Allegations Against 3M Corporation of Possible "Negligence and Recklessness" by The Porton Group, the Equity Partner of the British Ministry of Defence, for "Botched" U.S. Testing of Lifesaving Device to Detect the MRSA "Superbug"/Staph InfectionBy The Porton Group, PRNE
Tuesday, May 10, 2011
At an International Press Conference in Minneapolis, U.S. Attorneys for Porton Petition FDA to Investigate 3M for Allegedly Ignoring FDA Advice, Failing to Disclose Secret Internal Technical Committee Report on Testing Errors, and for Possible Financial Conflicts of Interest
MINNEAPOLIS, May 11, 2011 - The famous U.S. 3M Corporation today was alleged by the private equity
partner of the British Ministry of Defence, the Porton Group, to have
exhibited "negligence and possible recklessness putting lives at risk" due to
3M's "botched" 2007 clinical trials of a medical device called "BacLite,"
which can detect within five hours the presence of the potentially deadly
MRSA/staph "superbug." The trials were conducted after notification of the
U.S. Food and Drug Administration (FDA) and after seeking FDA advice, which
3M proceeded to ignore, according to Porton and public legal papers.
MRSAs have killed more people annually than AIDS. The only alternatives
to BacLite's inexpensive, five-hour or less detection system available today
are either far more expensive, DNA/molecular detection systems, or growth
solutions, which take 1-2 days to detect the presence or absence of MRSAs.
BacLite was invented by researchers in the British Ministry of Defence using
photo-fluorescent technology based on the firefly and originally seeking to
identify biological weapons of mass destruction, such as Anthrax.
At a press conference today in Minneapolis, next door to "twin city" St.
Paul, Minnesota, home of 3M's international headquarters, attorneys for
Porton, Lanny J. Davis of Washington, D.C. and Robert Hopper of Minneapolis,
cited a secret report by an 11-member internal 3M technical committee that
confirmed 3M testers had made fundamental errors that led to unacceptable 50%
reliability results. These results were in contrast to the 95%+ results
achieved in 2006 in British-run trials when the Porton and the U.K. Ministry
of Defence still owned BacLite, i.e., meaning European Union (EU) regulators
allowed the sale of BacLite to British hospitals to begin in 2006 based on
verifiable test trial results.
The secret 3M report cited many errors by 3M testers such as
refrigerating the "comparator" solution at temperatures colder than test
protocols permitted, thus artificially impeding the growth of MRSAs; and the
use of a different comparator solution than had been used in the successful
European trials, despite FDA's allegedly express approval of using the same
comparator as was used in Europe.
Background of 3M Purchase of BacLite
In approximately late 2006, 3M's chairman and CEO, George Buckley,
through an intermediary, sought to purchase rights to the British Ministry of
Defence-invented "BacLite," a rapid, inexpensive, MRSA-detection device
approved for sale in Europe in 2006. A purchase and sale contract was signed
in February 2007 between 3M and the combined company, Acolyte, comprising the
British- Ministry of Defence-wholly-owned subsidiary, Ploughshare, and a
group of equity investors called The Porton Group. 3M had approached Acolyte
and argued that it was in the best position to maximize global sales of
BacLite given its own health products division expertise and its global
experience. 3M did due diligence on the efficacy of BacLite, including data
from the U.K. clinical trials, and after its purchase, touted those data from
the U.K. trials and the reliability of BacLite on its own website and its
marketing procures. (See Exhibit A, H).
In the purchase and sale contract signed in February 2007, 3M promised to
"actively" market BacLite and to obtain regulatory approvals "diligently" in
the U.S., Canada, and Australia.
At an international telephonic press conference held today in
Minneapolis, Minnesota, a short distance from 3M's corporate headquarters in
St. Paul, Minnesota, Porton's U.S. attorneys, Lanny J. Davis of Washington,
D.C. and Robert Hopper of Minneapolis, Minnesota, announced they were filing
today a "citizens' petition" and letter with the FDA seeking an investigation
of 3M and a public hearing under applicable FDA regulations.
Grounds for FDA Investigation and Hearing
The attorneys cited at least three grounds for FDA under applicable
regulations to conduct such an investigation and public hearing in claiming
there was evidence that 3M had possibly misled the FDA when it:
- failed to disclose to FDA the contents of the secret technical report
on the multiple errors leading to failure of the U.S. trials;
- failed to explain why another round of tests were not conducted
consistent with its own technical committee's and FDA's advice; and
- failed to disclose possible financial conflicts of interest that might
explain such 3M decisions as:
- not re-doing the clinical trials in November 2007 to correct the errors
pointed out by its own internal technical committee in their secret report;
- withdrawing BacLite entirely from the European market at the end of
2008, one year from the term of the purchase and sale contract;
- at the end of 2008, removing BacLite system equipment from some U.K.
hospitals, despite being told by some hospital personnel that, according to
one physician, BacLite was "easy to use" and "very reliable" and "could save
- in May or June 2009, with more than six months to go in its purchase
and sale contract, appearing to announce an effort to sell its own more
expensive competitor to BacLite called "FastMan," which used molecular
technology to detect MRSAs but had not met reliability standards (and still
hasn't). (Just recently, on its Internet cite, 3M's medical products division
is promoting apparently another similar product, "Simplexa.")
Statements by Equity Investors and British Government Co-Owners of
Harvey Boulter, the CEO of the Porton Group, issued a public statement
"We trusted 3M when they urged us to sell after promising in writing they
would 'actively market' this product globally and, specifically, would
'diligently' seek to obtain regulatory approvals in the U.S., Canada, and
Australia" through the end of 2009," Mr. Boulter continued. "But we believe
they broke that promise, and we believe it is possible that, as a result,
hospital patients in Europe, the U.S., and all over the world could have been
unnecessarily exposed to MRSAs."
"We will not rest," he stated, "until 3M is held accountable for walking
away from its obligations."
The CEO of the company wholly owned by the British Ministry of Defence,
Mr. Pete Hotten, also issued a written statement, unusual for a
representative of the British government.
Mr. Hotten stated: "We are disappointed that 3M Corporation failed to get
an excellent diagnostic technology [to detect MRSAs in incoming hospital
patients] into the market, though what 3M's own [technical committee]
officials describe as avoidable mistakes. [We] believe 3M's decision not to
correct their mistakes and to reapply for FDA approval is contrary to its
obligation to its partners."
Legal Authorities for Porton Petition and Request for FDA
The two attorneys who signed the public petition to the FDA and the
letter, Messrs. Davis and Hopper, cited several FDA regulations as the basis
for their request for an FDA investigation and public hearing, including a
regulation permitting an administrative hearing and a third-party citizens'
petition when there is evidence of misconduct that could affect the public
health (21 C.F.R. Sections 10.25, 10.30, 12, 13, 14, 15, or 16 and 54.2), and
specifically, to look into any potential financial conflict of interests by
3M that could have influenced the outcome of its clinical trials (21 C.F.R.
In addition, in their letter to FDA the two Porton attorneys cited
additional FDA regulatory authority: (1) to initiate an audit of data derived
from the 3M investigators and its own internal (and still secret) technical
report concerning 3M's fall 2007 BacLite clinical trials; and (2) to appoint
an independent clinical investigator to re-conduct the 3M trial study because
of the serious public health - potential life-death ramifications of 3M's
clinical trial failure and errors pointed out by its own technical committee.
Authority for European / British Independent Public Health Investigations
The Porton attorneys also cited International Cooperation Agreements
between the EU and its European Medicines Agency, the U.K.'s Healthcare
Products Regulatory Agency (MHRA), and the FDA to allow the EU to request
documents and to conduct its own investigation of 3M's BacLite clinical trial
failures and the reasons they occurred, in contrast to the successful trials
qualifying BacLite for sale within the EU.
"To this end, we intend to petition the EU European Medicines Agency and
the U.K. MHRA to invoke their authority pursuant to International Agreements
[and their own Good Clinical Practices Directives] to…undertake an
investigation of 3M Corporation regarding its failed clinical trials," Davis
and Hopper wrote in their letter to FDA.
In fact, the two Porton attorneys cited the U.K.'s Healthcare Regulatory
Agency's requirements to conduct such an investigation when it is presented
with "evidence that shows significant and unjustified departures…for the
conduct of clinical trials, especially when such evidence shows the clinical
data to be unreliable and/or there exists a number of non-compliances across
areas of responsibility, indicating a systemic quality assurance failure" -
"as is the case," Davis and Hopper wrote, "with 3M Corporation and the
BacLite clinical trials."
FOR FURTHER INFORMATION: GO TO www.MRSA-INJUSTICE.com
(SEE FDA LETTER, ATTACHED FACTUAL CHRONOLOGY, RELEVANT DOCUMENTS, AND
OTHER RELEVANT INFORMATION ON WEBSITE.)
FOR FURTHER INQUIRIES CALL: U.S. MEDIA: Robert R. Hopper & Associates: +1-(763)-476-5809 firstname.lastname@example.org Maddie Melendez: +1-(202)-756-8293 email@example.com EUROPEAN MEDIA: Catherine Nicholls: +44-7789-644-979 firstname.lastname@example.org
Tags: May 11, Minneapolis, The Porton Group, United Kingdom, United States of America