19th April 02:42
Wall Street Journal--Dow Falsified Data
Thanks to Pam, for sending us the following from the evidentiary files
of breast implant litigation. . .Myrl
WALL STREET JOURNAL (J)
Dow Corning Employees Falsified Data On Breast Implants, Counsel
By Thomas M. Burton
Staff Reporter of The Wall Street Journal 11/03/92
Dow Corning Co. employees for several years falsified certain
do***ents concerning the manufacture of its silicone breast implants,
an outside counsel to the company concluded. The Midland, Mich.,
company, while maintaining that the issue has no implications for
women's health, disclosed that it supplied the Food and Drug
Administration with incomplete and thus inaccurate data earlier this
year because of the falsified records. Dow Corning said the internal
manufacturing records were "infrequently" falsified and that employees
have been disciplined.
Although the company was aware of the problem in 1987, it never made
its findings public and it never alerted the FDA until now. Senior FDA
officials said they are investigating the altering of do***ents by Dow
Corning, a joint venture of Dow Chemical Corp. and Corning Inc.
Griffin B. Bell, the independent counsel and former U.S. attorney
general, turned up evidence of the inaccurate records while conducting
a nine-month investigation for the company. The records in question
deal with the temperatures at which liquid silicone was heated, or
"vulcanized," before being placed in the implants.
That heating process is what turns liquid silicone into a. thicker gel
with less tendency to ooze from the implant throughout the body. It is
this migration - called gel bleed - that is at the center of the main
dispute over implants. The lengthy dispute has spawned hundreds of
product-liability lawsuits over the safety of the devices.
Many physicians and researchers contend the migrated silicone causes
illnesses of the auto-immune system and other maladies. An FDA panel
decided that evidence of a link with disease was of concern but
inconclusive; however, the agency sharply curtailed the sale of
The altered records were filled out after ovens stopped and had to be
restarted, the company maintained. The employees in many cases filled
out records to hide from company inspectors the fact that the ovens
had stopped. Keith R. McKennon, Dow Corning chairman, said there was a
possibility the process could have produced insufficiently high
temperatures. However, he said he was "satisfied there weren't cases
where there was insufficient time and temperature" devoted to cooking
Plaintiff lawyers and scientists who have testified for plaintiffs in
lawsuits against Dow Corning said the disclosure of altered do***ents
suggests the silicone in the implants wasn't of uniform consistency or
chemical content, raising questions about women's health and the
Further, they attacked the company for releasing only Mr. Bell's
recommendations - and not the body of his report, which contains most
of its factual findings. The company declined to make the entire
report public, asserting attorney-client privilege.
"If there are these inconsistencies in the heating, then all their
representations about uniformity are potentially untenable," said Marc
Lappe, health policy professor at the University of Illinois at
Chicago and an FDA panel member. "This raises fundamental questions
about the homogenity of the material, which is critical."
"This is exactly what we suspected for years, but we always gave the
companies the benefit of the doubt," said Pierre Blais, a chemist who
formerly was senior scientific adviser to Canada's national health
agency. "We never before could fathom why implants of one
manufacturing series were violently reactive in some patients and not
in others." He suggested insufficiently vulcanized gel can react more
inside women's bodies than properly treated silicone.
San Francisco lawyer Leroy Hersh, who handled the earliest lawsuits
against Dow Corning dating back to 1984, said, "We have gotten
do***ents through 1992 and have never seen anything that begins to
reveal this sort of disclosure." Minneapolis plaintiff lawyer Martha
K. Wivell said the revelation "comes as a big surprise and could
potentially be a criminal violation of the FDA statute." Mr. Bell and
colleagues at his Atlanta law firm, King & Spalding declined to
Mr. McKennon said the findings don't have health implications because
company inspectors scrutinized every implant before it was shipped
out. He said Dow Corning quality inspectors originally turned up the
do***ent discrepancies in 1987. The practice stopped then, and
employees were "disciplined" but not fired, Mr. McKennon said.
However, the finding wasn't made public until turned up by Mr. Bell's
investigators and disclosed yesterday.
Dow Corning in a statement said the company couldn&'t determine which
lots of breast implants were associated with altered charts about oven
temperatures - referred to as replacement charts by the company. Thus,
the company said, "the log of a-typical lots reviewed by the FDA in
1992 did not refer to the lots containing replacement charts."
"There is no way to tell one of these substituted temperature charts
from the good ones," said Mr. McKennon. He said the alterations were
"infrequent, but occurred over several years prior to 1987." The
discrepancies were first discovered when Dow Corning inspectors saw
two different charts for the same oven for heating silicone gel.
Dow Corning announced earlier this year that it was ceasing to
manufacture breast implants and that it would sell its health-products
division. It said it would spend $10 million or more on research into,
the safety of silicone implants. Meanwhile, federal lawsuits on
implants are consolidated in federal district court in Birmingham,