Hello,

Is the manufacturer of a medical device responsible for advertising claims made by their distributors on the distributors website? Their site is linked to our site.
Thanks,

Hello,

Is the manufacturer of a medical device responsible for advertising claims made by their distributors on the distributors website? Their site is linked to our site.
Thanks,
GCC

Generally, no, but I'm not a lawyer, nor do I play one on the Internet. The web is the worst place in the world to ask legal questions. Your company probably does have a lawyer though, and he/she should be consulted if you're concerned.

Hello,

Is the manufacturer of a medical device responsible for advertising claims made by their distributors on the distributors website? Their site is linked to our site.
Thanks,
GCCHi Gail, welcome to the cove. If you look at 21cfr801 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=801&showFR=1), in particular 801.4, you will see where the manufacturer can be held responsible because of knowledge of the false claim by the distributor.

PS: I'm not a lawyer, I just know where to find the answer.

Hi Gail, welcome to the cove. If you look at 21cfr801 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=801&showFR=1), in particular 801.4, you will see where the manufacturer can be held responsible because of knowledge of the false claim by the distributor.

PS: I'm not a lawyer, I just know where to find the answer.

The reference you give pertains to uses of products for which the product has not been properly labeled, and says that if the manufacturer has knowledge of those alternate uses, he must provide proper labeling. As I read the original post, Gail seemed to be concerned about a distributor making false claims in advertising, which is a different story. The manufacturer can hardly be expected to alter its labeling in keeping with the false claims of a distributor or reseller. Also, even if alternate uses were the case, the manufacturer's knowledge would have to be proven, and that's not an easy thing to do. As I said in my original response, Gail's company should consult an attorney if they're concerned.

The reference you give pertains to uses of products for which the product has not been properly labeled, and says that if the manufacturer has knowledge of those alternate uses, he must provide proper labeling. As I read the original post, Gail seemed to be concerned about a distributor making false claims in advertising, which is a different story. The manufacturer can hardly be expected to alter its labeling in keeping with the false claims of a distributor or reseller. Also, even if alternate uses were the case, the manufacturer's knowledge would have to be proven, and that's not an easy thing to do. As I said in my original response, Gail's company should consult an attorney if they're concerned.You are right in suggesting the manufacturer seek legal advice. Also, Gail stated that the distributor's web site is linked to the manufacturer's web site. Wouldn't the mfr be aware of a false claim by his distributor linked to the mfr's site?

The claims are not related tothe intended use of the device they are claiming it's the only one available the easiest one etc. I discovered this while auditing for compliance with the Australian Therapeutic Goods Regulations.

You are right in suggesting the manufacturer seek legal advice. Also, Gail stated that the distributor's web site is linked to the manufacturer's web site. Wouldn't the mfr be aware of a false claim by his distributor linked to the mfr's site?

It certainly increases the possibility that knowledge could be proven, but it ain't necessarily so. It's possible for one site to link to another without the operator of the first site knowing about it. Another thing that contributes to proof of knowledge is Gail's posts here. If it were to come down to a comprehensive discovery process in litigation, her posts, if made from work, might surface. That's why it's always best to discuss these things with counsel before discussing them publically.

Are you saying, Gail, that the claims are completely untrue or are they advertising "puffery?"

Even in the medical field, there are a lot of "weasel ways" to differentiate the seller's product which may be "misdirecting" or "misleading," but do not fall in the category of "false."

The manufacturer, of course, has some sort of contractual agreement with the distributor (my special legal expertise is "agency and contract") and part of that contract either confers or denies "agency" (the right and power to act in another's behalf.) In the absence of specific language regarding agency, the statutory and common law of the country of jurisdiction "interprets" the contract to determine whether agency exists. If agency exists, the manufacturer would probably be liable for statements made by distributor on behalf of the product.

The contractual agreement may be as simple as a purchase order written by the buyer (distributor) or it may be a multipage document conferring "exclusive dealership" for a product or product line.

The first and simplest course of action is for the manufacturer to review the subject advertising and determine if it is happy with the wording.

If yes, problem solved.
If not, it can informally request the distributor to "cease and desist."
Failing that, the next step is a formal "cease and desist" with a list of consequences for failure to comply, which may include canceling the distributorship.
In the informal request, the manufacturer might still retain liability if a regulator were to become involved. Issuing the formal "cease and desist" serves notice the manufacturer formally disavows the subject advertising and would serve as a defense against the regulator.

I hope this helps you put the issue in perspective. I, too, suggest your company consult a competent attorney familiar with regulatory and legal issues. The mere fact you question the advertising here is reason enough to consider the possibility it "crosses the line" and makes the manufacturer uncomfortable.

Wes, your response is very illuminating. I am developing distributorship agreement and we have mentioned that distributors have link to our website and vice versa.

In case the distributors are operating in areas, where they have a language that we do not know, we have a problem. Although we have specified that the distributors should have the translations approved by us before they circulate those documents. Also we ask distributors not to alter the intended purpose.

There is a problem in approving the translations, if we do not have in-house capability of doing that.

What would be the best way to word these in the distributorship agreements.

Wes, your response is very illuminating. I am developing distributorship agreement and we have mentioned that distributors have link to our website and vice versa.

In case the distributors are operating in areas, where they have a language that we do not know, we have a problem. Although we have specified that the distributors should have the translations approved by us before they circulate those documents. Also we ask distributors not to alter the intended purpose.

There is a problem in approving the translations, if we do not have in-house capability of doing that.

What would be the best way to word these in the distributorship agreements.
In matters as important as dealing with regulators, getting independent translations is a cost of doing business. Would you buy a product to use as a component of your product if you were unable to read the label? Do you think a regulator would say,

"Oh that's OK. We know you can't be bothered to pay for a translation."
or do you think he'd say,
"We're going to shut you down until you produce an independent translation which you and we understand and agree with."

The claims made by the distributor maybe true in that country I'm not so sure in the US. Our Regulatory dept is checking it now.