ORDER DENYING PLAINTIFFS’ MOTION FOR CLASS CERTIFICATION
THIS CAUSE is before the Court on Plaintiffs’ Motion for Class Certification, filed June 23, 2003 [DE #60], The Court has considered Plaintiffs’ Motion and Reply, Defendant’s Memorandum in Opposition to the Motion for Class Certification, Defendant’s Supplemental Affidavit of Edward Sherman, and Plaintiffs’ Reply to Dr. Sherman’s Affidavit. In addition, the Court held oral argument on Plaintiffs’ Motion on September 9, 2003. Upon consideration of these memoranda and the oral argument, the Court is persuaded that this case is not appropriate for resolution on a class basis and denies the Motion for Class Certification.
This case, originally filed in the Florida Eleventh Judicial Circuit Court, was removed to this Court on September 25, 2002. On January 31, 2003, Plaintiffs filed their First Amended Class Representation Complaint (“Complaint”), naming eight representative Plaintiffs, six of whom presently remain as named Plaintiffs: Franeella Perez, Elizabeth Cepero, Jeanette Cepero, William Burney, Beth Milstein Bouggarne, and Patricia Berni.
In them one-count Complaint, Plaintiffs request injunctive and equitable relief, primarily in the form of a medical monitoring program funded by the Defendant, but also including injunctive relief requiring Defendant to finance and undertake various forms of research, data collection, and educational outreach on potential long-term medical effects of Metabolife 356 usage. Id. at pp. 20-21. Plaintiffs do not allege a specific present injury, but rather indicate medical monitoring is necessary in order to detect, at an early stage while prevention is still possible, future injuries resulting from their use of Metabolife 356. Although the Complaint in-eludes few facts about each named Plaintiffs medical condition, history of usage of the product, or knowledge of the warnings, Defendant has deposed the named Plaintiffs and filed excerpts of the deposition transcripts, in addition to a summary of those excerpts. Defendant’s Opposition to Class Certification, Ex. 4-9, 11.
Franeella Perez is a 24-year-old woman who took two Metabolife 356 pills twice a day for a little over a month in about October 2000, and experienced some rapid heartbeats and possible hand shaking while taking the pills. She has not reported any symptoms since discontinuing her use of the product. Defendant’s Opposition, Ex. 4.
Jeanette Cepero, also 24 years old, used Metabolife for possibly as long as a year starting in February 1999, taking one pill three times a day. She has a family history that includes liver diseases, heart problems, and migraines, has a personal history of dizzy spells, panic attacks, and heart palpitations that have required consultation with a cardiologist, suffers from Crohn’s disease, and had taken Fen-Phen, another diet drug, prior to Metabolife. She reports suffering panic attacks and nausea while taking Metabolife and heart palpitations since discontinuing use. Defendant’s Opposition, Ex. 5.
William Burney is a 56-year-old man who took a total of only four Metabolife pills, two in the morning and two in the afternoon of August 13, 2002. He suffered an atrial fibrillation two days later requiring hospitalization for a period of more than three days. Mr. Burney has a family history of heart disease, colon cancer, and diabetes, has a medical history of hypertension, fatigue problems, and prostate cancer, had a prescription for an inhaler and diuretics, and had been told by his doctor that his medical and family history, combined with excessive weight, put him at risk for a number of serious medical problems. Defendant’s Opposition, Ex. 6.
Beth Milstein Bouggarne is 35 years old and took two Metabolife 356 pills three times a day for about a year-and-a-half starting in April 2000, stopping after hearing about pos
Patricia Berni is a 46-year-old woman who took two Metabolife pills three times a day for over two years beginning in January 1999 without suffering any adverse effects until March 2001, when she states that she began to suffer gastritis, headaches, and problems with nervousness, which was also the same time that she and her husband had to close their business due to financial difficulties. Some of these symptoms have continued after she stopped taking the pills, and she states that some events trigger tachycardia, that she has suffered hair loss, and that she can no longer eat certain foods. Defendant’s Opposition, Ex. 8.
Elizabeth Cepero, whose age is not specified but who is described as an “older woman” by Defendant, took one pill three times a day for three months in mid-1999, occasionally taking a fourth pill in the morning. She reports having felt jittery while taking the pills, having trouble falling asleep, and developing palpitations, anxiety, shortness of breath, and headaches on occasion. She continued to suffer milder palpitations after discontinuing use and currently suffers from depression. Her cardiologist indicated she should get a check up once a year for her tachycardia. Defendant’s Opposition, Ex. 9.
The Defendant’s summary of the deposition transcripts also points out the varying degrees to which the named plaintiffs read, understood, and heeded the product warning labels. That summary also notes that none of these Plaintiffs’ treating physicians have told any of them that they need medical monitoring due to their Metabolife 356 consumption or that Metabolife 356 was responsible for the symptoms or disorders they report. Defendant’s Opposition, Ex. 11.
Statement of the Case
Plaintiffs’ Complaint seeks recovery for medical monitoring, a cause of action recognized in Florida even absent a physical injury. See Petito v. A.H. Robins Co.,
(1) exposure greater than normal background levels; (2) to a proven hazardous substance; (3) caused by the defendant’s negligence; (4) as a proximate result of the exposure, plaintiff has a significantly increased risk of contracting a serious latent disease; (5) a monitoring process exists that makes the early detection of the disease possible; (6) the prescribed monitoring regime is different from that normally recommended in the absence of the exposure; and (7) the prescribed monitoring regime is reasonably necessary according to contemporary scientific principles.
Id. at 106-07. In that case, the court created and supervised a -fund to be financed by the defendant to pay for the costs of a medical monitoring program which would be available to all class members. Id. at 107-08.
Plaintiffs here seek certification of a class with the six named Plaintiffs described above acting as representative class members and the law firm of John H. Ruiz, P.A., acting as class counsel. Plaintiffs offer two classes that they purport to represent: “(1) All persons in the State of Florida who ingested Metabolife 356 at the dosage levels recommended by the Defendant” and “(2) All persons residing in States within the United States that recognize a cause of action for medical monitoring who ingested Metabolife 356 at the dosage levels recommended by the Defendant.” Plaintiffs’ Motion for Class Certification at 5.
In order to state a claim that is appropriate for class treatment, the Federal Rules of Civil Procedure require that the suit meet four prerequisites, commonly referred to as numerosity, commonality, typicality, and adequacy of representation. Piazza v. EBSCO Industries, Inc.,
One or more members of a class may sue on behalf of all only if (1) the class is so numerous that joinder of all members is*266 impracticable, (2) there are questions of law or fact common to the class, (3) the claims and defenses of the representative parties are typical of the claims or defenses of the class, and (4) the representative parties will fairly and adequately protect the interests of the class.
Fed. R. Civ. Pro. 23(a).
To be certified as a class action, the case must then also meet one of three additional requirements. Fed. R. Civ. Pro. 23(b). Rule 23(b)(1) permits class treatment when “the prosecution of separate actions would create a risk of ... inconsistent or varying adjudications ... which would establish incompatible standards of conduct for the party opposing the class.” Fed. R. Civ. Pro. 23(b)(1)(A). Alternatively, a class can be certified when injunctive relief or declaratory judgment is sought and the defendant has “acted or refused to act on grounds generally applicable to the class.” Fed. R. Civ. Pro. 23(b)(2). Finally, a class action is sustainable when “the court finds that the questions of law or fact common to the members of the class predominate over any questions affecting only individual members, and that a class action is superior to other available methods for the fair and efficient adjudication of the controversy.” Fed. R. Civ. Pro. 23(b)(3).
Plaintiffs claim that each of the four Rule 23(a) prerequisites for class certification has been met in this case. Plaintiffs further argue that any of the three Rule 23(b) requirements would provide grounds for class certification. Defendant, on the other hand, contends that the class is inadequately defined and that the class members are not clearly ascertainable. Further, Defendant contests the Plaintiffs’ claim that this case involves sufficient common issues to warrant class treatment, argues that the named Plaintiffs do not have standing to bring this action, and denies that these Plaintiffs can satisfy the typicality prerequisite or any of the Rule 23(b) requirements.
Analysis
While the idea of class treatment of these claims has some initial appeal, a closer analysis makes clear that the inability to precisely define the class, the individual differences among named Plaintiffs and unnamed class members, the difficulty of applying varying and unsettled legal principles in multiple states, and the danger of foreclosing unnamed class members from suing for individual damages in the future all mitigate against adjudicating these claims in a class action. The appeal of hearing expert opinion on the alleged dangers of Metabolife 356 and deciding the medical merits of these claims in one, consolidated hearing is thus far outweighed by the difficulty of determining causation for the variety of disorders and injuries allegedly caused by Metabolife 356 ingestion and by the inefficiencies and potential inequities that would result from class treatment.
I. Class Definition
The first step in determining whether a class should be certified is to decide whether the Plaintiffs have identified a class that exists and that can be precisely defined. See Simer v. Rios,
The Plaintiffs here have provided definitions for two classes they seek to certify, which essentially include all Metabolife 356 users in Florida and all Metabolife users in other states where medical monitoring is recognized as a cause of action. At oral argument, possible modifications to these definitions were discussed, but, even when modified, neither class definition is sufficiently precise and determinable to identify the appropriate class members. Both are overly broad and would require individualized determinations as to who are class members. The failure of Plaintiffs to adequately define
A. Class Including States Other than Florida
Including class members from states other than Florida appears particularly problematic due to differences and uncertainties in the law. Plaintiffs have filed a chart that discusses the status of medical monitoring claims in all fifty states. See Plaintiffs’ Motion, Ex. E. A handful of states have rejected the claim completely, another minority have recognized it as an independent cause of action, others allow it only as an element of damages when the plaintiff has sustained a physical injury, and the vast majority have not yet addressed the question. Although it was not entirely clear from Plaintiffs’ briefs which states were intended to be included in the category of states “that recognize a cause of action for medical monitoring,” Plaintiffs’ counsel represented at oral argument that the class definition should be restricted only to those four states that explicitly recognize medical monitoring as a separate cause of action even in the absence of a physical injury, specifically, Florida, Pennsylvania, Colorado, and Illinois.
Even with this more limited definition of the class, the Court would be required to create subclasses and apply state law to cases arising in each of those four states. This would be a particularly difficult task where, as here, the law in at least two of these jurisdictions is not well settled. In both Colorado and Illinois, rather than citing authoritative state cases defining a cause of action for medical monitoring, the Plaintiffs’ chart cites two federal cases where the judge predicted, in the absence of any state deeisions, that those states’ supreme courts would permit a separate cause of action for medical monitoring; in both cases, however, the court then denied the requested medical monitoring on other grounds. See Carey v. Kerr-McGee Chemical Corp.,
Moreover, as Defendant noted at oral argument, if the Court were to extend the class even just to the one or two other states where state courts have explicitly defined the medical monitoring cause of action, none of these named plaintiffs would be sufficiently representative. “It is well-settled that prior to the certification of a class ... the district court must determine that at least one
B. Minimum Daily Dosage and Duration of Usage
Moreover, Plaintiffs’ class definition for both Florida and out-of-state class members is deficient in that it contains no limitation as to dosage or duration of ingestion, and individualized hearings or trials would thus be required just on class membership issues. Plaintiffs claim that the dosage when defined as “the levels recommended by the Defendant” is sufficiently precise to make identification of the class members possible. However, the “recommended levels” include a wide range of dosage levels. Although the Metabolite 356 labels changed throughout the years, they consistently include the same “recommendation” as to intake of the product, stating “one to two caplets two to three times per day, or every 4 hours .... DO NOT EXCEED EIGHT CAPLETS PER DAY.” Each pill contains 12 milligrams of ephedra. Thus, the “recommended dose” could be as low as two caplets per day (24 milligrams of ephedra), or as high as six caplets (72 milligrams of ephedra), with a specific warning not to exceed eight caplets (96 milligrams of ephedra). Further, the class definition contains no minimum duration of usage. As currently stated, taking two pills on only one occasion would qualify an individual for class membership. In fact, the descriptions of the named Plaintiffs bear out this wide range of possible claimants. The named Plaintiffs alone ingested from two pills per day to six pills per day for a duration ranging from one day to over two years. For example, Mr. Burney took only four pills ever, while Ms. Elizabeth Cepero took three pills each day for more than two years.
To cure the likely over-inclusive range of the definition “at the levels recommended by the Defendant,” the Defendant conceded that setting a minimum daily dosage level of 32 milligrams of ephedra, or three Metabolite pills, might be appropriate.
C. Proving Class Membership
Even if the class definition could be refined by adding a minimum daily dosage and minimum duration of ingestion, there
As noted at oral argument, this problem was also presented to the judge who certified a class of individuals who had taken the appetite suppressants commonly referred to as Fen-Phen. See In re Diet Drugs, No. CIV 98-20626,
II. Rule 23 Requirements
As noted, the four requirements of numerosity, commonality, typicality, and adequacy of representation must be met before any civil suit can be certified as a class action. The problems with the numerosity prerequisite has largely been discussed above in the context of the class definition problems. See Mauldin v. Wal-Mart Stores, Inc., No. 01-CV-2755,
As the Eleventh Circuit has recognized, “the commonality and typicality requirements of Rule 23(a) overlap. Both requirements focus on whether a sufficient nexus exists between the legal claims of the named class representatives and those of individual class members to warrant class certification.” Prado-Steiman v. Bush,
Plaintiffs claim that this case involves at least five common questions of law and fact: (1) whether Metabolife 356 is dangerous, (2) whether Metabolife International, - Inc., was negligent, (3) whether Metabolife 356 causes increased risk of contracting serious latent diseases, (4) whether monitoring procedures exist for any such diseases, and (5) whether a monitoring regime is reasonably necessary. Plaintiffs’ Motion at 10. The Defendant, on the other hand, contends that these Plaintiffs are not typical of the class and that the claims of the class members require primarily individualized inquiry which overwhelm any commonality.
Although the commonality requirement is not a high threshold and generally only requires one common question of law or fact, the requirement is greater when the plaintiffs seek, as here, to resolve all issues, including the non-common issues, in one proceeding. See Barnes v. American Tobacco Co.,
The first element, above-normal exposure to a substance, will require the individualized determinations as to whether each class member had actually ingested this product, with all the attendant difficulties noted above of making such factual determinations in the absence of written documentation. The second element requires a determination as to whether Metabolife 356 is dangerous or hazardous. Unless the product is found to be inherently hazardous, such a finding may well depend on individual considerations. For example, Metabolife 356 may be dangerous to an individual who is simultaneously taking certain prescription drugs or to one who had already suffered heart palpitations, such as Plaintiff Jeanette Cepero, but still be safe for individuals on no medication and with no history of medical disorders.
The third element, proof of negligence by the Defendant, may depend largely on individualized issues related to what warning labels the particular class member received and whether the Defendant can defend by proving that the individual was comparatively negligent by ignoring warnings regarding contraindications or health risks for people suffering from certain conditions. As the factual summaries demonstrate, these issues are not common to the class. Different warning labels were affixed to the bottles throughout the years, and the extent to which just these six individuals read, understood, and abided by the warnings varied greatly.
The fourth element requires essentially proof of proximate causation: each Plaintiff must demonstrate that the use of Metabolife .356 significantly increased the risk of contracting a serious latent disease. See Rink v. Cheminova, Inc.,
The last three Petito elements involve the specific medical monitoring regimen that a plaintiff is entitled to undergo. Plaintiffs suggest that a uniform program can be established for all class members, but again ignore the significant individual differences that make such uniformity impossible. See Hoyte,
For many of these same reasons, the Court finds that Plaintiffs are not typical of the class and that they cannot adequately represent the class. These six individuals show great variance in dosages taken, duration of use, alleged symptoms from usage, health histories, age, and other risk factors. Across the class, even more individual differences which are critical to adjudication under Petito will emerge. Given the breadth of the relief sought, typicality would be nearly impossible to satisfy. This problem also implicates the adequacy of representation, because any medical monitoring regime set up here may foreclose future class members from seeking medical monitoring for a condition not suffered by any of these named plaintiffs. Further, the preclusive effect of providing medical monitoring to this class may bar unnamed class members from bringing claims for injuries actually suffered. See Hoyte,
B. Rule 23(b) Requirements
Because the Court has found this case does not satisfy the basic class action requirements of providing an adequate definition or presenting common claims and typical claim
1. Predominance and Superiority
Under Rule 23(b)(3), a class action can be certified if the Court finds that common questions of law or fact predominate and if class treatment is superior to other methods of adjudicating class members’ claims. “The predominance inquiry ... is far more demanding than Rule 23(a)’s commonality requirement.” Jackson v. Motel 6 Multipurpose, Inc.,
As to superiority, the Court cannot see how treatment as a class action would be superior in any instance. Severe manageability problems are a prime consideration that can defeat a claim of superiority. See Castano v. American Tobacco Co.,
2. Injunctive Class Actions
Plaintiffs claim, alternatively, that this case can be certified under one of the first two class action categories due to its primarily injunctive nature. Rule 23(b)(2) allows class actions for injunctive or declaratory relief where the class opponent “has acted or refused to act on grounds generally applicable to the class.” Fed. R. Civ. Pro. 23(b)(2). Although this rule does not have the same superiority and predominance requirement of Rule 23(b)(3), the class proponent must still demonstrate that the claims are cohesive. See Barnes v. American Tobacco Co.,
Plaintiffs, however, cite the class certification order involving Fen-Phen diet drugs, stating that it supports that Rule 23(b)(2) permits certification even when many individual issues are involved. See Plaintiffs Reply to Professor Sherman’s Affidavit at 5; In re Diet Drugs, No. Civ. A. 98-20626,
Finally, Plaintiffs argue that Rule 23(b)(1)(A) permits class certification in this case. That rule allows for class treatment in order to avoid inconsistent adjudications that would create “incompatible standards of conduct” for the defendant. Fed. R. Civ. Pro. 23(b)(1)(A). “The phrase ‘incompatible standards of conduct’ refers to the situation where ‘different results in separate actions would impair the opposing party’s ability to pursue a uniform course of conduct.’ ” In re Paxil Litigation,
Plaintiffs, however, state that the need for a uniform medical monitoring regimen creates a risk that multiple adjudications would lead to incompatible results. Plaintiffs Reply at 6-7. However, the Plaintiffs have not shown that a uniform medical monitoring plan is either appropriate or workable. As noted above, the various individual factors
Plaintiffs also contend that the Court’s reasoning for certifying a class in Gasperoni v. Metabolife International, Inc. under Rule 23(b)(1)(A) can be extended to this case. No. 00-71255,
III. Conditional Certification
At oral argument, Plaintiffs’ counsel suggested that the problems with the class definition could easily be resolved by conditionally certifying the class as defined and then refining the definition based on medical evidence and by creating subclasses where necessary based on differences in the legal requirements of separate states or the medical implications of different conditions. The Court rejects this suggestion as inconsistent with the requirement that the four Rule 23(a) prerequisites must be met and one of the three Rule 23(b) requirements must be found before any class can be certified. See Castano v. American Tobacco Co.,
Conclusion
For the reasons set out above, and particularly because this case requires many individualized determinations, the Court has determined that this case does not meet the requirements of Rule 23 for certification as a class action. It is therefore
ORDERED AND ADJUDGED that the Motion for Class Certification is DENIED.
Notes
. Two of the original Plaintiffs, Amelia Fernandez and Robert Nava, voluntarily withdrew as named Plaintiffs on June 30, 2003, and July 24, 2003, respectively.
. In fact, the district court in this case, noting that neither the Seventh Circuit nor the Illinois Supreme Court had addressed this question, held that the "medical monitoring issue involves a controlling question of law as to which there is a substantial ground for differences of opinion” and, as such, certified the question for interlocutory appeal. See Carey v. Kerr-McGee, No. 96-C-8583,
. The Court notes that, although not mentioned at oral argument, the Utah Supreme Court has allowed an independent cause of action for medical monitoring requiring proof of eight elements. See Hansen v. Mountain Fuel Supply Co.,
. Defendant argues that the 32 milligram minimum daily dosage would be more or less arbitrary, because there is no medical evidence to suggest that levels above that dosage increase the risk of injury. See Defendant’s Memorandum Addressing the Morgenstern Study. Although any such determination of the medical merits must wait for trial, Defendant's argument does demonstrate that the class definition is fluid and would likely be subject to change. ’
. For example, Metab-O-Lite and MetaboLIFT are two other diet products which formerly contained ephedra. See Home page, at http://www.slimstore.com (last visited Sept. 17, 2003). As Defendant noted during oral argument, this could lead to a problem where some class members may honestly believe and aver that they took Metabolife 356, unaware of the slight variation between it and the name of the product they actually used.
. The first half of the test concerns the adequacy of class counsel. See Griffin,
. Defendant also suggests that these issues need not be reached, arguing that the medical evidence does not support that Metabolife 356 users can suffer any injury after they have discontinued use of the product, and that, therefore, none of these individuals, who have all stopped talcing Metabolife 356, have standing to make a claim for medical monitoring. Defendant’s Opposition at 9-10. Nonetheless, Plaintiffs have submitted an affidavit from a licensed medical doctor stating his opinion that the effects of Metabolife ingestion can result in chronic problems that will manifest themselves even after usage has stopped. Plaintiffs’ Reply, Ex. 1 at 3-4. Therefore, any ruling that these Plaintiffs do not have standing would require a determination on the medical merits of the case that is impermissible at this stage.
. Plaintiffs are correct that the Court may not deny certification based on a preliminary inquity into the merits and a determination that the Plaintiffs are unlikely to succeed. See, e.g., Castano,
. For example, Plaintiff William Burney testified that he had read the warning on the Metabolife 356 label, "evaluated them and didn’t see a risk," and therefore did not consult a physician before trying the product. Defendant’s Opposition, Ex. 6. Plaintiff Patricia Berni similarly admitted to having read the label, looked at the ingredients, and decided to buy the pills because she "didn’t see anything that was dangerous for your health.” Defendant’s Opposition, Ex. 8. The absence of information in Defendant’s opposition about some of the other Plaintiffs’ deposition testimony regarding these labels suggests that some may not have paid such close attention to the warnings.
. Although there is some suggestion in Petito that plaintiffs who prevail under a medical monitoring cause of action would not be foreclosed from claim splitting, thus allowing them to bring a suit if they later suffer an actual injury due to the exposure, this is certainly not a well-settled or well-tested legal principle.
. The Court notes that one district court did find a medical monitoring claim warranted class certification under Rule 23(b)(1)(A) "because separate adjudications would impair [the Defendant’s] ability to pursue a single uniform medical monitoring program.” In re Telectronics Pacing Systems, Inc.,
. Although it will not go into effect until December, 2003, subject only to the unlikely possibility that Congress will reject the change entirely, the Supreme Court has approved an amendment to Rule 23(c) which would delete the reference allowing class actions to be "conditional.” See Transmittal Letter from William
. For example, the class might be very small if the medical evidence supports that only people who took six pills a day for more than three months are at increased risk of injury, whereas it would be much larger if taking only one pill ever were sufficient to increase the risk. The parties' litigation and settlement strategies could be quite different if they knew the approximate size of the class.
. In reversing certification of a class in another case, the Eleventh Circuit stated that "[o]nce one understands that the issues involved in the instant case are predominantly case-specific in nature, it becomes clear that there is nothing to be gained by certifying this case as a class action; nothing, that is, except the blackmail value of a class certification that can aid the plaintiffs in coercing the defendant into a settlement.” Rutstein v. Avis Rent-A-Car Systems, Inc.,