Trial Magazine

When handling cases involving dangerous and defective medical devices, some of your clients may not have had their devices removed and may need medical monitoring due to the device’s potential to cause serious injury. A medical monitoring claim that establishes a specific protocol—including periodic health screenings, research on the devices at issue, and diagnostic tests that can determine whether people exposed to the product may be developing early signs of injury or disease before they begin to demonstrate clinical evidence of disease¹—might be an option to pursue for your client. 

For example, a client who has a metal-on-metal hip implant may already have elevated cobalt levels in his or her blood before a doctor recommends that the device be removed. In instances such as this one, you may want to file a medical monitoring claim. Depending on whether your state recognizes such claims, the theory of liability is that the defendant’s wrongful conduct caused the plaintiff’s prolonged and continuous exposure to harmful or toxic substances—and that early detection will minimize the plaintiff’s now increased risk for disease.² But before you jump in, is such a claim viable? And can you clear class certification hurdles?

The predecessors to medical monitoring claims largely came from class action plaintiffs who sought redress for exposure to harmful chemicals in certain environmental disasters of the late 1970s and early 1980s, including the Agent Orange products liability ­multidistrict litigation (MDL) and the Three Mile Island litigation.³ By the mid-1980s, medical monitoring claims gained footing beyond the environmental context: In Friends for All Children Inc. v. Lockheed Aircraft Corp., a court affirmed that airline passengers injured during a crash were entitled to medical monitoring for potential brain injuries.⁴

Factors to Consider

Pursuing these claims in device litigation will depend on a careful analysis. Factors include

• the number of plaintiffs injured
• whether they have been injured by the same device
• whether their injuries are the same
• whether the state law in your client’s jurisdiction allows medical monitoring claims
• where to bring the claim 
• whether Federal Rule of Civil Procedure 23’s class certification requirements can be met. 

What does state law allow? First, research the law of the jurisdiction in which you intend to file.⁵ Currently, eight states and the District of Columbia allow medical monitoring claims.⁶ If a state does not recognize medical monitoring as its own claim, you may be able to secure medical monitoring relief for your client as a form of damages. For example, in a negligence claim, you can make a request for future damages in the form of payment for medical monitoring.⁷

The most challenging of these prerequisites for medical monitoring claims is the typicality prong.

Class certification hurdles. Federal Rule of Civil Procedure 23(a)(1)-(4) requires that the class be so numerous that joinder of all members is impracticable, that questions of law and fact are common to the class, that the claims or defenses are typical, and that the ­representatives adequately protect the interests of the class. The most challenging of these prerequisites for medical monitoring claims is the typicality prong—when the court analyzes whether each class member’s claims are truly typical or whether they involve too many distinct factual or legal questions to make class certification appropriate. 

Consider recent ­metal-on-metal hip cases involving plaintiffs who allege exposure to toxic metal ions that lead to complications such as infection, pain and swelling at the implant site, or necrosis.⁸ Detecting and monitoring the presence of heavy metals in the device recipients’ bloodstreams is beneficial—early detection of metal poisoning can lead to better outcomes, such as earlier revision surgery and lower levels of metal ions. 

But while it may seem like a claim for monitoring is sensible, you must first determine whether all the plaintiffs in the proposed class have the same device, whether different affirmative defenses apply solely to individuals as opposed to the class, and whether the plaintiffs’ exposures to the device and potential injuries are sufficiently identical. For example, some individual plaintiffs may be subject to a specific statute of limitations or a comparative negligence defense that does not apply to the class as a whole. 

Assuming you have satisfied Rule 23(a), you then also must meet the requirements of either Rule 23(b)(2) or (b)(3). Rule 23(b)(2) provides for injunctive relief, such as an injunction compelling the implementation of a ­defendant-funded monitoring protocol. Under Rule 23(b)(3), plaintiffs may seek compensatory damages, but they first must prove that common issues and facts not only exist among the proposed class but also predominate over individual ones.

Lessons Learned

Recent precedent shows that certifying a national (as opposed to a state) monitoring class is an uphill battle, but examples of successful and unsuccessful medical monitoring claims provide a valuable blueprint for attorneys. 

IVC filter MDL. In the IVC filter MDL, the court denied class certification of plaintiff classes from the states that recognize medical monitoring claims.⁹ The court held that the predominance and commonality requirements of Rule 23(b)(3) were not satisfied.¹⁰ It concluded that the plaintiffs’ proposed class encompassed seven different types of Bard filters; spanned more than a 10-year period; and involved devices with design, manufacturing, and testing differences.¹¹ The court also noted that class members would be subject to particularized affirmative defenses, such as comparative negligence and assumption of the risk.¹² Nor did the proposed class satisfy Rule 23(b)(2).¹³

Donovan v. Philip Morris. A federal court in Massachusetts certified a class of plaintiffs’ medical monitoring claims in Donovan v. Philip Morris USA, Inc. The class was highly specific—Massachusetts residents who are 50 and older, with a 20-year history of smoking Marlboro cigarettes—and the complaint asserted a breach of warranty claim against Philip Morris.¹⁴ The plaintiffs sought a court-administered medical monitoring program so that they could receive lung-cancer screenings.¹⁵

The district court denied the defendant’s motion for decertification under Rule 23(b)(2), explaining that the proposed relief was a structured program monitored by staffed medical personnel in which class members would receive regular screenings, not a direct payment of the plaintiffs’ medical expenses.¹⁶ The program required the defendant to hire medical personnel, buy equipment, and establish specific monitoring procedures.¹⁷

Unlike the proposed class in the IVC filter litigation—which comprised residents of 11 different states—the Donovan plaintiffs are all Massachusetts residents seeking certification of a single class under one state’s laws. The proposed remedy in Donovan was an entire monitoring protocol supervised by the court  and conducted by outside medical personnel. 

These cases illustrate that focusing on plaintiffs within one state as opposed to a national class comprising plaintiffs from several states in federal court may be a better route. The difficulty of satisfying Rule 23(a) and 23(b) are profound, and state courts—and juries—may be more reluctant to preclude the residents of their own state from pursuing a medical monitoring remedy when that state’s laws allow a separate claim for such relief. 

For example, the Supreme Court of West Virginia reversed a lower court decision and certified a class of West Virginia plaintiffs seeking medical monitoring in connection with Rezulin, an anti-diabetic drug.¹⁸ A Pennsylvania state court similarly certified a medical monitoring class of Pennsylvania residents who alleged that their use of the prescription cholesterol drug Baycol put them at risk of injuries such as kidney failure and end-stage renal disease, but the District Court of Minnesota denied certification of a national class.¹⁹

Ideally, the most viable medical monitoring claims will have a narrow set of facts and a focused set of plaintiffs under identical or similar state law:  

• one defective device at issue
• one type of exposure
• one type of long-term effect
• one type of screening for all plaintiffs
• a failure-to-warn or implied breach of warranty claim—as opposed to negligence—to minimize individual defenses
• a state court claim involving one state law or a federal class involving residents of one state. 

If attempting to certify a class under Rule 23(b)(2), consider injunctive relief like the Donovan plaintiffs, rather than asking for a court-administered trust fund to pay for the medical monitoring. And always remember to be cognizant of how medical monitoring claims could affect personal injury cases involving the same device. You must weigh all of these factors carefully.

M. Elizabeth (“Beth”) Graham is a director at Grant & Eisenhofer in Wilmington, Del., and San Francisco. Stephanie S. Riley is an associate at Grant & Eisenhofer in Wilmington. They can be reached at egraham@gelaw.com and sriley@gelaw.com.

Notes

1. Manual for Complex Litigation §22.74 (4th ed. 2016). 
2. Id. 
3. In re Agent Orange Prod. Liab. Litig., 818 F.2d 145 (2d Cir. 1987); In re Three Mile Island Litig., 557 F. Supp. 96 (M.D. Pa. 1982). 
4. 746 F.2d 816 (D.C. Cir. 1984).
5. The authors’ research into the law in all 50 states is restricted to online published opinions. The interpretation of the status of medical monitoring claims in each state is complicated. 
6. The eight states are Arizona, Florida, Massachusetts, New Jersey, Ohio, Pennsylvania, Utah, and West Virginia. Burns v. Jaquays Mining Corp., 752 P.2d 28, 33 (Ariz. Ct. App. 1987); Petito v. A.H. Robins Co., Inc., 750 So. 2d 103, 106–07 (Fla. Dist. Ct. App. 1999); Donovan v. Philip Morris USA, Inc., 914 N.E.2d 891, 900–01 (Mass. 2009); see also Genereux v. Hardric Labs., Inc., 950 F. Supp. 2d 329, 339 (D. Mass. 2013) (discussing “the elements of a cause of action for medical monitoring” (emphasis added)); Ayers v. Twp of Jackson., 525 A.2d 287, 312–13 (N.J. 1987); Day v. NLO, 851 F. Supp. 869, 880-81 (S.D. Ohio 1994); Redland Soccer Club, Inc. v. Dep’t of the Army and Dep’t of Def. of the United States, 696 A.2d 137, 145–46 (Penn. 1997); Hansen v. Mountain Fuel Supply Co., 858 P.2d 970, 979 (Utah 1993); Bower v. Westinghouse Elec. Corp., 522 S.E.2d 424 432–33 (W. Va. 1999).
7. See Potter v. Firestone Tire & Rubber Co., 863 P.2d 795, 824 (Cal. 1993) see Lockheed Martin Corp. v. Super. Ct. of San Bernardino Cnty., 63 P.3d 913 (Cal. 2003); Mehr v. Fedération Internationale de Football Ass’n, 115 F. Supp. 3d 1035 (N.D. Cal. 2015) (rejecting plaintiffs’ argument that they can assert a stand-alone cause of action for medical monitoring under California law); Burton v. R.J. Reynolds Tobacco Co., 884 F. Supp. 1515, 1523 (D. Kan. 1995); Sadler v. PacifiCare of Nev., Inc., 340 P.3d 1264, 1270 (Nev. 2014); Exxon Mobil Corp. v. Ford, 71 A.3d 105, 132 (Md. 2013); Bryson v. Pillsbury Co., 573 N.W.2d 718, 721 (Minn. Ct. App. 1998); Meyer v. Fluor Corp., 220 S.W.3d 712, 717–18 (Mo. 2007); Baker v. Saint-Gobain Performance Plastics Corp., 232 F. Supp. 3d 233, 250 (N.D.N.Y. 2017); Stead v. F.E. Meyers Co., 785 F. Supp. 56, 57 (D. Vt. 1990); Duncan v. Nw. Airlines, Inc., 203 F.R.D. 601, 606 (W.D. Wash. 2001).
8. See In re Stryker LFIT v40 Femoral Head Prods. Liab. Litig., No.1:17-md-02768-IT, MDL No. 2768 (D. Mass. Jan. 19, 2017). 
9. Barraza v. C.R. Bard Inc., 322 F.R.D. 369, 393 (D. Ariz. 2017).
10. Id. at 383–84.
11. Id. at 377–78.
12. Id. at 379–81.
13. Id. at 386. Although the plaintiffs sought an order compelling the establishment of a court-supervised and court-administered fund to pay for doctor visits for CT scans, the court found that this relief was not truly injunctive.
14. Donovan v. Philip Morris USA, Inc., 2012 WL 957633, at * 1 (D. Mass. Mar. 21, 2012).
15. Id. 
16. Id. at *6, *8.
17. Id. 
18. Compare In re W. Va. Rezulin Litig., 585 S.E.2d 52 (2003) with In re Rezulin Prods. Liab. Litig., 210 F.R.D. 61 (S.D.N.Y. 2002). The Southern District of New York denied certification of a national plaintiff class seeking relief based on the ingestion of the same drug.
19. Compare In re Baycol Prods. Litig., 218 F.R.D. 197 (D. Minn. 2003) with Lewis v. Bayer AG, 2004 WL 1146692 (Pa. Ct. Com. Pl. Nov. 18, 2004).