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The Importance of NDC Codes in Pharmaceutical Litigation

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There are areas of litigation where it’s important to conduct discovery prior to agreeing to representation, and those include pharmaceutical litigation and defective medications.  There are numerous multidistrict litigation panels that have been instituted over allegations of defective medication, and there are numerous other cases out there involving medications that are not part of an MDL.

National Drug Code (NDC)

The most important issue in the representation of a client in a defective medication suit is the NDC Code.  Even if you have a client with catastrophic injuries, it is first necessary to determine if the medication was labeled or manufactured by the target defendant.  For example, if your client was prescribed the generic version of a brand medication that has been found defective, you can still maintain a cause of action under the theory that the brand medication actually created an entire market for defective knock-offs.  However, as you can imagine, this is not an optimal cause of action, and it very well could be fatal to your client’s claim, even if your client has suffered injuries or death in a way that is medically linked to the medication.

The prescription itself will normally indicate the labeler or manufacturer of the medication in an abbreviated manner.  However, the FDA (along with others) maintains an online database and directory of NDC Codes.  If your NDC code returns with the target defendant as the manufacturer, you should then have your client screened by a capable and experienced medical expert to determine issues of causation.

Screening and filing suit

Once you receive the results of that screening, if you have a case, you should immediately file suit in a court of competent jurisdiction so as to preserve all viable claims of defective medication, personal injury, wrongful death, etc.  In the event the defective medication is already a part of a national MDL, you should research the case on Pacer and prepare the “Short Form” Complaint for filing.

Once your claim is on file, it is likely that it will be necessary for you and your client to complete and submit a Plaintiff Fact Sheet and a Product Identification Fact Sheet.  These discovery tools will be replete with questions about the consumption of the medication, along with a request for verification of the NDC Code.  By this point, you will already have all the information you need to accurately and fully respond to these discovery requests.

The process of screening and filing defective medication cases can be somewhat daunting.  For these reasons, it is imperative to hire a medical malpractice lawyer Little Rock AR relies on experienced in pharmaceutical litigation.


HFThanks to Steve Harrelson and our friends and co-contributors from Harrelson Law Firm, P.A. for their added insight into pharmaceutical litigation.

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