A Canadian federal court recently released an opinion holding that meta tags, at least in some circumstances, are not entitled to copyright protection. Although the precedent is not binding in American courts, the well-reasoned opinion provides an excellent logical analysis on why meta tags may or may not be afforded copyright protection.
In Red Label Vacations Inc. v. 411 Travel Buys Limited, the plaintiff travel business implemented meta tags including its registered trademarks: “redtag.ca,” “redtag.ca vacations,” and “Shop. Compare. Payless!! Guaranteed.” The defendant is a competing travel business in the Canadian market. In 2009, Red Tag experienced a drop in sales and noticed that search engine results for its company were returning results for its competitor, 411 Travel Buys. Upon further inspection, Red Label found that 411 had apparently copied its metadata including content, ordering, and misspellings. Red Label informed 411 of the violation and 411, being Canadian, immediately removed the content. Nevertheless, Red Label brought suit for lost profits during the period it was active.
In analyzing the duplicated meta tags, the court concluded that the tags were substantially derived from a list of Google keywords which were incorporated into phrases describing travel. The court held that there was little evidence of any degree of skill, judgment, or creativity in creating the meta tags at issue in the case. The court noted that there may be circumstances in which meta tags are so creative and original so as to qualify for copyright protection, but they were not present here.
The court further found that there was not substantial copying when viewing the website as a whole. Defendant 411 copied 48 pages out of approximately 180,000 on Red Tag’s website. The court considered substantial similarity between the original work and the allegedly infringing work when viewed as a whole, and did not find that a substantial reproduction had occurred.
Even though 411 used Red Tag’s trademarks in its meta tags, the court held that no trademark violation had occurred because the meta tags were not visible to the site’s visitors, but were rather used by search engines. The court found that even if a patron had reached the 411 site by searching for Red Tag terms, once visitors arrived at the website they would have no doubt that they were at the site of 411. Notably, the Canadian court identified a substantial difference between its law and trademark law in the US. In the US, a court may find a trademark violation occurred where trademark use causes “initial interest confusion” where a patron searching for one company diverts their business to what the patron realizes is a different company offering a similar product or service. Regardless, the Canadian court indicated that it wouldn’t find a trademark violation even under the initial interest confusion test, because when search engines use meta tags they return a list of links that customers may choose from at will, rather than directing the viewer to a particular competitor.
Despite the Canadian court’s thoughtful and in-depth analysis, in the six years since the events of the case meta tags have increasingly become a relic of the past as search engines increasingly use their own algorithms to determine search results. However this is still a claim that many plaintiffs include when throwing in the kitchen sink in a trademark case, and it would not be surprising to see US courts cite to the reasoning of our neighbors to the north in future decisions.
In the United States it is enormously difficult to remove allegedly defamatory information from the internet. A victim can take the expensive and time-consuming step of suing the author for defamation in court. However, even if a court rules that the statement is defamatory—that is, that the published statement is false and harmful to the subject’s reputation—the victim’s remedy is usually monetary damages. U.S. courts do not generally order that the speech be removed from the internet, out of First Amendment concerns regarding the prior restraint of speech. Even if a victim were to present the website’s registrar with the court’s finding of defamation, registrars are protected by the Communications Decency Act and are under no obligation to remove the offending content (although some registrars will, as a matter of internal policy).
The Texas Supreme Court recently issued a pioneering opinion which alters the legal landscape, at least as it applies to cases brought in Texas. In Kinney v. Barnes plaintiff Robert Kinney, a legal recruiter, left his employer BCG and started a competing company. BCG’s president Andrew Barnes later posted a statement on various websites accusing Kinney of participating in a kickback scheme. Kinney sued, not for monetary damages, but for an injunction requiring Barnes to remove the defamatory statements, and prohibiting him from making similar statements in the future. The trial court declined to grant the injunction and granted Barnes summary judgment on this issue, and the court of appeal affirmed, both finding that an injunction would be an unconstitutional restraint on prior speech.
On appeal to the Texas Supreme Court, however, Texas’ highest court distinguished between statements that had already been published and those that might be made in the future. The court declared that where a statement has been adjudicated by a court and found to be defamatory, the court may issue an injunction requiring the author to remove the speech from places where he had already published it. The decision does not limit an individual’s freedom to make the same or similar statements in the future because, “[g]iven the inherently contextual nature of defamatory speech…the same statement made at a different time and in a different context may no longer be actionable.” The Texas Supreme Court believes that this limited remedy strikes the proper balance between removing unprotected defamatory speech and upholding individual’s rights to speak freely in the future.
This case is seen as a victory for victims of defamatory speech, whose personal or business reputations have been ruined by false accusations that remain on the internet even after a court found them to be untrue, harmful, and unprotected. While the case only serves as biding precedent in Texas, other courts may look to this decision for guidance when determining how to protect individuals’ or businesses’ reputations from false past attacks while preserving the freedom of speech to criticize or otherwise speak about those same people or entities in the future.
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 www.stopmedicarefraud.org 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.
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.
The Supreme Court will soon be considering whether to take up an interesting question involving when monetary sanctions may be imposed for prosecutorial misconduct. More than 50 former federal judges and U.S. attorneys are pushing to get an 11th Circuit Court of Appeals ruling from last year overturned. In early August, the former judges and prosecutors signed onto an amicus brief that urges the Supreme Court to grant certiorari in United States v. Shaygan. The defendant is appealing the appeals court’s overturning of a lower court’s award of more than $600,000 in attorneys’ fees to him after the unsuccessful prosecution of his case.
Shaygan, a Miami doctor, was charged with trafficking illegal drugs following the overdose death of a patient. Events leading up to his trial demonstrated serious ethical questions about the prosecutors’ handling of the case. For instance, after Shaygan’s counsel moved to suppress testimony that was illegally obtained, in an act of retaliation the prosecution filed a 141-count superseding indictment. The prosecution initiated a collateral witness-tampering investigation in what defendants saw as a bad-faith effort to disqualify petitioner’s counsel on the eve of trial. And, in a “knowing and intentional” violation of court orders and discovery obligations, the prosecution withheld material information from both the court and the defendant. These actions led the trial court to impose sanctions because the prosecutors’ misconduct constituted “conscious and deliberate wrongs that arose from the prosecutors’ moral obliquity and egregious departures from the ethical standards to which prosecutors are held.”
The government appealed to the 11th Circuit, where a sharply divided panel overturned the trial court. The circuit’s rationale was based upon its interpretation of the statute,the Hyde Amendment, that provides for the award of attorneys’ fees and other litigation expenses “where the court finds that the position of the United States was vexatious, frivolous, or in bad faith, unless the court finds that special circumstances make such an award unjust.”
The circuit ruled that sanctions were not appropriate because the superseding indictment was objectively valid. And if the underlying (or superseding) indictment could be deemed objectively reasonable, the prosecution could not be held vexatious or frivolous and thus attorneys’ fees were not merited. See our earlier discussion of this issue in this blog.
The court’s holding raised the eyebrows of many former federal judges and prosecutors as well as scholars. Their main contention appears to be the 11th Circuit’s reading of the clause “vexatious, frivolous, or in bad faith.” The amicus brief filed on behalf of the former judges and prosecutors raised two main arguments for why the 11th Circuit’s decision was wrong: (1) based upon the canons of statutory construction, sanctions under the Hyde Amendment are appropriate when prosecutors act in subjective bad faith, even if an indictment is supported by probable cause; (2) acknowledging a subjective standard helps judges control their courtrooms and provides a necessary tool to address prosecutorial misconduct.
The first argument focuses on the “or” in the Hyde Amendment’s provision for sanctions where a prosecutor’s position is found to be “vexatious, frivolous, or in bad faith.” The amici argue that the disjunctive “or” separates the “bad faith” prong from the “vexatious” and “frivolous” prongs, indicating that bad faith can serve as an alternative basis for relief under the Hyde Amendment. Their reading of the statute, they argue, “comports with our basic principles of criminal justice. Our system’s greatness rests, in part, on our insistence that the process be conducted in a principled, clean manner. Thus, for example, we permit the guilty to go free when the evidence against them was obtained in violation of their Fourth Amendment rights. We suppress coerced confessions, even when they bear every indicia of reliability. And we do not permit the prosecution even of a guilty person on the grounds of that person’s race. ”
The amici’s second argument emphasizes the need to provide judges with control over their courtrooms, and the need to impose appropriate sanctions for prosecutorial misconduct. To rein in the overzealous, overreaching, or rabid prosecutor, the Hyde Amendment sanctions provide an important mechanism to restore control. The amici note that other sanctions, such as complaints with bar associations, have proved ineffective over the years and that prosecutors are immune from most lawsuits relating to their official conduct.
It remains to be seen whether the Court will take up the Shaygan case — the chances of the Court ever granting certiorari are pretty slim. But a strongly-worded amicus brief from more than 50 former prosecutors and judges and a notably sharp divide in the 11th Circuit could persuade the Court.
We recently blogged about the recent decision of the U.S. Court of Appeals for the 11th Circuit in Securities and Exchange Commission v. Goble, 2012 WL 1918819 (11th Cir. May 29, 2012). There, we discussed the appeals court’s limitation on the reach of the concept of “securities fraud” under Section 10(b) of the Exchange Act and Rule 10b(5).
Another aspect of that case is also quite noteworthy and may have an impact on many corners of white-collar criminal law. In the Goble case, the court vacated an injunction that simply tracked the language of the securities laws in defining what the defendant was barred from doing. This kind of injunction is often termed an “obey-the-law” injunction.
The court wrote: “Goble correctly identifies these paragraphs as an “obey-the-law” injunction and is rightly skeptical of their validity. As the name implies, an obey-the-law injunction does little more than order the defendant to obey the law. We have repeatedly questioned the enforceability of obey-the-law injunctions not only in the context of securities cases but other cases as well.”
The appeals court pointed out that any federal court injunction must comply with the requirements of Rule 65 of the Federal Rules of Civil Procedure:
“Glaringly absent from the SEC’s brief is any discussion explaining why the district court’s injunction complied with the requirements of Rule 65. Rule 65(d)(1) states that ‘Every order granting an injunction and every restraining order must: (A) state the reasons why it issued; (B) state its terms specifically; and (C) describe in reasonable detail — and not by referring to the complaint or other document—the act or acts restrained or required.’ Fed. R. Civ. P. 65(d)(1). We have never said that a court may simply ignore these requirements because it is entering an injunction in a securities case.”
The key issue that the appeals court pointed out is that an injunction requires a certain amount of specificity, so that the defendant is fully on notice about what he can or cannot do under the order.
“Plainly,” the court wrote, “Goble would need to look beyond the four corners of the district court’s injunction in order to comply with its strictures. The mere cross-reference to provisions of the United States Code and Code of Federal Regulations does not specifically describe the acts addressed by the injunction. And, without a compendious knowledge of the codes, Goble has no way of understanding his obligations under the injunction.”
This decision may open up new lines of argument for defendants in white-collar cases, and not only in securities actions. Since broad injunctions that do little more than track a statutory prohibition can be subject to challenge, defense attorneys may be able to argue convincingly that an injunction should be more specific and more narrowly tailored to a defendant’s past conduct.
On June 20, 2012, President Barack Obama escalated a battle with the GOP-controlled House of Representatives by claiming executive privilege for 1300 executive-branch documents that relate to the White House and the Justice Department’s response to subpoenas about the botched Fast and Furious gun-trafficking operation.
The House Oversight and Government Reform Committee, chaired by Rep. Darrell Issa (R-Calif.) then voted immediately along party lines to approve a contempt of Congress finding against Attorney General Eric Holder Jr. That recommendation is expected to go to the full House next week.
The committee asserts that it needs the documents in its investigation of Fast and Furious and of a possible executive-branch cover-up of that operation. The White House replies that handing over the documents would hamper the ability of government officials to discuss policy matters frankly and without fear that their deliberations would become public.
Confrontations between the President and Congress over documents and over claims of executive privilege are not new. In fact, executive privilege has been claimed by every president since President John F. Kennedy, and the roots of the doctrine go back to actions by President George Washington in 1792.
The privilege to withhold documents from a congressional committee is not found in the Constitution. It is, however, based on the constitutional principle of separation of powers, which provides that the three branches operate independently of each other. Although the Supreme Court rejected the application of executive privilege in 1974 when President Richard Nixon claimed it in relation to a criminal subpoena for Watergate tapes, there is no question that the privilege exists and can be properly claimed under some circumstances.
The problem is that Obama and Holder are claiming the privilege broadly, for all 1300 pages of documents, without specifying why each document or group of documents is privileged.
As Todd Gaziano, a former attorney in the Justice Department’s Office of Legal Counsel, which advises on executive privilege, wrote in the Heritage Foundation’s blog:
Even if properly involved, the Supreme Court has made clear that executive privilege is not absolute. DOJ must provide an explanation why all those documents fit one of the recognized categories of executive privilege. It is questionable whether they all are legitimately subject to executive privilege, for several reasons. First, the Supreme Court in United States v. Nixon (1974) held that executive privilege cannot be invoked at all if the purpose is to shield wrongdoing. . . . Congress needs to get to the bottom of that question to prevent an illegal invocation of executive privilege and further abuses of power. That will require an index of the withheld documents and an explanation of why each of them is covered by executive privilege—and more. Second, even the “deliberative process” species of executive privilege, which is reasonably broad, does not shield the ultimate decisions from congressional inquiry. Congress is entitled to at least some documents and other information that indicate who the ultimate decision maker was for this disastrous program and why these decisions were made.
At the very least, the Administration owes Congress and the American people a better explanation of what it is doing and why.
When you hear of FBI agents descending upon a place, you might think of a hostage situation, a drug raid, or the penetration of a terrorist cell. But you probably wouldn’t assume that those armed agents were working with the U.S. Department of Education on a raid on a Florida for-profit college.
FBI agents raided campuses of FastTrain College in May 2012 in order to obtain data (documents and a computer or two) in furtherance of a joint investigation of the FBI and DOE of allegedly deceptive practices. One might wonder why the drama was necessary: Couldn’t the government just subpoena the materials or go in with a little less gusto? Yes, but the drama may have been a part of the plan.
While on campus, the agents questioned students about their Pell grants, used for tuition and expenses. Not surprisingly, all this activity caused a good bit of chaos and stirred up concern among students. One student was quoted as saying he was glad he was on campus at the time of the raid, “because they could’ve took money from me, a lot of money from me, and I’d have been screwed.” Another student relayed concerns over whether FastTrain was going to continue to operate, and what would happen to his credits. The students’ statements demonstrate a real concern over the credibility and viability of the institution – a concern incited by the FBI’s dramatic entry.
The drama also had major impact online, where several reports seem to have already decided the guilt of the college, inaccurately stating that the investigation found “deceptive and otherwise questionable sales and marketing practices.” This inaccurate quote, which was picked up and disseminated by the Huffington Post, goes to show how careless journalism can set the tone of a story. Here’s what appears to have happened:
• One report noted that “[t]here was a major undercover investigation by the General Accounting Office in 2010 of for-profit trade schools, which receive billions in federal loans and grants. The investigation uncovered ‘deceptive and otherwise questionable sales and marketing practices’ according to a government inquiry.”
• A later report peeled off the second sentence, stating, “Our news partner Channel 4 reports the investigation uncovered ‘deceptive and otherwise questionable sales and marketing practices,’ according to a government inquiry.”
• That quote itself was then picked up by Huffington Post contributor David Halperin, who stated “One report says the investigation found ‘deceptive and otherwise questionable sales and marketing practices.’”
These latter two stories missed the point that the identified deceptive practices were a part of the earlier 2010 GAO investigation and had nothing to do with the still-pending investigation of FastTrain. It appears that some writers are more than eager to jump to conclusions about the alleged greed of for-profit educators.
The DOE and the FBI have raided for-profit schools several times over the past several years – including at ITT and Corinthian College campuses. One source says that years into the ITT investigation, it finally concluded with no finding of wrongdoing. (Tell that to the students who fled from the school’s programs after the FBI raid.)
So why do the DOE and FBI keep up these shows of force at for-profit college campuses? Some of us skeptics may posit that they already have figured out for themselves that these institutions are bad, so they are making life difficult for the schools in order to give the industry a bad name in students’ eyes.
The FBI and DOE should follow the normal steps of investigation. Playing out drama and rigging public opinion before facts are gathered seems as incendiary as crying “fire” in a crowded theater or inspiring a bank run.
While the recent economic crisis brought newly invigorated political support for SEC enforcement against financial services companies, a recent case shows that the courts will still prevent the SEC from overreaching in its efforts to punish those it views as wrongdoers. In Matter of the Securities and Exchange Commission v. Richard L. Goble, a May 29, 2012, decision by the United States Court of Appeals for the 11th Circuit reversed an SEC victory in a lawsuit claiming a violation of Rule 10b-5, on the ground that this anti-fraud provision did not reach the conduct that formed the basis for the enforcement action.
The SEC brought a civil enforcement action against Goble and others in 2008 alleging that Goble, the founder and owner of a brokerage firm called North American Clearing, Inc., had orchestrated a scheme to manipulate the amount of money that North American was required to set aside to protect the assets of its customers. North American was a securities and clearing brokerage firm for about 40 small brokerage firms and cleared trades for more than 10,000 customer accounts with a total value of more than $500 million. The case arose after North American’s revenues declined during 2007 and 2008 and a March 2008 audit by the Financial Industry Regulatory Authority (FINRA) revealed irregularities in North American’s calculation of its reserves.
After a bench trial, a U.S. district judge in the Middle District of Florida found that Goble had directed an employee to make a false entry in the company’s books, and thus found Goble liable for securities fraud in violation of Section 10(b) of the Securities and Exchange Act of 1934, 15 U.S.C. § 78j(b) and Rule 10b-5, 17 C.F.R. § 240.10b-5. The Court also found Goble liable for aiding and abetting violations of the Customer Protection Rule, 15 U.S.C. § 78o(c)(3) and 17 C.F.R. § 240.15c3-3, and the books and records requirements of the Exchange Act, 15 U.S.C. § 78q(a) and 17 C.F.R. § 240.17a 3.
The 11th Circuit’s reversal of the finding that Goble had violated Rule 10b–5 was based on the question of materiality – that is, for a defendant to be liable, to what did the misrepresentation in question have to be material? The appellate court found that, while knowledge that Goble and his company had cooked their books might be material to a customer’s choice of whether to use him as a broker-dealer, that was not relevant to his liability under Rule 10b-5. Rather, the Court emphasized that to be a basis for a liability for securities fraud, the misrepresentation had to be material to an investment decision by a customer and therefore (to use the language of the statute and rule) “in connection with” the purchase or sale of securities. The Court declined the SEC’s invitation to expand the scope of potential liability to include Goble’s conduct.
By rejecting the SEC’s overreaching, the Goble case is a reminder of the important role of the courts in checking the excesses of government enforcement against companies and individuals. And, given the availability of a private right of action under Section 10(b) and Rule 10b-5, the Court’s restriction on the scope of liability may serve to protect against some of the excesses of private securities fraud litigation as well.
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.