Printer Friendly

INAMED SUBSIDIARY FILES SUIT AGAINST FDA, COMMISSIONER KESSLER; COMPANY CALLS AGENCY'S BREAST IMPLANT REVIEW SCIENTIFICALLY, LEGALLY FLAWED

INAMED SUBSIDIARY FILES SUIT AGAINST FDA, COMMISSIONER KESSLER; COMPANY

CALLS AGENCY'S BREAST IMPLANT REVIEW SCIENTIFICALLY, LEGALLY FLAWED
 SANTA BARBARA, Calif., Feb. 13 /PRNewswire/ -- Charging Food and Drug Administration Commissioner Dr. David A. Kessler and the FDA with unfairly manipulating information regarding the safety of silicone-gel breast implants, McGhan Medical Corp., a wholly owned subsidiary of INAMED Corp. (NASDAQ: IMDC), today filed suit requesting the United States District Court for the District of Maryland to immediately shift responsibility for the investigation into the implants from Kessler to Secretary of Health and Human Services Louis Sullivan, M.D.
 Claiming violations of Fifth Amendment rights, McGhan, a manufacturer of both saline and silicone-gel implants, cited a litany of "unfair and illegal means" it said Commissioner Kessler used to ensure that manufacturers would be forced to remove implants from the market. The company also charged several members of the FDA's General and Plastic Surgery Devices Advisory Panel with "unfair and public bias" against the use of the products.
 Among the other actionable events alleged in the McGhan suit were public statements issued by Kessler indicating he had unlawfully prejudged the issue of implant safety; unprecedented limitations on manufacturers' ability to provide relevant information to the advisory panel; the use of unlawful procedures by Kessler in overturning the panel's recommendation to leave the implants on the market; and leaks of confidential and privileged information by the FDA.
 In its 25-page complaint, McGhan charged that before and during the panel review of implant premarket approval applications, Kessler limited the ability of the manufacturers to provide up-to-date information to the panel and encouraged it to reach a negative conclusion. The complaint also alleged that one of the commissioner's key advisors on the implant question is married to a senior attorney of Public Citizen, an organization which has played the leading role in seeking a ban on the implants.
 "We are not asking the court to reverse the current FDA moratorium," said McGhan spokesman Jan Varner. "All we are asking is that, for the sake of more than 2 million women who have implants in their bodies, a sound legal and scientific framework be established for resolving this vital medical issue."
 INAMED Corp. is a medical device company with 13 operating subsidiaries in the United States and Europe. The company develops, manufactures and markets medical devices for the plastic and reconstructive, bariatric and general surgery markets. INAMED reported sales of more than $35.7 million for the year ending Dec. 31, 1990, a 37 percent increase over sales during 1989.
 -0- 2/13/92
 /CONTACT: Jimmy Caplan of Market Makers, 805-569-6919, or Rick Eisenberg of Eisenberg Communications, 212-496-6828, both for INAMED/
 (IMDC) CO: INAMED Corp.; McGhan Medical Corp.; Food and Drug Administration ST: California IN: MTC SU:


KJ-CH -- LA009 -- 9755 02/13/92 12:30 EST
COPYRIGHT 1992 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Feb 13, 1992
Words:468
Previous Article:FEDERAL REALTY INVESTMENT TRUST AGREES TO ISSUE COMMON SHARES TO RETIRE $22,645,000 OF CONVERTIBLE DEBENTURES
Next Article:MCI OFFERS FREE VALENTINE'S CALLS TO THE MILITARY
Topics:


Related Articles
FDA PANEL RECOMMENDS BREAST IMPLANTS REMAIN ON THE MARKET
FDA CALLS FOR TEMPORARY MORATORIUM ON SILICONE GEL BREAST IMPLANTS
INAMED CORP. VOLUNTARILY SUSPENDS SHIPMENTS OF GEL-FILLED BREAST IMPLANTS
INAMED CORP. VOLUNTARILY SUSPENDS SHIPMENTS OF GEL-FILLED BREAST IMPLANTS
DOW CORNING CALLS UPON KESSLER TO IDENTIFY 'NEW INFORMATION' ECHOES ASPRS RECOMMENDATION OF NEW EXPERT PANEL
ASAPS STATEMENT ON RELEASE OF STUDIES & INTERNAL DOCUMENTS RELATED TO SILICONE-GEL BREAST IMPLANTS BY DOW CORNING
COALITION CALLS ON FDA COMMISSIONER TO REMOVE OTHER BIASED PANELISTS
INAMED SUBSIDIARY HALTS SUIT FILED AGAINST FDA AND COMMISSIONER KESSLER
INAMED CORP. ANNOUNCES RESULTS
AESTHETIC PLASTIC SURGEONS SAY FDA DECISION ON SILICONE GEL IMPLANTS IS 'TOO LITTLE, TOO LATE'

Terms of use | Copyright © 2016 Farlex, Inc. | Feedback | For webmasters