U.K. Firm: 3M Botched Clinical Trial

The Porton Group, a private equity firm based in the United Kingdom, claims that 3M Company "botched" the clinical trial of a product that 3M acquired through the purchase of a company in 2007. The firm is now asking that the FDA investigate 3M's trial for the product.

Maplewood-based 3M Company is weeks away from going to trial over claims that it “botched” a clinical trial for a product that it acquired in February 2007 and took off the market in December 2008.

A lawsuit against 3M was filed in 2008 by the Porton Group, a private equity firm in the United Kingdom that invested in Acolyte-a company that 3M purchased in 2007 and that developed a product called BacLite.

BacLite helps detect methicillin-resistant Staphylococcus aureus (MRSA), a type of bacteria that is resistant to certain antibiotics and occurs most frequently in hospital patients who have weakened immune systems.

The Porton Group claims that 3M exhibited “negligence and possible recklessness” through its “botched” clinical trial of BacLite that was performed in November 2007.

The firm also said that 3M promised in a purchase agreement to “actively” market BacLite and to obtain regulatory approvals “diligently” in the United States, Canada, and Australia through the end of 2009, but the product was discontinued in 2008.

But 3M claims that the BacLite product was not what it hoped or expected it to be. Donna Fleming Runyon, a 3M spokeswoman, told Twin Cities Business that the company purchased the product “with the expectation that it was fully developed and ready to market, but it wasn't.”

Runyon added that there was a “profound lack of acceptance of the product by consumers,” which also led to the company's decision to take it off the market.

On Wednesday, the Porton Group said that it would submit a citizens' petition and letter to the U.S. Food and Drug Administration (FDA) seeking an investigation and a public hearing to assess 3M's clinical trial and the “fundamental errors” that it made.

One of Porton's allegations regarding the clinical trial is that 3M used a different MRSA comparator, a solution used during clinical trials to determine the effectiveness of a product, than what had been used in other trials that were successful. But Runyon said the comparator that 3M used was deemed most appropriate by the FDA and the Clinical and Laboratory Standards Institute.

Porton also alleged that 3M refrigerated the testing solution at temperatures colder than test protocols permitted. Runyon denied that claim.

BacLite was invented by researchers in the British Ministry of Defense using photo-fluorescent technology and originally created to identify biological weapons of mass destruction, such as Anthrax. It was approved for sale in Europe in 2006.

3M is Minnesota's fifth-largest public company based on its 2009 revenue, which totaled $23.1 billion. The company reported revenues of $26.7 billion in 2010.