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Health Care Fraud and Abuse Class Three: Taking on Theories of Liability

This week’s class at BU Law School in Bob Thomas’ course on Health Care Fraud and Abuse started the deep dive into theories of liability under the False Claims Act, and recent ways in which the law has evolved.

 

Starting with the language from the False Claims Act, the question of what actually is “false or fraudulent” within the meaning of the law was a good place to start.  Most “claims” are on their face truthful (e.g., provider treated patient in XYZ manner on ABC date), so how does the statute capture concepts of falsity or fraud in these circumstances?  If a doctor’s medical judgment has been polluted by a kickback or by illegal off-label promotion, for example, how does that make the doctor’s claims for reimbursement “false or fraudulent”?

 

Courts grappling with this question came up with their own body of judge-made law, using concepts of “express” and “implied certification” to hold (sometimes) that as a “condition of participation” in government health care programs or a “condition of payment”, there can be embedded in every claim an express or implied certification of compliance with applicable laws.  Thus, the argument goes, the government requires that contractors obey applicable laws and contracts only for “taint-free” services and is entitled to reimbursement where claims, even those that on their face are truthful, have been tainted by illegality.  The entity engaged in the bad conduct “caused” the doctor to submit a tainted claim, the theory goes.

 

Some courts have had trouble with these concepts, particularly where the non-compliant activity was, relatively speaking, trivial in nature or something that the paying government agency was already well aware of.  The Supreme Court recently clarified this complicated landscape — to a degree — in its Escobar decision of 2016.   In Escobar, the Court held that “implied certification” is a valid theory of liability, BUT that only false claims “material” to the agency’s payment determination would count for liability under the FCA.   In other words, if the transgression, had it been known, would have had a reasonable chance of changing the agency’s decision to pay the claim, then it’s material.  Lawyers have been quick to point out, however, that “materiality” is a factual question requiring discovery from government agencies.  So while it may be easier for whistleblower suits to survive initial legal challenges (motions to dismiss), the discovery phase of a case could be tricky as defense lawyers try to prove that a paying agency such as the Center for Medicare and Medicaid Services (“CMS”) was sufficiently aware of the issue and didn’t care enough about it to deny the claims.  Lots of work for lawyers ahead on that front.

 

As an example of an “implied certification” type claim, the seminar explored the current state of liability theories relating to “off-label promotion” of drugs and/or medical devices.  This theory, long a favorite of prosecutors, is premised on the notion that the marketing of unapproved uses of drugs or devices can lead to FCA liability.  While doctors are free to write prescriptions off label, companies are constrained by regulations from the Food and Drug Administration (“FDA”) in what they can say to promote such uses.  Running afoul of those restrictions has landed many a company in hot water on the theory of implied certification:  that claims are valid only if they are not tainted by illegal activity that caused the claim to happen.

 

Recently, however, the defense bar has successfully argued for a free speech (First Amendment) limitation on such FDA regulation and FCA liability.  The argument, successfully advanced in a Second Circuit case known as Caronia, is that if there is nothing false or misleading about off-label promotion, it must be protected by the “commercial speech” doctrine under the First Amendment.  The Supreme Court has not taken this question up directly, so Caronia is the law only in the Second Circuit Court of Appeals, but prosecutors are now forewarned that any off-label case they bring should include, at a minimum, some showing of falsity or deception, or some material omission in the communications in order to survive a defense challenge under the First Amendment.

 

Finally, as a way of tying together some of these concepts of “materiality” under Escobar and deceptive marketing, the class examined the tricky fact pattern that is often presented in off-label scenarios:  where the FDA has expressly not approved a certain use, but CMS has decided, based on available data in certain “compendia”, to reimburse off-label claims anyway.  Under Escobar, the fact that the paying agency is aware of the off-label promotion and literature, even reviews it, and pays the claim anyway makes prosecution of an off-label case highly problematic.  A prosecutor or whistleblower lawyer would need, for an FCA case to survive, substantial evidence of false and deceptive practices, or other illegal conduct like kickbacks, to keep such a case alive.

 

Speaking of kickbacks, that’s what the class will talk about next week.

Second Session in Health Care Fraud and Abuse Seminar Focuses on False Claims Act

At BU yesterday, the Health Care Fraud and Abuse did its first deep dive into the False Claims Act, the government’s primary weapon in this field and an extraordinarily versatile tool.  The statute allows federal prosecutors to seek treble damages, plus penalties of $11,000 per false claim, plus possible exclusion and debarment from the government health insurance programs.

 

 

For reading, the class took on the statute itself, as well as Department of Justice statistical records showing how much money has been recovered over the years via the False Claims Act (over $40 billion).  Moreover, the trend is clear that increasingly each year, the government relies on whistleblower suits for its investigative leads, as these suits now account for a greater amount of recovery that suits initiated by the government itself.

 

 

Several key points were stressed in the review of the statute:

 

 

How the liability provisions include not only the submission of false claims but causing them to be committed, conspiring to have them be submitted, and also the retention of overpayments.

 

How the intent standard of the law does not require “specific intent” but can be satisfied with a lesser showing of intent, like “reckless disregard” for the law.

 

How certain hurdles are embedded on the statute that can make success in these cases difficult to predict, like:  the first to file requirement, the public disclosure bar, the Rule 9(b) specificity pleading standards, and 4) the “government knowledge” and “materiality” issues.  And

 

How the federal FCA and 30 state FCAs inter-relate and how law enforcement coordinates on these matters.

 

 

Of course, we covered as well the role of whistleblowers and their counsel in identifying these cases, bringing them to the government, and helping the government investigate and prosecute them.

 

 

The students asked excellent questions throughout.

 

 

Next week:  The FCA in action:  theories of liability, First Amendment defenses to “off-label” cases, and the new materiality standard of Escobar.

Health Care Fraud and Abuse Starts New Session

Happy day after Labor Day, everyone!  And welcome back to work after what we hope was a great summer.

 

Here in Boston, the Labor Day Weekend avalanche of students moving back in to their living arrangements is mostly behind us (there are so many colleges and universities here that the U-Haul companies run out of trucks and vans this time of year).  It’s always quite a buzz.

 

At BU Law School this afternoon, Whistleblower Law Collaborative attorney Bob Thomas will be starting his seminar on “Health Care Fraud and Abuse,” a 13-part semester long course on the intricacies of the fraud and abuse problem in our health care system and what is being done about it.  (For a glimpse of how the course goes, here’s the syllabus.)  This is the seventh time Bob has taught the course at BU, and it remains a popular one among students.  Last year’s student comments included:

“Best class I’ve taken at BU.”

 

“Professor Thomas has proven to be one of my favorite professors in my time in law school.  His ability to foster enthusiasm and interest is a valuable and rare quality.  He is an asset to the faculty here!”

 

“Fantastic course!”

 

Today’s introductory class will cover the big picture:  how did the health care fraud problem come to exist?  What is the scope of the problem, and why is it so easy to defraud government health insurance plans, as well as private plans?  Who is working to slow down this problem, and what tools do they have at their disposal?  Finally, we will talk about the many different professional opportunities for young lawyers in this dynamic area of the law.

 

We will endeavor to post updates on the course each week.

Data, Databases and Disclosure – What Can Whistleblowers Do with Publicly Available Data

A little known provision, of the Affordable Care Act, Section 6002, requires pharmaceutical companies and device manufacturers to report the payments they have made directly to physicians.  42 U.S.C. § 1320a-7h. The law also requires the Centers for Medicare and Medicaid Services to maintain a database of these payments and to release annual reports detailing this data, which they do annually a year behind the submission date. The Centers for Medicare and Medicaid Services recently released its 2016 data on payments to doctors by pharmaceutical and device manufacturers. The big headline is that industry paid more than $8.2 billion to physicians last year, slightly up from $8.1 billion in 2015.

 

As Biopharmadive reported, giants like Roche and Novartis spent hundreds of millions on physicians, with around half going to research projects and the rest to benefits like travel and consulting fees. Some, like GlaxoSmithKline, claimed they have cut back on payments for speaking engagements, but the data still shows the company paying $901,917 to doctors for such payments.

 

CMS warns that inclusion of particular payments in the database does not indicate “any wrongdoing or illegal conduct.” 78 Fed. Reg. 9457, 9460 (Feb. 8. 2013). There can be many legitimate reasons for a company to pay a doctor, for example for running a research project while being compensated at fair market value. Nevertheless, some of the largest False Claims Act cases in history have been based on companies paying kickbacks to physicians and fraudulently misrepresenting them as legitimate payments. For example, in 2016 Forest Laboratories and Forest Pharmaceuticals paid $38 million to resolve allegations that they had paid doctors kickbacks as part of speaker programs, and earlier this year Shire PLC Subsidiaries paid $350 to settle allegations that it had paid physicians kickbacks for bogus case studies and speaking engagements.

 

CMS data makes it increasingly easy to scrutinize these payment relationships by looking up the physician recipients of pharmaceutical payments in other databases, such as CMS’s Medicare Part D utilization datasets. Such data show what doctors are prescribing (and billing to the government). Some entities have created tools such as Propublica’s Prescriber Checkup, which links data from these and other sources to provide a more fulsome picture of physician and industry activity. Looking up companies of interest in these databases can provide additional evidence to supplement a whistleblower’s personal knowledge.

 

The extent to which such data can support an FCA case alone is more questionable. The FCA has a public disclosure bar that requires courts to dismiss actions based on certain public disclosures unless the whistleblower has information that “is independent of and materially adds to the publicly disclosed allegations or transactions.” 31 U.S.C. § 3730(e)(4). Those public disclosures include federal hearings, congressional, Government Accountability Office or other federal reports, or the news media. Case law has established that allegations released by government agencies through the U.S. Freedom of Information Act fall under the public disclosure bar. Schindler Elevator Corp. v. United States ex rel. Kirk, 563 U.S. 401, 410-11 (2011).

Whistleblower Law Collaborative & Our Client Help the Government Recover $13.5 Million For Healthcare Fraud

Helping whistleblowers report and prosecute fraud can be difficult and exhausting work for both the relators and their attorneys. When doing this work it’s important to celebrate successes. Along these lines, we are thrilled to announce that the United States settled a False Claims Act case brought by our client  against three companies, Medi-Lynx Cardiac Monitoring, LLC, AMI Monitoring, Inc., Spectocor, LLC, and individual defendants who had concocted a scheme to cause unwitting physicians to order their most lucrative services regardless of medical necessity or reasonableness.

 

As part of their service, defendants utilized an online enrollment portal that steered physicians to select the highest reimbursing monitoring service, even though less expensive monitoring services were often medically appropriate. Through this scheme, defendants submitted, and caused the submission of, false claims to Medicare for unnecessary and unreasonable telemetry services. Under the terms of the settlement, defendants have agreed to pay some $13.5 million to resolve these claims.

 

Our client, Eben Steele, an employee of AMI/Spectocor, had worked in the industry for many years and believes that healthcare companies should serve their patients’ needs, not line their own pockets. He was “offended by this underhanded scheme. Not only was it overriding the doctor’s judgment about what the patient needed, but it was lining the Defendants’ pockets at the expense of the taxpayer.”  Mr. Steele approached us in late 2013 to see if, together, we could do something to stop this fraud.   After investigating his allegations, compiling his evidence,  and conducting research, we drafted and ultimately filed his Complaint under seal in March 2014 and then served the Complaint along with a statement detailing his evidence on the government.  We then worked with the government over the course of the next three plus years until the settlement.

 

One of the most important factors in ensuring success for an FCA complaint is filing it in a district where the government prosecutors have the expertise and enthusiasm to ensure success. We filed Mr.  Steele’s complaint in the district of New Jersey, permitting us to work with the excellent office there. We simply cannot overstate the outstanding work of AUSA Bernard Cooney, who prosecuted this case from the beginning with the assistance of AUSA Andrew Caffrey, along with support provided by investigators in the Office’s Health Care & Government Fraud Unit and at the Office of Inspector General of the Department of Health and Human Services.”

 

Whistleblowers like Mr. Steele are vitally important in the fight against government fraud. Under the FCA, a private citizen-relator who suspects or knows of fraud against the government can act as a whistleblower and file a sealed complaint on behalf of the government. If the case is successful, as it was here, the relator is entitled to a share of the government’s recovery. In this case, after several years of hard work by Mr. Steele, his attorneys, and government prosecutors, our client will receive some $2.43 million for his part in stopping an ongoing fraud against the government was stopped, and helping ensure that government victims were compensated.

 

We offer Mr. Steele our congratulations and deep gratitude for his efforts on behalf of the government.

Whistleblower Dilemma: Should I Sign A Release?

Many whistleblowers we work with at the WLC are reporting fraud against their own employer, and are also in the process of leaving the company — either voluntarily or due to retaliation. Roughly a quarter of our clients are faced with a particularly stark dilemma: sign a release that waives the right to a whistleblower reward, or forfeit a severance payment. Employers regularly make signing such a release a condition of severance even when the payment was promised and counted on by employees. A company aware of its potential liability has an even greater incentive to structure severance payments to buy former employees’ silence. While severance payments are far smaller than the potential False Claims Act (FCA) rewards (which can include damages for retaliatory denial of severance as well as a share of the government’s damages), the promise of immediate financial assistance during a time of transition can be difficult to pass up in favor of the uncertain hope for a share of the government’s recovery after years of investigation or trial.

 

There is no one right answer to this dilemma, but one imperative is clear: never sign an employment release until you’ve sought legal advice, not just from an employment attorney but, from a specialist alert to the nuances of this area of whistleblower law.

 

Some whistleblower laws, such as the SEC whistleblower program, specifically forbid waivers of the right to a reward. Any release that requests you do so is not only unenforceable, but constitutes a separate illegal act on the part of the employer. Indeed in January, the SEC reached a $340,000 settlement with asset manager Blackrock, Inc. over charges it improperly included such waivers in the separation agreements for exiting employees. Upfront confidentiality agreements prohibiting communication of wrong-doing to the SEC can also be actionable as “pretaliation.”

 

Releases of FCA liability are always unenforceable because liability for fraud against the government can only be released by the government, not by a whistleblower or potential whistleblower. However, waivers of a putative relator’s right to collect a future reward have been enforced by some courts, but generally only if the government was already informed of the fraud allegations. Courts enforcing these agreements have reasoned that where the government was so informed, the public policy argument justifying these awards doesn’t apply.

 

Last year, the Second Circuit Court of Appeals interpreted this narrowed enforcement rule in United States ex rel. Ladas v. Exelis, Inc. , 824 F.3d 16 (2nd Cir., 2016). The court held that a contractor’s vague disclosure to the government regarding a change in its manufacturing process was not sufficient to put the government on notice of its fraud to justify enforcement of a release. The court noted that the contractor downplayed the change as “inconsequential,” didn’t disclose that it had changed the adhesive it was using, and failed to reveal that there was any kind of fraud or fraud allegation. Ladas represents relatively good news for whistleblowers who have already signed a release, as it suggests that employers who haven’t been fully candid with the government may not be able to enforce the agreement even in jurisdictions that would otherwise permit it.

 

However, for whistleblowers who haven’t signed releases, there’s still a need for caution. Determining which disclosures will be deemed sufficient to justify a release is a highly fact-dependent inquiry and very difficult to predict at the beginning of a case. See, e.g., United States ex rel. Ritchie v. Lockheed Martin Corp., 558 F.3d 1161, 1170 (10th Cir. 2009) (disclosures of what employer considered “baseless” allegations of fraud deemed sufficient to serve the policy interest in disclosure). Moreover, a potential whistleblower may not know what facts, if any, their employer has disclosed. Furthermore, sometimes a potential relator has already disclosed information to the government through a pre-filing disclosure or tip to the government before filing an FCA complaint in court.

 

Ultimately whether a release is upheld will depend on a court’s views and biases about the whistleblower and the defendant’s motives. Even in the best of circumstances, predicting these outcomes is nuanced and uncertain. For a potential whistleblower facing the prospect of unemployment, it is not a determination that should be made alone. It requires competent legal advice based on the facts of the case, the precise law of the filing jurisdiction, and the client’s situation.

Photo credit: Adapted from BSG Studio

Really Expensive Food You Didn’t Know You Bought

By Robert M. Thomas, Jr.

How much can you spend on overpriced bananas?

 

Quite a bit, it turns out. Late last week the government announced a $344-million-dollar settlement in a case filed thirteen years ago under the False Claims Act (“FCA”) by a whistleblower alleging that Kuwaiti food contractor Agility was over-charging the military for fresh fruits and vegetables delivered to U.S. troops during the Iraq war. $344 million. I don’t know about you, but that seems like quite a food bill to me.

 

The case was brought under the FCA, as are many of the cases we bring at the Whistleblower Law Collaborative in Boston. One of the many interesting aspects of False Claims cases is their scale. Small discrepancies, or seemingly insignificant mark-ups, can in the context of large contracts, yield huge dollars in illegal profits. Yes, even for fruit and vegetables. In the Agility case, the $344 million was $95 million in damages, plus another $249 million in claims submitted that the company agreed to withdraw as inappropriately charged.

 

In a normal transaction, a 5% mistake, say an extra $2.50 on a $50 dinner bill, is negligible. Depending on one’s attentiveness or neurosis about money, one might choose to ignore it rather than going back to the restaurant to complain or ask for the money back.

 

However, when you add a bunch of zeroes to the number, things start to look different. A 5% fraud rate on a $100 million contract is $5 million in single damages (but could be trebled to $15 million under the FCA). A 5% fraud rate on a $1 billion contract is $50 million, before possibly being trebled. The Iraq War cost several trillion dollars all told. You start to see the nature of the problem.

 

Similarly, during the “Big Dig” highway project here in Boston a few years ago, where the feds agreed to underwrite the sinking of an interstate highway below the city’s streets, the price tag evolved from one billion to two, and then seven, ten, eventually fourteen. How does that happen? The steady drip, drip, drip of contract amendments, change orders, and the like, and next thing you know the taxpayers are paying fourteen times what was agreed to. Whistleblowers eventually came forward (towards the end of the project) to explain the mischief in the project’s finances, which had ballooned out of control.

 

Another source of FCA fraud cases on an enormous scale is the government health insurance programs, such as Medicaid and Medicare. These are a huge problem for much the same reason (a 90% compliance rate in a trillion-dollar health care economy translates into a $100 billion per year problem). Health care fraud cases constitute the majority of our FCA cases at the Whistleblower Law Collaborative. Why are these so prevalent? Because federal reimbursement systems are largely based on a type of honor code: the systems allow the contractor to submit claims electronically, and coding manipulations can be hard to detect in the absence of a witness coming forward to help the government see what it cannot see on its own. The government typically pays the claims and chases the bad ones after the money’s been paid out, the so-called “pay-n-chase” model. For people and entities willing to engage in gamesmanship, it’s a lucrative game to manipulate these vulnerable honor systems. Whistleblowers have become the government’s primary weapon for making the lucrative game more risky — and for recovering the money wrongfully obtained.

 

False Claims Act cases can arise in any number of situations in which the government spends money. The Pentagon’s massive expenditures are certainly fertile ground. As documented in L.A. Times reporter Chris Miller’s 2007 book, Blood Money: Wasted Billions, Lost Lives, and Corporate Greed in Iraq, huge sums of money were lost and fraudulently spent in the Iraq War, as the price of that conflict (originally touted as a self-funding enterprise costing the taxpayers nothing) ballooned into the trillions of dollars and turning a national surplus into a national deficit. As whistleblower lawyers, the frustrating aspect of that situation was knowing that fraud existed but that it would be incredibly hard to get to the facts in sufficient detail to bring legal action. Very little paper existed for the contracts and sub-contracts; witnesses were in Iraq and throughout the Middle East. Traveling to those areas for fact-finding was almost impossible and would involve prohibitively expensive security details and the like. Because of this, the Iraq conflict became known among whistleblower lawyers as a “Free Fraud Zone.”

 

The money flowed and flowed in Iraq, but the whistleblower cases did not come, at least not right away. Just like the Big Dig, towards the end of the conflict when things had quieted down somewhat, people began to surface to make claims against defense contractors like Blackwater and Halliburton for a variety of over-charging schemes. And thirteen years after it was first filed, the Agility case shows that the money stolen in that conflict is still being recovered.

 

Taxpayers bear the brunt of these schemes. Whether it’s a city tunnel that cost fourteen times what was originally projected, or up-coded medical bills, or the most expensive bananas in the history of the world, you and I are stuck with the bill.

 

About the author: Bob Thomas is a Boston-based attorney and a principal in the Whistleblower Law Collaborative, whose work is the representation of whistleblowers. In addition to his work on behalf of whistleblowers, Bob is a board member of the ACLU of Massachusetts and an adjunct professor of law at Boston University, where he teaches a course on Health Care Fraud and Abuse.

 

John Oliver Explains Dialysis

John Oliver recently devoted most of his show “Last Week Tonight” to explaining how America funds kidney dialysis.  Oliver admitted the topic was likely to make his viewers push the button on your TV remote marked “Dear God Literally Anything Else.”

 

 

 

But it’s an important topic.  The United States “continues to have one of the industrialized world’s highest mortality rates for dialysis care,” despite spending more on it than other nations.

 

Since 1972, the federal government has covered all kidney dialysis.  We now spend 1 percent of the federal budget just on kidney dialysis.  That’s half as much as we spend on the entire Department of Education!

 

Why do we spend so much? You can probably guess, fraud and greed. Two large companies, Fresenius Medical Care and DaVita, control 70 percent of the market.

 

Megallan Handford, a former DaVita employee who was fired for trying to unionize its employees, explained that:

 

“When I was working at DaVita, the priorities for transitioning patients was to get them on dialysis and get the next patient on as soon as possible,” Handford told Oliver. “You would have sometimes 15, maybe 25 minutes to get that next patient on the machine, so you were not properly disinfecting.”

 

This focus on profits above patients is reflected in the nearly $1 Billion in False Claims Act Settlements that DaVita has paid out in the last several years:

 

 

Nor do these settlements appear to represent the end of DaVita’s legal issues.  DaVita faces a lawsuit and related government subpoenas over use of a non-profit, the American Kidney Foundation to push patients from government healthcare to Healthcare Exchange-offered private plans in order to dramatically increase its reimbursements.

 

Nor should you think that Fresenius is without blame.  For example, in 2000,  a team led by Suzanne Durrell  secured the largest global settlement to date in a health care fraud case against Fresenius Medical Care. The investigation resulted in a record-setting $101 million criminal fine; an aggregate civil settlement payment of $385 million; and the withdrawal by the company of more than $130 million in pending claims for reimbursement with the Medicare Program.

 

If you have concerns about patient harm and fraud against the government by a healthcare company, please contact us to discuss how whistleblower laws including those above can protect and reward you and help ensure that the patients and taxpayers are protected.

 

Experiments in Materiality: Escobar, the Recent Decision in Pfizer, and the Problem of Continued Payment

The U.S. Supreme Court perplexed health care fraud aficionados last summer with dicta listing a number of enigmatic factors for determining when fraud under the False Claims Act (“FCA”) counts as material; a requirement for liability. Universal Health Services v. United States ex rel. Escobar, 136 S. Ct 1989, 2003-04 (2016). Since then, the lower courts are predictably being faced with this issue in almost every litigated False Claims Act, with defendants arguing that for various reasons their alleged misconduct, even if true (or assumed to be true), was not material, and thus they should not be held liable. Defendants’ arguments hinge on the use of a counterfactual touched on by several of the Supreme Court’s factors: the question of whether the government would have paid an (allegedly) false or fraudulent claim, had it known of the fraud.

 

A recent case out of the Eastern District of Pennsylvania rejected two such arguments by defendant Pfizer.  United States ex rel. Brown v. Pfizer, Inc., No. 05-6795 (E.D. Pa., Apr. 11, 2017).  In that case, relators Catherine Brown and Bernard Vezeau, a former marketing manager and sales representative/product manager for Pfizer, are alleging that Pfizer made fraudulent representations to the Food and Drug Administration (“FDA”) when applying for approval for its antifungal medication Vfend to treat Candida infections. In specific, Relators alleged that in 2002 the FDA refused to approve Vfend to treat Candida infections because a study showed it was not as effective as another antifungal medication. But then, in 2004, Pfizer misrepresented that same study as showing Vfend was effective, even though the study showed the opposite, and won approval. Id. at 21.

 

In an attempt to dismiss the case, Pfizer argued that the relators failed to state a claim under the False Claims Act because the relator’s allegations that Pfizer’s representations “‘could have’ influenced the FDA [was] insufficient to make the false representations material.” Id. at 20-21 (citing to the holding in D’Agostino v. ev3, Inc., 845 F.3d 1 (1st Cir. 2016)). The Brown court disagreed, holding that the relators pled materiality successfully because they alleged the misrepresentations “did in fact cause the FDA to approve Vfend for Candida infections.” Brown, No. 05-06795, at 21. The relators were able to do this because they had access to the perfect controlled experiment: the 2002 application in which there was no fraud, and the drug was not approved, compared with the 2004 application in which there was a misrepresentation and the drug was approved. There was no need to speculate about the counterfactual (what the government would have done, had it known of the fraud) because the controlled experiment proved the fraud’s materiality to the government approval (as well as, presumably, casting light on Defendant’s motive, see id. at 24 (discussing scienter)).

 

Pfizer’s second argument, that the (alleged) falsity was not material because the government had continued to pay claims for the drug even after it had learned of the relator’s allegations in its qui tam complaint in 2005, fared no better. The court demonstrated how hard it is to establish the defense that the government’s continued payment of claims shields a defendant from liability. Taking its lead from the First Circuit’s post-remand opinion in Escobar, the Brown court held that “[t]he mere fact that the government has continued to pay and approve claims for Vfend even after Relators’ allegations in 2005 is insufficient to establish that Relators’ claims lack materiality.” Brown, No. 05-06795, at 23; see also U.S. ex rel Escobar v. Universal Health Services, 842 F.3d 103, 112 (1st Cir. 2016). That is because “mere knowledge of allegations regarding noncompliance is insufficient to prove actual knowledge of noncompliance” Brown, No. 05-06795, at 23 (emphasis added). This accords with the Supreme Court’s stringent language in Escobar, where the court says that continued payment weighs against materiality only in the case of “actual knowledge.” Escobar, 136 S. Ct at 2003-04 (comparing “evidence that the defendant knows that the Government consistently refuses to pay claims . . . based on noncompliance”—which weighs in favor of materiality–with evidence that “the Government pays a particular claim in full despite its actual knowledge that certain requirements were violated” –which weighs against).

 

Moreover, as a practical matter, do defendants really want the government to stop paying all their claims just because there are allegations by a relator (not the government) of fraud? We don’t think so; if this happened, it would go in the category of “be careful what you wish for” and have the potential to wreak havoc with government contractors and programs.

Today is Patriots’ Day, a Uniquely Massachusetts Holiday

 

Today we celebrate Patriots’ Day in Massachusetts. What is it? Held on the third Monday of April, it is a state holiday commemorating the start of the American Revolutionary War on April 19, 1775 at the Battles of Lexington and Concord. Famously recounted in the poems the Midnight Ride of Paul Revere by Longfellow and The Concord Hymn (better known as the “shot heard round the world” poem) by Emerson, there are many events commemorating and reenacting the historical events.

 
 

Also, the Boston Marathon, first held on Patriots’ Day in 1896, is run on this day, and the Boston Red Sox play a morning game at Fenway Park, timed so the end of the game coincides with the Marathon runners passing through Kenmore Square (it used to be timed to see the leaders in the race pass by, but alas, baseball games have gotten longer, runners have gotten faster, and the start time of the Marathon has moved because it is now so crowded).

 
 

The long, interesting, somber, and sometimes raucous history of Patriots’ Day is chronicled here. And we should mention that the Patriots’ Day holiday is also celebrated in Maine—because Maine was once part of Massachusetts (it became a separate state in 1820).

 
 

So Happy Patriots’ Day! May we all do our part every day to be true patriots!