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On December 1, 2006, many amendments to the Federal Rules of Civil Procedure went into effect. There are three rules specifically that impact Computer Forensics and E-Discovery which need to be considered when building a case for your client, as well as protecting your client's rights.

Most companies fail to realize the following two points

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

Any data that can be compiled into viewable form, whether presented electronically or printed on paper, is potentially within the definition of “document".
Electronic documents may be considered obsolete by the business in

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

Examples of combination products may in

erms of its current computer infrastructure, but may have archival value and be recoverable to a readable format by specialized forensic techniques.FRCP - Rule 26 (LII 2007 ed.)

With the new law regarding E-Discovery now in place, Rule 26a1 changes are ver

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

important.

At the first sign that litigation is coming, a company must use their Litigation Hold procedures and not wait for the courts to act. The problem is most companies do not have these procedures in place, nor do these companies know that litigation holds

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

rong>must start this early in the process.

Of course in order to have Litigation Hold Procedures, a company must have a retention policy and know where the company's data is stored and must be easily accessible.

Rule 26. General Provisions Governing Discovery; Duty of

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

Combination pro

isclosure

Except in categories of proceedings specified in Rule 26(a)(1)(E), or to the extent otherwise stipulated or directed by order, a party must, without awaiting a discovery request, provide to other parties:

(A) the name and, if known,

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

he address and telephone number of each individual likely to have discoverable information that the disclosing party may use to support its claims or defenses, unless solely for impeachment, identifying the subjects of the information;

(B) a copy of, or a de

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

cription by category and location of, all documents, electronically stored information, and tangible things that are in the possession, custody, or control of the party and that the disclosing party may use to support its claims or defenses, unless solely for

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

impeachment.

FRCP - Rule 34 (LII 2007 ed.)

With the new law regarding E-Discovery now in place, Rule 34 identifies new procedures regarding the production of documents and electronic data for litigation.

Rule 34. Production of Documents and Things and Entry

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

Upon Land for Inspection and Other Purposes

(a) Scope.

Any party may serve on any other party a request (1) to produce and permit the party making the request, or someone acting on the requestor’s behalf, to inspect, copy, test,

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

or sample any designated documents or electronically stored information — including writings, drawings, graphs, charts, photographs, sound recordings, images, and other data or data compilations stored in any medium from which information can be obtained — tr

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

Following aspects would a

anslated, if necessary, by the respondent into reasonably usable form, or to inspect, copy, test, or sample any designated tangible things which constitute or contain matters within the scope of Rule 26(b) and which are in the possession, custody or

dd to the challenges in developing combination products:

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

control of the party upon whom the request is served; or (2) to permit entry upon designated land or other property in the possession or control of the party upon whom the request is served for the purpose of inspection and measuring, surveying,

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

hotographing, testing, or sampling the property or any designated object or operation thereon, within the scope of Rule 26(b).

FRCP - Rule 45 (LII 2007 ed.)

With the new law regarding E-Discovery now in place, Rule 45 identifies new procedures to follo

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

when your company subpoenaed.

Rule 45. Subpoena

(d) Duties in Responding to Subpoena.

(1)(A) A person responding to a subpoena to produce documents shall produce them as they are kept in the usual course of business or shall organize and label them t

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

correspond with the categories in the demand.

(1)(B) If a subpoena does not specify the form or forms for producing electronically stored information, a person responding to a subpoena must produce the information in a form or forms in which the person ordi

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

Professional from academic institutions, pharmaceutical industries, health care indust

arily maintains it or in a form or forms that are reasonably usable.

(1)(C) A person responding to a subpoena need not produce the same electronically stored information in more than one form.

(1)(D) A person responding to a subpoena need not provide discov

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

ry of electronically stored information from sources that the person identifies as not reasonably accessible because of undue burden or cost. On motion to compel discovery or to quash, the person from whom discovery is sought must show that the information so

.

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

ght is not reasonably accessible because of undue burden or cost. If that showing is made, the court may nonetheless order discovery from such sources if the requesting party shows good cause, considering the limitations of Rule 26(b)(2)(C). The court may spe

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

Companies that provide selfless information through particip

ify conditions for the discovery.

These are just snippets of the rules and your attorney or corporate counsel should have access to the entire Federal Rules of Civil Procedure Amendments document. It is important to consider these rules when planning to use a Computer Forensics Investigator or E-Discovery service

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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