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PFIZER RESPONDS TO LAWSUIT FILED AGAINST HOWMEDICA

 NEW YORK, Jan. 29 /PRNewswire/ -- Pfizer Inc. (NYSE: PFE) today released the following statement on the lawsuit filed against Howmedica:
 Pfizer Inc and Howmedica Inc. have not yet been served with the complaint, and therefore cannot comment on the allegations it reportedly contains.
 The specific PCA hip socket identified in the plaintiff's press release was manufactured and sold by Howmedica for nearly a decade, has been rigorously evaluated by FDA, and is safe and effective when appropriately selected and implanted by surgeons. Howmedica intends to defend the product and this lawsuit fully and completely.
 BACKGROUNDER
 Orthopedic devices have developed over time as new designs, materials, and fixation methods have become available. The Howmedica PCA one-piece hip socket was marketed from 1983 to 1990 and was gradually succeeded by the two-piece hip socket, introduced in 1986, that allows adjustments to the polyethylene cup during implantation.
 No orthopedic implant, whether or not cemented, has ever been perfect. Improvements are constantly sought and often found. Each involves trade-offs in dealing with diseased or injured bone. Some diseased or injured natural bones and joints are not curable or repairable. Estimates indicate that up to 15 percent of all hip replacement operations including all prostheses from all manufacturers involve revision surgery of previous implants.
 In the Kearse case, despite numerous requests for information over the past six months since Mr. Kearse first contacted Howmedica, no information has been supplied about what product has been at issue, what has allegedly gone wrong with the product or what the injury is. All Howmedica has been told is that he received his implant in his late 20s and had the implant for seven and a half years before it was removed for undisclosed reasons.
 Howmedica's experience with the product has been positive. As Howmedica advised the FDA in 1991, of the nearly 100,000 devices shipped over the last seven years, the company has received a total of 160 complaints for all reasons including those unrelated to product function (for example, aesthetics) associated with the acetabular component. This translates into a cumulative gross complaint rate of 0.2 percent over seven years even allowing for the difference between reported events and actual events, this low rate indicates a safe product.
 The product was approved by FDA for use with bone cement and a Premarket Approval application (PMA) following extensive clinical testing was also prepared and filed for use without cement. The Orthopedic Advisory Panel of the FDA recommended approval of the device and the FDA issued an approvable letter for the device for use without cement. However, before the PMA was approved, FDA reclassified the category of devices so that they did not require a PMA.
 This case should have not been filed as a class action and should not be certified as one. Class action status is not appropriate considering Howmedica's experience with this product; the fact that the FDA has fully reviewed its safety and effectiveness; and that it is a personal injury claim. Instead, this case appears from the lawyer's press release to be more in the nature of mass advertising than good faith litigation.
 -0- 1/29/93
 /CONTACT: A. A. Biesada, 212-573-2055, or Rick Honey, 212-573-2051, both for Pfizer/
 (PFE)


CO: Pfizer Inc; Howmedica Inc. ST: New York IN: MTC SU:

LR -- NY068 -- 0853 01/29/93 15:06 EST
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Date:Jan 29, 1993
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