Plaintiffs’ attempts to certify medical monitoring classes have come under both Rule 23 (b)(2) and (b)(3). The 23(b)(2) claim typically alleges that the defendant has acted on grounds generally applicable to the class (for example, making a defective product or failing to warn of its hazards) and that injunctive relief for the class is appropriate in the form of a requirement that the defendant provide medical monitoring for the class. Claimants seeking certification under Rule 23(b)(2) often seek a court-established monitoring program, alleging it to be a claim for injunctive relief (see In re Sulzer HipProsthesis and Knee Prosthesis Liab. Litig., 455 F.Supp.2d 709 (N.D. Ohio 2006) ). Such a claim, however, may simply be an artful pleading of a simple pass-through mechanism in which claimants seek monetary damages for the payment of medical test bills for class members: essentially, a suit for damages. Thomas v FAG Bearings Corp., 846 F. Supp. 1400 ( W.D. Mo. 1994 ). The 23(b)(3) claim typically asserts that the defendant’s conduct, the significant exposure of class members, the hazardous nature of the product in question and the increased risk of future disease each class member faces, are common issues that predominate over any questions affecting only individual class members.

The 8th Circuit previously rejected certification of a medical monitoring class under Rule 23 (b)(2), saying in its 2005 opinion that whether an individual plaintiff will require additional monitoring “is an individualized inquiry depending on that patient’s medical history, the condition of the patient’s heart valves at the time of implantation, the patient’s risk factors for heart valve complications, the patient’s general health, the patient’s personal choice, and other factors.” Now, even if one assumed Minnesota law would apply to all the claims, the need for these detailed and individual factual inquires concerning the appropriate remedy weighed against a (b)(3) class certification as well. 2008 WL 942274 at *4-5.

This language is useful for defendants opposing (b)(2) or (b)(3) medical monitoring putative classes. While plaintiff’s proposed medical monitoring plan is typically a one-size fits all program, and hence seemingly a common issue, the court noted as a potential individual issue what the appropriate monitoring may be — turning, as it does, on the class member’s medical history, condition, risk factors for complications, and general health. The court also noted that a class member who had been implanted with the device might already require future medical monitoring – some type of periodic follow-up medical checks – as an ordinary part of his or her follow-up care.

Whenever this is the case, plaintiffs will stumble on the typical medical monitoring element that the testing being sought would not be done as part of the ordinary standard of medical care. Often called the “over and above” element, most courts that have adopted some form of medical monitoring require that the testing that defendant is being asked to pay for is something that is needed because of the harmful exposure to the defendant’s product, and not something that plaintiff needed and would or should have gotten even in the absence of exposure to defendant’s product. Very often, whether the recipient of an implant, the taker of a prescription drug, the user of a consumer product, might or would or should have undergone the same periodic medical testing is provable, and at the least, is an individual inquiry that depends on the specific facts concerning each putative class member.

Same Notion Seen in HRT

This notion was also explored in Wyeth, Inc. v. Gottlieb, 930 So.2d 635 (Fla. 3d Dist. Ct. App. 2006),
review denied, 950 So.2d 413 (Fla. 2007). The Florida appellate court reversed the decision of the state trial court to certify a state-wide medical monitoring class of about 300,000 women who took Prempro. The court saw the proposed monitoring plan for the HRT class as nearly the same medical testing recommended for all post-menopausal women. A person seeking medical monitoring must show that, given her own unique medical and other exposure history, the exposure caused by the defendants significantly increased her risk and necessitated the monitoring recommended for her. The HRT schemes proposed by plaintiffs are not programs for at risk Prempro users, but for any woman who had any breast cancer risk factor, including age, family history, weight or alcohol use. As a jury issue, the over and above notion has worked well for the tobacco industry, which has been subjected to multiple putative class actions seeking medical monitoring.

Medical monitoring remains a potential threat. While the Mississippi Supreme Court rejected medical monitoring in Paz v. Brush Engineered Materials, Inc., 949 So.2d 1 (Miss. 2007), the Missouri Supreme Court recognized a medical monitoring remedy in Meyer ex rel. Coplin v. Fluor Corp., 220 S.W.3d 712 (Mo. 2007). And the American Law Institute (ALI) has released a “Council Draft” of a Restatement (Third) Torts: Economic Torts and Related Wrongs, which would recognize a “limited” form of medical monitoring claim. Clear and careful analysis like that of Judge Colloton and the 8th Circuit panel is useful in responding to the threat.