Appeals Court Strikes Fraud Sentence for Lack of Proof by Government

The U.S. Court of Appeals for the 11th Circuit recently ruled on an issue lying at the intersection of fraud conspiracies and the U.S. Sentencing Guidelines: the government’s separate burden of proof against each co-defendant when multiple plea bargains are entered. Specifically, the 11th Circuit was addressing whether the government presented sufficient evidence to show, in a credit card fraud case, that the defendant’s criminal activity affected at least 250 victims. Finding that the government had come dramatically short of meeting its evidentiary burden, the appeals court opened its opinion with a flare of witty admonition: “Sometimes a number is just a number, but when the number at issue triggers an enhancement under the Sentencing Guidelines, that number matters.”

The facts of this case are as interesting as the court’s tone. The defendant was Gary Washington, who pleaded guilty to four offenses related to his role in a credit card fraud conspiracy that affected more than 6,000 individual cardholders. At first blush, it stands to reason that his sentence was calculated using a level-6 enhancement, which is reserved for crimes affecting 250 or more victims. However, there was a critical issue that the government and the district court failed to appreciate: Washington didn’t enter the conspiracy until four months after its inception, so the full victim count couldn’t be summarily applied to him.

Remarkably, before the sentencing hearing, Washington conceded that “in all probability there were more than 250 victims.” However, his sticking point was that he wanted the government to submit “hard evidence” supporting a level-6 enhancement in place of its “verbal assurances.” The government essentially ignored his requests and proceeded to the hearing without submitting additional evidence. Washington objected again at the sentencing hearing, but the district court overruled his objection and applied the level-6 enhancement, noting that the figure had been applied to the other defendants’ sentences.

On appeal, the 11th Circuit found the government’s representations insufficient and stated that “evidence presented at the trial or sentencing hearing of another may not – without more – be used to fashion a defendant’s sentence if the defendant objects.” The appeals court pointed out that it was especially inappropriate to use the other co-defendants’ sentences as a guide, because Washington joined the conspiracy well after it began. Following this reasoning, the appeals court set aside Washington’s sentence and remanded the case to the lower court for resentencing. The 11th Circuit declined the government’s request to present additional evidence on remand, because nothing had prevented it from presenting sufficient evidence at the original sentencing hearing.

This case is another example of federal prosecutors and trial courts losing sight of our system’s fundamental canon: a defendant is innocent until proven guilty. In some instances, the procedural safeguards that protect this system may seem inefficient and unnecessary. However, the alternative would beckon trial courts down the slippery slope of replacing actual evidence with assumptions. Fortunately, the appeals courts are present as a way of reining them in.

Appeals Court Set to Consider Key Sentencing Issue on Profits Derived From Fraud

The U.S. Court of Appeals for the 3rd Circuit is currently considering a sentencing issue of great significance in cases in which a number of individuals work together to bring about a financial fraud. The question posed is the extent to which a defendant can and/or should be punished based on the profits made through the fraud when the defendant did not receive as much money from the fraud as his co-conspirators.

In Kluger v. United States, the appeals court must determine whether former attorney Matthew Kluger’s sentence was unduly harsh. Kluger was one of three men who pleaded guilty to insider trading last year in federal district court in Newark, New Jersey. In his plea, Kluger, who is 51, admitted that he stole data on about 30 transactions during 17 years at law firms that included Skadden, Arps, Slate, Meagher & Flom and Wilson Sonsini Goodrich & Rosati. The companies involved include Sun Microsystems, 3Com Corp., and Acxiom Corp. Kluger gave that information to his co-defendant, Kenneth Robinson, who in turn gave them to trader Garrett Bauer, who traded on the information and then sold at a great profit when the deals went public. Following the scheme, Bauer then distributed the money to his partners. Over the last four years of this arrangement, according to prosecutors, Bauer made about $32 million in illicit profits, while Robinson made more than $875,000. Kluger claims to have made more than $500,000.

The sentences that were meted out to Kluger and Bauer did not track this huge disparity in the benefit that each received from their illegal activities. Bauer was sentenced to nine years imprisonment. Kluger received a sentence of 12 years – the longest prison sentence ever given for insider trading, eclipsing the 11-year sentence received by Galleon Group co-founder Raj Rajaratnam. In sentencing Kluger, Judge Katherine Hayden said that she wanted to send a strong message about the “radiating effect of the loss of confidence in the market” caused by insider trading. Judge Hayden also emphasized Kluger’s abuse of trust given his position as a lawyer. Robinson, who cooperated with authorities and secretly recorded the other men for the FBI, received a sentence of only 27 months.

The notion that a defendant may be sentenced based on the aggregated gains of his co-conspirators is nothing new. Section 1B.1.3(1)(a)(1)(B) of the U.S. Sentencing Guidelines expressly provides that, “in the case of a jointly undertaken criminal activity,” relevant conduct (which sets the amount to be used to calculate upward adjustments in the loss table of Section 2B1.1) includes “all reasonably foreseeable acts and omissions of others in furtherance of the jointly undertaken criminal activity . . .” But the acceptance of this approach may be strained by cases of insider trading and other white-collar crimes that increasingly involve astronomical amounts of money, and therefore expose all participants to draconian criminal sentences.

In appealing Kluger’s sentence, his attorneys stressed that the district court appeared not to have considered the disparity in the amount of money that Kluger actually received as a result of the insider trading compared with at least one of his co-conspirators. This argument echoes some of the reasoning of Judge Jed Rakoff in his sentencing of Rajat Gupta, who likewise received far less benefit from insider trading than his co-conspirator, Rajaratnam. The issue raises an interesting question: Should a defendant’s sentence be commensurate only with his or her own personal gain? Or is the measure of the proper severity of a sentence the total gain obtained by all of the participants – an approach that appears to be more in step with the concept of “relevant conduct” that plays an important role in calculating advisory ranges under the Sentencing Guidelines?

The Third Circuit’s determination on this issue may signal the direction that the courts take on this issue, or may be just the first ruling in what becomes a split among the circuits. The resolution of this issue will be particularly important in cases in which Section 2B1.1 (the loss value table) plays a critical role in determining Guidelines sentences.

Was This Identity Theft? Sixth Circuit Should Limit Meaning of That Term

What’s in a name?

When you think of identity theft, you typically think of someone taking a person’s name plus some other identifiers, like their address and Social Security number or credit card number, to go on a spending spree or drain the victim’s bank account. You may think of fraudulent impersonation. But what if someone falsely stated that another person gave him permission to use their joint property as collateral on a loan? That sounds like a false statement but not a case of stolen identity. Yet a federal district court in Tennessee found that just this scenario constituted identity theft in a current case against real estate broker David Miller.

Perhaps the court’s holding doesn’t sound too troubling. After all, identity theft is a crime and it’s clearly behavior that we want to deter. But expanding the reach of what may fall under the federal identity theft laws doesn’t really deter the behavior that Congress sought to address by statute. It just makes it harder to anticipate the bounds of the law, and that is troubling.

Congress passed the Identity Theft and Assumption Deterrence Act of 1998 in order to address the growing problem of fraudsters taking people’s personal information to either steal from their existing accounts or to run up debt in the victims’ names. The act criminalized fraud in connection with the theft and misuse of personal identifying information. (Before the law was passed, only fraud in connection with identification documents was a federal crime.) But there was some concern that prosecutors were not vigorously going after identity theft cases. So Congress passed the Identity Theft Penalty Enhancement Act of 2004. Again, this measure was aimed squarely at penalizing identity thieves who were attacking consumers’ financial accounts and credit. The bill’s sponsor, Rep. John Carter (R-Tex.), said identity theft is “a crime that we need to address and address seriously … for the protection of the credit of American citizens.”

Years later, the Department of Justice appears to have gotten the message and is actively prosecuting identity theft cases. All is well and good with the DOJ’s ordinary efforts in this area. On its website, the DOJ discusses identity theft issues in a familiar context, relating concerns over the misuse of “your Social Security number, your bank account or credit card number, your telephone calling card number, and other valuable identifying data.”

It also provides exemplary cases, which are again in keeping with the general understanding of what constitutes identity theft: (1) a woman pleaded guilty for using a stolen Social Security number to obtain thousands of dollars in credit and then filing for bankruptcy in the name of her victim; (2) a man pleaded guilty after obtaining private bank account information about an insurance company’s policyholders and using that information to deposit counterfeit checks; (3) a defendant was indicted on bank fraud charges for obtaining names, addresses, and Social Security numbers from a Web site and using those data to apply for a series of car loans over the Internet.

So with a pretty clear understanding of congressional intent and a fairly clear depiction of the scope of federal identity theft laws, it seems a bit like prosecutorial overreach for the DOJ to turn around and use these laws in a case like that against David Miller. Not in keeping with the sample cases above, Miller’s “theft” involved him “using the names of two individuals in a document that stated Miller had the authority to pledge real property as collateral for the loan when he had no such authority.” He was not trying to impersonate them to create new accounts or steal from their existing accounts. There are other laws to prosecute what Miller did – and he was found guilty of making false statements to a bank.

The concern here is that adding the identity theft count to Miller’s sentence is a misuse of the Identity Theft Penalty Enhancement Act and an overexpansion of what behavior falls under the rubric of identity theft. What is next? Will the department uses this law to prosecute those who lie about references on a job application?

The general rule is that criminal laws should be strictly construed in favor of the defendant. The ruling against Miller seems a case in point where the Rule of Lenity was not applied. Miller has appealed to the U.S. Court of Appeals for the Sixth Circuit, which will hopefully bring the law back within its intended scope.

Bitcoins: Online Currency’s Uncharted Frontier

Bitcoin – it sounds like a token you might use to play skeeball at a beachside arcade. It is actually a relatively new, virtual online “currency” being used for payments across the Internet. While some observers have noted that the Bitcoin has been utilized primarily for purchases in the Internet “underworld,” the Bitcoin actually has gained traction more recently as a legitimate payment exchange. The Bitcoin might just be the surprise of the next generation of e-commerce and its progeny, mobile commerce.

The Bitcoin originated in 2009 with the issuance of the first Bitcoins by Satoshi Nakamoto, the pseudonymous person or group of people who designed the original protocol and created the peer-to-peer network. Users connect with other users rather than with a central issuer or server. This makes the Bitcoin attractive for illegal activities – authorities can’t pounce on a central office or simply seize one organization’s assets. The Bitcoin has no central issuing bank. Prices fluctuate a great deal; this past summer one Bitcoin traded at around $10. It is estimated that the monetary base of the Bitcoin is around $110 million.

There are several advantages to Bitcoins. They are largely unregulated. Also, payments can be made anonymously, leaving a minimal or no paper trail. Unlike credit cards, merchants do not face the hassle and uncertainty of “charge backs.” However, because of its past “underground” use, the Bitcoin lacks a reputation and general acceptance by mainstream merchants. For instance, the website “Silk Road” allowed users to buy and sell heroin and other illegal drugs provided they paid for their purchases using Bitcoins. Online gambling services have utilized Bitcoins with relative success.

While the past use of the Bitcoin has been limited, the new currency is picking up steam. Just a few days ago, BitPay, a payment solutions company, announced a large investment by a group of well-known tech investors. They see the Bitcoin as the next “PayPal” offering a fast payment method without the exchange of sensitive personal information that goes along with traditional credit card payments. Investors also see the benefits for small businesses, which can much more easily take payments from overseas using Bitcoins. Today, we can use Bitcoins to buy a wide array of products and services. This website provides links where we can purchase, for instance, jewelry, electronic cigarettes, natural cosmetics, and even survival products and dry cleaning, just to name a few offerings.

Just last month, the Bitcoin gained further acceptance when the Bitcoin-Central exchange owned by Paymium announced that it is partnering with registered PSP Aqoba and Frank Bank Credit Mutuel Arkea in order to legally hold balances in payment accounts within the European regulatory framework. However, as Bitcoins have not to date been backed by a governmental entity and several users have reported losses from fraud and hacking into their computers where they stored Bitcoins, continued use and acceptance will be affected by the reliability of the payment network, as well as any attempts to regulate it.

As use of the Bitcoin expands, regulators (particularly in the United States) may seek to regulate the currency. U.S. prosecutors tend to view anonymous payments with skepticism and suspicion.

Our view is that use of the Bitcoin network has expanded in large part as a natural reaction to overly zealous authorities enforcing anti-money laundering rules and policies against banks and individuals. Parties facing onerous reporting obligations and over-the-top fines have been seeking alternative payment methods. The FBI has shown some interest in Bitcoin (in an April 2012 report the FBI expressed concern about cyber criminals using Bitcoins). Last year, a spokesman for FinCEN stated that “The anonymous transfer of significant wealth is obviously a money-laundering risk, and at some level we are aware of Bitcoin and other similar operations, and we are studying the mechanism behind Bitcoin.”

However, we think the law will take some significant time to catch up with the fast-moving network. It remains to be seen whether current U.S. law can be applied to cover Bitcoins, or if specific legislation would be needed. Further, even if U.S. authorities seek to regulate Bitcoins, actual enforcement would be difficult as there are no stationary “assets” to be seized (not even a domain name or website). Bitcoins are typically stored in a “wallet” on a user’s computer. Authorities would in many instances be required to pursue each “peer” in the peer to peer network, which does not seem terribly practicable. In the interim, Bitcoins appear to be growing in use across industries and geographic locations.

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.

Bill Could Put Reins on Prosecutors’ Efforts to Seize Domain Names

Rep. Zoe Lofgren (D-Calif), a senior member of the House Judiciary Committee, has indicated that she is drafting legislation that would seek to increase judicial oversight over prosecutors’ efforts to act against Internet domain names accused of copyright infringement. While the value of such legislation will depend on the details of the bill, the notion of creating greater control over prosecutorial seizure of domain names is laudable.

Lofgren is one of a small number of legislators who voted against the PRO-IP Act of 2008, which authorized the government to shut down websites accused of online piracy or copyright violations by seizing their domain names. Under the enforcement operation that followed passage of that Act – dubbed “Operation In Our Sites” – the U.S. Immigration and Customs Enforcement (ICE) has seized 1,630 domain names, of which 684 have been forfeited to the government. The increasing use of domain name seizures in this area tracks similar use of this tool in other areas of law enforcement such as internet gaming and online pharmaceutical sales.
Specifics about the contemplated legislation have not been disclosed, though Lofgren has been quoted as noting that there are “reasonable arguments” that the way in which the government has seized domain names under the PRO-IP Act violates the Constitution. Lofgren’s bill will apparently propose that the government must provide notice and an opportunity to be heard before domain names are seized or redirected.

The addition of a procedural requirement for notice and hearing prior to domain name seizure would clearly be a favorable development. There have been cases in which the government has seized a domain name and later permitted it to resume operations, under agreed-upon restrictions, pursuant to an arrangement with the affected business. To the extent that businesses may negotiate such arrangements with the government, those arrangements could be reached without the potentially devastating interruption of a seizure. By giving counsel for the affected business the opportunity to be heard, such a requirement may also chill the overuse of domain name seizure by government as a means of gaining unfair leverage in cases involving Internet-based businesses.

The devil, of course, is in the details. Lofgren has reportedly sought input from the online social media community on this bill – particularly from Reddit. Hopefully, she will also seek input from those members of the legal community who have been involved in litigation over domain name seizures as well in order to ensure that the bill presented for consideration is as effective as possible in balancing the interests of all affected parties.

Court’s Strict Interpretation of Bank Fraud Law May Rein In Prosecutors

A recent interpretation of the federal bank fraud statute by the United States Court of Appeals for the Second Circuit may prove to be a useful check to overreaching by federal prosecutors, who have tended to use that statute in the past as a catch-all law enforcement tool.

In United States v. Nkansah, the Court reviewed the conviction of a defendant for bank fraud and other crimes arising from a scheme in which the defendant and others stole identification information and used that information to file fraudulent tax returns from which they obtained tax refunds. The depositing of the refund checks involved forgery of endorsements and/or the use of false identification.

On appeal, the defendant challenged his bank fraud conviction on the ground that the government had failed to carry its burden of proof that he intended to victimize the banks, as opposed to the U.S. Treasury that issued the refund checks. Defendant argued that no such evidence of intent to defraud a bank was presented, nor did the government prove that the banks themselves actually lost any money.

The court agreed. In its opinion reversing the bank fraud conviction, the appeals court noted that “the bank fraud statute is not an open-ended, catch-all statute encompassing every fraud involving a transaction with a financial institution” but rather “a specific intent crime requiring proof of an intent to victimize a bank by fraud.” For this reason, the court specifically held that “[t]he government had to prove beyond a reasonable doubt that appellant intended to expose the banks to losses,” and noted that, if that intent were proved, there was no need for proof of actual or even possible loss.

The court noted that the evidence upon which the government relied – conversations among the participants about avoiding detection by the banks – was not sufficient to satisfy this required element of proof. The court acknowledged that, in some cases, the fact that a bank may suffer a loss based on the negotiation of a check with a forged endorsement permits an inference of intent. But, in this case, given that the checks at issue were genuine Treasury checks, the actual exposure of a bank to losses is “unclear, remote, or non-existent” because the banks could be deemed to be holders in due course of the checks, with the risk of loss borne entirely by the Treasury. Under such circumstances, the permissible inference urged by the government was far from sufficient to constitute proof beyond a reasonable doubt of the defendant’s intent.

The Second Circuit’s holding in this case is significant because of federal prosecutors’ frequent use of bank fraud charges when banks were part of the transactions included in the allegedly wrongful conduct but were not the intended victims of that conduct. Prosecutors like the bank fraud statute because it carries a hefty maximum statutory sentence of 30 years imprisonment. Bank fraud can also form the predicate (as it did in Nkansah) for other charges such as aggravated identity theft – a crime for which probation is prohibited and for which a defendant must receive a consecutive sentence to the punishment he receives for conviction of any other offense. By holding prosecutors to the strict requirements of the bank fraud statute, the Second Circuit may limit the ability of federal law enforcement to use that statute as leverage in its prosecutions.

Judge Rakoff and the Emperor’s New Clothes

On October 24, 2012, U.S. District Judge Jed Rakoff sentenced Rajat Gupta to 24 months after he was found guilty by a jury of one count of conspiracy and three counts of substantive securities fraud, in connection with providing material non-public information to convicted inside trader Raj Rajratnam. This two-year prison sentence was substantially below the applicable advisory range under the United States Sentencing Guidelines and, in the week since that ruling, much has been said about whether or not this sentence was appropriate.

But the most remarkable part of Judge Rakoff’s sentencing ruling was his unflinching analysis of the way in which the application of the Sentencing Guidelines to white collar fraud cases does not reflect empirical analysis about those offenses or those who commit them – an argument that defense counsel have been making for some time with mixed success.

Judge Rakoff began his analysis with an eloquent and incisive observation about his role as a sentencing judge and the inadequacy of the sentencing guidelines as a comprehensive tool to determine a defendant’s sentence:

Imposing a sentence on a fellow human being is a formidable responsibility. It requires a court to consider, with great care and sensitivity, a large complex of facts and factors. The notion that this complicated analysis, and moral responsibility, can be reduced to the mechanical adding-up of a small set of numbers artificially assigned to a few arbitrarily-selected variables wars with common sense. Whereas apples and oranges may have but a few salient qualities, human beings in their interactions with society are too complicated to be treated like commodities, and the attempt to do so can only lead to bizarre results.

Judge Rakoff noted that the Sentencing Guidelines were “originally designed to moderate unwarranted disparities in federal sentencing” on the theory that the Guidelines “would cause federal judges to impose for any given crime a sentence approximately equal to what empirical data showed was the average sentence previously imposed by federal judges for that crime.” Of course, as the Supreme Court has already observed, the Guidelines deviated from this goal almost from the start.

For example, based on “limited and faulty data,” the Sentencing Commission determined that an ounce of crack cocaine should be treated as the equivalent of 100 ounces of powder cocaine for sentencing purpose, even though the two substances were chemically almost identical and, as later studies showed, very similar in their effects. The result of this empirically unsupportable conclusion was an indefensible racial disparity in narcotics sentencing. Kimbrough v. United States, 552 U.S. 85, 96-98 (2007). Judge Rakoff noted that, even when the Sentencing Commission changed the ratio from 100-to-1 to 18-to-1 in 2010, that ratio was likewise not based on empirical evidence but was merely “plucked from thin air.”

Judge Rakoff went on to observe that the Guidelines applicable to white collar fraud likewise “appear to be more the product of speculation, whim, or abstract number-crunching than of any rigorous methodology,” and that this “maximize[es] the risk of injustice.” Noting the huge increases in the recommended Guidelines for fraud cases, Judge Rakoff noted that the resulting advisory ranges “are no longer tied to the mean of what federal judges had previously imposed for such crimes.” Rather, these sentences “instead reflect an ever more draconian approach to white collar crime, unsupported by any empirical data.”

In short, congressional mandates to get tougher on fraud have resulted in a singular focus on one factor – the amount of loss – that “effectively ignored the statutory requirement that federal sentencing take many factors into account, see 18 U.S.C. § 3553(a), and by contrast, effectively guaranteed that many such sentences would be irrational on their face.” The result, Judge Rakoff observed, was “to create, in the name of promoting uniformity, a sentencing disparity of the most unreasonable kind.”

Regardless of whether or not one agrees with the sentence ordered in the Gupta case, Judge Rakoff’s analysis of the way in which the Sentencing Guidelines fail to promote justice in white collar cases is sure to have significant weight in other cases going forward. As structured, federal sentencing begins with a calculation of the advisory Guidelines range, and then defendants seek a variance from that range under Section 3553(a) – a process that creates a de facto presumption that a defendant will be sentenced within the Guidelines range. A recognition that the Guidelines ranges applicable to fraud crimes are not fair is a good first step towards reforming sentencing in such cases in the interest of true justice.

In ‘Bitter Pill,’ FDA Seizes Domain Names of Firms Selling Illegal Pharmaceuticals

In an aggressive step against businesses selling drugs online, the U.S. Food and Drug Administration, in conjunction with the U.S. Department of Homeland Security, took legal action earlier this month against more than 4,100 websites this week that led to criminal charges, seizures of illegal products, and hundreds of domain name seizures.

This year Operation Pangea V, a campaign of law enforcement agencies across the globe to counter the global international prescription trade, resulted in the shutdown of over 18,000 unauthorized pharmacy websites and the confiscation of around $10.5 million worth of pharmaceuticals in 100 countries worldwide. Operation Bitter Pill, a federal law enforcement initiative that is part of Operation Pangea V, seized 686 domain names this week as part of the operation, bringing the total number of domain names seized by the domestic operation to 1,525.

The drugs being offered on the websites included such medications as antibiotics, anti-cancer medications, weight loss and food supplements, and erectile dysfunction pills, authorities said.

The FDA had sent warning letters to the managers of 4,100 websites in late September, warning them that products for sale on their sites were in violation of U.S. law. A copy of the letter that the FDA sent to one site can be viewed here.

The agency also sent notices to registries, Internet service providers, and domain name registrars notifying them as well.

Visitors to the websites that have been the subject of domain name seizures will now see an image informing them that the site has knowingly trafficked counterfeit goods, which is a federal crime. Customers were not targeted as part of the investigation. A government spokesman said they were considered to be unwitting victims who were simply purchasing drugs that they thought would be helpful for their conditions.

We don’t endorse counterfeit drugs or trademark violations. But we are concerned that broad domain name seizures, such as those in Operation Bitter Pill, could potentially shut down legitimate businesses and leave them without an online presence for a long period of time until they are able to obtain legal relief. Companies that operate solely with an online presence could see dramatic and potentially crippling effects on their business.  We have previously discussed this issue here, for example.

As digital rights groups have repeatedly noted, seizures such as these can run roughshod over the constitutional rights of website operators, including their First Amendment rights, and need to be undertaken by the government, if at all, with an understanding that a seizure of a domain name is not the same thing as the seizure of a truckload full of illegal drugs.

Previously, domain name seizures had been used in investigations by other federal agencies such as the Immigration and Customs Enforcement, the Commodity Futures Trading Commission, the U.S. Department of Justice, and the Federal Trade Commission. The practice appears to be expanding.

Only if the courts provide an adequate check on the powers of the federal government can it be assured that individuals are afforded their due process rights in cases such as this one.

Abbott’s $1.6 Billion Settlement Stands as Cautionary Tale to Pharma Companies

A recent settlement by global pharmaceutical giant Abbott Laboratories over its promotion of the drug Depakote shows that federal regulators remain prepared to pursue drug manufacturers for promoting unapproved uses of their products. Abbott has agreed to pay federal and state governments a total of $1.6 billion in criminal and civil fines and to plead guilty to a criminal misdemeanor violation of the Food and Drug Act to resolve allegations against it. This makes the case the second-largest in a series of multi-million dollar settlements of enforcement actions by the U.S. Department of Justice and state regulators against drug makers. Abbott will be subject to monitoring and reporting requirements as a condition of its plea.

When the Food and Drug Administration approves a drug as “safe and effective” for sale to the public, it specifies that the approval is for one or more defined medical purposes. It is a common practice among doctors, however, to prescribe drugs for other uses based on their understanding of other effects of use of the drug, and such “off label” prescriptions are not illegal.It is illegal, however, for drug manufacturers to promote off-label use of their products.

In the Abbott case, federal and state regulators and law enforcement agencies alleged that the company had promoted off-label use of Depakote, which the FDA has approved to treat epileptic seizures, migraines and the manic episodes suffered by people with bipolar disorder. As part of its settlement, Abbott has admitted that, beginning in 1998, it trained a portion of its sales force to promote Depakote to nursing home personnel as a way to control agitation and aggression in elderly patients suffering from dementia. Abbott continued to do so through 2006 even after it was forced to discontinue clinical trial testing in 1999 of the use of Depakote to treat patients with dementia because the drug caused increased drowsiness, dehydration and anorexia in the elderly test subjects.

The use of Depakote by nursing homes for the off-label use promoted by Abbott was attractive because, as Abbott’s sales force highlighted, Depakote was not covered by the Omnibus Budget Reconciliation Act of 1987 (OBRA) and its implementing regulations designed to prevent the use of unnecessary medications in nursing homes. Thus, use of the drug for this purpose could help nursing homes avoid the administrative costs and other burdens of complying with that law.

In some ways, the Abbott settlement is simply another reminder that pharmaceutical manufacturers that “misbrand” drugs by promoting off-label use will face scrutiny and enforcement from federal and state governments. On the other hand, the Abbott case is particularly egregious given the allegations that, after tests showed poor effectiveness and possible problems with the off-label use of Depakote, Abbott failed to disclose to its sales force the results of those studies. In highly regulated industries such as pharmaceutical manufacturing, the case is a reminder that companies that fail to adhere closely to legal and regulatory requirements do so at great risk.