A high school reunion can be a wonderful, surreal experience at best, and a handwringing, anxiety-ridden event at worst. During those formative years of our teenage lives, we were surrounded by – and spent countless hours with – a relatively small universe of people, for better or worse. Some we liked, some we didn’t; some we still keep up with, and some we don’t. I recently attended my (most recent) high school class reunion, and it was a bit jarring to realize how fast those old feelings shot to the surface some three decades later. Walking into the reception, I felt much the same way I did the first day of class way back when – excited but nervous; self-conscious, yet self-aware; and searching the crowd for a friendly, if not recognizable, face. I settled down over a cold beer and soon found myself chewing up the night, hanging out with old friends I had not seen in years. Even so, there were some people I flat-out could not identify and others that I did recognize but consciously avoided. Some of the stories told brought back memories that washed over me like a wave, yet others never landed, as I had no recollection of the events. It turned out to be a fantastic, rewarding evening, and I found some comfort in the fact that I appeared voluntarily, did not have to carry any conversations, and could leave when I wanted. I can’t say I would have felt the same if: 1) I had been ordered to be there, 2) I had to talk the entire time, 3) I could not leave until I was told, and 4) my arranged date was an out-of-town lawyer with a weird accent that I had known for less than a week.

Enter the former sales representative.

In the pharma and device litigation world, there has been a recent uptick of former employees being called back to testify, more often than not, sales representatives. Identified through discovery, plaintiffs have latched onto these individuals, seeking to get the boots-on-the-ground/face of the company testimony and admissions regarding: 1) product training, 2) compensation and rewards, 3) product detailing, 4) product labeling, 5) sales pieces and materials; and, perhaps most importantly; 6) communications (or lack thereof) to healthcare professionals regarding safety or efficacy of the product. In the absence of preparation, the testimony of these often entry-level employees can turn into a minefield for the defense.

This article will serve as a primer for both counsel and sales representatives as they prepare for the deposition. It is designed to cover the key themes and approaches for those instances where sales representatives who have been designated are no longer employed by the company, and thus have been out of the litigated drug/product space for some time. It is not designed – nor should it be read – to suggest ways to obstruct or thwart questioning, but rather it should provide a road map as to what the witness may or may not expect by way of questioning, as well as what obligations the witness may or may not have by way of testifying. At all times, the deponent and counsel should follow the applicable rules of civil procedure, including any local rules, or rules established by order or agreement. This primer also takes into consideration that there is uncertainty as to how much prep time, if any, will be available.

I. General Themes

Sales representative depositions have traditionally covered the following topics and themes:

• Sales representative background
• Sales training
• Compensation/prizes/incentives
• Reptile Theory
• Detailing & limitations of sales representative job
• Office visits/instructions to healthcare providers
• Call notes/data memorializing sales calls
• Comparisons between labeling, detail pieces, literature, etc.
• Potential off-label detailing/questions
• Primary litigation themes (drug/device-specific)

We should not expect much variance in the context of former sales representative depositions. Unlike the deposition of a current employee, however, where the deponent’s time, availability and commitment are generally understood and approved by management, the former employee is often working on their own time, without pay, and with little, if any, opportunity for reimbursement. While most witnesses appear voluntarily lest they be subject to the time and place restrictions of a subpoena, they are still, in many cases, taking time off from their current job or time away from their family, so the prep session (whether it be three hours or two days) should be as efficient as possible.

II. Building Rapport

With any witness, the most effective way to begin the prep is to establish knowledge and credibility as counsel. Witnesses are more receptive to preparation and direction and more tolerant of the tediousness of the exercise if they trust their counsel. The best way to build rapport with the witness in the limited time you have is to come prepared from a substantive and experiential standpoint. The representative should realize early on that you have done this before, are familiar with their history with the company, familiar with plaintiff counsel, understand what to expect from the other side at the deposition, and that you plan to get them through the process in the most efficient and painless way possible.

The first step, after the initial meet and greet, is to explain to them why they are here and what to expect the day of the deposition. No matter how much substantive material you must cover, it will likely fall on deaf ears until the process is understood.

• Establish the scope of representation.
• Explain that they have not been accused of doing anything wrong, and that they were named because they were identified as a sales representative who called on a healthcare provider who used/recommended/prescribed the drug/device for plaintiff.
• Explain the litigation history.
• Explain that the testimony will be given under oath, meaning, first and foremost, that the witness must tell the truth about facts which he or she may have personal or institutional knowledge.
• Explain the deposition process.
  • Specifically, explain how the video will be cut/argued/played.
• Explain the discovery process.
  • Provide background re: written discovery and prior depositions so the sales representative understands what plaintiff counsel knows at the time of deposition.
  • Walk through how a custodial file production works (if applicable) and explain what representative-specific documents were produced.
• Explain that there is no significance as to the substance of the documents just because they were produced from a “custodial file” or produced “by the company,” and any representations made by plaintiff counsel suggesting that these have some special importance should be disregarded and not given any credence.
• Explain who will be there.
• Explain how defense objections work (objections to form or otherwise).
• Explain that plaintiff counsel may “object as nonresponsive” or “move to strike” and that such objections do not mean the question was answered improperly or that the witness did anything wrong.
• Explain why there are no substantive discussions during breaks.
• Explain that plaintiff counsel may or may not be aggressive and that, in most cases, they are smart, deliberate and patient, no matter how they present themselves at the deposition.
• Prepare for a full day with breaks – let them know they will get tired, especially if it goes through the post-lunch witching hours from 2:00-4:00.
• Explain redirect – in terms of content, context and importance.

III. Success Via the Three-Legged Stool

The success of these sales representative depositions will generally rise and fall on the representative’s ability to understand and apply the “three-legged stool” principle of:

1) telling the truth;

2) staying in his/her lane; and

3) understanding and explaining the sales representative’s role

Easily 80%-90% of the deposition can be handled without much heartburn if these are followed.

A. Tell the Truth

Of course, the first rule of testifying is to tell the truth. Makes sense intuitively, but for an inexperienced witness, there is more to it than meets the eye.

• That being the case, it is acceptable, and even expected, for these witnesses NOT to be able to recall with any degree of specificity: 1) detail pieces, 2) territories, 3) compensation structures, 4) reporting chain of command, 5) clinical data/literature, 6) specific claims of performance, 7) labeling information/history, 8) specific healthcare provider interaction, etc.
• If the sales representative understands that it is okay to testify that they “don’t recall”/“don’t remember”/ “can’t comment,” etc.- and if that is, in fact, the truth, then this testimony is perfectly fine – and they should testify as such every single time.
  • THIS POINT CANNOT BE OVERSTATED. No one is expected to recall a document they showed a doctor four years ago, much less an email. The representative, who has spent their career trying to field questions and provide assistance, should reprogram themselves, if only for a day, and should find a way mentally to get comfortable being uncomfortable.
  • Plaintiff counsel will  repeatedly go back to the well in an attempt to try and rattle the witness, but the sales representative should stick to the truth – if he or she doesn’t know/doesn’t recall/doesn’t remember, this should be the answer no matter how many times the question is asked, and no matter how many times plaintiff counsel modifies the question in an attempt to camouflage it.
• Plaintiff counsel may try alternate tactics to get a representative to testify that a document/detail piece/label was one that the sales representative used/recalled using during a particular time period. Plaintiff counsel may even go so far as to suggest/ask if it is “similar” to or “could have been” one of the pieces the sales representative used.
  • If the sales representative doesn’t recall with specificity, the sales rep should say so.
  • If the sales representative even gives an inch, it gives the plaintiff counsel the green light to ask a litany of questions about the document; the document will also be used as a baseline document for comparison to labels, etc.
  • The deposition will not be shorter if the sales representative concedes that this is a “possible” document; if they don’t know that it is the actual document as represented (e.g. a draft, a different iteration of a sales piece that predated/postdated this representative’s time, etc.), then they should state this on the record and not offer any substantive testimony until a proper foundation is laid.
  • Of course, if the sales representative does recall the document with specificity, he/she should testify as such per the oath.

B. Stay In Your Lane

As a young private in the United States Army in a prior life, I was taught during the weapons training and combat maneuvering phases of basic training at Fort Jackson, South Carolina, to “stay in my lane” when engaging the enemy. The principle was that if I stayed in my lane, I wouldn’t shoot my buddy to my right or left; moreover, the added benefit of staying in my lane was to keep me from likewise taking a bullet.

It’s one of those lessons you don’t forget.

The concept is equally applicable during a deposition, even though the context may be different. While this should be self-explanatory on its face, “staying in your lane” is often the most ignored rule by the witness, especially as the day drags on and the deposition becomes more conversational. Prep points to cover:

• Sales representatives are appearing as former company employees during a finite time detailing a particular product to a particular individual healthcare provider or institution. THAT IS THE LANE. NOTHING MORE. 
• Accordingly, the sales representative can only testify as to their knowledge or experience – TO THE EXTENT THEY CAN RECALL IT. This may include:
  • Hiring
  • Training
  • Promotion
  • Compensation
  • Territory
  • Healthcare providers called on
  • Products
  • Detail pieces (leave-behinds, brochures, labels)
  • OR visits
• Conversely, sales representatives CANNOT and SHOULD NOT testify or offer opinions on things outside their lane if they have no personal knowledge or recollection of it. This would include, but is not limited to, testimony re:
  • What should/should not be in labels
  • Whether the label language is sufficient to warn healthcare providers of events
  • What should/should not be in detail piece
  • What healthcare providers rely on
  • Company’s duty
  • Regulatory issues
  • Medical affairs issues
  • Copy review process or decisions
  • Post-marketing surveillance/pharmacovigilance
  • Adverse event triage/follow-up
  • Distinguishing between product quality complaints and adverse events
  • Reporting/coding of adverse events
  • Acceptable occurrence rates of adverse events, etc.
  • Healthcare provider’s knowledge re: product’s risks/benefits
  • Whether healthcare provider knowledge is limited to what sales representative provides
  • Literature, emails and studies that the sales representative has no knowledge of
    • NOTE: This is an important point worthy of additional time. The sales representative may be shown a statement in a label, leave behind, detail piece, etc. – that is copy approved – and then may be shown an internal email, study, document, etc. that seems to contradict the copy approved document.
      • The sales representative should be reminded to be aware of documents/things that he/she knows nothing about.
      • The sales representative should be prepared to testify that he/she knows nothing about the study/internal document, etc. and would defer to the authors/clinicians as to what is meant.
      • The sales representative should not agree that the documents contradict each other and that one or the other is false/misleading/inappropriate, etc.
    • This is one of those examples where if plaintiff counsel does not get the answer or admission they want, they will come back time and time again.
      • The sales representative should be reminded to hold his/her ground when plaintiff counsel returns to the well.
• The sales representative is here in his/her capacity as a sales representative, and no one knows more about the job than the sales representative. That said, the sales representative is not a lawyer, and the sales representative cannot out-lawyer plaintiff counsel. These lawyers are talented, skilled, and are constantly looking for angles to get sound bites. The more the sales representative sticks to the truth and stays in his/her lanes, the more protected they will be as the deposition progresses.

C. Sales Representatives Are But One Resource for the Healthcare Provider

One of the primary themes for almost all sales representative depositions is to reinforce the  point that a sales representative is but one resource (one tool in the toolbox/one cog in the wheel, etc.) for the healthcare provider. Clinicians using the drug/device have a variety of other available sources to learn about the drug/device/procedure, including, but not limited to:

• Training, education, experience
• CMEs
• Literature
• Colleagues
• Preceptorships
• Professional education
• The company’s medical information request process/line

As a resource, a sales representative can provide a physician with basic information and can link up a physician to individuals qualified to provide additional information (via the physician information resource phone line/additional training/professional education/etc.). That list is only what the company provides – the majority of the healthcare provider’s knowledge comes from sources outside of the company.

We have observed in other similar cases situations where the plaintiff counsel tries to flip this approach. In these instances, plaintiff counsel will establish that the representative is limited as to what he/she can show to or discuss with physicians. The sales representative will admit that he or she can only use copy-approved materials from the company. After getting an [out of their lane] admission that the company should provide “complete, accurate, truthful and fair and balanced” [See Section III, infra] information to the healthcare providers, plaintiff counsel will introduce detail pieces, labels, etc. and suggest that the information contained in those documents are all the representative could discuss with the healthcare providers. Plaintiff counsel then later follows up and establishes that the documents don’t contain data regarding certain adverse events, certain publications, etc., and therefore, physicians and patients ultimately suffer due to lack of risk/benefit information or inability to conduct a proper informed consent.

It could play out as noted below:

• Plaintiff Counsel (PC) : the Physician Prescribing Information is the labeling for the product, and as such, you could not detail anything off-label, correct?
• Sales Representative (SR): there are other pieces we, as sales representatives, used with healthcare providers that may contain information not in the label
• PC: but you could only talk to the healthcare providers about the warnings and things on the label, correct?
• SR: I don’t know what other materials the healthcare providers had access to, and I don’t know if the doctor even read the label. You are suggesting that the label is the only company/product material he read.
• PC: If it’s not in the label, you can’t talk about it, correct?
• SR: What you are asking about may be in other pieces or things distributed to doctors. Also, there is a physician information request line that we can elevate questions to for doctor-to-doctor discussion.
• PC: But you as a sales representative could only talk about what was on the label, correct?
• SR: As a sales representative, yes, I had to stay within the confines of the label, but I also had access to the physician line for a surgeon to speak with physicians at the company to discuss the products in more detail. Also, physicians had resources other than the company to learn about the products.

If the sales representative had conceded here, plaintiff counsel could have built the rest of her examination on this point around his admission/suggestion that the doctors could only get information from sales representatives – something an uninformed jury may bite on – and that sales representatives and the company operate in a vacuum in the context of safety/risk-benefit information relayed to physicians. This is an area that will likely be ripe for redirect.

III. Anticipate Reptile Questions

We can expect plaintiff lawyers to spend some time on reptile questions. That said, they will likely ask a variation of one general question relatively early in the deposition, and a series of more litigation-specific questions once they get into the documents.

NOTE: the below question is asked in some way, shape or form in nearly every sales representative deposition:

• Do you believe the company should provide complete, accurate, truthful and fair and balanced information regarding its product?

Counsel for plaintiffs generally ask this in compound form, lumping all of the things the company “should” do regarding its products into one question. For prep purposes:

• The sales representative should expect an objection on this one as compound.
  • The sales representative should ask for clarity/unpack the question.
• As to the question of “complete” information: a sales representative is not a regulatory/medical affairs expert and cannot testify as to what information should/should not be disseminated to healthcare providers.
• As to “fair and balanced” question – same; the sales representative is not a regulatory/medical affairs expert.
• As to “truthful and accurate” – it is difficult to testify as to anything other than yes, even though it may be a set up for questioning down the road (is this info in the label true if internal documents say otherwise).

Examples of more additional reptile-type questions used with sales representatives include:

• Agree that the company’s labeling information should be truthful and accurate?
• Agree that healthcare providers rely on the company’s labeling in making risk/benefit assessment for patients?
• Agree that the label is the only labeling healthcare providers have on product?
• Agree that if the labeling is wrong, the healthcare provider cannot adequately assess the risks and benefits of the product?
• Agree that if labeling is wrong, the healthcare provider cannot adequately perform consent process with the patient?
• Agree if the company has information that goes to the safe use of the product, it should be included in labeling?
• Agree the company has a duty to warn healthcare providers of all known risks associated with a product?

IV. The Use of Documents (or Not) During Prep

With most company witnesses, a large part of the deposition preparation would involve document review, to include general documents at issue in the litigation, as well as specific documents relevant to the individual from his/her custodial file. The decision regarding the scope of document review (or whether to review documents at all) with a former sales representative will be more nuanced. It may not be beneficial to show or review documents with sales representatives who have been out of the field for six-plus years; after all, if the representatives have not seen the documents, it makes it easier for them to truthfully testify that they don’t recall using the document while they were with the company. Why attempt to refresh their recollection or educate them on topics and events for which they have no memory or context?

V. Additional Areas for Consideration and Potential Coverage

A. Label-to-Label Comparisons

We may see plaintiffs take the original product labeling and establish the presence of certain language, then follow up with the current labeling and contrast the language therein with the language from the earlier document. The current language is more comprehensive; it likely contains different, and in some cases, more detailed wording, as well as additional adverse events, contraindications and warnings. Plaintiff’s counsel will then ask questions (some reptile in nature) about what should or should not be in the labeling. They may also pull up emails, detail pieces, and literature in an attempt to show that what is in the labeling is incomplete, misleading, etc. 

Going back to the three-legged stool, the sales representative should stay in his or her lane and cannot – and should not – be offering opinions as to what should or should not be in the product labeling. Sales representatives are not regulatory experts, medical experts, labeling experts, etc. and therefore, they are not qualified. Finally, a sales representative cannot testify as to the mindset of a doctor and what the healthcare provider would like to have known as to the warnings, adverse events, etc. Sales representatives have no idea if the section of the labeling being discussed is clinically significant to the healthcare provider, nor does the representative know if the healthcare provider relied on any or all of the documents in assessing the risks and benefits of the product.

B. Background

The sales representative should be prepared to walk through his/her personal background, education and work history – both before and after the employment at issue – in detail.

C. Training

To the extent they can recall, the sales representative should be prepared to walk through the complete training history (at home, field training, etc.). For prep purposes:

• Plaintiffs will try to get an admission that training is the same for all sales representatives across the board. This should not be agreed to unless the representative knows this for a fact. If the sales representative agrees, it provides a foundation for plaintiff counsel to use any training documents produced by the company for cross and for comparison with labeling, detail aids, etc.
• The sales representative should only testify as to his/her training and should not be commenting on content or context of training materials and sessions utilized by other classes or individuals.

D. Compensation

The sales representative should be prepared to walk through compensation structure in detail, to include bonus and incentives. Plaintiffs will try to establish that salary is tied to numbers; i.e., the more you sell, the more you make. Representatives who have been away from the company, however, may not remember the details of their compensation and should not agree to the premises set forth by plaintiff counsel unless they are sure how it worked.

E. Call Notes/Calendars 

The sales representative will be asked about call notes or ways he/she documented visits/calendaring. This is usually not an issue, as call notes are relics of the distant past, but it should be covered regardless. 

F. Redirect Examination

Explain that in all likelihood, you may conduct a redirect examination, which could vary in time. Inform them that the purpose of redirect is to clear up any answers that may require further examination, or to put into the record facts or case history that may be needed to provide context to the testimony that was given.

In Closing

We do not know how much time we will get to prepare the sales reps for deposition. Regardless, if, thematically, the sales representative understands the primary principles discussed here: 1) tell the truth; 2) stay in your lanes; and 3) their role as a resource – but not the singular resource – for the physician, it will go a long way in keeping the deposition manageable, if not productive.

Much easier than being shoehorned into a corner having to talk to an old girlfriend. Much, much easier.

Finis