Say It Ain't So Joe: Louisiana Supreme Court Reverses $300 Million+ Verdict Against Janssen

via Drug and Device Law;
Breaking News: Risperdal Megaverdict In Caldwell Reversed

This just in:  The Louisiana Supreme Court has reversed the $300 million+ state Medicare verdict in Caldwell v. Janssen Pharmaceutica, Inc., Nos. 2012-C-2447, -2466, slip op. (La. Jan. 28, 2014).  

. . . . . . .

Caldwell, slip op. 21-22.  More later after we’ve had time to digest this.

J&J Risperdal LOSES $257.7 Million APPEAL In Louisiana

Bloomberg Business has;
J&J Loses Appeal of $257.7 Million Risperdal Verdict
By Jef Feeley and Margaret Cronin Fisk on August 31, 2012

Johnson & Johnson (JNJ) lost a bid to have a Louisiana appeals court throw out an award of almost $258 million that a jury ordered it to pay state officials over the marketing of its Risperdal antipsychotic drug.

A state appeals court in Lake Charles, Louisiana, today rejected J&J’s claims that it was unfairly barred from defending itself against allegations that its Janssen unit defrauded the state’s Medicaid program by misleading regulators and residents about Risperdal’s health risks.

“We find that the trial court was not manifestly erroneous in casting Janssen with civil monetary penalties, attorney fees, and costs for its violations” of Louisiana’s Medicaid fraud laws, the appellate court said in a 32-page ruling.

The ruling comes a day after New Brunswick, New Jersey- based J&J and Janssen agreed to pay $181 million to resolve claims by 36 states that they improperly marketed and advertised Risperdal and Invega, another antipsychotic medicine.

Janssen intends to appeal the decision to the Louisiana Supreme Court, Teresa Mueller, a J&J spokeswoman, said in an e- mailed statement.

Thank You Bloomberg, Mr Feely and Ms Cronin Fisk

Continue reading Bloomberg coverage here.

And with a little bit of Luck, the Louisiana Supreme Court will tell J&J the same thing.

AND: How's your gag reflex?

http://medgadget.com/2007/05/risperdal_legos.html

NOT FUNNY

Risperdal’s Lego’s

by GENE OSTROVSKY on May 25, 2007 • 1:23 am

Promotional materials for Risperdal (risperidone), an atypical antipsychotic medication, is drawing ire from some in the medical blogosphere.
Kevin, M.D.: ” a new low, drug marketing on children’s toys.”
Pharmalot: “Keep in mind that, as of last October, Risperdal is approved for kids showing autistic symptoms. So perhaps we should expect to see all manner of playthings with the drug’s brand name. How about a ‘Doctor Barbie’ with Risperdal samples?”
Medgadget: “Drugs are booooring… We do like the Legos though.”

Risperidone		Reported By
Adverse Reaction	Cases	MD	CN	OT	PH	LW	NR
Suicidal Ideations	142	86	63	51	3	2	10
Attempted Suicides	248	248	25	53	17	6	11
Completed Suicides	107	84	12	37	9	4	4
Deaths Not From Suicide	900	788	135	357	75	48	33
Homicidal Ideations	16	16	2	14	0	0	0
Homicides	14	14	3	1	2	1	1
Hypomania/Mania	31	18	8	9	0	0	5
Heart Disease	318	262	37	90	44	8	18
Movement Disorders	964	535	226	355	132	37	76
Birth Defects	50	37	3	24	6	0	3
Premature Births	11	9	0	6	0	0	0
Prenatal/Neonatal Deaths	45	34	12	22	4	0	0

Internal J&J E-Mails Detail Ugly Mismarketing Of Antipsychotics

BNET has;

Internal J&J E-Mails Detail "Ugly" Chapter In Mismarketing Of Antipsychotics

by Jim Edwards

One of the reasons Johnson & Johnson (JNJ) lost a recent trial verdict over its misleading marketing of Risperdal was because jurors saw the company’s internal emails in which senior staff described their own actions as “ugly” and not “competent.”

Although the emails don’t reveal anything we don’t already know about Risperdal — J&J marketed the atypical antipsychotic for years by playing down the risk of weight gain and diabetes associated with the drug — the communications do give us a rare glimpse into the backbiting that happens inside drug companies when they fall afoul of the FDA. Pharmaceutical companies almost never discuss this kind of thing in public. (The documents can be downloaded atCourtroomView Network.)

In 2003, the FDA became increasingly concerned that use of drugs such as Risperdal and Eli Lilly (LLY)’s Zyprexa led to weight gain, diabetes and, in some patients, an early death. So it wrote to all antipsychotic drug companies to require them to send a “dear health care provider” letter to all U.S. doctors advising them of this risk (click to enlarge):

But J&J began trying to figure out whether the “dear doctor letter” could actually be used to promote Risperdal, which executives believed was not as risky as similar drugs. SVP/R&D Scott Reines (pictured) had seen a previous “dear doctor letter” from Eli Lilly that had used the same sleight of hand, and he asked a colleague, “how much commercial liability would we incur if we sent a similar letter about Risperdal”?:

When J&J’s letter went out, instead of heightening doctors’ awareness of the risk of diabetes it said the opposite: “Risperdal is not associated with an increased risk of diabetes”:

The FDA — unsurprisingly — hit the roof, and sent J&J a warning letter, blasting the company for being “false and misleading.”

Inside J&J, Reines was furious: “The whole management team almost got canned,” he wrote to chief medical officer Joanne Waldstreicher. “The warning letter is ugly … it’s really a black mark for J&J … [and] no competent person would have let [the 'dear doctor letter'] go out”:

J&J faces up to $36 million in fines as a result.

And make sure you read Mr. Edwards Related Reports.

Related:

• J&J Drug Is a Wash for Schizophrenia but Worked Wonders on Taxpayers
• J&J May Be Liable for Antipsychotic Kickback Scheme Despite “Legal” Contract
• Dumbest PowerPoint Ever? J&J’s P&L Slideshow of Alleged Kickback Scheme

And Don't try telling us that the pill pushers down at consultation cubicle level don't/didn't know Exactly what Risperdal, or any Other antipsychotic drug is.

Check the AIMS form. It's from 1976.

http://www.servier.com/App_Download/Neurosciences/Echelles/AIMS.pdf

Tardive Dyskinesia is Risperdals' 9th most often FDA reported adverse Reaction, out of 1,935 distinct Adverse Reactions.

Who the Hell do you think has been filling out those forms, since 1976? It wasn't Bill Weldon or J&J's Board of Directors. And just in case any More of our State Attorney Generals are interested, Neuroleptic Malignant Syndrome was even More frequently reported than TD, occupying the number 7 spot.

http://psychroachesadverseevent.blogspot.com/2009/03/risperdal-adverse-reactions.html