NEURONTIN – FDA REJECTION FOR NEUROPATHIC PAIN AND MORE!

Neurontin ( Gabapentin ) November 3, 2010 Litigation PDF – US District Court of Massachusetts In RE NEURONTIN MARKETING AND SALES PRACTICE LITIGATION KAISER VERSUS PFIZER !

This is a very important document to read if you have ever been on Neurontin, might ever go on neurontin, had a loved one ever on the medication, or are in the medical profession. Here is the Table of Contents. I know it takes a while to read the whole thing but you won’t have to read the entire file to understand what happened. But if you deal with this medication, IT IS WORTH YOUR TIME!  Case 1:04-cv-10981-PBS Document 3120 Filed 11/03/10 Page 1 of 146

UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS
) IN RE NEURONTIN MARKETING ) AND SALES PRACTICES LITIGATION ) _______________________________) )

THIS DOCUMENT RELATES TO:

KAISER FOUNDATION HEALTH PLAN, INC., et al.

) CIVIL ACTION NO. 04-cv-10739-PBS ) ) )

) v. ) ) PFIZER, INC., et al. ) ) )

FINDINGS OF FACT AND CONCLUSIONS OF LAW

November 3, 2010

TABLE OF CONTENTS

Page INTRODUCTION AND SUMMARY . . . . . . . . . . . . 1 FINDINGS OF FACT. . . . . . . . . . . . . . . . 5

A. Kaiser Foundation Health Plan and Kaiser Foundation Hospitals. . . . . . . . . 5

1. Kaiser’s Proactive Drug Management . . . 5

2. Kaiser’s Placement of Neurontin on Formularies . . . . . . . . 8

B. Marketing of Neurontin . . . . ……. 9

1. FDA Approval of Neurontin For Epilepsy Treatment . . . . . . . . . 9

2. The “Strategic Swerve” to Maximize Neurontin Profits

Saris, U.S.D.J.

I. II.

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For Off-Label Indications. . . . . . . 12

3. Efforts to Expand On-Label Uses Fail at the FDA. . . . . . . . . . 13

4. The Two Marketing Partnerships. . . . . 14

5. Use of Medical Liaisons for Off-Label Marketing . . . . . . . . . . 19

6. Investigation by the FDA. . … . . . 22

7. FDA Rejection of Neurontin for Neuropathic Pain and Approval For Post-Herpetic Neuralgia (PHN) .

. . 22

8. Warner-Lambert Guilty Plea. . . . . . . 24 C. Target: Kaiser. . . . . . . . . . . . . . . 25 D. The Marketing Fraud

. . . . . . . . . . . . 27

1. Bipolar Disorder. . . . . . . . . . . . 27 i. Direct Marketing to Physicians . . 30 ii. Publication Strategy . . . . . . . 31 iii. Sponsorship of Continuing

Medical Education (CME). . . . . . 36

iv. Communications with the Cochrane Review. . . . . . . . . . 38

v. The Bottom Line. . . …. . . . 39 2. “Kick Ass” on Neuropathic Pain. . . . . 40 i. Publication Strategy …. . . . 42

ii. Direct Marketing and Sponsorship of CMEs. . . . . . . . 51

iii. Detailing Doctors. . . . . . . . . 53

iv. The Bottom Line. . . …. . . . 54 3. Migraine. . . . . . . . . …. . . . 54

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i. Publication Strategy . . . . . . . 54

ii. Sponsorship of CME Events. . . . . 59 4. Nociceptive Pain. . . . . . . . . . . . 60 5. Doses Greater than 1800 mg/day. . . . . 61

E. Kaiser’s Reliance on Pfizer’s Misrepresentations . . . . . . . . 65

F. Kaiser’s DUAT and DRUG Campaigns. . . . . . 72

G. Injury/Damages. . . . . . . . . . . . . . . 75

H. Neurontin’s Efficacy for Off-Label Conditions. . . . . . . . . . . . 80

1. 1.   Bipolar Disorder. . . . . . . . . . . . 83
   1. i.   Pande Trial . . . . . . . . . . . 83
   2. ii.   Frye Trial. . . . . . . . . . . . 84
   3. iii.   Guille Trial. . . . . . . . . . . 85
   4. iv.   Vieta Trial . . . . . . . . . . . 85
   5. v.   Mokhber Trial . . . . . . . . . . 86
2. 2.   Neuropathic Pain. . . . . . . . . . . . 90  
   1. i.   Gorson Trial. . . . . . . . . . . 90
   2. ii.   Backonja Trial. . . . . . . . . . 91
   3. iii.   Reckless Trial. . . . . . . . . . 93
   4. iv.   POPP Trial. . . . . . . . . . . . 94
   5. v.   Tamez-Pérez Trial . . . . . . . . 94
   6. vi.   Morello Trial . . . . . . . . . . 94
   7. vii.   Serpell Trial . . . . . . . . . . 95

   viii. Bone Trial. . . . . . . . . . . . 96

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1. ix.   Tai Trial . . . . . . . . . . . . 96
2. x.   Levondoglu Trial. . . . . . . . . 96
3. xi.   Van de Vusse Trial. . . . . . . . 97
4. xii.   Parsons Trial . . . . . . . . . . 97

3. Migraine . . . . . . . . . . . . . . . 104

1. i.   Trial 879-200. . . . . . . . . . 105
2. ii.   Trial 945-217. . . . . . . . . . 106
3. iii.   Mathew Trial . . . . . . . . . . 106
4. iv.   Di Trapani Trial . . . . . . . . 107

4. Doses Greater than 1800 mg/day . . . . 107 II. CONCLUSIONS OF LAW . . . . . . . . . . . . . . 109 A. Fraudulent Business Acts or Practices . . . 109 B. Pfizer’s Legal Defenses . . . . . . . . . . 114

1. 1.   Standing. . . . . . . . . . . . . . . . 114
2. 2.   Statute of Limitations. . . . . . . . . 115
   1. i.   Tolling Under American Pipe. . . 115
   2. ii.   The Discovery Rule . . . . . . . 116

3. Prescriptions Written Outside California. . . . . . . . . . . 123

4. Causation . . . . . . . . . . . . . . . 128

1. i.   Reliance by DIS and P&T Committees . . . . . . . . . 130
2. ii.   Prescribing Behavior by PMG Physicians . . . . . . . . . 135

iii. Quantifying the Fraud. . . . . . 138

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C. Restitution . . . . . . . . . . . . . . . . 139

III. ORDER. . . . . . . . . . . . . . . . . . . . . 143

—————————————————————————————————————————————–SOME KEY PASSAGES;READ ALL OF THE STUDY RESULTS FOR THE NEUROPATHIC PAIN;2.   Neuropathic Pain. . . . . . . . . . . . 90  

1. i.   Gorson Trial. . . . . . . . . . . 90 
   
2. ii.   Backonja Trial. . . . . . . . . . 91 
   
3. iii.   Reckless Trial. . . . . . . . . . 93 
   
4. iv.   POPP Trial. . . . . . . . . . . . 94 
   
5. v.   Tamez-Pérez Trial . . . . . . . . 94 
   
6. vi.   Morello Trial . . . . . . . . . . 94 
   
7. vii.   Serpell Trial . . . . . . . . . . 95 
   

viii. Bone Trial. . . . . . . . . . . . 96 They are all very similar. Here is one example of the studies listed above (read all of the information for yourself by clicking on any of the places that say LINK )

Page 94
The Serpell trial,sponsored by Pfizer,

 (makers of neurontin) was “a study of people with many different kinds of painful neuropathy” that “tested the efficacy of Neurontin against placebo in people who were symptomatically suffering from neuropathic pain rather than having a specific diagnosis.”
(Trial Tr. vol. 3, 36; TX 1552 at 557.) This DBRCT was completed in 2002. (Trial Tr. vol. 3, 37.)

When the study’s authors published the Serpell trial in 2002,they concluded that the “study show[ed] that gabapentin reduces pain

and improves some quality-of-life measures in patients with a wide range of neuropathic pain syndromes.”

(TX 1552 at 557.) In fact, the study’s authors stated that they “found . . . that there were no differences in treatment effect among the various pain syndromes studied, with all types of pain showing responsiveness to gabapentin.” (Id. at 564.) The raw data from the Serpell trial, however, did not support the published article’s conclusions.

In fact, improvement among patients suffering from PHN, an indication for which Neurontin received FDA approval, accounted for the vast majority of the improvement that was seen in the Serpell study. (Trial Tr. vol. 3, 37-38.)
Case 1:04-cv-10981-PBS Document 3120 Filed 11/03/10 Page 100 of 146 ALSO;

(xi) Van de Vusse Trial The Van de Vusse trial, published in the journal BMC

Neurology in 2004, looked at the use of Neurontin in the treatment of Complex Regional Pain Syndrome type I, which is a type of neuropathic pain. (TX 1727 at 1.) This DBRCT found that “[g]abapentin had a mild effect on pain in CRPS I. It significantly reduced the sensory deficit in the affected limb. A subpopulation of CRPS patients may benefit from gabapentin.” (Id.)

Case 1:04-cv-10981-PBS Document 3120 Filed 11/03/10 Page 101 of 146 

JANUARY 2014 UPDATE – Supreme Court Rejection of Pfizer’s Request for RICO Off Label Review: Could Open Floodgate of Cases – 

YOU CAN READ ALL OF THE STUDIES BY VISITING THE LINK 
ALSO;JUDGE PATTI B. SARIS – ADDRESSING RESTITUTION (section C)
Case 1:04-cv-10981-PBS Document 3120 Filed 11/03/10 Page 144 of 146

Because PMG physicians would likely have prescribed alternative medication to their patients had they not prescribed Neurontin, I conclude that the appropriate measure of plaintiffs’ damages is the difference between the cost of Neurontin and the cost of the cheaper and more optimal drug that would have been prescribed. I rely on the list of medications that Kaiser considered cheaper and more optimal than Neurontin as the alternative medications that would have been prescribed the Health Plan members but for the defendants’ fraud. 

Defendants argue that efficacy is a patient-specific issue. For example, they point out that while tri-cyclic anti-depressants are generally effective for the treatment of pain, they fail for certain patients and can have unpleasant side effects. (See Trial Tr. vol. 17, 28, 37, 47, 55-57; Trial Tr. vol. 18, 21-22.) They argue that Neurontin will be better tolerated by some patients because it is not metabolized by the liver, is not protein-bound in the blood, and does not interact with other drugs. Even if true, Kaiser has proven that other drugs are equally or more effective and much cheaper, and would likely have been the first line of treatment if the truth about Neurontin’s efficacy had been known.

Moreover, Neurontin has its own drawbacks; that is, depression with or without suicidal ideation in some patients.

LINK  to Leif, Cabraser, Heimann, and Bernstein; Attnys. at Law website and info on Neurontin litigation results. http://www.lieffcabraser.com/Search.shtml  _ L,C,H, & B Media Center. 

I would also encourage you to read the sections on HOW THEY MARKETED NEURONTIN and also DOSAGES.
They have an entire PDF file available, at least they did, on their website.

ALWAYS CHECK WITH YOUR DOCTOR BEFORE STARTING OR STOPPING ANY MEDICATION OR TREATMENT.Neurontin can be a very useful medication for those with seizures and other issues. It needs to be used appropriately and marketed appropriately as all medications should be. While it is not unusual for some medications to be used “off-label” now and then, the problems seem to occur when medications are pushed or marketed to the medical community and the public as something they are not. Always talk over with your Doctor and your pharmacist any questions you have about what your medications are supposed to do for your illness, disease, symptoms, etc. Find out what they expect them to do for you so you can give them better feedback as to whether or not they are working the way they expected them to. This helps them treat you more effectively and helps you manage your disease more effectively. We at American RSDHope are not medical professionals in any way. We are simply fellow patients and family members helping each other try to survive the chronic pain existence.