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Defense Research Institutes’s For the Defense, October 2000
“DNA Fingerprinting, if accepted, will revolutionize the disposition of criminal cases. In short, if DNA Fingerprinting works and receives evidentiary acceptance, it can constitute the single greatest advance in the ‘search for truth,’ and the goal of convicting the guilty and acquitting the innocent, since the advent of cross-examination.”
The above quotation is from People v. Wesley, 140 Misc.2d 306, 533 N.Y.S.2d 643 (Albany County 1988), believed to be the first reported decision on DNA testing in the United States. The study of genetics and biotechnology, while a relatively new topic to non-scientists, is having and will continue to have an increasingly profound effect on our society. sApplications of the growing body of knowledge have already revolutionized principles of evidence in certain types of criminal prosecutions, and they will undoubtedly have similar influences on civil litigation in the near future.
Genetics can be thought of as the investigation of the molecular blueprint—otherwise known as our DNA—that each of us carries in the chromosomes of every one of our cells. Chemical structures called nucleotides line up like train cars to form this blueprint. These nucleotides are represented by the symbols A, G, C, and T, which stand for adenine, guanine, cytosine, and thymine. The chromosomes of each one of our cells contains a train of over three billion nucleotides. Biotechnology can be thought of as the study, use, or alteration of the chemical structure of that blueprint.
Biotechnology has been used to identify human remains by comparing tissue samples from the body to a known standard. It has been used to identify blood and hair left at crime scenes (and whose sperm was left on a dress!). Increasingly, DNA testing is being used to free wrongly convicted criminals by proving that someone else’s DNA was left at the crime scene; powerful use of this tool has resulted in sweeping changes in the post-conviction review of capital punishment and other criminal cases. Genetic testing is also used to identify those who carry the gene for certain diseases, while gene therapy—the insertion of new genes into a person’s chromosomes—plays an increasingly prominent role in the treatment of those diseases. These are only a few of the applications of biotechnology reported regularly in our mainstream press. Scientists are in the process of completing the final draft of the Human Genome Project, an international gene mapping effort to determine the exact chemical sequence of the nucleotiees that form the DNA in every cell of every human body. The completion of thisproject is likely to produce a quantum leap in biotechnology of similar proportions to walking on the moon.
In the near future, the effects of these advances will likely flow into our judicial system as well—in both criminal and civil litigation. Biotechnology has enabled the identification of perpetrators in criminal prosecutions. Soon, it will enable parties to identify perpetrators in civil actions, too—not human perpetrators of a crime, but genetic perpetrators of diseases. As one court stated, “[w]e also know, based upon well established medical principles, that certain diseases are genetic in origin and may be passed on to offspring.” M.A. v. Estate of A.C., 274 N.J.Super. 245, 643 A.2d 1047, 1052 (1993).
An Application of Gene Mapping
In civil litigation, the results of genetic tests can be used as evidence in the quest to determine the cause of certain medical problems. It is foreseeable that such results will be used to indicate that some person’s problems are caused by their genetic “map”, as opposed to a medicine manufactured by a defendant corporation.
Some day a class of people might sue a drug manufacturer claiming that adverse reactions to a drug caused intestinal problems, such as abdominal pain, diarrhea, and rectal bleeding. However, a significant percentage of these plaintiffs may have had episodes of similar symptoms before taking the medication. In addition, a parent or sibling who did not take this medication may also have been treated for similar problems.
A medical condition that can be examined as an example of the importance of genetic testing is Crohn’s disease, a chronic inflammation of the digestive tract. Feldman, Scharschmidt, & Sleisinger, Gastrointestinal and Liver Disease, vol. 2, at 1708 (6th ed. 1998). There is evidence showing that Crohn’s disease has a strong genetic component. For example, siblings of people with the disease may be as much as 17 to35 times more likely to develop the disease than the general population. Fielding, “The Relative Risk of Inflammatory Bowel Disease Among Parents and Siblings of Crohn’s Disease Patients,” 8 J.Clin.Gastroenterol. 665 (1986). Further, people with Crohn’s disease often have unpredictable recurrences, even after years of remission. Feldman, et al., supra. As a result of the prior symptoms, or the family history, or both, it would be suspected that certain members of the class are suffering from Crohn’s disease as opposed to an adverse reaction to a drug.
In the past, the defense would prove its case by presenting evidence about the prior episodes and family histories. However, Crohn’s disease is a difficult diagnosis to make. The examination may include x-rays of the intestines, endoscopy, biopsy, CT scan, or ultrasound. There are several differential diagnoses, which do not have as strong a genetic influence as Crohn’s disease, that the doctor may consider, such as anemia or colitis. In litigation, the treating doctor may testify that the patient does not have Crohn’s disease, or may dilute the defense’s theory with wavering or inconclusive testimony. Such testimony may leave the jury considering many different and conflicting factors as it attempts to determine the extent to which a genetic predisposition to Crohn’s disease should be blamed for the plaintiff’s condition.
Here is where biotechnology may provide a powerful map in the search for truth. While researchers have yet to locate the exact gene or genes primarily associated with Crohn’s disease, it is only a matter of time before this occurs. Once this happens, we shall know how the genome of a person who does not have Crohn’s disease should look. On the other hand, if the nucleotides are not in the exact proper sequence, it is called a polymorphism (literally thought of as a different form than the normal gene), which results in a deficiency in some critical function of the cells that are regulated by that gene.
One theory about Crohn’s disease is that a genetic deficiency prevents the affected cells from being able to turn off their immune response to common intestinal microbes. Feldman, et al., supra, at 1712. That is, a person who does not have Crohn’s disease possesses the proper sequence of nucleotides in their DNA needed to make the proteins that turn off this immune response. However, a person with Crohn’s disease does not produce these proteins, or does not produce them in sufficient amounts, to be able to shut down this immune response. The inability to regulate this immune response causes the inflammation of the intestine seen in Crohn’s disease.
Thus, the significance of the Human Genome Project is that it will allow us to analyze a litigant’s DNA and determine objectively the extent to which a person has a genetic deficiency that predisposes him or her to Crohn’s disease. There will also be times when genetic testing rules out a genetic cause. A plaintiff may initiate the testing to refute the assertion of a genetic cause. In short, regardless of which side’s position is enhanced, the overall effect will be more information—and more reliable information—on which to decide whether the cause is related to genetic factors.
Compelling Genetic Testing
The remainder of this article examines the right of a litigant in a civil action to compel someone else to submit to a physical examination, including the taking of a blood or tissue sample for genetic testing, for the purpose of obtaining evidence about the other party’s genetic blueprint as proof of what caused his or her condition.
There is a variety of situations where biotechnology could aid the trier of fact. Genetic testing can produce evidence that an infant possesses a genetic condition associated with mental retardation (to contest a claim against an obstetrician of negligent delivery of the infant), evidence that a patient has a genetic condition that inhibits a tumor suppression response (to contest a claim that exposure to a toxic agent caused cancer), and evidence that a plaintiff has a genetic condition associated with limb malformation (to contest a claim that a drug taken by the mother during pregnancy caused the birth defect).
Until now, aside from applications aimed at identifying perpetrators of crime, the primary use of DNA evidence has been in paternity actions. Courts usually order testing of parties based on paternity statutes that expressly require them to provide blood or tissue samples. Florida’s statute is typical, providing that a court shall order the child, mother, and putative father to submit to genetic testing upon a sworn statement presenting “facts establishing a reasonable possibility” that the putative father could be the biological father. Fla.Stat. §742.12. The question in litigation other than paternity then becomes, by what authority can the court order a person in a civil case to offer a blood or tissue sample for testing? The underlying policy reasons for requiring testing in paternity actions are helpful in understanding why DNA evidence should be discoverable in non-paternity contexts.
In M.A. v. Estate of A.C., supra, the putative son of a deceased man sought to compel blood testing of the decedent’s wife and the children born of that marriage in order to prove that the decedent was his biological father. The court characterized the issue as one of first impression in New Jersey that involved:
balancing the compelling state interest in ensuring and protecting plaintiff’s interest by helping him to determine his parentage against the privacy rights of decedent’s heirs and their mother to refuse submitting to blood testing.
643 A.2d at 1047. The court found the use of DNA testing to be clearly helpful in “determining whether the decedent is M.A.’s biological father. It makes the establishment of paternity an objective finding of fact rather than a self-serving credibility contest.” Id. at 1050. The court observed that fundamental fairness prohibited the putative mother and siblings from refusing to provide this potentially relevant evidence to the court (id. at 1053), reasoning that since the court “has the inherent power to require a nonparty to give evidence in the form of testimony in the quest for truth, it also has the inherent power to require a nonparty to give evidence in the form of a blood sample in the quest for truth.” Id. at 1051.
Other courts in paternity settings have expressed the same policy reasons for compelling blood or tissue samples, based on a likelihood the sample will lead to admissible evidence. See Witso v. Overby, 609 N.W.2d 618, 621 (Minn.App. 2000) (recognizing a “judicial obligation” to weigh genetic-based presumptions); Redman v. Radovich, 451 Pa.Super. 97, 678 A.2d 416 (1996) (putative father seeking to establish custody over daughter was entitled to an order compelling testing); Anne R. v. Estate of Francis C., 167 Misc.2d 343, 634 N.Y.S.2d 339 (1995) (putative daughter was entitled to order compelling DNA testing on deceased man’s frozen blood sample); Succession of Robinson, 654 So.2d 682 (La. 1995) (court in a succession proceeding may compel blood tests); Estate of Sandler, 160 Misc.2d 955, 612 N.Y.S.2d 756 (1994) (court required testing of parents of deceased putative father).
M.A. v. Estate of A.C. is an example of a case that addressed the authority of a trial court, apart from paternity statutes, to order genetic testing in a civil action. There, the putative father, who was deceased, could not be made a party to the suit (although his estate was a party), so it was impossible to obtain a sample from him. As a result, the authority for ordering testing of the spouse and children could not be found in the applicable paternity statute, because that statute only applied where there was a living putative father. However, the court rejected the argument that the absence of legislative authorization precluded genetic testing in other settings, stating (643 A.2d at 1048):
On the other hand, the statute does not purport to prohibit blood testing in other situations. There is no indication that the statutory language expresses a deliberate policy of limitation. Therefore, this Court concludes that the statute is not controlling in this case, and the general rules of discovery and the court’s inherent right to compel the production of evidence must be applied.
In Sudwischer v. Estate of Hoffpauir, 589 So.2d 474 (La. 1991), the court also had to rely on authority outside of the state paternity statute. Sudwischer involved a putative daughter’s attempt to prove that a deceased man was her biological father. Since the putative father was deceased, the plaintiff sought an order requiring that the man’s daughter (her supposed sister) to submit to a blood test. Finding “no indication that the statutory language expresses a deliberate policy of limitation,” the court ordered the testing even though Louisiana’s paternity statute did not authorize blood testing of siblings. Id. at 475. The concurring opinion in Sudwischer stated that the Louisiana Rules of Civil Procedure provided an independent basis for ordering the test, because the Rules permitted discovery of non-privileged matters that are relevant to the subject matter of the pending action. Id. at 476.
Another case that arose in an entirely different context, Syring v. Tucker, 174 Wis.2d 787, 498 N.W.2d 370 (1993), illustrates the equitable powers of courts to compel testing. Syring was a civil assault and battery action, in which the plaintiff, a social worker, had been intentionally bitten by a disruptive client during an administrative hearing. As she bit her social worker, the client yelled that she had AIDS. The social worker sought an order requiring the client to submit to a blood test to determine whether the client in fact had the HIV virus. The Wisconsin Supreme Court held that the trial court erred in finding that the state’s discovery rules did not authorize courts to order such testing. The court stated that “Wisconsin courts do not rely on the legislature for their power to act,” and therefore the trial court could compel the testing based upon its equitable powers and upon “discretion in deciding discovery motions.” 498 N.W.2d at 375. The court disregarded the lack of explicit statutory authorization for this exact situation, stating that “[w]here a new condition exists, and legal remedies afforded are inadequate or none are afforded at all, the never-failing capacity of equity to adapt itself to all situations will be found equal to the case.” Id.
The decisions discussed above illustrate judicial authority to order genetic testing in nonpaternity settings that is found in state procedural rules and statutes, as well as in the courts’ inherent power to order discovery.
Establishing the legal authority to order testing is only one part of the equation. In order to compel a person to submit to testing, a litigant must also establish a sound factual basis for issuing the order. One court described this threshold as one of a “ reasonable quantum of individualized suspicion to support court ordered blood testing.” M.A. v. Estate of A.C. supra, 643 A.2d at 1048. Regardless of the exact language for this threshold, courts will probably require more than conclusory assertions unsupported by specific facts before ordering a genetic test on a person. For example, in the Crohn’s disease situation described above, the drug manufacturer’s motion should show specific facts concerning bouts of symptoms prior to the taking of the drug, family history, and other specific, individually tailored facts in support of its motion to compel.
Balancing the Interests
Before ordering testing, courts will also balance the parties’ interests to make sure that the privacy interests of the person to be tested do not substantially outweigh those of the party seeking the testing. The privacy interests generally include: (1) a person’s 4th Amendment right against unreasonable searches; and (2) preventing disclosure of test results to 3rd parties, which could ultimately lead to discrimination by entities such as employers and health insurance companies.
Courts have described the “minimal intrusion” a blood test has on the 4th Amendment as follows. Such a blood test should be performed by medical personnel in a medical environment, according to accepted medical procedures. The sample is typically drawn from blood, buccal cells, bone, or hair. The “buccal swab” method obtains skin cells from the inner mouth using a small stick resembling a Q-tip. The intrusion occasioned by such a blood test is “commonplace in these days of periodic physical examinations, and experience with them teaches that the quantity of blood extracted is minimal, and that for most people the procedure involves virtually no risk, trauma, or pain.” Syring v. Tucker, supra, 498 N.W.2d at 378; see also, Schmerber v. California, 384 U.S. 757, 771 (1966).
Courts will be unlikely to find that the 4th Amendment right outweighs a legitimate request for genetic testing. This is especially true in the case of a party who has placed his or her medical condition in issue by asserting the claim in the first place.
Concerns about the potential for overly broad disclosure of either the results of genetic testing, or the sample itself that led to the results, do not provide an overriding interest against genetic testing. While the information found in a person’s DNA could theoretically be used by employers and health insurance carriers in their hiring decisions and underwriting processes, courts possess the inherent power to order the testing in such a manner as to ensure there is no harm to the one providing the sample. For example, the sample can be sent to the lab with an identifying number instead of a name, and the court may seal the test results so that they cannot be seen except by those involved with the litigation. Further, it is likely that there will soon be legislative protection against undue dissemination of this information and against discrimination. For example, a February 8, 2000 Executive Order prohibits discrimination in federal employment based on genetic information. Exec. Order No. 13,145, 65 FFed. Reg. 6, 877 (2000).The Executive Order is intended to ensure that employees are judged based on present ability, and not on the possibility of developing a disease or condition in the future. It prohibits federal agencies from collecting, purchasing, maintaining, and disclosing potential genetic information about employees, and from making employment decisions based on such information.
In litigation alleging that the plaintiff suffered an injury because of his particular drug medication, the drug manufacturer would have a profound interest in obtaining the genetic information found in the plaintiff’s DNA. The defendant’s interest arises from its right to discover the truth. This interest includes the constitutional freedom from the deprivation of its property (in the form of an adverse judgment) without due process of law. Courts should also consider the defendant’s financial interest in having the opportunity to discover information that may exonerate the drug. The pharmaceutical company and the public have an obvious interest in being able to establish that the drug is safe. In paternity cases, financial interests such as inheritance rights, social security and other potential economic and medical benefits that have formed the basis for an order requesting testing. See M.A. v. Estate of A.C., 643 A.2d at 1052.In the same way, defendant’s financial interest in exonerating the ddrug must also be consideredin weighing the interests of the parties with respect to genetic testing.
On balance, the competing interests will often weigh in favor of testing. The affront to privacy is minimal. The potential benefits to the litigants and to the judicial system is great. The threshold requirement of a legitimate, fact-specific reason to support the testing will serve as a gatekeeper to guard against improper requests for genetic testing. As a practical matter, the cost initially for such testing, as well as the possibility of helping a plaintiff to establish his or her case, will provide incentive for defendants to be judicious when deciding whom to test.
DNA evidence that a person either does or does not have a genetic predisposition for a certain disease will soon serve as a powerful tool in the search for truth. A plaintiff who has placed his or her condition in issue through the filing of a lawsuit, and in some cases others who are not parties, should be compelled to provide this evidence in the form of a blood or tissue sample upon a reasonable showing that the sample is likely to contain admissible evidence.
Because gene mapping is a new technology, a new body of law will develop to address the right of a litigant to compel genetic testing. In determining the rights of litigants and witnesses, this body of law will draw upon the policy reasons found in the law of paternity, the civil rules of procedure, and the courts’ equitable power to compel discovery. In many cases, the interests of the litigant in having the DNA evidence should outweigh any interest in withholding the sample, provided the litigant can show a reasonable basis in fact to compel the testing.
Steve Hall is a former research chemist, and a life sciences and technology attorney with the Louisville, Kentucky law firm of Stoll Keenon Ogden PLLC. He is a registered patent attorney. He focuses on many aspects of technology development, commercialization, and litigation. These include patentability and freedom to practice, risk management, commercial litigation, and defense of product liability litigation.