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Thursday, July 31, 2008

Plaintiff's Verdict in First Mirapex Trial; Second One Already Going

So reports Pharmalot.  No damages set as yet.

--BC

http://lawprofessors.typepad.com/tortsprof/2008/07/plaintiffs-verd.html

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The verdict is deeply embarrassing to the civil justice system. It has no scientific validity, nor any logic, just based on the facts in the article.

But let's assume, the verdict is absolutely correct.

The plaintiff lost a specific amount gambling. 1) Should any gambling winnings go to the defendant?; 2) Should the value of the benefit of the medication be deducted, and reimbursed to the defendant if exceeding the value of the lost? He had Parkinson's disease. Say, it was bad enough to retire him. The medicine improved him, and allowed him to earn again, to enjoy activities, to have sex, to avoid placement in a nursing home, to go out as a tourist, to run about with family members, to be funny, to sleep better. Those benefits have value.

If the plaintiff gets to collect for his loss, but does not re-imburse the defendant for the benefit, the plaintiff has been unjustly enriched.

Posted by: Supremacy Claus | Jul 31, 2008 12:59:56 PM

The damage phase should discount for discovered factors not caused by the defendant, 1) the opening of a casino quadruples the pathological gambling rate within 50 miles; 2) the plaintiff had a pre-existing condition that increased the risk (true here); 3) the casinos violated any policy or regulation designed to exclude pathological gamblers (warrants a per se cross claim); 4) the plaintiff had fun gambling, a benefit, not a damage.

Posted by: Supremacy Claus | Aug 1, 2008 3:54:26 AM

The medication said it would do certain things; ie: improve user's life, to enjoy activities, to go out and ebjoy life .... so why should the winning plaintif in this case pay the medicine's maker for that when it was promised in the beginning?
Plus many of these people did not have to 'wait' for a casino to open; that has no merit. Many of the casinos (for example) in Atlantic City NJ have been there for ever.
Facts are Facts. The maker(s) of this drug were well aware of certain side effects (in this case compulsive behavor such as gambling) and they HID the facts from the people who took it. On that fact alone they should pay through the teeth.

Posted by: Bart | Aug 2, 2008 12:54:51 PM

The plaintiff gambled prior to taking the medication. It merely set him loose, by improving his Parkinsonian slowing. It was uncertain that the medication caused a complex intentional act such as gambling. Uncertainty is not the same as a cover up. It still remains unproven. This case was likely won on theatrics, and not on science.

The idea that a chemical can induce an intentional act is extraordinary. It requires an extraordinary amount of proof. I am interested in the name of the plaintiff expert. The Supreme Court has granted him absolute immunity for his misleading testimony. However, he still needs to be held accountable. I want to deter him.

The decision should be reversed on public health policy grounds. Aside from damage to the care of other patients, this decision endorses a new excuse for irresponsible and criminal behavior. The court has no competence to do that, only a legislature does.

Posted by: Supremacy Claus | Aug 2, 2008 7:20:12 PM

If you actually did some research, many of the plaintiffs out of the 400+ cases to come before the court system, MANY of them were not gamblers at all.
For some reason your are denying the facts that have been laid out in court. The court did not just hand out money willy nilly; the plaintiff's attorney obviously gave undeniable proof that the drug manufacturer(s) are responsible for this compulsive behavior (whether it be gambling or otherwise).
You MUST be a share holder of the drug manufacturer or some how associated with them; otherwise you would not be so ignorant to the fact that the prosecution & plaintiff have proved their point and that the judge found the defendant(s) to be liable. They obviously have proven that the drug caused obsessive behavior, like the gambling, otherwise the judge would have ruled otherwise.
With such ignorant behavior you are showing here, I too must revert back to being childish and say to you 'HAHA!'. Just wait too, there are 400+ more cases on the way!

Posted by: Bart | Aug 3, 2008 9:48:56 AM

I get a rash on a medication. I have a duty to stop the medication to mitigate the damage. If this allergic rash progresses to swelling in my throat, and I stop breathing, the damages are my fault. I had the most knowledge about my bad reaction of anyone in the world. I had the most power to stop the progression of damages.

There is no credible evidence of a causal link between the medication and gambling. If you walk through a casino, you will see many old people plunking the rent into those machines. They just enjoy it. The public should not pay for their pleasures, and their intentional irresponsible conduct.

Posted by: Supremacy Claus | Aug 3, 2008 12:34:13 PM

"2003 Muhammad Ali Parkinson Research Center Report
The Mayo Clinic study followed a 2003 report in the journal Neurology which also linked Mirapex to gambling addictions. Researchers at the Muhammad Ali Parkinson Research Center at the Barrow Neurological Institute in Arizona monitored 1,800 Parkinson's patients over a one year period and determined that of the 529 patients in the study who took Mirapex, eight developed gambling addictions. For most patients, the gambling behavior improved after they stopped taking Mirapex."

That rate is lower than the rate of pathological gambling in the general population, around 3%, up to 7% or higher withing 50 miles of casinos. Is it possible that Mirapex improved people, with more energy and ability to express their addiction?

I would appreciate any links to transcripts or to the name of the plaintiff expert.

Posted by: Supremacy Claus | Aug 3, 2008 8:40:06 PM

You are obviously too ignorant to debate with. Even though there is factual data all over the internet, you deny to acknowledge it.
You also refuse to acknowledge the fact that the courts have made a decision based on the data & information presented to them; which obviously was compelling enough to find the drug manufacturer(s) responsible for their actions of not releasing information that they knew was true.
You are a shining example of true ignorance.
Sign up to PACER and read the court complaints, dockets & documents for yourself before showing your obvious ignorance. Or is 8 cents per page too expensive for you?
Plus, your comparison to this situation to your 'rash' rational above is completely child-like. How much more are you willing to embarrass yourself with your complete ignorance and child-like intellegence?

Posted by: Bart | Aug 4, 2008 6:01:02 AM

Maybe this will shut you up :
http://www.pharmalot.com/2008/07/compulsive-gambler-wins-lawsuit-over-mirapex/#comment-368593

Enjoy!

Posted by: Bart | Aug 4, 2008 8:30:57 AM

Bart: Thanks much for the links. I reviewed all the evidence cited already. The complaint does not consider the baseline rate of pathological gambling, at around 3%, or twice the risk on Mirapex. The people on placebo were too Parkinsonized to get to a casino.

It is a simple error of ascertainment. They failed to consider the baseline population rate. This is forgivable for civilians. It is not forgivable for the plaintiff expert.

Where can I get the name of this expert, or if you know it, let me have it. I am also curious if you have a personal involvement in the Mirapex litigation.

Posted by: Supremacy Claus | Aug 4, 2008 11:26:24 AM

I am a person with no personal involvement but with some understanding of how the litigation process works. The defendants in this case are major pharaceutical companies with a lot at stake ($$) in this litigation. They have hired the best litigation defense attorneys in the nation. These attorneys have come up with the best defenses they can dream up. I'm sure their highly educated experts used the baseline rate of pathological gambling to counter the plaintiff's evidence or some other statistical data. In the end, the aggregious behavior of the defendants warranted the jury to give the victim what they felt was a fair and just.

Juries are made up average people, people who believe that someone should not be unjustly enriched just because they lost some money. In order for the jury to award such a large amount of punitive damages, they must have felt like the drug companies knowingly did something very very wrong.

Posted by: No Personal Involvement | Aug 4, 2008 1:04:19 PM

NPI: I appreciate your faith in the legal system. You have been persuaded by misleading lawyer propaganda.

Unfortunately, even the profs here have little awareness of its pretextual, rent seeking purposes. They have faith in the stated goals of torts, all of which are masking ideologies. The proof lays in the devastating effect on the economy. It lays in the self-dealt immunities of the lawyer, and of the lawyer on the bench. It lays in the utter failure of every self-stated goals. It lays in the stealthy industrial policy effects of these outcomes, all enforced at the point of a gun. Not even the profs hear are sophisticated enough to grasp simple logic. Opposing experts means a scientific controversy. It cannot be resolved at the point of a gun.

As to your faith in the trial. The trial is a competition of fairy tales. The outcome represents the better Broadway production values of one side compared to the other. The adversary structure has no scientific validation as a method of detecting the truth. The jury cannot detect the truth by using its gut feelings. Such a supernatural power violates the Establishment Clause. I bet no lawyer in the US can grasp that idea. It is an impossibility after they have undergone the indoctrination of 1L, even if they have an IQ of 300.

So, your faith in this anti-scientific, Scholasticist, unlawful Medieval era garbage process is mistaken. It is the process of 1250 AD. Nothing from 1250 AD is remotely acceptable as a methodology or practice. Nothing. If anyone else tried to make a product or deliver a service as they did in 1250 AD, they would not be sued. They would be arrested as immediate threats to the public safety.

Posted by: Supremacy Claus | Aug 4, 2008 1:43:46 PM

Supremacy Claus: Like I stated before, sign up to PACER (http://pacer.psc.uscourts.gov/) and their 'Case Management/Electronic Case Files' (http://pacer.psc.uscourts.gov/cmecf/index.html) and look for the following case '0:07-md-01836-JMR-FLN In Re: Mirapex Products Liability Litigation'.
READ EVERYTHING and all your ignorant questions you post here (and elsewhere) will be answered.
Every expert that testified is listed; every iota of exhibit proof is listed. READ IT ALL!
Presently you are speaking out of anger and ignorance. READ THE FACTS and then maybe you will know more.
But I can already tell that even when laid out in black and white right infront of you, you'll probably then blame it on little green space men......

Posted by: Bart | Aug 5, 2008 6:16:24 AM

Thanks for the reference.

Posted by: Supremacy Claus | Aug 5, 2008 10:58:15 AM

This case is not just about gambling winings and losses. The maker of Mirapex was well aware of a relationship to compulsive behavior and hid that info. They now warn about that relationship, but did not do so until after these problems became huge and legal action was taken. Compulsive gamblers never profit from jackpots, they just gamble more. Then they lose their health, their spouses, their jobs, and many times their lives. This is not about dollars, this is about destruction of lives, and the possibility that Mirapex was a factor.

Posted by: Migesh | Aug 12, 2008 5:53:05 AM

I found this on a blog...

Clinical research showed evidence

The Basic Product Information sheet was circulated to BIPI and the rest of BI’s operating
companies in September 2004 for incorporation into Mirapex product labeling worldwide. (Pl.
Ex. 85.) BIPI did not put a warning on the product label in the United States indicating that
pathological gambling symptoms subside upon treatment discontinuation. Rather, BIPI added
14
only “pathological gambling” to the “post-marketing experience” section of the label. (Pl. Ex.
86 at 7166-72.) The text stated that: “[b]ecause these reactions are reported voluntarily from a
population of uncertain size, it is not always possible to reliably estimate their frequency or
establish a causal relationship to drug exposure.” (Pl. Ex. 90 at 7170-71.)
Plaintiffs allege that BIPI then publicly denied that there was a causal link between
Mirapex and compulsive behaviors, in the face of contrary conclusions from its parent company
and with the knowledge that there had been reports of compulsive gambling in the clinical trials.

On November 30, 2004, Dr. Kirk Shepard appeared on CBS News in Cedar Rapids, Iowa and
communicated that “[t]here is no evidence of a causal effect between pramipexole and
compulsive behavior such as gambling” and that “[i]n the trials . . . there were no cases of
compulsive behavior.” (Pl. Ex. 91.) Plaintiff’s Exhibit 91 is an internal email summarizing Dr.
Shephard’s “key points.” (Id.) On December 16, 2004, Dr. Zerban, with BI Germany, sent an
email to Dr. Shepard and Dr. Corsico (BIPI’s Director of Drug Safety), stating that:
the attached document (CBS Q&A Final) addresses the question: Is Miarapex
causing the compulsive gambling? We do have indication of a causal
relationship. This is why we recommend a discontinuation of Pramipexole in our
corporate label, if pathological gambling is observed. I have already send a copy
of the report dealing with the issue of pathological gambling to Kirk. (Pl. Ex. 93.)

BIPI’s statement that there was no evidence of a causal relationship between Mirapex
and gambling was also reported on Good Morning America on December 23, 2004 where it was
reported that “[t]he manufacturer of Mirapex told ABC News in a written statement that . . . it
does not believe there is proof of a causal relationship between the product and gambling.” (Pl.
Ex. 94.) BIPI’s position that there is no link was reported in numerous other outlets, including
NBC News Baltimore (February 10, 2005), Associated Press (July 12, 2005). BIPI also emailed
a statement to the Wall Street Journal in July of 2005 stating that “there is no scientific evidence
of a causal effect between pramipexole and compulsive behavior[.]” (Pl. Ex. 98.)
Plaintiffs allege that BIPI also failed to report important information to the FDA in July
2005. At that time, the FDA requested information about reports of gambling that BIPI had
15
received. (Pl. Ex. 113.) In the letter sent to the FDA in response to their request, BIPI did not
mention BI’s Clinical Expert Statement which concluded that there was a clear
pharmacodynamic effect of Pramipexole on pathological gambling. (Pl. Ex. 78.) BIPI did not
disclose that BI had added a warning to labels outside the United States indicating that
pathological gambling was a possible side effect that was reversible upon discontinuation of the
treatment. (Id.) BIPI also failed to report three cases of compulsive gambling from the clinical
trials. (Bray Aff. ¶¶ 5-8.)
Plaintiffs contend that BIPI delayed conducting a study. In October of 2003, a panel of
expert consultants recommended that a study should be conducted on impulse control behaviors
in Parkinson’s Disease patients. (Pl. Ex. 72.) The panel explained that “such a study could
document the broad range of compulsive disorders in these patients and help determine if the
disorders are disease or treatment-related. Id. In April 2004, another expert panel made the
same recommendation. (Pl. Ex. 73.) Representatives from Pfizer and BIPI were present at this
meeting. (Id.) In May 2005, one expert, Dr. Olanow, was concerned that BIPI “had not taken
action steps on the issue despite advice [sic] provided by consultants.” (Pl. Ex. 75.) In June
2005, Dr. Olanow voiced his concern again, indicating that the study was “twelve months
overdue as it is.” (Pl. Ex. 76.) BIPI convened another expert meeting in July 2005. (Pl. Ex. 77.)
BIPI did not finalize the protocol for the study until July 2006, (Pl. Ex. 80), and BIPI will not
have the study completed and the report on it issued until March 2009. (Pl. Ex. 81.)
Plaintiffs’ allegations and the evidence presented in support constitute a prima facie case
that BIPI acted with deliberate or conscious disregard for the rights or safety of others.
Therefore, the Court finds that Plaintiffs may allege punitive damages against BIPI.
2. Plaintiff’s Evidence Against, Pharmacia & Upjohn, LLC, Pharmacia and Pfizer
a. Pharmacia & Upjohn, LLC
Plaintiffs allege that Pharmacia and Upjohn knew all along that Mirapex caused
compulsive behaviors and failed to research the issue or warn patients about the possible side effect


Plaintiff has presented evidence that Upjohn filed Mirapex Investigational New Drug application for the treatment of depression where it acknowledged that Mirapex targeted the
dopamine function and the mesolimbic pathways involved with motivation and reward resulting in mood enhancement and reduced depression. (Pl. Ex. 4.) Upjohn noted that dopamine
agonists caused compulsive behaviors in animals such as compulsive gnawing, licking, biting
and sniffing. (Id. at 8729.)

Plaintiffs have also presented evidence that Upjohn was also part of an effort to suppress Mirapex studies.

In February 1994, individuals on the BI/Upjohn Development team agreed that
“no [pramipexole] will be sent to the NIDA [National Institute on Drug Abuse] as we would not wish to be confronted with this data regarding addiction models[.]” (Pl. Ex. 10 at 9165.) BI and
Upjohn representatives also decided not to give a sample of pramipexole to researcher Torben
Kling-Peterson, who was conducting an intracranial self-stimulation model, because they did not
want to risk pramipexole being associated in any way with “addiction.” (Pl. Ex. 14.) They also
agreed that Mirapex should not be provided to external investigators “for models associated with
addiction.” (Id.) Plaintiffs allege that BI and Upjohn then worked together to suppress mention
of the terms “addiction” and “positive reinforcement” from a proposed abstract and presentation about Mirapex. (Pl. Ex. 17.)

The researcher eventually agreed to delete the terms from his
abstract and the discussion from his presentation and BI then agreed to release the abstract for
publication. (Id. at 7648.)
Plaintiffs also contend that the numerous reports of compulsive gambling from the clinical trials should have induced Upjohn and BIPI to research the issue further and to warn patients about the possible side effect. BI, BIPI and Upjohn were studying and developing
Mirapex between February 16, 1993 and December 26, 1995, during which time a number of cases of compulsive behavior were reported. See Section III.B supra. According to Defendant’s
chart, on July 2, 1997, BIPI entered into a Co-Promotion agreement with Pharmacia and Upjohn for marketing of Mirapex and both companies jointly marketed Mirapex until May 1, 2005.
17
During this time, there were also a number of cases of compulsive behavior reported. See
Section III.B.1 supra.
Plaintiffs have presented prima facie evidence that Pharmacia and Upjohn failed to
properly study possible side effects, failed to warn and attempted to suppress studies of Mirapex
as it relates to addiction. This evidence, if unrebutted, could be relied upon at trial to find that
Pharmacia and Upjohn disregarded the high probability of injury to the rights or safety of others.
b. Pharmacia
Plaintiffs allege that Pharmacia remained silent about compulsive gambling as a side
effect of Mirapex despite receiving many reports of gambling from patients and doctors.
Pharmacia received the following reports:
• In early September, 1996, patient 2421 in the M/2730/0002 trial developed
“compulsive behavior” and was hospitalized. (Ex. 25, BIPISELINSKY01147027
at 7152.) The patient was hospitalized for “depression with
suicidal ideation,” because she “had been having an ongoing problem with
gambling and has again spent money she didn’t have and overdrawn her bank
account again.” The records describe the patient as suffering “what she felt is a
gambling addiction.” (Ex. 26, BIPI-PFIZER-SELINSKY0042987.) But when
Pharmacia reported the event to the FDA nearly two years after her
hospitalization, they failed to disclose the true nature of the adverse
event—gambling addiction—instead reporting only that she suffered from
“anxiety” and “stress.” (Ex. 27, BIPI-PFIZER-SELINSKY00199704 at 9812.) In
fact, her gambling addiction has never been reported to the FDA. (Ex. 28, Tr.
Reidies Dep. at 109-115.)
• In August 2002, Pharmacia received a report that a woman taking Mirapex had
developed “compulsive gambling.” (Pl. Ex. 51 at 6819-20.)•


In September 2002, Pharmacia received a report that a woman and her husband on Mirapex developed gambling addiction and were “in financial ruin.” (Id. at
6825-28.) The woman also reported that she knew four other people taking
Mirapex who developed gambling addictions. (Id.at 6829-30.)
• In March 2003, Pharmacia received a report that a man who was on Mirapex had
developed a problem with gambling, and was “putting that activity before
business, paying bills, [or] gathering information for taxes[.]” (Id. at 6859-60.)
• In May 2003, Pharmacia received a report that a woman had been taking Mirapex
and had developed “a serious gambling compulsion, which caused her complete
financial ruin.” (Ex. 52 at 5345.) “After she was off the product for one month
18
she returned to normal and did not have a gambling compulsion any longer.”
(Id.)
Pharmacia did report this last event to the FDA but did not take any steps to warn
patients or doctors that compulsive behavior may be linked to Mirapex. Plaintiffs also allege,
that Pharmacia, along with the rest of the Defendants failed to properly study compulsive
behaviors as a possible side effect of Mirapex. These allegations and the evidence presented in
support establish a prima facie case that Pharmacia acted with disregard for the high probability
of injury to the rights or safety of others.
c. Pfizer
Plaintiffs allege that Pfizer learned in August of 2003 that three doctors who were
prescribing Mirapex, Dr. Stern, Dr. Ravin and Dr. Lieberman had patients develop gambling
addictions. (Pl. Ex. 61; Pl. Ex. 64) Pfizer did not report these cases to the FDA. (Pl. Ex. 42, Tr.
Castro Dep. at 239-50; Ex. 59 Tr. Taylor Dep. at 149.)


On January 30, 2004, after BI took over
reporting responsibilities from Pfizer, it concluded that Pfizer’s failure to report these cases
“placed BI in a non-compliance situation” because these reports were not made when Pfizer first
learned of them. (Pl. Ex. 111.)

Even though Pfizer did not report Dr. Lieberman or Dr. Ravin’s
cases to the FDA, in November 2003, it did share the existence of those cases with its “communications team for . . . planning purposes.” (Pl. Ex. 70.) When Pfizer shared this
information with its public relations consultant, Weber Shandwick, the consultant’s crisis
management proposal identified the doctors as “threats.” (Pl. Ex. 71.) That Pfizer failed to
timely report to the FDA what it had learned from Doctors Stern, Ravin and Lieberman, but
instead treated the information as a public relations issue constitutes prima facie evidence that
Pfizer acted with deliberate disregard for the rights and safety of others.

Posted by: To Supremacy Claus | Aug 15, 2008 1:48:17 PM

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