Trial Magazine

Competitive sports teach you that dedicated and active preparation is the best way to maximize your performance and counterbalance shortcomings. As basketball coach John Wooden said, “Failing to prepare is preparing to fail.” Depositions are no different: We cannot control or even predict what type of witness the prescribing doctor will be in a failure-to-warn case, but we can try to prepare for all possibilities.

You need the prescribing doctor’s testimony to establish specific causation. You can’t prove the drug or device caused the ­plaintiff’s injury if you can’t show that the doctor, if adequately warned, would not have written the prescription or recommended the device. The prescribing doctor’s testimony carries great weight with the jury, but these witnesses can be extremely unpredictable, so thorough preparation well before the deposition is crucial.

Notice the Deposition First

You need to be the first party to notice the deposition so that you can question the doctor first. Questioning first is a great advantage to either side when trying to establish, or defeat, proximate cause. Make sure the notice is not defective—give a real date and location, but be sure the doctor’s office knows that you will change these to fit the doctor’s schedule. Keep in mind that some doctors will require both a notice and a subpoena, even those who are willing to appear voluntarily.

The defense will attempt to notice the deposition first. In a mass tort case, the issue of “who questions first” is usually litigated or at least negotiated between the parties. Since plaintiffs have the burden of proof and this deposition often serves as the trial deposition, plaintiffs should argue the right to question first.

Courts have handled the issue in various ways. As part of the bellwether process in coordinated actions in which each side selects potential trial ­plaintiffs, the judge often will alternate which side is permitted to question the prescribing physician first—for example, plaintiff counsel questioning plaintiff picks and defense counsel questioning defense picks,¹ or vice versa.² A well-known New Jersey state court coordination judge had plaintiff counsel question first in cases ending in odd numbers and defense counsel question first in cases ending in even numbers. Case management orders may dictate the order of questioning, so be aware of any protocols (and explain them to the doctor, if possible).

Ex Parte Communications

Plaintiffs’ ex parte communications with their treating and prescribing physicians are not restricted under law. But defendants consistently try to limit communications between a plaintiff’s attorney and physicians, claiming unfairness and “woodshedding.”³ Courts have regularly rejected defendants’ attempts to impose such limitations because there is no basis in law or policy for doing so.⁴

Time and again, courts have been unconvinced by defendants’ claims of abuse by plaintiff counsel,⁵ finding that physicians are fully capable of comporting themselves professionally, ethically, and free from untoward influence in these situations.⁶ Rather than policing communications between ­plaintiff counsel and physicians prospectively, courts instead have relied on defendants’ ability to depose physicians and cross-examine them at trial as sufficient to remedy any perceived improprieties.⁷

But in motions to limit ­plaintiff’s ex parte communications, defense counsel often include a corresponding request for their own ex parte communications with the plaintiffs’ treating physicians—and more and more courts are granting limited access.⁸ Defendants’ justification for overcoming the protections related to the physician-patient relationship is a lack of local medical experts available for defendants to retain, especially when an MDL includes thousands of plaintiffs whose treating physicians would be off-limits to defense without an order permitting ex parte communications. The orders typically limit the substance of the communications to only general medical issues and treatment rather than the specific plaintiff patient, limit the number of treating physicians who can be contacted, and include disclosure requirements.

Some courts have required plaintiffs to make certain disclosures to defendants about ex parte communications with physicians. For example, the court in the Xarelto MDL, following the court in the Kugel Mesh MDL, required plaintiffs to disclose within 48 hours of the doctor’s deposition the dates of ex parte contacts; the approximate duration and location of the contacts; the participants; and the identity of the documents, photographs, or other materials that plaintiff counsel provided to the treating physician.⁹ Part of your preparation must include reviewing applicable case management orders for limitations or disclosure requirements before any ex parte communications with a prescribing physician.

The ability to have ex parte communications ahead of the deposition generally is an advantage, but some circumstances will suggest otherwise. Keep in mind that defense counsel will scrutinize all contacts with the doctor under cross-examination.¹⁰ In rare cases when you are confident that your prescribing physician has changed prescribing practices and that you will obtain the testimony needed for proximate cause, it may be better to eliminate the defense line of questioning that attempts to make the physician look biased in your client’s favor because he or she met with you before the deposition.

For example, in the Fosamax litigation, the side effect of atypical femur fractures after long-term use eventually became so well known that the industry practice and prescribing guidelines changed. This made the prescribing doctor depositions much easier and eliminated the need to meet with the doctor ahead of the deposition. But in most instances, information provided by your client is the only way to know ahead of time whether you will get the testimony you need—so gather intel from your client before you contact the doctor.

Client observations. One easy but often missed step is to talk to your client before contacting the doctor. Ask about his or her relationship with the doctor, including whether they discussed the lawsuit and, if so, what the doctor’s reaction was. Also ask about the nurses and office staff: Who is the “go-to” staff member, and what is the office environment like? I have had clients accurately predict what the doctor would be like in the deposition, including whether the doctor would be hostile, very friendly, or somewhere in between.

Pre-deposition meetings. After your initial research and review of the doctor and your client’s medical records, call the doctor’s office. This initial call often leads to an actual conversation with the doctor, and this may be your first and only chance to speak to the doctor before the deposition. Whether you speak to the doctor or the office assistant, make it clear that your client is not suing the doctor. Be very respectful, even apologetic, about the need to take time away from patients. Explain that the doctor is permitted to speak to you because you represent the plaintiff, unlike defense counsel, who cannot because of doctor-patient confidentiality.

See whether the doctor is willing to meet you in person. If not, find out if the doctor will only communicate through his or her attorney. Sometimes the conversations with the doctor’s attorney are more helpful because the attorney may understand the process better and can assist in coordinating the deposition. Request a meeting with the doctor’s attorney, even if the doctor is not willing or available to meet. Let the doctor and attorney know that you will do your best to schedule the deposition at the most convenient time possible for the doctor.

If you can arrange a pre-deposition meeting with the doctor, you may decide to present him or her with documents to show, for example, that the drug manufacturer hid information. Whether to show the manufacturer’s internal documents during a pre-deposition meeting with the doctor is a game-time decision: It may be better to save the documents for use when you’re on the record.

In virtually all failure-to-warn cases, protective orders will require ­third-party witnesses to sign an agreement to keep the information confidential before you can show company documents. Review the applicable order for terms related to use of confidential documents with third-party witnesses. Bring two copies of any protective order to the pre-deposition meeting, and get the doctor’s signature before showing him or her any documents. After the meeting, leave one copy of the protective order with the doctor and his or her attorney, retain the other signed copy, and follow any disclosure requirements.

Standard of Proof

Before deposing the prescribing doctor, determine the standard of proof necessary to establish that the drug or device was the cause in fact and proximate cause of your client’s injury. State case law on standard of proof varies. ­Plaintiffs alleging a failure-to-warn claim in Louisiana, for example, must fulfill a two-prong test: First, the plaintiff must show that the defendant failed to warn (or inadequately warned) the physician of a risk associated with the product that was not otherwise known to the physician; then the plaintiff must show that this failure to warn the physician was both a cause in fact and the proximate cause of the plaintiff’s injury.¹¹

Cause in fact. To establish cause in fact, you need to show that the defendant manufacturer failed to sufficiently warn the prescribing physician by not providing adequate instructions for safe use. All communications among the defendant’s employees and representatives and the doctor are relevant, including the drug or device warning label and any promotional materials (such as communications from sales representatives, speaker presentations, or other types of information made ­available to the physician).¹²

For example, one of the many ways pharmaceutical companies promote products to doctors is through educational presentations at dinner programs and “lunch and learns.” These direct communications between the company and the doctor are also opportunities when the defendant could have warned the doctor about the side effects at issue in the litigation.

In many states, even if a warning is deemed adequate, liability may attach based on the over-promotion theory that direct verbal representations, such as sales presentations, were sufficient to supersede or interdict the written warnings to the doctor.¹³ However, although a doctor’s reliance on promotional material is not necessary to clear the evidentiary hurdles of admission, courts require facts establishing a direct connection between the promotion and the doctor for the overpromotion theory to overcome the learned intermediary defense.¹⁴

In some states (for example, Massachusetts, Missouri, and Oklahoma), you may be able to meet the burden of proving cause in fact with the “heeding presumption,” which assumes that if an adequate warning had been provided, the physician would have considered that warning when making treatment decisions.¹⁵ Defendants can rebut this presumption with evidence that an adequate warning or instruction would have been futile under the circumstances.¹⁶ The heeding presumption originated from The Restatement (Second) of Torts,¹⁷ but because it was not included in The Restatement (Third) of Torts,¹⁸ many states do not apply it (for example, Alabama, California, and Connecticut).¹⁹  Thorough and updated research of the applicable state law is crucial.

Proximate cause. The standard of proof for proximate cause also is state specific. Typically, to survive summary judgment in a pharmaceutical case, the questions posed to the prescribing physician should elicit the following responses:

• The physician was not aware at the time he or she treated the plaintiff of the association between the drug and the side effect that caused the harm.
• The physician would have wanted complete and accurate information about the drug’s risks and benefits.
• A stronger warning would have affected the physician’s decision to prescribe the drug and his or her advice to patients, including the plaintiff.
• The physician would have deferred to the patient’s decision about whether to take the drug.

Obtain an affidavit from your clients stating that if they had been adequately warned of the risks, they would not have taken the drug. It is not uncommon to encounter doctors who are reluctant to admit they were unaware of information relevant to the drug they prescribed or the device they recommended. Consider asking some easy preliminary questions that should make the doctor less defensive. For example:

• Would you agree that information is important for you to do your job correctly?
• Is it fair to say that the more relevant information you have, the better you are able to use your experience and knowledge in treating your patients?
• If you, as a physician, were missing relevant information, would it be more difficult for you to properly diagnose and treat your patients?
• When you make treatment decisions for your patients, do you consider both the benefits and the risks of the medications you prescribe?
• Do you agree that it is important for manufacturers to inform you of both the benefits and the risks of their products?
• As a physician, do you think a drug manufacturer, such as the defendant, should be forthcoming and candid about the risks of its products?

The learned intermediary doctrine. In a failure-to-warn case, the defendant manufacturer inevitably will raise the learned intermediary doctrine as an affirmative defense, arguing that the plaintiffs’ claims are barred in whole or in part. Under this doctrine, the manufacturer has fulfilled its duty to warn if it gave the necessary warning information to the learned intermediary (the doctor) who then made an informed decision to prescribe the drug or device to your client.

An overwhelming majority of states have adopted the learned intermediary doctrine, including the highest courts of 35 states,²⁰ while intermediate state courts or federal courts in another 13 states have predicted adoption of the doctrine.²¹ Most likely the doctrine will apply to your client’s case, but you still should review the relevant state law to see how courts apply the facts to this important and powerful defense.

In MDLs, plaintiffs come from all over the country, so the law from all 50 states could be relevant. To assist plaintiff counsel, MDL leadership often provide a document summarizing state laws on key principles that will arise in the litigation. As with any shared resources, update the research related to the venue of your client.

Build a Strong Factual Foundation

To prove a doctor was not adequately warned of the dangers of the drug or device that harmed your client, you must gather relevant medical records and manufacturer marketing information to build a strong factual foundation.

Medical records. Shortly before the deposition, obtain updated medical records from the prescribing doctor, as well as from other relevant health care providers and facilities. Don’t just rely on your own records requests; verify that you have updated production of all records collected by the defendant. Defense counsel often can obtain medical records that plaintiff counsel does not get—and it’s critical that you have everything the other side has—so renew your request to defense counsel shortly before the doctor deposition for any supplemental medical records they may have obtained.

Once you have all the records, organize them to present to the doctor at the deposition. Typically, chronological order is the clearest way to make the record, but you can organize them however you want to present the evidence for trial. For example, you may want to start with the strongest medical records supporting your case, such as those that establish the product use and, if well documented, the injury. Jurors will clearly see the strongest evidence at the beginning, and again as you make the chronological presentation. Even if you are the second questioner at the deposition, you still can use your version of the medical records for your exhibits—and you should since your deposition of the prescribing doctor may be the testimony played to the jury.

Manufacturer and sales employee documents. It’s important to demonstrate the broader issue of corporate misconduct, even if you have not been involved in working up the general liability of the case, which is common in a mass tort. Collect the defendant’s sales employee materials, other promotional materials, and exhibits related to the drug or device.

Review the defense fact sheet and any accompanying case-specific documents the defendant produces. These will include the names of and call notes for the sales representatives who met with the prescribing doctor. Identify the sales representatives who met with the prescribing doctor most often and who was in the office right before the doctor prescribed the drug to your client. Show photos of the sales representatives to the doctor—he or she may not remember all the reps’ names, but people often remember a face, even years later.

The sales call notes usually include information about what was discussed during the call. While these notes tend to be cryptic, when you couple the sales call notes with the internal marketing documents, you will discover how the sales reps were promoting the drug to your client’s doctor during the relevant time period (and when they could have been warning the doctor about the risk or side effect). Search the company documents for the sales aids and patient brochures that were used during the relevant time. At the deposition, ask the doctor if he or she recalls seeing this information.

Inevitably, the defense will make a motion in limine to exclude all promotional materials. Promotional materials are relevant even without establishing reliance by the doctor, but what better way to win the motion than showing numerous instances of the defendant’s direct contact with your prescribing physician through its employees.

You can then argue (to the judge and then to the jury) that each face-to-face meeting, each company-sponsored speaker presentation, and each time the company representative left materials at the doctor’s office were opportunities for the defendant to personally tell your client’s doctor what it knew about the safety risk at issue in the litigation, but it failed to do so.

Deposing the prescribing physician in a drug or device failure-to-warn case can be the most nerve-wracking deposition because this independent third party can make or break your case. But there are many steps you can take well ahead of the deposition to ensure the best, most thorough preparation possible. As John Wooden would say, “Do not let what you cannot do ­interfere with what you can do.”

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Karen Barth Menzies is a partner at Gibbs Law Group in Los Angeles and can be reached at kbm@classlawgroup.com.

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Notes

1. See, e.g., Order Regarding Contact with Physicians, In re Abilify Prods. Liab. Litig., No. 3:16-md-02734 (N.D. Fla. Mar. 9, 2017) (Doc. No. 235).
2. See, e.g., Pretrial Order No. 70 (Regarding Contact with Physicians), In re Taxotere Prods. Liab. Litig., No. 16-md-02740 (E.D. La. Nov. 21, 2017) (Doc. No. 1137).
3. “Woodshedding” is commonly used by musicians for practicing in a private place until you can perform the tune flawlessly. The legal field has adopted the term to refer to privately and improperly coaching a witness on how to testify.
4. See, e.g., In re Testosterone Replacement Therapy Prods. Liab. Litig., 167 F. Supp. 3d 936, 937–38 (N.D. Ill. 2016).
5. In re Benicar Prods. Liab. Litig., 2016 WL 1370998 (D.N.J. Apr. 6, 2016); see also In re Xarelto Prods. Liab. Litig., 2016 WL 915288, at *4 (E.D. La. Mar. 9, 2016); Pretrial Order No. 28, In re Zoloft Prods. Liab. Litig., No. 12-MDL-2342 (E.D. Pa. June 18, 2013) (Doc. No. 498) (Order Approving Special Discovery Master’s Report and Recommendation No. 2, June 13, 2013, https://tinyurl.com/y2umlsyd).
6. See In re Benicar, 2016 WL 1370998, at *3 (“[These] learned professionals who have devoted themselves to the sciences . . . cannot be analogized to the cowed, reprimanded children referenced in the ‘woodshed’ idiom.”); see also In re Xarelto, 2016 WL 915288, at *5.
7. See, e.g., In re Benicar, 2016 WL 1370998, at *4; In re Zoloft, No. 12-MDL-2342 (Doc. No. 498).  
8. See, e.g., Revised Order Regarding Communication With Plaintiffs’ Treating Physicians for Purposes of Retaining Expert Witnesses, In re Ethicon Physiomesh Flexible Composite Hernia Mesh Prods. Liab. Litig., No. 17-md-02782 (N.D. Ga. March 8, 2019) (Doc. No. 437); Pretrial Order 70, In re Taxotere Prods. Liab. Litig., No. 16-md-02740 (E.D. La. Nov. 21, 2017) (Doc. No. 1137); In re Zimmer NexGen Knee Implant Prods. Liab. Litig., 890 F.Supp.2d 896, 911 (N.D. Ill. 2012). 
9. In re Xarelto, 2016 WL 915288, at *6; see also In re Testosterone Replacement, 167 F. Supp. 3d 936, 939–40; Case Mgmt. Order No. 21, In re Bard IVC Filters Prods. Liab. Litig., No. 15-md-02641, (D. Ariz. Feb. 6, 2017) (Doc. No. 4866); Order Regarding Contact with Physicians, In re Abilify Prods. Liab. Litig., No. 16-md-02734 (N.D. Fla. Mar. 9, 2017) (Doc. No. 235). In addition to the Xarelto, Benicar, and Testosterone Replacement MDLs, courts in the Kugel Mesh, Obtape Transobturator Sling, Vioxx, and Yasmin MDLs have issued substantially similar rulings. See In re Kugel Mesh, MDL Docket No. 07-1842ML, at 3 (D.R.I. Sept. 19, 2008) (on file with author); In re Mentor Corp. Obtape Transobturator Sling Prods. Liab. Litig., 2015 WL 12990485, at *1 (M.D. Ga. May 28, 2015); In re Yasmin & Yaz Mktg., Sales Practices & Prods. Liab. Litig., 2011 WL 9996459, at *1–2 (S.D. Ill. Mar. 4, 2011); In re Vioxx Prods. Liab. Litig., 230 F.R.D. 473, 477 (E.D. La. 2005).
10. See Michael Hewes, A New Look At the Doctor Deposition, Pro Te: Solutio, Vol. 12, No. 2 (2019), https://tinyurl.com/y3c9hvfu. 
11. Stahl v. Novartis Pharm. Corp., 283 F.3d 254, 268 (5th Cir. 2002).
12. See Order Ruling on Motions in Limine, Rheinfrank, et al. v. Abbott Laboratories, Inc., et al., No. 13-cv-00144 (S.D. Ohio Sept. 10, 2015) (No. 275); Kaleta v. Abbott Laboratories, Inc., No. 14-cv-847-NJR-SCW, slip op at *18 (S.D. Ill. Feb. 20, 2015) (on file with author); Order Regarding the Parties’ Motion in Limine, In re Yasmin & Yaz (Drospirenone) Mktg., Sales Practices & PMF Prods. Liab. Litig., No.3:09-md-2100-DRH, 2011 WL 6740391, at *10 (S.D. Ill. Dec. 22, 2011).
13. Brown v. Glaxo Inc., 790 So. 2d. 35, 40 (La. Ct. App. 2000); see also Caraker v. Sandoz Pharmaceuticals Corp., 172 F. Supp. 2d 1018, 1030 (S.D. Ill. 2001).
14. In re Zyprexa Prods. Liab. Litig., 649 F. Supp. 2d. 18, 33 (E.D.N.Y. 2009).
15. For a recent survey of which states do and do not apply the heeding presumption, see James Beck, Who Heeds the Heeding Presumption, Drug and Device Law Blog (Nov. 7, 2014), https://tinyurl.com/t9aprzw.
16. See, e.g., Dyson v. Pharmacia & Upjohn, Inc., 129 F. Supp. 2d 19, 21 (D.D.C. 2001), aff’d, 21 F. App’x 2 (D.C. Cir. 2001).
17. Restatement (Second) of Torts §402A, comment j (1965).
18. Restatement (Third) of Torts, Products Liability §2 (1998).
19. Beck, supra note 15.
20. See Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 158 n.17 (Tex. 2012).
21. See Tyree v. Boston Sci. Corp., 56 F. Supp. 3d 826, 828 n.3 (S.D. W. Va. 2014).