Earlier this year, I spoke with medical product liability expert and lawyer, Sara Dyson, now an executive with MedMarc Insurance Group. As part of March's SmarterCompliance newsletter, her interview focused on ways to reduce drug and device product liability risks through effective supplier due diligence and vendor qualification.
SmarterCompliance: Does a product liability lawsuit emerge fairly quickly once the product is distributed or a clinical trial is run?
Dyson: On average, it takes about two years after the original problem for the lawsuit to materialize. This is why companies are so easily caught off guard. It’s not the most recent batch or lot that rolled off the production floor that is the subject of a lawsuit; it’s an historical lot or batch.
The lawsuit may resurrect a problem that the company has already otherwise addressed. Firms without an effective records retention schedule and policy will suffer as far too many old documents that were eligible for destruction were, instead, kept and are now available to the plaintiff to make his/her case.
SmarterCompliance: What makes the discovery phase of a lawsuit so dangerous? Is it because records, data, emails, samples, and so on from at least two years ago have to be turned over to the plaintiff’s lawyers?
Dyson: Yes. That’s why both the initial due diligence and ongoing monitoring of suppliers is so important. You want to have a good track record of documents showing your efforts to consistently evaluate and oversee your suppliers.
Additionally, too frequently, companies have not implemented document management plans or have out-of-date record retention rules, meaning that there is an abundance of documents that must be sorted through to locate relevant information. This then bogs down the discovery process and increases costs.
It takes about two years after the original problem for a liability lawsuit to materialize.
SmarterCompliance: What are some steps – beyond looking at additional research points during initial supplier evaluation – that supplier due diligence and oversight teams need to take?
Dyson: You may want to hire a third-party expert to show your supplier oversight team members how to review supplier oversight records to find hidden gaps and risks. For instance, a sponsor of a clinical trial run by a contract research organization (CRO) might want to hire a third party to train their clinical project managers on how to review the CRO’s qualification of various clinical sites, sort of a train-the-auditor type of session.
To read the rest of the interview and see all nine critical points that Ms. Dyson recommends be incorporated into your supplier management and qualification program, you'll need to subscribe to the monthly regulatory intelligence and quality system newsletter, SmarterCompliance.
You can read more ways to reduce medical products liability risks at MedMarc.