Round 2: 3M turns on Porton group after losing Round 1 in High Court.

3M Healthcare and UK Government and associated groups have been in dispute over claims that 3M “deliberately mismanaged” trials of its BacLite product.

3M Healthcare corporation has lost its dispute with representatives of the British Government over the company’s failure to market a diagnostic for MRSA developed within the Ministry of Defence(MOD).

The complainants have won $1.3 million in damages, whereas they were seeking $40 million – an outcome viewed by both sides as a success.

“the victims here are those infected with MRSA. A weapon in that fight was wrongfully abandoned by 3M.”

The BacLite medical device, which uses photoluminescence to detect MRSA bacteria, was purchased by 3M from Acolyte Biomedica, in which Porton Group and MOD were investors in 2007. The price was £10.4 million in cash with up to £41 million to be paid based on worldwide sales of BacLite in 2009.  3M had seemingly convinced Acolyte that it had the medical device expertise and the global sales and marketing expertise to take over successful sales of BacLite worldwide and specifically in four major markets – the EU, including the UK, the US, Canada and Australia.

However the product was subsequently abandoned by 3M as having failed the necessary clinical trials to support its marketing in the EU and the US.

BacLite is designed to detect MRSA within 5-6 hours, a rapid detection time that could save lives around the world.  Consequently it’s unsurprising that Porton Group CEO Harvey Boulter said; “the victims here are those infected with MRSA. A weapon in that fight was wrongfully abandoned by 3M.”

The complainants together claimed that 3M had deliberately mismanaged the BacLite trials in order to protect its rival (and more expensive) Fastman device.

The Judge said that 3M was not only in breach of its obligation to “actively market” BacLite but also failed to gain regulatory approval in the US.

“I find that from the end of March 2008 3M was in breach of its obligation diligently to seek regulatory approval for BacLite in the US and that had it complied with its obligation such approval would have been obtained by the beginning of February 2009,” the Judge said

However, the judge did not find that 3M had “intended” a breach of contract and thereby conducted the clinical trials dishonestly.

3M has now announced its intention to pursue charges in the US against the Porton Group for alleged attempts to “extort” an out-of-court settlement by threatening to use political influence.

Medtech Business observes that while the arguments rage on, the question of whether BacLite has the potential to improve worldwide treatment of MRSA remains unresolved.

Source: Digitaljournal.com, Medtech business, medlatest staff

published: November 8, 2011 in: Clinical Studies/Trials, Contracts, News, Products

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