Controversy Stirs Over 3M BacLite MRSA Detector

May 12, 2011

A legal controversy is stirring over a device used to detect methicillin-resistant staphylococcus aureus (MRSA).  The device, called BacLite, works by emitting a special florescent light to detect MRSA quickly, within 3 hours.  This is much faster than conventional testing in petri dishes, and also less expensive than typical DNA testing.  A European clinical trial proved the device to be 95% effective.

The  device is currently owned by 3M.  3M purchased the patent for $17 million in 2007 from the British government and its private partner, Acolyte.  At that time, Baclite had been approved for use in Europe.  According to the terms of the purchase, once regulatory approval to market BacLite in the U.S., Canada, and Australia was obtained, 3M agreed to pay Acolyte shareholders an additional $67.1 million.

3M has failed to gain further regulatory approval.  Lawyers for a group of investors in the United Kingdom, the Porton group and the British government, have sued 3M in British courts alleging breach of contract, negligence, and possible recklessness.  They assert that 3M failed in its obligation to market BacLite in the U.S. and that it “botched” a clinical study needed to gain Food and Drug Administration (FDA) clearance.  The investors assert 3M failed to market the device because it owns a competing device, a more expensive molecular test.  The trial is set for this summer.

In addition to the suit in British courts, the investors are requesting the FDA to investigate 3M’s actions and to hold public hearings.  They want he FDA to use an independent party to proceed with a new clinical trial using BacLite.

Conversely, according to 3M, BacLite’s low success rate in detecting MRSA during the clinical trials convinced the company that the device could never be successfully marketed in the U.S.  3M’s spokesperson Donna Flemming Runyon stated the company “thought it bought a fully developed technology that was ready to market.  It wasn’t.”  Additionally, 3M determined that BacLite had a profound lack of acceptance from consumers,” she stated.

The following sources provide additional information:

Lyden, Tom.  British company calls on FDA to Investigate 3M over BacLite MRSA-detecting Device.  MyFox9.com.  May 11, 2011.

Tita, Bob and Sten Stovall.  Private equity firm wants FDA to probe 3Ms tests on medical device.  NASDAQ.  May 12, 2011.

Moore, Janet.  Suit claims 3M muffed approval for superbug test.  StarTribune.  May 10, 2011.

Moore, Janet.  Update on 3M superbug controversy.  StarTribune.  May 11, 2011.

 

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