Zinser v. Accufix Research Institute

• Decision Date: 14 December 2001
• Docket Number: PLAINTIFF-APPELLANT,No. 99-17073,DEFENDANTS-APPELLEES,99-17073
• Citation: 253 F.3d 1180
• Parties: (9th Cir. 2001) ROBIN ZINSER, INDIVIDUALLY AND ON BEHALF OF ALL OTHERS SIMILARLY SITUATED,, v. ACCUFIX RESEARCH INSTITUTE, INC., FORMERLY D.B.A. AS TPLC, INC., AND TELECTRONICS PACING SYSTEMS, DAD NOW KNOWN AS TPLC HOLDINGS, INC., A COLORADO CORPORATION; PACIFIC DUNLOP LIMITED, AND NUCLEUS LIMITED; NUCLEUS LIMITED,
• Court: U.S. Court of Appeals — Ninth Circuit

Page 1180

253 F.3d 1180 (9th Cir. 2001)

ROBIN ZINSER, INDIVIDUALLY AND ON BEHALF OF ALL OTHERS SIMILARLY SITUATED, PLAINTIFF-APPELLANT, v. ACCUFIX RESEARCH INSTITUTE, INC., FORMERLY D.B.A. AS TPLC, INC., AND TELECTRONICS PACING SYSTEMS, DAD NOW KNOWN AS TPLC HOLDINGS, INC., A COLORADO CORPORATION; PACIFIC DUNLOP LIMITED, AND NUCLEUS LIMITED; NUCLEUS LIMITED, DEFENDANTS-APPELLEES.

No. 99-17073

UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT

Argued and Submitted October 30, 2000

Filed June 15, 2001

Amended December 14, 2001

[Copyrighted Material Omitted]

[Copyrighted Material Omitted]

Elizabeth J. Cabraser, James M. Finberg (argued), Melanie M. Piech, and Scott P. Nealey, Leiff, Cabraser, Hiemann & Bernstein, Llp, San Francisco, California; C. Brooks Cutter, Friedman, Callard, Cutter & Panneton, Sacramento, California; Robert Hollingsworth, Cors & Bassett, Cincinnati, Ohio, for the plaintiff-appellant.

Charles F. Preuss, Thomas J. Pulliam, Jr., and Catherine W. Levin, Preuss, Walker & Shanagher, Llp, San Francisco, California; Charles P. Goodell, Jr. (argued), Richard M. Barnes, and Ian Gallacher, Goodell, Devries, Leech & Gray, Llp, Baltimore, Maryland; John M. LaPlante, Gregory J. Fisher, Edson & LaPlante, Sacramento, California; Patrick S. Coffey, Scott J. Fisher (argued), Gardner, Carton & Douglass, Chicago, Illinois; Robert S. Epstein, Epstein, Englert, Staley & Coffey, San Francisco, California, for defendantsappellees.

Appeal from the United States District Court for the Eastern District of California Garland E. Burrell, Jr., District

Judge, Presiding D.C. No. CV-97-0414-GEB

Before: Betty B. Fletcher, Diarmuid F. O'Scannlain, and Ronald M. Gould, Circuit Judges.

The opinion of the court was delivered by: Gould, Circuit Judge

Opinion by Judge Gould; Dissent by Judge B. Fletcher

OPINION

This is a products liability action involving pacemakers containing the allegedly defective ENCOR Bipolar Passive Fixation Pacing Lead Model 330-854 ("854 lead"). Plaintiff-Appellant Robin Zinser ("Zinser") filed a class action complaint alleging negligence, products liability, negligent misrepresentation, fraud and deceit, breach of express warranty, breach of implied warranty, and infliction of emotional distress against defendant Accufix Research Institute ("ARI"), formerly Telectronics Pacing Systems. Zinser also alleged that defendants Pacific Dunlop Limited ("Pacific Dunlop") and Nucleus Limited ("Nucleus") were derivatively liable for damages caused by ARI.

The district court denied class certification, holding that Zinser failed to meet her burden of proving that a class should be certified pursuant to Federal Rule of Civil Procedure 23 ("Rule 23") (b)(1)(A), (b)(1)(B), (b)(2), or (b)(3). Zinser appeals, and we affirm.

FACTUAL AND PROCEDURAL BACKGROUND

Pacemakers containing the 854 lead were implanted in a population of 10,549 patients in 48 states throughout the United States. Approximately 8,200 of these patients were still alive and implanted with an 854 lead when the district court considered class certification.

ARI designed, manufactured, and distributed the 854 lead. Pacific Dunlop is an Australian company and the ultimate parent and beneficial owner of ARI. Nucleus, another Australian company, is a wholly-owned subsidiary of Pacific Dunlop and also holds an indirect beneficial ownership interest in ARI.

A pacemaker consists of two parts: a pulse generator and one or two atrial leads. Because most atrial leads included in pacing systems are placed in the upper portion of the atrium, which is difficult to reach, many atrial leads are manufactured with a pre-existing "J" shape to help physicians stabilize the lead. The 854 lead consists of a polyurethane insulated conductor coil formed into its "J" shape through the use of a flat metal retention wire, which runs through the inside of a conductor coil. While implanted, the lead flexes and bends each time the heart beats, approximately 100,000 to 150,000 times per day.

Because of metal fatigue, the "J" retention wire may fracture over time. Whether a "J" wire in an 854 lead will fracture depends, in part, on whether the wire has suffered bends or kinks in the interelectrode region. Injury from a"J" wire in an 854 lead has been reported only when the wire fractures and protrudes through a small section of the tip of the lead in the interelectrode region.

On September 11, 1995, ARI published a "Dear Doctor" letter announcing its withdrawal of all models of passive fixation atrial "J" leads. The letter also advised physicians of new safety information related to its ENCOR 330-854 and ENCOR DEC 033-856 leads.¹ To date, ARI has issued a total of five "Dear Doctor" letters setting forth relevant clinical information and patient management guidelines. Individuals from the worldwide implant population have reported a total of five injuries related to fracture and protrusion of the 854 lead "J" wire, two of which occurred in the United States. Additionally, four patients in the United States have reported non-specific chest pain with an unconfirmed relationship to "J" wire fracture or protrusion.

ARI communicated the current lead patient management guidelines to the medical community on August 14, 1998. ARI recommended: (1) annual fluoroscopic screening for all patients implanted with 854 leads; (2) fluoroscopic screening every six months if a physician finds that a lead is fractured proximal to the anode band; (3) fluoroscopic screening every six months or consideration of extraction if fluoroscopic screening reveals that a lead is fractured or kinked within the interelectrode region; and (4) consideration of extraction if fluoroscopic evidence indicates that the "J" wire is protruded or severed within the interelectrode region. ARI maintains that the risk of extraction is greater than the risk of injury from a "J" wire protrusion.

ARI has previously faced litigation involving three different pacemaker leads, known as ACCUFIX atrial "J " lead models 330-801, 329-701, and 088-812 ("Telectronics litigation"). The Telectronics litigation's procedural history includes certification, decertification, and recertification by the district court of a class against ARI. See In re Telectronics Pacing Systems, Inc., 164 F.R.D. 222 (S.D. Ohio 1995) (certifying class pursuant to Rule 23(b)(3)); 168 F.R.D. 203 (S.D. Ohio 1996) (on reconsideration, decertifying class); 953 F. Supp. 909 (S.D. Ohio 1997) (denying Pacific Dunlop and Nucleus' motion to dismiss for lack of jurisdiction); 172 F.R.D. 271 (S.D. Ohio 1997) (recertifying class). After the parties to the Telectronics litigation reached a settlement agreement, Zinser moved to intervene, arguing that she might make a claim against monies allocated to the settlement class on behalf of the putative class in this case. The district court presiding over the Telectronics litigation denied the motion as untimely.²

On August 11, 1997, Zinser filed a putative class action complaint against ARI alleging negligence, products liability, negligent misrepresentation, fraud and deceit, breach of express warranty, breach of implied warranty, and infliction of emotional distress. Zinser also alleged that Pacific Dunlop and Nucleus, as parent corporations, were derivatively liable for damages caused by ARI.

Zinser sought class certification only for claims of negligence, products liability, and medical monitoring pursuant to Rule 23. Zinser defined the proposed class as:

All persons domiciled or residing in the United States of America and its territories, possessions, and the District of Columbia, who had implanted in their bodies, an ENCOR Bipolar Passive Fixation Pacing Lead Model 330-854. Excluded from the class are the defendant's officers and employees.

Zinser also sought certification of two subclasses:

The first subclass (the "Medical Monitoring Subclass") is composed of those individuals who are currently implanted with a model 330-854 pacing lead. The second subclass (the "Explantation Subclass") is composed of those individuals who have had a model 330-854 lead removed because of an actual injury or risk of injury.

The district court denied Zinser's request for class certification pursuant to Rule 23(b)(1)(A), (b)(1)(B), (b)(2), and (b)(3). Because of the procedural complexity of trying a class action under the laws of multiple jurisdictions, the district court refused to certify the class pursuant to Rule 23(b)(3). The district court denied certification of the proposed Rule 23(b)(1)(A) medical monitoring subclass, finding that individual adjudications of the medical monitoring claim would not expose ARI to conflicting obligations. The court also rejected certification of the subclass pursuant to Rule 23(b)(2), finding that the nature of the relief sought was primarily legal, not equitable, in nature. And the court refused to certify the class pursuant to Rule 23(b)(1)(B) as a limited fund. Because the Rule 23(b) requirements were dispositive, the district court declined to consider whether Zinser met the requirements of Rule 23(a).

On September 27, 1999, we exercised our discretion pursuant to Rule 23(f) and granted Zinser permission to appeal the district court's order denying class certification. Pursuant to 28 U.S.C. §§ 1292(e) and Rule 23(f), we have jurisdiction over Zinser's appeal.

DISCUSSION

I.

Class actions are governed by Federal Rule of Civil Procedure 23. As the party seeking class certification, Zinser bears the burden of demonstrating that she has met each of the four requirements of Rule 23(a) and at least one of the requirements of Rule 23(b). Hanon v. Dataproducts Corp. , 976 F.2d 497, 508 (9th Cir. 1992).³

Before certifying a class, the trial court must conduct a "rigorous analysis" to determine whether the party seeking certification has met the prerequisites of Rule 23. Valentino v. Carter-Wallace, Inc., 97 F.3d 1227, 1233 (9th Cir. 1996). While the trial court has broad...