8th Circuit Decertifies Medical Monitoring Class in Device Case

The Eight Circuit’s recent decision, In re: St. Jude Medical, Inc., Silzone Heart Valve Products Liability Litigation, No. 06-3860, 2008 WL 942274 (8th Cir. April 9, 2008), offers a number of potential lessons for mass tort defendants, and not just those in the medical device arena. (As always at MassTortDefense, we try to cross-pollinate from industry to industry and mass tort to mass tort those theories, rulings, etc. that can potentially assist a broad range of defendants.) So many lessons, in fact, that one posting can’t do them all justice. So let’s break it down into some sub-parts and see if we can’t gain some insights.

Today’s focus is medical monitoring, which of course is near and dear to MassTortDefense ever since having tried to a defense verdict a medical monitoring class action in West Virginia a few years back.

Some Background

As readers may know, before the 8th Circuit decertified a class of an estimated 11,000 plaintiffs who received one of St. Jude Medical Inc.’s allegedly defective Silzone heart valves, the case had a bit of an up and down history. The district court originally certified two subclasses of plaintiffs seeking damages and injunctive relief, respectively. Then in In re St. Jude Med., Inc., 425 F.3d 1116 (8th Cir. 2005), the appeals court reversed the district court’s certification of a subclass of plaintiffs seeking injunctive relief, which was described as a “medical monitoring class,” because the class presented “a myriad of individual issues making class certification improper.” Id. at 1122.

With respect to the subclass seeking damages and described as a “consumer protection class,” the 8th Circuit held that the district court should have conducted a more thorough choice-of-law analysis before it determined to apply Minnesota law to the claim of every plaintiff. Id. at 1121. It remanded the case to the district court for further consideration. On remand, the district court determined that Minnesota law should apply to all claims in the nationwide class, and recertified the consumer protection class pursuant to Federal Rule of Civil Procedure 23(b)(3). In re St. Jude Medical, Inc., No. 01-1396, 2006 WL 2943154 (D. Minn. 2006). St. Jude’s appeal of this certification of the class led to the April decision we discuss here.

Medical Monitoring

Among the individual issues that would predominate over so-called common questions were several related to the "highly individualized remedy of medical monitoring.” 2008 WL 942274 at *4. Medical monitoring, generally defined, is periodic testing and/or examination to facilitate the diagnosis and treatment of a latent disease by early detection. It is not the diagnostic testing that accompanies symptoms, but rather testing of seemingly healthy, asymptomatic persons who have been exposed to a potentially harmful substance and are at risk of future disease or injury.

Medical monitoring is almost always seen as a potential class action claim, for several reasons:

  • First, the individual damages associated with periodic testing of a so-far healthy plaintiff may not be all that financially attractive to plaintiff attorneys.
  • Secondly, a number of the elements of the claim (or remedy) of medical monitoring seem, on the surface, amenable to “common” proof in the form of epidemiological evidence. For example, the increased risk that typically must be shown.



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.

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