75 F.3d 1069 (6th Cir. 1996), 95-3303, In re American Medical Systems

Docket Nº:95-3303, 95-3327.
Citation:75 F.3d 1069
Party Name:In re AMERICAN MEDICAL SYSTEMS, INC.; Pfizer, Inc., Petitioners.
Case Date:February 15, 1996
Court:United States Courts of Appeals, Court of Appeals for the Sixth Circuit

Page 1069

75 F.3d 1069 (6th Cir. 1996)

In re AMERICAN MEDICAL SYSTEMS, INC.; Pfizer, Inc., Petitioners.

Nos. 95-3303, 95-3327.

United States Court of Appeals, Sixth Circuit

February 15, 1996

Argued July 25, 1995.

Page 1070

[Copyrighted Material Omitted]

Page 1071

[Copyrighted Material Omitted]

Page 1072

[Copyrighted Material Omitted]

Page 1073

[Copyrighted Material Omitted]

Page 1074

On Petitions for Writ of Mandamus.

Steven Glickstein, David Klingsberg (argued and briefed), Kaye, Scholer, Fierman, Hays & Handler, New York City, for Petitioners.

Stanley M. Chesley (argued), Waite, Schneider, Bayless & Chesley, Cincinnati, OH, Arthur R. Miller (argued), Cambridge, MA, for Respondents.

Before: CONTIE, RYAN, and SUHRHEINRICH, Circuit Judges.

SUHRHEINRICH, Circuit Judge.

Petitioners American Medical Systems ("AMS") and Pfizer, Inc., defendants below, both seek a writ of mandamus directing the district court to vacate orders conditionally certifying a class in a products liability suit involving penile prostheses. This court has held that class certification is generally not the kind of subject matter for which mandamus relief is available on the grounds that class certification decisions are reviewable on direct appeal. 1 However, on the extraordinary facts of this case we find that the district judge's disregard of class action procedures was of such severity and frequency so as to warrant its issuance here.


Since 1973, AMS, a wholly-owned subsidiary of Pfizer, has manufactured and marketed penile prostheses, which are used to treat impotence. The plaintiffs, respondents in this proceeding, all use or have used AMS' products.

Plaintiff Paul Vorhis was implanted with an AMS penile prosthesis on April 25, 1989. It failed to function in January of 1993, and Vorhis had the prosthesis replaced with an AMS 700 Ultrex prosthesis in May 1993. This second prosthesis caused him pain and discomfort, and plaintiff had it removed in August of 1993 and replaced with a third AMS prosthesis, with which he is presently satisfied. Vorhis filed this action against defendant AMS in the Southern District of Ohio on December 5, 1994, individually and on behalf of others similarly situated who suffered damages as a result of the implantation of penile prostheses manufactured by AMS. The complaint alleges strict product liability, negligence, breach of implied and express warranties, fraud and punitive damages, and seeks a declaratory judgment for medical monitoring.

On December 29, 1994, Vorhis filed a motion for class certification. On January 5, 1995, the district judge entered an order setting a hearing for January 27, 1995, later extended to February 24, 1995.

On January 20, 1995, AMS moved to stay or defer a ruling on the class certification question, based on virtually identical actions that had been previously filed. AMS informed the district judge that Miles v. American Medical Sys., Inc. & Pfizer Inc., No. C-94-1808 (N.D.Cal.), filed in May of 1994, 2 was

Page 1075

scheduled for hearing on the class certification question scheduled on March 3, 1995, 3 and that three other earlier actions, now consolidated in district court in Minnesota, 4 had a class certification hearing date of May 5, 1995. On February 14, 1995, AMS also filed a motion to dismiss based on lack of personal jurisdiction or to transfer based on improper venue. The district judge never ruled on either motion.

After expedited discovery, AMS submitted a brief in opposition to the class certification motion on February 17, 1995. Plaintiff filed his reply brief on February 23, 1995.

At the class certification hearing, the district judge indicated that he was concerned principally with the question of whether Vorhis was an appropriate class representative, and directed AMS to proceed first. AMS challenged Vorhis' suitability as a class representative on several grounds. First, AMS pointed out that Vorhis had a history of psychiatric problems, for which he received total and permanent disability benefits from the State of Ohio. AMS introduced reports prepared by Vorhis' psychiatrist and psychologist showing that Vorhis suffered from memory loss, impaired concentration, and a lack of common sense, all factors which AMS maintained would interfere with plaintiff's ability to make rational decisions on behalf of other members of the purported class. AMS also contended that Vorhis was an unsuitable representative because his need for the prosthesis stemmed from a unique condition, Peyronie's disease, or curvature of the penis. Third, AMS argued that because Vorhis had a problem with only one of the ten types of prostheses AMS manufactured, he could not represent those who had problems with the other kinds of devices.

In response to AMS' first argument, plaintiff offered the deposition testimony of his treating psychiatrist, Dr. Edelstein, who opined that Vorhis was competent to withstand the rigors of trial. As to defendant's third argument, plaintiff countered that the basic design of all ten devices was the same. Plaintiff pointed to a section 510(k) notice document 5 for the AMS 700 Ultrex Penile Prosthesis (the second AMS prostheses used by Vorhis) stating that all but one of the device's components were indistinguishable to those previously marketed. Vorhis did not directly respond to AMS' second argument.

The judge made no factual findings but took the matter under advisement. However, at the conclusion of oral argument, the district judge queried:

THE COURT: "Do you agree that if [plaintiff's counsel] adds class plaintiffs, that argument's [regarding Vorhis' psychological fragility] moot?"

[AMS' COUNSEL]: "If those class plaintiffs are appropriate, absolutely."

On February 28, 1995, the district judge issued a two-page order stating, "based upon the information currently available to it, that class certification appears to be the most efficient and appropriate manner in which to handle this matter," and promised a "further order outlining the reasoning supporting that conclusion" to follow. The order was conditional, subject to decertification at any time, and conditioned further "upon class counsel acting to amend the complaint within thirty (30) days ... in order to add additional plaintiffs who qualify as appropriate class representatives and who are free of the alleged infirmities on which Defendant's objections

Page 1076

to the suitability of the current Plaintiff/class representative are premised." Id.

On March 10, 1995, Vorhis filed an amended complaint, adding three additional plaintiffs as class representatives and Pfizer as an additional defendant. 6 AMS and Pfizer were both served with the amended complaint on March 13, 1995. Plaintiff neither sought nor obtained leave of court to add Pfizer as a defendant, as required by Federal Rule of Civil Procedure 15(a).

Without any further discovery, briefing, or argument, the district judge issued an amended order of class certification on March 16, 1995. The judge found that all the prerequisites of Fed.R.Civ.P. 23(a) 7 had been met, and that the class was maintainable under Fed.R.Civ.P. 23(b)(3) 8 because common questions of law or fact predominated. As to "numerosity," the court held:

It is asserted that the class to be certified consists of 15,000 to 120,000 persons. The United States Court of Appeals for the Sixth Circuit has previously held that a class of 35 was sufficient to meet the numerosity requirement. Afro American Patrolmen's League v. Duck, 503 F.2d 294 (6th Cir.1974).

Amended Order dated March 16, 1995, at 2. Regarding "commonality," the judge stated:

As persons who have undergone implantation of Defendants' inflatable penile prostheses [Plaintiffs] appear to have a common right to assert a claim against Defendants.

Id. at 3. For the third requirement of subsection (a), "typicality," the judge held:

The proposed representatives of the class assert claims that are typical of the class in

Page 1077

that all plaintiffs allege injury from the American Medical Systems, Inc./Pfizer, Inc. inflatable penile prostheses manufactured and distributed by Defendants. These claims are similar enough to those of the class that the representatives will adequately represent such class. General Telephone v. Falcon, 457 U.S. 147, 157, 102 S.Ct. 2364 [2370], 72 L.Ed.2d 740 (1982).

For purposes of the determination of liability at least, the claims of the representatives are the claims of the class. (Footnote omitted.)

Id. On the question of "adequate representation," the judge opined that

This Court has considered the qualifications of Plaintiffs' counsel and considers that they have sufficient experience and ability to fairly and adequately protect the interests of the class. Senter v. General Motors, 532 F.2d 511 (6th Cir.1976).

Id. Finally, the judge found the class maintainable under Rule 23(b)(3), stating:

There is an assertion here that there may be thousands of persons who are in the same position as Plaintiffs. Plaintiffs have asserted causes of action in fraudulent and negligent misrepresentation, failure to warn, negligence, strict liability and breach of warranty, both expressed and implied. Without determining the merits of Plaintiffs' claims, it is clear that a class action is far superior to numerous individual determinations of the same rights.

Id. at 4. The district judge therefore certified the class as:

All persons residing in the United States, who have had inflatable penile prostheses developed, manufactured and/or sold by Defendant American Medical Systems, Inc. and/or Defendant Pfizer, Inc. implanted in their bodies.

Id. (Attachment A).

In the notice attached to the class, the district judge named Vorhis as one of the parties that was bringing the class action lawsuit on behalf of all members of the class.

On March 13, 1995, AMS filed a petition for writ of mandamus pursuant to 28 U.S.C. § 1651 and...

To continue reading