Pfizer, Inc. v. Stryker Corp.

348 F. Supp. 2d 131, 2004 WL 2750090
CourtDistrict Court, S.D. New York
DecidedDecember 2, 2004
Docket02 Civ.8613(LAK)
StatusPublished
Cited by33 cases

This text of 348 F. Supp. 2d 131 (Pfizer, Inc. v. Stryker Corp.) is published on Counsel Stack Legal Research, covering District Court, S.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Pfizer, Inc. v. Stryker Corp., 348 F. Supp. 2d 131, 2004 WL 2750090 (S.D.N.Y. 2004).

Opinion

MEMORANDUM OPINION

(Corrected)

KAPLAN, District Judge.

In 1998, Pfizer, Inc. and MTG Divestitures, Inc. (collectively “Pfizer”) sold its prosthetic joint and implant business to Stryker Corp. and Howmedica Osteonics Corp. (collectively “Stryker”) for $1.6 billion. The pertinent agreements provided, broadly speaking, that Pfizer would retain liability for third party product liability claims arising in respect of prosthetic joints sold prior to the closing, while Stryker would be responsible for claims relating to joints sold after the closing. Once the deal closed, however, the parties each sought to shift responsibility to the other with respect to a particular prosthetic joint, the Duracon Uni-Compartmental Knee, on a variety of theories. Discovery having concluded, Pfizer moves for partial summary judgment on certain of its *135 claims. Both sides move for summary judgment on certain of Stryker’s counterclaims.

I

A. The Duracon Uni-Compartmental Knee

The Duracon Uni-Compartmental Knee system (“DUK”) is a prosthetic knee implant that was manufactured by Howmedi-ca, Inc., a former Pfizer subsidiary, and used to replace a part or a condyle of a knee. 1 The DUK has two components, a femoral piece made of cobalt chrome and a tibial component made of ultra high molecular weight polyethylene (“UHMWPE”) packaged in standard atmospheric conditions and sterilized through a process of gamma sterilization in air, also known as conventional radiation sterilization. 2

The DUK first was approved by the FDA in 1993. The tibial components were manufactured in Limerick, Ireland, between May and September of 1993 and shipped to Pfizer’s Rutherford, New Jersey warehouse for distribution in the United States. 3 As a result of Pfizer’s effort to redesign the femoral component, however, the DUKs were not distributed in the United States until May of 1997. 4

UHMWPE degrades over time when not implanted. 5 In accordance with FDA regulations, Pfizer adopted a policy in 1996 that all conventionally radiation sterilized UHMWPE products should not be sold for implementation more than five years after their manufacture. 6 Pfizer’s policy also prohibited distribution of UHMWPE products more than four years after their manufacture, although the scope of this aspect of the policy is unclear. 7

In order to implement this five year rule, Howmedica created a computer program, known as the SPCS or Poly Filter File, to track UHMWPE products and ensure that they were not shipped after they expired. 8 Although the SPCS was primarily responsible for tracking UHMWPE products, some Pfizer warehouse employees testified that they were supposed to check the labels of devices and manually remove those that had been manufactured more than five years earlier. 9

In late 1996 or early 1997, Howmedica decided to sell the DUK in the United *136 States and put together a team to launch the product and repackage the tibial components. As part of this effort, the team redesigned the label to indicate the date on which the components were manufactured. 10 Certain members of the Howmedica team had concerns about marketing the DUK so close to the time at which it no longer could be implanted. 11 For example, Paul Amregian, a packaging engineer for Howmedica, expressed concerned that the product was being released too close to the date after which it no longer should have been distributed. 12 Other employees expressed concerns about the timing of the release as well, specifically with regard to the Pfizer policy that UHMWPE products not be distributed more than four years after being manufactured. 13 In any event, Howmedica began to market the products in May of 1997 and reordered new products from Ireland for sale after the tibial components manufactured in 1993 were too old to be used. 14

None of the DUK components manufactured in 1993 was entered into the SPCS. 15 In a memo dated March 11, 1997, Robert Blair Harvey, then manager of regulatory compliance at Howmedica, requested that Douglas O’Connor, a Howmedica employee who worked on the development of the SPCS, 16 enter the catalog numbers of the DUK products into the SPCS. 17 Mr. Harvey never followed up on this request and Mr. O’Connor cannot recall receiving such a request, although he has no reason to suspect that he did not. 18 Mr. O’Connor testified that he did not know why the DUKs were never entered into the system and surmised that it was an oversight. 19 Similarly, Elizabeth Staub, an employee of Howmedica Osteonics Corporation, testified, on the basis of corporate documents she had reviewed, that she could find no reason why the DUKs would have been excluded from the tracking system. 20 Although Mr. O’Connor testified that the system had been tested thoroughly, he acknowledged that it was limited in scope and, at the time in question, did not include products manufactured outside the United States. 21

The first DUK tibial components were sold in the United States in or around May of 1997. 22 The tibial components continued to be sold and implanted in patients *137 until sometime in early 2000. 23 It is undisputed that some of the DUKs were sold and implanted more than five years after they had been manufactured and sterilized. 24

B. The Purchase Agreement

On August 13, 1998, Pfizer and Stryker entered into a written stock and asset purchase agreement pursuant to which Stryker bought Pfizer’s specialty trauma and prosthetic joint business, which primarily took the form of the Howmedica Corporation. 25 On December 4, 1998, the deal closed and Howmedica changed its name to MTG Divestitures, Inc. The new business was incorporated into Stryker as the Howmedica Osteonics Corp. (“HOC”). 26

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Bluebook (online)
348 F. Supp. 2d 131, 2004 WL 2750090, Counsel Stack Legal Research, https://law.counselstack.com/opinion/pfizer-inc-v-stryker-corp-nysd-2004.