician was charged in a 22-count indictment with conspiracy to dispense controlled substances and related violations. All of the alleged activities arose from his and his co-conspirators’ participation in a “pill mill” scheme involving several pain management clinics in the greater Atlanta area. A jury convicted the physician on one count of conspiracy to distribute controlled substances and seven counts of unlawful distribution of controlled substances, in violation of 21 U.S.C. §841. The district court sentenced him to 130 months of imprisonment. On appeal, he challenged his convictions and his sentence.

Expert testimony

The government’s expert witness described the standards set forth in the Federation of State Medical Boards’ model policy for the use of controlled substances to treat pain (FSMB), and he also relied upon several other sources that are generally accepted by the medical community when he reviewed the physician’s patient files. The expert witness summarized each of the guidelines in order to analyze the physician’s prescribing practices, and he then individually compared 96 patients’ files to this analysis, pointing out instances where the physician failed to adhere to the guidelines’ standards. The appellate court found that by commenting on and making conclusions about the physician’s care for each patient based on the review criteria, the expert witness applied his methodology reliably and did so without relying exclusively on his own experience as a prescribing physician. Accordingly, they found that his expert testimony met the required standards, and that the expert testimony was properly admitted.

“Deliberate ignorance” jury instruction

The government had requested that the pattern jury instruction on deliberate ignorance be modified by adding a sentence that “in this example, you would treat the defendant as having knowledge that the package contained a controlled substance.” The physician requested that the district court omit the deliberate ignorance instruction entirely, arguing that the instruction did not make sense based on the theories presented at trial: his theory was that he was deceived by a co-conspirator and did not know that he was working at pill mills, while the government’s theory was that the physician possessed actual knowledge that the clinics were pill mills. Therefore, neither party had raised an argument as to deliberate ignorance. The district court denied both parties’ requests and gave the pattern deliberate ignorance instruction. The appellate court ruled that the trial court did not err in giving the deliberate ignorance jury instruction based on the fact that the evidence presented at trial warranted it because the physician had advised a co-conspirator to lie to the Georgia Composite Medical Board, and because he had explained to his patients that he needed to write the prescriptions in a certain way in order to avoid criminal liability.

Firearms increase at sentencing

The district court cited two reasons for the firearm increase: (1) the co-conspirator’s security guard possessed a firearm while monitoring the parking lots at the clinics; and (2) several firearms were found in the physician’s bedroom at his own clinic. However, the appellate court found that the district court erred in applying §2D1.1(b)(1) of the U.S. Sentencing Guidelines Manual, a firearm increase, for two reasons. First, the evidence showed that the co-conspirator alone hired the security guard, and the government presented no evidence that the physician ever interacted with the guard or knew he had a firearm; and second, because the physician was a licensed firearm instructor and his possession of so many firearms was simply a reflection of his hobby.

For the foregoing reasons, the physician’s convictions were upheld, but his sentence was vacated and the matter remanded for resentencing.