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Reducing Legal Risks and Strengthening Compliance Efforts in the Face of Unprecedented Government Scrutiny
When: Wednesday, March 20 to Friday, March 22, 2013
Where: ONE UN New York, New York, NY, USA
For more information, and to register: click here
Use this code to benefit from a special discount when registering: LNKPHC
Industry related articlefrom Lexology.com, by Cadwalader Wickersham & Thaft LLP, Adam S. Lurie, Brian T. McGovern, Bret A. Campbell, Martin L. Seidel and Jason Jurgens, posted on 02/21/13:
Federal court finds that FDA drug approval is not complete defense to False Claims Act allegation involving on-label promotion
On January 30, 2013, in United States ex rel. v. Bristol Myers Squibb Company & Sanofi-Aventis U.S., LLC et al., Civ. No. 11-00246 (S.D. Ill.) (“BMS & Sanofi-Aventis”), the Court denied a motion to dismiss the relator’s second amended False Claims Act (“FCA”), 31 U.S.C. § 3729 et seq. complaint alleging the defendants made false efficacy claims regarding Plavix, even though the United States Food and Drug Administration (“FDA”) approved Plavix for the promoted uses. This decision is significant for several reasons, including because (a) it will likely embolden the continued emergence of new FCA relator and government enforcement theories concerning the marketing of drugs; (b) it does not expressly distinguish another recent court decision suggesting that FDA approval for a promoted use will preclude FCA liability for promotional activities consistent with that approved use; and (c) it will require life-science companies to remain vigilant as they monitor the promotion of their products, even for approved uses.
The BMS & Sanofi-Aventis Decision
In BMS & Sanofi-Aventis, relator’s second amended complaint alleged, among other things, that the defendants:
Promoted “Plavix as a superior drug to aspirin for certain indicated usages, and charg[ed] approximately one hundred times more for Plavix than could be charged for aspirin, when in fact Plavix was no more effective than aspirin for certain indicated usages.”1
“Targeted such efforts at physicians and prescribers whose patients relied upon public assistance programs such as Medicaid [and] Medicare . . . [and caused them to] submit many prescriptions for Plavix that resulted in grossly inflated costs” to the government “when compared to aspirin.”2
“[M]anipulated clinical trial data to support fraudulent claims regarding Plavix’s efficacy relative to cheaper alternatives, such as aspirin[,] mischaracterized clinical studies which contradicted the sales campaign. . . . [and] targeted doctors whose patients rely on [government programs] for health care treatment so as to wrongfully inflate sales and profits . . . .”3
Defendants moved to dismiss the complaint, arguing that relator failed to state an FCA claim because, among other reasons, relator did not allege any false certification of compliance with a statute or regulation, and because relator’s allegations related only to Plavix prescriptions for uses that the FDA had approved. Defendants asserted that:
Relator asks this Court essentially to overrule the FDA’s approval of Plavix for treatment of stroke patients and to substitute its judgment for the independent medical judgment of physicians who prescribed Plavix. Relator’s allegations are unprecedented. Defendants are aware of no case that has held a drug manufacturer liable for fraud under the FCA for on-label promotion without allegations of illegal kickbacks.4
The court, however, rejected this argument. The court first explained that pursuant to 42 U.S.C. § 1395y, a prescription must be “reasonable and necessary” as a prerequisite to Medicare reimbursement. In light of this requirement, the Court held that relator sufficiently alleged an FCA claim because – if accepted as true – defendants’ actions “caused physicians and pharmacists to submit claims for reimbursement of prescribed treatment that was not ‘reasonable and necessary’ and thus false.” 5
The court further concluded that “the fact a drug is FDA-approved does not mean it is ‘reasonable and necessary’ in every instance it is prescribed” and held that plaintiff sufficiently alleged that defendants caused “physicians to certify that Plavix was reasonable and necessary when it was not . . . .”6 Here, the court noted that the relator alleged that “defendants instructed their sales force to present various data and studies in a manner designed to confuse physicians and make them believe that Plavix was more effective than cheaper alternatives.”7
The Significance of the BMS & Sanofi-Aventis Decision
While the court recognized that the defendants’ arguments may be more effective at the summary judgment stage, the BMS & Sanofi-Aventis decision is nevertheless significant.
Recently, FCA and government enforcement actions have focused on the “off-label” promotion of drugs – that is, the marketing and promotion of drugs for uses that the FDA did not approve. In contrast, the BMS & Sanofi-Aventis matter concerns “on-label” FDA approved uses, a developing front in government and relator attacks on life science promotional practices. In other words, this action seeks punishment for causing purportedly unnecessary or excessive use of FDA approved purposes. Thus, the government and relators may look to this decision when developing FCA onlabel theories where there is no false certification of compliance with a statute or regulation, no allegation of a kickback, or based upon claimed violations of FDA requirements – which the defendants in BMS & Sanofi-Aventis argued courts had previously, and soundly, rejected.8
In addition, BMS & Sanofi-Aventis did not expressly distinguish United States ex rel. v. Pfizer, Civ. No. 04-0704 (E.D.N.Y. Nov. 15, 2012) where, according to the defendants, the court held FDA approval of an “on-label” use precluded FCA liability. There the court rejected the relator’s claim that Pfizer violated the FCA because it marketed Lipitor to patients who did not warrant drug intervention according to the National Cholesterol Education Program Guidelines, which were referenced in the drug’s label. The court dismissed the relator’s claims, however, because Pfizer was “marketing the drug, after all, for an FDA sanctioned purpose – to lower cholesterol.” Then the court stated that because Pfizer did not engage in “off-label” marketing it had “not violated the FCA.”9
Notwithstanding BMS & Sanofi-Aventis, life-science companies facing government or relator claims concerning an on-label, FDA-approved use, should continue to look to the Pfizer decision and other analogous decisions where regulatory approval helped defeat liability.
As many life-science companies know all too well, however, defending against an FCA claim or related enforcement action can be costly and time-consuming. Thus, it is important for those entities to continue to monitor carefully the promotion of their products, including for FDA approved on-label uses, and to tailor their compliance programs accordingly.
Expert Article by Deborah McMurray
Experience management and how to get one’s arms around it surfaces in every conversation that I have with firm leaders and senior marketers. As I noted in a February 2012 blog post “Experience Management – it’s been elevated to mission-critical,” cross-selling and revenue growth are the two top concerns of firm leaders as they see a future of shrinking demand for legal services and higher expenses. These issues remain at the top as we approach 2013 – but firm leaders are no closer to having a handle on how to cross-sell more effectively and otherwise drive new revenue.
According to Altman Weil’s MergerLine(tm), through the 3rd quarter there have been 68 law firm mergers completed. In Q4, there are several high profile and notable ones in the works - Fulbright’s merger with Norton Rose and SNR Denton’s three-way merger with Fraser Milner and Salans are two that will create literally thousands of laterals. Lateral integration is also at the top of firm leaders’ list of concerns – how do they quickly embed and inculcate a few laterals into the fabric (and client base) of the firm, let alone many hundreds?
The simplest answer is effective experience management. Sure, but how? It’s not easy, but it’s not nearly as paralyzing as you think. Reframe your thinking about how to go about it – don’t start with the lawyers and their many and assorted lists of deals and cases; start with the clients – the buyers of legal services. What do they want and need to make buying decisions in your various practice and industry areas? When your planning starts with the end in mind, it ensures that your focus, and consequently, your action is relevant.
To prepare for a recent experience management presentation to a Lex Mundi Americas group of senior marketing and business development professionals, I surveyed the group about their hottest button issues and concerns, wanting to understand where they were in the experience management life cycle. Most of the 19 respondents were in mid-sized to large law firms.
Here were their burning questions:
- 1. What is the limit of experience information that can be published that doesn’t affect the confidential client information?
- 2. How can we motivate the lawyers to keep the experience database updated? How do we keep it current?
- 3. How do we handle it when there are several practice areas working in one transaction? Is it better to consolidate as one big transaction, a transaction with different points of advice or several different matter entries?
- 4. Is it common to ask the client if the experience information can be published?
- 5. What is the best way to demonstrate the benefits of such a system to the attorneys, especially as an offset to its costs?
- 6. How are people doing this effectively? How do people connect to time and billing, follow-up, self-service, website, proposals, etc. What accountability share is there – lawyers vs. admins vs. BD/marketing staff?
- 7. Best practices, what systems are out there in the market, usability of system (lawyers, BD staff)?
- 8. How can we do this cheaply, but effectively?
I asked the senior marketers what their greatest challenge is regarding experience management:
- 1. Keeping the information updated
- 2. Leveraging data from other systems via integration
- 3. Getting the lawyers to cooperate
- 4. Which matters to highlight and capture
- 5. Convincing firm of the need for such a database
- 6. Resources to plan and implement it
- 7. Managing all the reports, rankings, pitches, web, etc. that need this data – and getting the right data to them all
- 8. Getting lawyers to think beyond the work they do (cross-sell)
- 9. The ability to capture specialized/unique skills
- 10. Disorganized process and incomplete data
Nearly 60% of the respondents do not have an experience database. These firms are struggling with multiple data sources – Microsoft Word documents, mini-databases, Excel spreadsheets – and many of these documents are closely-held by the partners. The ones that responded that they do have one are mostly “thinking about it” or are in the earliest planning stages.
Because the process of gathering thousands of matters into a single, flexible location is so debilitating, I thought it would be helpful to share best practices that we have developed for the launch of a successful experience database.
1. I previewed the secret above: Start with your ultimate end users (your clients) and work backwards >> your lawyers >> marketing/BD team >> IT.
2. Identify your top three use cases for your experience database (a few examples below). Choose only three to start – you can always expand it post-launch. Building a tool that satisfies the needs of all your use cases will take years – and the goal here is to get a workable tool launched in a matter of months – six months is average, depending on the quality of the data.
- Client pitches, proposals, RFPs
- Client expansion conversations – cross-selling
- Website – bios, practices, industries, more
- Surveys – Thomson League Tables, Chambers, other
- Lawyers – KM
- Lateral integration
3. Lawyers must use it or they won’t keep it current. They won’t care about it if, in some way, they don’t own it. Build it to be used by everyone in the firm – not just the marketing department.
4. Successful experience management is the perfect blend of people, process and technology. Don’t start with the technology tool.
People. Who needs this information? Who must be involved?
1. Clients – ultimate users of the information
2. Lawyers – practice group leaders, users of the information
3. Practice group marketers – consultants to the project for their practice/industry teams
4. Marketing/BD managers – users of the information for pitches, proposals, reports, surveys, rankings
5. Project manager in your firm – day-to-day oversight and accountability
6. Vendor partner – strategy, best practices, day-to-day project management, guidance, training, launch and post-launch.
1. Gather all the experience lists you have – scour pitches, proposals, website, personal matter lists – don’t get bogged down in the formatting; different formats are OK
2. Analyze the efficacy of this data – do lawyers trust it? (if they don’t, you can’t move on to any of the next steps. They have to trust the data first.)
3. Create consistent presentation styles for matter and narrative format for your proposals, web, reports, case studies, surveys, etc. for the experience you have
4. Develop your strategy: Who will use it, for what will they use it?
5. Meet with your vendor/IT partner to review all of the above and plan your tech strategy/approach.
Technology and Integration.
1. Build v. Buy – 58% of the marketers said they are or are planning to build it in-house compared to 25% buying a third party tool. In an ILTA survey we did in February 2012 of IT professionals, the results were the opposite – the majority planned to buy it.
2. What third party vendor to choose? Choose a vendor partner who intimately understands what lawyers do, law firm project strategy, and the process and the people aspects of such an endeavor in a law firm. This will make a huge difference in how smoothly the project goes and how much consulting value they can bring to the table.
3. Functional requirements – Your vendor partner will create these for you, and will design them based on your use cases and conversations with your IT team.
4. Integration – where does important data live? It’s all about leveraging trusted data that lives elsewhere – time/billing, CRM, document management system, conflicts, website, HR database, etc.
5. Mobility – experience on-the-go – The most effective cross-selling takes place spontaneously, when lawyers and clients are on the move. These opportunities are lost 80%+ of the time, because experience data lives somewhere back in the office. Lawyers need it at their fingertips when standing in a movie line, riding in a cab with a client, and having lunch or a drink. Velocity(tm) is the answer to this – it puts this trusted data into your lawyers’ hands via their smart phones or tablets.
The next critical piece is content – who contributes to it, who owns it.
Off-Label Promotion and the First Amendment: How a $25 Fine and 100 Hours of Community Service Sank the Titanic
Expert article by Michael Walsh:
December 3, 2012 was a good day for Alfred Caronia, a sales rep for a drug manufacturer. It was three years to the day after his trial for off-label promotion resulted in a conviction for a misdemeanor and subjected him to a $25 fine and 100 hours of community service. Not happy is one of his co defendants, Dr. Gleason, who settled before trial and, as a result of his federal criminal plea, spiraled downward taking his own life. So why is this sad little case ripping the fabric of FDA enforcement of off-label promotion?
On December 3, 2012, two years to the day from hearing the case, the Second Circuit, in United States v. Caronia, ruled that the FDA’s civil and criminal enforcement of drug companies violates the First Amendment. Not unlike the iceberg that sank the Titanic, it wasn’t the small object on the surface that presented the risk, it is what was lying beneath the surface.
Off-label promotion cases are simply too big and the stakes (i.e. losing the ability to conduct business) are simply too great for a company to seriously consider defending an off-label marketing claim. The government has poured tens of billions of dollars in fines and penalties into its coffers based on an enforcement regime that a federal circuit court has now found to be in violation of the First Amendment to the U.S. Constitution. Ironically, massive off-label promotion plea agreements involving big pharma have been the fodder of daily news reports for many years; yet, it took a small case involving a individual sales rep to question the constitutionality of FDA’s enforcement of off-label promotion.
While this case will provide real and immediate comfort to a great many sales representatives, manufacturers and distributors of FDA regulated products may see this case as a watershed. As suggested at footnote 12 in the Caronia opinion and by Justice Rehnquist in his dissenting opinion in the landmark Central Hudson case, private litigants may replace governmental prosecutions, and nationwide off-label promotion tort claims could pose a significant new threat to companies with products used off-label. Aboard the Titanic of FDA regulation of off-label promotion rode very potent cargo for manufacturers; deference to agency determinations, and, most importantly, preemption. Both may have gone down with the ship.
The command of the Constitution is a mere ten words:
“Congress shall make no law … abridging the freedom of speech …”
Yet the FDA places restrictions on what, when, where, why, who and how a manufacturer may disseminate information concerning regulated products. Over decades, the statutory and regulatory framework has expanded, placing more and more restrictions on information that may be disseminated. The enforcement of these regulations gradually infringed upon First Amendment protections and the court that have looked at the issue have expressed serious concerns that the government infringes First Amendment protections.
Off-label use presents a conundrum where a manufacturer with reliable scientific and medical information regarding a product is throttled under the rubric of off-label promotion, while a physician lacking any scientific or medical basis is free to prescribe or use that product. Effectively, the manufacturer is silenced while the physician, the consumer, and even academia are unrestrained in recommending any product for any use. From this conundrum, an urgent moral and ethical imperative exists to provide more—not less—reliable scientific and medical information.
When did it all begin?
In 1942 the United States Supreme Court made a profound and admittedly erroneous assumption that is taking decades for the Court to recognize and gradually walk back. In Valentine, the Supreme Court held that,
[T]he Constitution imposes no such restraint on government as respects purely commercial advertising.
From that ruling grew generations of cases confounding the public beyond comprehension and leaving legal scholars pleasantly divided. It wasn’t until the mid 1970’s that the Supreme Court said what the public instinctively knew all along:
As to the particular consumer’s interest in the free flow of commercial information, that interest may be as keen, if not keener by far, than his interest in the day’s most urgent political debate.
In the ensuing decades the Supreme Court has continued evolving. The debate circles around a few simple questions:
Is it speech? If yes: is the regulation subject to strict scrutiny and, if it is, test it under intermediate scrutiny anyway.
Is commercial speech involved and does the regulation survive the four prong Central Hudson intermediate scrutiny test?
Orphan Medical manufactured and marketed a sleep-inducing depressant, Xyrem. The drug had a black box and was labeled for serious potential side effects. A government informant, Dr. Charno, who had pled guilty to submitting fraudulent medical insurance bills, contacted Caronia, asking for information on off-label use and for a presentation by a medical liaison. Caronia arranged the presentation, and the sting operation resulted in prosecution. Unfortunately for Caronia, his employer admitted to a conspiracy to misbrand and took a plea bargain, and the former manager testified that he had personally instructed the medical liaison to misbrand the product on prior occasions.
In denying Mr. Caronia’s motion to dismiss, the trial court was prescient in stating:
Reduced to its essence, Caronia’s argument is that the government cannot restrict truthful, non-misleading promotion by a pharmaceutical manufacturer (or its employees) to a physician of the off-label uses of an FDA-approved drug … Squarely, Caronia’s constitutional attack calls into question America’s regulatory regime for the approval and marketing of prescription drugs.
The trial court went on to state: “The Constitutional issues raised in Caronia’s motion are very much unsettled, not only in the circuit but nationwide.”
The Second Circuit noted that the FDCA makes it a crime to misbrand or conspire to misbrand a drug, but the statute and its accompanying regulations do not expressly prohibit or criminalize off-label promotion. Based on the statutory and regulatory framework, the Second Circuit elected to avoid deciding the Constitutionality of the FDCA, and instead questioned the government’s prosecution. The result is the same for Mr. Caronia, but it enabled the Court to reach its result without finding the law unconstitutional. In this regard, the Court stated:
Thus, under the principle of constitutional avoidance, explained infra, we construe the FDCA as not criminalizing the simple promotion of a drug’s off-label use because such a construction would raise First Amendment concerns. Because we conclude from the record in this case that the government prosecuted Caronia for mere off-label promotion and the district court instructed the jury that it could convict on that theory, we vacate the judgment of conviction.
The Court went on to state:
To the extent there is any ambiguity as to whether off-label promotion is tantamount to illegal misbranding, we construe the FDCA narrowly to avoid a serious constitutional question. As we now explain, we decline the government’s invitation to construe the FDCA’s misbranding provisions to criminalize the simple promotion of a drug’s off-label use by pharmaceutical manufacturers and their representatives because such a construction – and a conviction obtained under the government’s application of the FDCA – would run afoul of the First Amendment.
In arguing the case to the Second Circuit, the government took a position it had not taken at the trial court level, arguing that the speech at issue “was not speech at all but was conduct evidence of intent to misbrand.” The Second Circuit was unimpressed with the government’s shameful ploy rejecting it as “simply not true” “the government clearly prosecuted Caronia for his words – for his speech.”
Following the Supreme Court in Sorrell, the Second Circuit analyzed the case under both strict scrutiny and intermediate scrutiny stating:
First, we conclude that the government’s construction of the FDCA’s misbranding provisions imposes content and speaker based restrictions on speech subject to heightened scrutiny. Second, we conclude the government cannot justify a criminal prohibition of off-label promotion even under Central Hudson‘s less rigorous intermediate test.
The Court found heightened scrutiny because the “government’s construction of FDCA’s misbranding provisions” is “content and speaker based” and therefore subject to heightened scrutiny. Content based because it distinguishes “favored speech” on the basis of ideas expressed. Particularly notable to the Second Circuit was that off-label speech is prohibited while off-label use is not. In addressing the “speaker based” aspect, the Circuit Court observed that the government’s construction only barred manufacturers from speaking where others are free to speak.
The Court went on to apply the now well known Central Hudson four part test holding as follows:
1. The commercial speech must concern unlawful activity and not be misleading. The court found the off-label promotion at issue concerned a lawful conduct and the information was truthful.
2. The asserted governmental interest in drug safety and public health must be substantial and the Circuit Court so found.
3. The regulation must directly advance the governmental interest asserted. In finding that the prohibition failed the third prong of Central Hudson, the Court found:
[I]t does not follow that prohibiting the truthful promotion of off-label drug usage by a particular class of speakers would directly further the government’s goals of preserving the efficacy and integrity of the FDA’s drug approval process and reducing patient exposure to unsafe and ineffective drugs.
Not only did the Court find that the prohibition failed to advance the government’s interest, it found the opposite:
[P]rohibiting off-label promotion by a pharmaceutical manufacturer while simultaneously allowing off-label use ‘paternalistically’ interferes with the ability of physicians and patients to receive potentially relevant treatment information; such barriers to information about off-label use could inhibit, to the public’s detriment, informed and intelligent treatment decisions.
Recognizing that it is the physician’s role to consider multiple factors to determine the best course of action for a patient, the Court stated:
The government’s construction of the FDCA essentially legalizes the outcome - off-label use - but prohibits the free flow of information that would inform that outcome. If the government’s objective is to shepherd physicians to prescribe drugs only on-label, criminalizing manufacturer promotion of off-label use while permitting others to promote such use to physicians is an indirect and questionably effective means to achieve that goal. Thus, the government’s construction of the FDCA’s misbranding provisions does not directly advance its interest in reducing patient exposure to off-label drugs or in preserving the efficacy of the FDA drug approval process because the off-label use of such drugs continues to be generally lawful. Accordingly, the government’s prohibition of off-label promotion by pharmaceutical manufacturers ’provides only ineffective or remote support for the government’s purpose.’
4. The regulation must not be more extensive than necessary. The courts have described this prong as whether there is a “reasonable fit” not the least restrictive means. The Second Circuit found the regulation is more extensive than is necessary to serve the government’s interest. The Court then provided a number of alternatives the government could pursue that would not implicate the First Amendment. According to the Court, “if the government is concerned about the use of drugs off-label, it could more directly address the issue” and the Court set out six potential alternatives:
i. It could guide physicians and patients in differentiating between misleading and false promotion, exaggerations and embellishments, and truthful or non-misleading information.
ii. The government could develop its warning or disclaimer systems, or develop safety tiers within the off-label market, to distinguish between drugs.
iii. The government could require pharmaceutical manufacturers to list all applicable or intended indications when they first apply for FDA approval, enabling physicians, the government, and patients to track a drug’s development.
iv. To minimize off-label use, or manufacturer evasion of the approval process for such use, the government could create other limits, including ceilings or caps on off-label prescriptions.
v. The FDA could further remind physicians and manufacturers of, and even perhaps further regulate, the legal liability surrounding off-label promotion and treatment decisions. In its Footnote 12 the Court states “Physicians and pharmaceutical manufacturers can be held accountable for off-label drug use through medical malpractice and negligence theories of liability.”
vi. Finally, where off-label drug use is exceptionally concerning, the government could prohibit the off-label use altogether.
According to the Court, “[t]he possibilities are numerous indeed.”
What should take the immediate attention of every company who markets and distributes FDA regulated products is the Court’s fifth recommendation concerns private litigation. Also notable is that where there is a right to speak, there is soon may follow a claim that there is a corresponding duty.
In conclusion, the Court purports to have a simple holding, stating:
We construe the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs. Our conclusion is limited to FDA-approved drugs for which off-label use is not prohibited, and we do not hold, of course, that the FDA cannot regulate the marketing of prescription drugs. We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.
The dissent fails to address the core issue in this case. The recognition by the medical community and, more importantly, the FDA that off-label use often represents the “standard of care.” creates an irreconcilable clash with both the First Amendment and Due Process when the law is currently enforced to prohibit the dissemination of truthful scientific information. The urgent public health issue for state and federal regulators, the medical community and manufacturers is to foster the dissemination of truthful, reliable medical and scientific information, and to focus enforcement on false, unsupported and unreliable misinformation that presents a real and immediate risk to the public.
While Caronia is major development in the FDA’s regulation of drug and device product promotion that will usher in a new era in how truthful information is disseminated, it may also signal the beginning of a new wave of private litigation.
ACI event related to this topic
ACI’s 10th Annual Expert Guide to Advertising, Promotions and Digital Marketing for the Life Sciences Industry
When: Thursday, January 24 to Friday, January 25, 2013
Where: Union League, Philadelphia, PA, USA
For more information, and to register: click here
In this article Why Paid Search for B2B Companies is Dead (or Dying) the author states that PPC is dead. Is it? Give us your insight, how do you use PPC?
Leave us a comment to share your thoughts!
Ryan Garcia is a Legal Director at Dell Inc. Mr. Garcia graduated from the University of Texas School of Law in 2000. Prior to joining Dell, Mr. Garcia was a technology litigator working on cases against Microsoft and hundreds of alleged satellite television pirates. At Dell, Mr. Garcia supports the global social media team, the North American Consumer Retail team, and the Alienware division. He posts about social media legal issues on Twitter (@SoMeDellLawyer) and on his SoMeLaw Thoughts blog (somelaw.wordpress.com). David Pogue of the New York Times has called Mr. Garcia “the funniest Dell lawyer I know.”
Subscribe to his SoMeLaw Blog at: http://somelaw.wordpress.com/
- I Never Meta-Contest I Didn’t Like (September 20, 2012)
Lee G. Dunst is a partner in the New York office of Gibson, Dunn & Crutcher. Mr. Dunst is a member of the firm’s Litigation Practice and White Collar Defense and Investigations Practice. His practice covers a wide range of general commercial litigation, as well as government investigations and white-collar criminal matters. His extensive experience includes securities class action cases, accountants liability cases, directors and officers liability matters and general business litigation. He also represents numerous clients, including individuals, companies and special board committees, in connection with criminal and regulatory investigations. Mr. Dunst has a particular focus on matters involving alleged violations of the Foreign Corrupt Practices Act. He has been recognized in the 2008, 2010 and 2011 editions of The Legal 500 US for his work in connection with the firm’s White Collar Defense and Investigations practice. The Legal 500 US, 2011 edition described Mr. Dunst as “knowledgeable and responsive,” and The Legal 500 US, 2010 edition noted that he “provides a broad range of expertise and regularly advises clients accused of corporate fraud and alleged accounting irregularities, as well as FCPA violations.”
Contact Lee G.Dunst
200 Park Avenue
New York, NY 10166-0193
Networking for Personal, Professional & Business Development at Conferences.
Benjamin Greenzweig, Managing Director, ACI
Matt Godson, Marketing Director, ACI
In a new era of heightened scrutiny, there is one place where you can learn how to reduce the risk of massive fi nes, litigation costs, misconduct charges, guilty pleas, negative publicity and more - ACI’s 12th National Summit on Reducing Legal Risks in the Sales and Marketing of Medical Devices. This annual conference will enable you to reshape your compliance programs to refl ect recent legislation and changes in enforcement priorities and to develop corporate policies that protect against future fraud claims.
Never before have device companies been so pressured by issues arising simultaneously on the state, national and international levels. At this uniquely trying time, day-to-day activities can become the focus of inquiries by members of Congress, investigations by federal and/or state prosecutors, and whistleblower claims. Additionally, see how other device manufacturers are responding to Sunshine Act requirements as you benchmark against your peers from: Baxter International, CareFusion, Covidien, Cyberonics, Inc., Fresenius Medical Care, Hollister Incorporated, Medline Industries, Medtronic, Roche Diagnostics Corporation, Smith & Nephew, University of Chicago Medical Center, Wright Medical, and Zimmer Holdings.
The Government Has You Under a Microscope – Learn The Enforcement Priorities for 2012
Prosecutors are using all the tools at their disposal to ensure that fraud and abuse by device manufacturers is kept at bay, including increased fi nes, prosecution of individuals and recalls?. By attending this conference, you will have an unparalleled opportunity to hear directly from government representatives regarding what activities are currently triggering enforcement. Gain insights from: federal and state enforcers:
- J. Gilmore Childers,
First Assistant U.S. Attorney,
New Jersey District
- Gejaa Gobena,
Trial Attorney, Fraud Section, Criminal Division,
U.S. Department of Justice
- Keith V. Morgan,
Assistant U.S. Attorney, Deputy Chief, Civil Division,
District of Columbia District
- Stephanie Morse,
Assistant Attorney General, Complex Civil Enforcement Bureau,
State of Florida Office of the Attorney General
- Tracy L. Price,
FCPA Unit, Division of Enforcement, U.S. Securities & Exchange Commission
- Jeremy Sternberg,
Deputy Chief, Health Care Fraud Unit,
U.S. Attorney’s Office, District of Massachusetts.
As Device Operations Become More Global, So Do the Global Compliance RisksIt is not uncommon for multinational device manufacturers to be put on notice that they are being investigated for payments made to foreign physicians and health offi cials in various countries. With FCPA enforcement heating up, and the UK Bribery Actbeginning to take shape, it is critical for you to learn how to build a global compliance program to withstand the scrutiny of multiple countries. Expert speakers from the SEC, Bausch & Lomb, Biomet and Becton Dickinson will share tips for installing adequate internal controls to oversee foreign subsidiaries.
Post-Conference Workshops Complete Your Training
Complement your conference experience and gain hands-on and in-depth guidance on training and contracting. The Interactive Working Group: Executing a Comprehensive Training and Monitoring System to Minimize the Risks of Sending Your Sales Team Into the Field will enable you to see what training techniques your competitors are utilizing and how to most effectively ensure your team is engaging in compliant practices. The Master Class on Drafting an Effective and Compliant Contract Between Device Manufactures and Hospitals will give attendees a better understanding of the requirements for the hospital-manufacturer contract, and highlight what areas are subject to increasing government review.