Porton Group, a private equity group, wants the FDA to investigate whether 3M botched clinical trials on BacLite, a product for detecting MRSA in hospitals. The group is already suing the company in the UK. Attorneys for the group said they would submit a citizens' petition to the FDA on behalf of the company, the Pioneer Press reports.
Back in 2007, 3M spent $20.4 million to acquire the BacLite, which incorporated technology developed for the British military to detect an attack by biological weapons, from Acolyte Biomedica. 3M, which makes a range of products that includes Scotch Tape and Post-It Notes, cited disappointing results from the trials as the reason for abandoning BacLite. The technology was already available in the EU at the time.
But Porton is accusing the company of mismanaging the trials to protect Fastman, a 3M-developed detection product, from the less expensive BacLite, according to the Dow Jones. Porton wants the FDA use an independent party to conduct a new round of clinical trials on BacLite.
"We will not rest until 3M is held accountable for walking away from its obligations," said Harvey Boulter, CEO of the Porton Group, in a news release, as quoted by the Pioneer Press. The release alleges that 3M exhibited "negligence and possible recklessness putting lives at risk."
Not so, says 3M's Fleming Runyon. She says BacLite had shortcomings in reliably detecting MRSA. She said by the time 3M pulled BacLite from the market in Europe in late 2008, there was already a "profound lack of acceptance by customers."