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In pharmaceutical or medical device litigation, the importance of the testimony of the treating physician cannot be overstated. Plaintiffs typically pursue claims against pharmaceutical companies under several different theories: strict liability, negligence, fraud and conspiracy. Each of these theories, in turn, often rests on the allegation that the pharmaceutical company failed to provide material information about the risks associated with a particular medication or medical device. These types of claims can all be viewed as failure-to-warn claims. Compared with other available liability theories, failure-to-warn claims are relatively easy and inexpensive to bring. The typical plaintiff alleges that if he or she had been told about the risk, which resulted in injury, he or she would not have used that particular medication or device. It’s as simple as that: no complicated scientific issues, no need for a panoply of expensive experts. And on its face, the plaintiff’s position is not only plausible, but credible: Who would use a medicine that causes injury if he or she were warned about the risk in advance? This simplicity in presentation is precisely one of the reasons that failure-to-warn claims can be difficult to defend. And this is precisely why the testimony of the prescribing physician is critical. Most jurisdictions recognize the learned intermediary doctrine in cases involving prescription medications. See, e.g., Kirk v. Michael Reese Hosp. & Med. Ctr., 513 N.E.2d 387 (Ill. 1987); Restatement (Third) of Torts: Prod. Liab. � 6(d). This doctrine is premised on the commonsense principle that although a pharmaceutical company may provide information about a medication, the physician decides which medicine to prescribe and what risks, under the circumstances, to discuss with the patient. When it applies, [FOOTNOTE 1]the learned intermediary doctrine works for the defense in two ways. First, it identifies the party to whom the pharmaceutical company’s legal duty runs. The legal duty owed to the patient requires the pharmaceutical company to inform the patient’s physician of the risks associated with a particular medication. If the pharmaceutical company adequately warns the physician, it cannot be held liable for failing to warn the patient. [FOOTNOTE 2] Second, the doctrine works for the defense in relation to proximate cause. Because the duty runs to the prescribing physician, the pharmaceutical company cannot have proximately caused the plaintiff’s injuries if the medical community was aware of the complained-of risk at the time of treatment, regardless of what information was provided to the physician. See, e.g., Hansen v. Baxter Healthcare Corp., 764 N.E.2d 35, 42 (Ill. 2002). What the prescribing physician knew (or should have known) is thus critical; the plaintiff’s failure-to-warn claim virtually rises or falls on the treating physician’s testimony. The physician’s deposition provides the defense with a singular opportunity to undermine one of the plaintiff’s strongest product liability claims. GOALS OF PHYSICIAN’S TESTIMONY There should be two overarching goals. The first is to establish that the physician was aware of the risk and considered it when prescribing the medicine to the plaintiff. The second is to develop helpful evidence relating to causation. Indeed, having examined and treated the patient, the treating physician is in a unique position to comment on the patient’s medical condition. Although a nonparty physician generally cannot be compelled to form opinions regarding causation or other subjects, he or she may have formed opinions during the course of treatment and may provide them voluntarily. PREPARING THE PHYSICIAN TO TESTIFY Developing helpful testimony requires substantial preparation. Preparation begins with understanding the medication at issue and, in particular, the language contained in the labeling and other information that the pharmaceutical company provided regarding that medication. If the labeling warns against the complained-of risk, the object of the deposition should be to establish that the physician either read the labeling or was independently aware of the risk at the time of prescription. If the labeling does not warn against the complained-of risk, the defense attorney should try to establish either that the physician did not read the labeling (and therefore did not rely on it) or that, again, he or she was independently aware of the risk at the time of prescription. If the labeling changed over time, the defense attorney needs to consider labeling history and take into account the label in place at the time of the plaintiff’s prescription. The second aspect of preparation is to identify the sales representatives or other company representatives who came in contact with the physician. The defense lawyer should interview them and determine whether the complained-of risk was discussed with the physician and what promotional or educational literature relating to the medication at issue was provided. The defense lawyer should attend the deposition armed with copies of any such literature, as well as copies of any other relevant literature that the company made available to the medical community at the time. The third aspect of preparation is to gather and review the plaintiff’s relevant medical records. Physicians and other health care providers typically require signed consents attesting that the patient was told about risks associated with treatment. They may also have recorded the substance of specific discussions with patients about particular risks or at least noted generally that risks were discussed. Also focus on other potential explanations for a particular plaintiff’s injuries: A plaintiff may have a particular medical condition that may be responsible for certain complaints or may have used other medicines that carry the same potential complications as the medicine at issue. The next step is to research published literature to determine what other information was available about the complained-of risk. Searches of peer-reviewed medical publications commonly read by physicians, such as the Journal of the American Medical Association, as well as publications directed to the physician’s area of practice, are important; most health care professionals regularly subscribe to and review such publications to remain abreast of developments in the specialties in which they practice. The physician may have run across an article discussing the complained-of risk in association with the medication at issue in this manner. But the defense attorney should not ignore other published sources of information, such as newspaper articles or television news programs, as a means by which a physician may have been apprised of the complained-of risk. Then consider searching an online legal database (such as Westlaw or Lexis) to determine whether the physician has been involved in litigation before. The physician may have been involved in a case arising over the use of the medication at issue. Organizations such as the Defense Research Institute also maintain databases of expert witness deposition and trial transcripts. Next, research whether the physician has authored any relevant publications or done any work that would have provided him or her with information about the medication or risk at issue. If the physician is affiliated with a hospital, general background information regarding the physician may be available on the hospital web site. Some physicians even have their own web sites. Consider consulting with a medical expert. Most lawyers lack medical expertise. Discussions with a retained medical consultant may aid in the understanding of any complex medical issues involved as well as in formulating appropriate questions for the deposition. A final consideration regarding preparation is whether to try to interview the physician before the deposition. Many jurisdictions prohibit direct communications between the defense attorney and a plaintiff’s treating physician, or allow direct contact only if the plaintiff’s counsel is permitted to participate, so in many places this is not an option. However, some jurisdictions allow direct contact or contact limited to general information that is not patient-specific. Interviewing the physician informally affords defense counsel the opportunity to learn in advance what the physician knew about the medicine and when and whether he or she received, reviewed or relied on literature provided by the pharmaceutical company before hearing it for the first time during the deposition. The defense lawyer can also provide medical literature available at the time at issue that may help the physician place the risk in its proper context. That direct contact is permitted, however, does not mean that the physician will talk to defense counsel. But learning even this before the deposition can be important. THE PHYSICIAN’S DEPOSITION Once prepared, the next step is to schedule the deposition. Most often, the treating physician is deposed after the plaintiff has been deposed. This affords the defense attorney the opportunity to identify other potential causes of injuries not reflected in the medical records that he or she may wish to discuss with the treating physician. However, there may be sound strategic reasons for considering taking the deposition of the treating physician first in a particular case. In any event, subpoena the patient’s file; it may contain documentation that was not obtained with a medical authorization. And request an updated copy of the physician’s curriculum vitae. This leads to the conduct of the deposition itself. Keeping in mind that the physician may provide competent expert testimony, refrain from opening the deposition with questions about his or her educational background and experience. Do not mark the physician’s curriculum vitae as an exhibit, at least not at the outset. If the physician gives helpful testimony, qualify him or her at the end of the deposition by marking the curriculum vitae and asking questions about his or her education and experience at that time. Although the plaintiff’s attorney may choose to qualify the witness anyway, better he or she than defense counsel if the testimony is unhelpful. Instead of general background questions, consider starting with questions designed to establish that the physician knew of the complained-of risk at the time of prescription. Determine what publications the physician reviewed in the ordinary course of his or her professional practice to remain abreast of developments in the field. Ask about the physician’s practices as to reviewing the labeling of medications he or she prescribes or consulting the Physician’s Desk Reference. Ask whether he or she recalls meetings with sales representatives and then consider showing the physician the literature provided by the sales representative. If the labeling did not warn against the complained-of risk or if it proves that the physician was not independently aware of the risk, attempt to establish that the physician did not read the package insert or otherwise rely on information provided by the pharmaceutical company in deciding to prescribe the medication at issue. Then ask about the physician’s regular practice with respect to discussing risks with patients. The times of “doctor knows best” have been over in this country for some time. It is now the extremely unusual practitioner who does not discuss the panoply of relevant risks with a patient. Establish that it is the physician’s custom and practice to discuss risks with patients. Ask whether he or she remembers discussing the complained-of risk with the plaintiff. If he or she does not remember, establish, if possible, that he or she has no reason to believe that he or she concealed that risk from the plaintiff. Confirm that the reason he or she prescribed the medication at issue was because he or she believed it to be the best medication for the patient’s particular condition. Most physicians will not be able to disagree with questions posed in such a manner. If possible, establish that the physician conducted a risk-benefit analysis and determined that the benefits to the patient from the medication outweighed the risks. Inquiry along these lines tends to establish that the physician acted responsibly and professionally and may help establish a good rapport with the physician. Next, turn to questions designed to elicit helpful testimony regarding causation. Establish that in light of the patient’s medical history and condition, the complained-of medication cannot be said to be the cause of the plaintiff’s injuries. Go over the medical history and identify every potential cause of the plaintiff’s complaints. Establish that the physician is unable to exclude other medications, products, diseases or illnesses as potential causes for the plaintiff’s complaints. Also, have the physician identify the health problem that the medication at issue was prescribed to treat and that there can be significant complications if the problem were left untreated. Then, if possible, have the physician establish that that problem resolved or at least improved following administration of the complained-of medication. It goes without saying that in addition to developing helpful testimony on these subjects, the defense attorney should try to avoid the creation of a harmful record. Anticipate likely areas of potentially harmful inquiry available to plaintiff’s counsel and be prepared to respond. Although plaintiff’s lawyers often refrain from asking questions during the deposition of a treating physician, one tactic that they may employ is to focus not on the complained-of risk, but instead on what are legally irrelevant but potentially emotionally charged matters. For example, the plaintiff’s lawyer may ask the physician if he or she would have prescribed the medication had he or she known that the medicine was made in a certain way. Plaintiff’s counsel may try to present data, suggest that the data indicate that the safety profile of the medicine at issue is not as favorable as that of other similar medicines, and ask the physician whether he or she would have prescribed the medicine at issue if he or she had known of this “fact.” Such questions should have no legal consequence; a duty-to-warn claim turns on whether the plaintiff proves that the pharmaceutical company failed to warn of the relevant risk, not whether the pharmaceutical company provided detailed (and possibly confidential and proprietary) information about its processing methods or a comparison analysis of its competitor’s medications. However, questions such as these can be effective in confusing a physician and shaping his or her testimony — the physician, often a target of failure-to-warn claims, may be inclined to point the finger of responsibility at the pharmaceutical company. The potential for confusion requires the defense lawyer to prepare for such questions in advance. Consider raising such issues affirmatively. Using the same example, a physician could be asked whether knowledge about a particular processing method, based on what was known at the time, would have made any difference to him or her in determining whether to prescribe the medication in light of the risk at issue. Questions like these can be useful in restoring focus on the complained-of risk and away from matters irrelevant to the plaintiff’s claims. The learned intermediary doctrine makes the prescribing physician one of the most important witnesses to the defense. Because the treating physician plays a pivotal role, a defense attorney cannot afford to take his or her deposition lightly; indeed, an effective deposition can result in summary judgment or force a favorable settlement. Make the most of it. ::::FOOTNOTES:::: FN1Some jurisdictions do not apply the doctrine in certain cases involving vaccines or contraceptives, particularly if the medicine was marketed to the patient directly. See, e.g., Davis v. Wyeth Labs. Inc., 399 F.2d 121, 131 (9th Cir. 1968); Stephens v. G.D. Searle & Co., 602 F. Supp. 379 (E.D. Mich. 1985). FN2Although failure-to-warn claims are typically based on negligence or strict liability, at least one court has persuasively noted that even fraud claims can be subject to the learned intermediary doctrine if they are premised on the notion that misinformation was provided. In re Norplant Contraceptive Prods. Liab. Litig., 215 F. Supp. 2d 795 (E.D. Tex. 2002); In re Norplant Contraceptive Prods. Liab. Litig., 955 F. Supp. 700, 709 (E.D. Tex. 1997), aff’d, 165 F.3d 374, 378 (5th Cir. 1999). Steven J. Ellison, a partner with Sidley Austin Brown & Woodin Chicago, specializes in pharmaceutical and medical device litigation. The views expressed herein do not necessarily reflect those of the firm or any of its clients. To subscribe to the newsletter, “Pharmaceutical & Medical Device Law Bulletin,” click here.

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