Business Law

Ask a Business Lawyer. Get Business Law Questions Answered ASAP.

Ask a Lawyer,
Get an Answer ASAP!

Business Law
This answer was rated:

This is for Bizlaw please. I notified the FDA in 2002 of

This is for Bizlaw please. I...
This is for Bizlaw please.

I notified the FDA in 2002 of the defendant's fraud that it used in 44 instances throughout its New Drug Application for its drug. The FDA ultimately agreed that it was fraudulent as I had reported. I reported it strictly as a concerned citizen and not as a relator of a qui tam or for any litigation purposes at all. I just wanted them to do something about it through enforcement actions. The FDA reacted by taking the information out of all publicized literature as of 2004. As a result of the action the FDA took in agreeing that the NDA was in fact fraudulent, caused the drug to be labeled by FDA law as a misbranded drug and therefore not eligible for reimbursement through Government programs such as Medicare and Medicaid. Six months ago I was researching another unrelated situation involving another drug and found that under FCA laws misbranded drugs are in fact a fraud upon the government when submitted for payment or approval for payment. Each prescription submitted is a separate instance of fraud. In fact, every prescription ever submitted to the Government for reimbursement of this drug is a fraud, some 3-million to date. I have a six year statute of limitations running backward from about Feb of 2013 when I first realized the fraud on these reimbursements had occurred and was obligated to timely file a qui tam with the Government in order to stop the ongoing monetary damages to the Government and the resulting fraud itself. Since I am the only person that can track back to the original disclosure being made the to Government in my email contact with the FDA it seems I should be able now to file as the relator and original source of this new concept which again I have uncovered which is on going fraud that is damaging the government without being checked or ended. I would be bringing to the government for the first time without any public disclosure of any kind being made a multi-billion dollar ongoing fraud that will surely continue if it is not brought to the government's attention through a qui tam action where a recovery of damages is possible. You should analyze this as though I am the original source of the new information I am bringing forward, I am the relator, I have direct knowledge of the fraud, the Government is totally unaware of this continuing fraud, it was my actions back in 2002 that caused the drug to become a misbranded drug. I do not intend to claim any thing of wrong doing past 2007 or 6-years to stay well withing the FCA SOL. I only describe my original reporting to the FDA as that of a concerned citizen's report, nothing else except that my report, unbeknownst to me at the time, caused the drug to become misbranded. At first glance and assuming a lot of the last sentences to be true, which it is, do you see any reason I should not qualify for this qui tam action as a relator?
Show More
Show Less
Ask Your Own Business Law Question
Answered in 6 minutes by:
8/5/2013
Richard - Bizlaw
Category: Business Law
Satisfied Customers: 10,685
Experience: 30 years of corporate, litigation and international law
Verified

bizlaw :

Hello, I will try to help you. Please remember I just report or interpret the law, so the outcome may not be what you hoped for.I will review in the morning and get back to you.

bizlaw :

I am not clear on something. if the drug was misbranded and then is properly branded, does its proper use still meet FDA standards for use of the drug once correctly branded? For example if the product was branded to treat disease A. The FDA finds that it does not treat disease A but does treat disease B. Since the misbranding was discovered is the drug being prescribed and paid for treating disease B or is it still be used to treat disease A?

Customer :

The drug is misbranded for all uses under FDA 21 U.S.C. section 502(a) stating that an NDA approval that is based upon fraud causes the approved drug to be misbranded for all indications. The drug cannot be rebranded or brought back into branded status unless and until the pharma resubmits a new NDA that corrects the fraud and other misrepresentations the original NDA contained. That has not occurred thus the drug remains misbranded for all uses. FDA 21 U.S.C. section 331(a)(b)(c) states that a misbranded drug is ineligible for utilization in government reimbursement programs. The Defendant continues to submit and cause others to submit prescriptions of the drug to the Government Medicaid and other programs for payment. But as for the misbranded status getting cleared up it will take some type of qui tam or governmental action to correct this wrong.

bizlaw :

U reference 21 USC 502 but that section has been repealed. Is there another section that discusses the impact of fraud on misbranding for all purposes

bizlaw :

I looked at 21 USC 352(a which may be applicable and provides as follows: a)False or misleading label


If its labeling is false or misleading in any particular. Health care economic information provided to a formulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations, shall not be considered to be false or misleading under this paragraph if the health care economic information directly relates to an indication approved under section 355 of this title or under section 262 (a) of title 42 for such drug and is based on competent and reliable scientific evidence. The requirements set forth in section 355 (a) of this title or in section 262 (a) of title 42 shall not apply to health care economic information provided to such a committee or entity in accordance with this paragraph. Information that is relevant to the substantiation of the health care economic information presented pursuant to this paragraph shall be made available to the Secretary upon request. In this paragraph, the term “health care economic information” means any analysis that identifies, measures, or compares the economic consequences, including the costs of the represented health outcomes, of the use of a drug to the use of another drug, to another health care intervention, or to no intervention.
bizlaw :

I am still looking for a section comparable to the 502 you cite.

Customer :

the drug is sufficiently misbranded under 21 USC 352a I think for the purposes of this argument which would have the drugs status reach the misbranded bar.

Customer :

I will look through my files for the additional info required to describe the subject matter you request.

bizlaw :

If I assume you are correct that prescriptions of this drug should not be paid for by medicare then I think you have a good case to proceed. The critical issue is that medicare should not be paying for the drug. You must be able to establish that under either a recognized theory of the law or one that has a reasonable chance of being adopted.

bizlaw :

If I have answered all your questions, please rate my answer excellent as that is how I am compensated. If you have more questions, please let me know. If the answer was especially helpful you can provide a bonus.

Customer :

OK, thanks for your information. You have accomplished for me what I needed.

bizlaw :

You are welcome and thank you for the excellent rating.

Richard - Bizlaw
Category: Business Law
Satisfied Customers: 10,685
Experience: 30 years of corporate, litigation and international law
Verified
Richard - Bizlaw and 87 other Business Law Specialists are ready to help you
Ask your own question now
Customer reply replied 4 years ago

bizlaw:


 


I have one other thing to ask of you, you mentioned that 21 502 had been repealed but I can only find where 502 (d) was repealed. Would you please share with me if indeed you found the total 502 repealed or just this section sub-set 502 d?

I went to an online listing for the US Code. Here is the link showing 21 USC 501-517 being repealed. http://www.law.cornell.edu/uscode/text/21/chapter-11

Ask Your Own Business Law Question
Ask Richard - Bizlaw Your Own Question
Richard - Bizlaw
Richard - Bizlaw
Richard - Bizlaw, Attorney
Category: Business Law
Satisfied Customers: 10,685
10,685 Satisfied Customers
Experience: 30 years of corporate, litigation and international law

Richard - Bizlaw is online now

A new question is answered every 9 seconds

How JustAnswer works:

  • Ask an ExpertExperts are full of valuable knowledge and are ready to help with any question. Credentials confirmed by a Fortune 500 verification firm.
  • Get a Professional AnswerVia email, text message, or notification as you wait on our site. Ask follow up questions if you need to.
  • 100% Satisfaction GuaranteeRate the answer you receive.

JustAnswer in the News:

Ask-a-doc Web sites: If you've got a quick question, you can try to get an answer from sites that say they have various specialists on hand to give quick answers... Justanswer.com.
JustAnswer.com...has seen a spike since October in legal questions from readers about layoffs, unemployment and severance.
Web sites like justanswer.com/legal
...leave nothing to chance.
Traffic on JustAnswer rose 14 percent...and had nearly 400,000 page views in 30 days...inquiries related to stress, high blood pressure, drinking and heart pain jumped 33 percent.
Tory Johnson, GMA Workplace Contributor, discusses work-from-home jobs, such as JustAnswer in which verified Experts answer people’s questions.
I will tell you that...the things you have to go through to be an Expert are quite rigorous.

What Customers are Saying:

Mr. Kaplun clearly had an exceptional understanding of the issue and was able to explain it concisely. I would recommend JustAnswer to anyone. Great service that lives up to its promises!

Gary B.Edmond, OK

My Expert was fast and seemed to have the answer to my taser question at the tips of her fingers. Communication was excellent. I left feeling confident in her answer.

EricRedwood City, CA

I am very pleased with JustAnswer as a place to go for divorce or criminal law knowledge and insight.

MichaelWichita, KS

PaulMJD helped me with questions I had regarding an urgent legal matter. His answers were excellent.

Three H.Houston, TX

Anne was extremely helpful. Her information put me in the right direction for action that kept me legal, possible saving me a ton of money in the future. Thank you again, Anne!!

ElaineAtlanta, GA

It worked great. I had the facts and I presented them to my ex-landlord and she folded and returned my deposit. The 50 bucks I spent with you solved my problem.

TonyApopka, FL

Wonderful service, prompt, efficient, and accurate. Couldn't have asked for more. I cannot thank you enough for your help.

Mary C.Freshfield, Liverpool, UK

< Previous | Next >

Meet the Experts:

Infolawyer

Infolawyer

Attorney

1,793 satisfied customers

Experienced lawyer

Dimitry K., Esq.

Dimitry K., Esq.

Attorney

1,611 satisfied customers

Run my own successful business/contract law practice.

MShore Law

MShore Law

Attorney

1,233 satisfied customers

Drafted Negotiated and/or Reviewed Thousands of Commercial Agreements

RGMacEsq

RGMacEsq

Attorney

742 satisfied customers

Licensed Texas General Practice Attorney

Barrister

Barrister

Attorney

640 satisfied customers

17 years practicing attorney, JD, BA, MBA

Ely

Ely

Attorney

564 satisfied customers

Counselor at Law.

J.Hazelbaker

J.Hazelbaker

Attorney

393 satisfied customers

Experienced and trained in the area of business law.

< Previous | Next >

Related Business Law Questions
I graduated from Law school I took the bar exam in Florida,
I graduated from Law school I took the bar exam in Florida, but I have not yet pass the bar exam. Florida has completed the character and fitness investigation, and already issued me the notice of com… read more
Ray
Ray
Lawyer
Doctoral Degree
30,227 satisfied customers
I have a bar in New Rochelle and I'm interested in getting a
I have a bar in New Rochelle and I'm interested in getting a hookah license … read more
Damien Bosco
Damien Bosco
2,992 satisfied customers
I'm looking into getting into the nootropic business but
ma'am, I'm looking into getting into the nootropic business but instead of doing a store front I'm looking to do a more personalized approach. … read more
PaulmoJD
PaulmoJD
Attorney At Law
Doctoral Degree
106 satisfied customers
I am a 20% owner in an s-corp (a small restaurant/bar in
Hi I am a 20% owner in an s-corp (a small restaurant/bar in NYC) and plan to resign as shareholder, officer. What paper work do I need to file? I also need to submit paperwork to remove my name from t… read more
Roy Hadavi
Roy Hadavi
Attorney
Juris Doctorate
886 satisfied customers
I am an accountant for a c corp, it is a restaurant/bar with
I am an accountant for a c corp, it is a restaurant/bar with an illinois liquor license. He want to open another bar and not use the full name of the corp. Can he do a D/B/A under the corp. Does he th… read more
Infolawyer
Infolawyer
Attorney
Doctoral Degree
1,793 satisfied customers
I sold my business (bar) to a person I have a contract. He
I sold my business (bar) to a person I have a contract. He took over the first of DE em … read more
LegalGems
LegalGems
Juris Doctorate
10,176 satisfied customers
I was hoping to get more expert advice on this question that
Hi, I was hoping to get more expert advice on this question that was previously asked:http://www.justanswer.com/business-law/8emdd-sell-etizolam-powder-online-long-disclaimer.html There seem to be a l… read more
PaulmoJD
PaulmoJD
Attorney At Law
Doctoral Degree
106 satisfied customers
I have a personal lubricant I would like to start marketing.
I have a personal lubricant I would like to start marketing. Do I need FDA approval? I've been told if I label it for men only that I do not need FDA approval.… read more
KJL LAW
KJL LAW
Juris Doctorate
1,621 satisfied customers
I recently paid a FDA/GMP certified company in California to
I recently paid a FDA/GMP certified company in California to make my alcohol based tincture recipes so that I can sell them online. My LLC is registered in Colorado and I am trying to find out whether… read more
KJL LAW
KJL LAW
Juris Doctorate
1,621 satisfied customers
A Florida Condo Board President "C" files a Bar complaint
A Florida Condo Board President "C" files a Bar complaint for good and sufficient reason against a lawyer "J" and another lawyer "K". J heads a law firm with 2 other associates. The complaint was agai… read more
Phillips Esq.
Phillips Esq.
Attorney
Juris Doctor
17,992 satisfied customers
I had a legal case versus my bar. I never was notified snd
Hi. I had a legal case versus my bar. I never was notified snd just got letter I lost and owe 300 g … read more
Richard - Bizlaw
Richard - Bizlaw
Attorney
10,685 satisfied customers
I am a business owner of a small bar that also serves food.
I am a business owner of a small bar that also serves food. A "regular" customer had asked to run a small tab ($60) until their next paycheck. Thinking this would be no issue, I agreed that they could… read more
Dwayne B.
Dwayne B.
Juris Doctor
28,499 satisfied customers
Merry Christmas. I have 30 kgs of gold bar dores shipped to
Merry Christmas. I have 30 kgs of gold bar dores shipped to me by my girlfriend through an Agent (Robertson Consults) - It was labeled as a "GIFT". I paid for the shipping & agent charges. Currently, … read more
LawGuy
LawGuy
Juris Doctor
123 satisfied customers
I run a license bar is it leagal for the.cops to come in say
I run a license bar is it leagal for the.cops to come in say they r looking for someone then.say they smell marijuana and.serch everyone… read more
Thelawman2
Thelawman2
Doctoral Degree
1,240 satisfied customers
I have a question about FDA (Food & Drug Administration)
I have a question about FDA (Food & Drug Administration) compliance for medical devices. I own an algorithm that detects beat location and rhythm abnormalities in an ECG signal. My intent is to sell t… read more
Richard - Bizlaw
Richard - Bizlaw
Attorney
10,685 satisfied customers
Under FDA cosmetics claims guidelines, no claims can be made
Hi,Under FDA cosmetics claims guidelines, no claims can be made as a cosmetic regarding structural changes to the skin without being classified as a drug.Am I responsible for the reviews that are left… read more
PaulmoJD
PaulmoJD
Attorney At Law
Doctoral Degree
106 satisfied customers
I have an air shipment stuck in Atlanta airport by FDA
i have an air shipment stuck in Atlanta airport by FDA visual inspection. Product is dietary supplement, all natural herbal extract and the country of origin is South Korea. This is my first shipment … read more
PaulmoJD
PaulmoJD
Attorney At Law
Doctoral Degree
106 satisfied customers
If i take pictures in my establishment - and irish bar and
If i take pictures in my establishment - and irish bar and grill - do I need to get patrons permission before publishing those pictures to my web site or to other social media sites (facebook etc)… read more
Ely
Ely
Attorney
Juris Doctor
564 satisfied customers

DISCLAIMER: Answers from Experts on JustAnswer are not substitutes for the advice of an attorney. JustAnswer is a public forum and questions and responses are not private or confidential or protected by the attorney-client privilege. The Expert above is not your attorney, and the response above is not legal advice. You should not read this response to propose specific action or address specific circumstances, but only to give you a sense of general principles of law that might affect the situation you describe. Application of these general principles to particular circumstances must be done by a lawyer who has spoken with you in confidence, learned all relevant information, and explored various options. Before acting on these general principles, you should hire a lawyer licensed to practice law in the jurisdiction to which your question pertains.

The responses above are from individual Experts, not JustAnswer. The site and services are provided “as is”. To view the verified credential of an Expert, click on the “Verified” symbol in the Expert’s profile. This site is not for emergency questions which should be directed immediately by telephone or in-person to qualified professionals. Please carefully read the Terms of Service (last updated February 8, 2012).

DISCLAIMER: Answers from Experts on JustAnswer are not substitutes for the advice of an attorney. JustAnswer is a public forum and questions and responses are not private or confidential or protected by the attorney-client privilege. The Expert above is not your attorney, and the response above is not legal advice. You should not read this response to propose specific action or address specific circumstances, but only to give you a sense of general principles of law that might affect the situation you describe. Application of these general principles to particular circumstances must be done by a lawyer who has spoken with you in confidence, learned all relevant information, and explored various options. Before acting on these general principles, you should hire a lawyer licensed to practice law in the jurisdiction to which your question pertains.

The responses above are from individual Experts, not JustAnswer. The site and services are provided “as is”. To view the verified credential of an Expert, click on the “Verified” symbol in the Expert’s profile. This site is not for emergency questions which should be directed immediately by telephone or in-person to qualified professionals. Please carefully read the Terms of Service (last updated February 8, 2012).

Show MoreShow Less

Ask Your Question

x