Of all the creatures in Greek mythology, the Hydra is perhaps the most nightmarish. A nine-headed reptilian serpent-beast guarding the entrance to the underworld, the Hydra was said to be so venomous that even her breath would kill anyone who dared to come too close. It was not until Hercules, son of Zeus, set out to slay the Hydra that she finally met her match. Even then, Hercules found her to be a formidable challenge. When he cut off one head, two grew back and, of the nine original heads, only one was the immortal head that could kill off the Hydra forever – and it breathed fire. So Hercules had to get creative. He approached the reproducing heads with a one-two approach: first, he enlisted family to help him in the fight. Whenever Hercules lopped off one of the heads, his nephew immediately burned the stump, cauterizing it so a new head could not grow back. When Hercules ripped off the middle, immortal head, he buried it under a boulder.

THE HYDRA, FINALLY, WAS NO MORE.

Although the Hydra of the Mount Olympus time was destroyed, we see the modern-era serpents pop up in litigation every day, and it is most prevalent in depositions of corporate employees. Whether as a 30(b)(6) designee or fact witness, plaintiff lawyers are utilizing the corporate deposition more and more frequently as the primary platform to advance their core themes via what has been called the “Reptile approach.” Identification and preparation of multiple witnesses, coupled with various degrees of expertise and experience, can turn what should be a relatively straightforward process into a multipronged beast involving numerous players. And whether the issues in your cases have reared their heads in the context of pharmacovigilance, labeling, science or FDA compliance, one thing is for certain: if not given proper deference, the Reptile approach can leave a nasty mark with after effects that can linger throughout the life of the litigation. Done right and with the proper [unprepared] witness(es), skilled plaintiff lawyers can rattle the most experienced corporate witness and create multiple jury-friendly sound bites that have the potential to reverberate far beyond the deposition and into trial.

The best way for defendants to blunt the attack is to follow Hercules’ lead by getting creative in our approach to witness preparation and defense – and by fighting back. We must effectively and aggressively counterattack these approaches by plaintiffs’ counsel before they get any traction. It may require extra preparation time and it will not be easy, but if we come prepared to the deposition, neither chicanery nor misdirection will rear their cunning heads, and plaintiff attorneys will be forced to do what many would rather not: try the actual facts of the case without the use of smoke and mirrors (or flutes and baskets).

THE REPTILE APPROACH

Snakes. Why’d it have to be snakes?

Indiana Jones, “Raiders of the Lost Ark”

In 2009, jury consultant David Ball and trial attorney Don Keenan published a book on trial strategy entitled Reptile: The 2009 Manual of the Plaintiff’s Revolution. The book’s Dedication page reads as follows:

The first edition of Reptile is dedicated to the pioneers: the national array of trial attorneys who, instead of caving to mean times, have allied themselves with the Reptile by successfully field-testing her in negotiations and in trial after trial.

So what is the “Reptile?” According to Ball & Keenan, Yale neuroscientist Paul D. McLean’s research identified what he called the three-part “triune” brain. Dr. McLean identified one of these parts as the “Reptilian brain,” also known as the “R-Complex.” It is the oldest part of the brain and over time, the R-Complex ultimately gave rise to those parts of the brain that think and feel. The Reptilian brain houses basic life functions such as breathing, balance, hunger, sex drive and, most importantly in the context of litigation, survival.

Why is survival so important? According to Ball and Keenan, the most powerful decision-making occurs when the reptile brain senses danger and survival are at stake; accordingly, in trial the goal is to get the juror’s brain into survival mode by framing the case in terms of Reptilian survival. This approach is done by equating “justice” with “safety” by convincing the jury that community safety is enhanced by means of justice. Thus, the “major axiom” throughout the Reptile theory is “when the Reptile sees a survival danger, she protects her genes by impelling the juror to protect himself and the community.” In sum, plaintiff lawyers use the Reptile approach to sell danger – make the jurors believe that the dangers identified in the lawsuit go well beyond the courtroom and into their cities, neighborhoods and homes.

TACTIC 1: ESTABLISH IMMEDIATE DANGER

One of the primary goals of employing the “reptile” theory is to show the immediate danger of the kind of thing the defendant did and how fair compensation can diminish that danger in the community. In other words, demonstrate a danger to the community. In the context of drug and device litigation, for example, plaintiff lawyers may try to establish this tactic by giving the jurors the impression that the label is dangerous. Is it transparent? Does it contain all of the risks associated with the medication? Does it reference reported adverse events? Does it contain all the risks identified during clinical trials? Does it reflect all patient experiences? Would mothers buying this drug for their children want to know that the medication has a risk of [injury/adverse event at issue]? This type of focus extends the juror’s thought beyond that of the immediate plaintiff to his or her own household and community. If effective, the juror will believe a verdict against the defendant will not only compensate the plaintiff, but will give the juror the power to enhance the safety of his or her community by encouraging (if not forcing) the company to change its label to make it safer – thus satisfying the survival instinct, sometimes at the expense of logic or emotion.

TACTIC 2: ESTABLISH VIOLATION OF A SAFETY RULE

In addition to establishing an immediate, community danger, attorneys using the reptile theory must likewise establish the defendant’s violation of an existing “safety rule.” When someone breaks a safety rule that protects others, the jurors are not very motivated to act. If, however, someone breaks a safety rule that affects the juror or the juror’s family, the “Reptile” takes over and compels the juror to act. For purposes of Reptilian behavior, a safety rule has six characteristics:

1. It must prevent danger;
2. It must protect people in a wide variety of situations, not just someone who was in your client’s position;
3. It must be clear with no legalese or technical jargon;
4. It must expressly state what a person can or cannot do;
5. It must be practical and easy to follow; and
6. It must be one a defendant has to agree with (or looks foolish or dishonest disagreeing with).

The plaintiff’s ultimate objective when utilizing the safety rule is to show that “every wrongful defendant act derives from a choice to violate a safety rule.” Once a safety rule has been established and the defendant has agreed to the existence of a safety rule, a plaintiff lawyer can then show how violations of the rule endanger everyone, not just the plaintiff. At the outset, plaintiff lawyers utilizing the Reptile theory are encouraged to always have an “umbrella” rule. An umbrella rule is the widest rule the defendant violated – wide enough to encompass every juror’s Reptile. For drug and medical devices, the umbrella rule is as follows:

A drug/device company is not allowed to needlessly endanger the public.

Once the umbrella rule has been established, plaintiff lawyers are then instructed to develop and establish case-specific rules. The case-specific rules are subsets of the umbrella rule that “protects us all” that further assist in “spreading the tentacles of danger.” That is, like the umbrella rule, the case-specific rules are designed to apply to not only the plaintiff, but the community (including the jurors) as a whole. In the context of drugs and medical devices, case-specific safety rules may include the following:

• Company must ensure its products are safe
• Company must ensure its products are labeled properly
• Company must ensure the general public is adequately apprised of the risks associated with its product
• Company must do adequate research and testing of its product before it reaches the market
• Company marketing materials must be accurate, transparent and thorough
• Company must monitor its product post-marketing
• Company must continue to investigate warning signs/adverse events associated with its product
• Company must not improperly influence healthcare professionals and thought leaders

The ultimate goal after identifying the rule is to have the defendants, via their company witnesses, agree with the rules by essentially admitting that these rules exist. Once the umbrella and case-specific rules are established, the effective plaintiff lawyer will use the reptile approach to show:

1. how the defendant violated these established safety rules relating to its product;
2. how the defendant’s violation endangered the public (and thus endangered the jurors/jurors’ families);
3. how the violation ultimately led to the injuries alleged in the lawsuit; and
4. how the jury has the power to improve everyone’s safety by rendering a verdict that will correct or eliminate the danger posed by the defendants.

THE REPTILE APPROACH –ANTICIPATED QUESTIONS AT DEPOSITION

Round and round they went with their snakes, snakily…

Aldous Huxley, Brave New World

Not surprisingly, plaintiff lawyers utilizing the Reptile strategy do not wait until trial to put the gears in motion. In fact, the book encourages attorneys to start utilizing the Reptile strategy early by seeking admissions from defendants “in paper and oral discovery.” Because these lawyers will see the deposition as an opportunity to have the company agree to the safety rules at play in the litigation – and thus set the table for plaintiff’s trial and settlement strategy – it is imperative that corporate witnesses have some familiarity with these Reptilian themes as they come up during deposition. Below is a sampling of the types of Reptile questions often seen in products cases involving pharmaceuticals and medical devices:

GENERAL MANUFACTURER DUTY QUESTIONS

• Do you agree that a manufacturer assumes the responsibility for the safety of consumers using its products?
• Do you agree that part of that responsibility includes providing products that are as safe as they can be for the reasonable use of those products by the consumers that use them?
• Do you agree that a manufacturer should adequately warn public of known dangers associated with its product?
• Do you agree that it is the duty of a manufacturer to design, formulate and manufacture a safe product for customers?
• Do you agree that after a product hits market, certain adverse effects become known?
• Do you agree that it’s the duty of the manufacturer to adequately warn of adverse effects?
• Do you agree that, once a manufacturer becomes aware of adverse events related to its product, a company should proactively try to reduce these adverse events from occurring?
• Do you agree that a manufacturer has a duty to continue to seek ways to improve the efficacy and safety of products?
• Do you agree that, if a manufacturer makes a product that is defective and someone is injured because of that defect, then the manufacturer is responsible for the injuries/losses caused?
• Do you agree that a manufacturer should communicate what it knows to the public about the devices and pharmaceuticals they place into the market?
• Do you agree that a manufacturer should never expose a consumer to unnecessary danger?

REGULATORY-RELATED QUESTIONS

• Do you agree that a manufacturer can take its own measures to protect the safety of patients taking a drug without approval of the FDA if it wants to?
• Do you agree that [your company] can ask the FDA at any time to revise the label to make it stronger?
• Is a manufacturer allowed to needlessly endanger the public?
• Even if the manufacturer has met all the Federal regulations?
• Is a manufacturer allowed to hide a danger?
• Even if the manufacturer has met all the Federal regulations?
• Is a manufacturer allowed to ignore a known danger in its products?
• Even if the manufacturer has met all the Federal regulations?

COMPANY-SPECIFIC SAFETY QUESTIONS

• Is [your company] an ethical company?
• Does [your company] believe in safety?
• Do you agree that, if [your company] violates any public-safety rules, it is responsible for any harm caused by that violation?
• Should [your company] have to make safety more important than profit?
• Do you agree that, if [your company] can make the product that it is selling to consumers safer, it should?
• Is it ever proper for a company to refrain from making labeling/warning changes because it is concerned that a change would have a negative impact on sales?

PERSONAL OPINION QUESTIONS

• Do you not have an opinion, as a mother/father/provider [not corporate representative], as to whether customers have a right to know about the risks and adverse events associated with a medical product?
• As a mother/father/provider, wouldn’t you want to know the scope of what [your company] knew in terms of life-threating complications associated with the medication/product?
• If a medication/product had the potential to cause life-threatening side effects or illnesses, wouldn’t you like to know before giving or recommending it to your child/spouse/family member?
• As a parent, wouldn’t you want to know everything you can about a product before giving it to your children?
• As a parent, do you rely on pharmaceutical/medical device manufacturers to provide all safety information relating to a product so you can make an informed decision?
• Would you as a user of the product not expect the manufacturer to hold back or not disclose any safety information relating to a product?
• Would you as a user of the product be surprised if you were taking/using a product that had a risk of death or severe injury if that risk wasn’t disclosed in the labeling/medication guide/PPI, etc.?
• Do you believe everyone in [your company] is responsible for safety?
• Do you, as [insert job title], hold yourself accountable for the safety of users of [your company’s] products?

PREPARING CORPORATE WITNESSES FOR THE REPTILE APPROACH

If you see a snake, kill it.

H. Ross Perot

The first rule in all depositions is that the witness should tell the truth, regardless of the form or substance of the question. If a witness understands and gets comfortable with this principle, the witness should be able to effectively address any Reptilian questions thrown his or her way, because almost every Reptile question lacks one key element: specificity. Lacking this element leaves the door open for truth telling because it provides a witness with a foothold to bring clarity to the question and focus the response in a manner that eliminates the sound bite the plaintiff lawyers seek.

Consider the below scenario, which is based on an actual exchange a colleague of mine had while preparing a senior, seasoned corporate witness for deposition. Although this witness had testified before, the witness had never been cross-examined by a plaintiff lawyer using the Reptile theory. The opening line of the mock went something like this:

“Do you believe [your company] is a good company?”

“Yes.”

“Do you believe products manufactured by [your company] should be safe?”

“Yes.”

“Do you believe products manufactured by [your company] are safe?”

“Yes.”

“But a product is not safe if it causes [known adverse event] is it?”

[Pause] “Let’s take a break from this exercise and talk about these questions some more.”

Needless to say, when the witness found himself in a corner two questions in to the mock cross, the witness realized there was more work to be done. A better and more accurate response to these questions would have been as follows:

“Do you believe [your company] is a good company?”

“Yes.”

“Do you believe products manufactured by [your company] should be safe?”

“It depends on what you mean by safe. All products have risks and benefits, and those risks and benefits have to be weighed for each individual using the product. What works for one individual may not be proper for another.”

“Do you believe products manufactured by [your company] are safe?”

“I would defer to my prior answer. All products have risks and benefits which must be weighed before using the product. Moreover, when you ask if our products are ‘safe,’ are we assuming that the individuals using the products are doing so in accordance with the labeling? If so, the product has been approved by the FDA as safe and effective when used according to the labeling, recognizing that the FDA approved the product with the knowledge that certain adverse events have been associated with the product.”

“But a product is not safe if it causes [known adverse event] is it?”

“Again, I defer to my two prior answers.”

When preparing a corporate witness for a deposition, a substantial amount of time will be spent covering substantive issues: case history, case facts, timelines, relevant documents, etc. Prior to getting into those issues, however, the persons responsible for preparing the witness should consider addressing the Reptile questions first. Using a Reptilian exercise at the outset serves two purposes. One, it snaps the witness to attention. These questions seem simple and straightforward on their face, but as noted in the above example, they are laced with pitfalls and let the witness know that they are serious and dangerous. Second, these types of questions provide the witness with a good mental workout up front, allowing the witness to flex his or her mental muscles and thus providing the proper context for discussing the substantive deposition materials.

While there may be more than one way to skin a cat, the best way to maneuver through a pit of vipers is by 1) being prepared for strikes from all directions; and 2) having an end game in mind before taking the first step. This strategy is accomplished in the Reptile deposition by: 1) identifying and addressing Reptile questions head on; 2) having a working knowledge of the defense themes; and 3) using the themes as go-tos when responding to Reptilian inquiries.

IDENTIFYING REPTILE QUESTIONS

Section II, supra, lists a series of representative Reptile-type questions. While it is not intended to be an exhaustive list, it provides a foundation that can be tailored to the facts of your individual case. Because the plaintiffs design the questions to be as general as possible, they potentially apply across the board, regardless of the corporate designee. Each and every question can be asked of each and every individual – from a line worker to the CEO – keeping in mind that and the scope and quality of the answers or your corporate witness will resonate with jurors – regardless of the status of the witness within the company. That being the case, depending on time considerations, the preparation session should cover as many Reptile questions and answers as time permits. The more questions are covered, the better equipped the witness will be to not only answer Reptile-type inquiries, but to recognize Reptile questions when they are shuffled into the case-specific substantive areas of inquiry.

DEVELOP AND COVER THEMES

By the time the corporate depositions begin, you should have a decent understanding of the general themes of the case. Where are your weak points and strong points? What do you want to tell the jury? What themes do you anticipate being covered with this particular witness? These themes should be addressed during prep, and the witness should understand how to use these themes to advance the truth during a Reptile deposition. Some key themes to cover with your witnesses regardless of the specific facts of your case follow:

STAY IN YOUR LANES

During the weapons-training phase of United States Army Basic Training, one of the first things privates are taught is to “stay in your lane.” “Staying in your lane” on the battlefield means that you must observe your left and right limits of fire when discharging your weapon. This approach ensures that your designated lane will be covered, thus preventing the enemy’s advance. At the same time, it ensures you don’t venture into lanes assigned to others (which keeps you from getting shot). The same principle applies at these depositions.

Your witness likely has expertise in one, maybe two areas within the company. He or she should understand his or her testimony should not go beyond his or her qualifications. Stated simply: it is perfectly fine for your witness, in response to a Reptile question, to respond by saying: “I don’t know,” “That’s not my area of expertise,” “I don’t have familiarity with that topic,” or “You’ll have to ask someone in another department about that” – so long as the witness is speaking the truth. For example, if the witness works in pharmacovigilance and is asked “shouldn’t a company include all of the risks of its product on the label?,” the witness should recognize the question is out of her lane, and respond by saying as much.

Witnesses should be encouraged to keep the “stay in your lane” mantra in mind throughout the deposition. Many witnesses will, in fact, embrace the opportunity to push back on a question that they are not qualified to answer in order to keep them out of the weeds. Conversely, they should feel comfortable testifying about the topics within the zone of their expertise. This box, however, should be drawn around those individualized topics of expertise with a bright line, and the witness must stay in the box to stay out of trouble.

KEEP IN MIND THAT ALL DRUGS/DEVICES HAVE RISKS

The underlying goal of the plaintiff lawyer during a Reptile deposition is to show that your company has needlessly placed an unsafe product on the market. These attorneys would prefer that the suit be tried in absolutes: a product should be absolutely safe for absolutely everyone. That is simply not the case. The FDA recognizes that all products/drugs have risks and the risks must be weighed against the benefits. The witness should keep this theme in mind when questions of product safety and risk come into play.

HAVE A GOOD KNOWLEDGE OF THE REGULATORY HISTORY

Where relevant, the corporate witness should have a general appreciation of the regulatory history of the product at issue. He or she should also understand that the FDA’s involvement with the product extends far beyond the approval process, but may also extend into advertising, labeling, package inserts, patient medication guides, warnings, post-marketing surveillance, adverse-event reporting and safety. Where applicable, when questions pertaining to these issues come up, the witness should only offer testimony on these topics and, as noted above, “stay within the lanes.”

TAKE ADVANTAGE OF THE OPPORTUNITY TO CONDUCT A THOROUGH REDIRECT

The corporate witness should be reminded that when the plaintiff’s counsel completes his questioning, the deposition is not over. In today’s drug and device litigation, plaintiff lawyers are trending toward marathon depositions, trying every possible angle and tactic to exhaust the witness and in so doing, get the sound bites and admissions they seek for purposes of settlement or jury consideration. There is rarely a situation in the current environment where defense counsel should forego the opportunity to conduct a thorough redirect. A redirect serves a number of purposes: 1) it can rehabilitate any questionable or unclear testimony from the corporate witness; 2) it provides an opportunity to place the themes developed by the plaintiff lawyer into context and to show the jury the flip side of the proverbial coin; 3) it gives the witness a venue to discuss those topics where he or she has expertise and by so doing provides an opportunity to build the witnesses’ credibility with the jury. Finally, and perhaps most importantly, if the testimony of the witness is played via video at trial, it creates a bookend to counter the points made by plaintiffs and doesn’t leave unfinished or unrealized issues dangling in front of the jury during the critical days or weeks before plaintiff rests and you are able to put on your case.

CONCLUSION

. . .the serpent you will trample down.

Psalms 91:13

The Reptile method of examination can be a dangerous tool for the skilled examiner. When used effectively, it can shape the outcome of the litigation – for both the settlement and trial. When a corporate witness is properly prepared for the Reptile, however, the approach has little impact. A confident, educated witness, armed with the truth, having knowledge of the salient themes, with the ability to anticipate and understand the types of questions being asked, forces the plaintiff lawyers to engage on an equitable playing field – trying the case on its merits and essentially leaving the serpent lifeless, defanged and defeated.

Finis