In re Telectronics Pacing Systems, Inc.

164 F.R.D. 222, 1995 U.S. Dist. LEXIS 18552, 1995 WL 744954
CourtDistrict Court, S.D. Ohio
DecidedNovember 17, 1995
DocketNo. MDL-1057
StatusPublished
Cited by18 cases

This text of 164 F.R.D. 222 (In re Telectronics Pacing Systems, Inc.) is published on Counsel Stack Legal Research, covering District Court, S.D. Ohio primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re Telectronics Pacing Systems, Inc., 164 F.R.D. 222, 1995 U.S. Dist. LEXIS 18552, 1995 WL 744954 (S.D. Ohio 1995).

Opinion

ORDER GRANTING MOTION FOR CLASS CERTIFICATION

SPIEGEL, District Judge.

This matter is before the Court on the Plaintiffs’ Motion for Class Certification (doc. 2 in Case No. C-l-95-094, entered in this action on March 10, 1995), the Defendants’ Memorandum in Opposition (doc. 47), the Plaintiffs’ Response (doc. 55), the Defendants’ Reply to the Plaintiffs’ Response (doc. 55) and the Defendants’ Supplemental Memorandum (doc. 57), the Plaintiffs’ submission of additional cases (doc. 63) and the Defendants’ Supplemental Memorandum (doc. 66).

BACKGROUND

The Plaintiffs seek to certify the following class:

[a]ll persons worldwide who have had Ac-cufix atrial ‘J’ pacemaker leads, Model 330-801, Model 329-701 and Model OSS-812 placed in their bodies, and spouses of such persons.

Master Complaint, Document 37, ¶ 31. The Court heard oral argument on this issue on September 8,1995, at 2:00 P.M.

The “J” Stiffener Wire

The heart pacing system at issue consists of three main parts: a pulse generator, leads, and a programmer. Each pacing system usually contains one or two leads, which traverse through a person’s veins, directly from the pulse generator to inside the heart. The leads utilize a retention wire to hold the atrial lead in the “J” shape. The lead’s retention wire is a filament of one of two metal alloys, Elgiloy or MP35N. The retention wire has nothing to do with the conduction of the electrical signal or the operation of the pacing system since it is not electrically active in the pacing circuit. The retention wire is encased in polyurethane insulation and bends back and forth within the system. This use has caused the retention wire to break in some instances and poke through the polyurethane. Such a fracture can cause serious injury to the heart or blood vessels.

[225]*225Defendant TPLC Pacing Systems, Inc. and TPLC, Inc. (collectively “TPLC”)1 manufactured the “J” lead at issue in this case, although other companies may have supplied them with the component parts including the retention wire. TPLC distributed over 40,-000 “J” leads2 worldwide between 1988 and 1994. TPLC distributed Models 329-701 and 330-801 in the United States and Model 033-812 outside of the United States. Estimates show that in excess of 20,000 leads are in use in the United States.

The Plaintiffs claim that all the “J” leads in the three models are essentially the same." While the models may differ in some minor details, the Plaintiffs claim that they are defective because of the same defective design: a “J” stiffener wire that fractures as a result of metal fatigue. The Defendants argue that pacemakers are inherently dangerous devices, and that various reasons exist why the retention wire could fracture, including the procedures the physicians used to install the device.

The History

On October 21, 1994, TPLC notified the Food and Drug Administration (“FDA”) that it was recalling all unsold leads. On December 19, 1994, the Plaintiffs claim the FDA notified TPLC that it classified the recall as a Class I Recall.3 The FDA issues such notices when it finds that “a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death.” 21 U.S.C. § 360h(e)(l).

TPLC also initiated the Accufix Atrial “J” lead Multi-Center Study. The study evaluates the prevalence of retention wire fracture at ten international medical centers and uses x-ray techniques to detect fractured wires. TPLC also created a physician advisory committee to help it with patient management issues.

On November 3, 1994, TPLC issued a letter to physicians recalling all un-implanted “J” leads, models 330-801 and 329-701. TPLC issued these letters after receiving seven reports of fracture of the “J” shaped retention wire. TPLC has now received notice of eighteen fractures, including two which caused deaths. Additionally, four people have died from having the lead extracted.

The Proposed Class Representatives

The Plaintiffs have eight people who are seeking to represent the class.

1. Mr. Edwards

Mr. Edwards is a forty-eight year old Ohio resident, who was implanted with a pacemaker system which included a “J” lead on October 10, 1991. In June 1995, Mr. Edwards had his lead explanted because it failed to conduct the electrical impulses necessary for the proper functioning of his pacemaker. Mr. Edwards had the lead explanted after his doctor warned him of the possibility of the stiffener wire fracturing. TPLC paid the expenses for having the Lead extracted.

2. Mr. Owens

Mr. Eugene Owens is a seventy-two year old Ohio resident, who had the pacemaker system including the “J” lead implanted on June 24, 1992. Mr. Owens lead has functioned without failure and has not caused him any physical injury. Once he learned of the possibility of fracture, however, he has had “many sleepless nights worrying about [his] defective pacemaker.” Eugene Owens Answer to Interrogatory 8. Mr. Owens still has the pacemaker system.

3. Mrs. Owens

Mrs. Owens claim against TPLC is based upon loss of consortium. She seeks to represent spouses of implant recipients.

4. Mr. Bechert

Mr. Bechert is an eighty-two year old Ohio resident, who had the pacemaker system in-[226]*226eluding the “J” lead implanted on November 12, 1992. Mr. Bechert’s Leads have functioned without failure, fracture or complication. Mr. Bechert learned of the possibility of a retention wire fracture from the Defendants, and although his lead has not fractured he fears that it may in the future.

5. Mrs. Bechert

Mrs. Bechert also seeks to represent the class of spouses of implant recipients and seeks damages for loss of consortium.

6. Mr. Cheyene

Mr. Cheyene is seventy-six year old former farmer, who had the pacemaker system including the “J” lead implanted on March 11, 1993. After finding a possible retention wire fracture, Mr. Cheyene’s lead was ex-planted on June 19, 1995. The doctors successfully removed the lead except for a small portion of the tip, which broke off and remains lodged in the sear tissue in the heart. Apparently, the remaining piece has not caused Mr. Cheyenne any problems.

7. Mrs. Cheyene

Mrs. Cheyene seeks to represent the class of spouses of implant recipients and seeks damages for loss of consortium.

8. Ms. Warren

Ms. Warren is a thirty-year old Canadian citizen who had the pacemaker system including the “J” lead implanted in Canada. Ms. Warren first learned of a potential problem with her lead, specifically the retention wire, in January, 1995. Her cardiologist explained to her that she may have potential problems, and then a chest x-ray indicated that the retention wire had split and a small piece of metal had migrated into her lung. Eventually, doctors removed both the lead and the pulse generator.

The Causes of Action

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Cite This Page — Counsel Stack

Bluebook (online)
164 F.R.D. 222, 1995 U.S. Dist. LEXIS 18552, 1995 WL 744954, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-telectronics-pacing-systems-inc-ohsd-1995.