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Four out of five doctors say that if they were stranded on a deserted island with no lawyers, they wouldn’t need any aspirin. American Medical Association. Device Labeling and Promotion. presented by Bradley Merrill Thompson Epstein Becker & Green, P.C. February 27, 2009. Topics.

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slide1

Four out of five doctors say that if they were stranded on a deserted island with no lawyers, they wouldn’t need any aspirin.

American Medical Association

device labeling and promotion

DeviceLabeling and Promotion

presented byBradley Merrill Thompson

Epstein Becker & Green, P.C.

February 27, 2009

topics
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 Gabor’s fifth husband.

I know what I'm supposed to do

but I don't know if I can make it interesting.

Al Gore

part one regulatory requirements
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?

it s good to know the basics
It’s good to know the basics

politicalhumor.about.com

definitions
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.

definitions1
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?
definitions2
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
fundamental prohibition
Fundamental Prohibition
  • The term misbrandedmeans:
    • “Falseor misleadingin 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
fundamental prohibition1
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
good accuracy
Good Accuracy

4.bp.blogspot.com

mixed disclosure
Mixed Disclosure

www.txrollergirls.com

fundamental prohibition2
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
adequate disclosure
Adequate Disclosure?

Photoshoptalent.com

fundamental prohibition3
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

could be deceptive
Could be deceptive

Img.ffffound.com

what else is misbranded
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
exemptions from adequate directions for use
Exemptions from Adequate Directions for Use
  • Prescription devices
  • Commonly-known directions
  • IVDs
  • Products intended for further processing
  • Teaching, law enforcement and research
ftc regulation of advertising
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
lanham act
Lanham Act
  • Action against a competitor in federal court
  • Liability arises from deceptive statements about either the competitor’s or the company’s 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
state regulation of advertising
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

risks in interactions with physicians
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
risks in interactions with physicians1
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
part two claim substantiation
Part Two: Claim Substantiation

Topics

Generally

Comparative claims

Establishment claims

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

claim substantiation generally
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
ftc factors for adequate substantiation
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
comparative claims
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
establishment claims
Establishment claims
  • These are claims that declare or even suggest that a device’s 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
part three off label promotion
Part Three: Off-Label Promotion
  • Off-Label Use Rules
    • Basic Intended Use Framework
    • Evolution of the Legal Landscape
    • Promotion Dos & Don’ts
  • First Amendment Issues

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

basic intended use framework
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. …

off label use rules basic framework
Off-Label Use Rules: Basic Framework
  • 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”

If promoted off-label, a device may be deemed “misbranded” or “adulterated”

evolution of the legal landscape
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)
evolution of the legal landscape1
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

evolution of the legal landscape2
Evolution of the Legal Landscape

The Next Change

  • FDA’s 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
evolution of the legal landscape3
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
first amendment
First Amendment
  • FDA’s 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)
washington legal foundation
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 determination—a technicality
washington legal foundation1
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
western states
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
western states1
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
impact of the litigation
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
sec disclosure requirements
SEC Disclosure Requirements
  • SEC’s requirement that companies disclose material information to the investment community, including both positive and negative results of clinical trials, is often inconsistent with FDA’s limitations on disclosure
    • Clash of pro-speech policy with FDA’s 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
conclusions
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
part four marketing in a regulated environment
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 spoken—the bastards.

Richard M. Nixon

development phases
Development Phases

Phase

Regulatory Category

Requirements Related to Promotion

1

Early Development

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.

2

Investigational (Human use)

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.

3

510(k) pending

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.”

4

Cleared or approved

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...

5

Cleared and

investigational

A blend of both phase 2 and 4.

issues by development phase
Issues by Development Phase

Phase

Regulatory Category

Special settings and issues

1

Development

  • Investor communications about research

2

Investigational (Human use)

  • Trade shows
  • Investor communications about clinical trials
  • Medical meeting discussions of clinical trials
  • Peer reviewed articles about marketed devices

3

510(k) pending

  • Trade shows
  • Investor communications about clinical trials
  • Medical meeting discussions of clinical trials
  • Peer reviewed articles about marketed devices

4

Cleared or approved

  • Contracts for future generations
  • Investor communications about clinical trials
  • Medical meeting discussions of clinical trials
  • Peer reviewed articles about marketed devices

5

Cleared and investigational

  • Contracts for future generations
  • Investor communications about clinical trials
  • Medical meeting discussions of clinical trials
  • Peer reviewed articles about marketed devices
basic rules for pre approval promotion
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.
basic rules for pre approval discussion
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.
fda guidance good reprint practices
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.
fda guidance good reprint practices1
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.
fda guidance good reprint practices2
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.
fda guidance good reprint practices3
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
unsolicited requests
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
investor communications
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
contracts for future generations
Contracts for Future Generations

The Law, or Some Rules of Thumb

  • Can’t 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
  • Can’t pre-promote except in compliance with the rules for pre-approval communication
websites
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 manufacturer’s or own label distributor’s 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
website enforcement examples
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)
fda monitoring of websites
FDA Monitoring of Websites
  • FDA watches web closely for off-label promotion
  • From FDA’s page on buying medicines online:
best practices websites
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
best practices websites1
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
trade shows
Trade Shows
  • What standards apply to information disseminated at trade shows?
    • Labeling regulations apply
  • FDA frequently cites companies for their trade show activities.
best practices trade shows
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)
scientific meetings two types
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 sponsor’s control but sponsor provides support for the program (speakers without employment/consultant relationships with the sponsor)
    • Sponsored CME
meetings controlled communications
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
meetings supported communications
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 company’s products when alternatives are available)
    • Relationship between provider and sponsor
    • Etc. in 1997 Guidance
trends in enforcement
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)

trends in enforcement1
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
compliance isn t always easy
Compliance isn’t always easy

www.mustreadblogs.blogspot.com

good promotional practices
Good Promotional Practices
  • Many leading companies are developing their own GPPs
  • Essentially a risk management tool—sets the company’s preferred path forward in a gray area
  • Looked favorably upon by regulators if done well.
  • Become the basis for training and auditing
part five case studies
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?

democracy used to be a good thing but now it has gotten into the wrong hands senator jesse helms

Definition of Device/Intended Use

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

definitional case studies
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 doctor’s 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.
actual trial question was it you or your brother that was killed in the war

Meetings

Actual Trial Question

Was it you or your brother that was killed in the war?

case study meetings
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 manufacturer’s 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.

case study meetings1
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?

case study meetings2
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 company’s 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?

I’ll be three months on November 8.

Apparently, then, the date of conception was August 8?

Yes.

What were you doing at that time?

actual trial question how far apart were the vehicles at the time of collision

Sales Scenarios

Actual Trial Question

How far apart were the vehicles

at the time of collision?

case study sales scenarios
Case Study – Sales Scenarios
  • Background: Your joint replacement device is labeled for use in individuals 65 years and older while your competitor’s 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:
  • Lanham Act?
  • FD&CA?
  • FTC Act?
  • State FD&C Acts?
  • State Unfair Trade Practices Acts?
case study sales scenarios1
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?
comments or questions
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.