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Consulting a Regulatory Expert in a Virginia Defective Drug/Device Case

January 25, 2013 by The Parrish Law Firm

Parrish Law Firm, PLLC works with Virginia residents in defective pharmaceutical drug and device cases in the hopes of obtaining compensation from the pharmaceutical company in question. The success of such a case is determined in part by the quality of the regulatory expert, i.e., someone who understands the laws of product labeling and recalls and can give testimony in support of a case.

Goals of the Regulatory Expert

The regulatory expert will set out to assist in proving one or more (if applicable) of these three claims:

  • The defendant should have placed a warning on the labeling of the product.
  • The warning on the label was insufficient.
  • The product in question should have been recalled.

Selecting a Regulatory Expert

Firstly, we will consult with a regulatory affairs specialist early in the process in order to assess the strength of the defective drug/device case and the possibility of moving towards litigation. If we find that there is strength enough for litigation after consultation, we will prepare the regulatory expert to give testimony in court.

We will look for the following traits in a regulatory expert:

  • He or she has a Regulatory Affairs Certificate, the only certification particular to the profession.
  • He or she has a background in affairs similar to the case at hand.
  • Whether he or she has a background on the industry or government side of regulation.
  • He or she has a considerable background in science that will allow him or her to determine the scientific relevance of the dangerous event.

Preparing the Regulatory Expert

The keys to the regulatory expert’s testimony are as follows:

  • The expert can give opinions on industry standards based on statistics and facts, as well as provide information on the Food and Drug Administration’s regulatory framework.
  • The expert can give information on industry standards in terms of when a warning is added or amended on a product label, or when and why a product is recalled.
  • Joining with the regulatory expert, we would attempt to prove that the pharmaceutical company had a duty of reasonable care (the defendant had a duty to take remedial steps). The expert would also bring up facts that would put the pharmaceutical company on notice of a health danger (the safety signal).

Parrish Law Firm, PLLC is committed to doing everything we can to help you obtain fair compensation in a defective drug or device lawsuit. Call us today at 703-906-4229, or fill out a free case consultation form.

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