Court orders USDA to disclose HLS investigation files

By Nick Taylor

- Last updated on GMT

Related tags: Contract research organization

A US court has ordered the USDA to disclose 1,017 pages of animal testing documents relating to its investigation into HLS, despite testimonies stating that their release could be detrimental to the CRO’s business.

The release follows a Freedom of Information Act request by In Defense of Animals (IDA), which sought to obtain documents relating to the US Department of Agriculture’s (USDA) investigation into Huntingdon Life Sciences (HLS).

IDA initially received 31 pages from the USDA, with the rest being fully or partially withheld under Exemption Four. In this case, and the District of Columbia Circuit, this allows withholding of proprietary information if its release could give an advantage to HLS’ competitors.

In his testimony to the court Michael Caulfield, general managed of HLS, argued that the documents contain information about the contract research organisation’s (CRO) standard operating procedures (SOP) that could be used by competitors.

However, a proportion of a CRO’s SOPs will be reflective of procedures required by applicable regulations and consequently similar at all organisations. In the judge’s opinion Caulfield failed to explain if the records reveal SOPs unique to HLS that could be advantageous to competitors.

Caulfield made further arguments, which can be found in the court document linked below, but failed to convince the judge.

Further debate

A second testimony was given by Robert Szot, a toxicology expert, which included the importance of ensuring the confidentiality of a client’s study.

Szot explained that if he worked at a pharma and discovered a CRO had released data he would never conduct another study with the company “regardless of the reason why it was released​”.

However, Exemption Four only allows the withholding of information that would be advantageous to competitors, not documents that are detrimental to the defendant’s relationship with clients.

Consequently the judge regarded this argument as insufficient to warrant withholding the documents. Other arguments are put forward in the testimonies but ultimately the judge decided that neither speaker “established a likelihood that disclosure would cause a competitive harm​”.

IDA filed the lawsuit in 2002. The judge’s Memorandum Opinion can be viewed here​.

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