Litigation Update: ECT Device Manufacturer Issues Warning of "Permanent Brain Damage"

madinamerica
Connor M. Karen November 15, 2018 

Hi everyone. As you may have heard from Dr. Breggin’s recent update, after the judge told us that the case wasn’t a class action, our case on behalf of ECT victims Jose Riera and Deborah Chase settled favorably on the eve of trial. In a development that we didn’t expect, Somatics, LLC has now issued a warning of “permanent brain damage” in its new risk disclosures of October 19, 2018. I wanted to talk a little bit about the implications and how this might affect litigation going forward.

First, you might be curious if this warning (the words “brain damage” buried in the middle of a laundry list paragraph of risks) is enough to shield the manufacturer from future liability. The answer to that is maybe. In product liability law, the adequacy of the warning of a particular risk is a “question of fact” for a jury to decide at trial. That means that even if a jury decides that a manufacturer has included warning of a particular risk, the jury could decide that the warning was insufficient in that it wasn’t prominent enough, the text was too small, not enough attention was given to it, etc.

In my opinion, with respect to the unavoidable risk of brain injury that ECT presents, there needs to be a standalone page with huge red font and a hazard symbol that states “ECT, necessarily the application of sufficient electricity to the cranium to induce a major motor seizure, presents an unavoidable risk of injury to the brain, and both the efficacy and safety of the treatment remain intensely controversial to this day.” We will keep bringing cases against ECT device manufacturers until either the manufacturers start providing that warning, or a jury states that their warning of brain damage is adequate.

That being said, their disclosure will still have effects on future litigation. First, my father DK and I think that this makes the case of anyone who underwent ECT within the statute of limitations — two years before 10/19/18, their date of disclosures — MUCH stronger, as they spent the entire litigation vehemently denying that brain injury was even a possible result of ECT. They basically put their foot in their mouth. (You still might have a good case if you underwent the “treatment” outside the statute of limitations — the arguments just take on a different nature, and we have to take a good look at your case to know whether we can help.)

Also, we think this makes individual medical malpractice cases against psychiatrists and hospitals much stronger. Somatics, LLC’s new disclosure would appear to take the legal force away from their claim that brain damage doesn’t occur from ECT, and winning medical malpractice cases over failure to give informed consent seems to me to be much more of a possibility.

One more interesting point to note: on page 4 or 5 of their disclosures, they state that the FDA “Approved” the Thymatron in 1984. This is false, as the Thymatron was grandfathered in as “substantially equivalent” to a pre-1976 ECT device through the “premarket notification” process, NOT given official premarket approval by the FDA. Further, the FDA’s regulations state:

“Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.” 21 C.F.R. sec. 807.97.

In essence, Somatics, LLC is representing to the public that the FDA has approved its device based on premarket notification, which the FDA’s regulations state is misleading, and constitutes misbranding. Misbranding is significant — if your device is misbranded, it can’t be manufactured or distributed. I’m not sure exactly how this will play out, but you can be sure we will be thinking of creative ways to get the Thymatron’s misbranding in front of future judges to see what shakes out.

I’m happy to answer any questions anyone has here in the comments. I’m also considering doing an AMA on Reddit soon.

If you suffer injury from electroconvulsive shock therapy, please fill out the questionnaire on ectjustice.com or send an email to ect@dk4law.com. Justice for ECT victims has been long delayed, and we think we can help bring it to you.

Previous articleFelitti and Burke Harris Inspire 850+ at National ACEs Conference
 
Connor M. Karen
Connor M. Karen, Esq. is a graduate of UC Davis School of Law, California Bar admittee, and winner of the 2017 national law student class action writing competition hosted by American Association for Justice. Connor's entry was a paper on class certification of injuries caused by violations of FDA regulations. Connor and Jim Truxaw, Esq. conceptualized and drafted the linked litigation documents.

Thank You Mr Karen and MIA.

Huge Breakthrough in Lawsuits Against ECT Manufacturers

madinamerica
Peter Breggin, MD October 23, 2018

A long-awaited major electroconvulsive therapy case that was on the eve of trial just settled to the satisfaction of the injured ECT patients and the DK Law Group, LLP by trial attorney David M. Karen in California. While the settlement amount remains confidential, as an expert in the case I am pleased to report that this resolved litigation is a significant victory. The evidence secured has paved the way for more suits against ECT manufacturers that are on the way!

The lawsuit against the ECT manufacturer had its critical breakthrough when the California judge recently allowed the case to proceed to jury trial after their motion for summary judgment was denied. The judge’s decision has effectively established the methodology for bringing this and other lawsuits against ECT manufacturers for their failure to warn of known or knowable risks of brain damage caused by ECT.

As summarized by plaintiff’s attorney Karen, the Court effectively ruled as follows:

• A reasonable jury could find that the ECT device manufacturer failed to warn plaintiffs’ treating physicians of brain damage resulting from ECT, leading to the oft-reported and acknowledged symptoms of permanent memory loss and cognitive impairment.

• A reasonable jury could find that the ECT device manufacturer was in violation of the relevant federal regulations.

• A reasonable jury could find that Plaintiffs suffered brain damage as a result of ECT.

• A reasonable jury could find that the ECT device manufacturer caused Plaintiffs’ brain damage through failure to warn their treating physicians of brain injury, or alternatively by failing to investigate and report allegations of brain damage and permanent memory loss to the FDA, so that information would be available to the public.

My task as the psychiatric expert was to establish that ECT does in fact cause chronic cognitive and mental impairment, and brain damage. I did so in part with the many scientific articles available for free on my ECT Resource Center at www.123ECT.com. I will follow up this first report on the case with analyses of the implications of the lawsuit and with my scientific analysis that helped the judge understand that a reasonable jury might indeed find that ECT causes brain damage.

An excerpt from the law firm’s announcement, published for the first time below, describes their outstanding array of experts:

An assembled cast of accomplished experts in the industry all stepped up to support the ECT Plaintiffs. Including the single most compelling and critical ECT Psychiatrist in the country, the ex-Director of the FDA; the author of the ECT FDA Citizen Petition; and the preeminent NASA/JPL electrical engineer, Plaintiffs were surrounded by some of the greatest experts anywhere — all testifying on behalf of these Plaintiffs that violations of law occurred and establishing that brain injuries were and are caused by ECT.

This is the first in a series from me on the implications of this monumental lawsuit.

Meanwhile, here is the concluding portion of DK Law Group, LLP commentary on the case, including an application for anyone wishing to be evaluated as the plaintiff in potential future suits:

[Despite the array of experts] throughout the litigation, the defense for the manufacturer continued to shirk its responsibility, refusing to acknowledge the flagrant violations in FDA reporting requirements that were at the root of this litigation. Despite decades of complaints of cognitive impairment and disability following ECT, the evidence amassed demonstrated ZERO adverse event reporting on the FDA’s MAUDE database by the Defendant as of the date suit was filed.

While the manufacturers have sought to ignore it for decades, brain damage is the reason now being demonstrated as the cause for the cognitive impairment and memory loss that results after the administration of electroconvulsive shock therapy. All ECT patients are entitled to a warning of that undeniable fact. If that warning is not supplied and an ECT patient suffers the likely brain damage as a result of ECT, those that have sustained lingering cognitive impairment or disability following ECT are entitled to a remedy from the manufacturers who unlawfully failed to warn. Following the recent favorable rulings, the trial attorneys were able to conclude the matter with a confidential settlement on behalf of these Plaintiffs. The discovery obtained from the FDA and the Defendant themselves has now paved the way for help to continue to be provided to all others that have been injured by ECT so that justice can now be achieved for the world of ECT shock survivors.

If you or a loved one are still suffering from lingering side effects of ECT treatment performed within the last few years, (or were misled/advised that ECT was not the cause of your lingering issues from earlier ECT treatment) our experts have determined that brain damage is the likely cause. While testing is required, if you were not warned of the risk of brain damage or permanent impairment of cognitive ability as a risk that may occur from ECT and would like more information to determine if remedies are available to you, feel free to send the following information to: ect@dk4law.com:

Name, Address, Cell # and Email address
# of ECT sessions
Date of last ECT
State of residence
Location of treatment
Summary of post-ECT complaints and duration
Description of any Post-ECT treatment or testing

While the liability and damage evidence secured was compelling for this California trial, laws in all States vary and require individual assessment. Accordingly, don’t wait as statutes of limitation may apply to limit the time in which remedies may be sought.

“Well, what is the sense of ruining my head and erasing my memory, which is my capital,
and putting me out of business? It was a brilliant cure but we lost the patient.
It’s a bum turn, Hotch, terrible.” —Ernest Hemingway on ECT

To be continued….

Previous articleFlooding the World With Psychiatric Drugs Could Increase Mental Disorders

Thank You Dr Breggin and MIA.

Judicial Watch Files Ethics Complaint Against Maxine Waters For 'Inciting Violence'

Medical Malpractice Verdict Seen As Powerful Message To Mental Health Providers

PR newswire

News provided by

The Mark D Truskie Foundation

May 21, 2018, 08:28 ET

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---

COAROPOLIS, Pa., May 21, 2018 /PRNewswire/ -- Stanley D. Truskie, President of the Mark D. Truskie Foundation, issued a statement that the $2 million verdict on Wed, May 16, 2018 in favor of him and his wife, Marianne, as a result of the death of their son Mark, is a decision that will send a powerful and important message to the psychiatric community, and to psychiatric clinics throughout the country. Mark lived at home with the Truskies and died at the age of 46.

After Mark's death on November 12, 2013, the Allegheny County coroner determined that he died from toxic levels of Celexa and Cloziral, two medications used to treat his mental condition. Mark's psychiatrist, Dr Grace Huang of the Staunton Clinic in Sewickley, PA, prescribed both medications.

"We were able to prove that Huang and the Staunton Clinic ignored two critically important FDA Safety warnings regarding Celexa, which is a medication known to cause sudden cardiac death when prescribed above certain doses," stated attorney Tyler Smith, representing the Truskie family.

"The evidence demonstrated that Huang and the Staunton Clinic prescribed Celexa to Mark at twice the allowable dose without informing Mark or the Truskies of the FDA warnings, or informing them about simple and safe tests that could have been used to protect Mark from the increased risk of harm caused by his medications," Smith added.

Truskie believes there are several valuable lessons psychiatrists and psychiatric clinics should learn from this important case including the following:

• Patients, and caregivers, must be informed of the side effects of the psychiatric medications being prescribed;
• Warnings from physician instructions accompanying the medications, and FDA warnings regarding the prescribed medications must be communicated to patients, and caregivers;
• Treating psychiatrists should ensure that periodic health exams are scheduled and completed for their patients, such as heart monitoring, drug concentration measurements, liver enzyme testing and other appropriate tests, especially when multiple psychiatric medications with known, dangerous side effects are being prescribed;
• Referrals to appropriate specialists such as cardiac physicians, metabolic specialists, lipidologists, and nutritional counselors should be incorporated into the treatment plan of the patient;
• Patients/caregivers should be alerted to signs and symptoms such as toxicity, heart arrhythmia, and other life-threatening conditions when such side effects are indicated by the medications being prescribed, and further, they should be instructed on what to do in an emergency; and
• Managers and administrators of psychiatric clinics must ensure that policies and procedures are in place to guarantee these standard of care practices are in place and followed.

In closing, Truskie stated, "This award will help fund the Mark D. Truskie Foundation which we started in Mark's name to help protect the health and safety of those dealing with mental health problems."

Contact:
Stanley D. Truskie, Ph.D.
412-979-8146
195605@email4pr.com
www.markdtruskiefnd.org

SOURCE The Mark D Truskie Foundation

Related Links

http://www.markdtruskiefnd.org

NY Psychiatry Researcher Charged With Embezzlement, Faces Jail Time

retraction watch
Nov 29, 2017

A researcher specializing in post-traumatic stress disorder is facing jail time for allegedly embezzling tens of thousands of dollars of federal grant money.

Yesterday, the US Attorney’s Office for the Southern District of New York and the U.S. Department of Health and Human Services’s Office of Inspector General (OIG) announced criminal charges against Alexander Neumeister, alleging he used the grant funds on trips and meals for family and friends. As the New York Times reported last year, Neumeister was dismissed from his position at New York University (NYU); NYU shut down eight of his studies following an investigation by the U.S. Food and Drug Administration, which found evidence of lax oversight, falsified records, and inaccurate case histories. 

The U.S. Attorney has also filed a civil lawsuit against Neumeister under the False Claims Act, also for misuse of grant funding. The complaint does not specify the total amount of funds he allegedly misused.

In a statement, Acting U.S. Attorney Joon Kim said Neumeister:

fraudulently charged tens of thousands of dollars in personal expenses as research or school-related expenses. For allegedly betraying the trust of the medical school that employed him and the government institute that funded his research, Neumeister now faces serious federal charges.

Those charges include one count of theft of government funds, which carries a maximum prison sentence of 10 years, and one count of wire fraud, which carries a maximum sentence of 20 years. In the civil suit, the government can recover three times the alleged damages plus financial penalties for each false claim.
A spokesperson for the OIG told us:

The U.S. Attorney’s Office received an allegation that they looked into. Based on interviews with current and former employees, it was uncovered that some of the test results were skewed and, based on that, the USAO decided to bring charges. Our office is conducting an ongoing investigation in coordination with the USAO.

We asked if this means there is an investigation into research misconduct involving Neumeister; the OIG spokesperson referred us to the US Attorney’s Office. A spokesperson for the US Attorney’s Office said they couldn’t comment further. 

Neumeister was arrested Nov. 21 in Ogdensburg, a New York town on the border with Canada. He’s an Austrian citizen and has surrendered his passport, according to court documents. He has since been released, but his travel is restricted to New York and Connecticut. We contacted the attorney who represented Neumeister in the FDA investigation, but haven’t heard back. 

John Thomas, an attorney at Gentry Locke who is bringing a False Claims Act case against Duke University, told us the Neumeister case is:

…a little bit more than just an embezzlement case. It’s a reminder that universities and principal investigators are stewards of taxpayer dollars.

Neumeister, 51, was principal investigator on several grants issued by the National Institute of Mental Health (NIMH). He has published dozens of papers, one of which was corrected in 2014.
The statement from the US Attorney’s office said that, from 2012 to 2014, Neumeister allegedly used funds from NYU or the NIMH to buy things for his family and a “Friend,” a professional ballet dancer he met in New York in 2012. Items included: 

• airline tickets so that the Friend could travel from Charlotte, North Carolina, or Salt Lake City, Utah, depending on where the Friend was then living, to New York City, where NEUMEISTER was then living;
• airline tickets so that NEUMEISTER could travel from New York City to Charlotte and Salt Lake City to visit the Friend, as well as lodging, bar tabs, meals and other travel-related expenses associated with this travel;
• an all-expense paid trip to Miami Beach for the Friend, during which the Friend was given authorization by NEUMEISTER to use NEUMEISTER’s [credit card] to pay for food, beverages, and beach facilities;
• an iPhone for the friend; and
• airline tickets so that NEUMEISTER’s spouse could travel from Newark, New Jersey, to Vienna, Austria, to attend a family event.

The statement alleges:

In addition, NEUMEISTER falsely claimed that the Friend was a research study participant in studies that NEUMEISTER was overseeing for the School, and caused the School to pay over $10,000 of the School’s own funds directly to the Friend.  

The civil complaint said that NYU confronted Neumeister in 2015 about the credit card expenditures after it had conducted an audit. Whether the audit was routine or triggered by something else isn’t clear. 

The complaints — also covered by the New York Daily News — note that Neumeister offered to pay back the allegedly misappropriated funds, but never did.

The FCA suit includes many of the same allegations.
Neumeister’s LinkedIn page says that he’s currently a program director for research supported by the World Health Organization in the Democratic Republic of Congo.

A spokesperson for the NYU School of Medicine told us:

As soon as the potential issues specific to this research were identified and reviewed, findings were shared with the appropriate oversight agencies. The researcher is no longer employed at the School of Medicine.

NYU added:

As a victim of Dr. Neumeister’s actions, as to which NYU School of Medicine may be called to give testimony or further information, it would be inappropriate to provide additional comment while the federal investigation is ongoing.

Thomas said that this case, and the FCA case that Columbia University settled last year for $9.5 million over problematic costs arising out of grant, could be the beginning of a trend:

It shows the Southern District of New York is paying close attention to grant fraud.

Hat tip: Theresa Defino

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Thank You Retraction Watch. 


What do you expect from an Industry that charges the tax payers for it to Ideate?

28 Wisconsin Counties Hit Big Pharma With Separate Lawsuits

dailycaller
Steve BirrVice Reporter
4:33 PM 11/08/2017

More than two dozen counties in Wisconsin are going after pharmaceutical companies in an attempt to hold the drug makers accountable for the public cost of the opioid epidemic.

Twenty-eight counties in the state filed separate lawsuits in eastern federal district court in Wisconsin Tuesday that accuse top drug makers, their subsidiaries and several doctors of fraudulent marketing of opioids painkillers. The lawsuits seek unspecified damages from the companies for the millions of dollars spent by localities to combat opioid addiction, reports the Journal Sentinel.

Officials from these counties say their communities are suffering under the financial toll of the drug crisis, which is impacting emergency services, law enforcement, hospitals and social services. The lawsuits allege drug makers created a public nuisance through their fraudulent advertising of opioid painkillers that led to the current overdose crisis.

“County governments are bearing the brunt of the costs of this crisis,” Erin Dickinson of Crueger Dickinson LLC, who is part of the legal effort in Wisconsin, said Tuesday, according to the Journal Sentinel. “Defendants must be held responsible for the devastating effects their actions have produced on counties across this country.”

The lawsuits target Purdue Pharma, Johnson & Johnson, Endo Health Solutions, along with their subsidiaries and three doctors from Utah and California. Lawsuits are mounting against the largest drug makers in the country for their alleged complicity in sparking the opioid crisis through dishonest advertising.

The pharmaceutical companies deny wrongdoing and say they are committed to working with the government to solve the opioid epidemic.

“We are deeply troubled by the opioid crisis and we are dedicated to being part of the solution,” a company spokesman previously told The Daily Caller News Foundation in response to a lawsuit filed by the attorney general of New Jersey.

President Donald Trump declared the opioid epidemic a “public health emergency” Oct. 26, giving states hit hard by opioid addiction flexibility on how they direct federal resources to combat rising drug deaths.

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Content created by The Daily Caller News Foundation is available without charge to any eligible news publisher that can provide a large audience. For licensing opportunities of our original content, please contact licensing@dailycallernewsfoundation.org.
Tags: Purdue Pharma, Wisconsin

Thank You Mr Birr and the DC.

Gynecomastia Risperdal Plaintiff Wins First Lawsuit Outside Philadelphia Court

Lawyers and Settlements
October 27, 2017, 02:00:00PM. By Jane Mundy
 

Syracuse, NYA federal jury at the beginning of October found that Johnson & Johnson and Janssen, the Risperdal manufacturer, failed to warn about gynecomastia to doctors and patients and awarded a young man $1million.

Shaquil Byrd, a 24-year-old New Yorker, proved to a federal jury in Syracuse that Johnson & Johnson and its Janssen Pharmaceuticals subsidiary failed to provide adequate warnings of gynecomastia. Shortly after Byrd started taking Risperdal for mood disorders, at the age of nine, he developed excessive breast growth and he experienced lactation by the time he was 10. Byrd told the Times Union that his classmates teased and bullied him relentlessly. “They constantly asked me if I had milk. They did a thing called a 'scoop slam dunk' and that was when they basically cuffed my chest and slapped it down. They actually grabbed my chest.”

He had his breasts removed three years ago, but still continues to feel self-conscious. “It can really like mess up how you view yourself and how you view the world,” Byrd told WYNT News. Byrd’s attorney, Luke Malamood, accused the drug makers of hiding Risperdal's side effects from doctors. “Prescribing doctors with the best intentions aren't able to fully do their job and really consider the risks and benefits of a drug if they don't know accurately what the risks are,” said Malamood. Byrd’s lawsuit is the first outside of Philadelphia Courts that found in favor of the plaintiff. (Case No. 1:14-cv-00820)

Spokesperson for Janssen Pharmaceuticals Kelsey Buckholtz, told NYup.com that this verdict is not justified by the evidence. "Contrary to the impression the plaintiffs' attorneys have attempted to create over the course of this litigation, Risperdal is an important FDA-approved medicine that, when used as part of a comprehensive treatment plan, continues to help millions of patients with mental illnesses and neurodevelopmental conditions,” she said.

READ MORE RISPERDAL LEGAL NEWS

• New York State Risperdal Plaintiff Awarded $1 Million
• Risperdal Judge Explains Reasons for Denying Janssen a New Trial
• Risperdal Plaintiff Green Lighted to Pursue Risperdal Lawsuit in New York

The Risperdal label was updated in October 2006 to state that 2.3 percent of male adolescents treated with the drug had developed gynecomastia. The label previously stated the condition was a rare side effect that had been seen in fewer than 1 in 1,000 patients. Byrd's attorneys argued that some of J&J’s own studies show at least 1 out of 20 children - or 4.8 percent of adolescents who take Risperdal can develop gynecomastia.
Johnson & Johnson reported $17 billion in profits on $72 billion in sales last year. Risperdal brought in sales of $3 billion a year in the early 2000s. In 2013, J&J agreed to pay $2.2 billion to settle civil and criminal charges with the Justice Department and 45 states. Justice accused the company of pushing Risperdal and two other drugs "for uses not approved as safe and effective by the FDA," including for autistic children and dementia patients, and paid "kickbacks" to doctors and pharmacy officials,” reported Philly.com(Oct. 20, 2017). The deal "allows us to move forward," the company said in 2013.

READ ABOUT RISPERDAL LAWSUITS  or  MORE RISPERDAL LEGAL NEWS ARTICLES

Thank You Ms Mundy and L&S.

JNJ Hit With Lawsuit Alleging They Paid Bribes Which Cost American Military Lives In Theater: Terrorism

NBC news
Ken Dilanian and Carol E. Lee
Oct 17, 2017

WASHINGTON — A group of American veterans filed a federal lawsuit Tuesday against U.S. and European drug companies and medical device makers, accusing them of supporting an Iran-backed Iraqi militia that killed and wounded hundreds of Americans.

The suit is filed under a law that allows Americans injured by terrorism overseas to seek civil damages. The more than 100 plaintiffs include injured U.S. Iraq war veterans and their families. The defendants are either parent companies or subsidiaries of AstraZeneca plc (AZN); Johnson & Johnson (JNJ); Pfizer Inc. (PFE); Roche Holding AG (RHHBY); and the General Electric Company (GE).

The 203-page lawsuit accuses the companies of paying bribes to officials of Iraq's health ministry that benefited the Mahdi Army, an Iranian-backed militia that the suit says worked closely with Hezbollah, a Lebanese group that has been designated a terrorist organization by the U.S. government.


It's a lengthy and detailed report, so read it in full at the link. 


Here's the lawsuit.

New York State Risperdal Plaintiff Awarded A Million Dollars

lawyersandsettlements

October 11, 2017, 02:30:00PM. By Gordon Gibb

Syracuse, NY One of the few Risperdal lawsuits to be tried outside Philadelphia has resulted in a win for the plaintiff, a resident of Troy in New York State who was awarded $1 million in compensation. A jury in US District Court, Northern District of New York delivered their verdict in the trial on September 27, awarding 24-year-old Shaquil Byrd $500,000 for past and/or present pain and suffering, as well as an additional $500,000 for future pain and suffering.

According to WNYT News Channel 13 (10/04/17), Byrd was nine years of age when he was diagnosed with psychosis and prescribed Risperdal. He eventually suffered from Risperdal gynecomastia – male breast growth – that traumatized him as a youth.

“You know, thinking people are judging me,” (sic) Byrd said in comments broadcast by WNYT. “So, it’s still something that, you know, I feel bad about.” (sic).

His male breast tissue was surgically removed three years ago when he was 21. However, the teasing he endured as an adolescent has not yet left him. “It can really, like, mess up how you view yourself and how you view the world,” Byrd said to WNYT.

Byrd’s Risperdal lawsuit was the first to be tried outside Philadelphia that resulted in a win for the plaintiff, according to WNYT. Meanwhile, in Philadelphia there are no fewer than 6,000 Risperdal lawsuits housed in a mass tort in the Pennsylvania Court of Common Pleas. Risperdal gynecomastia cases have been tried in Philadelphia since February, 2015 with both plaintiffs and the defendant prevailing in several of the cases. Many Risperdal lawsuits have been settled out of court just prior to trial – however, the four occasions when plaintiffs have prevailed resulted in jury awards ranging from $500,000 to $70 million.

Risperdal gynecomastia, which is the growth of male breast tissue, remains a relatively rare side effect of Risperdal (risperidone) that nonetheless proves devastating for those affected. In rarer cases still, gynecomastia victims have been known to actually secrete fluids through the nipples. The only known treatment for Risperdal gynecomastia is surgery to remove the excessive breast tissue.

Byrd’s Risperdal lawsuit asserts that male breast tissue had begun to form within months of starting Risperdal, an anti-psychotic.

READ MORE RISPERDAL LEGAL NEWS

• Risperdal Judge Explains Reasons for Denying Janssen a New Trial
• Risperdal Plaintiff Green Lighted to Pursue Risperdal Lawsuit in New York
• Philadelphia Judge Refuses to Overturn $2.5 Million Risperdal Plaintiff Verdict

“I feel like I have a new beginning, like, I can be who I am without, you know, caring about who’s trying, who’s going to judge me,” (sic) Byrd said to WNYT. The news outlet reports Byrd is pursuing therapy for depression, and hopes to enroll in college.

Janssen issued a statement following the Risperdal gynecomastia verdict, as reported by WNYT. “Contrary to the impression the plaintiffs’ attorneys have attempted to create over the course of this litigation, Risperdal (risperidone) is an important FDA-approved medicine that, when used as part of a comprehensive treatment plan, continues to help millions of patients with mental illnesses and neurodevelopmental conditions.”

It is not known if Janssen, a division of Johnson & Johnson, plans to appeal.

The case is Byrd v. Janssen Pharmaceuticals, Inc. et al, Case No. 1:14-cv-00820, in US District Court for the Northern District of New York at Syracuse.

READ ABOUT RISPERDAL LAWSUITS  or  MORE RISPERDAL LEGAL NEWS ARTICLES

Thank you Mr Gibb and Lawyers and Settlements. 

If you're a potential gynecomastia plaintiff interested in filing your own suit for relief, this might prove interesting:

https://www.aboutlawsuits.com/wp-content/uploads/2014-07-08-Byrd-Complaint.pdf 

It took 3 years.

https://www.pacermonitor.com/public/case/3986261/Byrd_v_Janssen_Pharmaceuticals,_Inc_et_al#

Philadelphia Risperdal Docket Almost Triples In First Half of 2017

National Law Review
Monday, September 18, 2017

The number of cases involving the anti-psychotic drug Risperdal almost tripled in the first half of 2017, jumping from approximately 2,000 cases at the beginning of the year to more than 5,500 as of June 2017, comprising the largest mass tort litigation in Philadelphia.

The new filings in the Risperdal litigation were largely triggered when Johnson & Johnson terminated tolling agreements on thousands of cases, which had paused the statute of limitations deadline. A Johnson & Johnson subsidiary, Janssen Pharmaceuticals, Inc., manufactures Risperdal.

The Risperdal litigation mostly involves a condition called gynecomastia, which causes breast tissue enlargement in males. Risperdal was originally approved in 1993 to treat schizophrenia in adults. In 2006, clinical studies linked an increased risk of gynecomastia in male adolescents to Risperdal use. The Risperdal gynecomastia lawsuits allege the manufacturer did not sufficiently warn doctors and patients of the male breast growth problem, and that Johnson & Johnson and Janssen Pharmaceuticals failed to properly share information with the FDA.

In 2016, a Pennsylvania jury awarded $70 million to a teenage male who claimed Risperdal caused him to grow enlarged breasts. The jury found that Johnson & Johnson failed to warn Risperdal could cause gynecomastia, and that the company “intentionally falsified, destroyed, or concealed records” that Risperdal could cause boys to develop breasts.

More Risperdal cases may be filed in the wake of the United States Supreme Court’s recent jurisdictional decision in Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco County. In that case, a group of plaintiffs sued Bristol-Myers Squibb Company (BMS), asserting claims based on injuries allegedly caused by the BMS drug Plavix. Of the more than 600 plaintiffs, 592 are residents of states other than California. BMS is incorporated in Delaware and headquartered in New York. It maintains substantial operations in New York and New Jersey, and engages in business activities and sells Plavix in California. The nonresident plaintiffs did not allege that they obtained Plavix from a California source, that they were injured by Plavix in California, or that they were treated for their injuries in California. The United States Supreme Court found that California courts lack specific jurisdiction to consider the nonresidents’ claims. In order for a state court to exercise specific jurisdiction, the suit must arise out of or relate to the defendant’s contacts with the forum.

Ninety-four percent of the most recent filings in the Risperdal mass tort litigation are from outside of Pennsylvania. Plaintiffs from all over the country have filed suit in Philadelphia, which is a home venue for Janssen Pharmaceuticals.

COPYRIGHT © 2017, STARK & STARK


Thank You National Law Review and Stark and Stark

Risperdal Judge Explains Reasons For Denying Janssen A New Trial

lawyersandsettlements

September 17, 2017, 03:00:00PM. By Gordon Gibb

Philadelphia, PAAs the manufacturer of Risperdal (risperidone) continues their attempts to have a recent plaintiff verdict overturned, the Pennsylvania state judge assigned to the case explained last month why he denied a request by Johnson & Johnson subsidiary Janssen Pharmaceuticals Inc. for a new trial in the Risperdal side effects lawsuit.

According to Court documents plaintiff Austin Pledger had begun taking Risperdal in 2002 to counter behavioral issues associated with autism. Pledger was prescribed Risperdal when he was seven years of age. At that time risperidone was sanctioned by the US Food and Drug Administration (FDA) for use only in adults.

An expanded indication for use in children would come four years later – in October, 2006 when the FDA, on the 6th of that month issued an updated indication for irritability associated with Autistic Disorder in children as young as five years of age, and as old as 16. The FDA also, at the same time, updated the Risperdal label to reflect a 2.3 percent risk for male breast growth, a condition known as gynecomastia.

Prior to that, according to Law 360 (08/14/17), the Risperdal label had only referenced gynecomastia as a rare event.

Medical doctors have the medical and ethical authority to prescribe medications to their patients beyond restrictions mandated by the FDA – thus it was completely within the purview of Pledger’s physician to prescribe the boy risperidone for his autism. As noted above, Risperdal would eventually be sanctioned by the FDA for children as young as five when the indication for risperidone was expanded in 2006 – tagged as it was with a warning about a 2.3 percent risk for gynecomastia.

However, the heightened level of risk for Risperdal and growing male breasts was still four years out when Pledger first started taking Risperdal at the behest of his doctor. At the time, in 2002, gynecomastia was only considered rare.

Pledger, over the course of five years taking Risperdal, was seen to grow large breasts and was diagnosed with Risperdal gynecomastia. His family sued Janssen and, following a month-long trial in February, 2015 won a $2.5 million jury award (Pledger et al. v. Janssen Pharmaceuticals Inc. et al., Case No. 120401997, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia).

In response, Janssen filed post-trial motions seeking a new trial on grounds that expert witness for the plaintiff Dr. David Goldstein had examined the plaintiff in Pledger’s home state of Alabama. The problem, as noted by the defendant, was that Goldstein was licensed to practice in Missouri and, as such may have violated the law.

Goldstein, at trial, withdrew as an expert witness in the face of the jurisdictional issue, and Pledger brought in a new expert witness. Janssen, however, cried foul asserting that the opinions of plastic surgeon Dr. Mark Solomon differed significantly from those of Goldstein. Because of that, Janssen asserted they had no opportunity to prepare an effective cross examination of the expert witness, and petitioned the Court for a new trial.

Judge Ramy Djerassi in the Philadelphia County Court of Common Pleas took exception to Janssen’s tactics.

“The timing of Janssen’s motion and the nature of their accusation were extraordinary and seemed calculated for maximum surprise,” the opinion said. “If Janssen’s late motion were granted, plaintiff would have no choice but [to] move for voluntary nonsuit. If the motion were denied, then Dr. Goldstein would likely choose to take the Fifth Amendment or testify with predictable damage to his credibility. Either way, if the motion had been filed before trial, there would not have been extraordinary prejudice to plaintiff who would likely have moved for a continuance before undergoing the expense of trial.”



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Djerassi also noted that Solomon had been deposed a few months prior in association with a separate Risperdal lawsuit for which he was acting as an expert witness also and thus, Janssen would have been well aware of the substance of Solomon’s testimony.

“There was no undue surprise to Janssen,” the opinion said. “The trial record shows Janssen’s trial lawyers were prepared.”

Janssen is continuing to appeal, in an effort to have the original verdict overturned. A spokesperson for Janssen said in a statement: “We continue to believe this verdict should be overturned, and we are appealing,” said Jessica Castles Smith, on behalf of Janssen. “Contrary to the impression the plaintiffs’ attorneys have attempted to create over the course of this litigation, Risperdal is an important FDA-approved medicine that, when used as part of a comprehensive treatment plan, continues to help millions of patients with mental illnesses and neurodevelopmental conditions.”


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Risperdal $2.5 Million Verdict Upheld On Appeal

Pa. Judge Explains Verdict To Keep $2.5 Million Risperdal Verdict

Law 360

By Matt Fair

Law360, Philadelphia (August 14, 2017, 4:09 PM EDT) -- A Pennsylvania state judge has explained his reason for denying a Johnson & Johnson unit’s request for a new trial over abnormal breast growth allegedly linked to the drug Risperdal, saying the company's “extraordinary” defense tactics warranted allowing an Alabama boy’s family to find a new expert witness during the case.

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In Penn. Parties To Risperdal Mass Tort Gynecomastia Case To Meet Next Month

satprnews
Posted on June 23, 2017 by Monika Donimirska

Parties to Pennsylvania Risperdal Gynecomastia Lawsuits Set to Meet Next Month to Discuss Status of Mass Tort Litigation, Bernstein Liebhard LLP Reports 

NEW YORK, June 23, 2017 /PRNewswire/ -- Thousands of Risperdal lawsuits involving the antipsychotic medication's alleged potential to cause gynecomastia (male breast growth) continue to move forward in a mass tort litigation now underway in Pennsylvania's Philadelphia Court of Common Pleas. According to a posting on the website for the Philadelphia Complex Litigation Center, the Court will convene a meeting on July 11th, 11:30 p.m. EST, to discuss the status of the Risperdal litigation. (Case No. 130600861)

"Our Firm is representing many men and boys who allegedly developed female-like breasts due to treatment with Risperdal. We will continue to monitor the Pennsylvania litigation closely for any developments that could impact our clients' cases," said Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. The Firm continues to provide free legal reviews to men and boys who were diagnosed with gynecomastia allegedly related to their use of Risperdal.

Risperdal Gynecomastia Allegations

Court records indicate that Johnson & Johnson and its Janssen Pharmaceuticals subsidiary have been named defendants in more than 5,800 Pennsylvania Risperdal lawsuits. In May, Johnson & Johnson reported that at least 16,900 product liability claims have been filed in courts nationwide over the medication's alleged side effects. Gynecomastia plaintiffs claim that the drugs' manufacturers concealed data linking Risperdal to excessive male breast growth and failed to provide the public with appropriate warnings regarding this risk.

The Pennsylvania litigation has convened 8 Risperdal trials since early 2015. So far, juries have ruled for plaintiffs in four cases, awarding damages ranging from $500,000 to $70 million. Confidential Risperdal settlements have also been reached in some gynecomastia lawsuits just prior to trial. Bernstein Liebhard LLP continues to provide free legal reviews to alleged victims of Risperdal and gynecomastia. To learn more about filing a Risperdal lawsuit, please contact Bernstein Liebhard LLP by visiting the Firm's website, or by calling 800-511-5092.

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"Risperdal Boys" Photo Project Vividly Captures Pain of Gynecomastia

Injury Help
Published on June 21, 2017 by Laurie Villanueva

Thousands of Risperdal lawsuits have been filed in U.S. courts on behalf of men and boys who allegedly developed gynecomastia due to treatment with the antipsychotic drug. Now a new photography project is vividly capturing the suffering endured by victims of this disfiguring condition.

Entitled “Risperdal Boys,” the project features six young men, all of whom experienced excessive breast development after they were prescribed the medication. According to PetaPixel.com, each was featured in a candid portrait, a posed shot in a natural environment, and a shot in front of a backdrop with a single strobe. The photos were taken during a 6-day road trip that covered 10 cities and over 4,000 miles.

“Of the young men who agreed to allow their pictures to be used, to a man, it was because they wanted the world to know what happened to them,” photographer Richard Johnson said.

“All agreed their struggle would be easier if they knew others were facing the same bullying and social isolation that they faced as a boy with breasts,” he continued.

Risperdal and Gynecomastia

Gynecomastia is marked by the development of female-like breasts in men and boys. The condition may be accompanied by breast pain and tenderness, as well as a discharge from the nipple. Breast growth associated with gynecomastia is permanent, and can only be treated via surgical intervention such as liposuction or mastectomy.

Risperdal is known to increase the amount of prolactin produced by the pituitary gland. While this hormone plays a role in female breast development and lactation, high levels can cause excessive breast growth in males. Prior to October 2006, the Risperdal label characterized gynecomastia as a rare side effect that appeared in less than 1 in 1,000 patients. That month, the prescribing information was updated to note that 2.3% of male adolescents treated Risperdal had developed the condition.

Risperdal Litigation

Risperdal is currently indicated to treat adult and adolescent schizophrenia, bipolar disorder in adults and children ages 10-to-17, and irritability in children (5-to-16 years of age) with autistic disorder. While Risperdal was introduced in the 1990s, its pediatric indications weren’t approved by the U.S. Food & Drug Administration (FDA) in October 2006.

In November 2013, the U.S. Department of Justice announced that Johnson & Johnson and its Janssen Pharmaceuticals unit had agreed to pay $2.5 million to resolve criminal and civil charges stemming from the marketing of Risperdal and other drugs. Among other things, federal prosecutors had alleged that the companies improperly marketed Risperdal for off-label pediatric indications and concealed gynecomastia and other side effects associated with its use.

More than 18,000 Risperdal lawsuits are currently pending in U.S. courts, most of which involve gynecomastia. Plaintiffs allege that the drug’s manufacturers concealed data linking Risperdal to excessive male breast growth and failed to adequately warn the public about this potential risk. The lawsuits also claim that around 20% of Risperdal prescriptions were written for children, allegedly due to the defendants’ aggressive off-label marketing efforts.




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Risperdal Victims Candid Photos Speak Volumes

lawyers and settlements

May 23, 2017, 10:30:00AM. By Jane Mundy

Detroit, MIMost jurors in Risperdal trials are likely sympathetic and at the same time shocked to discover how boys who developed female breasts have suffered. The public are likely reacting the same way after seeing a photo project online titled “Risperdal Boys”.

Photographer Richard Johnson has captured the pain and suffering and embarrassment of six young men (four others opted out before publication) who developed gynecomastia. Johnson explains on his website why these young men chose to go public. “They wanted the world to know what happened to them,” Johnson said. “Most of the young men in the project suffered alone; they’ve never met someone else with their condition.”

They are indeed brave men to step forward. One striking thing about the photographs is the background Johnson captured. For instance, Eddie from Oklahoma stands outside his run-down home. All six young men appear to fall into the ‘lower income’ category. And that comes as no surprise: Risperdal targeted patients on Medicaid, but it isn’t easy to get Medicaid to cover breast removal surgery.

Even if a family scrapes together enough money to pay for surgery, there are challenges and the outcome may not be satisfactory. Most boys who develop breasts also gain a lot of weight—up to 100 pounds a year. Doctors are reluctant to operate on a Risperdal patient until he loses weight, and the surgery is painful as well as costly. So much so that Michael from Cleveland, one of Johnson’s “Risperdal boys” had to undergo a “no frills” surgery with disappointing results. Another boy said his mother paid for the surgery but couldn’t afford general anesthesia, so he had breasts removed with a local.

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“All agreed their struggle would be easier if they knew others were facing the same bullying and social isolation that they faced as a boy with breasts,” Johnson said. “There are potentially tens of thousands more guys out there that don’t know why they’ve developed breasts, and they don’t realize how many others? have similar stories.”

A few Risperdal victims have prevailed in their lawsuits and were awarded huge sums of money. Andrew Yount was awarded $70 million by a Philadelphia jury, for instance. But thousands of boys without the benefit of an experienced attorney haven’t received a dime, despite Johnson & Johnson (the Risperdal maker) being fined $1.2 billion in 2012 and a whopping $2.2 billion fine just one year later. And the mammoth drug company raked in $800 million in Risperdal sales last year alone.

Our hats off to photographer Richard Johnson and the six courageous men profiled in “Risperdal Boys”.

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