Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Thursday, January 19, 2012

Risperdal Whistleblower



There has been much in the news recently about the whistleblowing case currently ongoing in Austin, Texas.

Allen Jones is blowing the whistle on Johnson & Johnson’s Janssen unit, whom, he alleges, paid a Texas mental health official to speak around the U.S. about state guidelines on prescribing antipsychotic drugs that gave preference to the company’s Risperdal medicine.

Risperdal is an atypical antipsychotic [2nd generation] and is used for the treatment of schizophrenia, bipolar disorder, and behaviour problems in people with autism. Many children have been prescribed Risperdal because they have been diagnosed with behavioural problems, ADHD being just one of many in a long line of labelled mental disorders that range from the sublime to the ridiculous.

Jones had stumbled across payments that were being made by pharmaceutical giants to state employees to promote the off-label use of Risperdal in children. Off-label because Risperdal is not recommended for children but its usage in children is a huge cash cow that has brought untold riches to its manufacturers. They saw a niche, saw the hurdle, then saw a workaround.

Award winning author Alison Bass wrote a piece on this case yesterday, she writes:

Jones first noticed these illegal payments when he was investigator for the state of Pennsylvania’s Office of Inspector General. He discovered that the state’s top pharmacist, the guy in charge of deciding what drugs should be included in its Medicaid formulary, was receiving hidden payments from J&J, the maker of Risperdal. Jones was fired when he brought those illegal payments to light, but he persevered, and with the help of GAP, won a lawsuit against the state of Pennsylvania and eventually saw the state pharmacist who was on the take fired from his job.

Many other commentators have chipped in with their thoughts and opinions on this particular case, none more so than the blogger who goes by the name of "1 Boring Old Man", his posts are far from boring. 1 Boring Old Man has flown down to Texas for the trial and his perspective on matters is refreshing, evidence of which can be seen HERE.

Last year saw another high profile whistleblower case. Cheryl Eckhard blew the whistle on GlaxoSmithKline.

Eckard's role at GSK [before she was too was fired] was to oversee the quality assurance at various GSK operational plants. One such plant was, the now infamous, Cidra plant in Puerto Rico.

Eckard was appalled at the state of the plant in Puerto Rico, she even told her seniors, for this, it appears, she was fired.

The drugs affected by the Glaxo's conduct included Paxil, Paxil CR, Avandia, Avandamet, Coreg, Bactroban, Abreva, Cimetidine, Compazine, Denavir, Dyazide, Thorazine, Stelazine, Ecotrin, Tagamet, Relafen, Kytril, Factive, Dyrenium and Albenza.

Examples of defective and/or misidentified products that the defendants released to the United States market from the Cidra plant were:

a. Drug product that was mixed up with drug product of a different type or strength, e.g., 30mg and 10 mg tablets of an anti-depressant mixed in the same bottle, and 12.5 and 6.25 mg tablets of a heart medication mixed in the same bottle.


b. A diabetes medication that was sub-potent and/or superpotent.


c. An antibiotic ointment used to treat a skin infection common in small children that was contaminated with a microorganism associated with bacteranemia, urinary tract infections, meningitis, wound infection, and peritonitis.


d. An injectable drug used to treat nausea and vomiting in patients undergoing chemotherapy that was contaminated with micro-organisms.

Lawyers defending the claims of both Eckhard and Jones stop at nothing to protect their clients. My opinion of pharmaceutical defence lawyers is that they are just as bad, if not worse, than the clients they are defending. They know, in the Risperdal case, that children were targeted and they know that this was an abhorrent way of profit-making - yet they defend their client's actions. Okay, everyone, even the likes of Johnson & Johnson and GlaxoSmithKline, are entitled to a defence. In both cases employees were fired from their positions when they brought failings/fraud to the attention of superiors. Life after that became 'uncomfortable' for the whistleblowers. It's all part of the game that defence lawyers and their clients play to 'muddy the waters' of the opposition.

As a blogger I like to cause as much pain and misery to those that have harmed myself and others. It's becoming more apparent that to sue a pharmaceutical company through the UK legal system one needs to jump through so many legal loopholes just to get financial aid, the system is designed in such a way to protect those causing the harm. Imagine, if you will, if serial-killers or murderers had the same protection, our prisons would be empty and those offenders would be given carte blanche to continue doing what they do best...in pretty much the same way pharmaceutical companies are allowed to do.

That's Britain. America is a whole different ball game.

US Attorney's Baum, Hedlund, Aristei & Goldman hit the nail on the head when they write:

Whistleblowers play a pivotal role in the detection, investigation and prosecution of fraud against the government. According to Taxpayers Against Fraud, more than 80 percent of cases pursued under the False Claims Act are initiated by whistleblowers. The False Claims Act, also called the Whistleblower Act or the Qui Tam Act, encourages citizens to bring forward evidence of fraud against the government and sue on the government's behalf.

They add:

Many people who step forward and become whistleblowers do so because they feel the risks are worth taking, to save lives, to protect the innocent and to right a wrong. It is because there are risks involved in filing a qui tam claim that the federal False Claims Act provides both whistleblower protection and a substantial reward for the “relator” (whistleblower who files a qui tam claim).

Jones has stepped up to the plate, he witnessed something that he knew wasn't morally right, In essence, children were being used by adults to make a fast profit, it's no better than child slavery. Jones needs to be applauded at every given opportunity, the American people owe him a great debt. Turning a blind eye to this wanton neglect of children is a vile and shameful act. Defending a person or persons when you know what you are defending is an abominable act is even more shameful.

With a bit of luck, courage, ethics, call it what you will, more and more people will start coming forward to whistleblow. Maybe, just maybe, the pharmaceutical companies will then start to get their house in order and come to terms with the fact that children, under no circumstances, should be used to make billions of dollars for a product they are selling.

We, as bloggers, have a moral obligation too. What the press fail to report on is the human aspect of cases such as Eckhard and Jones. We are in a position to whistleblow by proxy and offer our full support to those who stand up to be counted. The usual suspects are covering the Risperdal case, drum-bangers such as Soulful Sepulcher, 1 boring old man, Alison Bass... to name but a few.

I was recently contacted by an ex-pharmaceutical employee who has a story to tell, I won't go into matters [because I don't know the full ins and outs] but it involves yet another act of fraudulent behaviour by a pharmaceutical company. It's too early at this stage to say if this person will become a whistleblower...I sincerely hope they do.

So, do you want to be the next whistleblower? Got something you want to get off your chest? Do you want to put all those wrongs, right?

Good place to start would be Attorney's with a proven track record against the pharmaceutical industry.



**UPDATE -J&J Said to Settle Texas Risperdal Drug Case






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