Reporting Reg Chapman
ST. PAUL (WCCO) — 3M Corporation is under fire after a private equity partner of the British Ministry of Defense alleged the company botched a clinical trial of a product designed to save lives.
The Porton Group claims 3M exhibited negligence and possible recklessness, and put lives at risk.
The group wants the U.S. Food and Drug Administration to conduct an administrative proceeding and then hold a public hearing to receive evidence and testimony regarding 3M’s clinical trials of “BacLite.”
BacLite was invented and patented by the British Ministry of Defense and was approved by the European Union regulators in 2006. It’s used for the detection of the antibiotic resistant staph infection, called MRSA.
The EU regulators found over 95 percent reliability that BacLite could accurately detect the presence of the superbug within five hours, compared to using a Petri dish growth method that could take two or three days.
According to attorneys for Porton, 3M Corporation stepped forward with an offer to buy the patented MRSA detecting biotechnology with the promise to actively market BacLite in Europe and to further market it after getting regulatory approval in the U.S., Canada and Australia.
Attorneys claim 3M botched the clinical trials, chose not to re-do the trials and ignored the findings of its own internal technical committee.
3M claims to have done nothing wrong and says the device was defective.