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A few months ago, a headline in The New York Timesread: “Trial Lawyers Are Now Focusing on Lawsuits Against Drug Makers.” This headline is an understatement. In the last three years alone, 10 of the 19 products liability litigations transferred to the judicial panel on multidistrict litigation have involved pharmaceuticals or medical devices. Moreover, five of the eight currently pending litigations designated as mass torts by the New Jersey Supreme Court involve drugs. See the JPML’s Web site, www.jpml.uscourts.gov, and the state’s judiciary mass tort homepage, www.judiciary.state.nj.us/mass-tort. Drug and medical device companies should look to aggressively and offensively defend these actions � and do so as soon as the mass tort litigation emerges. Critical to stemming the mass tort tide is an understanding of the factors that drive the filing of these actions: (1) the ease with which controversial issues relating to drugs and medical devices can be recognized; and (2) complicated causation issues. The most important pretrial goal for any defendant must be the early exposure of frivolous claims based on tenuous causation and junk science. Of course, the immediate benefit of this strategy is obvious: the dismissal of the individual case at hand. The benefits of early exposure, however, are much more far-reaching in that it can act as a deterrent to the filing of new cases, as well as a catalyst for the dismissal of existing actions based on similar unsupported theories. Drug and medical device companies are the latest mass tort target because of the ease with which controversial issues relating to drugs and medical devices can be recognized and complicated causation issues. Early exposure of frivolous claims is the key to stopping the growth of a particular mass tort litigation. Read the Label While pharmaceuticals and medical devices are certainly not the only class of products used or consumed in large numbers, medical devices and prescription and over-the-counter drugs are unique in that any known potential adverse effects are contained right on the labeling. For example, pursuant to C.F.R. �201.57, a prescription drug’s label must contain, among other things, sections regarding contraindications, warnings and precautions. The labeling also can give rise to other factors triggering a mass tort litigation. Even a cursory review of the history and timing of recent pharmaceutical mass tort designations in New Jersey reveal the most prevalent mass tort triggers: (1) voluntary withdrawal from the market (as in the instances of Rezulin, PPA and Propulsid); and (2) significant label changes accompanied by “Dear Doctor” letters (as in the instance of Vioxx). Additional triggers include Food and Drug Administration advisory committee meetings and FDA Talk Papers. The mere existence of labeling and the related mass tort triggers can raise concern, often unfounded, about drug safety as it relates to the overall population. The result is the public perception that anyone who took the medication has suffered an injury. This perception is usually baseless, largely because potential risks associated with the use of the medication may only affect a small section of the population and individuals vary greatly in their responses to medications. Nonetheless, this public perception can serve to increase the number of mass tort litigation filings. The other factor driving pharmaceutical and medical device mass tort litigation is the very complicated causation issues inherent in drug and medical device actions. In the case of most drugs, the possible side effects are not “signature” diseases or injuries. For example, the Rezulin litigation has evolved due to the allegation that exposure causes liver failure. Liver failure, however, has many possible causes, including, but not limited to, viral infections, certain vascular diseases, metabolic disorders, autoimmune disorders, ingestion of potentially toxic foods such as wild mushrooms, alcoholism, other prescription medications, over-the-counter medications and weight loss supplements. As this example illustrates, it is very difficult to isolate the single cause of a particular injury. Instead of dissuading the emergence of a mass tort, confusing or complicated causation issues actually tend to encourage mass tort litigation. Some litigants’ hope is that companies will settle early to avoid adverse publicity and potential judgments. Many important tasks must be completed once a mass tort litigation surfaces, including retention of counsel, corporate document collection and management, identification and preparation of company witnesses and retention of expert witnesses. (For a comprehensive discussion of these tasks, see “Respond to New Mass Tort Litigation with a Global Strategy,” 163 N.J.L.J. 432, Jan. 29, 2001.) Keeping in mind that the goal of mass tort litigations is an early settlement, defendants must focus on two critical tasks as soon as a mass tort litigation emerges: (1) early and aggressive case management; and (2) exposing junk science and the accompanying lack of causation. These tasks are crucial to achieving the early dismissal of existing causes of action and setting a precedent for the dismissal of future cases. Case Management Orders The first step to achieving the dismissal of baseless claims is the early implementation of a case management order, which should provide the most direct and expedient route to obtain discovery and narrow the issues for trial. Although there are several important issues that can be dealt with in a case management order, those tasks most critical to ultimately defeating causation are plaintiff questionnaires, medical authorizations and medical records, and causation procedures. (For examples of comprehensive case management orders, see www.jpml.uscourts.govand www.judiciary.state.nj.us/mass-tort.) To defeat causation, it is critical to gather as much information about the plaintiffs as possible. One of the best ways to do this is through a plaintiff questionnaire, which is also referred to as a patient profile form. The advantage to the plaintiff questionnaire is that it is much more direct and streamlined than interrogatories and will not prompt delay-causing objections. Such a questionnaire should seek information about a plaintiff’s background, education, medical history, work history, medical conditions, treating physicians and contraindicated medications. The questionnaire can also highlight causation issues. Using the Rezulin example, the questionnaire could be specifically tailored to ask about exposure to other possible causes of liver failure. It is also an effective tool for narrowing the involvement of contraindicated medications. Additionally, part of implementing a plaintiff questionnaire should include a definitive time frame for initial completion (that is, 45 days after the filing of the complaint), as well as an affirmative and continuing obligation to provide updated information every six months. The procedural mechanism for failing to comply with patient questionnaire obligations should be automatic dismissal. Another essential element of any case management order is the early production of medical authorizations and obtaining of medical records. Obviously, the plaintiff questionnaire only provides a snapshot of facts related to causation issues. Early access to medical records is critical, albeit often hard to accomplish, particularly under the Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. � 1320(d) et seq. Medical records will often provide critical information regarding alternative causation, as well as a medical history, providers and records omitted from the questionnaire. The case management order should contain: a provision for defense counsel to automatically receive a packet of blank medical authorizations within a certain time period after the filing of the complaint (i.e., 45 days); a requirement that additional packets of blank medical authorizations be automatically provided to defense counsel every six months; a mechanism for providing plaintiff’s counsel with notice of which records were requested; and a procedure for parties to obtain the records from each other. Since a common trend has been for providers to insist upon execution of their own “specialized” HIPAA-compliant authorizations, a case management order should include a deadline for plaintiffs to return these specialized authorizations to defense counsel (that is, within two weeks of receipt). As in the case of the plaintiff questionnaire, the procedural mechanism for failing to follow the medical authorization procedure should be automatic dismissal. Finally, defense counsel should attempt to include in an initial case management order a procedure requiring a prima facie showing of causation by the plaintiffs. An example of a prima facie causation requirement procedure occurred in connection with Lore v. Lone Pine Corp., No. L-33606-85, 1986 WL 637507 (N.J. Super. Law Div. Nov. 18, 1986). In Lone Pine, with respect to claims for personal injury, the case management order specifically provided that the plaintiff provide “facts of each individual plaintiff’s exposure” and “reports of treating physicians and medical or other experts, supporting each individual plaintiff’s claim of injury and causation.” And Cottle v. Superior Court, 5 Cal. Rptr. 2d 882 (Ct. App. 1992), provided for a similar mechanism: “Each plaintiff shall file and serve a statement establishing a prima facie claim for personal injury . . . [setting forth] the chemical or toxic substance to which that plaintiff was exposed; the date or dates and places of exposure; the method of exposure; the nature of plaintiff’s injury; and the identity of each medical expert who will support the plaintiff’s personal injury claim.” Several other jurisdictions have also permitted such a procedure. While Lone Pineand Cottleinvolved exposure to toxic torts and not medical devices or drugs, there is no reason why the same mechanism cannot be implemented in a pharmaceutical mass tort case. The advantage of such a case management procedure is a reduction in the number of plaintiffs � taking some of the “mass” out of the “tort” � and narrowing the issues to the most pertinent claims. Even if courts are initially reluctant to apply Lone Pineor Cottleto drug and medical device cases, defendants should persist in seeking these orders in an attempt to turn the tide in their favor. Causation Absent a Lone Pineor Cottleprocedure, a Daubertmotion on causation can be made. Although not as convenient a mechanism for forcing plaintiffs to make a prima facie showing of causation at the inception of the litigation, Daubertmotions are still an effective and powerful tool to derail a mass tort litigation. Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), is the seminal federal case on exposing unsubstantiated causation. In Daubert, the U.S. Supreme Court declared that expert opinions based on junk science and pseudoscience have no place in federal court. Daubertsets forth the following five-part, nonexclusive test to determining the validity of scientific evidence under Federal Rule of Evidence 702: � whether the technique or theory can be or has been tested; � whether the theory or technique has been subject to peer review and publication; � the known or potential rate of error; � the existence and maintenance of standards and controls; and � whether the theory or technique has been generally accepted in the scientific community. Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137 (1999), expanded Daubert‘s application to testimony based on technical and other specialized knowledge. Federal Rule of Evidence 702 was modified, effective Dec. 1, 2000, to more closely reflect the Daubertreasoning. Rubanick v. Witco Chemical Corp., 125 N.J. 421 (1991), and Landrigan v. Celotex Corp., 127 N.J. 404 (1992), which predate Daubert, apply similar reasoning in the toxic tort context. The recent case of Kemp v. State, 174 N.J. 412 (2002), however, specifically held that Rubanickapplied in a vaccine case. To date, New Jersey Rule of Evidence 702 has not been amended to reflect the 2000 revision to the federal rule. Making a Daubertmotion is critical to a mass tort litigation for several reasons. First, it can be a powerful tool for defeating claims at an early stage of litigation. Second, an early Daubertvictory can act as a deterrent for the filing of additional cases. Third, it can serve as a basis to defeat other claims supported by the same experts. Finally, it is an excellent way to educate the court on the science of the litigation. Bufano is a senior associate with Gibbons, Del Deo, Dolan, Griffinger and Vecchione of Newark.

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