challenging hypotheticals kai peters, partner, gordon & rees llp joy liu, partner, ropes &...
TRANSCRIPT
Challenging Hypotheticals
Kai Peters, Partner, Gordon & Rees LLP
Joy Liu, Partner, Ropes & Gray LLP
Moderated by Colleen Heisey, Partner, Jones Day
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CHALLENGING HYPOTHETICALS
FDLI Advertising & Promotion Conference
October 2, 2015
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PANELISTS
Joy J. Liu, Partner, Ropes & Gray LLP Kai Peters, Partner, Gordon & Rees
LLP Ralph F. Hall, Counsel, Faegre Baker
Daniels LLP
Moderated by: Colleen M. Heisey, Partner, Jones Day
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HYPOTHETICAL AYou're the compliance officer for Company A. You've just completed your compliance address at the company's national sales meeting involving all your representatives and have called for questions. A sales representative steps to the auditorium's microphone and eagerly proceeds: “I just wanted to share a compliance success story! My highest prescriber told me a competitor had shared that the Wikipedia page for our blockbuster product detailed how dangerous our product was. Dr. Z – a key opinion leader – is one if our best paid speakers, and gleaned from the conversation that the competitor likely had something to do with the mischief on the wiki. He quickly revised the page to include some glowing efficacy information based on personal, clinical experience with the product and based on recently published data on that huge clinical trial we did. Dr. Z said I should address all that misleading safety information though, so I did. Stuff that doesn't happen with our product and isn't even in our PI – I just deleted it. And since FDA issued that ‘Addressing Misinformation’ guidance document, I knew it was fine. Compliance rocks!” The happy sales rep contentedly sits down.
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HYPOTHETICAL A, QUESTION 1 Who/what presents the largest
compliance risk to your Company? A. The sales representative B. The competitor C. The doctor D. The Wikipedia page
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HYPOTHETICAL A, QUESTION 2 In response, from the stage, you:
A. Attempt to address each of the issues presented by the scenario
B. Highlight problematic areas, including whether an investigation will be forthcoming
C. Defer, request the sales representative see you after the session closes
D. Close the session and meet with the representative immediately
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HYPOTHETICAL A, QUESTION 3 How do you feel about the paid
speaker’s use of the pivotal trial to update the page? A. Great, that’s protected commercial speech B. Fine, it’s personal to him and his practice C. Egad, this is going to be a long day D. Ambivalent
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HYPOTHETICAL B Modification of fact pattern:
Instead of reporting during the sales meeting, the sales representative reports the Wikipedia situation via your compliance hotline and before taking any action. After reviewing the information on the page, you determine it contains information overstating efficacy, discussing unapproved uses, and minimizing risk. It is unclear, what if any, information was input by the Doctor. Based on the egregious nature of some of the claims, you decide it is in the Company’s best interest to correct the page. The company has the page corrected only to see it promptly reverted by some other person. The changes are made a second time, and again, the misleading information re-input as well as additional derogatory claims about the product and your company. Contemporaneously with these changes, a patient decides to use the product for the unapproved use based on what she read on the page and has Dr. Z prescribe the product. She experiences a significant, life-threatening adverse event and sues the Company, among others.
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HYPOTHETICAL B, QUESTION 1 Do you follow the “Bright Line Rule”?
A. Yes, of courseB. No, of course C. I’m not sure D. None of the above, I’d never change a
Wikipedia entry
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HYPOTHETICAL B, QUESTION 2 What liability does the Company have
with respect to the patient? A. None, obviously the patient made the
decision with her prescribing physician B. A lot, it was the Company’s paid speaker
and the Company didn’t address the webpage quick enough
C. Some, she relied on the Wikipedia page while the Company was editing it
D. I need more information
The Wunderstent Xenostent, Inc. (NASDAQ XOMA) is a
manufacturer and seller of the “Wunderstent Device.” The Wunderstent is a 510(k) cleared device that is indicated for use in right coronary arteries that are up to 50% occluded. Xenostent is obligated under the conditions for clearance to provide training to device users. During the training process, a physician must demonstrate successful deployment in at least twenty procedures, be trained in troubleshooting techniques, and pass a test on various aspects of use of the device. 12
Xenostent employs twenty territory managers and ten sales representatives across the United States. Xenostent tasks the territory managers with acting as overseers of the sales process and also as the “trainers” of physicians in the use of the devices.
Hypo. No. 1 – What would you advise Xenostent to do with respect to their sales and training functions?
a) Continue with its current structure.b) Create a new Training Specialists Division which
is independently responsible for training.c) Hire a third party to handle the training
obligations.d) Continue with its current structure but remove
the existing commission component for territory managers’ compensation.
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Joe Xeno is one of Xenostent territory managers. Joe Xeno is training Dr. Cath. After the tenth procedure, Dr. Cath says to Joe, “Hey, Joe. Love your Wunderstent Device. You have really sold me on this device with your excellent instruction and explanation. I will have our cath lab triple our orders as my colleagues and I really find it to be effective. We will use those devices in the right coronary artery and test them out in the left anterior descending artery and brachial artery as well.”
Hypo. No. 2 – Can Joe place the order for Dr. Cath?
a) Yes. Physicians can use medical devices for off-label uses.
b) Yes, so long as Joe has not discussed or advocated use of the Wunderstent in any artery other than the right coronary artery.
c) Yes, so long as Joe does not tell his company that Dr. Cath might use the ordered Wunderstent off-label.
d) No, because Joe Xeno as a representative of Xenostent has been told that Dr. Cath will test the Wunderstent in arteries other than the right coronary artery.
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On the fifteenth of twenty procedures, while Joe is in the cath lab monitoring Dr. Cath for purposes of certification in use of the device and while a patient is on the table, Dr. Cath. tells Joe, “Whoa, Nelly! What a surprise. Now this is an interesting patient! This is a patient who, in addition to the occluded RCA that I saw before, has a near total occlusion of the left anterior descending (LAD) artery, a particularly tortuous, twisty artery, that just has to be cleared. I am going to use this Wunderstent. All of my colleagues are using it in the LAD. OK with you?” Hypo. No. 3: What should Joe do?
a) Inform Dr. Cath that the Wunderstent is not indicated for use in the left anterior descending artery and immediately leave the cath lab.
b) Inform Dr. Cath that the Wunderstent is not indicated for use in the left anterior descending artery but stay to assist since Dr. Cath is in a training procedure.
c) Inform Dr. Cath that the Wunderstent is not indicated for use in the left anterior descending artery, that Joe is not allowed to train Dr. Cath if he uses the Wunderstent in an off-label use procedure, but stay in the cath lab as the patient also has an occluded RCA.
d) Tell Dr. Cath that by no means is he allowed to use the Wunderstent and remove the Wunderstent from the cath lab.
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Dr. Cath says to Joe, “Just kidding, Joey. I am only using the Wunderstent in the right coronary artery.” Dr. Cath proceeds but actually only uses the device in the left anterior descending artery. During the procedure, Dr. Cath inserts the Wunderstent but the device becomes stuck in the left anterior descending artery. Dr. Cath cannot remove the device and turns to Joe, “Joe, I used it in the LAD. You know this device better than anyone. My patient is in serious trouble here. What should I do? The Instructions for Use tell me that I can just yank this device out if it is stuck.”
Hypo 4: What should Joe do? a) Say nothing. Leave the room immediately.b) Tell Dr. Cath that he is using the device off-label and
that Joe cannot assist as he does not know how to advise about this off-label use.
c) Tell Dr. Cath that he is using the device off-label but that Joe has been told by other physicians that the same Instructions for Use should apply.
d) Give Dr. Cath the cell phone number of Dr. Smith, a lead investigator in clinical trials involving the Wunderstent, whom Joe believes has had similar cases.
e) Do his best to advise Dr. Cath after telling him that the use was off-label and that Joe has no clinical data to support his advice.
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Joe reviews the training materials that he was provided by the company and that every territory manager/trainer is provided. The training materials state that, “If the physician uses the device in an artery not included in the Indications for use, inform the physician that he should just follow the Instructions for Use as they are the best guidance that the company has.” Joe knows that all of the territory managers follow these procedures. He tells Dr. Cath to follow the Instructions for Use even though he is using the device off-label. Dr. Cath proceeds to forcefully pull the Wunderstent device. A perforation of the Left anterior descending artery quickly develops and the patient dies.
Hypo. No. 5: Which of the following should Joe do? Choose your best answer.
a) Inform all the other territory managers of the adverse event.
b) Say nothing. Leave the room immediately.c) File a lawsuit against Xenostent under the False
Claims Act, 31 U.S.C. section 3729.d) Immediately inform Xenostent of the adverse event
so that the appropriate MAUDE report can be filed.
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Joe reviews the training materials that he was provided by the company and that every territory manager/trainer is provided. The training materials state that, “If the physician uses the device in an artery not included in the Indications for use, inform the physician that he should just follow the Instructions for Use as they are the best guidance that the company has.” Joe knows that all of his territory managers follow these procedures. He tells Dr. Cath to follow the Instructions for Use even though he is using the device off-label. Dr. Cath proceeds to forcefully pull the Wunderstent device. A perforation of the Left anterior descending artery quickly develops and the patient dies.
Hypo. No. 6: Who may be suing Xenostent?
a) Joe Xenob) The FDA and DOJc) The shareholders of Xenostentd) Dr. Cathe) The hospitalf) The patient’s wifeg) All of the above
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ROPES & GRAY LLP
Challenging HypotheticalsFDLI Advertising & Promotion ConferenceJoy LiuOctober 2, 2015
ROPES & GRAY20
Proactive Communications by MSLs
BACKGROUND FACTS
• DrugA. DrugA is FDA-approved for the reduction of the risk of another heart attack in patients who have already had a heart attack.
• Clinical Study. The manufacturer of DrugA has conducted a phase III trial evaluating the safety and effectiveness of the drug in reducing the risk of a stroke or cardiovascular death in patients who have had a heart attack.
• Results. Strongly positive interim results from the trial were just presented at the annual meeting of the American Association of Cardiology.
ROPES & GRAY21
Proactive Communications by MSLs
Question:
Would you permit MSLs from the manufacturer of DrugA to make proactive presentations to cardiologists about the interim data from the phase III trial?
A: Yes
B: No
C: Not sure
ROPES & GRAY22
Detailing HCPs in Certain Specialties
BACKGROUND FACTS
• DrugA. DrugA is FDA-approved for the reduction of the risk of another heart attack in patients who have already had a heart attack.
• Results. Strongly positive interim results from a phase III trial show that DrugA may be effective in reducing the risk of heart attack in patients who have had a stroke.
• Cardiologists and Neurologists. A cardiologist treats and prevents diseases of the heart and blood vessels. A neurologist treats and prevents diseases of the brain, spinal cord, and nerves. There are approximately 30,000 cardiologists and 17,000 neurologists in the U.S.
ROPES & GRAY23
Detailing HCPs in Certain Specialties
Question:
Would you permit sales reps from the manufacturer of DrugA to proactively call on neurologists, but only to discuss the approved indication (reduction of risk of heart attack in patients who have had a heart attack)?
A: Yes
B: No
C: Not sure
ROPES & GRAY24
Detailing HCPs in Certain Specialties
Question:
Would you permit MSLs from the manufacturer of DrugA to make proactive presentations to neurologists about the approved indication (reduction of risk of heart attack in patients who have had a heart attack)?
A: Yes
B: No
C: Not sure
ROPES & GRAY25
Promotion of a Meta-Analysis
BACKGROUND FACTS
• DrugA and DrugB. Both are FDA-approved for the same indication, reduction of the risk of another heart attack in patients who have already had a heart attack.
• NEJM Publishes Article. Article describes a robust meta-analysis of 20 RCTs assessing the efficacy outcomes and safety profiles of DrugA and Drug B.
• Article’s Conclusion. DrugA is more effective than Drug B.
• No Relationship with Authors. The manufacturers of DrugA and DrugB did not sponsor the meta-analysis and none of the authors are otherwise affiliated with or paid by the manufacturers.
ROPES & GRAY26
Promotion of a Meta-Analysis
Question:
Would you permit the manufacturer of DrugA to make a promotional claim in a detailing aid that DrugA is more effective than DrugB, based on the meta-analysis published in NEJM?
A: Yes
B: No
C: Not sure
ROPES & GRAY27
Promotion of a Meta-Analysis
BACKGROUND FACTS
• 2009 Final Reprint Guidance:
Information contained in a reprint disseminated by the company “should address adequate and well-controlled clinical investigations” and “these can include . . . meta-analyses if they are testing a specific clinical hypothesis.”
• 2014 Draft Reprint Guidance:
Information contained in a reprint disseminated by the company should address adequate and well-controlled clinical investigations and “in the case of devices . . . meta-analyses, if they are testing a specific clinical hypothesis . . . may be consistent with this guidance”
ROPES & GRAY28
Promotion of a Meta-Analysis
Question:
Would you permit the manufacturer of DrugA to distribute reprints of the NEJM study to health care professionals?
A: Yes
B: No
C: Not sure
ROPES & GRAY29
Promotion Based on IMS Data
BACKGROUND FACTS
• DrugA and DrugB. Both are FDA-approved for the same indication, reduction of the risk of another heart attack in patients who have already had a heart attack. They are the only drugs approved for this indication.
• IMS Data. Based on IMS data, DrugB has 70% U.S. market share and DrugA has 30% market share.
ROPES & GRAY30
Promotion Based on IMS Data
Question:
Would you permit the manufacturer of DrugB to make promotional claims that DrugB is the most prescribed drug for its approved indication?
A: Yes
B: No
C: Not sure
ROPES & GRAY31
Promotion Based on IMS Data
Question:
Would you permit the manufacturer of DrugB to make promotional claims that DrugB is the most preferred drug for its approved indication?
A: Yes
B: No
C: Not sure
ROPES & GRAY32
Promotion Based on Survey Results
BACKGROUND FACTS
• DrugA and DrugB. Both are FDA-approved for the same indication, reduction of the risk of another heart attack in patients who have already had a heart attack. They are the only drugs approved for this indication.
• IMS Data. Based on IMS data, DrugB has 70% U.S. market share and DrugA has 30% market share.
• Survey. Based on a survey of 3,000 cardiologists, 66% prefer DrugA for their patients over DrugB. The manufacturer of DrugA conducted the survey.
ROPES & GRAY33
Promotion Based on Survey Results
Question:
Would you permit the manufacturer of DrugA to make promotional claims that DrugA is the most preferred drug for its approved indication?
A: Yes
B: No
C: Not sure