Keep from Drowning in the Sea of Mass Torts!

While pharmaceuticals and medical devices are certainly not the only class of products used or consumed in large numbers, medical devices, over-the-counter and prescription drugs are unique in that any known potential adverse effects are more readily obvious than with other products: They are listed 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 torts reveals that the most prevalent mass tort triggers are: 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 FDA 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 has taken the medication in question 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 opulation and individuals vary greatly in their responses to medications. Nonetheless, it is this public perception that fuels the mass tort litigation fire.

Causation and the Lack of Signature Diseases

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 caused liver failure. However, liver failure has many possible causes, including, but not limited to, viral infections, certain vascular diseases, metabolic disorders, autoimmune disorders, ingestion of potentially toxic foods, alcoholism, and separate or concomitant ingestion of 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. The hope is that companies will settle early to avoid adverse publicity and potential judgments. But there is no need for drug and medical device companies to be fearful of these tactics.

Early Exposure of Frivolous Claims

There are many important tasks that must be completed once a mass tort litigation surfaces. These include retention of counsel, corporate document collection and management, and identification and preparation of company witnesses and retention of expert witnesses, to name only a few. (For a comprehensive discussion of these tasks, see Lifton, “Respond to New Mass Tort Litigation with a Global Strategy,” New Jersey Law Journal (Jan. 29, 2001).) Keeping in mind that the goal of mass tort litigations is early settlement, a defendant's most important goal is to expose frivolous claims early on. 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. The case management order should serve to provide the most direct and expedient route to obtaining discovery and narrow the issues for trial. While there are several important issues that can be dealt with in a case management order, those tasks most critical to ultimately defeating causation are: 1) plaintiff questionnaires; 2) medical authorizations and medical records; and 3) causation procedures. For examples of comprehensive case management orders, see the Web site of the Judicial Panel on Multidistrict Litigation at www.jpml.uscourts.gov.

In order to defeat causation, it is critical to gather as much information about plaintiffs as possible early in the litigation. 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 definite time frame for initial completion, as well as an affirmative and continuing obligation to provide updated information every 6 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 obtainment of medical records. Obviously, the plaintiff questionnaires provide only a snapshot of facts related to causation issues, so early access to medical records is critical, albeit often hard to accomplish, particularly now under the Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. ' 1320(d) et seq. (HIPAA).

Medical records will often provide critical information regarding alternative causation, as well as a trail of medical history, providers and records omitted from the questionnaire. The case management order should: 1) provide for an automatic provision to defense counsel of a packet of blank medical authorizations within a certain time period after the filing of the complaint; 2) contain a requirement that additional packets of blank medical authorizations be automatically provided to defense counsel every 6 months; 3) contain a mechanism for providing plaintiff's counsel with notice of which records were requested; and 4) set up 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 (ie, within 2 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 requirement that the plaintiff make a prima facie showing of causation. The advantage of such a procedure is obvious: early exposure of baseless claims before time, money and resources are spent on discovery. An example of a prima facie causation requirement procedure occurred in connection with the New Jersey case of Lore v. Lone Pine Corp., No. L-33606-85, 1986 WL 637507 (N.J. Super. Law Div. Nov. 18, 1986). In Lone Pine, the case management order specifically provided that plaintiff provide the following documentation with respect to claims for personal injury: “[f]acts of each individual plaintiff's exposure” and “[r]eports of treating physicians and medical or other experts, supporting each individual plaintiff's claim of injury and causation.” Additionally, a later California case, 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 the Lone Pine and Cottle cases involved exposure to toxic substances and did not involve medical devices or drugs, there is no reason why the same mechanism cannot be implemented in a pharmaceutical mass tort case. Again, 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 and the most pertinent claims. Even if courts are initially reluctant to apply Lone Pine or Cottle to 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 Pine or Cottle procedure, a Daubert motion 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, Daubert motions 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, of course, the seminal federal case on exposing unsubstantiated causation. In Daubert, the U.S. Supreme Court declared, in no uncertain terms, that expert opinions based on junk science and pseudo-science have no place in federal court. Daubert sets forth the following five-part, nonexclusive test to determining the validity of scientific evidence under Federal Rule of Evidence ' 702. It asks:

• Whether the technique or theory can be or has been tested;
• Whether the theory or technique has been subject to peer review and publication;
• What the known or potential rate of error is;
• Whether standards and controls exist and whether they are maintained; 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 Daubert reasoning.

Daubert motions are critical to mass tort litigation for several reasons. First, they are a powerful tool for defeating claims at an early stage of litigation. Second, an early Daubert victory can act as a deterrent to those contemplating filing additional cases, and can aid in the vigorous pursuit of already-filed cases. Third, they can serve as a basis to defeat other claims supported by the same experts. Finally, they are an excellent way to educate the court on the science of the litigation.

An example of the significant impact a favorable Daubert ruling can have on a mass tort litigation occurred in the case of In re: Phenylpropanolamine (PPA) Litigation, MDL No. 1407. On June 18, 2003, the court issued a lengthy order/opinion granting in part the defendants' Daubert motion as it related to cardiac injuries, as well as seizures and psychoses occurring more than three days after ingestion of PPA-containing products. (A copy of this order/opinion can be found at the court's Web site, www.wawd.uscourts.gov/wawd/mdl.nsf/main/page.) Since that time approximately 300 additional cases have been dismissed either voluntarily or on the merits in connection with related summary judgment motions.

Conclusion

The decision to fight early and hard to avoid drowning in the sea of mass torts requires a commitment of time, money, resources and sheer determination. No matter how good, aggressive or “offensive” the defense, the going is usually rough and the case not quickly won. Staying the course, however, can be an immeasurable deterrent. By taking a hard line and forcing plaintiffs to actually prove their cases, the message is sent that litigation involving pharmaceuticals and medical devices does not result in quick settlements and easy cash. Hopefully, the ultimate result is that plaintiffs conclude that drug and medical device companies are really not easy mass tort targets after all.

“Enriched and emboldened after successful fights against asbestos and tobacco companies, some of the nation's top plaintiffs' lawyers have trained their sights on drug makers, claiming that many giant pharmaceutical companies have hidden the dangers of medicines the lawyers say have harmed thousands of people.” Thus began an article on the front page of the May 18, 2003 the Sunday New York Times, entitled, “Trial Lawyers Are Now Focusing on Lawsuits Against Drug Makers,” which reported on a significant increase in the number of lawsuits against pharmaceutical companies over the last several years. (See Alex Berenson, “Trial Lawyers Are Now Focusing on Lawsuits Against Drug Makers,” N.Y. Times, May 18, 2003, at 1.) In fact, during the last 3 years alone, ten of the 19 products liability litigations transferred to the Judicial Panel on Multidistrict Litigation have involved pharmaceuticals or medical devices. (See Web site of the Judicial Panel on Multidistrict Litigation at www.jpml.uscourts.gov.)

In order to avoid drowning in the sea of mass tort litigation, drug and medical device companies must 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 against pharmaceutical and medical device companies: 1) the ease with which controversial issues relating to drugs and medical devices can be recognized; and 2) complicated causation issues. Armed with that understanding, the single most important pre-trial 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. Early exposure of frivolous claims is the key to stopping the growth of a particular mass tort litigation, as well as to causing its ultimate demise.

It's All Right on the Label

While pharmaceuticals and medical devices are certainly not the only class of products used or consumed in large numbers, medical devices, over-the-counter and prescription drugs are unique in that any known potential adverse effects are more readily obvious than with other products: They are listed 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 torts reveals that the most prevalent mass tort triggers are: 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 FDA 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 has taken the medication in question 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 opulation and individuals vary greatly in their responses to medications. Nonetheless, it is this public perception that fuels the mass tort litigation fire.

Causation and the Lack of Signature Diseases

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 caused liver failure. However, liver failure has many possible causes, including, but not limited to, viral infections, certain vascular diseases, metabolic disorders, autoimmune disorders, ingestion of potentially toxic foods, alcoholism, and separate or concomitant ingestion of 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. The hope is that companies will settle early to avoid adverse publicity and potential judgments. But there is no need for drug and medical device companies to be fearful of these tactics.

Early Exposure of Frivolous Claims

There are many important tasks that must be completed once a mass tort litigation surfaces. These include retention of counsel, corporate document collection and management, and identification and preparation of company witnesses and retention of expert witnesses, to name only a few. (For a comprehensive discussion of these tasks, see Lifton, “Respond to New Mass Tort Litigation with a Global Strategy,” New Jersey Law Journal (Jan. 29, 2001).) Keeping in mind that the goal of mass tort litigations is early settlement, a defendant's most important goal is to expose frivolous claims early on. 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. The case management order should serve to provide the most direct and expedient route to obtaining discovery and narrow the issues for trial. While there are several important issues that can be dealt with in a case management order, those tasks most critical to ultimately defeating causation are: 1) plaintiff questionnaires; 2) medical authorizations and medical records; and 3) causation procedures. For examples of comprehensive case management orders, see the Web site of the Judicial Panel on Multidistrict Litigation at www.jpml.uscourts.gov.

In order to defeat causation, it is critical to gather as much information about plaintiffs as possible early in the litigation. 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 definite time frame for initial completion, as well as an affirmative and continuing obligation to provide updated information every 6 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 obtainment of medical records. Obviously, the plaintiff questionnaires provide only a snapshot of facts related to causation issues, so early access to medical records is critical, albeit often hard to accomplish, particularly now under the Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. ' 1320(d) et seq. (HIPAA).

Medical records will often provide critical information regarding alternative causation, as well as a trail of medical history, providers and records omitted from the questionnaire. The case management order should: 1) provide for an automatic provision to defense counsel of a packet of blank medical authorizations within a certain time period after the filing of the complaint; 2) contain a requirement that additional packets of blank medical authorizations be automatically provided to defense counsel every 6 months; 3) contain a mechanism for providing plaintiff's counsel with notice of which records were requested; and 4) set up 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 (ie, within 2 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 requirement that the plaintiff make a prima facie showing of causation. The advantage of such a procedure is obvious: early exposure of baseless claims before time, money and resources are spent on discovery. An example of a prima facie causation requirement procedure occurred in connection with the New Jersey case of Lore v. Lone Pine Corp., No. L-33606-85, 1986 WL 637507 (N.J. Super. Law Div. Nov. 18, 1986). In Lone Pine , the case management order specifically provided that plaintiff provide the following documentation with respect to claims for personal injury: “[f]acts of each individual plaintiff's exposure” and “[r]eports of treating physicians and medical or other experts, supporting each individual plaintiff's claim of injury and causation.” Additionally, a later California case, 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 the Lone Pine and Cottle cases involved exposure to toxic substances and did not involve medical devices or drugs, there is no reason why the same mechanism cannot be implemented in a pharmaceutical mass tort case. Again, 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 and the most pertinent claims. Even if courts are initially reluctant to apply Lone Pine or Cottle to 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 Pine or Cottle procedure, a Daubert motion 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, Daubert motions 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, of course, the seminal federal case on exposing unsubstantiated causation. In Daubert, the U.S. Supreme Court declared, in no uncertain terms, that expert opinions based on junk science and pseudo-science have no place in federal court. Daubert sets forth the following five-part, nonexclusive test to determining the validity of scientific evidence under Federal Rule of Evidence ' 702. It asks:

• Whether the technique or theory can be or has been tested;
• Whether the theory or technique has been subject to peer review and publication;
• What the known or potential rate of error is;
• Whether standards and controls exist and whether they are maintained; 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 Daubert reasoning.

Daubert motions are critical to mass tort litigation for several reasons. First, they are a powerful tool for defeating claims at an early stage of litigation. Second, an early Daubert victory can act as a deterrent to those contemplating filing additional cases, and can aid in the vigorous pursuit of already-filed cases. Third, they can serve as a basis to defeat other claims supported by the same experts. Finally, they are an excellent way to educate the court on the science of the litigation.

An example of the significant impact a favorable Daubert ruling can have on a mass tort litigation occurred in the case of In re: Phenylpropanolamine (PPA) Litigation, MDL No. 1407. On June 18, 2003, the court issued a lengthy order/opinion granting in part the defendants' Daubert motion as it related to cardiac injuries, as well as seizures and psychoses occurring more than three days after ingestion of PPA-containing products. (A copy of this order/opinion can be found at the court's Web site, www.wawd.uscourts.gov/wawd/mdl.nsf/main/page.) Since that time approximately 300 additional cases have been dismissed either voluntarily or on the merits in connection with related summary judgment motions.

Conclusion

The decision to fight early and hard to avoid drowning in the sea of mass torts requires a commitment of time, money, resources and sheer determination. No matter how good, aggressive or “offensive” the defense, the going is usually rough and the case not quickly won. Staying the course, however, can be an immeasurable deterrent. By taking a hard line and forcing plaintiffs to actually prove their cases, the message is sent that litigation involving pharmaceuticals and medical devices does not result in quick settlements and easy cash. Hopefully, the ultimate result is that plaintiffs conclude that drug and medical device companies are really not easy mass tort targets after all.