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Jury trials are expensive, time consuming, stressful and risky. Many litigants prefer Alternate Dispute Resolution (ADR). The principle forms of ADR are mediati

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

on and binding arbitration. ADR can take place in virtually any setting, utilizing virtually any procedure, provided that everyone agrees.

There are many compan

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

Examples of combination products may in

es that offer arbitration/mediation services for legal disputes.

Mediation involves bringing the sides together before a (hopefully) neutral mediator. This can

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

e a judge, an ex-judge, a practicing attorney, a professional mediator or any other individual both sides agree on. By bringing the parties together in this set

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

ing, the mediator hopes to expedite settlement of the case or, at least, to bring the sides closer together.

Mediators promote settlements by pointing out vulner

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

Combination pro

bilities that the parties may not realize exist in their own case. The mediator's neutral perspective may give both sides the first truly independent evaluation

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

f the case. This can greatly influence the way the parties view the settlement value of the case.

Binding arbitration is second choice, and a better option if t

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

e sides are entrenched in their positions. Binding arbitration may involve a mini or summary trial. The rules of evidence are relaxed to permit admission of evi

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

ence without the formalities required in jury trials.

For example, medical reports may be used to prove damages rather than medical testimony. This greatly redu

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

es the length and expense of litigation. With binding arbitration, the ruling of the arbitrator ends the dispute. With non-binding, the ruling is advisory only.

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

High-low arbitrations are a special kind of binding arbitration in which the parties agree to high-low parameters. These parameters set the upper and lower limi

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

Following aspects would a

ts of the award. For example, in a 100/10 high-low arbitration, the most the plaintiff could receive is $100,000, regardless of the size of the award. The lowes

dd to the challenges in developing combination products:

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

possible award would be $10,000, even if the arbitrator returned a $0 award. If the award is somewhere between $10,000 and $100,000, the plaintiff receives that

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

in-between amount.

United States Arbitration and Mediation is a company that uses high-low arbitrations.

The scary thing about submitting your legal dispute to

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

inding arbitration is that it is binding. Absent gross misconduct by an arbitrator or litigant, here is essentially no appeal from an unsatisfactory binding arbi

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

ration award. With jury trials, the grounds for reversal on appeal are much broader. Thus, one of the most crucial elements of any binding arbitration is the id

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

Professional from academic institutions, pharmaceutical industries, health care indust

ntity of the arbitrator(s).

With a jury trial, you case is decided by “a jury of your peers”. You have some degree of control over the makeup of that jury throu

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

h the voir dire process. Effective voir dire is crucial to a good outcome and requires great care. With binding arbitrations, you must select the arbitrator(s)

.

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

ith an even higher degree of care.

The danger with arbitration is that the arbitrator(s) often have pre-existing relationships with one or more of the attorneys

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

Companies that provide selfless information through particip

nd/or the insurance company. There is little danger of that with juries since jurors who know one of the parties or lawyers are stricken for cause from the panel

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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