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Phillips Esq.
Phillips Esq., Attorney-at-Law
Category: Personal Injury Law
Satisfied Customers: 19284
Experience:  B.A.; M.B.A.; J.D.
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In 1997, a Pharma gained approval for its drug through the

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In 1997, a Pharma gained approval for its drug through the use of substantial fraudulent data it knew to be fraudulent at the time of submitting its NDA. The drug is very dangerous and to date has, according to FDA records, killed 28 individuals and harmed many 10's of thousands of others. It is still on the market today. Taking all of this as the truth on its face, is there any type of litigation you can think of that would include every user of this drug since it was approved becoming a potential plaintiff in that lawsuit? Regardless of the SOL typically in place for such. It seems to me the Pharma knowingly placed everyone who ever used the drug in harms way of being injured whether they were or not due to Pharma's intentional use of data it knew would demonstrate the drug was in fact very safe when it knew the drug was extremely dangerous which is why they used the fabricated safer data in its NDA approval process. Whether or not a user of the drug was injured, the pharma placed everyone that used the drug at a higher risk of being injured by the fraudulent publicized data their treating physician used to make the determination of its safe use in their patients care being based upon intentional fraud to make it appear more safe than in fact it is.
Good afternoon,

I'm Doug, and my goal is to provide you with excellent service today. In order to give you a clear and concise answer, I will need some additional information about the circumstances, please.

1. Are you perhaps referring to Purdue Pharma, and their drug Oxycontin?

Doug
Customer: replied 3 years ago.

Actually I am not. I would rather not disclose the particular drug at this time. Please don't think bad of this as I am not really able to disclose very much information at this time. I can try and give you a bit more concise information thought that I hope will allow you to opine on my question. The Pharma's NDA contained 44-instances of intentional fraud that was deliberately employed for no other reason than to demonstrate a fabricated safer drug profile for its drug knowing that the FDA would never have approved the drug had it not used this gross amount of fraudulent "positive" data in place of the true data. The FDA has acted on parts of this data by having it deleted from publicized data like in the product sheet for the drug. However, other safety and efficacy profiles for this drug still exist in the product sheet today without the knowledge of the FDA. The FDA is and was at the time of the NDA unaware of this fraudulent data being so grossly used by the Pharma. There has been countless 10's of thousands of injured victims from their use of this drug ever since the drug obtained approval in 1997 and to date. Please give me a specific question you need answered in order to opine on this issue. I am just trying to understand if there is any type action available to all of these unassuming victims of the past that would not fall under a SOL barring them from being plaintiffs and seeking the just consideration they need and deserve under this scenario.

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Doug
Hello: A different Professional here. I am a licensed Attorney and I will be further assisting you.



You are writing as someone with intimate knowledge of the situation; perhaps, a former researcher.

Have you contacted FDA and reported this fraud? If this drug is destructive, then FDA must be alerted so that FDA can take action in recalling this dangerous drug.

As for litigation for unsuspecting victims, the only way exposed individuals would be able to know is if the information that you have regarding the fraud is exposed, or if FDA recalls the drug because of the fraud. The product liability Attorneys would get to work in figuring out the causes of action to sue the “Pharma” under. This is obviously a class action case waiting to happen. However, if no one knows of the fraud, then it would be difficult to start a class action case for damages done by the drug to the consumers who unwittingly used the drug. In any event, unless consumers have been adversely affected by the drug, they cannot be included as part of the class action suit, they would not have cause of action.

Customer: replied 3 years ago.

So, all victims would have to be injured by the drug to join any litigation. Now, what about the SOL? Could all injured victims, under these or any other circumstances that you are aware and regardless of the age of their injuries, join in the class action? Or would they be barred by the 2-yr SOL here in Texas, i.e., only those injured looking back 2-yr's from today could join the class? I am just trying to learn if there is, under any condition, a legal maneuver that can help all of these victims, not just a few that happen to fall in a very narrow class of injured victims that have occurred over the past 2-yrs and let the Pharma off the hook for all the rest to suffer and in some cases die.

So, all victims would have to be injured by the drug to join any litigation.


Response 1: Yes, that is correct in any product liability case.



Now, what about the SOL? Could all injured victims, under these or any other circumstances that you are aware and regardless of the age of their injuries, join in the class action?




Response 2
: Yes, I would argue that the Statute of Limitations would start running upon discovery of the injury.


Or would they be barred by the 2-yr SOL here in Texas, i.e., only those injured looking back 2-yr's from today could join the class?



Response 3: I do not think so. The Statutes state when the cause of action arose. See Texas Civil Practice and Remedies Code Section 16.003(a). I would argue that the cause of action arose when the consumers discovered that the drug caused their injury.


I am just trying to learn if there is, under any condition, a legal maneuver that can help all of these victims, not just a few that happen to fall in a very narrow class of injured victims that have occurred over the past 2-yrs and let the Pharma off the hook for all the rest to suffer and in some cases die.




Response 4: See my previous response.
Phillips Esq., Attorney-at-Law
Satisfied Customers: 19284
Experience: B.A.; M.B.A.; J.D.
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