Signature Diseases - Asbestos and Mesothelioma and Beyond. Ronald G. Peresich Page Mannino Peresich, & McDermott, PLLC Biloxi, Mississippi

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1 Signature Diseases - Asbestos and Mesothelioma and Beyond. Ronald G. Peresich Page Mannino Peresich, & McDermott, PLLC Biloxi, Mississippi

2 RON PERESICH: Ron is one of the founding partners of Page, Mannino, Peresich & McDermott, PLLC which has offices in Gulfport, Biloxi and Jackson, Mississippi and serves as the firm s managing partner. He has extensive experience handling complex commercial and personal injury litigation and has represented a wide variety of business and personal clients throughout his career in the areas of Civil and Commercial Litigation, Mass Torts; Toxic Torts, Insurance Defense, Gaming Law, Construction Law, Products Liability, Premises Liability, and Commercial Transactions. Ron has been named as a Mid-South SuperLawyer in 2007 and i.

3 What is a signature disease? Simply stated, signature disease is one that has a defined and specific cause. As one court has phrased it, [s]ignature diseases are those that are uniquely related to exposure to a certain substance and are rarely observed in individuals that are not exposed. Hurtado v. Pharma Co., 6 Misc.3d 1015(A), 2005 WL at *6 (N.Y. Sup. Ct. 2005). A signature disease has also been described as one that bears the signature of the substance. Daniel A Farber, Toxic Causation, 71 Minn. L. Rev. 1219, (1987). It is a [d]isease that is rarely found outside a particular type of exposed population.... Howard Marks, Electromagnetic Forces From Overhead High-Voltage Transmission of Electricity, 13 J. Envtl. L. & Litig. 163, 180 (1998). According to the Reference Guide to Epidemiology, a signature disease is one that is associated uniquely with exposure to an agent (e.g. asbestosis and exposure to asbestos). Green, Michael D.; D. Mical Freedman; and Leon Gordis. Reference Guide on Epidemiology, Reference Manual on Scientific Evidence, 2nd ed., Washington, DC: Federal Judicial Center (2000). 1

4 By far the most well known conditions that have been deemed signature diseases are asbestosis and mesothelioma, which are generally believed to be acquired only by exposure to asbestos. Daniel A. Farber, Toxic Causation, 71 Minn. L. Rev. 1219, (1987); In re Seventh Judicial Dist. Asbestos Litig., 744 N.Y.S.2d 304, 308 (N.Y.Sup. 2002). The term signature disease has also been attributed to acute myeloid leukemia, a signature condition of benzene exposure. U.S. v. Apex Oil Co., Inc, 2008 WL (S.D.Ill. July 28, 2008); Castellow v. Chevron USA, 97 F.Supp.2d 780, 785 (S.D.Tex. 2000) (finding that relevant medical-scientific literature supports the conclusion that cumulative benzene exposure, at certain levels can result in acute myelogenous leukemia). Exposure to the drug diethylstilbesterol (DES) has been found to be uniquely associated with vaginal adenocarcinoma in women. See Braune v. Abbott Lab., 895 F.Supp. 530, 537 (E.D.N.Y. 1995). Finally, hepatic angiosarcomas (liver cancers) are associated with vinyl chloride exposure and have been considered a signature disease. See Taylor v. Airco, Inc., 494 F.Supp.2d 21, (D. Mass., 2007). Most recently, some litigants have asserted that a condition known as Nephrogenic 2

5 Systemic Fibrosis (NSF) and also referred to as Nephrogenic Fibrosing Dermopathy (NFD) is a signature disease. See In re: Gadolinium Contrast Dyes Prod. Liab. Litig., MDL No. 1909, (U.S.Jud.Pan.Mult.Lit., 2008); Demarco v. General Elec. Co., 2008 WL (N.D.Ohio, 2008); Carolus v. General Elec. Co..2d, 2007 WL (D.Colo. 2007). The claim is that the only means of acquiring NSF/NFD is through gadolinium contrast injections given during MRI and MRA scans for patients being treated for kidney disease. See Cowper SE. Nephrogenic Fibrosing Dermopathy [NFD/NSF Website] (Available at How Courts Have Addressed cases involving Signature Diseases. Legal actions involving an alleged signature disease have been handled by courts a variety of ways. In Hurtado v. Purdue Pharma Co., 6 Misc.3d 1015(A), 2005 WL at *6 (N.Y. Sup. 2005), plaintiffs sought class certification for a group having been prescribed the drug OxyContin. While not deciding liability as to the individual plaintiffs, the court declined to certify a class, reasoning that without a common injury or signature disease like asbestosis or mesothelioma, which only come from asbestos contact, it is difficult to define a 3

6 class or establish causation. Hurtado, 2005 WL at *7. The court noted that the alleged addictions to the drug were individual issues not appropriate for class certification. Id. Among other things, the court held that without a signature disease, or common injury, the named plaintiffs could not be typical of a larger group. Id. In Gehring v. Denko, 1994 WL (E.D. Pa. 1994), L-tryptophan, an amino acid used to treat insomnia, depression and other diseases, was found, only in the form sold by the defendant, to cause eosinophilia-myaliga syndrome (EMS). On a defense motion for summary judgment, the drug-maker maintained that plaintiff s case failed because she could not specifically identify what brand of L-tryptophan she used to show that her EMS was caused by the drug. Id. at *1. Noting that a so-called signature disease is one which is caused only by the product at issue, the court concluded that while epidemiological studies are useful in establishing evidence that a drug was ingested, such studies do not provide direct evidence that a particular plaintiff was injured by exposure to a substance. Id. at *3 (quoting DeLuca v. Merrell Dow Pharm., Inc., 911 F2d 941, 945 (3d Cir. 1990)). In Shield v. Eli Lilly & Co., 895 F.2d 1463, 1467 (D.C.Cir. 1990), the plaintiff 4

7 contracted vaginal cancer and brought a legal action against the drug manufacturer of diethylstilbestrol (DES) which was taken by her mother when she was pregnant with plaintiff. The drug manufacturer moved for summary judgment arguing that plaintiff could not prove that she had been exposed to DES. Id. at While the plaintiff conceded that there was no direct evidence of exposure to DES, she put on indirect evidence that her mother received the medication during the course of her pregnancy but was not told the drug s name; that the prescribing doctor was deceased; and that both his prescription records and the pharmacy records were lost. Id. Based upon her mother s description of the medication, the circumstances in which her mother was prescribed the drug, and the practice of the doctor who prescribed the medication, Plaintiff intended to identify the medication as DES. Id. In addition, there was evidence of the prescribing doctor s practice of prescribing the medication to patients and evidence of the physical description of the pill that matched the Plaintiffs mother s description. Id. Finally, there was evidence of medical examinations of the plaintiff in which several doctors noted irregularities with the plaintiffs uterus that were consistent with exposure to DES. 5

8 Granting summary judgment, the district court concluded that plaintiff had not met her burden of showing sufficient evidence of exposure. Id. at On appeal the Court of Appeals reversed, holding that plaintiff s evidence created a jury issue as to exposure. Id. at The court found that not only did plaintiff have statements by experts who believed that her conditions were produced by exposure to DES-based, but also that two of the experts drew their conclusions prior to her contracting cancer and one expert determined that medical evidence of DES exposure is not subject to dispute. Id. See also Bulthus v. Rexall Corp., 789 F.2d 1315, (9th Cir. 1985) (holding that plaintiff overcame summary judgment motion with physician affidavits stating her injuries were caused by DES and issue of material fact existed as to whether plaintiff s mother had taken DES during her pregnancy precluding summary judgment). DES was also the subject of the case Braune v. Abbott Laboratories, 895 F.Supp. 530 (E.D.N.Y. 1995). Plaintiffs brought claims that various reproductive tract abnormalities and pregnancy-related difficulties were caused by DES exposure. Braune, 895 F.Supp. at 537. In dicta, the court recognized that: 6

9 where a disease is prevalent in the nonexposed population, a plaintiff may need to know more than her symptoms, or a medical diagnosis, to realize that her medical problem has a human cause. Not all manifestations of exposure to latent toxic substances are signature diseases -i.e., those that occur almost exclusively in connection with exposure to a particular substance. An example is sterility, which may arguably be caused by DES but which is common in the nonexposed population. It is, in fact, defendants' position in the instant cases that scientific knowledge even now does not support a conclusion that plaintiffs' sterility was caused by DES. Id. at 552. The trial court denied the drug-makers motion for summary judgment on the statute of limitation defenses, and elaborated on proof of causation in signature disease cases: [t]he fact finder s role may also be implicated in the determination of what constitutes a signature disease, and whether a recently manifested medical problem is separate and distinct from an earlier one. Both statistical and medical testimony may be required to determine if a particular medical problem constitutes a signature disease, and medical testimony may be required to determine whether a later medical problem reflects predictable, progressive deterioration from an earlier condition. Id. at (citations omitted). Ultimately, the court denied the motion for summary judgment on the statute of limitation defenses. In National Bank of Commerce v. Dow Chemical Company, 965 F.Supp (E.D.Ark., 1996), the plaintiff claimed an infant s in utero exposure to the pesticide, Dursban, 7

10 caused certain birth defects. In evaluating the propriety of expert testimony as to exposure and causation of the injury, the court considered the signature disease theory and concluded that the doctor s expert testimony was unreliable for a number of reasons. Id. Significantly, the court found that the expert s testimony did not support the conclusion that exposure to Dursban was always associated with certain birth defects to create a signature disease. Id. at In Hall v. Baxter Healthcare Corp., 947 F.Supp (D.Or. 1996), silicone breast implants recipients brought products liability claims against manufacturers of implants. Prior to trial, defendants moved in limine to exclude plaintiffs proposed expert testimony on causation. Hall, 947 F.Supp Plaintiffs asserted that silicone from the implants migrated and degraded in their bodies causing a systemic syndrome or illness, which plaintiffs referred to as atypical connective tissue disease or ACTD. Id. at The court determined, however, that the ailments asserted by the plaintiffs were not a signature disease. Id. at The court recognized that the women alleging ACTD did not exhibit the same signs and symptoms, and that there [was] no signature disorder to suggest either that the cause is silicone 8

11 exposure or that the cause is the same for all women showing this constellation of symptoms. Id. Rather, the court found that plaintiffs asserted constellation of symptoms that comprise ACTD and which overlap with symptoms of chronic fatigue syndrome and fibromyalgia. Id. On the motions to exclude the testimony of plaintiffs experts as to causation of their ACTD, the court granted the motions holding the testimony of plaintiffs experts unreliable under Daubert. Id. at 1414.Asbestos/Mesothelioma Numerous courts and commentators have acknowledged that asbestos and/or mesothelioma are signature diseases of asbestos exposure. See e.g. Joseph Sanders, William C. Powers, Jr., & Michael D. Green, The Insubstantiality of the Substantial Factor Test for Causation, 73 Mo. L. Rev. 399, 401 (2008); Jamie A. Grodsky, Genomics and Toxic Torts; Dismantling the Risk-Injury Divide, 59 Stan. L. Rev. 1671, 1731 (2007); Berger v. Amchem Prod., 13 Misc.3d 335, 818 N.Y.S.2d 754 (N.Y.Sup. Ct. 2006); Zimko v. American Cyanamidm, 905 So. 2d 465 (La.App. 4 Cir. 2005); Illinois Cent. R.R. Co. v. Gregory, 912 So. 2d 829, 835 (Miss. 2005); Hurtado v. Purdue Pharma Co., 6 Misc.3d 1015(A), 800 N.Y.S.2d 347 (Table) (N.Y.Sup. Ct. 2005); Torrejon v. Mobil Oil Co., 876 9

12 So. 2d 877 (La. App. 4 Cir. 2004); Margaret A. Berger, Upsetting the Balance Between Adverse Interests: The Impact of the Supreme Court s Trilogy on Expert Testimony in Toxic Tort Litigation, 64 Law & Contemp. Probs. 289, 289 (2001); In re Joint Eastern and Southern Dist. Asbestos Litig., 798 F.Supp. 925, 931 (E.D.N.Y. 1992) (rev d on other grounds); Daniel A. Farber, Toxic Causation, 71 Minn. L. Rev (1987). Indeed, several have stated that asbestos and/or mesothelioma are the classic cases of signature disease. See e.g., Zimko, 905 So. 2d at 484; Farber, Toxic Causation, 71 Minn. L. Rev. at