Four out of five doctors say that if they were stranded on a deserted island with no lawyers, they wouldn

1
Four out of five doctors say that if they were
stranded on a deserted island with no lawyers,
they wouldnt need any aspirin.

• American Medical Association

2
DeviceLabeling and Promotion

• presented byBradley Merrill Thompson
• Epstein Becker Green, P.C.
• February 27, 2009

3
Topics

• Part One Regulatory Requirements
• Part Two Claim Substantiation
• Part Three Off-Label Promotion
• Part Four Marketing in a Regulated Environment
• Part Five Case Studies

I feel like Zsa Zsa Gabors fifth husband. I
know what I'm supposed to do but I don't know
if I can make it interesting.
Al Gore
4
Part One Regulatory Requirements

• Topics
• Definitions
• Fundamental prohibition
• Special labeling rules
• Risks in interactions with physicians

Actual Trial Question What happened then? He told
me, he says, I have to kill you because you can
identify me. Did he kill you?
5
Its good to know the basics
politicalhumor.about.com
6
Definitions

• Label" is a
• display of written, printed, or graphic matter
  upon the immediate container of any article....
• Labeling" is
• all labels and other written, printed, or graphic
  matter
• (1) upon any article or any of its containers or
  wrappers, or
• (2) accompanying such article.

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Definitions

• Accompanying"
• Is interpreted liberally to mean more than
  physical association with the product
• Extends to posters, tags, pamphlets, circulars,
  booklets, brochures, instruction books,
  direction sheets, fillers, etc., depending how
  they are used
• Includes labeling that is brought together with
  the device after shipment or delivery for
  shipment in interstate commerce.
• But what of an oral sales pitch?

8
Definitions

• Advertising
• Not defined in the FFDCA
• FDA likes to treat advertising as labeling
• According to an appellate court decision "Most,
  if not all advertising, is labeling. Congress
  did not, and we cannot, exclude from the
  definition printed matter which constitutes
  advertising.
• But consider radio and TV ads
• Where do magazine ads fit
• FTC has jurisdiction over device advertising
  other than for restricted devices

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Fundamental Prohibition

• The term misbranded means
• False or misleading in any particular.
• False generally is understood to mean a
  statement that in any material respect is
  untrue.
• Misleading is less clear
• Twin goals of
• Safety and effectiveness
• Preventing economic fraud

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Truth in Advertising
Funky.co.uk
11
More Truths
12
Fundamental Prohibition

• Examples of false labeling include
• Incorrect, inadequate or incomplete
  identification
• Unsubstantiated claims of therapeutic value
• Substitution of parts or material
• Inaccuracies concerning condition, state,
  treatment, size, shape or style

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Good Accuracy
4.bp.blogspot.com
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Mixed Disclosure
www.txrollergirls.com
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Fundamental Prohibition

• Examples of misleading labeling include
• Ambiguity, half-truths, and trade puffery
• Expressions of opinion or subjective statements
• Failure to reveal material facts, consequences
  that may result from use, or the existence of
  difference of opinion

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Adequate Disclosure?
Photoshoptalent.com
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Fundamental Prohibition

• Examples of other objectionable labeling
  practices include
• Deceptive pictorial matter
• Misleading testimonials
• Misleading list of parts or components
• Use of brand or trade names instead of
  "established names"
• Often the surest way to convey
• misinformation is to tell the strict truth.
• Mark Twain

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Misleading testimonial?
A6.vox.com
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Good Use of Brand Name
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Could be deceptive
Img.ffffound.com
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What else is misbranded?

• FDA specifically requires certain information,
  prominently displayed (unless exempt)
• Established name of the product
• Name and place of business of themanufacturer,
  packer, or distributor
• Net quantity of contents
• Adequate directions for use andadequate warnings

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Make sure materials are clear
www.gdarguad.net
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Exemptions from Adequate Directions for Use

• Prescription devices
• Commonly-known directions
• IVDs
• Products intended for further processing
• Teaching, law enforcement and research

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FTC Regulation of Advertising

• FTC has jurisdiction over advertising for a
  non-restricted device
• FTC applies three requirements
• Adequate substantiation
• No deception, from the standpoint of the
  reasonable consumer
• Fairness
• Agency influenced by lawyers who focus on
  consumers and how they are affected

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Lanham Act

• Action against a competitor in federal court
• Liability arises from deceptive statements about
  either the competitors or the companys own
  product alleged to harm the other party,
  including
• False or misleading claims
• Unsubstantiated comparative claims
• Overstatements of efficacy
• Minimization of risks
• Damages injunctive relief are available

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State Regulation of Advertising

• State Food Drug Cosmetic Acts
• State consumer protection laws
• Enforcement by state attorneys general
• Consumer class actions

Politics gives guys so much power that they tend
to behave badly around women. And I hope I never
get into that.
Bill Clinton
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Risks in Interactions with Physicians

• Applicable law
• Federal Anti-kickback statute
• Fraud and Abuse provisions of the Social Security
  Act (Medicare/Medicaid statute)
• Federal False Claims Act
• State Anti-kickback statutes
• State False Claims Acts
• State statutes requiring disclosure of gifts to
  prescribers

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Risks in Interactions with Physicians

• Government enforcement risks arise in the
• context of
• Business courtesies
• Ensure sales personnel follow applicable guidance
  with respect to gifts, meals and entertainment
• Consulting arrangements
• Consulting arrangements must be for necessary
  services pursuant to written agreements in
  compliance with regulatory requirements
• Research grants
• Grants should be administered outside marketing
  function, based on objective criteria
• Educational activities meetings
• Sponsored meetings must take place in locations
  conducive to educational activities, without
  providing entertainment and with only modest
  meals and accommodations

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Part Two Claim Substantiation

• Topics
• Generally
• Comparative claims
• Establishment claims

The pure and simple truth is rarely pure and
never simple. Oscar Wilde

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Claim Substantiation Generally

• Refers to the evidence needed to support a claim
  regarding some feature or performance of the
  device
• Must support both express and implied claims
• In labeling, revolves around the FDCA false and
  misleading language
• In advertising, revolves around the FTC standard
  requiring a reasonable basis in objective
  evidence before the claim is made
• Unlike with drugs, there is no explicit FDA
  guidance yet on device claim substantiation

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FTC Factors for Adequate Substantiation

• Type of product
• Type of claim
• Benefits of a truthful claim
• Cost/feasibility of developing substantiation for
  the claim
• Consequences of a false claim
• Amount of substantiation that experts in the
  field believe is reasonable

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Comparative claims

• These compare the device to another device
• FDA considers them inherently misleading
• Requires that such claims be supported by sound
  scientific data, usually a rigorous study that
  directly compares the devices
• FTC does not have that same predisposition,
  instead favoring useful comparisons
• But likewise requires rigorous scientific
  evidence, again a study or studies comparing
  the devices

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Establishment claims

• These are claims that declare or even suggest
  that a devices superiority has been
  scientifically proven
• Both FDA and FTC require the company to have at
  least the level of evidence stated or implied in
  the claim
• There is also a baseline of support required
• Studies must be able to withstand criticism

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Part Three Off-Label Promotion

• Off-Label Use Rules
• Basic Intended Use Framework
• Evolution of the Legal Landscape
• Promotion Dos Donts
• First Amendment Issues

Winter related injuries occur more often in the
winter.-newswoman for WHIZ-TV, Zanesville Ohio
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Basic Intended Use Framework

• Under 21 CFR 801.4, the words intended uses
  refer to the objective intent of the persons
  legally responsible for the labeling of devices.
  The intent is determined by such persons'
  expressions or may be shown by the circumstances
  surrounding the distribution of the article. This
  objective intent may, for example, be shown by
  labeling claims, advertising matter, or oral or
  written statements by such persons or their
  representatives. It may be shown by the
  circumstances that the article is, with the
  knowledge of such persons or their
  representatives, offered and used for a purpose
  for which it is neither labeled nor advertised.

36
Off-Label Use Rules Basic Framework
If promoted off-label, a device may be deemed
misbranded or adulterated

• The uses promoted are intended uses under 21
  CFR 801.4
• If an intended use is for other than the
  approved indication, the lack of approval and
  inadequate labeling make device adulterated
  and misbranded

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Evolution of the Legal Landscape

• Where FDA was
• Strict regulation of off-label promotion
• FDA Guidances
• Guidance on Dissemination of Reprints and
  Reference Texts (1996)
• Guidance on Industry Supported Scientific and
  Educational Activities (1997)

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Evolution of the Legal Landscape

• Then FDAMA Section 401 (1997)
• Sets forth process for disseminating off-label
  information
• Requires disclosure statements labeling
• Requires later filing for approval of any
  unapproved uses in the materials
• Sets forth audience restrictions
• Limited to dissemination of certain
  referencejournals
• Now sunset

Gofethiye.com
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Evolution of the Legal Landscape

• The Next Change
• FDAs authority to regulate off-label promotion
  has been limited by the courts
• Washington Legal Foundation
• Western States Medical Center
• More on those later
• Result FDA cannot infringe on the right of
  medical device companies to promote their
  products on-label or off-label if other, less
  restrictive measures can achieve FDA's goals

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Evolution of the Legal Landscape

• What the Law is NOW
• FDCA sections on misbranding are still in effect
• FDAMA 401 provisions on dissemination of
  off-label materials and regulations have sunset
• CME guidance is still in effect
• New Guidance on journal reprints
• FDA cannot infringe on promotion of products if
  it has other options

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First Amendment

• FDAs authority to regulate off-label promotion
  has been limited by the courts any such
  regulation must be narrowly tailored to achieve
  FDA's purpose
• Cases
• Washington Legal Foundation v. Henney (2000)
• Thompson v. Western States Medical Center (2002)

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Washington Legal Foundation

• WLF brought action challenging 1996/1997
  Guidances (and later, FDAMA) as unconstitutional
  under the First Amendment
• WLF won at trial
• On appeal, when FDA asserted they were not
  mandatory, but created only safe harbors, the
  court held the matter was not ripe for
  determinationa technicality

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Washington Legal Foundation

• Trial court suggested restrictions of its own,
  which many manufacturers have adopted.
• Articles from bona fide peer-reviewed journals or
  text books published by a bona fide independent
  publisher
• Product must be cleared or approved for at least
  one indication
• False and misleading materials still open to FDA
  enforcement
• Must disclose off-label use
• Must disclose any relationship between the
  company and product or authors

44
Western States

• Background FDAMA exempted "compounded drugs"
  (mixed by pharmacist) if, among other things
• Drug is compounded by licensed pharmacist
• Providers don't advertise or promote compounding
  of a particular drug, drug class or drug type
• Challenge
• Compounding provision challenged by group of
  pharmacies arguing provisions prohibiting
  advertising violated First Amendment

45
Western States

• U.S. Supreme Court held FDAMA compounding
  provision unconstitutional
• Lesson learned
• Government must use the least restrictive means
  possible to achieve its objectives
• If government can achieve its purpose without
  restricting speech, or by restricting less
  speech, it must do so

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Impact of the Litigation

• FDA cannot infringe on the right of medical
  device companies to promote their products if
  other, less restrictive measures can achieve
  FDA's objectives, such as
• Disclaimers and warning labels
• Disclosures
• Limitations on non-speech related activity
• Narrowing of speech restrictions
• FDA is reassessing its own authority
• On May 16, 2002, FDA requested comments on its
  authority to regulate communications More than
  730 comments received

47
SEC Disclosure Requirements

• SECs requirement that companies disclose
  material information to the investment community,
  including both positive and negative results of
  clinical trials, is often inconsistent with FDAs
  limitations on disclosure
• Clash of pro-speech policy with FDAs speech
  restrictions
• First Amendment typically does not permit
  regulation of speech based on audience
• SEC has brought enforcement actions against
  companies for failure to disclose important
  information about products in clinical trials

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Conclusions

• Basic principle Truthful speech should be
  allowed
• Many argue that truthful should be judged in
  the eye of the audience
• Doctors are sophisticated they can be told the
  truth
• Patients should be protected
• Begs the question, what level of substantiation
  is required to establish the truthfulness of a
  statement?
• But is handing a doctor a peer-reviewed article
  untruthful? Does it matter who hands it?
• FDA needs to protect the integrity of its
  clearance/approval process

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Part Four Marketing in a Regulated Environment

• The Stages of Promotion
• General Risk Areas
• Good Reprint Practices
• Unsolicited Requests
• Contracts for future generations
• Investor Communications
• Websites
• Trade Shows
• Scientific Meetings
• Trends in Enforcement
• Good Promotional Practices

The voters have spokenthe bastards.
Richard M. Nixon
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A lot of the rules are obvious
www.okaponds.com
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Development Phases
Requirements Related to Promotion
Regulatory Category
Phase
As a legal technicality, none on promotion until
introduced into interstate commerce. See CPG
300.600. Remember design control requirements
that will apply to labeling. But customers and
FDA will remember what is said.
Early Development
1
IDE regulation places explicit restrictions. For
example, no promotion is allowed beyond what is
necessary for its use in investigations (e.g.
recruiting subjects). Here, no clinical
performance claims are permitted.
Investigational (Human use)
2
According to FDA CPG section 300.600 Although a
firm may advertise or display a device that is
the subject of a pending 510(k)--in the hope that
FDA will conclude that the device is
substantially equivalent to a pre-amendments
device--a firm may not take orders, or be
prepared to take orders, that might result in
contracts of sale for the device unless limited
to research or investigational use.
510(k) pending
3
A whole slew of restrictions apply, including
limits on off-label promotion, truth in labeling,
adequate directions for use, and a number of
affirmative requirements related to name,
quantity, etc...
Cleared or approved
4
A blend of both phase 2 and 4.
Cleared and investigational
5
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Issues by Development Phase
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Basic Rules For Pre-approval Promotion

• Thou Shall Not Promote Beyond the Anticipated
  Approved Label
• Whatever the company says now about its upcoming
  product will create an impression in the minds of
  the customers who may ultimately be asked to
  purchase that product.
• If the company describes uses that do not
  ultimately get approved, the company will be
  creating an off-label promotion situation once
  the product is introduced into commercial
  distribution.

54
Basic Rules For Pre-approval Discussion

• Thou Shall Tell the Truth in Promotional
  Materials
• Both FDA and FTC would have difficulty proceeding
  against the company for statements made in
  advance of any product being placed in commercial
  distribution. (But other laws may still be
  relevant.)
• However, once the opportunity to acquire the
  product exists, any prior statements made would
  be evaluated for their truthfulness. Being
  truthful means, among other things, the
  statements made are adequately supported by valid
  scientific evidence at the time they are made.

55
FDA Guidance Good Reprint Practices

• Publishing Organizations must
• Utilize an independent editorial review board
  and
• Have a publicly stated policy regarding full
  disclosure of any conflicts of interest
• Channels of Distribution. A reference
  publication
• May not be primarily distributed by the
  manufacturer and
• Must be generally available.
• Influence of the Manufacturer. Reference
  publications and reprints may not be disseminated
  if
• Written, edited, excerpted, or published for, or
  at the request of, a product manufacturer
• Edited or significantly influenced by the product
  manufacturer or any party in a financial
  relationship with the manufacturer
• They are special supplements or publications that
  a manufacturer funded in whole or in part.

56
FDA Guidance Good Reprint Practices

• Content of Disseminated Information. A reprint
  or reference publication
• Must not pose a significant risk to the public
  health.
• Must address adequate, well-controlled,
  scientifically sound clinical investigations
  include historically controlled studies,
  pharmacokinetic and pharmacodynamic studies and
  meta-analyses if they are testing a specific
  clinical hypothesis.
• Must be truthful and not misleading. Examples of
  misleading information include
• Information that is inconsistent with the weight
  of credible evidence,
• A withdrawn journal article or disclaimed
  reference publication, or
• Information based on studies FDA deemed
  inadequate or not well-controlled.
• Must be disseminated in its original state.

57
FDA Guidance Good Reprint Practices

• Manner of Dissemination.
• The information must be accompanied by
• a copy of the approved product labeling
• a comprehensive bibliography and
• a publication representative of any articles
  reaching different conclusions.
• Dissemination must take place separate and apart
  from promotional activities. For example
• a reprint may not be physically attached to any
  promotional materials
• sales representatives may not discuss the
  content and
• reprints may not be distributed at promotional
  exhibitions or speaker programs.

58
FDA Guidance Good Reprint Practices

• Disclaimers.
• The article or text must bear permanent and
  prominent disclaimers.
• That the uses described in the information have
  not been approved or cleared by FDA
• The manufacturer's interest in the drug or
  medical device that is the subject of the journal
  reprint or reference text
• Any author known to the manufacturer as having a
  financial interest in the product or manufacturer
  or who is receiving compensation from the
  manufacturer, along with the nature and amount of
  any such financial interest of the author
• Any person known to the manufacturer who has
  provided funding for the study and
• All significant risks or safety concerns known to
  the manufacturer concerning the unapproved use
  that are not discussed in the journal article or
  reference text

59
Unsolicited Requests

• When may off-label information be provided?
• In response to an unsolicited request of a health
  care provider
• Best Practices Unsolicited Requests
• Make sure unsolicited
• Keep the discussion objective, non-promotional in
  nature, and fairly balanced
• Confine responses to the specific question asked,
  narrowing broad questions before responding
• Clearly disclose that the device has not been
  cleared or approved for the discussed use
• Document all responses to unsolicited requests

60
Investor Communications

• What legal standard applies to information
  regarding investigational uses?
• Labeling regulations apply, unless disclosure can
  be classified as purely business or a scientific
  exchange
• Pre-approval off-label information, including
  study announcements, will be tolerated by FDA if
  segregated in the investor or news section of a
  website and/or distributed to the press
  concurrently with a newsworthy event

61
Contracts for Future Generations

• The Law, or Some Rules of Thumb
• Cant sign, or perhaps even negotiate, a contract
  where successful performance (e.g. delivery)
  would require FDA approval/clearance
• Some believe this is true even if the contract
  conditions performance on FDA clearance or
  approval (penalty free)
• Note that exempt devices or changes that do not
  require a new 510(k) would not be included
• Cant pre-promote except in compliance with the
  rules for pre-approval communication

62
Websites

• Who regulates medical device website content?
• FTC and FDA
• Is a website labeling or advertising?
• FDA considers written, printed, or graphic
  material placed on a manufacturers or own label
  distributors Internet website to be labeling.
• We suggest that you review your current
  labeling, including any internet advertising
  .
• Source FDA, CDRH, Letter Re Medical Claims on
  Labeling and Promotional Materials of Infant
  Mattresses and Infant Positioners Distributed in
  the U.S.
• FDA uses conduct prohibited in any medium as a
  basis of enforcement actions related to websites
• New intended use
• Promotion of investigational devices

63
Website Enforcement Examples

• Warning Letters to
• Laser Therapeutics (Despite disclaiming U.S.
  medical claims, website caused device to be
  adulterated and misbranded)
• Medical Device Resource Corp (Claims made on
  website caused device to be adulterated)
• Diomed (U.S. website headlines and links to
  industry and general media articles cause device
  to be misbranded and adulterated)
• Ximed (Link to "gene therapy" page and pictorial
  caption implies unapproved use in gene therapy)

64
FDA Monitoring of Websites

• FDA watches web closely for off-label promotion
• From FDAs page on buying medicines online

65
Best Practices Websites

• Avoid discussion of investigational or OUS uses
  on sites targeting a US audience
• Physical location of server hosting the site is
  irrelevant, accessibility is key Use gateway
  page to select location
• Indications only approved abroad must be
  segregated from the US site, with no links
  between them
• Disclaimers are insufficient

66
Best Practices Websites

• Monitor linked sites for off-label/ unapproved
  information
• What you link becomes yours
• Provide notice that viewer is leaving your site
• Observe the two click rule for off-label
  information
• Avoid links to chat rooms or sites known to
  discuss off-label use of the product

67
Trade Shows

• What standards apply to information disseminated
  at trade shows?
• Labeling regulations apply
• FDA frequently cites companies for their trade
  show activities.

68
Best Practices Trade Shows

• Train marketing personnel extensively in
  permitted disclosures
• Consider having clinical personnel present to
  respond to questions that are off-label
• Maintain a separate space for international uses
• Control disclosures regarding pending 510(k)

69
Scientific Meetings Two Types

• Controlled - speakers under the control of the
  sponsor (e.g., employees, consultants)
• Investigator meetings
• Speaker training
• Trade show booths
• Supported - speakers are not under the
  sponsors control but sponsor provides support
  for the program (speakers without
  employment/consultant relationships with the
  sponsor)
• Sponsored CME

70
Meetings Controlled Communications

• Regulated as promotional material
• Remarks should
• Be consistent with intended use
• Conform to rules applicable to unsolicited
  requests
• Also consider rules applicable to
• Dissemination of written materials
• Appropriate locations
• Interactions with healthcare professionals
• Speaker agreements

71
Meetings Supported Communications

• Unregulated scientific exchange, unless sponsor
  is in a position to influence the presentation of
  information about its products
• In determining independence, FDA will consider
• Sponsor's control over content and speakers
• Meaningful disclosure of sponsor support,
  relationships with speakers, regulatory status of
  any unapproved uses discussed
• Focus of the program (e.g., on a single product
  or single companys products when alternatives
  are available)
• Relationship between provider and sponsor
• Etc. in 1997 Guidance

72
Trends in Enforcement

• FDA focus is on low hanging fruit
• Trade show exhibits and booths
• Website advertising and links
• Broadcast and print advertising
• Promotional materials
• FDA Creativity
• Connection of off-label promotion to Medicaid or
  Medicare reimbursement claims (Parke-Davis)

73
Trends in Enforcement

• OIG continues to investigate off- label promotion
• Abbott
• Amgen
• Boston Scientific
• FCA actions have alleged off-label promotion
• Cephalon (425M)
• Eli Lilly (1.4B)
• Pfizer (2.3 B)
• State AG Investigations of off-label promotion
  are on the rise

74
Compliance isnt always easy
www.mustreadblogs.blogspot.com
75
Good Promotional Practices

• Many leading companies are developing their own
  GPPs
• Essentially a risk management toolsets the
  companys preferred path forward in a gray area
• Looked favorably upon by regulators if done well.
• Become the basis for training and auditing

76
Part Five Case Studies

• Topics
• Definition of Device/Intended Use
• Meetings
• Sales Scenarios
• Promotional Materials

Actual Trial Question How far apart were the
vehicles at the time of collision?
77

Definition of Device/Intended Use

• Democracy used to be a good thing, but now it has
  gotten into the wrong hands.-Senator Jesse Helms

78
Definitional Case Studies

• Which of the following are regulated as medical
  devices?
• Popsicle stick
• Exercise treadmill
• Computer software for a standard PC. Doctors
  type in symptoms, and an algorithm suggests the
  most likely diagnosis.
• An off-the-shelf modem that connects to a blood
  glucose monitor. The modem transmits data over
  the internet to the doctors office, so the
  doctor can stay informed.
• A website on which a patient can enter
  information such as height, weight, family health
  history and existing medical conditions. The
  website makes recommendations for life style
  improvements such as diet, exercise and dietary
  supplements.

79

Meetings

• Actual Trial Question
• Was it you or your brother that was killed in
  the war?

80
Case Study - Meetings

• Speaker Thought-leader physician who has a
  consulting agreement with the company
• Motivation Speaking at CME for educational
  purposes.
• Content Discussing an off label use of the
  generic category of devices that includes the
  manufacturers product
• Audience Doctors attending CME
• Setting Aspen Hotel

Actual Trial Question Doctor, did you say he was
shot in the woods? No, I said he was shot in the
lumbar region.
81
Case Study - Meetings

• Speaker Company Medical Director
• Motivation CME Seminar, education purpose, but
  an official company spokesman who gets paid
  partly based on stock performance
• Content Primary remarks are on label, but an
  audience member asks about an off label use
• Audience Physicians
• Setting Aspen Hotel

Actual Trial Question Were you acquainted with
the deceased? Yes, sir. Before or after he
died?
82
Case Study - Meetings

• Speaker Physician who serves as an investigator
  in a company-sponsored clinical trial
• Motivation Publishes an article in a peer
  reviewed journal for prestige
• Content The journal discusses an off label use
  for the companys product under investigation.
• Audience Physicians
• Setting The journal is subscription based, so
  they get it through the mail.

Actual Trial Question Do you know how far
pregnant you are now? Ill be three months on
November 8. Apparently, then, the date of
conception was August 8? Yes. What were you doing
at that time?
83

Sales Scenarios

• Actual Trial Question
• How far apart were the vehicles
• at the time of collision?

84
Case Study Sales Scenarios

• Background Your joint replacement device is
  labeled for use in individuals 65 years and older
  while your competitors device is designed and
  labeled for a younger population.
• Scenario By way of comparison with its device,
  your competitor is disseminating case studies
  demonstrating failures of your device when
  implanted in younger, more physically active
  patients.
• Is this a violation of

1. Lanham Act?
2. FDCA?
3. FTC Act?

1. State FDC Acts?
2. State Unfair Trade Practices Acts?

85
Case Study Sales Scenarios

• A peer reviewed journal article describes an
  independent clinical trial comparing on-label,
  lumbar spine uses of your bone screw device with
  your biggest competitor. Superior efficacy of
  your product is clearly demonstrated.
• In the introductory paragraph describing the
  devices, authors note in a single paragraph the
  off-label use of these devices in the cervical
  spine.
• Can you disseminate this article to prescribers?

86
Comments or Questions?

• Arguing with a lawyer is like
• mud wrestling with a pig after a while
• you realize that the pig actually enjoys it.