Zinser v. Accufix Research Institute, Inc.

253 F.3d 1180, 49 Fed. R. Serv. 3d 1414, 2001 Daily Journal DAR 6097, 2001 Cal. Daily Op. Serv. 4955, 2001 U.S. App. LEXIS 13386, 2001 WL 668939
CourtCourt of Appeals for the Ninth Circuit
DecidedJune 15, 2001
DocketNo. 99-17073
StatusPublished
Cited by103 cases

This text of 253 F.3d 1180 (Zinser v. Accufix Research Institute, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Ninth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Zinser v. Accufix Research Institute, Inc., 253 F.3d 1180, 49 Fed. R. Serv. 3d 1414, 2001 Daily Journal DAR 6097, 2001 Cal. Daily Op. Serv. 4955, 2001 U.S. App. LEXIS 13386, 2001 WL 668939 (9th Cir. 2001).

Opinions

Opinion by Judge RONALD M. GOULD; Dissent by BETTY B. FLETCHER.

RONALD M. GOULD, Circuit Judge:

This is a products liability action involving pacemakers containing the allegedly defective ENCOR Bipolar Passive Fixation Pacing Lead Model 380-854 (“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 Aceufix Research Institute (“ARI”), formerly Te-lectronics 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 preexisting “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 interelee-trode 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 [1185]*1185854 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 Mnked within the interelectrode region; and (4) consideration of extraction if fluoroscopic evidence indicates that the “J” wire is protruded or severed within the intereleetrode 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 (“Te-lectronics litigation”). The Telectronics litigation’s procedural history includes certification, decertification, and recertifi-cation 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, de-certifying 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 re[1186]*1186moved 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.

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253 F.3d 1180, 49 Fed. R. Serv. 3d 1414, 2001 Daily Journal DAR 6097, 2001 Cal. Daily Op. Serv. 4955, 2001 U.S. App. LEXIS 13386, 2001 WL 668939, Counsel Stack Legal Research, https://law.counselstack.com/opinion/zinser-v-accufix-research-institute-inc-ca9-2001.