Ifrah Law represents major health, pharmaceutical and biotechnology companies and executives in the defense of federal and state criminal prosecutions and in civil litigation.  In fact, our founding partner has been listed by Nightingale’s Healthcare News as one of 12 outstanding fraud and compliance attorneys in the U.S. and recognized by LexisNexis as an expert in healthcare and securities fraud.

We have represented some of the largest players in the healthcare and pharmaceutical industry, including pharmaceutical giant Merck & Co. In one such case, we obtained a dismissal of a complaint alleging million dollar claims under the False Claims Act. We have also successfully represented the owner of a pharmaceutical supply company who was indicted for multiple counts of false statements relating to commercial transactions in the secondary wholesale market. Through our persistence and responsiveness, we prevailed in convincing the U.S. Attorney handling the case to dismiss the indictment in its entirety.

Defending a Healthcare Provider Against Claims of Fraud

Our client, a prominent anesthesiologist, employed a medical services billing specialist to submit insurance claims for his practice and surgery center. The terms of the specialist’s contract stated that she would receive 18% of each claim she filed using a specific step-by-step submission and follow-up process.

After the billing specialist was terminated for not following the established submission procedures, she sued the doctor to retain her full commission on outstanding claims she had worked on prior to her dismissal, including those that hadn’t yet been paid. In addition to this contract dispute, she also accused our client and his surgery center of fraud, alleging that they funneled money into a “secret account” to avoid paying her commission under the contract.

Although there was very little basis for the fraud claim, the court allowed it to move forward.  Jeff understood the importance of attempting a settlement on the contract claim, so he analyzed the agreement and claims reports and devised a methodology for valuing the claim. When the plaintiff refused to settle, Jeff and the client pursued mediation with confidence, understanding both the fair value of the case and specific details of the parties’ contract. During mediation, the plaintiff’s side raised several arguments that demonstrated their lack of familiarity with the contract.  Jeff’s thorough understanding of certain provisions allowed the defendant to quickly address and dismiss the arguments.  As a result, the plaintiff ended up settling for much less than she originally claimed.

While the settlement terms are confidential, our client was thrilled with the final result, not only with the amount and the dismissal of the fraud claims, but also in terms of how well the matter was handled. 


Successfully Negotiating the Sale of Assets During a Government Investigation

When a company that is under investigation for money laundering decides to sell its assets, what was once a straightforward sales process becomes a complex negotiation. That is what happened with our client, a provider of diagnostic testing equipment.

Ifrah Law and Michelle Cohen represented the company in its sale of radiology and cardiology diagnostic services equipment, which involved numerous challenges. Understandably, the buyer was concerned about the ongoing criminal investigation, and Michelle worked closely with them to address their concerns about representations and warranties and possible post-sale seizure from the government. Additionally, since there were bank liens on some of the assets, Michelle worked with the bank’s outside counsel to arrange a prompt payoff, obtain a satisfactory pay-off letter and secure a release of the liens in order to close the deal. Michelle also worked with the buyer to create a creditor payment plan that would payoff unsecured creditors and obtain releases from them in order to address the buyer’s concerns about unsecured creditors seeking relief from the buyer. Finally, she created an employee fund (funded by the buyer) to pay for uncompensated leave time.

These complicated issues were resolved in less than two weeks, as a result of Michelle’s skilled negotiations with all parties. The buyer was represented by Delaware’s largest law firm.


Successfully Defending a Government Contractor Against a Terminated Employee’s Health Care Claim

Ifrah Law successfully defended a government contractor against claims by a terminated company employee. Our client, a health care professional supplier, faced allegations that it failed to offer the former employee COBRA insurance coverage, as required under the COBRA statute.

Ifrah Law conducted a bench trial in the U.S. District Court for the Eastern District of Virginia in January 2012. The judge sustained minimal claims and awarded the plaintiff a mere $500.

(Middlebrooks v. Godwin Corporation, U.S. District Court, Eastern District of Virginia, No. 1:10CV1306))


Securing Dismissal of a False Claims Qui Tam Suit

Jeff Ifrah successfully represented global healthcare leader Merck in a False Claims Act qui tam suit and got the case dismissed.

The suit involved a whistleblower that worked for a healthcare buying company (a group purchasing organization that purchases supplies and drugs). Terminated from the buying group, the employee alleged she was retaliated against because of issues she raised about the buying process.

The case was brought before the U.S. District Court for the Northern District of Texas, and 18 drug companies were named as defendants in an alleged bribery scheme. Jeff represented Merck, which was one of the named defendants. He filed a successful motion to dismiss the complaint, based on the former employee’s alarming lack of specificity in her claim.

Not only was our motion to dismiss successful, it was efficient: Jeff won the dismissal roughly one year after Merck and the other defendants were originally served.

(United States ex rel. Fitzgerald v. Novation LLC, et al., S.D. Tex., No. 3:03-CV-01589))


Supreme Court Expands Whistleblower Protection

The U.S. Supreme Court recently held that Sarbanes–Oxley extends whistleblower protection, not just to employees of public companies, but to employees of private contractors and subcontractors that serve public companies. In a 6-3 decision, the Court rejected the First Circuit’s narrow construction of the statute in favor of the Labor Department’s more expansive interpretation. Now more than ever, affected contractors and subcontractors need to ensure they have robust policies in place for addressing whistleblower complaints.

Congress passed the Sarbanes–Oxley Act in 2002, the year after Enron’s collapse. The Act was intended to protect investors in public companies and restore trust in financial markets. It achieved these goals in part by providing whistleblower protection: 18 U.S.C. § 1514A makes it unlawful for employers to retaliate against employees who report suspected fraud. The provision certainly protects employees of publicly traded companies. It was less clear whether § 1514A protects employees of private contractors that service public companies. The plaintiffs in Lawson v. FMR, LLC, claimed it did.

Jackie Lawson and Jonathan Lang were employees of private companies that serviced the Fidelity family of mutual funds. As is often the case with mutual funds, the Fidelity funds were subject to SEC reporting requirements, but had no employees. Private companies contracted with the funds to provide accounting and investment advisory services. In this case, the private companies were Fidelity-related entities referred to collectively as FMR. Lawson was a 14-year veteran and Senior Director of Finance for her employer, Fidelity Brokerage Services. She alleged that she was constructively discharged after raising concerns about cost accounting methods for the funds. Zang was an 8-year veteran of Fidelity Management & Research Co. He alleged that he was fired for raising concerns about misstatements in a draft SEC registration statement related to the funds. Both plaintiffs sued for retaliation under § 1514A.

FMR responded by asking the district court to dismiss the claims on grounds that § 1514A protects employees of public companies, not employees of privately held companies. The trial judge rejected FMR’s argument, but the First Circuit Court of Appeals reversed. Months later, the Labor Department’s Administrative Review Board issued a decision in another case, making clear that ARB agreed with the trial judge. Last year, the Supreme Court agreed to consider the question.

On March 4, the Court issued its opinion that § 1514A shelters employees of private contractors, just as it shelters employees of public companies served by those contractors. Speaking for the majority, Justice Ginsburg explained that the Court’s broad construction finds support in the statute’s text and broader context. As relevant to the plaintiffs’ claims, § 1514A provides, “‘No public company . . . , or any officer, employee, contractor, subcontractor, or agent of such company” may take adverse action “against an employee . . . because of [whistleblowing or other protected activity].’” Boiled down to its essence, the phrase in question states that “no . . . contractor . . . may discharge . . . an employee.” In ordinary usage, the phrase means that no contractor (of a public company) may retaliate against its own employees. After all, those are the people contractors have power to retaliate against. According to the Court, if Congress had intended to limit whistleblower protections to employees of publicly traded companies, as FMR argued, Congress would have said “no contractor may discharge an employee of a public company.” The statute doesn’t say that because Congress was not attempting to remedy a nonexistent problem. Enron did not collapse because its private contractors retaliated against Enron employees who tried to report the company’s fraud.

The Lawson Court explained further that its interpretation flows logically from the statute’s purpose to prevent another Enron debacle. Often, the first-hand witnesses of corporate fraud are employees of private companies that service a public company—law firms, accounting firms, and business consulting firms, for example. Without adequate protections against retaliation, contractor employees who come across fraud in their work for public companies will be less likely to report misconduct. The Court’s point was particularly relevant with respect to the Fidelity funds. Like most mutual funds, the Fidelity funds had no employees. A narrow reading of § 1514A would insulate a $14 million industry from retaliation claims. Congress could not have intended that result.

Given the Court’s decision in Lawson v. FMR, LLC, privately held companies that service public companies should consider how best to deal with whistleblower complaints. At a minimum, robust whistleblower policies will (i) safeguard whistleblower anonymity to the extent possible; (ii) encourage whistleblowers to exercise discretion without discouraging them from reporting misconduct; (iii) address the preservation of evidence relating to putative fraud; and (iv) establish procedures for the conduct of internal investigations into suspected fraud.


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Omnicare Decision Limits the Reach of False Claims Act

A recent decision by the Court of Appeals for the Fourth Circuit limiting the reach of the False Claims Act demonstrates how relators who pursue cases in which the government declines to intervene can end up making law that is unfavorable to the government’s enforcement of that statute.

United States ex rel. Rostholder v. Omnicare, Inc., et al., No. 12-2431, a qui tam case alleging violations of the False Claims Act (FCA), 31 U.S.C. §§ 3729, arose from a whistleblower’s claim that defendants violated certain Food and Drug Administration (FDA) safety regulations requiring that penicillin and non-penicillin drugs be packaged in complete isolation from one another.  The violation of these regulations resulted in a legal presumption of penicillin cross-contamination.  The relator asserted that the contaminated drugs were not eligible for reimbursement by Medicare and Medicaid and, therefore, claims presented to the government for reimbursement of these drugs were false under the FCA.

In affirming the district court’s grant of Omnicare’s motion to dismiss, the Court of Appeals focused on the specific requirement of the FCA that there be a claim that is, indeed, false.  The Court noted that the statutes providing for reimbursement require that the drug in question be approved by the FDA but these statutes do not require compliance with FDA safety regulations as a precondition for reimbursement.

The Court therefore held that, while the cross-contamination might be a violation of safety regulations, it did not transform Omnicare’s requests for reimbursement into false claims.  The Court observed statements in its own earlier cases that “the correction of regulatory problems is a worthy goal, but is ‘not actionable under the FCA in the absence of actual fraudulent conduct.’”  (citing Mann v. Heckler & Koch. Def., Inc., 630 F.3d 338, 346 (4th Cir. 2010)).  If it were “to accept relator’s theory of liability based merely on a regulatory violation,” the Court noted, “we would sanction use of the FCA as a sweeping mechanism to promote regulatory compliance, rather than a set of statutes aimed at protecting the financial resources of the government from the consequences of fraudulent conduct.”  Given the FDA’s “broad powers to enforce its own regulations,” to permit the FCA to be used in this manner “could ‘short-circuit the very remedial process the Government has established to address non-compliance with those regulations.’”  (citing U.S. ex rel. Wilkins v. United Health Grp., Inc., 659 F.3d 295, 310 3d Cir. 2011)).

Based on these principles, the Court of Appeals found that the relator had failed adequately to allege the existence of a false statute or fraudulent conduct, and that he could not plausibly allege that Omnicare acted with the requisite scienter when submitting the claims in question to the government.

This Court of Appeals decision could offer support for companies in highly regulated industries that face qui tam cases under the False Claims Act that arise from violations of safety regulations.  In industries such as pharmaceutical manufacturing and packaging in which payment reimbursements are not expressly tied to compliance with safety rules, those companies may face regulatory enforcement for those violations, but will not also face assertions that they have also violated the False Claims Act.

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Healthcare Fraud Recoveries at All-Time High Since 2009

Fiscal year 2013 marked the fourth consecutive year in which the Department of Justice has recovered at least $2 billion from cases involving charges of healthcare fraud.  Make no mistake: these record-setting yields were no accident.  The Obama Administration has prioritized busting healthcare fraudsters since it took office, and for good reason.  A 2009 analysis by the AHIMA Foundation, estimated that only 3 to 10 percent of healthcare fraud was being identified. To help crackdown, Attorney General Eric Holder and Human Services Secretary Kathleen Sebelius formed the Health Care Fraud Prevention and Enforcement Action Team (HEAT) in 2009.The Government also launched in an effort to curb ongoing fraud. From January 2009 through the end of the 2013 fiscal year, the Justice Department used the False Claims Act to recover an unprecedented $12.1 billion in federal healthcare dollars.

In this past year alone, DOJ successfully recovered $2.6 billion. More than half of that amount related to alleged false claims for drugs and medical devices under federally insurance health programs, including Medicare, Medicaid and TRICARE.

Many of the DOJ settlements involved allegations that pharmaceutical manufacturers engaged in “off-label marketing” –that is, promoting sales of their drug products for uses other than those for which the Food and Drug Administration (FDA) approved them.  A notable “off label” settlement was with Abbott Laboratories, which paid $1.5 billion to resolve allegations that it illegally promoted the drug Depakote to treat agitation and aggression in elderly dementia patients and schizophrenia – neither of which was the use for which the FDA had approved the drug as safe and effective.  Abbott’s settlement included $575 million in federal civil recoveries, $225 million in state civil recoveries and nearly $700 million in criminal fines and forfeitures.  DOJ also reached a settlement in 2013 with biotech giant Amgen, Inc., which paid $762 million (including $598.5 million in False Claims Act recoveries) over allegations that included promotion of Aranesp, approved to treat anemia, in doses and for purposes not approved by the FDA.

DOJ settlements in the past year also addressed allegations of the manufacture and distribution of adulterated drugs.  For example, in May, Ranbaxy USA Inc. paid $505 million, including $237 million in federal civil claims, $118 million in state civil claims and $150 million in criminal fines and forfeitures, due to adulterated drugs from its facilities in India.

Kickbacks were the subject of other DOJ enforcement in 2013.  DOJ obtained a $237 million judgment against Tuomey Healthcare System Inc. after a four week trial. Tuomey was accused of violations\ the Stark Law (which prohibits hospitals from submitting Medicare claims for patientsreferredto the hospital by physicians with a prohibited financial relationship with the hospital) and the False Claims act.  Tuomey’s appeal is pending; if upheld, the judgment will be the largest in the history of the Stark Law.  DOJ’s $26.3 million settlement with Florida dermatologist Steven J. Wasserman M.D., arising from allegations of illegal kickbacks from a pathology lab, was one of the largest with an individual in the history of the False Claims Act.

DOJ Civil Division’s Consumer Protection Branch was likewise active during 2013, obtaining 16 criminal convictions and more than $1.3 billion in criminal fines, forfeitures and disgorgement under the Federal Food, Drug and Cosmetic Act.

These numbers make clear that DOJ continues to view healthcare fraud as a priority.  Providers and others who operate in this highly regulated space ignore this law enforcement focus at their peril in 2014.

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Online Pharma Exec Gets 4 Years in Prison for Selling Foreign Drugs in U.S.

Andrew Strempler, a Canadian citizen who helped to pioneer the cross-border online pharmacy industry, was sentenced on January 9, 2013, to four years in prison in connection with allegations that his former company sold fake and misbranded drugs to U.S. citizens.

The sentence follows Strempler’s guilty plea in October in federal court in Miami to a charge of conspiracy to commit mail fraud. Strempler also agreed to forfeit $300,000 and pay a $25,000 fine. A hearing will be held to determine if Strempler will also need to pay restitution.

Strempler operated companies that sold foreign pharmaceuticals to consumers in the United States, where drug costs are significantly higher than in other countries. The drugs were obtained in markets with lower prices on drugs, but the U.S. government has long taken the stance that selling these drugs is illegal because the sources of the drugs could not be assured.

Under the plea agreement, the guidelines range for Strempler’s sentence would be 46 to 57 months, on a charge that carries no mandatory minimum sentence. The government recommended a sentence of 57 months. Prosecutors had originally sought up to 20 years in prison and the forfeiture of $95 million.

Counsel for Strempler asked the court for a downward variance and a sentence of 24 months. Strempler’s attorneys argued that since he is a Canadian citizen, any sentence imposed on him would be more difficult and onerous than an identical sentence imposed on an American citizen. They contended that he would likely not be assigned to a minimum security prison, even though he would likely otherwise qualify based on the nature of the offense and his lack of criminal history. Additionally, as a Canadian citizen Strempler would not be allowed to participate in an early release to a community corrections facility. After he serves his sentence he will be sent to immigration custody, where he will likely be held until his removal from the country.

Strempler’s attorneys also noted that the pre-sentence investigation report states that “there is no evidence that any victim sustained an actual loss or physical injury as a result of this offense.” Additionally, the forfeiture judgment of $300,000 to the government that Strempler agreed to pay prior to sentencing was nearly doubled the agreed-to loss amount.

According to court papers, Strempler believed that the drugs his company was selling were “safe and effective,” and his attorneys noted that he purchased the same drugs for his family and had sample drugs tested by a lab in Canada. His attorneys argued that he did not act with malice and had no actual belief that the drugs were fake and ineffective. He believed that the drugs were safe because they were purchased in accordance with the regulations of foreign countries.

The court essentially rejected the arguments by Strempler for a more lenient sentence and went along with the government’s request for a lengthy sentence. It appears to us that Strempler received a long sentence for a first-time nonviolent offender who did not act with malice. It seems that this is more of a regulatory violation parading in the clothing of a criminal case.

By asking for such a significant sentence, the government may have been trying to serve notice that this type of case will not be taken lightly. Given the stance taken by the prosecution in this case, it will be interesting to see if this leads to further prosecutions for related offenses.

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Are the Feds Enlisting FedEx to Police the Illegal Pharma Market?

The government may be coming up with a new cost-effective measure to help balance the federal budget – enlisting private companies to do their policing. A 2011 settlement between the Justice Department and Google for $500 million is one recent example. Under the settlement, Google acknowledged responsibility for improperly aiding rogue pharmacies by allowing the pharmacies to post ads through the search engine’s AdWords program. Google not only agreed to forfeit this sizable sum (one of the largest in history by a U.S. company), it also agreed to new compliance and reporting measures. And that is after the company, on its own initiative, took steps to block foreign-based pharmacies from advertising in the United States.

Currently in the works are similar investigations by the Drug Enforcement Agency of FedEx and UPS. The shipping companies have been targets of a criminal probe dating more than four years into whether they aided and abetted illegal drug sales from online pharmacies. As the investigations are still ongoing, it is unclear what the extent or type of evidence against them may be. What is clear is that at least one of the targets is asserting its innocence and plans to defend itself vigorously. While UPS has announced that it is in settlement talks that would involve upgrading its compliance program, FedEx has come out with gloves on, pronouncing that “settlement is not an option when there is no illegal activity.”

UPS’ (and Google’s) course of action is understandable: Companies commonly do a cost-benefit analysis between settling and defending and determine that settlement is a better business decision. But it is good to see FedEx taking the higher, though riskier, road. A brief review of relevant law supports FedEx’s stance. For instance, common carriers are specifically excluded from liability under the Prescription Drug Marketing Act (PDMA): the implementing regulations provide that “distributing” under the Act does not include “[d]elivering or offering to deliver a drug by a common carrier in the usual course of business as a common carrier.” Interestingly enough, the FDA “on its own initiative” had revised its final rule to exclude common carriers.

The FDA’s earlier determination to exclude common carriers made sense, as it would be prohibitively expensive and potentially crippling to put shipping companies on the hook for packages that pass through their system. But the tides are changing, and federal agencies seem less concerned with the broad and adverse economic impact upon private companies and are more focused on how they may use those companies to do their bidding. As FedEx spokesman Patrick Fitzgerald noted, the government wants to “deputize” FedEx delivery to help “catch criminals.”

This type of effort by the feds can be quite effective, as can be seen from the Google settlement and impending UPS settlement. A federal enforcement agency launches an investigation that may be both extensive and costly to a company. The company does its cost-benefit analysis and determines it more efficient to simply pay a fine and institute a government-directed compliance program than to defend itself. The government thereby has a direct and simplified road to instituting new policies, company-by-company, through its settlement agreements. And all this can be accomplished without having to trouble itself with notice and rulemaking procedures. This process plays out frequently, which is what makes FedEx’s stance so refreshing.

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