Showing posts with label Trial. Show all posts
Showing posts with label Trial. Show all posts

Tuesday, October 2, 2012

J&J Sales Reps Earned BONUSES For Breaking The Law!

And the Hits just keep Rolling in.

The Philadelphia Enquirer has;
Risperdal Trial: Sales Rep Cites Pressure From Above
September 26, 2012|By David Sell, Inquirer Staff Writer


A former Janssen Pharmaceuticals sales representative who was promoted because of his success in selling the antipsychotic drug Risperdal told a Philadelphia Common Pleas Court jury Monday that he and his team followed orders from the top of the company in promoting the drug for uses not approved by the U.S. Food and Drug Administration.
Janssen is a wholly owned subsidiary of health-care giant Johnson & Johnson, which has headquarters in New Brunswick, N.J., and divisions elsewhere in the region.
"Janssen wanted Risperdal to be a $1 billion drug, and that led to how we would communicate with our customers," said Tone Jones, referring to doctors who would prescribe the drug to patients. Jones was a sales representative for Janssen and Risperdal.
The jury of eight men and four women will decide whether J&J owes money to the family of a 17-year-old from Texas who was prescribed the drug when he was 5 and started growing breasts at age 12. Judge Mark Bernstein told the jury he expected the case to last about three weeks.
J&J faces hundreds of individual lawsuits alleging harm to patients, but it also faces - or has paid to settle - multiple state and federal cases involving inappropriate promotion of Risperdal.
The drug was approved in 1993, but only to treat adults with schizophrenia and bipolar disorder, which have small populations, and that makes generating huge profits difficult. Doctors can legally prescribe anything, but drug companies can't promote a drug for anything not on the official FDA-approved label. The allegations across all the suits is that Janssen did just that.
J&J attorney Laura Smith dismissed that idea and encouraged jurors not to view the case as one of a multinational corporation ignoring federal law and patient safety in pursuit of profit, but as a case of a boy with multiple mental problems who was genuinely helped by the drug and had minimal side effects.
"Risperdal was a very good choice" for the boy's three physicians, Smith told the jurors.
Smith later told the jury that if any Janssen personnel had been found promoting drugs for unapproved uses, they would have been fired.
That set up a direct contradiction when Jones took the stand. The plaintiff's attorney, Bob Hilliard, in his opening statement, had shown a group photograph that included Jones and then-Janssen president Alex Gorsky, who is now chief executive officer of J&J.
Hilliard asked Jones whether he knew of anybody who got fired for selling Risperdal off-label.
"No," said Jones, who started four years at quarterback for Oklahoma State and then spent about 10 years working for Janssen.
Did you get bonuses based on selling Risperdal off-label? Hilliard asked.
"Yes," said Jones.
Earlier in the day, Hilliard and Philadelphia lawyers Stephen Sheller and Brian McCormick formally asked Judge Arnold New to reconsider his decision Thursday that Gorsky could not be compelled to testify. New gave no reason for his decision. Gorsky's assistant had said in an affidavit that he would be in Asia. The boy's attorneys said New was setting a terrible precedent because every corporate leader would suddenly find the need to be out of the country when subpoenaed by opposing counsel.
"A decision to quash the subpoena of Mr. Gorsky would result in denial of the rights of ordinary citizens, such as Plaintiffs, and would favor large businesses over the interests in a trial by jury," the plaintiff's attorneys wrote.

Thank You Philly.com and Mr Sell


And here's more on the business of Off-Label Marketing from State Attorneys General filed Lawsuits against J&J's Risperdal.


State of Texas, 3rd Amended Petition

State of Arkansas

Commonwealth Of Massachusetts

And then there's this slip opinion from Justice Crouch in South Carolina, characterizing the Risperdal Gang, as he ordered them to Pay $327 Million to the State, as "Detestable".

Below, we've previously shared out that particular 'Detestable'.


"this Court finds the actions of the Defendants, upon this audience, to be detestable."
"Annual Sales of Risperdal worldwide per annual reports of Johnson & Johnson, Inc.
1994: $0.172 Billion
1995: $0.343 Billion
1996: $0.502 Billion
1998: $0.588 Billion
1999: $0.892 Billion
2000: $1.083 Billion
2001: $1.845 Billion
2002: $2.146 Billion
2003: $2.512 Billion
2004: $3.05 Billion
2005: $3.552 Billion
2006: $4.180 Billion
2007: $4.697 Billion
2008: $1.309 Billion
2009: $1.425 Billion
2010: $1.50 Billion


Total for the period: $29.796 Billion

Testimony at trial indicated that the profit margin for sales of Risperdal was 97% or $28.90 Billion for the period of 1994-2010"
And there's more 'Detestable' from J&J and their Risperdal gang. There's Always More Detestable. Like this Detestable, where 40 State AGs are looking into Joining the Detestable fray, which Never should have been Allowed, BY DC's FDA, to have Detestabled in the First place:
After J&J Failed 48% of 161 FDA Inspections in One Year
And then there's This King Sized Let Down where 36 States took Their 30 Pieces of Silver/Chump Change and decided to just, Take their 30 Pieces of Silver.

And now it's Bonuses, for Off-Label Marketing, to Children.
It really is a shame that all that Bonus money didn't inflict the crippling Tardive Dyskinesias that Risperdal itself inflicts, on Every Hand that Took that Money. 

Thursday, September 20, 2012

DEPOSED: Risperdal, Prolactin & Gynecomastia: The Gorksy Transcript Pt III

IF you haven't availed yourself of J&J CEO Alex "Risperdal" Gorsky's deposition yet, what's keeping you?

A 15 year old boy was poisoned with Risperdal, grew male breasts from it, and later had to have them surgically removed. 
Here's the transcript.
'Mental Health' at its, well, ...... butt covering non-disclosing to the consumer, usual self.
Let's start with a J&J Ideation or two of how J&J views the definition of "Off Label Marketing"
Deposition: starting on pg 158 (pg 41 of the pdf)
We're finding the hair splitting here between Marketing Plans and Selling Plans for the pediatric market (in 2001/2002 pre FDA pediatric approval) fascinating.
“11 Q. Turn to the top of the next page, please, page
12 261. See where it says “RISPERDAL use in the
13 child/adolescent population is exploding”? Is that
14 correct?
15 A. That’s what it says, yes.
16 Q. Then down below it says, “Key Base Business
17 Goals — well, strike that. I’m sorry.
18 “RISPERDAL use in the child/adolescent
19 population is exploding,” but in this time frame,
20 2001/2002, Risperdal is not indicated by the FDA for
21 any pediatric use, is it?
22 A. Again, we did not have the specific
23 indication, as we discussed earlier, until 2006. I
24 don’t remember exactly what the labeling said regarding
Page 158
1 use in children, but as I discussed earlier, there was
2 a significant — there appeared to be a significant
3 increase in the recognition of this condition in
4 children and adolescents during this time, which was
5 substantiated by data and its occurrence.
6 And physicians have an opportunity to use a
7 treatment that they perceive to be appropriate and
8 effective in a particular patient population, and
9 that’s clearly what we were seeing happening in this
10 area.
11 Q. Look down at the heading that says “Key Base
12 Business Goals and Objectives.” Do you see that?
13 A. Yes.
14 Q. And the fifth of the Key Base Business Goals
15 says “Grow and protect share in child/adolescents.” Is
16 that right?
17 A. Yes, that’s correct.
18 Q. My question is, how can Johnson & Johnson grow
19 a share in a child and adolescent market when the drug
20 isn’t even indicated for use in the child and
21 adolescent market?

22 A. Well, my interpretation of that is, this is in
23 fact a marketing plan, (1) not a selling plan. As a
24 marketing plan, its intent is to cover a wide range of
1 activities regarding the development as well as the
2 promotion of Risperdal.



3 That being said, all of our actual promotion
4 to the physicians would follow what was outlined in our
5 package insert and all of our materials went through a
6 significant review process, and that’s the way our
7 representatives were trained. And in an area such as
8 this, this is a marketer versus a sales representative,
9 their language.
10 And when in fact physicians took it upon
11 themselves and their patients to prescribe the product,
12 their statement would in fact be correct: To ensure
13 that when a physician made that choice, that it was in
14 fact Risperdal.
15 Q. You were the vice-president of sales and
16 marketing at this time frame, 2000/2001, correct?

And according to now CEO, and then VP of Marketing and Selling Gorsky, there's a Difference between Marketing plans and Selling plans. Apparently it's only illegal if it leaves the J&J premises themselves as Marketing rather than Selling, but In House Off Label Marketing is a different Ideation.

UPDATES:
March 20, 2014
Arkansas Supreme Court Reverses Billion Dollar Risperdal Case

June 1st, 2015
Janssen To Pay $7.5 Million In Risperdal Settlement


Back to the deposition:
On pg 21 of the pdf:
8 Q. And then one of the safety areas that’s
9 discussed there is prolactin. Is that right?
10 A. It says, “Safety areas include prolactin (in
11 publication), cardiovascular” and a number of other
12 items.
pg 38
18 Q. The date is May 17th, 2002 in the top
19 left-hand corner?
20 A. Yes.
21 Q. If we turn to page two at the topline results
22 summary, it has two numbers there I want to talk about.
23 The first one in the second paragraph: What was the
24 rate of EPS-related adverse events and risperidone, if
1 you can find that for me?
2 A. It was noted as 47.8 percent.
3 Q. And what was it for haloperidol?
4 A. 57.8 percent.
5 Q. And then next under that they say there was a
6 statistically significant difference between the
7 treatment groups and the number of patients with
8 prolactin-related adverse events, too. Is that
9 correct?
10 A. That’s correct.
11 Q. And what was the percentage of
12 prolactin-related adverse events for Risperdal?
13 A. It says five percent.
14 Q. And what was it for haloperidol?
15 A. 0.4 percent.
16 Q. So, let’s turn back to page 8779, please. Do
17 you see in the middle there 3.1.3, it has
18 “Prolactin-related adverse events”?
19 A. Yes, I do.
20 Q. And then it has the same percentages down
21 there in the third or fourth row, the total number of
22 patients with prolactin-related AEs? It has five
23 percent for risperidone and 0.4 for Haloperidol?
24 A. Yes, it does.
Page 148
1 Q. And that’s fourteen patients out of 278 had
2 prolactin-related adverse events in this clinical
3 trial. Is that right?
4 A. That’s correct.
11 Q. And what was the percentage of
12 prolactin-related adverse events for Risperdal?
13 A. It says five percent.
14 Q. And what was it for haloperidol?
15 A. 0.4 percent.

Prolactin/Gynecomastia, a 12.5 fold Increase over Haldol.
And as we All know, Haldol, Another J&J Wonder Drug, is Also a Dr. Paul Janssen developed product.

Atypical Trials Rigged: Haldol, Risperdal, Tardive Dyskinesia & SFDPH, Again