What liability does the QA Manager/Management Rep hold? (US FDA environment)

[Kymmie]

Hi everyone! My first post here so please bear with me.

I'm fairly new to my position as QA Manager/Management Rep (1yr). The position didn't exist within my company until last year when we were inspected by the FDA and got handed a fistful of 483s. Suddenly, I got a new job.

My question is this... as QA Manager/Management Rep am I in anyway liable for practices of the company? I'm a fairly quick learner, and I think I have come a long ways in establishing a quality system for us. However, I'm having a very hard time getting everyone to comply. Also, with some things, the owner doesn't believe me when I tell him we need to go through approval processes, etc. He says "I've been doing things this way for 17 years why should I change now?"

(For example, he would like to manufacture a class III medical device for a client of ours that has not done ANYthing towards getting PMA - he just "has some doctors that would like to use the thing")

I don't want to get myself in hot water here. I appreciate any advice you have for me.

Thanks!

 

[Jen Kirley]

Welcome to the Cove!

I am afraid your first post here does not represent an encouraging scenario.

To fully understand the extent of your personal liability under a QMS operating under FDA rules, you should contact an attorney; I expect the civil liability could exceed the regulatory liability, but I can vouch the FDA's guidance on its Medical Devices 2. Quality Systems page:

Management Responsibility

As set forth by the QS regulation (820.20), one of the most important responsibilities of management when developing a quality system is to establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization. This means each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks. The QS regulation also requires that each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the GMP requirements. To meet these regulatory requirements, manufacturers are required to provide adequate resources, including the assignment of trained personnel for management, performance of work, and assessment activities, including internal quality audits.

 

[MIREGMGR]

There are two ways in which "liability" could matter: being targeted or affected in some manner by an FDA enforcement action, and becoming a defendent in a civil (or, hypothetically, criminal) legal action arising from some product-related circumstance or use-outcome.

The number of instances in recent years where FDA has taken enforcement action against senior managers of a medical device company--for instance, asking the court to approve their debarment from employment by a registered Establishment for some number of years--is quite small, and to my knowledge every such instance has involved strongly evidenced personal causative involvement by a senior corporate official in intentional subvention of the rules resulting in death or significant injury. In a situation like yours, where you may have a senior title but obviously are new to the job and have little real power and influence over the real decision maker, I think you are pretty much totally unlikely to be subject to such FDA action.

In a civil action, plaintiffs' lawyers include as a defendent everyone that has significant assets and might have a share of blame. I'd guess that compared to the company itself and the owner, you aren't rich. Therefore as a practical matter, you are unlikely to end up being a defendent.

Ditto regarding a criminal action. Your level of power and influence isn't great enough for a prosecutor to target you.

If any of the above were to come to pass, you might however be subpoenaed or equivalent, to tell what you know to the court. That isn't at all the same as liability, though.

Of course, I agree with Jennifer's recommendation that you consult an attorney for definitive guidance.

 

[Kymmie]

I appreciate both of your replys. Fortunately, the devices we deal in normally have very little chance of actually harming anyone. I hope I am on my way to convincing him not to go through with this most current "idea" of his re: the class III device - I have been bombarding him with information for the last 24 hrs as to why it's a bad move. However, given that these issues keep coming up I think I will take your advice and discuss the issue more thoroughly with an attorney. Thank you both.

 

[Wes Bucey]

There are two ways in which "liability" could matter: being targeted or affected in some manner by an FDA enforcement action, and becoming a defendent in a civil (or, hypothetically, criminal) legal action arising from some product-related circumstance or use-outcome.

The number of instances in recent years where FDA has taken enforcement action against senior managers of a medical device company--for instance, asking the court to approve their debarment from employment by a registered Establishment for some number of years--is quite small, and to my knowledge every such instance has involved strongly evidenced personal causative involvement by a senior corporate official in intentional subvention of the rules resulting in death or significant injury. In a situation like yours, where you may have a senior title but obviously are new to the job and have little real power and influence over the real decision maker, I think you are pretty much totally unlikely to be subject to such FDA action.

In a civil action, plaintiffs' lawyers include as a defendent everyone that has significant assets and might have a share of blame. I'd guess that compared to the company itself and the owner, you aren't rich. Therefore as a practical matter, you are unlikely to end up being a defendent.

Ditto regarding a criminal action. Your level of power and influence isn't great enough for a prosecutor to target you.

If any of the above were to come to pass, you might however be subpoenaed or equivalent, to tell what you know to the court. That isn't at all the same as liability, though.

Of course, I agree with Jennifer's recommendation that you consult an attorney for definitive guidance.

I appreciate both of your replys. Fortunately, the devices we deal in normally have very little chance of actually harming anyone. I hope I am on my way to convincing him not to go through with this most current "idea" of his re: the class III device - I have been bombarding him with information for the last 24 hrs as to why it's a bad move. However, given that these issues keep coming up I think I will take your advice and discuss the issue more thoroughly with an attorney. Thank you both.

The issue of civil liability is usually true when we say plaintiffs only go for deep pockets, but there is a growing number of cases where relatively penniless employees are named in liability suits as a "bargaining chip" (really a form of extortion) to induce them to provide evidence and testimony against the "deep pockets" in return for being dropped from the suit.

In terms of criminal action or regulatory action, the government ALSO uses a similar bargaining tactic. It's venal, but it's very effective in getting witnesses and accounts in large part for the high conviction rate the federal government has when bringing cases to court.

In Chicago, my home town, it is well known that the first ones to "get on the federal bus" ride free.