Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca8-04-03117/USCOURTS-ca8-04-03117-0/pdf.json

Nature of Suit Code: 365
Nature of Suit: Personal Injury - Product Liability
Cause of Action: 

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United States Court of Appeals

FOR THE EIGHTH CIRCUIT

___________

No. 04-3117

___________

In re: St. Jude Medical, Inc., Silzone *

Heart Valve Products Liability *

Litigation *

____________ *

*

Lester Grovatt; Beatrice Bailey; *

Levy D. Redden; Bonnie L. Sliger; *

Joe W. Sanchez, on behalf of *

themselves and all others similarly *

situated, *

*

Appellees, *

* Appeal from the United States

v. * District Court for the District

* of Minnesota.

St. Jude Medical, Inc., *

*

Appellant, *

*

____________ *

*

Product Liability Advisory Council, *

Incorporated; Minnesota Chamber *

of Commerce, *

*

Amicus on Behalf of Appellant. *

*

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State of Minnesota; Public Citizen, *

Public Citizen, Incorporated; *

Minnesota Trial Lawyers Association, *

*

Amicus on Behalf of Appellees. *

___________

Submitted: June 20, 2005

Filed: October 12, 2005 

___________

Before RILEY, BOWMAN, and BENTON, Circuit Judges.

___________

RILEY, Circuit Judge.

St. Jude Medical, Inc. (SJM) produced the Silzone prosthetic heart valve. A

test conducted by SJM showed a slightly higher risk of paravalvular leaks at the site

where the valves were implanted. SJM thereafter recalled all unimplanted Silzone

valves. Numerous suits were then filed across the nation, and the cases were later

consolidated in Minnesota. On motions by the plaintiffs, the district court issued

three orders that collectively had the result of certifying two subclasses–one seeking

damages based on Minnesota’s consumer protection statutes, and another seeking

primarily injunctive relief. SJM appeals these two class certifications. We reverse

and remand.

I. BACKGROUND

SJM received approval from the Food and Drug Administration (FDA) for the

Silzone Heart Valve. The valve had as a unique characteristic a sterile, antimicrobial

silver coating on the valve’s polyester sewing cuff where the valve connected to a

patient’s heart tissue. Months after receiving FDA approval, SJM sponsored a

random, controlled study comparing patient experience with Silzone- and nonSilzone-coated heart valves. The study data showed a statistically significant 2%

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increase for patients implanted with Silzone-coated valves over those implanted with

non-Silzone-coated valves in the incidence of paravalvular leaks severe enough to

require valve explantation.

SJM immediately recalled all unimplanted Silzone valves. Following the

recall, plaintiffs sued SJM in courts across the nation. The cases were consolidated

for pretrial proceedings in Minnesota pursuant to the Judicial Panel on Multidistrict

Litigation. Eventually, five plaintiffs filed a consolidated amended class action

complaint, claiming to represent over 11,000 Silzone valve recipients. The plaintiffs

alleged common law strict liability, breach of implied and express warranties,

negligence and medical monitoring, and claims under various Minnesota consumer

statutes–the False Advertising Act, the Consumer Fraud Act, the Unlawful Trade

Practices Act, and the Uniform Deceptive Trade Practices Act. The plaintiffs moved

for class certification of an injunctive class, called the “medical monitoring class,”

and a personal injury class seeking money damages, although both classes made many

of the same claims under the same legal theories noted above. The district court

found both proposed classes met the threshold requirements of Federal Rule of Civil

Procedure 23(a), then conditionally certified the common-law claims in both classes

under Rule 23(b)(3) and (c)(4). The court also conditionally certified the medical

monitoring class under Rule 23(b)(2) and (c)(4). Finally, the court concluded

common issues of law and fact predominated over plaintiffs’ claims under

Minnesota’s consumer protection and deceptive trade practices acts, and a class

action was the superior method to adjudicate those claims. The court unconditionally

certified a consumer protection class under those statutes pursuant to Rule 23(b)(3).

As to the common law claims, the district court “envision[ed] a minimal

number of subclasses, and [found] that only significant variations in state law will be

sufficient to require different subclasses,” then requested briefing from the parties

with regard to subclasses in the conditionally certified classes. After receiving

briefing, the court decertified the personal injury class, citing Erie Railroad v.

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Tompkins, 304 U.S. 64, 78-80 (1938), and Castano v. American Tobacco Co., 84

F.3d 734, 740-41 (5th Cir. 1996), wherein the Fifth Circuit reversed a district court’s

class certification order because the district court failed to consider how the variations

in state law would affect predominance and superiority. The district court found no

two states’ laws were substantially alike, which, in the court’s estimation, would

require management of at least 25 subclasses. The court again conditionally certified

the medical monitoring class, subject to the plaintiffs submitting to the court the

identities of suitable class representatives and a manageable trial plan. After

reviewing the laws of different states with regard to medical monitoring, the court

observed it would apply the medical monitoring law of different states, conditionally

certifying the class only as to “those plaintiffs whose valves were implanted in states

that recognize a stand-alone cause of action for medical monitoring, absent proof of

injury.” The court concluded the elements of medical monitoring claims in states that

recognize such claims “appear[ed] to be the same.” In a third order, the court added

plaintiffs from more states (for a total of 17) to the list of those presenting medical

monitoring claims. Following the third order, two certified subclasses remain: the

class based on Minnesota’s consumer protection statutes, and the medical monitoring

class.

II. DISCUSSION

“We review a district court’s ruling granting or denying class certification for

abuse of discretion.” Glover v. Standard Fed. Bank, 283 F.3d 953, 959 (8th Cir.

2002). “The district court’s rulings on issues of law are reviewed de novo, and the

court abuses its discretion if it commits an error of law.” Blades v. Monsanto Co.,

400 F.3d 562, 566 (8th Cir. 2005) (citing Emery v. Hunt, 272 F.3d 1042, 1046 (8th

Cir. 2001)) (italics removed). “Thus, even under the abuse of discretion standard, a

district court’s rulings on issues of law are reviewed de novo.” Emery, 272 F.3d at

1046. 

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Rule 23 was amended in 2003, but those amendments have no bearing on our

analysis of this appeal. Class Action Fairness Act of 2005, Pub.L. 109-2, § 7, 119

Stat. 13.

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To be certified as a class, plaintiffs must meet all of the requirements of Rule

23(a) and must satisfy one of the three subsections of Rule 23(b).1

 Amchem Prods.,

Inc. v. Windsor, 521 U.S. 591, 614 (1997); Blades, 400 F.3d at 568-69. The Rule

23(a) requirements for class certification are: (1) the putative class is so numerous

that it makes joinder of all members impractical; (2) questions of law or fact are

common to the class; (3) the class representatives’ claims or defenses 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. P. 23(a). The district court

certified the class based on Minnesota’s consumer protection statutes using Rule

23(b)(3), which provides that a class action may be maintained if the court finds the

questions of law or fact common to members of the class predominate over the

questions affecting only individual class members, and a class action is the superior

method for fair and efficient adjudication of the dispute. The district court certified

the medical monitoring class under Rule 23(b)(2), which provides a class action is

appropriate if “the party opposing the class has acted or refused to act on grounds

generally applicable to the class, thereby making appropriate final injunctive relief

or corresponding declaratory relief with respect to the class as a whole.” 

A. Consumer Protection Class

The district court concluded it would apply Minnesota law to the consumer

protection statutes class because the Minnesota statutes permit “any person” to bring

suit thereunder. The court conducted a cursory conflict-of-laws analysis as to the

application of the Minnesota consumer protection statutes. The court concluded

applying Minnesota law was proper because the parties, particularly SJM, had

significant contacts with Minnesota, including SJM being headquartered in

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Minnesota, and the fact that “much of the conduct relevant” to the claims “occurred

or emanated from Minnesota.”

SJM makes numerous assertions of error regarding the district court’s order

certifying the consumer protection class. SJM argues the U.S. Constitution does not

permit a nationwide personal injury class action using the consumer protection law

of one state to the exclusion of all other states. SJM claims the nationwide class

violates the Constitution’s Commerce Clause, the Due Process Clause, the Full Faith

and Credit Clause, the Erie doctrine, and the Rules Enabling Act. SJM also argues

the nationwide consumer protection class violates Federal Rule of Civil Procedure 23,

questioning the manageability of the class, the adequacy of the class representatives,

and the typicality of their claims. Finally, SJM argues the plaintiffs cannot meet the

predominance or superiority requirements of Rule 23(b)(3).

Addressing the class certification issues only with regard to the Due Process

and Full Faith and Credit Clauses, we conclude the district court did not conduct a

sufficient conflicts-of-law analysis. The due process and full faith and credit issues

“are dispositive, and we believe it prudent not to decide issues unnecessary to the

disposition of the case,” especially given the numerous constitutional issues

implicated in such an analysis. See Georgine v. Amchem Prods., Inc., 83 F.3d 610,

623 (3d Cir. 1996), aff’d sub nom., Amchem Prods., Inc. v. Windsor, 521 U.S. 591

(1997).

The district court’s class certification was in error because the district court did

not conduct a thorough conflicts-of-law analysis with respect to each plaintiff class

member before applying Minnesota law. The Supreme Court has held an

individualized choice-of-law analysis must be applied to each plaintiff’s claim in a

class action. Phillips Petroleum Co. v. Shutts, 472 U.S. 797, 822-23 (1985). There

is, of course, no constitutional injury to out-of-state plaintiffs in applying Minnesota

law unless Minnesota law is in conflict with the other states’ laws. Therefore, we

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must first decide whether any conflicts actually exist. See id. at 816. The district

court certified a class of over 11,000 Silzone valve recipients, assumedly residing in

numerous states. We deem it unnecessary here to review each state’s consumer

protection laws, and rather rely on our sister circuit’s conclusion that “[s]tate

consumer-protection laws vary considerably, and courts must respect these

differences rather than apply one state’s law to sales in other states with different

rules.” In re Bridgestone/Firestone, Inc., 288 F.3d 1012, 1018 (7th Cir. 2002).

“[F]or a State’s substantive law to be selected in a constitutionally permissible

manner, that State must have a significant contact or significant aggregation of

contacts, creating state interests, such that choice of its law is neither arbitrary nor

fundamentally unfair.” Allstate Ins. Co. v. Hague, 449 U.S. 302, 312-13 (1981).

Here, we cannot determine whether the district court’s choice of Minnesota law was

arbitrary or unfair, because the court did not analyze the contacts between Minnesota

and each plaintiff class member’s claims. Application of Minnesota law to all

plaintiffs’ claims ultimately may be proper, although we suspect Minnesota lacks

sufficient contacts with all the parties’ claims, and the different states have material

variances between their consumer protection laws and Minnesota’s. There is no

indication out-of-state parties “had any idea that [Minnesota] law could control”

potential claims when they received their Silzone-coated valves. Phillips Petroleum,

472 U.S. at 822. Regardless, protection of out-of-state parties’ constitutional rights

requires an inquiry into their claims’ contacts with Minnesota and their individual

state laws before concluding Minnesota law may apply.

The district court justified its decision not to conduct a conflicts analysis by

relying on section 8.31 of the Minnesota Statutes. This section permits “any person

injured by a violation of” Minnesota’s consumer protection statutes to bring suit.

Minn. Stat. § 8.31, subd. 3a. The court also cited statutory language allowing “[a]

person likely to be damaged by a deceptive trade practice” to seek injunctive relief.

Minn. Stat. § 325D.45, subd. 1. The court reasoned these statutes permit out-of-state

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plaintiffs to bring suit under Minnesota law, and “[t]he fact that individual plaintiffs

hail from other states is immaterial,” relying on Group Health Plan, Inc. v. Philip

Morris Inc., 621 N.W.2d 2 (Minn. 2001), and In re Lutheran Brotherhood Variable

Insurance Products Co. Sales Practices Litigation, 201 F.R.D. 456, 461 n.1 (D. Minn.

2001). In Group Health, the Minnesota Supreme Court addressed the question

whether “a private plaintiff [must] be a purchaser of the defendant’s products in order

to properly plead a claim under Minnesota’s misrepresentation in sales statutes, Minn.

Stat. §§ 325F.67, 325F.69, subd. 1, 325D.13 (2000), and Minn. Stat. § 8.31, subd. 3a

(2000).” 621 N.W.2d at 4. The plaintiffs were all Minnesota companies, thus the

court did not consider the extraterritorial application of the “any person” language

contained in the statutes. Instead, the court considered only who had standing to sue

under the statutes, i.e., “individual consumers” rather than “sophisticated purchasers.”

Id. at 8-9. Lutheran Brotherhood cited Group Health to conclude “any person” meant

the Minnesota consumer protection law could be applied to a nationwide class. 201

F.R.D. at 461 n.1. Lutheran Brotherhood’s citation to Group Health was misplaced

because Group Health spoke only to standing rather than extraterritorial application

to a nationwide class.

The district court essentially attempted to preempt the Due Process and Full

Faith and Credit Clauses with state standing statutes. This opposes basic

constitutional law and is error. See U.S. Const., art. VI, cl. 2; Brooks v. Howmedica,

Inc., 273 F.3d 785, 792 (8th Cir. 2001) (“State law which conflicts with federal law

is preempted under the Supremacy Clause of the Constitution.”) State consumer

protection standing statutes do not extinguish federal constitutional rights or relieve

courts from performing the analysis required to safeguard those rights. We therefore

conclude the district court should have conducted the proper choice-of-law analysis,

Phillips Petroleum, 472 U.S. at 822-23, and we reverse and remand for that analysis.

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B. Medical Monitoring Class

SJM also asserts the district court erred in certifying the medical monitoring

class. SJM argues this class defies Erie’s command that federal courts refrain from

altering or creating new state law. SJM further argues certification of this class as

one seeking injunctive relief under Rule 23(b)(2) violates the Due Process Clause.

Finally, SJM argues certification of this class is improper due to diverse legal and

factual issues that would make a classwide trial inefficient and unmanageable. We

conclude the diverse legal and factual issues preclude class certification, and we

reverse on this ground. As this ground again is dispositive, we do not address the

Erie and due process arguments. 

Class certification under Rule 23(b)(2) is proper only when the primary relief

sought is declaratory or injunctive. Although Rule 23(b)(2) contains no

predominance or superiority requirements, class claims thereunder still must be

cohesive. Barnes v. Am. Tobacco Co., 161 F.3d 127, 143 (3d Cir. 1998). Because

“unnamed members are bound by the action without the opportunity to opt out” of a

Rule 23(b)(2) class, even greater cohesiveness generally is required than in a Rule

23(b)(3) class. Id. at 142-43. A “suit could become unmanageable and little value

would be gained in proceeding as a class action . . . if significant individual issues

were to arise consistently.” Id. (citation and quotation omitted); see also Lemon v.

Int’l Union of Operating Eng’rs, 216 F.3d 577, 580 (7th Cir. 2000) (same). “At base,

the (b)(2) class is distinguished from the (b)(3) class by class cohesiveness . . . .

Injuries remedied through (b)(2) actions are really group, as opposed to individual

injuries. The members of a (b)(2) class are generally bound together through

‘preexisting or continuing legal relationships’ or by some significant common trait

such as race or gender.” Holmes v. Cont’l Can Co., 706 F.2d 1144, 1155 n.8 (11th

Cir. 1983) (citation and quotation omitted).

Proposed medical monitoring classes suffer from cohesion difficulties, and

numerous courts across the country have denied certification of such classes. See,

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e.g., Ball v. Union Carbide Corp., 385 F.3d 713, 727-28 (6th Cir. 2004); Zinser v.

Accufix Research Inst., Inc., 253 F.3d 1180, 1195-96, amended, 273 F.3d 1266 (9th

Cir. 2001); Barnes, 161 F.3d at 143-46; Boughton v. Cotter Corp., 65 F.3d 823, 827

(10th Cir. 1995). Quoting the Third Circuit, the Supreme Court in Windsor listed

some of the individual variations precluding class certification: “[Exposure-only

plaintiffs] will also incur different medical expenses because their monitoring and

treatment will depend on singular circumstances and individual medical histories.”

521 U.S. at 624 (quoting Georgine, 83 F.3d at 626). Differences in state laws on

medical monitoring further compound these disparities. See id.

In this case, like in Windsor, each plaintiff’s need (or lack of need) for medical

monitoring is highly individualized. Every patient in the 17-state class who has ever

been implanted with a mechanical heart valve already requires future medical

monitoring as an ordinary part of his or her follow-up care. A patient who has been

implanted with the Silzone valve may or may not require additional monitoring, and

whether he or she does 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. The plaintiffs concede the states

recognizing medical monitoring claims as a separate cause of action have different

elements triggering culpability. Simply put, the medical monitoring class presents a

myriad of individual issues making class certification improper. For the same reasons

the district court decertified the personal injury tort class, the medical monitoring

class was certified incorrectly.

Bolstering our conclusion is the fact the plaintiffs never demonstrated to the

district court they “would sue for the medical monitoring program sought here even

in the absence of a claim for damages.” In re Rezulin Prods. Liab. Litig., 210 F.R.D.

61, 73 (S.D.N.Y. 2002). As the Southern District of New York ruled, a district court

certifying a medical monitoring class must be satisfied

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that a reasonable plaintiff, based on a medical and economic calculus,

would have sued solely for a medical monitoring program, not merely

that a lawyer could have been found who would have located a plaintiff

and brought a class action in the hope of a fee, else the test would be

meaningless.

Plaintiffs have not persuaded the Court that this criterion has been

satisfied here. Neither the American Diabetes Association nor the

American Association of Clinical Endocrinologists, which promulgate

guidelines for the care and treatment of diabetics, nor any public health

agency or professional medical society or institution, has recommended

special monitoring for patients who formerly took Rezulin.

Id. While every mechanical heart valve patient will require follow-up care in

connection with the implant, the question of additional monitoring above that

required for normal mechanical heart valve implantation is not clear.

For the above reasons, we conclude class certification of the medical

monitoring class was an abuse of discretion. We reverse the district court’s

certification of this class.

III. CONCLUSION

For the foregoing reasons, we reverse and remand for further proceedings

consistent with this opinion.

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