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I use Microsoft Word, Outlook, Excel and many other office programs. Do you use the same? What many of us to not know is that in each email and office file we create, we are also creating a hidden trail of data about

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

our documents. These programs automatically save information such as who worked on the document, when and for how long was the document open, who printed the document, when was it printed and from what work station. I

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

addition to personally identifying information, is private comments used for intra office use as well as a trail of all content that was deleted from a document. For those of us who are in the know, it is not difficu

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

t at all to retrieve some if not all of this information from every document that is sent to us. The question clearly beckons, should lawyers review metadata in documents? Is reviewing this data ethical, when the auth

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

r of such data likely had no idea they were creating it?

Metadata by its definition is simply, data about data. It can contain all sort of identifying information. One of the easiest ways for metadata to be left in a

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

document is for the comments section to leave the comments feature turned on. Similarly, if you leave track changes turned on, the receiving attorney can not only read confidential comments that were meant to be intr

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

-office or privileged communications between he attorney and client, but also the attorney can see what content was deleted from the document.

In a recent American Bar Association opinion by its ethics committee, rev

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ewing issues such as metadata sent to lawyers, the committee stated that reviewing metadata meets with the professional responsibility guidelines. 06-442 (August 5, 2006). The committee did add the footnote, “This opi

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ion assumes that the receiving lawyer did not obtain the electronic documents in a manner that was criminal, fraudulent, deceitful, or otherwise improper, for example, by making a false statement of material fact to o

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

pposing counsel or to any other third person (Model Rule 4.1(a)), using a method of obtaining evidence that violated the legal rights of a third person (Model Rule 4.4(a)), or otherwise engaging in misconduct (Model R

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

le 8.4). Such scenarios are beyond the scope of this opinion.”

Perhaps even more interesting than the opinion itself, the committee stated that there is no specific language in the ABA Model Rules of Professional Con

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

uct that would forbid an attorney from reviewing the metadata in electronic documents. The ABA Model Rules of Professional Conduct Rule 4.4(b) reads: “A lawyer who receives a document relating to the representation of

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

the lawyer’s client and knows or reasonably should know that the document was inadvertently sent shall promptly notify the sender.” However, when an attorney receives a document that they requested, and the opposing c

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ounsel is negligent in removing or redacting information, it is not the job of the receiving attorney to censor what they read.

Is it negligent for an attorney to send an electronic document such as a Microsoft word

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ocument or archived email file without first scrubbing it for metadata? This question beckons an analysis of whether even in today’s technologically savvy business and legal environment, the reasonable attorney is awa

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

e of metadata and how it can possibly breach privilege by sending confidential comments, or reviling trade secrets, in addition to arming the opposing the counsel with great evidence for a deposition and cross examina

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ion. Does the attorney have a duty to scrub the file and does that duty extend to files sent to the attorney by the client to hold similar to an escrow agent holding funds? If there is a duty does simply sending a f

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ile breach that duty? Even if a breach occurred is there an injury to the attorney’s client and was the damage proximately caused by the breach where the attorney sent the document?

It is my contention that too much

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

as been written on the existence of metadata in the past couple of years for someone to not know of its existence. Yet, to understand how to clear out metadata, or even all of the specific details it contains may fall

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

outside the scope of what a reasonable attorney might know. As such, I would suggest that it is fair to review metadata, but at the same time, I believe it is also fair that you must inform the sender of their mistake

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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