Law.com Subscribers SAVE 30%

Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.

A Review of Recent Medical Monitoring

By Vivian M. Quinn and Tracey B. Ehlers
August 27, 2008

Courts have historically been divided over several key elements with respect to what a plaintiff must prove to support a claim for medical monitoring. For example, some courts have allowed medical monitoring as an independent cause of action, while others only permit it as an element of damages. See Badillo v. Am. Brands, Inc., 16 P.3d 435, 438, 440 (Nev. 2001) (recognizing medical monitoring as a remedy rather than a cause of action); Bower v. Westinghouse Elec. Corp., 522 S.E.2d 424, 433 (W. Va. 1999) (medical monitoring may proceed as an independent cause of action if a plaintiff can demonstrate “a significantly increased risk of contracting a particular disease”). In this article, we review recent decisions regarding medical monitoring and assess whether there has been any consensus among the courts as to whether an actual, present physical injury is required to support a medical monitoring claim and whether class certification is appropriate for medical monitoring claims.

An Update

Since the first decision allowing recovery for medical monitoring, Friends for All Children, Inc. v. Lockheed Aircraft Corp., 746 F.2nd 816 (D.C. Cir. 1984), the die has been cast for a controversy among litigants with respect to the legitimacy of such claims. The court in Lockheed relied on a public policy rationale to find a means to compensate 149 Vietnamese orphans who were injured in an aviation incident in Vietnam. Id. at 819. The District of Columbia U.S. Circuit Court of Appeals held that medical surveillance expenses were recoverable without proof of present physical injury because the plane crash exposed the children to an increased risk of serious brain damage. Id. at 824-25 (ordering the defendants to pay the costs of certain diagnostic tests). A medical monitoring claim is distinguishable from a claim for enhanced risk of future harm where a plaintiff seeks compensation for the anticipated harm itself, proportionately reduced to reflect the chance that it will occur. See In re Paoli R. Yard PCB Litig., 916 F.2nd 829, 850 (3d Cir. 1990), cert. denied, 499 U.S. 961 (1991). A medical monitoring claim seeks recovery for the costs of periodic, long-term diagnostic testing used to detect the onset of latent injuries or diseases caused by exposure to toxins or other tortious acts. See, e.g., Sutton v. St. Jude Med. S.C., Inc., 419 F.3d 568 (6th Cir. 2005). Such a “non-traditional” method of recovery is meant to reimburse the cost of future, periodic medical examinations, but does not provide recovery for actual treatment expenses. Id. at 575.

Is a Present Physical Injury Required?

Since 1984 when the first court recognized the claim, courts have been divided on whether to allow causes of action for medical monitoring. Even now, more than 20 years later, although several courts have allowed a cause of action for medical monitoring absent present physical injury, other courts require plaintiffs to prove a present injury before recognizing such claims.

For instance, in Muniz v. Rexnord Corp., 2006 WL 1519571 (N.D. Ill. May 26, 2006), the district court held that the Illinois Supreme Court would uphold a cause of action for medical monitoring without requiring a present physical injury. In that case, plaintiffs alleged that defendants released chemicals that contaminated their property and water supply. Defendants sought summary judgment on plaintiffs' medical monitoring claim, contending that the claim, without a present physical injury, was not legally cognizable under Illinois law. The court denied the motion, however, concluding that “'a claim seeking damages for the costs of medical examinations is not speculative and the necessity for such examinations is capable of proof within a reasonable degree of medical certainty.'” Id. at *6 (quoting Lewis v. Lead Indus. Ass'n, Inc., 793 N.E.2d 869, 874 (Ill. App. Ct. 2003)). Thus, plaintiffs' medical monitoring claim was cognizable under Illinois law. See also Gates v. Rohm and Haas Co., 2007 WL 2155665 (E.D. Pa. July 26, 2007) (applying Illinois law) (based on prior state appellate and federal decisions, the court believed the Illinois Supreme Court would recognize a medical monitoring claim without proof of a present physical injury).

Similarly, West Virginia does not require plaintiffs to prove a present physical injury to sustain a medical monitoring claim. See Stern v. Chemtall Inc., 617 S.E.2d 876 (W. Va. 2005). To state a claim for medical monitoring under West Virginia law, a plaintiff must prove that: 1) he or she has, relative to the general population, been significantly exposed; 2) to a proven hazardous substance; 3) through tortious conduct of the defendant; 4) as a proximate result of the exposure, plaintiff has suffered increased risk of contracting a serious latent disease; 5) the increased risk of disease makes it reasonably necessary for the plaintiff to undergo periodic diagnostic medical examinations different from what would be prescribed in the absence of the exposure; and 6) monitoring procedures exist that make the early detection of a disease possible. Id. at 884 (citing Bower, supra, 522 S.E.2d at 431).

In Stern, the plaintiffs, asymptomatic coal plant workers, alleged chemical exposure to an industrial water cleaner. 617 S.E.2d at 879. The court allowed the plaintiffs to intervene in a class action because there were common questions of law and fact between the parties, including whether acrylamide was a hazardous substance, whether the defendants' conduct was tortious, whether those exposed to acrylamide faced an increased risk of contracting a serious latent disease, whether the increased risk made monitoring reasonably necessary, and whether monitoring procedures were available. Id. at 884. But see dissent in Bower, 522 S.E.2d at 434-35 (arguing that the majority lacked the authority to create a medical monitoring cause of action and highlighting a fundamental problem with post-exposure, but pre-symptom medical monitoring. “The practical effect of this decision is to make almost every West Virginian a potential plaintiff in a medical monitoring cause of action.”). Other courts have remained unwilling to recognize medical monitoring claims without the plaintiff's proof of a present physical injury. See Parker v. Brush Wellman, 2007 WL 1149982 (11th Cir. Apr. 18, 2007) (applying Georgia law). In Parker, plaintiffs' allegations of subclinical and cellular damage from exposure to beryllium were insufficient to state a current physical injury because such injuries did not establish a cognizable injury under Georgia law. Id. at **3-4. Accord Houston County Health Care Auth. v. Williams, 961 So.2d 795 (Ala. 2006) (holding that a person exposed to a known hazardous substance but not claiming a present physical injury or illness may not recover the costs of medical monitoring under Alabama law); Lowe v. Philip Morris USA, 142 P.3d 874 (Ore. 2006) (dismissing a longtime smoker's medical monitoring claim, saying the allegations in her complaint do not establish the present harm required to establish liability in negligence under Oregon law), rev. granted, 155 P.3d 874 (2007).

Many state courts, and federal courts applying state law, have found it difficult to recognize medical monitoring claims without proof of present physical injury based on public policy concerns. See Metro-North Commuter Railroad Co. v. Buckley, 521 U.S. 424, 426-27 (1997) (expressing concern that judges and juries would have to consider medical monitoring costs beyond those that are recommended for the general public and would have to divert limited medical resources from persons with more serious injuries); Paz v. Brush Engineered Materials, Inc., 949 So.2d 1, 8 (Miss. 2007) (the “potential floodgate of trivial litigation and the resultant delay and decrease in remedy for those with manifested illnesses as well as the extra burden on consumers resultant from virtually unlimited liability” were deciding factors for the court in rejecting plaintiff's medical monitoring claim) (quoting Buckley, 521 U.S. at 426-27). In Paz, the court was unwilling to depart from the traditional elements of tort actions, particularly the requirement to prove an identifiable injury. 949 So.2d at 5-6.

Similarly, in Curl v. Am. Multimedia, Inc., 654 S.E.2d 76, 81 (N.C. App. Ct. 2007), the court refused to create a cause of action for medical monitoring without proof of a present physical injury due to the numerous policy-related issues involved, including humanitarian, environmental and economic factors. The court concluded that the legislature, not the courts, was in a better position to weigh such factors and determine whether to create a new cause of action for medical monitoring. Id.

Is Class Certification

Allowed?

Until relatively recently, courts disfavored class action status for medical monitoring claims for the reasons set forth by the U.S. Supreme Court in Amchem Prods. v. Windsor, 521 U.S. 591, 624 (1997) (denying claims of “exposure only” asbestos plaintiffs):

[Exposure-only plaintiffs share] little in common, either with each other or with the presently injured class members. It is unclear whether they will contract asbestos-related disease and, if so, what disease each will suffer. They will also incur different medical expenses because their monitoring and treatment will depend on singular circumstances and individual medical histories.

See also Barnes v. Am. Tobacco Co., 161 F.3d 127 (3d Cir. 1998) (denying class certification in tobacco exposure case).

Plaintiffs, however, have recently increased their efforts to obtain class certification status for “exposure only” medical monitoring claims, and in several cases they have prevailed. For example, in Meyer ex rel. Coplin v. Fluor Corp., 220 S.W.3d 712, 717-18 (Mo. 2007), the Missouri Supreme Court found there was ample support to certify a class of more than 200 children exposed to lead and other toxins from a lead smelter, because common questions predominated over individual questions even where plaintiffs did not exhibit present physical injuries. Indeed, plaintiffs' exposure to toxins from a single source was the common and overriding issue in the case. Id. at 719. The court found that the trial court relied too heavily on the present physical injury requirement. Such a requirement “is inconsistent with the reality of latent injury and with the fact that the purpose of medical monitoring is to facilitate the early diagnosis and treatment of latent injuries caused by exposure to toxins. In short, a physical injury requirement essentially extinguishes the claim and bars the plaintiff from a full recovery.” Id. at 718. A plaintiff must, however, demonstrate a “significantly increased risk of contracting a particular disease relative to what would be the case in the absence of exposure.” Further, a plaintiff must show that “medical monitoring is, to a reasonable degree of medical certainty, necessary in order to diagnose properly the warning signs of disease.” Id. See also Gates, supra, 2007 WL 2155665 (applying Illinois law) (allowing medical monitoring class of town residents exposed to contaminated drinking water).

On the other hand, defendants have successfully challenged class certification and convinced courts to disallow medical monitoring awards absent a “present injury.” In Norwood v. Raytheon Co., 414 F. Supp.2d 659 (W.D. Tex. 2006), the U.S. District Court for the Western District of Texas refused to certify a medical surveillance class of former military personnel who worked near radar systems, predicting that the Texas Supreme Court would not recognize a cause of action for medical monitoring. The court dismissed plaintiffs' medical monitoring claims reasoning that judges and juries would have difficulty evaluating such claims due to their variability, inconsistency, and unpredictability. Id. at 664. See also In re Welding Fume Prods Liab. Litig., 245 F.R.D. 279 (N.D. Oh. 2007) (denying welders' motion for class certification of medical monitoring claims under eight different state laws ' Arizona, California, Florida, New Jersey, Ohio, Pennsylvania, Utah, and West Virginia); In re St. Jude Medical, Inc., 425 F.3d 1116 (8th Cir. 2005) (reversing class certification for medical monitoring, finding that each plaintiff's need for medical monitoring was highly individualized and that states recognizing medical monitoring as a cause of action have different elements triggering liability).

In the context of pharmaceutical drug litigation, federal and state courts have repeatedly refused to grant class certification status to plaintiffs based on the individualized proof required for such claims. See, e.g., In re Vioxx Prods. Liab. Litig., 239 F.R.D. 450 (E.D. La. 2006); In re Prempro Prods. Liab. Litig., 230 F.R.D. 555 (E.D. Ark. 2005); In re Baycol Prods. Litig., 218 F.R.D. 197 (D. Minn. 2003); In re Paxil Litig., 212 F.R.D. 539 (C.D. Cal. 2003). In Wyeth, Inc. v. Gottlieb, 930 So.2d 635, 643 (Fla. Dist. Ct. App. 2006), a Florida appeals court found that plaintiffs failed to show that medical monitoring would involve common questions of fact. For instance, a plaintiffs' expert testified that Prempro was a hazardous substance only if prescribed for cardiovascular purposes, which is not an FDA-approved use. Gottlieb, however, was prescribed Prempro to prevent osteoporosis. Further, plaintiffs' expert acknowledged that claims regarding an increased risk of breast cancer or heart disease were better addressed individually. Moreover, physicians prescribed class members the drug at different times over a period of 10 years. The court concluded that plaintiffs could not establish defendant's knowledge by common proof. Thus, the trial court erred in granting class certification.

Recently, the U.S. District Court for the Southern District of New York, in In re Fosamax Prods. Liab. Litig., 2008 WL 58890 (S.D.N.Y. Jan. 3, 2008), refused to certify a class of Pennsylvania, Florida, and Louisiana Fosamax users who have not been diagnosed with the “signature disease” (osteonecrosis of the jaw), but who claimed they were at increased risk of developing the condition in the future. Plaintiffs reasoned that the rarity of developing osteonecrosis of the jaw, coupled with the limited potential causes of the disease, militated strongly in favor of class relief. The court rejected plaintiffs' reasoning, concluding that the medical monitoring claims failed to meet the typicality requirement of Rule 23(a)(3) as a determination of each claim would require “inherently individualized” proof. Id. at *10. “[C]lass membership is not feasibly ascertainable where it hinges on myriad medical factors individual to each class member.” Id. at *8. In a similar vein, the court found that plaintiffs failed to meet the predominance and superiority requirements of Rule 23(b)(3). Id. at *13. The court held that many individual questions of fact and law rendered class treatment inappropriate. In the final analysis, the court stressed that “[t]he proposed class actions call for an extraordinary intrusion into the FDA's regulatory mandate, even while many of the scientific community believe that more research is needed.” Thus, given that the condition is a recent phenomenon, the court preferred the more prudent case-by-case approach rather than “leading the scientific community in an area of medical science,” which was something the Southern District of New York was reluctant to do. Id. at *14 (citing In re Propulsid Prods. Liab. Litig., 208 F.R.D. 133, 147 (E.D. La. 2002)).

Conclusion

Although state and federal courts continue to tackle issues related to medical monitoring claims, there remains a panoply of approaches taken to the claim. Due to the lack of uniformity and guidance among the courts, to the extent that plaintiffs continue to assert medical monitoring claims, defendants should carefully research and analyze the appropriate jurisdiction's common law. A first line of attack remains that the claims fail for lack of a present physical injury and, where class certification is sought, that individualized proof would be required to determine such claims, thus rendering class certification inappropriate.


Vivian M. Quinn, a member of this newsletter's Board of Editors, is a partner and Tracey B. Ehlers is an associate in Nixon Peabody LLP's Products Liability Group. Their practices involve the health effects of food, chemical, and medical products, and they devote a significant amount of time to defending medical device and pharmaceutical companies as well as counseling clients regarding safety and regulatory compliance.

Courts have historically been divided over several key elements with respect to what a plaintiff must prove to support a claim for medical monitoring. For example, some courts have allowed medical monitoring as an independent cause of action, while others only permit it as an element of damages. See Badillo v. Am. Brands, Inc. , 16 P.3d 435, 438, 440 (Nev. 2001) (recognizing medical monitoring as a remedy rather than a cause of action); Bower v. Westinghouse Elec. Corp. , 522 S.E.2d 424, 433 (W. Va. 1999) (medical monitoring may proceed as an independent cause of action if a plaintiff can demonstrate “a significantly increased risk of contracting a particular disease”). In this article, we review recent decisions regarding medical monitoring and assess whether there has been any consensus among the courts as to whether an actual, present physical injury is required to support a medical monitoring claim and whether class certification is appropriate for medical monitoring claims.

An Update

Since the first decision allowing recovery for medical monitoring, Friends for All Children, Inc. v. Lockheed Aircraft Corp. , 746 F.2nd 816 (D.C. Cir. 1984), the die has been cast for a controversy among litigants with respect to the legitimacy of such claims. The court in Lockheed relied on a public policy rationale to find a means to compensate 149 Vietnamese orphans who were injured in an aviation incident in Vietnam. Id. at 819. The District of Columbia U.S. Circuit Court of Appeals held that medical surveillance expenses were recoverable without proof of present physical injury because the plane crash exposed the children to an increased risk of serious brain damage. Id. at 824-25 (ordering the defendants to pay the costs of certain diagnostic tests). A medical monitoring claim is distinguishable from a claim for enhanced risk of future harm where a plaintiff seeks compensation for the anticipated harm itself, proportionately reduced to reflect the chance that it will occur. See In re Paoli R. Yard PCB Litig. , 916 F.2nd 829, 850 (3d Cir. 1990), cert. denied , 499 U.S. 961 (1991). A medical monitoring claim seeks recovery for the costs of periodic, long-term diagnostic testing used to detect the onset of latent injuries or diseases caused by exposure to toxins or other tortious acts. See, e.g., Sutton v. St. Jude Med. S.C., Inc., 419 F.3d 568 (6th Cir. 2005). Such a “non-traditional” method of recovery is meant to reimburse the cost of future, periodic medical examinations, but does not provide recovery for actual treatment expenses. Id. at 575.

Is a Present Physical Injury Required?

Since 1984 when the first court recognized the claim, courts have been divided on whether to allow causes of action for medical monitoring. Even now, more than 20 years later, although several courts have allowed a cause of action for medical monitoring absent present physical injury, other courts require plaintiffs to prove a present injury before recognizing such claims.

For instance, in Muniz v. Rexnord Corp., 2006 WL 1519571 (N.D. Ill. May 26, 2006), the district court held that the Illinois Supreme Court would uphold a cause of action for medical monitoring without requiring a present physical injury. In that case, plaintiffs alleged that defendants released chemicals that contaminated their property and water supply. Defendants sought summary judgment on plaintiffs' medical monitoring claim, contending that the claim, without a present physical injury, was not legally cognizable under Illinois law. The court denied the motion, however, concluding that “'a claim seeking damages for the costs of medical examinations is not speculative and the necessity for such examinations is capable of proof within a reasonable degree of medical certainty.'” Id. at *6 (quoting Lewis v. Lead Indus. Ass'n, Inc., 793 N.E.2d 869, 874 (Ill. App. Ct. 2003)). Thus, plaintiffs' medical monitoring claim was cognizable under Illinois law. See also Gates v. Rohm and Haas Co., 2007 WL 2155665 (E.D. Pa. July 26, 2007) (applying Illinois law) (based on prior state appellate and federal decisions, the court believed the Illinois Supreme Court would recognize a medical monitoring claim without proof of a present physical injury).

Similarly, West Virginia does not require plaintiffs to prove a present physical injury to sustain a medical monitoring claim. See Stern v. Chemtall Inc. , 617 S.E.2d 876 (W. Va. 2005). To state a claim for medical monitoring under West Virginia law, a plaintiff must prove that: 1) he or she has, relative to the general population, been significantly exposed; 2) to a proven hazardous substance; 3) through tortious conduct of the defendant; 4) as a proximate result of the exposure, plaintiff has suffered increased risk of contracting a serious latent disease; 5) the increased risk of disease makes it reasonably necessary for the plaintiff to undergo periodic diagnostic medical examinations different from what would be prescribed in the absence of the exposure; and 6) monitoring procedures exist that make the early detection of a disease possible. Id. at 884 (citing Bower, supra, 522 S.E.2d at 431).

In Stern, the plaintiffs, asymptomatic coal plant workers, alleged chemical exposure to an industrial water cleaner. 617 S.E.2d at 879. The court allowed the plaintiffs to intervene in a class action because there were common questions of law and fact between the parties, including whether acrylamide was a hazardous substance, whether the defendants' conduct was tortious, whether those exposed to acrylamide faced an increased risk of contracting a serious latent disease, whether the increased risk made monitoring reasonably necessary, and whether monitoring procedures were available. Id. at 884. But see dissent in Bower, 522 S.E.2d at 434-35 (arguing that the majority lacked the authority to create a medical monitoring cause of action and highlighting a fundamental problem with post-exposure, but pre-symptom medical monitoring. “The practical effect of this decision is to make almost every West Virginian a potential plaintiff in a medical monitoring cause of action.”). Other courts have remained unwilling to recognize medical monitoring claims without the plaintiff's proof of a present physical injury. See Parker v. Brush Wellman, 2007 WL 1149982 (11th Cir. Apr. 18, 2007) (applying Georgia law). In Parker, plaintiffs' allegations of subclinical and cellular damage from exposure to beryllium were insufficient to state a current physical injury because such injuries did not establish a cognizable injury under Georgia law. Id. at **3-4. Accord Houston County Health Care Auth. v. Williams, 961 So.2d 795 (Ala. 2006) (holding that a person exposed to a known hazardous substance but not claiming a present physical injury or illness may not recover the costs of medical monitoring under Alabama law); Lowe v. Philip Morris USA, 142 P.3d 874 (Ore. 2006) (dismissing a longtime smoker's medical monitoring claim, saying the allegations in her complaint do not establish the present harm required to establish liability in negligence under Oregon law), rev. granted, 155 P.3d 874 (2007).

Many state courts, and federal courts applying state law, have found it difficult to recognize medical monitoring claims without proof of present physical injury based on public policy concerns. See Metro-North Commuter Railroad Co. v. Buckley, 521 U.S. 424, 426-27 (1997) (expressing concern that judges and juries would have to consider medical monitoring costs beyond those that are recommended for the general public and would have to divert limited medical resources from persons with more serious injuries); Paz v. Brush Engineered Materials, Inc. , 949 So.2d 1, 8 (Miss. 2007) (the “potential floodgate of trivial litigation and the resultant delay and decrease in remedy for those with manifested illnesses as well as the extra burden on consumers resultant from virtually unlimited liability” were deciding factors for the court in rejecting plaintiff's medical monitoring claim) (quoting Buckley, 521 U.S. at 426-27). In Paz, the court was unwilling to depart from the traditional elements of tort actions, particularly the requirement to prove an identifiable injury. 949 So.2d at 5-6.

Similarly, in Curl v. Am. Multimedia, Inc. , 654 S.E.2d 76, 81 (N.C. App. Ct. 2007), the court refused to create a cause of action for medical monitoring without proof of a present physical injury due to the numerous policy-related issues involved, including humanitarian, environmental and economic factors. The court concluded that the legislature, not the courts, was in a better position to weigh such factors and determine whether to create a new cause of action for medical monitoring. Id.

Is Class Certification

Allowed?

Until relatively recently, courts disfavored class action status for medical monitoring claims for the reasons set forth by the U.S. Supreme Court in Amchem Prods. v. Windsor, 521 U.S. 591, 624 (1997) (denying claims of “exposure only” asbestos plaintiffs):

[Exposure-only plaintiffs share] little in common, either with each other or with the presently injured class members. It is unclear whether they will contract asbestos-related disease and, if so, what disease each will suffer. They will also incur different medical expenses because their monitoring and treatment will depend on singular circumstances and individual medical histories.

See also Barnes v. Am. Tobacco Co. , 161 F.3d 127 (3d Cir. 1998) (denying class certification in tobacco exposure case).

Plaintiffs, however, have recently increased their efforts to obtain class certification status for “exposure only” medical monitoring claims, and in several cases they have prevailed. For example, in Meyer ex rel. Coplin v. Fluor Corp. , 220 S.W.3d 712, 717-18 (Mo. 2007), the Missouri Supreme Court found there was ample support to certify a class of more than 200 children exposed to lead and other toxins from a lead smelter, because common questions predominated over individual questions even where plaintiffs did not exhibit present physical injuries. Indeed, plaintiffs' exposure to toxins from a single source was the common and overriding issue in the case. Id. at 719. The court found that the trial court relied too heavily on the present physical injury requirement. Such a requirement “is inconsistent with the reality of latent injury and with the fact that the purpose of medical monitoring is to facilitate the early diagnosis and treatment of latent injuries caused by exposure to toxins. In short, a physical injury requirement essentially extinguishes the claim and bars the plaintiff from a full recovery.” Id. at 718. A plaintiff must, however, demonstrate a “significantly increased risk of contracting a particular disease relative to what would be the case in the absence of exposure.” Further, a plaintiff must show that “medical monitoring is, to a reasonable degree of medical certainty, necessary in order to diagnose properly the warning signs of disease.” Id. See also Gates, supra, 2007 WL 2155665 (applying Illinois law) (allowing medical monitoring class of town residents exposed to contaminated drinking water).

On the other hand, defendants have successfully challenged class certification and convinced courts to disallow medical monitoring awards absent a “present injury.” In Norwood v. Raytheon Co. , 414 F. Supp.2d 659 (W.D. Tex. 2006), the U.S. District Court for the Western District of Texas refused to certify a medical surveillance class of former military personnel who worked near radar systems, predicting that the Texas Supreme Court would not recognize a cause of action for medical monitoring. The court dismissed plaintiffs' medical monitoring claims reasoning that judges and juries would have difficulty evaluating such claims due to their variability, inconsistency, and unpredictability. Id. at 664. See also In re Welding Fume Prods Liab. Litig., 245 F.R.D. 279 (N.D. Oh. 2007) (denying welders' motion for class certification of medical monitoring claims under eight different state laws ' Arizona, California, Florida, New Jersey, Ohio, Pennsylvania, Utah, and West Virginia); In re St. Jude Medical, Inc., 425 F.3d 1116 (8th Cir. 2005) (reversing class certification for medical monitoring, finding that each plaintiff's need for medical monitoring was highly individualized and that states recognizing medical monitoring as a cause of action have different elements triggering liability).

In the context of pharmaceutical drug litigation, federal and state courts have repeatedly refused to grant class certification status to plaintiffs based on the individualized proof required for such claims. See, e.g., In re Vioxx Prods. Liab. Litig., 239 F.R.D. 450 (E.D. La. 2006); In re Prempro Prods. Liab. Litig., 230 F.R.D. 555 (E.D. Ark. 2005); In re Baycol Prods. Litig., 218 F.R.D. 197 (D. Minn. 2003); In re Paxil Litig., 212 F.R.D. 539 (C.D. Cal. 2003). In Wyeth, Inc. v. Gottlieb, 930 So.2d 635, 643 (Fla. Dist. Ct. App. 2006), a Florida appeals court found that plaintiffs failed to show that medical monitoring would involve common questions of fact. For instance, a plaintiffs' expert testified that Prempro was a hazardous substance only if prescribed for cardiovascular purposes, which is not an FDA-approved use. Gottlieb, however, was prescribed Prempro to prevent osteoporosis. Further, plaintiffs' expert acknowledged that claims regarding an increased risk of breast cancer or heart disease were better addressed individually. Moreover, physicians prescribed class members the drug at different times over a period of 10 years. The court concluded that plaintiffs could not establish defendant's knowledge by common proof. Thus, the trial court erred in granting class certification.

Recently, the U.S. District Court for the Southern District of New York, in In re Fosamax Prods. Liab. Litig., 2008 WL 58890 (S.D.N.Y. Jan. 3, 2008), refused to certify a class of Pennsylvania, Florida, and Louisiana Fosamax users who have not been diagnosed with the “signature disease” (osteonecrosis of the jaw), but who claimed they were at increased risk of developing the condition in the future. Plaintiffs reasoned that the rarity of developing osteonecrosis of the jaw, coupled with the limited potential causes of the disease, militated strongly in favor of class relief. The court rejected plaintiffs' reasoning, concluding that the medical monitoring claims failed to meet the typicality requirement of Rule 23(a)(3) as a determination of each claim would require “inherently individualized” proof. Id. at *10. “[C]lass membership is not feasibly ascertainable where it hinges on myriad medical factors individual to each class member.” Id. at *8. In a similar vein, the court found that plaintiffs failed to meet the predominance and superiority requirements of Rule 23(b)(3). Id. at *13. The court held that many individual questions of fact and law rendered class treatment inappropriate. In the final analysis, the court stressed that “[t]he proposed class actions call for an extraordinary intrusion into the FDA's regulatory mandate, even while many of the scientific community believe that more research is needed.” Thus, given that the condition is a recent phenomenon, the court preferred the more prudent case-by-case approach rather than “leading the scientific community in an area of medical science,” which was something the Southern District of New York was reluctant to do. Id. at *14 (citing In re Propulsid Prods. Liab. Litig., 208 F.R.D. 133, 147 (E.D. La. 2002)).

Conclusion

Although state and federal courts continue to tackle issues related to medical monitoring claims, there remains a panoply of approaches taken to the claim. Due to the lack of uniformity and guidance among the courts, to the extent that plaintiffs continue to assert medical monitoring claims, defendants should carefully research and analyze the appropriate jurisdiction's common law. A first line of attack remains that the claims fail for lack of a present physical injury and, where class certification is sought, that individualized proof would be required to determine such claims, thus rendering class certification inappropriate.


Vivian M. Quinn, a member of this newsletter's Board of Editors, is a partner and Tracey B. Ehlers is an associate in Nixon Peabody LLP's Products Liability Group. Their practices involve the health effects of food, chemical, and medical products, and they devote a significant amount of time to defending medical device and pharmaceutical companies as well as counseling clients regarding safety and regulatory compliance.

This premium content is locked for Entertainment Law & Finance subscribers only

  • Stay current on the latest information, rulings, regulations, and trends
  • Includes practical, must-have information on copyrights, royalties, AI, and more
  • Tap into expert guidance from top entertainment lawyers and experts

For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473

Read These Next
COVID-19 and Lease Negotiations: Early Termination Provisions Image

During the COVID-19 pandemic, some tenants were able to negotiate termination agreements with their landlords. But even though a landlord may agree to terminate a lease to regain control of a defaulting tenant's space without costly and lengthy litigation, typically a defaulting tenant that otherwise has no contractual right to terminate its lease will be in a much weaker bargaining position with respect to the conditions for termination.

How Secure Is the AI System Your Law Firm Is Using? Image

What Law Firms Need to Know Before Trusting AI Systems with Confidential Information In a profession where confidentiality is paramount, failing to address AI security concerns could have disastrous consequences. It is vital that law firms and those in related industries ask the right questions about AI security to protect their clients and their reputation.

Generative AI and the 2024 Elections: Risks, Realities, and Lessons for Businesses Image

GenAI's ability to produce highly sophisticated and convincing content at a fraction of the previous cost has raised fears that it could amplify misinformation. The dissemination of fake audio, images and text could reshape how voters perceive candidates and parties. Businesses, too, face challenges in managing their reputations and navigating this new terrain of manipulated content.

Authentic Communications Today Increase Success for Value-Driven Clients Image

As the relationship between in-house and outside counsel continues to evolve, lawyers must continue to foster a client-first mindset, offer business-focused solutions, and embrace technology that helps deliver work faster and more efficiently.

Pleading Importation: ITC Decisions Highlight Need for Adequate Evidentiary Support Image

The International Trade Commission is empowered to block the importation into the United States of products that infringe U.S. intellectual property rights, In the past, the ITC generally instituted investigations without questioning the importation allegations in the complaint, however in several recent cases, the ITC declined to institute an investigation as to certain proposed respondents due to inadequate pleading of importation.