Suit claims 3M muffed approval for superbug test

A group of private investors from the United Kingdom is accusing 3M Co. of "negligence and possible recklessness" after 3M failed to gain U.S. regulatory approval of a technology that rapidly detects an antibiotic-resistant and potentially deadly superbug in hospitals.

The investors, known as the Porton Group, have sued in British courts alleging that 3M "botched" a clinical study needed to gain Food and Drug Administration (FDA) clearance for the technology, known as BacLite. The Maplewood-based company acquired the Porton-backed technology in 2007.

The test uses a special light to detect the superbug, methicillin-resistant staphylococcus aureus (MRSA), which is resistant to commonly prescribed antibiotics such as penicillin and amoxicillin.

Porton Group's lawyers have scheduled a news conference in Minneapolis for Wednesday morning.

They're calling on the FDA to investigate 3M's actions regarding BacLite and say they unearthed a "secret report" in legal filings indicating that 3M researchers made "fundamental errors" that led to poor study results that ultimately thwarted regulatory clearance in the United States. Porton Group's lawyers are also calling for the FDA to hold public hearings on the matter.

"We believe it is possible that, as a result, hospital patients in Europe, the United States and all over the world could have been unnecessarily exposed to MRSAs and possibly exposed to life-and-death risk" said Harvey Boulter, CEO of the Porton Group.

But 3M spokeswoman Donna Fleming Runyon said the company "thought it bought a fully developed technology that was ready to market. It wasn't." In addition, 3M discovered that BacLite suffered from "a profound lack of acceptance from customers," she said.

In 2007, 3M purchased Acolyte for about $16 million with the idea of using its vast global network to market the test abroad, as well as gain FDA clearance for a U.S. launch, according to lawyers from the Porton Group.

But 3M shut the business down in Europe in 2008. Instead, 3M pursued another MRSA test that, Porton Group's lawyers allege, is more expensive and takes far longer than BacLite.

A trial in the United Kingdom is set for this summer.

Superbug can be deadly

The MRSA bug spreads quickly and can be deadly. The U.S. Centers for Disease Control and Prevention (CDC), citing 2007 statistics, estimates one out of 20 patients will be infected with the bug if hospitalized, causing health care costs to skyrocket.

The Porton Group is led in the United States by Lanny Davis, former special counsel to President Clinton from 1996 to 1998, who is now in private practice in Washington, D.C., as well as Minneapolis-based lawyer Robert Hopper.