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Personal injury cases are getting increasingly more difficult to win, despite hearing about the occasional “big wins.” Why might that be? It’s due in large part to current conservative politics, resulting in chang

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

es in laws that affect personal injury cases. These changes come in the form of restrictions that limit how a Plaintiff and his attorney can prove his claim in court.

I believe another reason is that juries are be

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

Examples of combination products may in

coming tougher to convince. Many television shows depict courtroom dramas. These even include real trials that keep us glued for information, like O.J. Simpson’s murder trial. During Michael Jackson’s trial, we c

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

ouldn’t avoid hearing tidbits. The regular network schedules are filled with 30-minute “people’s court” type shows. We’ve become a country of folks almost painfully aware of the legal arena. I’d even venture a gu

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

ss that if we haven’t been involved in a lawsuit ourselves, we personally know several people who have been.

As a result, we run the risk of becoming jaded about the entire legal process. A person is innocent unti

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

Combination pro

l proven guilty. Isn’t that true? It would certainly be nice if that’s how people felt, but I don’t think it is. Oh we applaud the saying, and if the finger of the law points our way we certainly demand our right

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

s. But we’re a judgmental society. We zero in on flaws and weaknesses, and crack them wide open for our perusal. Jurors are reminded to determine the value of cases based on the facts and evidence. We actually h

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

ave to be reminded!

How might today’s negativity toward the legal process and trials affect a Plaintiff in a personal injury case? Well, just imagine. If you don’t toe the line, you might get cracked wide open.

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

iguratively speaking, of course. What I’m getting at is how important it is for a Plaintiff to seek medical treatment immediately, and to follow a prescribed course to the letter.

This prescribed course I mention

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

is one thing, with two-fold reasoning. A Plaintiff in a personal injury claim has been injured. Medical assistance was required. Often, such medical assistance extends for a long time while the Plaintiff-patient

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

is recovering or rehabilitating. What happens when a Plaintiff didn’t seek medical treatment at all (or suspiciously later), or stops following doctor’s orders?

First, this could have a detrimental effect on his h

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

Following aspects would a

ealth. Secondly, this could have major impact on his legal claim.

There were great justifications and rationalizations why this injured Plaintiff stopped going to see the doctor. It could have been because there

dd to the challenges in developing combination products:

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

as no insurance available. Maybe he isn’t able to work so he’s not bringing in any income. Or perhaps therapy is actually hurting him and he sees no improvement. Perhaps he doesn’t like or trust his doctor any mo

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

re. Depressed, he might even want to go to sleep and hope the whole thing just goes away.

So he hasn’t been following medical advice or was sluggish in seeking treatment. Well now he’s up in the witness box descr

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

ibing his injury and what happened, trying to prove his case to receive an award for the wounds and pain he suffered. A jury hears how he’s not seeing his doctor, from himself, from his treating physician, and even

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

more detrimental, from the Defendant’s expert witness. Take it from me – I’ve seen it – this is going to significantly impact his case! No more medical treatment? Hmm, must not be hurt very badly. This casts do

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

Professional from academic institutions, pharmaceutical industries, health care indust

bt in the minds of the jury. Ultimately, you’ve lost their trust.

If a Plaintiff plans to present a legal claim or has one actively pending, do not stop seeing your doctor. Follow what your medical professional a

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

dvises EXACTLY. If you don’t see eye-to-eye on your treatment plan, for whatever reason, tell the doctor what’s happening and change the treatment plan. Under your doctor’s care, try something different and have t

.

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

he change documented, and why, in your medical file. If you must change doctors, get a referral. Then get ANOTHER referral if need be.

If it’s a money problem, try mightily to figure it out – the doctor may accep

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

Companies that provide selfless information through particip

t a lien, friends and family might chip in, there may be state programs that will provide assistance. But do not simply fade away into no treatment at all. You don’t want to get “cracked open” on the witness stand

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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