Tagged: Wendy

Should A Proven Felon And Criminal (GSK) Have Any Credibility At All In A Court Of Law?…


Think about it..

Would you trust the word of a convicted felon and fraudster? one that had to pay the department of justice 3 Billion dollars for fraud, bribery and ‘harm to patients’ offenses dating back many years? Would you trust the word of a sociopathic organization like this? It would be absurd to afford GSK any credibility in trustworthiness and truth wouldn’t it?

See Whistle-Blower Greg Thorpe’s hair raising legal complaint about GSK here-

https://truthman30.wordpress.com/2015/08/28/whistleblower-greg-thorpes-7th-ammended-complaint/


 

https://www.law360.com/articles/950287/reed-smith-atty-s-doctor-knew-of-suicide-risk-gsk-says

 

Reed Smith Atty’s Doctor Knew Of Suicide Risk, GSK Says

Law360, New York (August 1, 2017, 10:12 PM EDT) — GlaxoSmithKline pressed an Illinois federal court Monday to undo a $3 million verdict in favor of the widow of a Reed Smith LLP lawyer who committed suicide after taking generic Paxil, saying the prescribing doctor’s knowledge of the risks relieved the drugmaker of responsibility.
Wendy Dolin sued GSK in 2012, two years after her husband Stewart stepped in front of a train in downtown Chicago. Stewart Dolin had struggled with anxiety and depression off and on, and began taking paroxetine just a few days before his death. A jury this spring awarded $2 million for wrongful death and $1 million for pain and suffering in the days before he took his life.

Glaxo’s new brief elaborates on earlier arguments it has made in favor of a new trial, after Wendy Dolin urged against the move in recent weeks. The drugmaker said that the trial testimony of Stewart Dolin’s prescribing doctor revealed that he believed paroxetine could increase Dolin’s suicidality. Via the learned-intermediary doctrine, Glaxo said, that would mean it had washed its hands of the matter.

“Plaintiff fails to identify a single Illinois decision holding that a manufacturer can be held liable for failure to warn” in a suit like this, the company said.

The trial testimony of prescribing doctor Martin Sachman “shows that he was aware of the very risk that mattered to him when deciding to prescribe paroxetine for Mr. Dolin.”

GSK included an excerpt of his questioning where he was asked, “When you reinitiated paroxetine for Mr. Dolin in 2010, you went over with him the fact that he needed to be on the [lookout] for the signs and symptoms of agitation, increased restlessness or insomnia, panic attacks, worsening depression, or suicidal thoughts or behavior after he started the medication?”

Sachman replied, “Right.”

The company pushed back against Wendy Dolin’s claim that the risk Sachman was saying he was aware of was the obvious depression-related suicide risk, not a medication-related risk; Dolin “selectively cites” Sachman’s testimony to reach that conclusion, the drugmaker said, and didn’t try to push back against Sachman’s agreement that he didn’t realize that a 2006 label that warned him properly about what happened to Dolin was later changed before Dolin’s death.

GSK also said its hands were tied because drug regulators would not allow the company to use the specific warning language that it wanted. The label for the drug changed more than once between 2006 and 2010 as the U.S. Food and Drug Administration examined it.

And the company also took issue with a myriad of jury instructions that it says didn’t fully separate out different elements necessary for liability.

According to Wendy Dolin, the doctor testified that when he decided to prescribe the drug he relied on the 2010 Paxil label, which didn’t warn that Paxil could lead to suicidality in adults over 24. The doctor also testified that if GSK had warned of that risk, he wouldn’t have prescribed paroxetine to Dolin in 2010, Wendy Dolin said.

But Dolin says GSK never proposed her desired warning: A short statement that taking Paxil is associated with suicidality in adults over 24. “Since GSK never attempted to insert that simple warning anywhere into the Paxil label, GSK cannot meet its burden of providing ‘clear evidence’ that the FDA would have rejected such a labeling change, especially when the only FDA expert to testify at trial rejected that notion,” Dolin said.

Dolin argued the company had failed to alert drug regulators that research showed increased suicide risk in adults. With a short exception, the potential for suicide in adults was left off, and doctors were left uninformed, the suit said.

The FDA also invited GSK to discuss the inclusion of language specific to adult suicidality in the label at a formal meeting in 2007, but the company didn’t take the agency up on its offer, Dolin said.

Representatives for the parties were not immediately available for comment Tuesday.

Wendy Dolin is represented by R. Brent Wisner, Michael Baum, Bijan Esfandiari and Frances Phares of Baum Hedlund Aristei & Goldman PC, and David Rapoport and Matthew Sims of Rapoport Law Offices PC.

GSK is represented by Andrew Bayman, Todd Davis, Ursula Henninger and Heather Howard of King & Spalding LLP and Alan Gilbert and Anders Wick of Dentons.

The case is Dolin v. SmithKline Beecham Corp. et al., case number 1:12-cv-06403, in the U.S. District Court for the Northern District of Illinois.

–Additional reporting by Emily Field. Editing by Brian Baresch.

Stewart Dolin’s Paroxetine Induced Suicide..


Despite tens of thousands of reports of SSRI induced suicidal thoughts, behaviours and completed acts over the decades, GSK are still trying to deny the reality of Seroxat/Paxil (Paroxetine) induced suicides..

Paroxetine is a killer drug….

I hope that Wendy Dolin wipes the floor with GSK (and their sociopathic lawyers) in court…


http://missd.co/wp-content/uploads/2016/07/DOLINLAW360Catch-22.topostpdf.pdf

Screen Shot 2016-07-24 at 23.40.38.png

On a muggy evening, Wendy Dolin was walking her dog a month after the bewildering suicide of her husband, the former Reed Smith partner Stewart Dolin, when a friend accompanying her uttered a strange word suggesting an explanation: akathisia. Looking up the condition online that night in 2010, Dolin was stunned by how closely its symptoms of intense restlessness and anxiety seemed to match her husband’s puzzling behavior in the days before he took his life by jumping on the tracks of an O’Hare airport- bound Blue Line train in Chicago.

The name of the condition, more familiar to neuropsychiatry professionals and pharmaceutical injury lawyers than to Wendy Dolin, a licensed clinical social worker in Illinois, shone to her through the fog of an inexplicable act by a man she had known for 42 years. He had seemed his usual self until just days before the incident, she said, when he had begun taking paroxetine, the generic version of the antidepressant Paxil.

Stewart Dolin

He became so distressed soon after going on the medication that he pled to her one night that week in July: “I don’t get it, Wendy. I still feel so anxious,” she recalled.

After poring over internet search results about lawsuits that alleged that akathisia was a known side effect of Paxil, which belongs to a class of antidepressants called selective serotonin reuptake inhibitors, Dolin decided on a seemingly improbable course of action. She would sue the drugmakers responsible for the manufacturing and labeling of Paxil, a drug whose generic version her husband had taken for only six days before his death.

“I’d got home that night and Googled akathisia, Paxil, and suicide, and lo and behold, all this information pops up,” Dolin said, referring to search results of papers published in psychiatry journals and litigation summaries on law firm websites.

“It was completely clear — all of us were looking through our emails and notes from him and there was no clue, nothing, that it could have been something else,” she said.

Baum Hedlund Aristei & Goldman PC, a small personal injury firm based in Los Angeles, had been litigating wrongful death and injury suits involving suicides and suicide attempts related to antidepressants for about 20 years when Dolin contacted it in 2010 to take on her mission. Nearly two years later, the firm filed her negligence and wrongful death suit against Mylan Inc., the Netherlands- based generic-drug maker that manufactured the drug her husband was taking, and GlaxoSmithKline, which sold the drug’s branded versions and devised its labels, as the U.S. Food and Drug Administration requires.

The timing of her suit was inopportune for a plaintiff alleging an injury from a generic drug. The U.S. Supreme Court had just issued a landmark decision in 2011 in Pliva v. Mensing that shielded generic- drug makers from claims about their labeling of drug side effects and contraindications because FDA rules require them to follow the same warning language of their branded counterparts. Meanwhile, dozens of courts around the country were taking cues from a 1994 decision by the Fourth Circuit in Foster v. American Home Products Corp., which had found that although branded-drug makers are responsible for the labeling of their products, they don’t have a duty to warn patients taking generic versions of their drug.

The mountain of unfavorable case law had threatened to nip Dolin’s suit in its early pleading stages. Instead, she prevailed through multiple summary judgment motions by GSK — although the Mensing decision did jettison Mylan from her suit — as her lawyers strategized to counter the difficult precedent and found a willing ear in the Illinois federal judge overseeing the suit, James Zagel. Guided by the handful of courts before him to find branded-drug makers could be held liable under other tort theories besides strict product liability, he issued a surprising endorsement of Baum Hedlund’s arguments in the Dolin case, finding in February 2014 that GSK could be held liable for common law negligence claims.

Judge Zagel found that, unlike some other states, Illinois common law did not compel him to treat all claims stemming from a product injury as product liability claims.

“The injury here did indeed occur in connection with a product. And GSK manufactures products,” he wrote in his ruling. “Yet Plaintiff has not brought suit against GSK for tortious conduct committed strictly

The idea that in this country, so many people take generics and that they have no legal recourse, it’s just unthinkable.

— Wendy Dolin

as a manufacturer of products. And, though GSK implicitly urges to the contrary, I see no reason why all suits brought against GSK must be brought against GSK qua manufacturer.”

Under his watch, the case is set to proceed to a monthlong trial in January, and it will be the first to involve a suicide allegedly caused by a generic antidepressant, and the first to test whether a jury would actually hold a branded-drug maker liable for a generic-drug injury. Many of the earlier suits filed over suicides allegedly linked to generic antidepressants have either settled or been dismissed.

Wendy Dolin with her husband Stewart on a 2007 vacation in Aspen, Colorado.

If Dolin prevails, the stakes will be high for generic-drug patients across the country. Her attorneys believe it would likely set the stage for the Seventh Circuit to address the issue for the first time in the event of a GSK appeal. In that scenario, the question before the court would be whether branded-drug makers can be held liable for injuries caused by generic-equivalent drugs that they did not themselves make. If the Seventh Circuit were to answer the question differently from the few other federal appeals courts that have done so — the Fourth and Sixth circuits have ruled against the idea that a branded-drug maker could be liable for a generic-drug injury — the suit could very well wend its way up to the nation’s highest court.

“The idea that in this country, so many people take generics and that they have no legal recourse, it’s just unthinkable,” Dolin said. “I’d love this case to be the one that says, ‘This is no longer acceptable.’”

The Paradox of Litigating Over Generics

Generic drugs account for roughly 80 percent of all prescription drugs dispensed in the U.S., according to the FDA. Their prevalence is due in part to their cost, which can be as low as a tenth of the price of their branded equivalent. In 2010, the use of generic drugs saved the U.S. health care system roughly $158

billion, according to an estimate by the generic-drug trade group the Generic Pharmaceutical Association, which the FDA cites on its website.

Those savings often interact with state laws in ways that ensure the widespread use of generics. A number of states have laws that encourage pharmacists to choose cheaper equivalents to a brand name prescription, unless a prescribing doctor includes explicit instructions not to do so. Such is the case in Illinois, where state pharmaceutical laws actually require such a substitution unless a doctor has advised against it. Some of the few courts that have sided with plaintiffs in generic-drug injury cases have also highlighted this conundrum for generic-drug plaintiffs.

The Alabama Supreme Court, the highest state court in the country to address the issue of whether a branded-drug maker can be held liable for a generic-drug injury
— and one of the few to answer it in the affirmative —
emphasized those implications in a 2014 ruling.

“Additionally, many insurance plans are structured to promote the use of generic drugs,” the court wrote in the decision. Dolin’s own health insurance plan covers only generics, she said. The Alabama Supreme Court ruling, however, which came in the then-groundbreaking case Weeks v. Wyeth, has since been negated by a 2015 law by the state Legislature that rejects the notion that a branded-drug maker can be held liable for a generic drug.

The unique position of generics has a relatively recent history. The Federal Food Drug and Cosmetics Act once required all drugmakers to show that their drugs were safe and properly labeled before the agency would approve them. Then the 1984 Hatch-Waxman amendments to the FDCA sought to simplify the process for generic-drug makers, in order to expand affordable treatment options for patients. The amendments allowed generic-drug makers to sidestep requirements to conduct clinical trials to show the drugs’ safety and effectiveness, but it required them to show that they have followed the formulation and labeling of branded counterparts that have already undergone such trials.

Consumer advocates believe that such requirements have
created a significant gap in protecting patients for injuries they
may have sustained because of inadequate warnings, while protecting generic-drug makers from most liability claims involving their products. Public Citizen, the consumer advocacy group that petitioned the FDA in 2011 for the agency to allow generics to independently go about making changes to their labels, holds that view.

“A majority of prescriptions are filled with generic drugs because it makes health care more affordable, but when the drug doesn’t have adequate warnings on it, then physicians and patients can’t make proper decisions,” said Allison Zieve, the director of Public Citizen’s litigation group.

“Brand name manufacturers are required to update their labeling when they become aware of new information of drug risks, but once a generic is on the market, the market share for the branded version drops very quickly, and the brand name often stops selling the drug altogether,” she said. “There’s nobody under the current regime monitoring the drug to make sure that labels are updated.”

But the U.S. Supreme Court cited the Hatch-Waxman Act in cementing the protections for generic-drug makers in its 2011 Mensing decision. That case involved claims by Gladys Mensing and Julie Demahy, plaintiffs from Minnesota and Louisiana, respectively, that their long-term use of a generic version of the heartburn drug Reglan sold by drugmakers including Pliva caused them to develop tardive dyskinesia, a neurological condition that causes involuntary movements such as uncontrollable twitching or blinking.

The court found in its ruling that generic-drug makers cannot satisfy state law requirements to strengthen their warnings when they are already required by
federal law to match branded-drug labels.

In 2013, the Supreme Court expanded these protections further in Mutual Pharmaceutical Co. Inc. v. Karen Bartlett, largely blocking design defect claims by citing, among other factors, “Congress’ decision to regulate the manufacture and sale of generic drugs in a way that reduces their cost to patients but leaves generic-drug manufacturers incapable of modifying either the drugs’ compositions or their warnings.”

The Dolin Litigation

It was around the time of this flurry of major precedent against generic-drug plaintiffs in the courtroom that Brent Wisner of Baum Hedlund, then an associate at the firm in its San Francisco office, took on Dolin’s suit in 2012, his first case as a practicing attorney.

The suit faced hurdles not only because of the Mensing decision and the eventual Bartlett decision but also because of the sweeping influence of the Fourth Circuit’s Foster ruling, which had barred just the type of allegations that Dolin was making, he said.

Dolin’s suit claimed her husband had killed himself after exhibiting
uncharacteristically high anxiety within days of taking generic Paxil,
which had been prescribed to him by his family doctor and friend
of 20 years, Dr. Martin Sachman. GSK’s warning label, which the generic version’s maker, Mylan, was required to follow, had misled patients and doctors, she claimed. It did not sufficiently warn that akathisia, which according to her complaint is marked by “profound inner restlessness and agitation,” could give rise to suicidal tendencies, she said. GSK has argued that the 2010 labels for Paxil contained warnings about akathisia that said the condition was “most likely to occur during the first few weeks of treatment.” Dolin insists that GSK did not connect the dots clearly enough between akathisia and suicide or sufficiently note the incidence of such risks in adults.

Her suit also claimed that although GSK apparently knew of a statistically significant risk of suicidal behavior in adults taking the medication — roughly 6.7 times higher compared with patients on a placebo — the drug’s label concealed that risk by claiming that “the suicidality risk did not extend past the age of 24.” GSK has said that this language was ordered by the FDA as part of its warnings on all SSRIs that “short term studies” of antidepressants did not show such risks of suicidal behavior.

The Fourth Circuit’s ruling in the Foster case involved the death of a six-week-old infant who had been given a generic version of a colic medication called Promethazine Syrup Plain. The appeals court squarely rejected the notion that a brand-name pharmaceutical
could be held liable for negligent misrepresentation claims in that

instance. But in the pre-Mensing era of that ruling, the court had found that generic drugs were responsible for their own labeling, emphasizing the benefits they enjoyed because of the Hatch- Waxman amendments allowing them to circumvent expensive clinical trials.

“Name brand manufacturers undertake the expense of developing pioneer drugs, performing the studies necessary to obtain premarketing approval, and formulating labeling information,” the panel wrote. “Generic manufacturers avoid these expenses by duplicating successful pioneer drugs and their labels.”

At the time Wisner prepared to fight motions by Mylan and GSK challenging the viability of Dolin’s case, some 70 other courts had more or less adopted the Fourth Circuit’s view in Foster, according to court documents.

“Coming out of law school you want to deal with complicated legal issues,” said Wisner, who had just graduated with his law degree from the Georgetown University Law Center in 2010. “But I had a lot of people telling me I had no chance to prevail.”

I had a lot of people telling me I had no chance to prevail.

— Brent Wisner, Wendy Dolin’s attorney

So he hatched a plan. Anticipating that Mylan and GSK would seek to quickly dispose of his claims, he approached them in February 2013 with a calculated compromise. He would agree to put discovery on hold while the parties addressed questions of whether Dolin’s claims were preempted or not viable, but in exchange, Mylan and GSK would have to file their motions challenging her claims roughly at the same time.

That way, Wisner reasoned, he could address both defendants’ motions in a single opposition, creating a path for the judge to issue a cohesive response addressing the arguments of both defendants in the same opinion. Mylan filed its motion to dismiss in August 2012, citing the Mensing ruling. GSK followed suit with its summary judgment motion in January 2013, arguing that there was “virtual unanimity” among the numerous courts to consider this question and that they had rejected the kind of misrepresentation theories that Dolin was advancing. The drugmaker also argued that Illinois product liability laws require claims related to injuries caused by a product be brought against the company that actually manufactured it.

“Regardless of how plaintiff couches her claims, they are all barred under Illinois law because GSK did not manufacture, distribute or sell the immediate-release paroxetine that allegedly caused Mr. Dolin’s death,” it argued. “Without this fundamental predicate, Plaintiff cannot establish the necessary elements of her claims.”

Wisner believed his approach could nudge Judge Zagel to make a more comprehensive analysis about whether case and state laws truly end up leaving most generics plaintiffs with no legal recourse for alleged injuries.

“I wanted him to be ruling on the ability of my client to get any sort of justice,” Wisner said. “My thinking was, when you consider both of these issues together — innovator and generic immunity — it is easy to see how unfair the law has become.”

Judge Zagel took the cue and found in his now-renowned ruling in February 2014 that Illinois law doesn’t call for common law negligence claims to be treated like product liability claims just because the suit involves a product and an alleged injury it caused.

“GSK vigorously contends that the design and warning label are not in themselves ‘products,’” Judge Zagel wrote. “[But] GSK has not shown why Plaintiff should be precluded from claiming at common law that GSK, independent of its capacity as a manufacturer of one particular iteration of paroxetine, was negligent in connection with its responsibility for these ‘non-products,’ and that this negligence contributed to her injury.”

The ruling was a breakthrough for Dolin, too. “The phone rings [that day], and Brent [Wisner] says, ‘I think you just sorta made history here,’” she said.

The Trial

The Dolin trial is set to boil down to a few crucial questions for the jury, foremost of which is whether the drug Paxil, which the FDA first approved in 1992, causes suicidal tendencies in adults. Dolin’s experts, who are expected to testify on this issue of general causation, have so far withstood GSK’s challenges.

 

Among them is Dr. Joseph Glenmullen, a psychiatry professor at the Harvard Medical School who has written two books about antidepressant side effects. In a 2007 report to Baum Hedlund, unsealed in a different case over Paxil in Kansas state court, Glenmullen argued that GSK’s own data to the FDA in 1989 showed a substantial increase in risk of suicidal tendencies in patients on Paxil compared to those on placebo pills but that the drugmaker underreported or downplayed such risks to regulators.

It was only in 2006 that the company acknowledged in a so-called Dear Health Care Provider letter, which is meant to inform doctors of updated safety information, that Paxil could increase the risk of suicidal tendencies in certain patients by about six times as compared with a placebo, according to his report. That year, GSK modified its label to warn that it had found Paxil posed a “statistically significant” increase in the frequency of suicidal behavior in adult patients with major depressive disorder. This language made way for the FDA’s classwide labeling for all SSRIs the following year that would update all black box warnings — the agency’s most serious safety warnings — on the drug. The classwide label would warn patients and consumers only about increased suicidal tendencies among young patients aged 18 to 24.

In 2011, Wendy Dolin founded a nonprofit dedicated to spreading awareness of akathisia titled MISSD, shorthand for “the Medication-Induced Suicide Prevention and Education Foundation in Memory of Stewart Dolin.”

Glenmullen’s report, along with a similar one that followed the same year by the British drug safety regulator finding GSK knew of such risks in adolescent patients since 1998, prompted Iowa Republican Senator Chuck Grassley to urge the FDA in June 2008 to determine if the drugmaker had suppressed any safety information when it sought approval for the drug.

Glenmullen has maintained his position in the Dolin case, in which he has testified that taking paroxetine was a “proximate cause” in Stewart Dolin’s suicide. GSK sought to exclude his testimony in September, arguing that Glenmullen had not shown any idea linking Paxil to suicides, only to suicide attempts, which the drugmaker argued was not an adequate substitute.

Judge Zagel denied such motions in November, finding that Dolin’s experts had offered “reliable” testimony.

Dolin’s experts also include Dr. David Healy, a psychiatry professor at the University of Wales in England. Healy, who has worked as an expert witness for Baum Hedlund for years in lawsuits involving antidepressants, has stated in the case so far that GSK’s own labeling documents from 2006, including letters to physicians, had acknowledged that “the frequency of suicidal behavior was higher in patients treated with paroxetine compared with placebo … this difference is statistically significant.”

If the jury agrees on that question of general causation, it would then have to decide whether GSK adequately warned of the risk. If it decides the warnings were insufficient, the jury would then have to consider whether the failure to warn led to the suicide — that is, whether better warnings would have led Dr. Martin Sachman to prescribe a different treatment.

Baum Hedlund has also enlisted former FDA physician David Ross to testify on the regulatory history between GSK and the FDA and what data the drugmaker shared with the agency.

One of the key points of contention is whether GSK did its thorough due diligence to make sure its labels contained warnings specific to Paxil’s potentially increased risk for suicidal tendencies — the FDA’s own analysis found a 2.76 times higher risk for patients taking paroxetine.

Although GSK had asked the FDA about adding Paxil-specific warnings to the agency’s classwide warnings in 2007 in order to alert doctors and patients about the drug’s potential to cause suicidal tendencies in adults, it did not follow through with the agency’s invitation to ask for a formal meeting to discuss that change, Dolin has argued.

GSK has dismissed this argument as mere “conjecture about a meeting that did not take place,” countering that it had submitted two different sets of documents to the FDA under its Changes Being Effected program, which allows branded-drug makers to update their labels based on new information. Each time, GSK said, it sought to retain warnings specific to Paxil on its label, but it received a rejection by the agency, according to its filings.

Defense attorneys believe GSK’s argument could offer an important window for the drugmaker to persuade the jury that even if it had actually called for such a meeting, the FDA would likely not have approved it.

“Both Judge Zagel and Dolin have said here, ‘You could have had that meeting, so you haven’t exhausted all your options to show that the FDA couldn’t be convinced otherwise,” said Henninger Bullock of Mayer Brown LLP, who has represented branded-drug makers in similar suits. “But GSK can say: ‘Well, we tried, and the FDA told me twice already that I couldn’t modify the classwide label, so to request a meeting would be futile.’”

A spokeswoman for the FDA declined to comment on pending litigation.

Besides experts, Dolin and her two adult children with Stewart are expected to testify, along with Sachman, who said at deposition last year that he didn’t know of the drug’s risks and if he had he would never have prescribed it to his best friend, Wisner said.

Wendy Dolin may be questioned at trial over the circumstances surrounding her husband’s death. “I knew my husband, and I don’t even consider it a suicide anymore,” she said.

GSK, which has taken a whopping 30 depositions in the case over a one-and-a-half-year period, has designated more than two dozen witnesses, including company witnesses and about nine experts.

“GSK is not responsible for Mr. Dolin’s death and we’ve submitted our position in filings to the court,” spokeswoman Jenni Ligday told Law360 in a statement.

Dolin herself may be grilled on the specifics of her husband’s mental state and activities leading up to his death. Some salient details of his final hours stand out to her as especially convincing evidence that he did not plan his suicide in a state of anxiety over long-simmering work-related problems, as GSK has argued.

The drugmaker had argued that Stewart Dolin had experienced work-related anxiety and depression for years, according to a heavily redacted segment of its summary judgment motion in October.

Shortly before his bizarre and tragic visit to the subway station, he had had lunch with an accountant at the Rivers Restaurant near his office in the Chicago Loop. There, he had ordered a chicken salad, requesting the dressing on the side, Wendy recalled, remarking ruefully, “You had the dressing on the side an hour before you [supposedly] planned to die?”

“I knew my husband, and I don’t even consider it a suicide anymore,” Dolin said. “I consider it a fatal drug reaction.”

Sindhu Sundar is a feature writer at Law360. Follow her on Twitter.

Paxil/Seroxat/Aropax (Paroxetine) : “Question Of Drug’s Label Goes To Trial…”


http://www.chicagolawbulletin.com/paxil-2-16-16.aspx

Question on drug’s label goes to trial

paxil-2-16-16,ph02

James B. Zagel
Law Bulletin staff writer

A federal judge has again declined to throw out a lawsuit accusing the maker of the anti-depressant Paxil of liability in the suicide of a Chicago lawyer who took a generic version of the drug.

In a written opinion last week, U.S. District Judge James B. Zagel rejected the argument that the negligence claims brought under Illinois law by Stewart Dolin’s wife are pre-empted by federal law.

Wendy Dolin filed the suit in Cook County Circuit Court, and GlaxoSmithKline (GSK) removed it to federal court under diversity jurisdiction.

The suit maintains the labels on Paxil and its generic version are false and misleading because they failed to warn of an increased risk of suicide in adults over the age of 24.

In a motion for summary judgment, GSK argued such a warning is pre-empted by the Federal Food, Drug and Cosmetic Act.

Zagel didn’t see it that way.

A failure-to-warn claim is preempted by federal law, he wrote, citing Wyeth v. Levine, 555 U.S. 555 (2009), only if there is “clear evidence” the U.S. Food and Drug Administration would not have approved the warning the plaintiff alleges is required by state law.

GSK presented no such evidence, Zagel wrote.

In 2007, he wrote, the FDA invited GSK to discuss the option of keeping language on Paxil’s label warning of the possibility of an increased risk of suicide or suicidal thoughts in adults.

GSK didn’t take the FDA up on that invitation, Zagel wrote.

GSK, he wrote, did not ask for a formal meeting with the FDA and did not ask to include additional language on the label concerning Paxil’s possible effect on adults.

Under those circumstances, GSK failed to meet the “demanding burden” of showing it would have been futile to seek permission from the FDA to add an adult suicide warning on Paxil’s label, Zagel held.

Wendy Dolin is represented by attorneys who include R. Brent Wisner of Baum, Hedlund, Aristei & Goldman P.C. in Los Angeles.

The lead attorney for GSK is Alan S. Gilbert of Dentons U.S. LLP.

Neither attorney could be reached for comment.

In 2010, Stewart Dolin killed himself by leaping in front of a Chicago Transit Authority train at the Blue Line station at Washington and Dearborn streets in the Loop.

Dolin, 57, was a partner in Reed, Smith LLP.

He had started taking a generic version of Paxil, the brand-name version of paroxetine hydrochloride, six days before he committed suicide.

In addition to alleging the warning on the paroxentine label was inadequate, Wendy Dolin contends GSK concealed and manipulated data concerning the drug.

GSK wanted to obscure the fact that paroxetine carries a 6.7 times higher risk of suicide in adults who take the drug compared to those who take a placebo, Dolin contends.

In 2014, Zagel dismissed all claims against Mylan Inc., which made the paroxetine taken by Dolin.

But he held GSK must face claims under Illinois law of common-law negligence, negligent misrepresentation and product liability based on a negligence theory.

In the 2014 opinion, Zagel conceded GSK did not manufacture the paroxetine taken by Dolin.

But the federal Hatch-Waxman Act requires that a generic drug’s design and warning label must match those of the name-brand drug, Zagel wrote.

Therefore, he held, the brand-name maker must in some circumstances face claims based on the warnings on the generic version’s label.

In last week’s opinion, Zagel declined to reverse his 2014 ruling.

Noting that GSK and Wendy Dolin plan to call expert witnesses to the stand during the trial, Zagel also declined to hold that the Paxil’s label is adequate as a matter of law.

And Zagel rejected arguments that the doctor who prescribed Paxil for Stewart Dolin knew of the drug’s risk and, therefore, GSK could not be liable in Dolin’s suicide.

The doctor’s testimony suggests he didn’t know of the increased risk of suicide in adults over 24, Zagel wrote, and he relied on the 2010 Paxil label before prescribing the drug.

The suit is to go to trial on Sept. 19.

Zagel issued the opinion Thursday in Wendy B. Dolin v. SmithKline Beecham Corp., No. 12 C 6403.

You Think GSK Are Unscrupulous Sociopaths?… You Haven’t Met Their Lawyers…


“…Cecily’s doctor was hardly alone in prescribing Paxil that year. A year before, in 2001, a much-publicized paper described a clinical trial that showed Paxil to be safe and effective in teenagers as well as adults. Study 329, as it became known, helped spur a huge increase in Paxil prescriptions. In 2002 alone, over 2 million prescriptions were written for children and teens, and many more for adults. (As a 25-year-old, Cecily Bostock was, from a neurophysiological perspective, on the cusp between adolescence and adulthood.) Did Cecily’s psychiatrist choose Paxil because of Study 329? It’s hard to believe the answer is not at least partly yes..”

“…As Carey notes in his Times story, thousands of children, teens, and young adults attempted or committed suicide while on Paxil—but it’s impossible to know how many, if any, did so because of Paxil. This new BMJ paper makes it seem more likely than ever than some did. And of her daughter, Sara Bostock has no doubt…”

(The Atlantic 2015)

Bob Fiddaman has just done an excellent post on the Stuart Dolin Paxil Suicide trial and the various shenanigans of GSK’s (one of many) law firms- King And Spalding.

You can read the post here

Personally, I don’t know how any lawyers or firms can justify working for a company like GSK. I understand that everyone has to do a job, but seriously, defending a drug company with a record of widespread corruption and fraud spanning decades (see here) is paramount to endorsing this behavior is it not?

Not to mention working for a company which actively encourages promoting their (proven to be) dangerous medications (Paxil, Pandemrix) for children. If any of these lawyers have kids, then I don’t know how they sleep at night?

Does King and Spalding endorse the corporate manslaughter of kids by pharmaceutical companies?

Because that’s what GSK did with Paxil study 329 (read about it here). Supporting this drug company- or taking pay checks from it- is supporting the corporate killing of kids for profit and endorsing GSK’s bribery and fraud networks. King and Spalding should be ashamed of themselves, as should every other law firm who works for this abhorrent company.

King and Spalding- your GSK paychecks are blood money, gained from the blood of Paxil suicides, how do you justify this to your conscience?

Not content with working for one of the most corrupted and fraudulent sociopathic corporations on the planet, it seems that now King and Spalding have decided to out-do their masters GSK in the sociopath stakes…

King And Spalding have tried every trick in the book in order to try to discredit the Dolin family, Stewart’s memory, and in particular his widow, Wendy.

Law360, New York (August 14, 2014, 3:32 PM ET) — A deceased Reed Smith LLP partner’s wife, who claims her husband’s suicide can be traced to GlaxoSmithKline PLC’s antidepressant Paxil, on Wednesday challenged the drugmaker’s subpoena for cellphone and text message records, accusing GSK of using aggressive discovery tactics that invade her privacy.

King And Spalding’s behavior seems to imitate that of their bosses, it’s totally unethical and morally repugnant.

These lawyers are nothing but bullies…

Dr David Healy is the expert witness in this trial, and King And Spalding are also trying to intimidate Healy in the same way that they did with the grieving widow, Wendy Dolin.

GSK hate critics like Healy because Healy was one of the first to speak out against them. GSK have been killing kids for decades with their anti-depressant Paxil (Seroxat) and they don’t like it when people try to get access to their internal documents through the courts. It seems that for GSK, and their sociopathic lawyers- money, legal fees and company profits- are more important than human lives, even the lives of children are disposable and immaterial to these deplorable, amoral individuals…

Healy is a patient activist, he fights for patient rights, access to data, and highlights side effects of medications like Paxil.

GSK are patient killers, they have nothing but contempt for those harmed by their medicines- that’s why they seek to discredit people like Healy..

Law360, New York (April 30, 2015, 4:14 PM ET) — GlaxoSmithKline PLC told an Illinois federal judge Wednesday that the widow of a former Reed Smith LLP partner claiming a generic version of GSK’s antidepressant Paxil caused his suicide must provide more information on an expert who said the company is out to get him.

GSK said Dr. David Healy, a Welsh psychiatrist whose report linking paroxetine hydrochloride to suicidal behavior was submitted as evidence by plaintiff Wendy Dolin, was referred to the U.K.’s General Medical Council following an investigation for which Healy believes GSK is responsible, and said Dolin’s counsel instructed Healy not to discuss the GMC’s probe and refused to provide some documents relevant to Healy’s qualifications.

The documents are relevant to the potential bias Dr. Healy may have against GSK based on his claims that GSK specifically, or the pharmaceutical industry generally, may be behind his referral to the GMC,” GSK said.

According to GSK, Healy has blogged about his “conspiracy theories” concerning pharmaceutical companies including GSK, and that during his deposition in another case, Healy said the Royal College of Psychiatrists had written the council to say that Healy should be suspended.

Healy reportedly obtained that information through the U.K.’s Freedom of Information Act and GSK said it wants access to the documents he received.

The day before GSK’s April 2 deposition of Healy in London, Dolin’s attorneys stepped in with a “laundry list” of objections on the basis of relevance and confidentiality, and instructed Healy not to answer any questions about the investigation, GSK said.

The drug maker then requested that Dolin provide a privilege log to identify what documents were being withheld, but the plaintiff’s counsel refused, according to GSK.

GSK said Wednesday that Dolin’s argument that documents and testimony regarding the investigation are privileged are too vague to even be addressed.

However, the pharmaceutical company said that if the plaintiff’s objections relate to concerns over the release of patient information, those details could simply be redacted.

In 2012, Wendy Dolin sued GSK and Mylan Inc., which produced the generic medication her husband and former Reed Smith partner Stewart Dolin took before jumping in front of a Chicago “L” train.

Dolin’s complaint said her husband killed himself six days after he began treating his anxiety and depression with paroxetine hydrochloride.

Michael Baum, an attorney for Dolin, told Law360 on Thursday that he is in the process of filing a response.

On Friday, Dolin accused GSK of needlessly attempting to delay the trial after she and her attorneys had already accommodated an earlier request to bump the trial to late November.

Wendy Dolin is represented by Michael L. Baum, Bijan Esfandiari, Frances M. Phares and R. Brent Wisner of Baum Hedlund Aristei & Goldman PC and Joshua Weisberg and Lindsey Epstein of Rapoport Law Offices PC.

GSK is represented by Alan S. Gilbert of Dentons, Andrew T. Bayman and Todd P. Davis of King & Spalding LLP. Mylan is represented by Robert E. Haley of Swanson Martin & Bell LLP and Clem C. Trischler and Jason M. Reefer of Pietragallo Gordon Alfano Bosick & Raspanti LLP.

The case is Dolin v. SmithKline Beecham Corp. et al., case number 1:12-cv-06403, in the U.S. District Court of the Northern District of Illinois.


I experienced Akathisa on Seroxat (Paxil) -Akathisa is the side effect which drive Stewart Dolin to kill himself on Paxil. I can only imagine how it feels for a child.. I wonder if the GSK’s lawyers in this case ever tried to imagine what it must feel like to experience it? Do they care that many thousands of kids (and adults) have been driven to suicide from Paxil? or is their pay check more important?

http://missd.co/


Are you suffering from akathisia?

Have you recently started taking a new medication for anxiety, depression, or any other mental health issue?

Akathisia: What to look for

Are you experiencing an increase in any of the following symptoms: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, or physical/inner restlessness, which have in turn caused suicidal thoughts or feelings?

Perhaps a friend or loved-one, shortly after starting a new medication, has engaged in strange, unusual or violent behavior, or without warning has even taken his/her own life.

You or your loved-one may be suffering from akathisia.

Contact

If medication-induced suicide or akathisia has affected your life – or you would simply like to learn more – we would love to hear from you. To send us your stories, articles, questions or comments, please drop us a line:

share@missd.co

What is akathisia?

Akathisia is a disorder, induced by SSRI medications, which can cause a person to experience such intense inner restlessness that the sufferer is driven to violence and/or suicide.

Akathisia

Akathisia is a disorder, induced by SSRI medications, which can cause a person to experience such intense inner restlessness that the sufferer is driven to violence and/or suicide. It has been said, “Death can be a welcome result.” For reasons related to the strong political and lobbying power of pharmaceutical companies, akathisia is rarely explained as a possible side effect of SSRIs, and medical professionals and the general public know very little of the existence of this disorder.

In fact, the drug lobby would like you to believe that akathisia is simply “restless leg syndrome.” As a result, sufferers of akathisia, as well as the medical professionals with whom they consult, are not able to recognize the symptoms of akathisia and therefore take the steps necessary to stop it. This lack of knowledge has tragically resulted in akathisia sufferers taking their own lives, and leaving behind devastated loved ones.

MISSD is not anti-drug. We know that prescription drugs have been life-saving for so many individuals who struggle with mental health issues. We are for truth in disclosure, honesty in reporting and legitimate drug trials.

What should I do?

If you or someone you know is suffering from the symptoms of akathisia, you should tell the doctor who prescribed the drugs, call 911 or go to the nearest emergency room. MISSD does not give medical advice or counsel (see disclaimer).

According to the FDA:

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.

Stewart Dolin 1952-2010

About MISSD

Stewart Dolin had the perfect life. He was married to his high school sweetheart for 36 years. He was the father of two grown children with whom he had a very close and meaningful relationship. He was a senior partner of a large international law firm, managing hundreds of corporate lawyers. He enjoyed his work and derived satisfaction from cultivating relationships with his clients, as well as helping them achieve the results they desired. He enjoyed travel, skiing, dining, joking around with his family and friends and an occasional cigar. He was 57 years old, and high on life.

In the summer of 2010, Stewart developed some anxiety regarding work. He was prescribed Paxil (paroxetine), a selective serotonin reuptake inhibitor (“SSRI”). Stewart’s prescription was filled with a generic version of Paxil, manufactured by Mylan. Within days, Stewart’s anxiety became worse. He felt restless, had trouble sleeping, even asked his wife to listen to a meditation tape with him (hardly typical behavior). He kept saying, “I still feel so anxious.”

On July 15, 2010, (six days after beginning the medication), following a regular lunch with a business associate, Stewart left his office and walked to a nearby train platform. A registered nurse who was also on the platform later reported seeing Stewart pacing back and forth and looking very agitated. As a train approached, Stewart took his own life. This happy, funny, loving, wealthy, dedicated husband and father who loved life left no note and no logical reason why he would suddenly want to end it all. Neither Paxil nor the generic version listed suicidal behavior as a potential side effect for men of Stewart’s age.

We did not know it then, but Stewart was suffering from akathisia.

MISSD (The Medication-Induced Suicide Prevention and Education Foundation in Memory of Stewart Dolin) is a unique non-profit organization dedicated to honoring the memory of Stewart and other victims of akathisia by raising awareness and educating the public about the dangers of akathisia. MISSD aims to ensure that people suffering from akathisia’s symptoms are accurately diagnosed so that needless deaths are prevented. A website, the creation of educational materials and support of conferences such as Selling Sickness, will help to raise awareness and knowledge of akathisia and medication-induced suicides. Again, we feel it’s important to note that we are not anti-drug, and recognize that prescription drugs can be positive and life-saving for many individuals. We are for truth in disclosure, honesty in reporting and legitimate drug trials.

If this could happen to Stewart, then it could happen to anyone. MISSD will make a difference.

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