GSK’s Zofran Drug And Birth Defects..


http://www.lawyersandsettlements.com/articles/zofran-birth-defects/zofran-glaxosmithkline-llc-gsk-us-20540.html#.VRduKEbIto5

Is Zofran Manufacturer GSK Talking from Both Sides of Its Mouth?

March 27, 2015, 08:00:00AM. By

Pittsburgh, PA: Twenty-three years is a long time. And yet, that’s the timespan a Zofran lawsuit alleges that Zofran manufacturer GlaxoSmithKline (GSK) has been in possession of evidence suggesting a risk of birth defects associated with the use of Zofran in pregnancy.

Is Zofran Manufacturer GSK Talking from Both Sides of Its Mouth?Various studies have offered conflicting views on Zofran, and other generic versions of ondansetron (Zofran). And there is little doubt about ondansetron’s capacity for curbing nausea – an often debilitating byproduct of pregnancy. For some women, morning sickness can be so extreme that only medication can prevent the sometimes constant vomiting, dehydration and weight loss that severe morning sickness can foster.

And yet, ondansetron was never approved by the US Food and Drug Administration (FDA) for use as a treatment for morning sickness. Zofran manufacturer GSK makes that very point, noting in a Canadian media report last June that “the safety of ondansetron for use in human pregnancy has not been established…[GSK] monitors and reports all adverse event reports…” (The Toronto Star, 6/25/14).

But is GSK talking from both sides of its mouth? That’s the way it appears, as GSK was previously accused of promoting Zofran off-label for morning sickness, or so it is alleged. The US Department of Justice asserted that GSK had not only promoted Zofran and other drugs off-label, but that the company provided kickbacks to doctors in exchange for prescribing Zofran for morning sickness. Court documents, according to The Toronto Star, alleged that GSK disseminated false and misleading information about the safety and effectiveness of Zofran.

In 2012, GSK settled with the US Department of Justice for $3 billion. As part of the settlement, GSK was not required to admit to any wrongdoing. That latter bit is a frequent feature of government settlements: the ability to escape a finding of wrongdoing in exchange for a massive payment.

One of the more recent Zofran lawsuits, filed by plaintiff Cheri Flynn in Pennsylvania, mirrors allegations contained in the US Department of Justice lawsuit: that GSK knowingly marketed Zofran to pregnant women without sharing information about the potential for Zofran birth defects – information the lawsuit alleges GSK has had in its possession since 1992, if not before.

“GSK not only concealed this knowledge from healthcare providers and consumers in the United States, and failed to warn of the risk of birth defects,” the Flynn lawsuit states, “but GSK also illegally and fraudulently promoted Zofran to physicians and patients specifically for the treatment of morning sickness in [pregnant] women.”

Drug manufacturers do not have the legal, ethical or medical authority to market a drug off-label. Ondansetron was originally approved by the FDA for treatment of nausea in cancer patients following chemotherapy. It was never indicated for pregnant women, although doctors have always had the authority to prescribe off-label should they feel it would benefit the patient. And yet, The Toronto Star last June suggested that doctors in Canada are prescribing ondansetron off-label without having all the facts.

One wonders if the same thing is happening in the US.

“Women ingested the drug because they innocently believed that Zofran was an appropriate drug for use in their circumstance,” the Flynn lawsuit contends. “When they ingested the drug, these pregnant women had no way of knowing that Zofran had never been studied in pregnant women, much less shown to be a safe and effective treatment for pregnancy-related nausea.”

The Zofran lawsuit is Cheri Flynn v. GlaxoSmithKline LLC, Case No. 2:15-cv-00709-PD, United States District Court of the Eastern District of Pennsylvania. The lawsuit alleges that Flynn’s two children suffered congenital heart defects and other birth defects following fetal exposure to Zofran.

http://www.wkrg.com/story/28277705/zofran-lawsuit-alleges-gsk-failed-to-disclose-zofran-dangers

Zofran Lawsuit Alleges GSK Failed to Disclose Zofran Dangers

Posted: Mar 06, 2015 8:06 AM GMT

This article was originally distributed via PRWeb. PRWeb, WorldNow and this Site make no warranties or representations in connection therewith.

Zofran lawyers at the Onder Law Firm have expanded their website to provide information about the allegations made in a new Zofran lawsuit filed in Pennsylvania.

St. Louis, MO (PRWEB) March 06, 2015

A new Zofran lawsuit has been filed in U.S. District Court in Pennsylvania, according to attorneys handling Zofran lawsuit claims alleging birth defects.* The lawsuit alleges that the plaintiffs two children suffered congenital heart defects and other birth defects after fetal exposure to Zofran, according to court documents.

This Zofran lawsuit alleges that the defendant, pharmaceutical company GlaxoSmithKline (GSK) was aware of evidence supporting a link between Zofran use during pregnancy and the increased incidence of congenital heart defects and other birth defects, according to court documents:

Since at least 1992, GSK has had mounting evidence showing that Zofran presents an unreasonable risk of harm to babies who are exposed to the drug during pregnancy.* According to court documents, the lawsuit cites numerous pieces of evidence in support of this statement, saying GSK was aware of the following:

  • Zofran readily crosses human placental barriers during pregnancy.*
  • Animal studies conducted on Zofran indicate that Zofran cannot be used safely or effectively in pregnant women.*
  • Since 1992, GSK has received hundreds of reports of major birth defects associated with prenatal Zofran exposure.*

According to court documents, the plaintiff alleges that GSK knowingly marketed Zofran to pregnant women, without issuing a birth defects warning, despite evidence suggesting this was not a safe application of the drug: GSK not only concealed this knowledge from healthcare providers and consumers in the United States, and failed to warn of the risk of birth defects, but GSK also illegally and fraudulently promoted Zofran to physicians and patients specifically for the treatment of morning sickness in pregnancy women.*

The FDA has never approved Zofran as safe for pregnant women, yet women are still being prescribed Zofran during pregnancy, believing the drug is safe, according to court documents: “Women ingested the drug because they innocently believed that Zofran was an appropriate drug for use in their circumstance. When they ingested the drug, these pregnant women had no way of knowing that Zofran had never been studied in pregnant women, much less shown to be a safe and effective treatment for pregnancy-related nausea.”*

A few women have now stepped forward to file Zofran lawsuits. As more families learn about the allegations of birth defects from Zofran, we anticipate hearing from others interested in filing Zofran lawsuits, said Jim Onder of the Onder Law Firm.

The Onder Law Firm, nationally-renowned as a leading family safety and consumer liability law firm, provides legal representation for families seeking to file Zofran lawsuits for allegations of birth defects. Zofran attorneys representing clients nationwide offer Zofran lawsuit news and updates at their website. The firm provides no-cost, no-obligation case evaluation for mothers and families whose babies wer born with a birth defect following prenatal exposure to Zofran. Individuals who fit this description may contact a lawyer to discuss whether they have grounds for a Zofran lawsuit. The firms Zofran lawyers believe persons who meet this description may be entitled to real compensation. For more information, visit the Zofran lawsuit website.

The Onder Law Firm welcomes Zofran case inquiries from law firms in regards to handling them or working as co-counsel.

About The Onder Law Firm
Onder, Shelton, OLeary & Peterson, LLC is a St. Louis based personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The pharmaceutical and medical device litigators at The Onder Law Firm have represented thousands of Americans in lawsuits against multinational conglomerates from products liability for manufacture of defective or dangerous products to deceptive advertising practices. Other firms throughout the nation often seek its experience and expertise on complex litigation. It is also a recognized leader in products liability cases such as window blind cord strangulation. The Onder Law Firm offers information on Zofran lawsuits at http://www.247LawsuitNews.com.

*Cheri Flynn vs. GlaxoSmithKline LLC, Case 2:15-cv-00709-PD, United States District Court of the Eastern District of Pennsylvania

For the original version on PRWeb visit: http://www.prweb.com/releases/zofran-birth-defects/zofran-lawsuit/prweb12564236.htm

Information contained on this page is provided by an independent third-party content provider. WorldNow and this Station make no warranties or representations in connection therewith. If you have any questions or comments about this page please contact pressreleases@worldnow.com.

Depresion Doesn’t Cause This To Happen To People But Psychiatric Drugs Do..


http://www.cchrint.org/2015/03/27/germanwings-co-pilot-spent-18-months-under-psychiatric-treatment/

Germanwings Co-pilot Who Purposefully Crashed Plane Had Spent 18 Months In Psychiatric Treatment

andreas-lubitz2

Germanwings co-pilot Andreas Lubitz who purposefully crashed Flight 9525 into the French Alps, killing all 150 people on board had spent 18 months overall under psychiatric treatment, Bild reported on Friday, citing anonymous sources within Lufthansa, Germanwings’ parent company. The pilot was diagnosed with a ‘severe depressive episode’ in 2009.

By CCHR International – March 27, 2015

Numerous reports are now surfacing that Germanwings co-pilot Andreas Lubitz who purposefully crashed Flight 9525 into the French Alps, killing all 150 people on board, had in fact been under psychiatric care.  What media are not reporting is the fact that Lubitz, in all likelihood was under the influence of antidepressants, drugs documented to cause depersonalization, mania, psychosis, and even homicidal ideation,  considering he spent more than 18 months undergoing “psychiatric care.”  Moreover, Lubitz would not be the first commercial pilot to purposefully crash a plane while under the influence of psychotropic drugs— In 2010, the National Transportation Safety Board (NTSB), issued a report on the probable cause of a 2008 plane crash in Mount Airy that killed everyone on board, showing that toxicology tests revealed the pilot had the antidepressant Zoloft in his system.  The NTSB report stated, “Officials say the pilot ‘displayed non-professional behavior’ and that a cockpit voice recording documented the pilot singing, ‘Save my life, I’m going down for the last time’” shortly before crashing the plane.

The emerging facts regarding Lubitz’ psychiatric treatment:

Russia Today (RT) reports, “Lubitz had spent 18 months overall under psychiatric treatment, Bild (a German newspaper) reported on Friday, citing anonymous sources within Lufthansa, Germanwings’ parent company. The pilot was diagnosed with a ‘severe depressive episode’ in 2009.”

According to Reuters, “The pilot who appears to have deliberately crashed a plane carrying 149 others into the French Alps received psychiatric treatment for a ‘serious depressive episode’ …. Citing internal documents and Lufthansa sources, Bild said Lubitz spent a total of one and a half years in psychiatric treatment.”

faa-quoteThe Guardian reports, “Investigators searching the Düsseldorf apartment of the co-pilot on the Germanwings flight that crashed into the French Alps on Tuesday have found evidence he hid an illness from his employers, prosecutors said on Friday. The evidence is a torn-up doctors’ note, signing him off work on the day of the crash. ‘Medical documents were found that indicate an ongoing illness and suitable medical treatment,’ Düsseldorf prosecutors said in a statement.”

Mirror states that, “Killer co-pilot Andreas Lubitz was treated in hospital just two weeks before the plane crash which killed 150 people. The 27-year-old attended a clinic at the University of Dusseldorf Hospital in February and March. The most recent visit was March 10, exactly a fortnight before he guided the Germanwings Airbus A320 into its fatal descent. The hospital said Lubitz attended for ‘diagnostic evaluation’ but insisted he was not treated for depression…. They confirmed he was suffering from a serious illness which he had concealed from his employers Germanwings. One of the sick notes was reportedly signed by either a local neurologist or psychologist.”

While the drug policies of Lufthansa, the parent company of Germanwings, are unknown,  in the U.S, the Federal Aviation Administration (FAA) allows the use of antidepressants among pilots, a policy instituted in 2008,  This is despite the fact there have been 134 regulatory warnings from eleven countries, including the United Kingdom, Canada, Japan, Australia, New Zealand, Ireland, Russian, Italy and Germany on antidepressants causing suicidal ideation.

Given the increasing number of questionable aircraft disasters, which, on their surface, provide no rhyme or reason for a motive, one may begin to question the use of antidepressants, especially in light of a 2007 FAA report that revealed that of the 61 air crashes between 1990-2001, “the pilot’s psychological condition and/or SSRI use was reported to be the probable cause or a contributing factor in 31% (19/61) of the accidents.”

The fact is, whether Lubitz was on psychiatric drugs, or in withdrawal from them, there is enough evidence to show that the use of antidepressants or other mind-altering psychiatric drugs by commercial pilots, in the U.S. and abroad, should be banned.

3 Months Update..


Apart from the 2 posts on GSK whistleblowers (which created a surge in hits)- the last week- I haven’t posted anything on this blog in 3 months.

However, I will likely post every 3 months or so, just to keep the blog going, and besides, GSK always seem to hit the headlines every few months with some sordid story or other about corruption, fraud, skullduggery etc… therefore there is always material to highlight, but I have scaled back on blogging, and I intend to keep it that way…

Here is some of the last few months news:

GlaxoSmithKline CEO Andrew Witty’s pay cut 46%

http://www.philly.com/philly/business/294305461.html

LONDON – The total compensation for Andrew Witty, CEO of GlaxoSmithKline P.L.C., was reduced 46 percent last year as profits of the largest U.K. drugmaker slumped.

Witty’s annual bonus was cut 51 percent to $1.41 million, while his salary climbed 2.6 percent, to $1.68 million, taking his total pay for 2014 to $6 million, according to London-based GSK’s annual report. Compensation for chief financial officer Simon Dingemans, 51, was pared to $2.85 million.

The pay cut reflects Witty’s struggle to halt a slide in U.S. market share for Advair, the company’s top-selling asthma medication, and failure to win over doctors and insurers to products designed to replace it. Shares of GSK fell 8 percent in the past year as the drugmaker was also battered by a bribery scandal in China that resulted in a $457.6 million fine.

___________________________________________________________________________________________________

Glaxo Fires More Than 100 Employees in China

GlaxoSmithKline PLC said it is firing about 110 employees in China for what it describes as misconduct, the latest fallout from a bribery scandal there that has dogged the U.K. drug company for more than a year.

The move comes six months after a Glaxo subsidiary in China was found guilty by a Chinese court of bribing doctors, hospitals and other nongovernment personnel and fined more than $490 million. A Glaxo spokeswoman said on Friday the misconduct leading to the dismissals dates back more than 18 months.

“Based on the findings, we have taken disciplinary action against employees whose conduct went against GSK’s values and code of conduct. We have zero tolerance for this kind of behavior,” the company said in a statement. The spokeswoman added that the drug maker has increased its monitoring of expense claims and compliance efforts in China, and also hired lawyers and consultants to review operations.

A tally of Glaxo’s total workforce in China wasn’t immediately available.

The firings come as Glaxo seeks to rebound from the long-simmering bribery scandal in China, which resulted in suspended prison sentences for five of the company’s managers, including Mark Reilly, its former top China executive.

The episode set back Glaxo’s efforts to restore its image and revamp business practices in the wake of a $3 billion settlement with U.S. authorities three years ago. The drug maker had been accused of failing to disclose clinical trial data for certain medicines and improperly marketing drugs, among other things.

Whistling In The Wind..


Yesterday I posted a public document which gave a judgement from a judge presiding over part of the GSK whistleblower complaint (which led to a record breaking 3 Billion dollar fine for GSK in 2012, after a US dept of Justice investigation). The complaint itself goes back decades, and in this particular part of the legal case, one of the ‘whistleblowers’, Blair Hamrick, was recently denied compensation for his claim for ‘unfair dismissal’.  I have no idea how much exactly Blair expected to receive with this part of the claim, but I gather it would likely be in the “few million” bracket. However, I’m sure Blair probably isn’t feeling overly hard-done-by considering the multiples of millions he has already received from his original whistleblower case.

I found this document interesting because, although the 3 billion dollar fine itself made headline news back in 2012, little is known about the whistleblowers themselves. The only whistleblower who seems to have made much media appearances, since GSK were fined, is Blair Hamrick, and the (now failed) unfair dismissal case (which I posted yesterday) was brought against GSK by Blair Hamrick. The other whistleblower Greg Thorpe seems to have been the first to instigate the case against GSK, therefore it would seem that it was Greg who blew the whistle initially. Greg has given just one interview, and is apparently still caught up in legal actions but is beginning to speak out.  However, apparently there were at least another 4 whistleblowers who were part of this case- Thomas Gerahty and Matthew Burke, were both mentioned in news articles but nothing has been forthcoming in the media from those two men. Why?

The two other apparent ‘whistleblowers’, have surnames Graydon, and LaFauci, and they  apparently filed suit much later than the others. Why are these two men not mentioned in news articles? (but they are mentioned in court documents here). What did they reveal? or was it just a rehash of the previous claims already filed? Furthermore, what has the dubious Dr. Piacentile (who seems to have made his living through whistleblowing and suing drug companies who once courted him) got do do with some of the later claims?

http://www.businesswire.com/news/home/20131104006221/en/Stone-Magnanini-LLP-Announces-1.3-Billion-Department#.VRQ2u0Yvlo4

Stone & Magnanini, a firm with a history of representing whistleblowers in groundbreaking settlements, represented Dr. Joseph Piacentile, a physician who was the first to blow the whistle on Johnson & Johnson and Janssen’s fraudulent conduct back in 2001. Following Dr. Piacentile’s filing, five other whistleblowers filed actions against the companies, and relators and their counsel formed a team to assist Government lawyers in achieving this groundbreaking settlement.

I have always thought that the GSK 3 Billion fine was a slap on the wrist for GSK, and I have also thought that paying out whistleblowers such high amounts of cash was  bordering on obscene, particularly considering some of these drugs (detailed in the court complaint) killed people, and most of them caused a lot of harm. I understand that some of the whistleblower’s took risks, and should be rewarded for loss of earnings etc, but I don’t believe that all these whistleblowers were genuine whistleblowers. It would be interesting to ask them what drugs did they prescribe off-label themselves? (if any?). Why, and when did they decide to come forward, was it before or after they realized they would get rewarded handsomely? These are important questions.

There is no money that can replace the loss of your life from a drug like Seroxat (Paxil), or the loss of your health, and anyhow most people can’t get GSK anywhere near a court to claim compensation for that, particularly in the UK and Europe. In my opinion compensation from GSK is blood money, plain and simple- it is money tainted with bad karma, unless the person receiving it was a victim, or a real whistleblower (with genuine intentions not just freeloading on the back of a potential payout)- then I think the money is seriously tainted… Think of it this way- any money GSK has, and any money it pays out, has been earned on the back of fraud and corporate murder. It’s blood money- no doubt about it. It’s money soaked from the blood of Seroxat teenage suicides,  Avandia heart attacks, babies with defects…

Another intriguing aspect of all this is, what happened to the Paxil complaint? Why did the main part of the original fine allegations focus on Advair? Why not Avandia or Paxil (Seroxat)? It seems to me that GSK got off extremely lightly for their most dangerous and damaging drugs- Paxil and Avandia- and that the department of Justice allowed the least damaging complaint (Advair) to gain the most traction and attention- particularly in the media. Why are the whistleblowers not talking about the whitewash and the deal that GSK did with the justice department?  It was obviously a good deal for GSK- 3 months profits for decades of damaging and killing tens of thousands of people? why are they not talking about the nitty gritty of what GSK did- corporate manslaughter and corporate murder? Why did the big executives walk away scot free? What really happened in the dubious Lauren Stevens trial? What was Witty’s involvement (pre CEO) with Wellbutrin? (one of the main fraudulent drugs mentioned in the original DOJ complaint?).

If anyone has any information on any of this, please contact me on my e-mail

truthman30@gmail.com

Thanks


Money: Pink Floyd

Money, get away
Get a good job with more pay and you’re okay
Money, it’s a gas
Grab that cash with both hands and make a stash
New car, caviar, four star daydream
Think I’ll buy me a football team

Money, get back
I’m all right Jack keep your hands off of my stack
Money, it’s a hit
Don’t give me that do goody good bullshit
I’m in the high-fidelity first class traveling set
And I think I need a Lear jet

Money, it’s a crime
Share it fairly but don’t take a slice of my pie
Money, so they say
Is the root of all evil today
But if you ask for a raise it’s no surprise
That they’re giving none away
Away, away, way
Away, away, away

Interesting…


BlairGSK-1

___________________________________

UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
CIVIL ACTION NO. 03-10641-RWZ
UNITED STATES OF AMERICA ex rel. Gregory Thorpe, et al.
v.
GLAXCOSMITHKLINE PLC, et al.
MEMORANDUM OF DECISION
March 6, 2015
ZOBEL, D.J.
Plaintiff Blair Hamrick brought this suit under the anti-retaliation provision of the
False Claims Act (“FCA”), 31 U.S.C. § 3730(h), for his termination from employment at
the defendant GlaxoSmithKline (“GSK”). GSK has moved for summary judgment.
I. Background
Plaintiff spills much ink recounting his long and difficult history at the company,
including various perceived and actual slights and mistreatment, all of which is
irrelevant to the present cause of action. The essential facts for this opinion follow,
taken from the undisputed record.
Blair Hamrick began work at GSK as a pharmaceutical sales representative in
Colorado in 1997. On January 30, 2002, plaintiff met with a GSK Compliance Officer to
discuss plaintiff’s allegations regarding off-label drug presentations sponsored by GSK.
Case 1:03-cv-10641-RWZ Document 197 Filed 03/06/15 Page 1 of 8
2
On October 19, 2003, Hamrick was cited for driving under the influence of
alcohol (“DUI”). On October 24, 2003, he voluntarily took a medical leave of absence
because of anxiety and symptoms of post-traumatic stress disorder. On January 22,
2004, Hamrick pled guilty to driving while alcohol impaired (“DWAI”) in connection with
the October 2003 DUI citation.
Plaintiff returned to work on January 27, 2004, in his then current position as
Senior Executive Sales Representative. On January 29, he had a call with Gail
Fletcher and Claudia Pattison, managers in the Human Resources Department (“HR”),
concerning his allegations of off-label drug presentations. On February 12, he met with
Pattison to continue discussing his concerns regarding off-label drug presentations.
During the February 12, 2004, meeting with Pattison, plaintiff expressed anger
towards his co-worker Peter Copeland, saying that he “would never do this, but …
[Peter] is lucky I don’t rip his trachea out of his throat.” Pattison was particularly
concerned about this violent ideation, as she was aware Hamrick in fact carried a gun.
On March 16, 2004, Hamrick attended a GSK conference in Dallas, Texas.
During the conference, while under the influence of prescription anti-anxiety
medications and alcohol, he made several threats of violence against GSK managers.
Three GSK employees reported plaintiff stating, and plaintiff does not dispute stating,
the following:
• “I hate this company. I’ve hated it since the merger. I’d like to take a gun
and shoot some people.”

• “[I]f there’s one thing I need from a 30-day psych leave, it’s another leave.
Case 1:03-cv-10641-RWZ Document 197 Filed 03/06/15 Page 2 of 8
3
You don’t understand, I’m obsessed with these thoughts. Let me give you
an example. I’ve been having these dreams where I am in a wrestling
match with Jerry [Nelson] and Pat [Keith] and I hit Jerry in the eye and his
eye pops out and I hit Pat and crush his windpipe.”

• “I’d like to kill [Jerry Nelson]. No, I wouldn’t have any remorse
whatsoever. I’d like to kill him.”

• “I want to kill that fucker [Pat Keith].”

• Hamrick was also reported to have said he was having dreams of
jamming his thumbs into Pat Keith’s eyes and ripping the eyeballs out.
GSK’s “Violence-Free Workplace Policy” states that
“[a]ny person who threatens, [or] exhibits threatening behavior … on [GSK]
property or at [Gsk] sponsored events will be removed from the premises
immediately, and will remain off premises pending the outcome of an
investigation. A timely investigation will be made concerning the allegations.
Should the investigation substantiate that violations of this policy have ocurred,
[GSK] will initiate a decisive and appropriate response.”
Pursuant to that policy, Hamrick was immediately placed on administrative leave with
pay pending an investigation into his statements in Dallas.
During this administrative leave, GSK became aware of Hamrick’s DUI citation
and DWAI conviction through its annual motor vehicle record check of those who, like
Hamrick, possessed company-owned vehicles. He had not reported either occurrence
to GSK, in violation of company policy.
In light of the reason for Hamrick’s leave, GSK requested he undergo a fitness
for duty (“FFD”) evaluation on April 2, 2014, with an understanding by Hamrick that
refusal to undergo the FFD would be grounds for termination. In response to this
request, Hamrick provided a letter from his own psychiatrist, Dr. Crandall, stating her
Case 1:03-cv-10641-RWZ Document 197 Filed 03/06/15 Page 3 of 8
4
opinion that Hamrick is capable of performing his job responsibilities at GSK. Doctor
Crandall had not evaluated Hamrick since his violent threats.
On April 19, plaintiff sent GSK a request for severance. On June 2, GSK
responded with a counter-offer, and on June 6, plaintiff rejected the counter-offer and
stated that he no longer wished to resign.
GSK’s then Director of HR, Bill Reedy, scheduled a meeting with Hamrick on
June 23 to discuss Hamrick’s allegations about off-label marketing and his violations of
policy (his driving offense and his threats of violence). Hamrick was informed that, per
company policy, he could be accompanied by his attorney when GSK’s attorneys were
present during the meeting, but not during the HR portion of the meeting when no GSK
attorneys would be present, which would cover his conduct issues.
On June 22, Hamrick’s attorney, Keith Cross, informed Mr. Reedy that Hamrick
would not meet with GSK without his attorney present. Due to this refusal, the meeting
was cancelled. On September 1, GSK’s outside counsel, Geoffrey Hobart, sent Cross
a letter concerning Hamrick’s refusal to meet with GSK, and explained that Hamrick
was bound by GSK’s Code of Conduct, and that “failure to fully cooperate with an
investigation of an incident that occurs in the workplace” would be a further violation of
company policy, potentially subjecting Mr. Hamrick to termination.
There followed a series of communications between counsel for the parties. On
September 3, Cross responded, setting multiple conditions and terms of any meeting
between Hamrick and GSK. On September 20, Hobart reiterated the company’s
request for an investigatory meeting and again stated that Cross could attend the
Case 1:03-cv-10641-RWZ Document 197 Filed 03/06/15 Page 4 of 8
5
portions of the meeting regarding off-label marketing but not those portions solely
concerning the HR investigation of Hamrick’s threats and unreported driving infraction.
On September 24, Cross informed Hobart that plaintiff would not meet with GSK. On
October 13, GSK informed Hamrick, through his attorney, that he had been terminated
due to his threatening and violent statements regarding GSK employees, his failure to
report his DUI citation and DWAI conviction, and his refusal to cooperate with GSK’s
investigation.
II. Standard of Review
Summary judgment is appropriate when the moving party shows that there is no
genuine dispute of material fact and the movant is entitled to judgment as a matter of
law. Fed. R. Civ. P. 56(c). In considering whether or not a genuine issue of material
fact exists, the court “must view the evidence in the light most favorable to the opposing
party.” Tolan v. Cotton,134 S. Ct. 1861, 1866 (2014). Only if “a reasonable jury,
drawing favorable inferences, could resolve [the motion] in favor of the nonmoving
party” is the dispute genuine. See Travers v. Flight Sers. & Sys., Inc., 737 F.3d 144,
146 (1st Cir. 2013).
III. Analysis
The burden in this case is on the plaintiff to show (i) that he was engaged in
conduct protected under the FCA; (ii) the employer had knowledge of this conduct; and
(iii) the employer retaliated against the employee because of this conduct.” Harrington
v. Aggregate Indus. Ne. Region, Inc., 668 F.3d 25, 31 (1st Cir. 2012). Once this prima
facie showing is made, the burden shifts to the employer to provide a legitimate, non-
Case 1:03-cv-10641-RWZ Document 197 Filed 03/06/15 Page 5 of 8
6
retaliatory reason for the adverse employment action. When the employer provides
such a reason, it is the plaintiff’s burden to raise a jury question as to whether the
reason provided is merely “a pretext calculated to mask retaliation.” Id.
The standard for this case is laid out in the First Circuit’s decision in Travers v.
Flight Services & Systems, Inc., 737 F.3d 144 (1st Cir. 2013). In Travers, the First
Circuit reversed a trial court’s grant of summary judgment in an employment retaliation
case:
“[T]he applicable standard requires “but-for” causation. … [Plaintiff]’s
claim would fail if [defendant] would have fired him absent retaliatory
animus. And [defendant] also correctly reasons that the evidence here
would allow a reasonable jury to conclude that [defendant] would have
fired [plaintiff] … even if he had never [engaged in protected activity]. On
… summary judgment … , however, the question is not whether a
reasonable jury could find that [defendant] would have fired
[plaintiff] even in the absence of retaliatory intent. Rather, the
question pertinent to our review of summary judgment is whether no
reasonable jury could find otherwise.”
Travers, 737 F.3d at 148 (emphasis added).
There is no dispute that Hamrick was engaged in protected activity and that GSK
was aware of that activity from as early as 2002. The decision to terminate Hamrick
came only shortly after implicit confirmation to GSK that he was, in fact, a qui tam
relator. This temporal proximity is, perhaps, sufficient to give an inference of animus,
so I assume, without deciding, that plaintiff’s prima facie burden was met.
Defendant provides a substantial non-retaliatory basis for its decision to
terminate Hamrick, linked to three main things. First, the company cites Hamrick’s
erratic behavior and verbal threats made before and during a company retreat in March
Case 1:03-cv-10641-RWZ Document 197 Filed 03/06/15 Page 6 of 8
7
2004. Second, it points out Hamrick’s failure to disclose to the company his conviction
of DWAI, in contravention of company policy requiring its disclosure. Third, GSK notes
that company policy requires the termination of employees who refuse to cooperate
with internal investigations, and defendant’s refusal to fully comply with GSK’s
investigation into his erratic behavior and fitness for duty, by setting conditions to his
meeting with the company. These events, taken together, are more than enough to
shift the burden back to plaintiff.
The remaining question is whether plaintiff can point to sufficient evidence to
allow a reasonable jury to find that, but for his protected whistleblowing activity, he
would not have been terminated. Plaintiff is right that he may, to some extent, rely on
timing-driven inference to make out his case for retaliation to a jury. See Harrington,
668 F.3d at 33 (the “sequence of occurrences leading up to a challenged decision, and
close temporal proximity between relevant events” can “give rise to an inference of
pretext.”). However, other than a generic pattern of alleged mistreatment, going back
several years and attributable to many causes unrelated to his protected activity,
plaintiff has produced no evidence whatsoever, other than the loose temporal
inference, to support his allegation of retaliatory firing. In the face of the overwhelming
and largely undisputed evidence of defendant’s serious misconduct immediately
preceding the termination of his employment, he has failed to produce any evidence to
create a genuine issue of material fact, i.e., to provide a basis for a reasonable jury to
conclude that, but for his whistleblowing, he would not have been terminated.
IV. Conclusion
Defendant’s motion for summary judgment is ALLOWED.
Judgment may be entered for the defendant.
Case 1:03-cv-10641-RWZ Document 197 Filed 03/06/15 Page 7 of 8
8
March 6, 2015 /s/Rya W. Zobel
DATE RYA W. ZOBEL
UNITED STATES DISTRICT JUDGE
Case 1:03-cv-10641-RWZ Document 197 Filed 03/06/15 Page 8 of 8

Murder-Suicide Again In Ireland: What Did They Prescribe Michael Greaney?


A psychiatrist’s report said it would be safe to allow him back to the family home, subject to his being on whatever medication and receiving any psychiatric attention he needed.” 


 

Which psychiatric medication was Micheal Greaney prescribed? What dose? And why was he, or his family, not warned of the dangers?


“They expressed fears that the glass of wine may have reacted with his medication to drastically alter his mood.” (Evening Herald 30/12/2014)

It looks like there had been another murder-suicide in Ireland, and this case, like the many others, in Ireland and world-wide, it seems likely that it’s linked to psychiatric medication. It has been well established that psychiatric medication can cause hostility, aggression, suicidal thoughts and homicidal impulses. These effects are now listed in patient information leaflets, however many people are still in the dark about these dangerous side effects and withdrawal symptoms. I felt these side effects on GSK’s Seroxat drug, an SSRI which is notorious for causing suicide, violence, and sometimes murder/suicides. I wonder was  Michael Greaney’s family warned of these side effects, and particularly the dangers of mixing psychiatric meds with alcohol. Irish psychiatrist, Dr David Healy, has been warning of these lethal dangers of psych-drugs for decades, and Irish state pathologist, Declan Gilsenan has also spoken out on what he said were “too many suicides linked to these drugs.” Many other psychiatrists, psychologists, social workers, researchers, and in particular (ex) psych service users, have also been calling for wider warnings on psychiatric drugs for years now…

Dr Gilsenan, who retired last year, says he has seen “too many suicides” among people who had started taking the drugs. In his considered view the evidence was “more than anecdotal” and he now hopes to raise the matter with Kathleen Lynch, minister of

state with responsibility for mental health.”

 I hope the Greaney family find peace. RIP.


http://www.irishtimes.com/news/ireland/irish-news/garda%C3%AD-not-seeking-anyone-else-in-connection-with-cobh-deaths-1.2050009

Gardaí have said they are not looking for anyone else in connection with an incident in which a man was found dead, his wife stabbed to death and their 21-year-old daughter left critically injured.

The bodies of Michael Greaney (53) and his wife, Valerie (49), were discovered in their house at O’Neill Place in Cobh, Co Cork, and their eldest daughter, Michelle, was lying in the road after fleeing the house.

Mr Greaney had returned to the family home in recent weeks after being discharged from the Central Mental Hospital in Dublin in November.


http://www.dailymail.co.uk/news/article-2889928/Triple-stabbing-horror-bishop-s-gardener-kills-wife-leaves-daughter-21-fighting-life-knifing-death.html

A businessman is believed to have fatally stabbed his wife and left his daughter fighting for her life before knifing himself to death - just months after he was released from a mental hospital.

Michael Greaney, 53, who had a history of ‘serious’ mental issues, stabbed his daughter Michelle, 21, in the chest before killing his wife Valerie, 49, at their home in Cork, reports suggest.

The physical therapist was admitted to the Central Mental Hospital in 2013 after being found guilty of assaulting and falsely imprisoning a woman and a barring order was put in place.

But the order was removed at the request of the family after his wife pleaded on his behalf saying he had been under tremendous financial and psychological pressure at the time.

http://www.herald.ie/news/killer-dad-had-drink-with-pal-before-murdersuicide-30869234.html

“He seemed to be in quite good form coming up to Christmas. I think his friend just wanted to wish him well for Christmas over a quick drink,” a former Irish Navy colleague of Mr Greaney’s told the Herald.

They expressed fears that the glass of wine may have reacted with his medication to drastically alter his mood.

2014-12-30_new_5779579_I1

Mass Murderers and Psychiatric Drugs
by PHIL on SEPTEMBER 22, 2014323
0
There’s an interesting article in the current issue of the National Psychologist written by David Kirschner, PhD, a New York psychologist.  The National Psychologist is a newspaper-type magazine that publishes articles of general interest to psychologists and others working in this field.  Most issues contain a mix of opinion pieces, news, changes in government regulations, etc…

Dr. Kirschner’s article is titled Mass shooters received only limited treatment.

Here are some quotes:

“As a forensic psychologist, I have tested/evaluated 30 teenage and young adult murderers, and almost all of them had been in some kind of ‘treatment,’ usually short term and psychoactive drug-oriented, before they killed.”

“After each episode of school killings or other mass shootings, such as the Aurora, Colo., Batman movie murders and Tucson, Ariz., killing of six and wounding of Rep. Gabrielle Giffords and 12 others, there is a renewed public outcry for early identification and treatment of youths at risk for violence.

Sadly however, most of the young people who kill had been in ‘treatment,’ prior to the violence, albeit with less than successful results.”

“Most of the young murderers I have personally examined had…been in ‘treatment’ and were using prescribed stimulant/amphetamine type drugs before and during the killing events. These medications did not prevent but instead contributed to the violence by disinhibiting normal, frontal cortex control mechanisms.”

“Prior to the violent event, for which he is currently serving a life without parole sentence, Jeremy [Strolmeyer], an honor student with no history of violence, was misdiagnosed with attention deficit hyperactivity disorder (ADHD) and ‘treated’ with nothing more than a bottle of Dexedrine following a brief 20-minute ‘cost-effective’ psychiatric consultation.”

“And so, despite ongoing congressional debates regarding stricter gun control laws vs. improved access to mental health treatment, our concern should be about the quality of mental health care, not just a societal safety net insuring treatment for all children and young adults. Almost all of them are covered by some type of managed care or insurance company, and the issue is not access to preventive treatment. The real problem, in my opinion, is the quality and competence of therapy for potential violent offenders when insurance companies are the gatekeepers.”

Obviously it’s a compelling article, particularly Dr. Kirschner’s assertion that “almost all” 30 young murderers he has worked with had been in some kind of treatment and had been taking psychiatric drugs.  Dr. Kirschner’s call for more competent and more intensive therapy makes sense, but as long as the mental health system is dominated by psychiatrists and psychiatric dogma, it is likely that psychiatric drugs will continue to be the essential ingredient of these interventions.  And as long as this is the case, all that we can reasonably expect is more of the same.

Dr. Kirschner’s comments are, of course, anecdotal. But there is an ever-growing body of anecdotal information implicating psychiatric drugs in mass killings and suicides. There is a desperate need for a formal study of this matter, but calls for such studies have been routinely ignored and resisted.

In December 2012, a petition on the White House “We the People” website calling for the government to initiate such an investigation was removed without explanation, even though it was well on the way to receiving the requisite number of signatures.

And let us not forget what Patrick B. Kwanashie, Assistant Attorney General for the State of Connecticut, said on this matter on August 22, 2013 when he was pressed in a freedom of information meeting to release Adam Lanza’s history of psychiatric drug use.

“…you have to advance reasons that you actually do have a real interest in the…medical records.  The plaintiff, the complainant have not shown any such interest.  The complainant is proposing that they can make generalizations, generalized from one single incident, no matter how the outcome of the use of antidepressants, or the causal link between the use of antidepressants and the kind of violence that took place in Newtown.  You just can’t, that’s not a legitimate use of that information.  You can’t generalize just from one case.  Even if you can conclusively establish that Adam Lanza’s murderous actions were caused by antidepressants, you can’t logically from that conclude that others would commit the same actions as a result of taking antidepressants.  So it’s simply not legitimate, and not only is it not the use to which they are proposing to put the information not legitimate, it is harmful, because you can cause a lot of people to stop taking their medications, stop cooperating with their treating physicians, just because of the heinousness of what Adam Lanza did.  As the material, the FDA material that they submitted show, it would take a lot of studies over a long period of time and among, and within various demographic groups to even begin to establish causal links between antidepressants and aggressive actions or suicidal behavior.  And the informed opinion has not quite reached the point to say definitively that there’s a causal link between the use of antidepressants and violent behavior.  Having correlations, there are correlations, but to say there are correlations doesn’t necessarily mean the relationship is causal.  And this is an issue the FDA is still grappling with, and so far it’s been willing to do is ask the drug makers to put warnings on their products and to advise physicians, treating physicians, to follow monitor their patients closely at the beginning of the taking of antidepressants.  So it’s a complex issue, and to pretend that you can just, based on this one case, make recommendations as to how people should make judgment choices is a disservice to the public and illustrates why these types of reports should not be made available, because in the wrong hands they can be the source of mischief.” [Emphasis added]

In other words, psychiatric drugs are safe until proven dangerous.  And, apparently, the only acceptable evidence is a large scale, randomized, controlled trial.  But the only group who has the data and the resources to conduct such a trial is psychiatry-pharma!  And meanwhile we should cover up any anecdotal information that might cast the drugs in a bad light – because that might induce people to stop taking them!

Psychiatric drugs are not medications in any meaningful sense of the term. Whatever temporary lift they may give people in the short term, is offset by their adverse effects – particularly their contribution to suicides and murder.

Information on this issue is being spun and suppressed by psychiatrists, and by their moneyed collaborators in pharma.  How much longer must this destructive charade continue?

Last updated by Phil at September 21, 2014.

Related posts:

The Link Between Psychiatric Drugs and Violence
Psychiatric Drugs and Suicide
Mass Murders and Mental Health
Another Mass Shooting: Link to SSRIs?
Opposition to Psychiatric Drugs is Fuelled by Puritanism!

Save The Children, GSK And The Non Child-Friendly Seroxat Pill


The company they keep

     

December 2014

Ian Brown on the love-in between the big charities and transnational corporations.

– See more at: http://newint.org/features/2014/12/01/charities-and-transnationals/#sthash.4zxbMuAJ.dpuf

http://newint.org/features/2014/12/01/charities-and-transnationals/

 Save the Children’s message couldn’t be clearer: ‘Teaming up with Save the Children to market a new or existing product could boost your sales, profile and customer base.’

But do such partnerships offer the win-win solution claimed by the NGOs and their corporate funders, or are there losers? Does Erinch Sahan, an Oxfam private-sector adviser, have a point when he blogs: ‘I want to believe that pursuing profits will result in a sustainable world and the end of poverty’? One such partnership involves Save the Children and pharmaceuticals giant GlaxoSmithKline (GSK). Since 2011 Save the Children has benefited from GSK’s initiative to reinvest 20 per cent of the profits it makes in the world’s least developed countries (a fraction of its global $7.5 billion profit in 2013) back into projects which strengthen healthcare infrastructure and support the research and development of child-friendly medicines. Save the Children’s website claims a million children will be helped as a result of a ‘ground-breaking’ deal signed with GSK to improve children’s health in some of the poorest countries of Africa.

‘Teaming up with Save the Children to market a product could boost your sales, profile and customer base’ – Save the Children’s assurance to potential corporate partners

No mention on Save the Children’s website, however, of one of GSK’s less child-friendly products – the antidepressant Paxil (Seroxat/paroxetine).

In 2012 the company was fined $3 billion by the US government after pleading guilty to criminal charges, including bribing doctors and encouraging the prescription of Paxil to children, even though the drug was unsuitable and unapproved for this use.2

We would never refrain from speaking out on an issue because we had a partnership with a particular company. That would clearly compromise our values,’ claims Save the Children.

When contacted for a response, it admitted it was ‘aware of reports on the historic issues relating to Paxil… but our belief is that the risks are outweighed by the benefits of the partnership.’3

– See more at: http://newint.org/features/2014/12/01/charities-and-transnationals/#sthash.9szBC5bZ.dpuf