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In today’s computer dependent world, the zealous advocate must be able to navigate his way through every conceivable form of discovery in order to effectively represent his or her client. Failure to seek the appropriate records or the failure to respo

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

nd to discovery requests with the appropriate electronic discovery knowledge could potentially expose both client and attorney to the risk of sanctions for discovery abuses and/or result in the spoliation of evidence. Knowledge of the electronic evide

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

Examples of combination products may in

ce is crucial to any attorney hoping to retain clients. Once electronic evidence is in hand though, an attorney faces additional obstacles, specifically, regarding how to properly use such evidence. Gaining a true understanding of metadata can mean th

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

difference between success and failure.

Metadata is more than simple electronic evidence. General electronic discovery typically considers easily accessible electronic files, such as those on an active network file server. Metadata< is more obscu

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

e and difficult to locate, and is found through an examination of often hidden and deleted files, or even left over file fragments that were supposed to be deleted. Specifically, metadata describes how, when and by whom particular set of data is

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

Combination pro

collected and formatted. Metadata can often be thought of as the “DNA” of documents. It is hidden from view and often contains the most damaging information. Discovering the metadata behind a piece of data, such as a document or spreadsheet, c

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

n reveal the authors of the document, all comments and edits made and any other trait related to its creation. Mining for metadata is the newest tool in the ongoing battle between those seeking to conceal and those seeking to reveal electronic ev

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

dence.

The “hard” paper evidence obtained throughout the discovery process only reflects the most recent form of the document, and often does not reveal the most useful information. Direct or cross examination based strictly on the hard copy docum

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

nt restricts the examiner to questions regarding the information only contained on the printed page. It is therefore difficult to determine the document’s authenticity, its author and any edits made while the copy was still a work in progress. Often t

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

mes though, these documents were created in a word processing program such as Microsoft Word, which leaves a trail of information regarding the life of the document itself. The use of a skilled attorney or a forensic examiner can lead to the discovery

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

f every detail regarding the document.

The metadata contained in documents will include ‘tags’ and information regarding when and by whom the document was created, what changes were ever made to the document, and even what else may have been on th

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

Following aspects would a

creator’s computer screen when making the document. For example, a forensic examination of a single fax cover letter can reveal not only the name and fax number but can also reveal every message sent by that user, using the same fax template. The me

dd to the challenges in developing combination products:

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

adata can reveal this information because when text is deleted using a word processor program, it is never truly removed from the document. In reality, when deleting the text the processor is simply instructed not to print or display the data. Knowledg

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

of what the creator thought was deleted can be an extremely useful tool, for persuasive, substantive and impeachment purposes throughout the trial.

The hiring of an expert Data Forensics Expert may well be a justified expense when in the best int

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

rests of a client. The examiner will be able to help paint a picture by providing a story line with corroborating evidence including creation and edits dates, authorship, all communications regarding the document and potentially even the intent behind

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

the acts. Such experts should be used in cases where substantial hidden digital evidence may exist. This is not restricted to intellectual property cases, but may involve every area of law, including family law, breach of contract, discrimination and

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

Professional from academic institutions, pharmaceutical industries, health care indust

sexual harassment.

The ability to spot the cases when metadata may be recovered is an important skill for any practitioner. The more important skill, however, is the ability to know how to use the electronic discovery means once identified.

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

It is wise to use an attorney experienced in electronic discovery and metadata mining when faced with such a case. “Because of their ubiquitous nature, documents stored in electronic form…should be specifically targeted by counsel in developing

.

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

their discovery plans. Failing to do so may not only prejudice their case, but may also constitute malpractice.” CEB California Discovery Practice 3rd Ed Vol. 2, §8.24 p. 711 (1998). It is the duty of every advocate to have a sufficient lev

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

Companies that provide selfless information through particip

l of knowledge regarding electronic discovery and metadata, or to at least associate with counsel who does. Failure to understand the importance and usefulness of metadata and electronic discovery in general may lead to undesirable consequences

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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