1. Chemical Products Liability & Environmental Litigation 1 MEDICAL MONITORING: Class Action Issues Sean P. Wajert Dechert, LLP Philadelphia, PA www.masstortdefense.com

2. Chemical Products Liability & Environmental Litigation 2 MEDICAL MONITORING CLASS ACTIONS Medical monitoring is often presented as a class action claim: Expanding universe of potential plaintiffs from injured plaintiffs to so-far healthy plaintiffs plaintiffs who have been exposed plaintiffs at increased risk of future disease A number of elements of medical monitoring seem more amenable to “common” proof

3. Chemical Products Liability & Environmental Litigation 3 MEDICAL MONITORING: CLASS ACTIONS Facing the class claim: Is medical monitoring recognized in the relevant jurisdiction? If so, Is it a cause of action or remedy? Is it equitable relief or a damages action?

4. Chemical Products Liability & Environmental Litigation 4 MEDICAL MONITORING: CLASS ACTIONS Lowe v. Philip Morris USA, Inc., 344 Ore. 403; 183 P.3d 181 (2008) Threat of future harm is insufficient to state a claim The need to undergo periodic medical monitoring is insufficient “harm.” Donovan v. Philip Morris USA, Inc, 455 Mass. 215 (2009). Recognized when defendant's negligence causes plaintiff to become exposed to a hazardous substance that produces sub-cellular changes that substantially increased the risk of serious disease

5. Chemical Products Liability & Environmental Litigation 5 MEDICAL MONITORING: Class Actions Is it a remedy or a cause of action? Class certification implications If recognized as a remedy, need to also examine underlying tort/cause of action elements If independent cause of action, additional focus may be on medical monitoring elements

6. Chemical Products Liability & Environmental Litigation 6 MEDICAL MONITORING: CLASS ACTIONS Do plaintiffs seek injunctive/equitable or damages/legal relief? Manual for Complex Litigation: courts are divided over whether 23(b)(2) or 23(b)(3) is the appropriate vehicle for certifying a class for medical monitoring

7. Chemical Products Liability & Environmental Litigation 7 MEDICAL MONITORING: CLASS ACTIONS Do plaintiffs seek injunctive or legal relief? Gates v. Rohm and Haas Co., 2010 WL 774327 (E.D. Pa. 3/5/10) Doctors’ Hospital L.P. v. Webb, 704 S.E.2d 185 (Ga. App. 2010)

8. Chemical Products Liability & Environmental Litigation 8 MEDICAL MONITORING: CLASS ACTIONS Increasingly, plaintiffs seek alleged injunctive relief… Why? Insurance for impact of Rule 23(b)(3): predominance of common issues Plaintiffs think that certification under (b)(2) allows them to push medical monitoring elements into “program”

9. Chemical Products Liability & Environmental Litigation 9 MEDICAL MONITORING: CLASS ACTIONS Rule 23(b)(2) different than (b)(3) No predominance requirement But courts differ cohesiveness more stringent than predominance Barnes v. American Tob. Co., 161 F.3d 127 (3d Cir. 1998) Kelecseny v. Chevron, U.S.A., Inc., 262 F.R.D. 660, 681 (S.D. Fla. 2009) no cohesiveness requirement at all? Wal-Mart Stores v. Dukes,79 USLW 3128 (U.S. Dec. 6, 2010)

10. Chemical Products Liability & Environmental Litigation 10 MEDICAL MONITORING: CLASS ACTIONS Several cases on injunctive relief with dicta, little analysis Gates v. Rohm & Haas Co., 265 F.R.D. 208, 230 (E.D. Pa. 2010) (“request for a court-ordered, court-supervised medical monitoring program can be considered a request for injunctive relief” but denying class certification on other grounds); Rowe v. E.I. Dupont De Nemours, 2008 U.S. Dist. LEXIS 103528, at *30 (D.N.J. Dec. 23, 2008) (“requests for medical monitoring in this case can be considered requests for injunctive relief.”); Rhodes v. E.I. Dupont De Nemours & Co., 2008 U.S. Dist. LEXIS 46159, at *13 (S.D. W. Va. June 11, 2008) (“plaintiffs are seeking primarily injunctive or declaratory relief in the form of a court-supervised medical monitoring program.”); In re Welding Fume Prods. Liab. Litig., 245 F.R.D. 279, 290 (N.D. Ohio 2007) (Rule 23(b)(2) applies to medical-monitoring claims because “plaintiffs ask only for injunctive relief, in the form of a court-supervised medical monitoring program” and not “money damages” but denying class certification on other grounds).

11. Chemical Products Liability & Environmental Litigation 11 MEDICAL MONITORING: CLASS ACTIONS How to combat characterization as injunctive relief? How is the remedy defined under state law? Does this class really fit the test of (b)(2)? Absence of cohesiveness- where available Especially if jurisdiction does not recognize need for cohesiveness: ascertainability manageability

12. Chemical Products Liability & Environmental Litigation 12 MEDICAL MONITORING: CLASS ACTIONS How to combat alleged injunctive relief How is the remedy defined under applicable law? Potter v. Firestone Tire & Rubber, 863 P.2d 795 (1993)(“it is simply a compensable item of damages”) if damages, it’s not injunctive relief

13. Chemical Products Liability & Environmental Litigation 13 MEDICAL MONITORING: CLASS ACTIONS How to combat alleged injunctive relief? Courts view of applicability to medical monitoring generally. Zinser v. Accufix Res. Inst., Inc., 253 F.3d 1180, 1195 (9th Cir.), amended, 273 F.3d 1266 (9th Cir. 2001) (medical monitoring not “injunctive” because it “is appropriate only as an element of damages after independent proof of liability”). Certification under Rule 23(b)(2) is inappropriate if the injunction is a "disguised request for compensatory damages." Barnes, 161 F.3d at 131 (3d Cir. 1998); see also Day v. NLO, Inc., 144 F.R.D. 330, 335-36 (S.D. Ohio 1992), rev'd on other grounds, 5 F.3d 154 (6th Cir. 1993). Cook v. Rockwell Int’l Corp., 181 F.R.D. at 479-80 (medical monitoring relief was primarily a suit for damages); Thomas v. FAG Bearings Corp., 846 F. Supp. 1400, 1404 (W.D. Mo. 1994) (declining to certify class because costs were nothing more than compensation for necessary medical expenses reasonably anticipated to be incurred in the future).

14. Chemical Products Liability & Environmental Litigation 14 MEDICAL MONITORING: CLASS ACTIONS How to combat alleged injunctive relief? Can you use the test of (b)(2) (1) that plaintiff has suffered an irreparable injury; (2) that remedies available at law, such as monetary damages, are inadequate to compensate for that injury; (3) that, considering the balance of hardships between the plaintiff and defendant, a remedy in equity is warranted; and (4) that the public interest would not be disserved by a permanent injunction.

15. Chemical Products Liability & Environmental Litigation 15 MEDICAL MONITORING: CLASS ACTIONS How to combat alleged injunctive relief? Have plaintiffs obtained such scanning? If no, may undermining any claim of irreparable harm. under the rubric of “self-inflicted harm,” which precludes a claim for injunctive relief when the alleged irreparable harm for which the plaintiff seeks relief is self-inflicted. See, e.g., FIBA Leasing Co., Inc. v. Airdyne Indus., Inc., 826 F. Supp. 38, 39 (D. Mass. 1993) (“injunction movant does not satisfy the irreparable harm criterion when the alleged harm is self inflicted.”)

16. Chemical Products Liability & Environmental Litigation 16 MEDICAL MONITORING: CLASS ACTIONS How to combat alleged injunctive relief? If money damages will adequately redress harm, injury is not considered irreparable. Plaintiffs may argue that monetary damages are not adequate: insurance coverage is not available. alleged lack of available testing machines. damages not accurately measurable due to uncertainty as to the costs of scanning. need a court-supervised “program” need record keeping. alleged purpose is studies. Are these factual? merely incidental?

17. Chemical Products Liability & Environmental Litigation 17 MEDICAL MONITORING: CLASS ACTIONS How to combat alleged injunctive relief? Requirement of cohesiveness in many courts Perez v. Metabolife Int’l., Inc., 218 F.R.D. 262 (S.D. Fla. 2003) (courts “should be hesitant to grant certification” of medical-monitoring claims where “the many individual issues involved in determining whether a monitoring program is” required for class “preclude a finding of cohesiveness under Rule 23(b)(2).”) Zehel-Miller v. AstraZenaca Pharms., LP, 223 F.R.D. 659, 664 (M.D. Fla. 2004) (denying class certification of medical monitoring class under Rule 23(b)(2) because “all of the individual issues identified in [the 23(b)(3) analysis] destroy any semblance of cohesion”). Sweet v. Pfizer, 232 F.R.D. 360, 374 (C.D. Cal. 2005)(court refused to certify a class of purchasers of the prescription drug Mirapex seeking injunctive relief under 23(b)(2)). Lewallen v. Medtronic USA, Inc., 2002 U.S. Dist. LEXIS 20153, at *10-11 (N.D. Cal. Aug. 28, 2002)(court applied the cohesiveness standard to a proposed medical monitoring class under Rule 23(b)(2), noting that “even though the rule does not contain a predominance and superiority requirement, the requisite cohesiveness is lacking where individual issues predominate.”)

18. Chemical Products Liability & Environmental Litigation 18 MEDICAL MONITORING: CLASS ACTIONS Individual issues affecting cohesiveness (and predominance) Underlying tort elements Medical monitoring elements Affirmative defenses

19. Chemical Products Liability & Environmental Litigation 19 MEDICAL MONITORING: CLASS ACTIONS Individual issue hurdles Medical monitoring elements, e.g., Exposure levels Risk Levels Causation Over and above

20. Chemical Products Liability & Environmental Litigation 20 MEDICAL MONITORING: CLASS ACTIONS Exposure Levels Leib v. Rex Energy Operating Corp., 2008 WL 5377792 (S.D. Ill., 2/26/09) In re FEMA Trailer Formaldehyde Products Liability Litigation, 2008 WL 5423488, at *16 (E.D.La. 2008) Rowe v. E.I. duPont de Nemours and Co., 2008 WL 5412912, at *12-15 (D.N.J. 2008) Gates v. Rohm and Haas Co., 2010 WL 774327 (E.D. Pa. 3/5/10).

21. Chemical Products Liability & Environmental Litigation 21 MEDICAL MONITORING: CLASS ACTIONS Risk Levels Does epidemiology establish increased risk? On a class-wide basis? Mann v. CSX Transp., Inc., 2009 WL 3766056, at *4 (N.D.Ohio 2009) Rhodes v. E.I. du Pont de Nemours and Co., 253 F.R.D. 365, 376-77 (S.D, W.Va. 2008) Gates v. Rohm and Haas Co., 2010 WL 774327 (E.D. Pa. 3/5/10)

22. Chemical Products Liability & Environmental Litigation 22 MEDICAL MONITORING: CLASS ACTIONS Causation What must be caused? Does the defendant’s conduct need to cause the exposure to the hazardous product, or the increased risk, or both? Must the defendant’s conduct have caused the “need” for medical monitoring? When court requires proof of an underlying tort, must the plaintiff also show causation in some traditional sense?

23. Chemical Products Liability & Environmental Litigation 23 MEDICAL MONITORING: CLASS ACTIONS Causation Myers v. BP America, Inc., 2009 WL 2341983, at *6-10 (W.D.La. 2009) In re FEMA Trailer Formaldehyde Products Liability Litigation, 2008 WL 5423488, at *19 (E.D.La. 2008)

24. Chemical Products Liability & Environmental Litigation 24 MEDICAL MONITORING: CLASS ACTIONS “Over and Above” Different from what would be prescribed in absence of the exposure Other risk factors? Individual assessments? Leib v. Rex Energy Operating Corp., 2008 WL 5377792, at *13 (S.D. Ill., 2/26/09) Hoyte v. Stauffer Chemical Co., 2002 WL 31892830, *30, 50 (Fla.Cir.Ct.)

25. Chemical Products Liability & Environmental Litigation 25 MEDICAL MONITORING: CLASS ACTIONS Lesson from life sciences In re: St. Jude Medical, Inc., Silzone Heart Valve Products Liability Litigation, No. 06-3860, 2008 WL 942274 (8th Cir. April 9, 2008) "highly individualized remedy of medical monitoring” whether an individual plaintiff will require additional monitoring is individualized inquiry depending on that patient's medical history, condition of the patient's heart valves at the time of implantation, patient's risk factors for heart valve complications, patient's general health, patient's personal choice, and other factors.

26. Chemical Products Liability & Environmental Litigation 26 MEDICAL MONITORING: Class Action Trials Defeating the (b)(2) class motion Ascertainability membership requires plaintiff-specific inquiry Solo v. Bausch & Lomb Inc., 2009 U.S. Dist. LEXIS 115029, at *13 (D.S.C. Sept. 25, 2009) involves subjective, state of mind inquiry Guillory v. Am. Tobacco Co., No. 97 C 8641, 2001 WL 290603, at *3 (N. D. Ill. Mar. 20 2001) (individuals who “desire[d]” to participate in a medical monitoring program) fail-safe class: can take advantage of win but not bound by loss See generally Intratex Gas Co. v. Beeson, 22 S.W.3d 398 (Tex. 2000).

27. Chemical Products Liability & Environmental Litigation 27 MEDICAL MONITORING: Class Action Trials Defeating the (b)(2) class motion Manageability Shook v. El Paso Cnty., Bd. of Cnty. Comm’rs, 386 F.3d 963, 972–73 (10th Cir. 2004) (considering manageability and efficiency in (b)(2) determination); Robinson v. Metro-N. Commuter R.R., 267 F.3d 147, 164 (2d Cir. 2001) ( (b)(2) certification only when “class treatment would be efficient and manageable, thereby achieving an appreciable measure of judicial economy.”); In re Rezulin Prods. Liab. Litig., 210 F.R.D. 61, 74 (S.D.N.Y. 2002)(Applying to medical monitoring).

28. Chemical Products Liability & Environmental Litigation 28 MEDICAL MONITORING: Class Action Trials Defeating the (b)(2) class motion Manageability Trial Plan- how will plaintiffs get there from here put them to the test Due process violations Rules Enabling Act violations 7 th Amendment in federal cases Choice of law

29. Chemical Products Liability & Environmental Litigation 29 MEDICAL MONITORING: Class Action Trials Manageability Medical Monitoring Plan Combat vagueness Plaintiffs must come forward with detailed plan Pin down the experts Watch for “access” approach Need a target to shoot at Plaintiffs cannot prove elements without a plan  Rink v. Cheminova, Inc., 203 F.R.D. 648, 662 (M.D. Fla. 2001)  Gates v. Rohm and Haas Co., 2010 WL 774327 (E.D. Pa. 3/5/10)

30. Chemical Products Liability & Environmental Litigation 30 MEDICAL MONITORING: Class Action Trials Manageability Plaintiffs’ Typical Plan “prove” individual issues through affidavits “prove” individual issues through administrative process move individual issues into the “plan” outside of court affirmative defenses are “barred” in equitable claim Rule 23 is procedural device that cannot be used to change substantive law McLaughlin v. Am. Tobacco Co., 522 F.3d 215 (2d Cir. 2008) In re Bridgestone/Firestone Inc., 288 F.3d 1012 (7 th Cir. 2002), cert. denied, 537 U.S. 1105 (2003)

31. Chemical Products Liability & Environmental Litigation 31 MEDICAL MONITORING: Class Action Trials Manageability Plaintiffs’ Plan “prove” individual issues through affidavits “prove” individual issues through administrative process move individual issues into the plan affirmative defenses are “barred” in equitable claim Perez v. Metabolife Int’l, Inc., 218 F.R.D. 262, 269 (S.D. Fla. 2003) (“allowing such uncorroborated and self-serving evidence without giving Defendant an opportunity to challenge the class member’s evidentiary submissions would likely implicate Defendant’s due process rights”); Fisher v. Ciba Specialty Chems. Corp., 238 F.R.D. 273, 302 (S.D. Ala. 2006) (rejecting “plaintiffs’ optimistic argument that prospective class members could be counted on to self- select whether” they satisfy the class definition because such a process “could not reasonably be expected to produce reliable results”).

32. Chemical Products Liability & Environmental Litigation 32 MEDICAL MONITORING: Class Action Trials Manageability- Plan Ahead All or nothing Plaintiffs obtain class certification with claim that elements can be shown on common basis Hold them to common proof Point out any examples of people who fit the class definition but who do not fit the “common” pattern  Don’t have exposure; or risk; or need for medical monitoring; or already need it Some or even most not good enough Cf. Mann v. CSX Transportation, 2009 WL 3766056 (N.D. Ohio Nov. 10, 2009)

33. Chemical Products Liability & Environmental Litigation 33 MEDICAL MONITORING: Class Actions Manageability: Choice of Law Even if recognized, elements vary Exposure necessary Risk level Type of conduct Efficacy of test/treatment Standard of Care Over and above Payment plan

34. Chemical Products Liability & Environmental Litigation 34 MEDICAL MONITORING: Class Actions Choice of law - National classes Zehel-Miller v. Astrazeneca Pharmaceuticals, LP, 223 F.R.D. 659 (M.D.Fla. 2004). In re Rezulin Products Liability Litigation, 210 F.R.D. 61 (S.D.N.Y. 2002). Sanders v. Johnson & Johnson, Inc., 2006 WL 1541033 (D.N.J. June 2, 2006).

35. Chemical Products Liability & Environmental Litigation 35 MEDICAL MONITORING: Class Actions Choice of law – Multi-state classes In re FEMA Trailer Formaldehyde Products Liability Litigation, 2008 WL 5423488 (E.D.La.) In re St. Jude Medical, Inc., 425 F.3d 1116 (8th Cir. 2005)

36. Chemical Products Liability & Environmental Litigation 36 MEDICAL MONITORING: Class Actions Choice of law – Plaintiffs’ response In re Welding Fume Products Liability Litig., 245 F.R.D. 279 N.D.Ohio (2007) State of West Virginia ex rel. Chemtall Inc. v. Madden, 216 W.Va. 443, 607 S.E.2d 772 (2004)

37. Chemical Products Liability & Environmental Litigation 37 MEDICAL MONITORING: Class Action Issues Sean P. Wajert Dechert, LLP Philadelphia, PA sean.wajert@dechert.com Blog: www.masstortdefense.com