Monsanto Roundup Lawsuit


Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Wednesday, March 31, 2010

Eli Lilly and Company and Sandoz lose Preemption Battle in Generic Prozac Case Litigated By Baum Hedlund


Rosemary Dorsett explained to the FDA why she believes
an antidepressant caused her son's suicide.
Image: baumhedlundlaw.com

**HOT OFF THE PRESS

Courtesy of Baum, Hedlund, Aristei & Goldman, PC

[LINK]

Last Friday, March 26, 2010, a United States District Court Judge in Los Angeles rejected Eli Lilly and Company (“Lilly”) and Sandoz Inc.’s attempt to dismiss a case arising from the suicide of Noe Carrasco, a 26-year-old Southern Californian man who was taking the generic version of the antidepressant Prozac at the time of his suicide. The lawsuit was brought by the young man’s mother, Rosemary Dorsett, who claims the manufacturers failed to warn of the suicide risks associated with fluoxetine (Prozac).



Both Lilly and Sandoz moved to dismiss the case arguing that the FDA would not have allowed a warning concerning fluoxetine’s suicide risks. Sandoz additionally argued that, as a generic manufacturer, it is not legally allowed to voluntarily revise its warning labels. In a 30 page opinion, Judge A. Howard Matz of the U.S. District Court for the Central District of California rejected Lilly and Sandoz’s arguments. The case is Dorsett v. Sandoz, Inc., Case No. CV 06-7821 (C.D.Cal., March 26, 2010).



The Court ruled, amongst other things:



• FDA standards for labeling are minimum standards (Order, p. 9);



• The Court criticized Lilly’s preemption argument, stating that the company “ignores its burden here. To establish a preemption defense, a drug manufacturer must produce ‘clear evidence that the FDA would not have approved a change to [the drug’s] label.’ ... A mere possibility that the FDA might not have allowed an enhanced suicidality warning for Prozac ... is not enough to warrant preemption.” (Order, p. 23)



• That, “at no point prior to Carrasco’s suicide in August 2004 did Lilly request to add suicide or suicidality language to the Prozac warning label ... Consequently, of course, the FDA never rejected any such request” (Order, p. 12);



• Sandoz’s argument that FDA regulations prohibited it from making any changes to the fluoxetine label and that generic manufacturers may not change a warning label without prior FDA approval “lacks merit” (Order, p. 24);



• The Court “[gave] no weight whatsoever to the position the FDA articulated in amicus briefs [previously filed by the agency in favor of preemption in other cases]” noting that the FDA withdrew the briefs following the Supreme Court’s rejection of preemption in Wyeth v. Levine (Order, p. 16);



• Defendants offer nothing but theoretical assumptions of what the FDA would have done, and that is not enough to warrant a finding of preemption.” (Order, p. 23);



• In permitting Ms. Dorsett’s claims to be tried on the merits, the Court held: “Absent clear Congressional intent to do so, the Court will not foreclose the traditionally available state law remedy for which the [Food Drug and Cosmetics Act] provides no substitute.” (Order, p. 29)
.



Despite her own personal tragedy, Rosemary Dorsett has taken proactive steps to try to prevent others from having to endure the emotional pain she has been forced to suffer. She traveled to Maryland for the December 13, 2006 Psychopharmacologic Drugs Advisory Committee meeting to testify about her son’s death and to urge the FDA to issue stronger warnings about the increased risk of suicidality associated with antidepressants, including fluoxetine. Her testimony is available online at: www.baumhedlundlaw.com/fda_testimony/rosemary_dorsett.php



Ms. Dorsett is represented by the national law firm, Baum, Hedlund, Aristei & Goldman. Baum Hedlund has the longest track-record of handling SSRI (selective serotonin reuptake inhibitor) antidepressant cases such as Prozac, Paxil and Zoloft, and is currently representing hundreds of antidepressant birth defect clients in addition to suicide cases.



Baum Hedlund attorney Bijan Esfandiari, who briefed and argued against preemption on behalf of Ms. Dorsett, stated of the Court’s ruling:



“The Court's well-reasoned decision confirms that both generic and name brand manufacturers have an ongoing responsibility to ensure their products remain safe and that they provide adequate warnings regarding life threatening risks. The Court's ruling further confirms that negligent and reckless manufacturers will no longer be allowed to seek blanket immunity from liability through the shield of preemption. The decision is a victory for all consumers.”



The firm has successfully argued against preemption in numerous antidepressant product liability cases, including: Motus v. Pfizer, 127 F. Supp. 2d 1085 (C.D. Cal. 2000); Witczak v. Pfizer, 377 F.Supp.2d 726 (D.Minn. 2005); Zikis v. Pfizer, Inc., 2005 WL 1126909 (N.D. Ill. 2005); Cartwright v. Pfizer, Inc., 369 F.Supp.2d 876 (E.D. Tex. 2005); Tucker v. SmithKline Beecham Corp., 596 F.Supp.2d 1225 (S.D.Ind. 2008); Knipe v.SmithKline Beecham, 583 F.Supp.2d 553 (E.D.Pa 2008); Collins v. SmithKline Beecham Corp., 2008 WL 744070 (Pa. Ct.Com.Pl. March 11, 2008); Turek v. SmithKline Beecham, Case No. 3596 (Pa. Ct.Com.Pl. March 18, 2009); Forst v. SmithKline Beecham Corp., 639 F.Supp.2d 948 (E.D.Wis., 2009); Mason v. SmithKline Beecham, __F.3d __, 2010 WL 605922 (7th Cir. 2010).



Lilly was represented by Shook Hardy & Bacon, LLP (Kansas City and Irvine). Sandoz was represented by Hollingsworth, LLP (Washington, D.C.) and Parker, Milliken, Clark, O’Hara & Samuelian (Los Angeles).



I have managed to obtain a copy of the ruling, which can be downloaded here.



Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Cervical Cancer Vaccine For Boys!


Image: exitsignwarehouse.com


Drug Watch is reporting that a recent study, carried out by scientists, are to re-evaluate their recent findings which suggest that boys as well as girls may benefit from either of the two HPV Vaccines, Gardasil and Cervarix.

They write:

Following a sharp increase in cases of a certain cancer of the middle part of the throat, which appear to be linked to the human papillomavirus (HPV), scientists say it may be time to actively recommend the HPV vaccine for boys as well as girls.


“We need to look at the evidence again to re-evaluate the cost-effectiveness of male children in light of this new and rapidly rising incidence,” said Hisham Mehanna, a scientist at the Institute of Head and Neck Studies at University Hospital Coventry.

It comes as no surprise, to me at least, that Hisham Mehanna is director of the GSK funded Institute of Head and Neck Studies and Education at University Hospital here in the UK. Nor does it surprise me that oral sex cancer affects fewer than two people per 100,000 in the United States. In the UK it is somewhat higher at 11 per 100,000.

I think if GSK want people to take their drugs seriously then they should distance themselves from the scientists that carry out these kinds of tests - or maybe the scientists should distance themselves from the pharmaceutical companies, whose drugs they seem to 'big up'.

Jim Edwards, who writes over at bnet, talks more about it here

Coming soon - An erectile dysfunction pill for eunuchs!

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Thursday, March 25, 2010

Simvastatin - "No 'significant benefit' of simvastatin above 20mg"


Image: all-drugs-online.com


So, an update on whether I dispensed my prescription for simvastatin.

Yup.


I was ready to drop the 40mg tablet into my mouth after my evening meal.

But... the power of the Internet intervened... or rather those folks at the MHRA did.

A report on today's Pulse website runs with the headline, 'No 'significant benefit' of simvastatin above 20mg, says drugs regulator.'

Pulse adds:

The UK medicines regulator is set to run into conflict with NICE guidance by advising there is ‘no significant benefit’ in using doses of simvastatin over 20 mg.

A spokesperson from the Medicines and Healthcare products Regulatory Agency told Pulse they were intending to issue a revised label for simvastatin in the next few weeks after a review raised concerns over the risk of myopathy with the 80 mg dose.

The spokesperson also said the review had concluded there was little evidence doses over 20 mg provided any additional benefit.

Full story here

Maybe the Gods are on my side and it was fate that this matter should be brought to my attention [Special thanks to Cyndi, who is a regular poster on the UK Survivors forum]

It's a sorry state of affairs when one has to learn that the medicine they were prescribed less than 48 hours ago has been deemed ineffective over 20mg doses by the UK Medicine's Regulator.

I bet my left nut my new doctor is unaware of this.

Further evidence that the regulatory system here in the UK is too slow in getting the message out to professionals regarding the drugs you and I take.

A quick search on the MHRA web site shows nothing about this announcement by Pulse. In fact only a month ago, the MHRA uploaded the following document to their database. It states quite clearly:

"Simvastatin 10mg, 20mg, 40mg and 80mg film-coated tablets raised no clinically significant safety concerns and it was, therefore, judged that the benefits of using these products outweigh the risks; hence Marketing Authorisations have been granted."

This on page 2 of a 34 page document. I really cannot be bothered to continue reading through the rest of it. If there is a warning it should have been on the first two pages anyway.

So, what do I do?

Do I halve my 40mg tablet or just not bother taking them at all.

Christ knows how long the MHRA have known about this.

What a complete sham of an organisation!

It's enough to send one's blood pressure and cholesterol levels rising!

You can read more about them in my new book, The Evidence, However, Is Clear...The Seroxat Scandal.

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Wednesday, March 24, 2010

HIGH CHOLESTEROL... YIKES!


Image: jagonews.com

So last week I had blood samples taken, my gout had got to the stage of 'acute' and my doctor wanted to test my cholesterol levels.

My appointment yesterday was to 'discuss' my results.

Turns out my cholesterol level is very high - 7.9 to be exact.

So, there has to be a few life changes around here. I'm 46 and want to live as long as possible so I guess yesterday's discussion was my warning sign.

I've been prescribed Simvastatin [40mg per day] - I'll research it before I dispense the prescription so feedback on this post would be appreciated folks.

I realise that I have to either cut down or stop my smoking all together - I have a nicotine addiction - well, according to the NHS 'Addiction' test I do.

The addiction test can be taken here

I wasn't surprised by the results but was shocked by the 'therapy' they offer.

"You have a high addiction to nicotine but don't worry if you use a stop smoking medicine such as Nicotine Replacement Therapy (NRT), Zyban or Champix it will make it much easier for you to quit."

Zyban or Champix?

Yeh, right. Zyban is basically an SSRi disguised as a helpful aid to quit smoking whilst Champix is another drug that can cause havoc with your rational thinking. I have, in the past, wrote about both - here - and here.

I don't think I'll be taking the advice of the NHS in this particular instance.

I guess I will start to taper first - as is the norm with any addiction - cut down and instead of allowing myself to smoke in my apartment, I will force myself outdoors. I got that tip from my girl friend.

I briefly looked at Tesco online this morning - it would appear it's going to cost me an arm and a leg to eat healthily, although if I can quit smoking, the money I save will go toward living healthier.

It's going to be a bind but hey, I kicked Seroxat so smoking should be a piece of cake.

Lots of walks with my dog ahead it seems and in general just be careful I don't eat, a; foods high in cholesteral and b; foods that can set off another acute gout attack.

Thing is, I rarely eat junk food, I drink alcohol once a fortnight and I already walk 4 times daily. It would appear it's not enough.

Oh, the joys of living a healthy life!

Recipes would be appreciated folks - remember I'm on a tight budget here so nothing too expensive please!

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Tuesday, March 23, 2010

UPDATE 3-Glaxo's rotavirus vaccine use suspended - US


Image: artbyblas.com


Source: Reuters

By Maggie Fox

WASHINGTON, March 22 (Reuters) - Doctors should temporarily stop using GlaxoSmithKline Plc's (GSK.L) (GSK.N) Rotarix vaccine against a diarrhea-causing virus called rotavirus because it is contaminated with an apparently harmless pig virus, regulators and the company said on Monday.

"No safety issue has been identified by external agencies or GSK. GSK is committed to patient safety and to the highest manufacturing standards for all our vaccines and medicines. We are already working closely and discussing this finding with regulatory agencies around the world," said Thomas Breuer, Glaxo's chief medical officer.

FULL STORY


Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

If Calling Mom Makes You Hear Voices, Then AstraZeneca Has a Pill for You


Image: cartoonstock.com


Great article from Jim Edwards of BNET.

Jim opens with:

Can calling your mom worsen your symptoms if you’re a schizophrenic? Or does taking antipsychotic medicine help you to remember to call your mom more often?

One of those possibilities seems to be the claim in this ad (click to enlarge) for AstraZeneca (AZN)’s Seroquel, an antipsychotic that has been the subject of 10,399 lawsuits.

FULL ARTICLE HERE

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Saturday, March 20, 2010

GlaxoSmithKline's Extraordinary Lengths of Denial? [Paxil/Seroxat Withdrawal]


Image: goddessintellect.com



The following was posted in the forums of the Paxil Progress forum. It was posted by former Paxil activist Rob Robinson, a name that GlaxoSmithKline must cringe at everyv time they hear it mentioned. I dedicated a chapter to Rob in my book, The Evidence, However, Is Clear...The Seroxat Scandal'.

In this thread, posted on 07/09/2005, Rob writes about "the extraordinary lengths GlaxoSmithKline has, and is, going to in an ongoing series of unconscionable efforts to escape ANY responsibility or liability relative to Paxil withdrawal suits."

It's applicable even today as Glaxo still contest that Paxil [UK Brand Name - Seroxat] does not cause any severe problems during withdrawal.

Rob's initial thread starter can be found here and many forum members responded with insightful replies.

Here's Rob's post in it's entirety:

[Some of the links provided by Rob have since been removed]

Very Important: Paxil withdrawal lawsuit updates

The following information is a cut and paste from the March, 2005 issue of Mealey's Litigation Report Antidepressant Drugs (free version). See http://www.mealeys.com/free%20views/...stimony%20Abou [Link dead]

The record reveals the extraordinary lengths GlaxoSmithKline has, and is, going to in an ongoing series of unconscionable efforts to escape ANY responsibility or liability relative to Paxil withdrawal suits.

This thread also reveals riveting details about the first five Paxil withdrawal suits which were set to begin on May 2nd, 2005; these suits have been "postponed."

Feel free to cut and paste content from this thread and repost it to other forums, or send it via email to anyone you think might find it to be of interest.

GSK: Experts’ Opinions On Paxil Dependence Should Be Barred

LOS ANGELES — Expert testimony regarding Paxil’s alleged addictive nature and ability to induce dependence is inadmissible because any attempt to equate withdrawal symptoms with addiction is not generally accepted in the scientific community, the manufacturer of the antidepressant argues in a recently filed motion (In re: Paxil Products Liability Litigation, MDL No. 1574, C.D. Calif.)

(Motion available. Document #75-050325-012M.)

In fact, plaintiffs’ experts have admitted in their depositions that Paxil is not habit-forming and does not meet the criteria for substance dependence as defined by medical literature, GlaxoSmithKline (GSK) says in its Feb. 18 motion, which seeks to exclude the testimony of five experts from all cases proceeding in the Paxil withdrawal MDL.

The manufacturer also asks the U.S. District Court for the Central District of California to strike the expert report of British psychiatrist and psychopharmacologist David Healy, M.D., because it contains confidential data from other manufacturers of selective serotonin reuptake inhibitors (SSRIs) that GSK does not have access to. As a result, the manufacturer contends that it cannot refute Healy’s opinions.

It is clear that people have struggled with all sorts of prescription drugs. If you have issues with prescription drugs causing you problems, prescription drug rehabilitation can get you back on the right track.


Maladaptive Behavior

According to the manufacturer, Paxil is not addictive and does not induce substance dependence based on the definition of the term addiction and because it does not cause substance dependence, which is classified by the Diagnostic and Statistical Manual — Fourth Edition (DSM-IV) as signs or symptoms that a person continues to use a substance compulsively and maladaptively, despite significant problems associated with the use.

GSK notes that its own witness, Dr. Charles O’Brien, was a member of a committee established in the 1980s by the American Psychiatric Association and World Health Organization to review the definition of addiction and that committee concluded that one of the main characteristics of addiction was a loss of control over drug use, resulting in compulsive drug-taking behavior.

“In other words, one who is ‘addicted’ uses a drug despite antisocial consequences,” the manufacturer says pointing to the committee’s finding. “The outcome of the drug is harmful, not helpful.”

According to the manufacturer, addiction is best characterized by abusers of opiates, who demonstrate maladaptive behavior, use the substance in order to get “high” and use the drug in excess of therapeutic doses to achieve other than a therapeutic effect. Such is not the case with Paxil.

“On the contrary, the most common dosage issue with antidepressants in general, and Paxil in particular, is that physicians often prescribe dosages that are too low to achieve maximum therapeutic benefits,” GSK says. “Nor is there any evidence of a ‘street market’ value for Paxil, or any indication that patients forge prescriptions in order to obtain Paxil, or otherwise experience ‘uncontrolled craving.’”

Experts Agree

GSK further argues that even the plaintiffs’ experts agree that Paxil is not a drug of addiction, is not habit-forming and does not meet the definition or the criteria for substance dependence listed in the DSM-IV.

For example, Drs. Richard Kapit, Cherly Blume, George Glass and Joseph Glenmullen each stated in their depositions that Paxil does not meet the criteria for substance dependence characterized by the DSM-IV.

Similarly, Healy has written articles in which he states that Paxil and other SSRIs are not addictive, habit-forming or associated with substance dependence, GSK says.

Regulatory Agencies

In addition, both the Food and Drug Administration and the European Medicines Agency (EMEA) have found that there is no evidence demonstrating the SSRIs have addictive properties.

Dr. Robert Temple, director of the FDA’s Office of Medical Policy and acting director of the Office of Drug Evaluation, stated in September 2002 that GSK’s use of the phrase “Paxil is not habit-forming” is not misleading, finding that the fact a drug causes discontinuation syndrome does not mean it is habit-forming.

Also, an April 12, 2000, report prepared by the EMEA’s Committee for Proprietary Medicinal Products (CPMP) found no evidence that SSRIs were drugs of dependence, GSK says.

Moreover, mental health organizations such as the National Institute of Mental Health and the National Depressive and Manic-Depressive Association have each said on their Web sites that antidepressants are not habit-forming or mind-altering, the company notes.

No Authority

The opinions of the plaintiffs’ experts are baseless, GSK contends, because their theories have not been tested and are not supported by scientific literature.

“GSK is unaware of any published peer-reviewed literature reaching the conclusion that SSRIs in general, or Paxil in particular, are addictive, habit-forming or meet the criteria for substance dependence under DSM-IV,” GSK asserts. “Indeed, plaintiffs’ own experts are unable to cite such literature.”

However, two published studies have concluded that SSRIs, notably Zoloft and Paxil, show little evidence of abuse potential when compared to methamphetamines, the manufacturer notes.

Conversely, none of plaintiffs’ experts’ opinions has been subject to peer review, GSK says.

Counsel

Thomas M. Moore, David J. Fleming and Mario Horwitz of Drinker, Biddle & Reath in Los Angeles and Chilton D. Varner, Andrew T. Bayman and Todd P. Davis of King & Spalding in Atlanta are counsel for GSK.

Karen Barth Menzies of Baum Hedlund in Los Angeles, Christopher Coffin of the Pendley Law Firm in Plaquemine, La., Donald J. Farber of the Law Offices of Donald J. Farber in San Rafael, Calif., and Kevin J. Yourman and Jennifer Liakos of Yourman, Alexander & Parekh in Manhattan Beach, Calif., represent the plaintiffs.

GSK Moves To Exclude Testimony About Paxil-Induced Suicidality

LOS ANGELES — The testimony of three experts concerning alleged suicidal behavior caused by Paxil discontinuation should be excluded from all MDL cases because there is no reliable scientific evidence to support their opinions, manufacturer GlaxoSmithKline (GSK) says (In re: Paxil Products Liability Litigation, MDL No. 1574, C.D. Calif.).

(Motion available. Document #75-050325-011M.)

The company contends in its Feb. 18 motion that the opinions of British psychiatrist and psychopharmacologist David Healy, M.D., Ph.D.; Harvard psychiatrist Joseph Glenmullen, M.D.; and Houston psychiatrist George Glass, M.D., are inadmissible under Daubert because their theories have not been adequately or objectively tested and the methodology of their research is not generally accepted in the scientific community.

Healy proffers general testimony regarding the alleged relationship between Paxil discontinuation and suicidal behavior, while Glenmullen opines that plaintiff James Meythaler’s suicidal ideation was caused by Paxil withdrawal syndrome. Glass’ testimony would support Andrew Barton’s assertion that taking Paxil caused him to become suicidal.

The manufacturer is seeking to block the testimony of the plaintiffs’ experts from all cases pending in the Paxil withdrawal MDL.

Association

GSK asserts that Healy fails to satisfy the burden of proof to establish the admissibility of his testimony. Specifically, the manufacturer argues that there is insufficient epidemiological evidence to support the expert’s opinion in which he suggests that there is an association between Paxil use and suicidal behavior

In support of his opinion, Healy submitted a supplemental expert report that reviews epidemiological studies conducted by antidepressant manufacturers and regulatory agencies such as the Food and Drug Administration and the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA). Healy asserts that the data shows claim that there is an association between Paxil and suicidal behavior.

According to the manufacturer, an association in epidemiological terms is not the equivalent of a causal relationship because associations in epidemiological studies can result from factors such as bias, chance, confounding or cause and effect.

The company also refers to a report filed by its expert, Anthony Rothschild, M.D., a professor of psychiatry at the University of Massachusetts, in which he says that an association is meaningful only if differences between study groups reach statistical significance.

Both Healy and Glenmullen also base their opinion on case reports and case series that describe individual adverse reactions, GSK says. However, case reports and case series are not reliable forms of evidence because there are no controls, which aid in the assessment of the relationship between exposure or treatment and disease or outcome. Moreover, the manufacturer points out that many courts have held that case reports are not sufficient to support an expert opinion under Daubert.

Agencies’ Findings

GSK further argues that neither the FDA nor the MHRA has found that Paxil or any other antidepressant increases the risk of suicide in adults. In fact, after mandating stronger warnings for antidepressants prescribed to children and adolescents based on finding an increased risk of suicidality, the FDA declared that no similar finding had been made as to whether the risk extends to adults, the company says.

“During the course of the hearings leading to the pediatric label change, FDA stated on several occasions that it has examined the suicidality data in adults in a number of different ways and has found no evidence of any increased risk in adults,” GSK states.

Similarly, the U.K’s Committee on the Safety of Medicines (CSM), an advisory body to the MHRA, empanelled a so-called Expert Working Group (EWG) on the Safety of Selective Serotonin Reuptake Inhibitors (SSRIs) to study the risk of suicidality in the adult population. GSK says that the EWG on Dec. 6, 2004, issued a report that addressed pediatric and adult suicidality associated with SSRIs that found the incidence of possible suicide-related events was similar in the Paxil and placebo groups. In addition, the EWG concluded that “[t]here is no clear evidence that there is an increased risk of self-harm and suicidal thoughts when SSRIs are discontinued.

Healy

GSK further argues that Healy’s analysis of data from studies included in Paxil’s 1989 New Drug Application (NDA) in his supplemental expert report is unreliable because it is “non-transparent, methodologically flawed and unverifiable.” Moreover, the manufacturer asserts that the numerous tables in his report referring to data from other analyses are inadmissible based on the methodology.

For example, Healy allegedly misrepresented data from the FDA’s analysis of suicides in adult placebo-controlled depression trials, which was conducted by FDA investigator Dr. Tarek Hammad, and an analysis conducted by the British General Practice Research Database.

In addition, the manufacturer says that Healy’s most recent analysis is inadmissible because it has not been peer-reviewed and that his opinions must be excluded because they depend on information from other SSRI manufacturers that is not available to GSK.

Glenmullen And Glass

Finally, GSK claims that the opinions of Glenmullen and Glass are inadmissible because they fail to cite evidence to support their assertion that Paxil caused the suicidal ideation allegedly experienced by Meythaler and Barton, respectively.

Specifically, Glenmullen could not identify a single study reporting increased suicidality or deliberate self-harm associated with discontinuing Paxil, had done no independent evaluation of the Paxil clinical trials data and conceded that he is not in a position to refute the analysis of suicidality done by the FDA, which found no association between Paxil and suicidality in adults.

Similarly, Glass should not be able to testify regarding the alleged association between Paxil withdrawal and suicidal behavior because he too was unable to a study finding a statistically significant increased incidence of suicidality associated with either taking or discontinuing Paxil.

Take me to the Top

GSK: Pollster’s Opinions Are Irrelevant, Unreliable

LOS ANGELES — A proposed expert’s testimony regarding the findings of a poll conducted to determine whether GlaxoSmithKline’s (GSK) use of the phrase “non-habit forming” in its advertisements for Paxil is inadmissible because it prevents jurors from making their own analysis on the issue, the manufacturer says in a recently filed motion (In re Paxil Products Liability Litigation, MDL No. 1574, C.D. Calif.).

(Motion available. Document #75-050325-008M.)

GSK further argues in the Feb. 18 motion that Kelly Anne Conway’s testimony regarding the results of her research is inadmissible because it is unreliable and irrelevant to the claims of five trial plaintiffs because they could not possibly have seen or relied on the advertisements before deciding to take Paxil.

Conway conducted a telephone survey of consumers to evaluate how the public understood GSK’s use of the phrase “Paxil is non-habit forming” in a direct-to-consumer (DTC) advertising campaign that began airing in October 2001. Conway unveiled the findings of her research in a Sept. 23, 2002, declaration, but GSK contends that her methodology contradicted what she told the court was the purpose of her poll.

For example, GSK asserts that Conway removed any reference to Paxil from the questions she asked participants in the survey and that the poll never asked respondents to comment on the exact language in the DTC advertisement. In addition, her questions to participants were often “suggestive and leading to reach its results.”

Unqualified

GSK further argues that Conway, the president of The Polling Co. Inc., is not qualified to render an expert opinion whether its DTC advertisements were truthful and nonmisleading because she has a Bachelor of Arts degree in political science and a Juris Doctor and has no scientific, medical or regulatory training or knowledge.

However, the manufacturer points out that in her deposition, Conway was unable to identify the Food and Drug Administration regulation that applies to DTC advertisements. Conway also stated in her deposition that GSK did not violate any Food and Drug Administration regulations by airing the DTC advertisements.

“She cannot, on the one hand, state that GSK complied with the law and then on the other state that GSK acted inappropriately,” GSK argues. “What is most striking, however, is that this pollster wishes to give this contradicting testimony based solely upon a 15-minute telephone poll of unnamed and unknown respondents that GSK cannot examine to determine why they arrived at their responses to the poll.”

Unreliable

Aside from the irrelevance of the proffered testimony, Conway’s opinion is also unreliable because the methodology of her poll failed to satisfy the requirements of Daubert. GSK notes that in her deposition, Conway admitted that the results of the poll would have been different if she had mentioned Paxil specifically.

Similarly, GSK argues that Conway’s poll was not conducted in accordance with the accepted principles of polling research.

Finally, Conway’s opinions are suspect because she formed them solely as a result of litigation and has shared them only with lawyers involved in the litigation.

GSK Challenges Admissibility Of ‘Addictionologist’s’ Testimony

LOS ANGELES — The opinions of a psychiatrist and self-described “addictionologist” regarding Paxil’s effects on a person’s drinking habits are inadmissible, manufacturer GlaxoSmithKline (GSK) says, because the expert’s proffered testimony is not supported by reliable scientific evidence (In re: Paxil Products Liability Litigation, MDL No. 1574, C.D. Calif.).

(Motion available. Document #75-050325-009M.)

The company also argues in its Feb. 18 motion that the opinions of Dr. William Glass M.D., should not be allowed during trial because his postulations are derived solely for the purposes of litigation and because the assertion that plaintiff Andrew Barton’s alcohol consumption was affected by his use of Paxil was not contained in his Dec. 30, 2004, expert report.

Glass, a Houston-based psychiatrist, was designated by five trial plaintiffs as an expert specializing in addiction, dependence and withdrawal to proffer testimony regarding adverse reactions Barton, Kenneth Borenstein and Gerri Marin experienced as a result of using Paxil. Specifically, Glass opines that Barton’s use of the antidepressant caused him to increase his consumption of alcohol.

No Opinion

However, GSK contends that based on his expert report and deposition testimony, Glass has not opined that Paxil caused any changes in Barton’s drinking habits. Rather, Glass in his deposition only affirmed Barton’s belief that Paxil was causing him to drink more and did not offer any scientific support by way of research or journal articles to bolster the allegation.

According to GSK, Barton has a medical history of alcoholism that began at age 16 and has been unable to accurately recall how much and how often he consumes alcohol. Although Glass admitted in his deposition testimony that Barton’s lack of reliability in reporting his drinking habits stems from his alcoholism, the psychiatrist maintains that Barton’s alcohol abuse became worse when he was using Paxil.

“Dr. Glass clearly lacks any reliable underlying data or objective findings to support such a novel theory,” GSK avers. “Dr. Glass has not identified another doctor or scientist who espouses the ‘Paxil-makes-him-drink-more’ hypothesis. His only data, the past self-reports of Plaintiff Barton’s increased alcohol abuse, are, as Dr. Glass admits, inconsistent and less than reliable because Plaintiff is an alcoholic with a propensity to distort his alcohol consumption.”

Remaining Plaintiffs

GSK asserts that Glass’ opinions regarding Borenstein and Marin should also be excluded as unreliable and irrelevant because he holds his opinions that Paxil caused plaintiffs’ withdrawal symptoms with the requisite degree of legal certainty.

The manufacturer notes that in his deposition, Glass could not state any case-specific causation issues with regarding to Borenstein’s and Marin’s claims.

“At best, Dr. Glass’ case-specific causation testimony amounts to mere speculation and conjecture that is utterly unhelpful to a jury because it fails to meet the legal to prove causation,” GSK concludes.

English Professor Unqualified To Discuss Adequacy Of Ads, GSK Argues

LOS ANGELES — GlaxoSmithKline (GSK) has asked a federal court to exclude from trial the opinions of an English professor who opines that language appearing in the company’s advertisements and brochures for Paxil was false and misleading with regard to the antidepressant’s potential for dependence and withdrawal symptoms on grounds that the expert is unqualified and the testimony is irrelevant (In re: Paxil Products Liability Litigation, MDL No. 1574, C.D. Calif.).

(Motion available. Document #75-050325-010M.)

William Lutz, an English professor at Rutgers University in Camden, N.J., and a self-proclaimed expert on “plain English,” does not have the qualifications to proffer his opinions because he has no expertise with Food and Drug Administration regulations, GSK says in a Feb. 18 motion.

Lutz said during his deposition that the language in the FDA-approved package insert for Paxil “is extremely difficult to read,” “is not a clear communication of information,” “is not arranged in a hierarchy of importance to communicate to doctors” and “violates just about every principle of information design.” In addition, the professor proclaims that the use of the phrase “Paxil is non habit-forming” in television advertisements is misleading because it essentially told consumers that the antidepressant is not addictive, GSK says.

However, GSK notes that although Lutz has published several books and papers, the subject matter of these materials does not relate to the issue about which he is proffering testimony. Furthermore, Lutz’s inexperience in developing a warning label or advertisement for a pharmaceutical drug and his lack of training in the regulations governing the wording of direct-to-consumer (DTC) advertisements demonstrate that he is unqualified to proffer his opinion, the manufacturer asserts.

“Lutz may have ‘opinions’ on the appropriateness of the Paxil package insert and GSK’s promotional activities,” GSK says. “He may be a critic of those activities. But, he hardly has the ‘specialized’ or ‘scientific knowledge’ required by Federal Rule of Evidence 702.” Shepardize

Relevance

GSK also claims that Lutz’s testimony should be excluded because it is irrelevant to the plaintiffs’ claims because they did not rely upon the advertisements in question when they were prescribed Paxil for the first time. In support of its assertion, GSK looks to the depositions of trial plaintiffs Andrew Barton, Kenneth Borenstein, Gerri Marin, Trishia Medema and James Meythaler, who each stated that they did not specifically recall the Paxil advertisements.

“If these five plaintiffs did not see or rely on GSK’s advertising — as they did not — Lutz’s proposed expert testimony can provide nothing probative that would be relevant to any issue in this case,” GSK asserts.

Furthermore, Lutz’s opinions invade the province of the jury, GSK claims.

“Whether or not GSK’s promotional statements about Paxil are misleading is precisely the type of question that the jury is fit to answer,” the company contends. “The proper question is not what possible connotation this phrase may have to a Rutgers English professor and linguist, but what the jury understands this phrase to mean. The danger in allowing such inappropriate expert testimony is that it may lead jurors to suspend their own independent analysis.”

Reliability

Finally, the manufacturer says that Lutz’s opinions are not reliable because they fail to satisfy the standards of Daubert, which requires that expert testimony be derived from research using a methodology that is generally accepted in the scientific community.

GSK points out that this is Lutz’s first attempt at pharmaceutical work and that it was prepared solely for the purpose of litigation.

“Lutz’s methodology in this litigation defies description; indeed it is nonexistent, let alone reliable,” GSK argues. “Lutz’s failure to follow a rigorous scientific approach is consequent to his lack of experience and familiarity with medical research and pharmaceutical medications subject to rigorous requirements imposed by the FDA.”

Take me to the Top

GSK Seeks Dismissal Of 5 Trial Plaintiffs’ Claims

LOS ANGELES — Paxil manufacturer GlaxoSmithKline (GSK) seeks to dismiss with prejudice the claims of five plaintiffs whose cases are scheduled for trial in May, arguing that their causes of action are barred by the learned intermediary doctrine and preempted by federal law (In re: Paxil Products Liability Litigation, MDL No. 1507, C.D. Calif.).

(Barton motion available. Document #75-050325-002M. Borenstein motion available. Document #75-050325-003M. Marin motion available. Document #75-050325-004M. Medema motion available. Document #75-050325-005M. Meythaler motion available. Document #75-050325-006M.)

In five separate motions filed Feb. 18, the manufacturer further asserts that Andrew Barton, Kenneth Borenstein, Gerri Marin, Trishia Medema and James Meythaler failed to proffer evidence that Paxil caused their alleged injuries and have not produced any expert testimony on the existence or amount of their economic damages.

The plaintiffs, who were randomly selected to have their cases tried first, seek damages for withdrawal symptoms they allegedly suffered when stopping or tapering their use of Paxil. They assert claims of fraud, negligence, strict products liability, breach of express and implied warranties and violation of California’s unfair competition law.

Learned Intermediary Doctrine

GSK argues that the language on the Paxil label when the plaintiffs used the drug sufficiently explained the risk of withdrawal symptoms and that plaintiffs’ prescribing physicians understood the risk when they prescribed the drugs.

The manufacturer further contends that each of the plaintiffs’ prescribing physicians has stated in depositions that he or she was aware of Paxil’s association of withdrawal symptoms upon discontinuation of the antidepressant. As a result, the plaintiffs’ fraud, negligence and strict liability claims are barred by the learned intermediary doctrine.

In addition, the plaintiffs’ cannot rely on the California’s Supreme Court ruling in Stevens v. Parke, Davis (9 Cal. 3d at 51 Shepardize, 107 Cal. Rptr. 45 [Calif. Sup. 1973]) to support their assertion that the learned intermediary does not apply in cases where the company overpromoted the drug, GSK asserts.

“Here, unlike there, plaintiff has no evidence to support any contention that GSK’s sales representatives ‘overpromoted’ Paxil or minimized scientifically-supported facts about discontinuation symptoms plainly included in Paxil’s labeling or package insert,” the drug company says.

Causation

The plaintiffs’ claims should also be dismissed with prejudice because they fail to proffer evidence demonstrating that Paxil is capable of causing their alleged injuries or did in fact cause their injuries.

Specifically, GSK argues that Meytheler fails to provide expert testimony to support his allegation that Paxil can cause suicidality and whether it is addictive or causes substance dependence or abuse. Similarly, the company contends that Medema cannot prove that the antidepressant is addictive because she was never diagnosed with substance dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders — Fourth Edition (DSM-IV).

Moreover, the remaining plaintiffs do not have reliable expert testimony to prove that Paxil caused their injuries. For example, Barton’s injuries could have been the result of his history of alcohol dependence, GSK says.

GSK also states that the testimony of the plaintiffs’ designated experts is unreliable under Daubert and points out that it has filed separate motions in which it argues that the experts’ testimony should be deemed inadmissible (See Page X).

The company further argues that plaintiffs’ proffered expert testimony on economic damages is inadmissible.

Statute Of Limitations

Furthermore, GSK notes that in 2002 the California Legislature extended the statute of limitations for personal injury cases from one year to two years. However, the claims of Barton and Meytheler are time-barred because they failed to file their complaints within the one-year statute of limitations in effect and the time their claims accrued and because the Legislature allowed the new statute of limitations to retroactively apply only to victims of the Sept. 11, 2001, terrorist attacks.

Barton and Meytheler also stated in their depositions that they had reasonable belief that their alleged injuries were the result of their discontinuation of Paxil more than one year before they filed suit, GSK asserts.

Alleged Misrepresentations

In their complaints, the plaintiffs contend that GSK misrepresented to consumers and the medical community the scope and severity of withdrawal symptoms caused by Paxil. For example, the plaintiffs assert that GSK said in its advertisements that the antidepressant was non-habit forming. In addition, GSK told its sales representatives to distort the findings of studies that found that rates of withdrawal symptoms were higher in patients receiving Paxil than other selective serotonin reuptake inhibitors (SSRIs) to focus on a classwide effect.

Although plaintiffs use these allegations to support their fraud and breaches of warranties claims against GSK, the manufacturer avers that the allegations fail because the plaintiffs cannot show that they or their physicians detrimentally relied on the alleged misrepresentations.

To recover damages for their breach of warranty claims, the plaintiffs would be required to show that the manufacturer’s alleged misrepresentations became part of the basis of the bargain and demonstrate that Paxil failed to conform to the promises or affirmations made on its label.

The plaintiffs must also show that their physicians relied on the company’s alleged misrepresentations when deciding to prescribe the drug, GSK says.

Preemption

GSK further argues that plaintiffs’ claims are preempted by the supremacy clause of the U.S. Constitution because their failure to warn claims conflict with the Food, Drug and Cosmetic Act (FDCA).

Finally, the manufacture asserts that the plaintiffs’ failure to show a causal link between Paxil and their injuries and their inability to demonstrate reliance upon the alleged misrepresentations warrant judgment in its favor on the plaintiffs’ claims for unfair competition.

Counsel

Thomas M. Moore, David J. Fleming and Mario Horwitz of Drinker, Biddle & Reath in Los Angeles and Chilton D. Varner, Andrew T. Bayman and Todd P. Davis of King & Spalding in Atlanta are counsel for GSK.

Karen Barth Menzies of Baum Hedlund in Los Angeles, Christopher Coffin of the Pendley Law Firm in Plaquemine, La., Donald J. Farber of the Law Offices of Donald J. Farber in San Rafael, Calif., and Kevin J. Yourman and Jennifer Liakos of Yourman, Alexander & Parekh in Manhattan Beach, Calif., represent the plaintiffs.

Plaintiffs: Disclaimer Did Not Waive Confidentiality

SAN FRANCISCO — A disclaimer at the end of a law firm’s online questionnaire did not waive the confidentiality of information supplied by prospective clients even though it did not establish an attorney-client relationship, plaintiffs argue in a March 1 petition for a writ of mandamus seeking the reversal of a federal judge’s ruling (Andrew Barton, et al. v. U.S. District Court for the Central District of California, No. 05-71086, 9th Cir. See February 2005, Page 12).

(Petition available. Document #68-050318-104X.)

The five plaintiffs, who are involved in the Paxil withdrawal MDL and have a trial scheduled for May 2, are asking the Ninth Circuit U.S. Court of Appeals to overturn U.S. Judge Mariana Pfaelzer of the Central District of California’s Jan. 28 order requiring the production of online questionnaires submitted to their attorneys before they were clients.

Judge Pfaelzer found that although the questionnaires constituted preliminary consultations that the Ninth Circuit has held are privileged, the plaintiffs waived their right to confidentiality when agreeing to the disclaimer at the end of the questionnaire.

The plaintiffs, led by Andrew Barton, assert that numerous law firms use the Internet to market their services and that Judge Pfaelzer’s ruling, if it stands, could have a tremendous impact on how attorneys advertise.

“If the District Court’s order is upheld, it could have the effect of chilling communications between attorneys and potential clients,” the plaintiffs say. “In effect, the District Court’s order turns California law upside down and shifts the presumption of confidentiality for internet communications to the proponent of the privilege.”

Disclaimer

The plaintiffs note that disclaimers appearing on law firms’ Web sites are not uniform. Although most disclaimers state that submitting information does not form an attorney-client relationship, the topic of confidentiality varies in three ways. For example, some law firms’ disclaimers expressly state that the information will not be treated as confidential, while others assure the potential client that the information will be protected.

In the present case, the disclaimer on plaintiff counsel Baum Hedlund’s Web site is silent on the issue of confidentiality, the plaintiffs note.

“Although the disclaimer clearly and expressly disclaims the formation of an attorney-client relationship by the mere fact of transmitting the answers on the intake questionnaire to counsel, it never mentions the confidentiality of the information being sent to counsel,” the plaintiffs say. “And the disclaimer certainly does not say that, by submitting the information, the potential client is agreeing that their information is no longer confidential.”

In addition, the plaintiffs say the main reason the disclaimer appears is to avoid any conflicts of interest and protect from client confusion and malpractice.

“These issues of possible client confusion, malpractice, potential conflicts of interest, and other jurisdictions highlight the need for attorneys who maintain a presence on the internet to disclaim any formation of an attorney-client relationship or the rendering of legal advice based solely on the potential client’s visit to the Web site or submission of information to the firm,” the plaintiffs argue. “Indeed, any failure by Petitioners’ counsel to have such a disclaimer would have inevitably led to numerous issues of possible malpractice given the large number of potential clients which Petitioners’ counsel chose not to represent [emphasis original].”

Preliminary Communications

The plaintiffs further assert that California law holds generally that preliminary communications between potential clients and attorneys are privileged.

“Here, Petitioners submitted to Petitioners’ counsel answers to an intake questionnaire which sought information that enabled counsel to determine whether Petitioners had a legal claim against GSK (GlaxoSmithKline) for which counsel could represent them,” the plaintiffs say. “That Petitioners were contemplating legal representation when they transmitted the information to counsel is not in dispute. Clearly, then, these communications were preliminary discussions between attorney and a potential client seeking legal representation, which the District Court so held.”

Moreover, the information submitted to the firm included sensitive information regarding the plaintiffs’ medical history and use of the antidepressant Paxil, the plaintiffs say.

Karen Menzies and Robert Brava-Partain of Baum Hedlund in Los Angeles; Christopher Coffin of the Pendley Law Firm in Plaquemine, La.; Donald Farber of the Law Offices of Donald Farber in San Rafael, Calif.; and Kevin Yourman of Yourman, Alexander & Parekh in Manhattan Beach, Calif., are counsel for the plaintiffs.

David J. Fleming of Drinker, Biddle & Reath in Los Angeles and Todd Davis and Chilton Varner of King & Spalding in Atlanta represent real party in interest SmithKline Beecham.

9th Circuit Will Review Ruling On Disclaimers

SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeal on March 23 said it will review a federal judge’s finding that a disclaimer at the end of an online questionnaire waived the attorney-client privilege, sources told Mealy Publications (Andrew Barton, et al. v. U.S. District Court for the Central District of California, No. 05-71086, 9th Cir.)

(Order available. Document #75-050325-014R.)

In addition, the federal appeals court granted lead plaintiff Andrew Barton’s motion seeking a stay of U.S. Judge Maria Pfaelzer of the Central District of California’s Jan. 28 order compelling the production of online questionnaires from a law firm’s Web site.

Plaintiffs completed the questionnaires before forming an attorney-client relationship with the Los Angeles-based firm Baum Hedlund, but Judge Pfaelzer ruled in her order that a disclaimer at the end of the questionnaire waived the confidentiality of the information. Plaintiffs each hired Baum Hedlund to represent them in their cases against GlaxoSmithKline (GSK) for injuries they allegedly sustained as a result of tapering or discontinuing the antidepressant Paxil.

The appeals court ordered GSK to file a response to plaintiffs’ petition for a writ of mandamus within 10 days; the District Court can file a response if it so desires.

Plaintiffs will then have five days to file a reply, the appeals court ruled.

Amicus Brief Supports Review Of Ruling On Disclaimers

SAN FRANCISCO — The Ninth Circuit U.S. Court of Appeals should review a federal judge’s order requiring the disclosure of private information contained in online questionnaires because it jeopardizes the privileged and confidential nature of preliminary communications between attorneys and potential clients, attorneys from the Los Angeles County Bar Association (LACBA) say in a March 10 amicus curiae brief (Andrew Barton, et al. v. United States District Court for the Central District of California, No. 05-71086, 9th Cir.).

(Letter available. Document #68-050318-008X.)

Attorneys Daniel Koes and Pamela Dunn filed the brief on behalf of the more than 25,000 members of the LACBA and say allowing the ruling of U.S. Judge Maria Pfaelzer of the Central District of California to stand would have a chilling effect on the methods in which attorneys communicate with potential clients before the establishment of the attorney-client relationship.

Judge Pfaelzer ordered five plaintiffs selected for the nation’s first Paxil withdrawal trials to disclose the contents of online questionnaires completed on Los Angeles-based law firm Baum Hedlund’s Web site. In her Jan. 28 order, Judge Pfaelzer found that though the information was privileged under California law, a disclaimer at the end of the questionnaire that discharged the establishment of an attorney-client relationship also constituted a waiver of confidentiality (See February 2005, Page 12).

“The exception to confidentiality created by this ruling threatens to completely swallow the privileged nature of preliminary communications between lawyers and potential clients,” the LACBA says. “Until the Court unravels the procedural pretzel created by this ruling, attorneys cannot safely advise potential clients that no attorney-client privilege exists — using the internet or any other means — without rendering all their pre-engagement communications open to discovery by their adversaries.”

Unworkable Conundrum

The LACBA further urges the Ninth Circuit to review Judge Pfaelzer’s ruling based on the effect her decision will have on attorneys across the country. Specifically, the ruling has created an “especially unworkable conundrum” because it allows sensitive information, such as prescription drug use and medical history, open for disclosure despite the presence of a disclaimer.

In addition, the ruling affects how attorneys will be able to use the Internet to communicate with potential clients.

“Many LACBA members have a presence on the internet that would be directly impacted by this ruling,” the group says. “Many more regularly participate in pre-engagement communications with potential clients, often exchanging confidential information in anticipation of a future engagement. And it is likely that most have had some occasion to advise potential clients that no attorney-client relationship will arise until the parties’ pre-engagement evaluation is complete and they have entered into a written engagement agreement.”

Dunn and Koes of Dunn Koes in Pasadena, Calif., represent the LACBA.

Plaintiffs’ Claims Should Be Tried Individually, GSK Argues

LOS ANGELES — The claims of five Paxil withdrawal plaintiffs should be tried separately because they do not share any common issues of law aside from their use of the antidepressant, manufacturer GlaxoSmithKline (GSK) says in a March 3 motion (In re: Paxil Products Liability Litigation, MDL No. 1574, C.D. Calif.)

(Motion available. Document #75-050325-101M.)

For example, the company argues that each of the plaintiffs, who claim that they suffered withdrawal symptoms when tapering or discontinuing their use of the selective serotonin reuptake inhibitor (SSRI), used the antidepressant at different times and for different reasons. In addition, the plaintiffs do not share similar medical histories or methods for discontinuing Paxil, the company says.

Plaintiffs Andrew Barton, Kenneth Borenstein, Gerri Marin, Trishia Medema and James Meythaler were each randomly chosen to be the first Paxil withdrawal clients in the nation to go to trial. Each contends that GSK is liable for withdrawal symptoms they experienced when attempting to discontinue or taper their use of Paxil.

“This lone common thread — the consumption of Paxil — is similarly insufficient to meet the requirements for joinder or consolidation of trials (as opposed to pre-trial proceedings),” the company asserts.

Moreover, trying the plaintiffs’ claims simultaneously would lead to jury confusion, GSK argues, because of the number of expert witnesses expected to testify. According to the motion, no less than 88 witnesses have been deposed by the parties and plaintiffs responded to the manufacturer’s interrogatories by stating that they may call up to 166 witnesses during the trial.

Same Transaction

As a result of the highly individualized nature of each of the plaintiffs’ claims, GSK contends that severance is warranted because the plaintiffs do not meet the standards for joinder or consolidation under Federal Rule of Civil Procedure 20(a). Under Rule 20(a), the joinder of plaintiffs is permitted only if the claims arise out of the same transaction or occurrence and if there are common questions of law or fact.

The manufacturer argues that plaintiffs’ use of Paxil and alleged injuries stemming from discontinuing the drug do not satisfy the same transaction standard. Similarly, although the plaintiffs’ cases share sufficient common facts to warrant the consolidation of pretrial proceedings, it does not lead to the conclusion that they should be joined or consolidated for trial.

In their motions for class certification, plaintiffs claimed that GSK’s conduct in testing, marketing and labeling Paxil and the question of whether the drug is capable of producing withdrawal symptoms supported the commonality of their claims.

“It is well-established that alleging the same general theories of law against a defendant is not sufficient to satisfy the ‘common question of law or fact’ prong of Rule 20,” GSK avers.

Prejudice

GSK further contends that a trial encompassing the claims of all five plaintiffs would be severely prejudicial because evidence concerning one plaintiff’s case will inevitably bias the jury against GSK with respect to the other plaintiffs.

Also, jurors may not be able to keep track of which evidence applies to each particular plaintiff.

“This problem is two-fold,” GSK says. “First, a jury might attribute to all plaintiffs evidence that is relevant only to one plaintiff’s case, thereby essentially fabricating evidence that does not exist. Second, GSK’s defenses — such as the statute of limitations, the learned intermediary doctrine and assumption of the risk — must be decided as to each individual plaintiff. If the jury fails to apply the evidence to the appropriate plaintiff, these defenses will be meaningless.”

Finally, the company asserts that a single trial would be no more efficient than holding separate trials.

Counsel

Thomas M. Moore, David J. Fleming and Mario Horwitz of Drinker, Biddle & Reath in Los Angeles and Chilton D. Varner, Andrew T. Bayman and Todd P. Davis of King & Spalding in Atlanta are counsel for GSK.

Karen Barth Menzies of Baum Hedlund in Los Angeles, Christopher Coffin of the Pendley Law Firm in Plaquemine, La., Donald J. Farber of the Law Offices of Donald J. Farber in San Rafael, Calif., and Kevin J. Yourman and Jennifer Liakos of Yourman, Alexander & Parekh in Manhattan Beach, Calif., represent the plaintiffs.

Plaintiffs Seek Certification Of Class To Resolve Common Questions

LOS ANGELES — Plaintiffs in the Paxil withdrawal MDL have asked the court to certify a nationwide class to determine liability as to GlaxoSmithKline’s (GSK) conduct regarding its alleged misrepresentations about Paxil’s ability to induce dependence (In re: Paxil Products Liability Litigation, MDL No. 1574, C.D. Calif.).

(Renewed motion available. Document #75-050325-015M.)

In their Feb. 7 renewed motion for class certification, lead plaintiffs Katherine Keith and Dan Kabic say certification of a nationwide common issues class is necessary because although GSK has conceded that Paxil can cause withdrawal symptoms in some people, questions of law remain as to the manufacturer’s motivation and conduct.

For example, the plaintiffs opine that questions regarding when GSK knew that Paxil could cause moderate to severe withdrawal symptoms, whether it misrepresented the degree of frequency and severity of withdrawal symptoms in its advertisements, marketing and labeling, whether GSK failed to warn physicians and the medical community regarding withdrawal reaction and whether its representations regarding Paxil’s ability to cause withdrawal symptoms was misleading can all be resolved in a single forum, upon a single presentation and in front of a single fact finder.

“These questions only relate to the conduct and motivation of GSK,” plaintiffs argue. “They are highly relevant not only to the plaintiffs’ claims, but to determining the intentional nature of GSK’s conduct.”

The common issues class would include people who suffered withdrawal reactions as a result of discontinuing or tapering their use of Paxil.

Consumer Class

The plaintiffs also ask the court to certify a class of California residents seeking mandatory injunctive relief and disgorgement based on GSK’s alleged violation of California’s Unfair Competition Law (UCL).

U.S. Judge Mariana Pfaelzer of the Central District of California on Aug. 29, 2003, rejected the plaintiffs’ previous motion for a UCL class, noting that GSK said it was no longer claiming that Paxil was not habit-forming. However, the plaintiffs point out in their current motion that as of Jan. 17, GSK’s sales representatives were still telling doctors that the company had “taken care” of the withdrawal symptoms associated with Paxil and that there are “no problems . . . with discontinuation.”

“The fact that GSK’s sales representatives are still making these types of statements to physicians, when GSK has already admitted to this Court that it concedes that withdrawal symptoms do occur in some cases, is preposterous,” the plaintiffs assert. “It is exactly these types of statements and conduct that plaintiffs respectfully request this Court to permanently enjoin.”

Arguments on the motion are scheduled to be heard March 31 before Judge Pfaelzer.

Karen Barth Menzies of Baum Hedlund in Los Angeles; Christopher L. Coffin of the Pendley Law Firm in Plaquemine, La.; Donald J. Farber of the Law Offices of Donald J. Farber in San Rafael, Calif.; and Kevin J. Yourman, Jennifer R. Liakos and Angela S. Rupert of Yourman, Alexander & Parekh in Manhattan Beach, Calif., represent the plaintiffs.

----

To read the responses to this thread, visit Paxil Progress


Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Friday, March 19, 2010

GlaxoSmithKline - Money & Avandia Research


Image: s.wsj.net

Reuters is reporting that virtually all who wrote in favour of GlaxoSmithKline's diabetes drug Avandia had financial ties to drug makers.

Julie Steenhuysen writes:

"A team at the Mayo Clinic in Rochester, Minnesota, pored through more than 200 scientific studies and commentaries that offered positive opinions about the drug after a May 2007 study suggested Avandia significantly increased the risk of heart attacks.
They found that 94 percent of the authors who defended the drug, known generically as rosiglitazone, had ties to drug companies, and nearly half had financial ties that presented a conflict of interest."


Glaxo spokeswoman Mary Anne Rhyne defended the drug.

"Of the 202 publications reviewed by the authors, only 10 were original scientific research," she said in a statement.

"Many of the articles reviewed were opinion pieces -- editorials, commentaries or letters. It is important to note that the authors' conclusions do not impugn the validity of the scientific data," she said
.


It was Mary Anne Rhyne who also once said in 2002:

"Obviously doctors are very busy people, and their day is packed with patients. The question is how do doctors get information about medicines and new research into treatments and disease, and one of the easiest ways is this kind of presentation [”dine and dash”]. We think this is a benefit to both physicians and patients.

More worryingly, in 2005, Mary Anne Rhyne had this to say about Paxil/Seroxat withdrawal:

"If ‘discontinuation reactions’ occur in patients stopping [Paxil], the majority will experience symptoms that are mild to moderate in intensity, and are usually limited to two weeks."

The full Avandia story can be read here

There's also a bloggers account of this breaking news here

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Thursday, March 18, 2010

The Time To File A Paxil Birth Defect Claim Is Running Out


Image: seroxatkillsbabies.files.wordpress.com


PRESS RELEASE FROM 1888PressRelease

March 18, 2010 - It appears that the time to seek compensation for birth defects allegedly caused by exposure to the antidepressant Paxil during pregnancy is running out. DrugSettlement.com reports that court records indicate many cases have been resolved and have been removed from the docket. Parents who took Paxil during pregnancy and gave birth to a child with a congenital heart defect should act quickly to determine whether they my file a claim on behalf of their child.

Parents may visit www.DrugSettlement.com for more information.

No Paxil birth defect cases have been tried since the October 13, 2009, verdict where a jury awarded $2.5M to the family of Lyam Kilker, a child born with a congenital heart defect caused by Paxil use during pregnancy. Though multiple trials were scheduled for December, January and February, not one even began trial. It is presumed that these cases, all alleging heart birth defects caused by exposure to Paxil during pregnancy, were settled by GSK.

Since Paxil came on the market in 1992, if has faced three significant litigations. GSK resolved approximately150 suicide cases reportedly for an average of $2 million. Other cases including 300 cases where it was alleged that consumers attempted suicide were settled for approximately $300,000, according to a December 14, 2009 report by Bloomberg News.

In cases alleging withdrawal problems, GSK faced approximately 3200 cases for which it settled for an average of about $50,000.

GSK has also paid about $400 million to end antitrust, fraud and design claims, Bloomberg reports. Since 1992, Glaxo has paid out close to $1 billion to resolve Paxil lawsuits. It has been reported that it may now be trying to resolve the nearly 800 birth defect cases now confronting it.

Here's a video I first published back in December 2009. It relevant to the Paxil birth defects lawsuits, in particular the Kilker v GlaxoSmithKline case.

Court transcripts from the Kilker case can be read here

PRESS PLAY BUTTON ON VIDEO BAR [First 30 secs are audio only]



Special thanks to the production team at Law Journal TV for passing this on to me and granting me permission to use on the Seroxat Sufferers blog.


Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Karl Winn Refuses To Hire Ex-Soldiers


Image: boingboing.net

It seems Webeurope Design boss, Karl Winn, has caused outrage with his stance on employing ex-servicemen.

Forces Recruitment Services, which help find jobs for former British ex-servicemen had emailed Winn [60] inviting him to consider taking on ex-servicemen and women at the Webeurope design company he runs in Taunton, Somerset.

Winn, a former social worker, replied:

"Personally, I'd rather recruit ex-drug dealers, convicts and even child molesters rather than consider anybody who has been in the pay of the British Government."


He added:

"Anybody who has been in the pay of such a military force, and by their silence and complicity has condoned such illegal and immoral actions while accepting a monthly blood-stained pay-packet, certainly will not be considered for employment by us!

"Please remove us from your email list. Regards, Karl."


Winn, has for many years supported numerous organisations (NGO's), such organisations include:

The International Human Rights Network - Supporting others in applying Human Rights Based Approaches to UN Agencies, countries, and organisations.

Film Makers Against War - FAW seeks to educate and raise awareness of UK and international war law.

Art and Sacred Places - Encourages the interaction of art and religion by commissioning artists to make work in sacred places.

Relatives for Justice – A northern Ireland based organisation that supports and campaigns on behalf of the families of the 367 men, women, and children, who have been killed by members of the British Military and Police services. The campaign seeks to bring the perpetrators of such killings before the courts.


So it appears that Winn is just anti-British Army then?

It would be interesting to see if Winn would employ the services of an ex- provisional IRA member or ex-soldier of the Argentine Forces. Or maybe he would prefer to employ [age permitting] a former member of the SS?

Winn has made a rod for his own back with these outlandish remarks - after all, it is wrongful to discriminate against certain groups, is it not?

He has the right to his beliefs but any logical thinking human being can see that it is not the soldiers who should be held accountable for war - it is the powers that be.

Winn needs a reality check - a history lesson will teach him that his right to voice his opinions was given to him by ex-servicemen. He may also find it interesting to learn that the British military actually train soldiers in Internet Technology and by not offering these heroes employment because of his 'opinion' could well be deemed discriminatory.

I'm guessing he does not like the American Armed Forces either.

It shows the mark of a real man when he tried to deny he had sent the email, instead blaming it on a "disgruntled worker" who had hacked into his email account. He later admitted he had written them after being confronted with further emails between him and the recruitment agency.

Cometh the hour... cometh the coward.

The WebEurope Careers page can be found here

WebEurope's press statement regarding Winn's comments can be read in full here

Oh, by the way Mr. Winn, I hear Gary Glitter is out of work. You may wish to use his services - I hear he is a dab hand at computer technology!

UTRINQUE PARATUS

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Tuesday, March 16, 2010

I May As Well Be A Rabbit!


Image: media.comicvine.com

Just back from the doctor's, the gout has been with me for over two weeks now and is actually getting worse!

A course of tablets for acute gout, blood tests [3] and a list of what I can and cannot eat/drink.

Lucky me.

I CAN drink up to 2 litres of water and... well basically, that's it.

Here's what I have to avoid:

Shell fish
Oily fish
Offal e.g. liver, kidney
Pheasant or other game.
Meat extracts, e.g. Bovril, Marmite, Gravy
Peas
Beans
Anchovies
Asparagus
Mussels
Red Meats
Processed Meats
Fried Foods.
Roasted Nuts
Any food cooked in oil
Rich [sugar] foods, cakes, biscuits, chocolate.
Dried fruit
Eggs
Yeast products
Aspirin


So whose up for a party at mine tonight?

Water and potatoes.

I think the phrase rhymes with clucking bell.

Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Sunday, March 14, 2010

Dubai: Is it wrong to show affection?


Image: elvision.net


I had to double check today to see whether it was April the 1st.

I'm left scratching my head at the following story.

Apparently, a local Dubai woman was offended when she saw two people kissing in a restaurant... so offended that she called the Police. The couple, Ayman Najafi and Charlotte Lewis, were promptly arrested, sentenced to a month in prison and also fined £180 for consuming alcohol, which was allegedly just a quarter of the British driving limit.

Now, I'm all for showing ones emotions. I've always been comfortable showing my affection in public, be it holding hands or sneaking a quick kiss. I'd kind of draw the line at ravishing the person I'm dining with over the restaurant table - some things are best left to the privacy of your own space.

I wonder if Ayman Najafi and Charlotte Lewis had ordered their meat and two veg?

Really, this is just so absurd. A man and a woman kiss because they feel the urge to show a sign of affection toward one another. What's so bad about that?

Why was an on-looker so offended? Wouldn't it have been far easier for her to turn the other way and continue eating whatever it was she was eating?

How awful, a man and a woman kissing each other... on the mouth too. Crime of the century!

These ancient laws are ridiculous - probably fuelled by religious fanatics who think women should be seen [only their eyes] and not heard.

This is for the woman who was so offended by two human beings kissing. It is also for the Judge who sentenced them to one month in prison. It's also for the draconian lawmakers of Dubai.

You are all awarded the Seroxat Sufferers dumbass award. It's time for you all to move with the times and come to terms with one of the most natural things a man and a woman do. Kiss!



To read more about this heinous crime visit Sky News


Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Saturday, March 13, 2010

BLAST FROM THE PAST - SEROXAT - THE LEGAL QUESTIONS THAT MUST BE ANSWERED


Image: i.dailymail.co.uk

Thought I'd repost this.

It's a post taken from the Head of Legal blog written by Carl Gardner.

Carl is a barrister, and worked as a government lawyer for twelve years, advising ministers and government departments on a wide range of public law issues from tax to terrorism, from freedom of information to pensions, from discrimination to health and from defence to broadcasting.

His post from March 2007 came shortly after the MHRA had [basically] let GlaxoSmithKline off the hook regarding their suppression of clinical trial data concerning Seroxat and children.

Seroxat: the legal questions that must be asked [LINK]

Yesterday the Medicines and Healthcare Products Regulatory Agency announced it had decided not to prosecute GlaxoSmithKline for offences under medicines legislation, although it says GSK failed to inform it promptly of data it had from clinical trials suggesting that the anti-depressant drug Seroxat (GSK’s UK brand name for the active substance paroxetine – marketed in the US as Paxil) is associated with increased suicidal behaviour in some depressed children. Here is the MHRA webpage with its press release and related documents.

At the time the MHRA found out about this data about seven thousand under-18s were being prescribed the drug – so GSK’s late reporting is bound at the very least to have caused some British teenagers to have suicidal thoughts. Who knows whether some young person died because of this. In fairness I should say that GSK deny they reported the data late. The MHRA claims that GSK knew as early as 1998 that Seroxat was ineffective in treating children’s depression. But it didn’t tell them. Amazingly, it planned in 2003 to apply for a licence specifically for children!

In my view, this whole affair represents a serious failure of the medicines regulatory system, and a number of hard questions need to be asked of the MHRA Chief Executive Kent Woods, and of health ministers. In particular:

Were the MHRA and its lawyers right to think that GSK was not, or may not have been, required to report adverse reactions from Seroxat used in trials outside the terms of its UK marketing authorisation?

Were they right to think Seroxat was not authorised for use in children?

Why were MHRA officials unable to question GSK staff?

Does the MHRA have the powers it needs to properly regulate pharmaceuticals industry?

This monster post is my attempt to explain why I’m not satisfied with the MHRA’s explanation for its decision, and why I think these questions need to be answered.

The key document explaining the decision not to prosecute is this MHRA report into its investigation and legal consideration of prosecution. In the remainder of this post I’ll refer to various paragraphs in that report.

Were the MHRA and its lawyers right to think GSK may not have been required to report adverse reactions in trials outside the terms of Seroxat’s license?

Para. 33 sets out the potential offences that were considered in this case. From 28 February 2002, Schedule 3, paragraph 10(d) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 it was an offence for a “qualified person” (a specialist that every drug firm must employ specifically to provide information to the regulator) to fail to provide to the MHRA any information relevant to the risk/benefit analysis of a medicine as required by the European Medicines Code, Directive 2001/83.

I’ve not posted a link to the Regulations because the version on the Statute Law Database is out of date; the MHRA document correctly explains the position as from 2002.

So what did the EU Code require? As para. 42 of the MHRA report says, article 103d of the Code says the qualified person is responsible for providing to national regulators any information relevant to evaluating the risks and benefits of a medicine.

I think that’s all very clear. The EU Medicines Code requires the QP to give the regulator any risk/benefit data; and the UK Regulations make it an offence for the QP to fail to fulfil that responsibility. So why did the MHRA think there was some doubt here about whether late reporting would amount to an offence?

Paragraph 49 of the report explains this. It explains that the requirement in article 103d of the Code to report information on post-authorisation safety studies only covers studies of the drug within its licensed use.

That is I presume because post-authorisation safety studies are defined in article 1.15 of the Code as studies carried out in accordance with the marketing authorisation of a drug. But in addition this view sees article 102 of the Code, which requires national regulators to maintain a pharmacovigilance system to ensure good regulatory decisions having regard to adverse reactions under normal conditions of use, as colouring what information a qualified person must provide. According to this argument, the normal conditions of use are those approved in the marketing authorisation.

I have to say, I have real problems with this legal view. Firstly, article 103d of the Code does not limit the qualified person’s responsibility to report simply to data gathered in “post-authorisation safety studies”. The qualified person must in any event report any other information that relates to risks and benefits. So the definition of “post-authorisation safety studies” is simply irrelevant.

Secondly, I don’t read article 102 as cutting down or limiting what the qualified person must report; it simply explains in very general terms what the purpose of pharmacovigilance is as far as regulators are concerned.

In any event, thirdly I think it is too much to read the phrase normal conditions of use in the Code as meaning use within the terms of a marketing authorisation. It helps when thinking about this to consider article 116, which gives the regulator power to revoke marketing authorisation, and article 117 which enables it to recall products and stop further supplies. Under article 116, revocation can happen where a drug is harmful under the normal conditions of use, is ineffective or where the risk/benefit balance is not positive under the normal conditions of use. Do the MHRA’s lawyers seriously think that the fact that a serious risk arises from a drug only when used outside the strict terms of its authorisation – say, if you dropped dead if you took those two paracetamols just a little less than fours hours after the previous two – means the MHRA could not withdraw authorisation? That’d be silly. If people did start dropping dead for getting their timings wrong, you can be sure the MHRA would revoke authorisation for paracetamol on the basis that the normal conditions of use, in the real world, are not necessarily in all respects strictly limited to the authorised use.

I must be fair, and refer you to article 117. That as I’ve said is about product recall and impounding products at the factory gates, something the regulator can do if the product is harmful under the normal conditions of use, is ineffective or where the risk/benefit balance is not positive under the authorised conditions of use. Now, admittedly, this drafting causes confusion since it seems to suggest that the phrase authorised conditions of use can be used interchangeably with the phrase normal conditions of use. There’s no easy answer to this, European legislation being drafted pretty slackly on the whole. It’d be misconceived to attempt to draw some fine distinction between articles 116 and 117 or even between the different grounds for withdrawal under article 117. I can’t rationalise away this drafting problem.

But equally, it doesn’t work to rationalise it away by concluding that revocation and recall can only happen on the basis of harmful authorised use. That would actually run counter to the purpose of the Code, as revealed by recital (2), which says its essential aim must be to safeguard public health – and EU legislation must of course be interpreted purposively, in line with its aim.

Let me put it more starkly. The MHRA report says use in children is outside the authorised use. Would the MHRA claim that, if those children who were prescribed the drug all killed themselves en masse, it as the regulator would have no power to revoke the authorisation? Of course it wouldn’t. The product would be harmful in the normal conditions of use even if that use was unauthorised.

That ends up being a long way of explaining why I think it’s clear that GSK’s qualified person was required by law to inform the MHRA of the results of its trials, both as regards efficacy and safety, and why any failure to do so was an offence. The view of the MHRA lawyers seems to me an excessively cautious one, implying a very feeble view indeed of the duties of drug firms and the powers of the regulator.

Were the MHRA right to think Seroxat was not authorised for use in children?

Let me begin by saying it seems to be widely believed among drug firms, regulators and health care professionals that a medicine is not licensed for use in children unless the terms of its license explicitly say so. And ministers have said in Parliament that Seroxat was never licensed for use in children. My view of this will seem, therefore, contrarian. But it seems to me that Seroxat probably was licensed for use in children anyway.

How do you know what a drug is, and is not, licensed for? Well, if we could see a document called a marketing authorisation making it clear Seroxat is only licensed for use in adults, that would settle things. But I’m not sure such a document actully exists, or is available online. What does exist is the MHRA’s published “UKPAR”, or UK Public Assessment Report, a document which summarises the scientific basis on which marketing authorisation has been granted. Here’s an UKPAR for generic paroxetine. In that document there is no mention of children except in the text of the SPC or summary of product characteristics, which is a document aimed primarily at doctors explaining the drug’s use and which must be approved by the MHRA. Here’s Seroxat’s SPC. You can see that sections 4.2 on posology, and 4.4 on special warnings, both say Seroxat should not be used in children. It seems to me that it’s on the basis of these statements and these statements alone that the MHRA believe Seroxat is not licensed for children.

Well, fair enough: those statements are pretty clear, and I’ll buy that argument. But what did the SPC say before the MHRA was told about the increased risk of suicidal thoughts? Paragraph 2 of the MHRA report tells us that. The SPC said (presumably in section 4.2 on posology):

The use of Seroxat in children is not recommended as safety and efficacy have not been established in this population.

Is that it? I have to say that that standard wording, to me, seems very different from a clear statement that use in children is not authorised. What’s more, paragraph 14 of the MHRA report tells us that, once the MHRA knew about the increased suicide risk, it asked GSK to submit a variation to the marketing authorisation contraindicating use in the under 18s. So aren’t I right to suggest the authorisation was not clearly limited in that way before?

And another thing: article 116 of the EU Code say that a marketing authorisation can be varied if the risk/benefit balance is not positive in the normal conditions of use. If Seroxat wasn’t licensed for use in children, as the MHRA are now saying, and if the normal conditions of use means simply licensed use, as the MHRA’s lawyers seem to have concluded – how come the MHRA had power to vary the authorisation? None of this adds up.

Why were MHRA enforcement investigators unable to question GSK staff?

Paragraph 23 of the MHRA report tells us that GSK staff, presumably including the qualified person,

declined invitations to attend interviews under caution

Amazing. I think I’d decline an invitation like that, too. But shouldn’t the MHRA have powers to require someone to attend for questioning (which would not be the same as making it compulsory to answer)? Shouldn’t they be able to apply for a warrant of some kind? Why didn’t they get the police involved? After January 2006 they had power to arrest GSK staff for questioning in relation to these offences. Here’s Alison Hannah’s critical explanation of the new powers.

Does the MHRA have the powers it needs to properly regulate pharmaceuticals industry?

This whole affair seems to me a serious failure of the medicines regulatory regime, a regime riddled with legal confusions, doubtful assumptions, excessive caution and misunderstanding. Does the MHRA have power even to vary drug licences in these circumstances? They seem not to think so. How can it be that the regulator thinks the law doesn’t require this safety data to be passed to it? Why does the MHRA seem so toothless in the face of the drugs industry? I’m glad legal changes are being made now, but are they really necessary, or is my analysis correct? Is the regulator being unduly cautious about its powers? Why have these “gaps” in the law, if indeed they are gaps, only been spotted now?

I’m not sure this regulatory system is fit for purpose.

CARL GARDNER [Barrister]

----

Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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