Johnson & Johnson Fined $2.2 Billion for Reckless Drug Distribution

Posted on November 19, 2013 by Cal Warriner

One has to wonder how this will play with stockholders. Johnson & Johnson, the healthcare giant, has agreed to pay more than $2.2 billion to settle criminal charges over the marketing of its antipsychotic drug, Risperdal. The company’s Janssen Pharmaceuticals division is accused of marketing the drug to treat elderly patients with dementia, children and the disabled.

This case, brought by the Department of Justice, is a big win for American patients.

Risperdal was approved 20 years ago by the U.S. Food and Drug Administration (FDA) for managing psychotic disorders, not to keep the elderly subdued or children quiet.

In announcing the settlement this week, U.S. Attorney General Eric Holder called it among the largest healthcare fraud settlements in U.S. history.

J&J marketed Risperdal for unapproved uses from 1999 through 2005. And it had help. Omnicare, which dispenses drugs to nursing homes, billed the government for the unapproved drugs, and received kickbacks from Risperdal sales reps to prescribe the drug as well as another antipsychotic, Invega (for the treatment of schizophrenia) and Natrecor, a heart drug, according to a report in Bloomberg.

- See more at: http://www.searcymasstort.com/blog/2013/11/19/johnson-johnson-fined-2-2-billion-for-reckless-drug-distribution/#sthash.exfHp6zJ.dpuf

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Damages top $11M against J&J in vaginal-implant lawsuit

March 1, 2013 11:12 am by Sell, David | 2 Comments

A jury in Atlantic City ordered Johnson & Johnson on Thursday to pay $7.8 million in punitive damages to a former hospice nurse for the pain and suffering she endured after using a vaginal mesh implant sold by J&J’s Ethicon subsidiary.

The verdict follows a $3.35 million award for compensatory damages, delivered Monday.

The Gynecare Prolift implant was supposed to help support muscles and sagging internal organs near the pelvis, a condition, referred to as prolapse, that affects some women in years after giving birth. The device did not work for Linda Gross, 47, who had 18 surgeries in hope of relieving the pain after the initial operation.

Gross, who lives with her family in Watertown, S.D., missed so many days of work because of health issues that she was fired from her job.

She was unavailable for comment Thursday, but testified during the seven-week trial that her life after surgery was a “living hell.”

J&J began selling the implant in 2005 before withdrawing it in 2012 in the face of reports of problems and lawsuits. J&J said it would appeal the jury decision and both awards.

“Ethicon acted appropriately and responsibly in the research, development, and marketing of the Prolift pelvic organ prolapse repair kit,” J&J said in a statement.

The statement angered Gross’ attorney, Adam Slater.

“We’re going to need more and bigger punitive-damage awards against Johnson & Johnson before they ever have the humility to realize they are not above the law,” Slater said in an interview.

There are thousands of implant cases in state and federal courts around the country against multiple manufacturers of vaginal implants. This was just the second verdict, and both verdicts have gone to the plaintiffs.

New Jersey Superior Court in Atlantic County has, like Philadelphia’s Court of Common Pleas, become a common venue for multidistrict litigation in cases of a similar nature.

In March 2006, Slater filed his first implant suit. Gross and her husband, Jeff, researched the matter and contacted Slater that year. He now has 250 implant cases pending in state court.

J&J, which is based in New Brunswick, N.J., and has operations in several places in the Philadelphia region, faces about 1,800 implant lawsuits in New Jersey. Multiple J&J divisions face product lawsuits and are dealing with product recalls.

The company’s McNeil Consumer Healthcare plant in Fort Washington has been closed since April 2010 after dozens of product recalls and will not reopen until a federal judge approves.

In the implant case, J&J lawyer Christy Jones urged jurors — six women and three men — not to award punitive damages because J&J had not acted in a way to warrant it, according to Bloomberg News.

“I understand that you have found that we could have done a better job and that we in fact fell short,” Jones said Tuesday. “My clients understand that. We hear you, I promise you. While I confess to you from the bottom of my heart that it hurts, and we’re disappointed in the verdict, we nonetheless appreciate what you have said and recognize and respect your verdict.”

J&J was less apologetic Thursday after the punitive-damages award and said the jury decision was conflicted. The company argued that the jury said the implant was not defective in design and that J&J did not misrepresent the product to surgeons.

“While we are always concerned when a patient experiences medical conditions like those suffered by the plaintiff, all surgeries for pelvic organ prolapse present risks of complications,” the company said in its statement.

Attorney Jeff Grand joined Gross’ attorneys because his firm is involved in implant litigation and he serves as a liaison among groups of plaintiffs’ attorneys. He said the $11.15 million total award was a message from the jury.

–

Contact David Sell at dsell@ phillynews.com or 215-854-4506. Read his blog at http://www.philly.com/ phillypharma and on Twitter @phillypharma.

Read more: http://medcitynews.com/2013/03/damages-top-11m-against-jj-in-vaginal-implant-lawsuit/#ixzz2MeoDecTT

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• Jury awards $3.35 million in vaginal mesh case (healthnexercise.com)

J&J’s lawyers claim Kransky already has diseased blood vessels in his body, and that the elevated metal levels in Kransky’s body can be traced to diabetes, high blood pressure and cholesterol, stroke and kidney cancer instead of hip replacement failure, a Bloomberg article reported.

J&J recalled the ASR hip in August 2010 after 12 percent of the devices had failed. That number has since climbed to 40 percent in Australia.

Paustenbach was part of a team of researchers who claim they were unable to find previously published medical literature on the effects of cobalt on the body. The research conducted by the firm ChemRisk Inc. – which been retained in the past by companies accused of being responsible for chromium pollution – has cost J&J’s DePuy unit at least $5 million over the past 18 months. Paustenbach also claimed they found no evidence of an increased cancer risk associated with the device, and that cobalt is “not an issue to be concerned about at concentrations observed in patients with implants.”

Paustenbach cited several different studies to support his claims, including 1950s research of anemia patients given cobalt doses. “In the blood, we found that there were virtually no adverse effects in the people who had levels up to 300 parts per billion,” while Kransky’s highest cobalt reading was 57 parts per billion. He also cited an unpublished study of ten people who received cobalt doses for 30 days with no adverse effects (although the men’s blood levels reached 32 parts per billion and the women reached 91 parts per billion).

Kransky’s attorney read a list of dozens of corporations by which Paustenbach was paid to conduct research; his work has been used on numerous occasions to undermine carcinogen exposure concerns involving materials such as asbestos. When asked if he was referred to as the “go-to guy for industry,” Paustenbach reacted angrily and then acknowledged he had been described that way.

Paustenbach was also questioned extensively about ChemRisk’s Journal of Occupational and Environmental Medicine article that reversed a study that found a significant association between chromium in drinking water and high rates of cancer in certain regions of China. The journal retracted the article in 2006 for failing to disclose that it was written by his company.

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• Bullshit-R-Us …. J&J’s Toxicologist Says Metal From Recalled Hip Harmless – Bloomberg (earlsview.com)
• J&J’s Toxicologist Says Metal From Recalled Hip Harmless – Bloomberg (bloomberg.com)
• DePuy ASR Lawsuit Update: Toxicologist Testifies That Plaintiff Kransky Has High Levels of Metal in His Blood – Yahoo! Finance (earlsview.com)
• DePuy ASR Hip Recipient Feared for His Life before Revision Surgery (earlsview.com)
• J&J Failed to Weigh Hip Metal Debris Risk, Witness Says – Bloomberg (earlsview.com)
• J&J metal hip failed because of toxic debris -expert at trial | Reuters (earlsview.com)
• J&J metal hip failed because of toxic debris – expert at trial | Reuters (earlsview.com)
• Metal hip patients ‘need annual checks’ – Health News – Filey and Hunmanby Mercury (earlsview.com)
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Trials Tell Us So Much about the Groupthink of Corporations

The doctor, who was also a paid J&J consultant, wrote the note nearly two years before the company recalled the ASR in 2010. Despite the fact that this was only one of several early warnings the executives received from consultants, J&J’s DePuy subsidiary continued to sell the device and no one alerted doctors who continued to implant it in patients’ bodies.

J&J insists it responsibly determined when to recall the ASR, but plaintiffs’ lawyers allege the executives put profits ahead of patients and even planned to fix the device instead a New York Times article explains. This conflict points to a bigger medical issue that involves physicians’ ethical obligations to warn about dangerous medical devices.

Why would doctors keep quiet, when they know people will get hurt? They may fear subsequent lawsuits against them; some claim to be too busy to file paperwork with the U.S. Food and Drug Administration (FDA); or they may believe that a product’s defect was their fault, the article explains. Another reason doctors remain silent is their financial ties to a drug or device maker. And breaking ties can carry a cost.

For example, when orthopedic specialist Dr. Lawrence D. Dorr wrote an open letter in 2008 to warn fellow surgeons a Zimmer Holdings hip implant was flawed, a whisper campaign questioned his skills as a surgeon. His practice suffered for a year.

Doctors have traditionally drawn attention to medical issues by publishing their research in a medical journal, which not only ensures the data’s credibility but also protects the researchers from attack. Unfortunately, studies often take a year or more to be published. For example, data were published about J&J’s flawed hip device, but most did not appear until after the recall.

The repercussions of not speaking out are playing out during the first J&J trial. The DePuy ASR multidistrict litigation (MDL) consolidates similar pending lawsuits into one case under one federal judge.

Many patients with the ASR hip have suffered from hip implant failure, which can cause pain, fatigue, walking difficulty, lack of flexibility, hip popping or squeaking, and swelling in the surrounding tissue. Some of these symptoms point to metal poisoning or substantial tissue loss that can never be restored.

Another J&J Product TRIAL… follow the links for all 22 days…

Legal News

Day 22: Linda Gross v. Ethicon Case Wraps with Expert Refuted

Feb 12th, 2013 | By Jane Akre

Thanks to Courtroom View Network for its live video stream. February 12, 2013~ On this last day of evidence presented in the Linda Gross v. Ethicon trial in New Jersey Superior Court both sides took the opportunity to make a final impression on the jury.  For the defense that meant to cement the testimony of
[continue reading...]

Posted in Legal News | 1 Comment »

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Day 21: Linda Gross v. Ethicon Expert Says Prolift Did Not Injure Gross

Feb 11th, 2013 | By Jane Akre

February 11, 2013 ~  The trial of Linda Gross v. Ethicon started late in the day around noon on Day 21 of the proceedings.  Apparently legal arguments were taking place off camera and out of the ear of the jury. The case has now gone to Ethicon to refute the evidence presented so far. Remember
[continue reading...]

Posted in Legal News | 12 comments
Tags: Adam Slater, Adverse events, Christy Jones, complications, Courtroom View Network, Day 21 Linda Gross v. Ethicon, Dr. Elizabeth Kavaler, Dr. Shlomo Raz, Gynemesh PS, Mesh medical Device News Desk, miles murphy, Prolift,rectovaginal, sean O’bryan, transvaginal, Urogynecologist, vincent lucente

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Johnson & Johnson (NYSE:JNJ) and recalls have started to seem like synonyms as the company is hit with another recall relating to its surgical stapler devices, which could pose serious health issues for patients. The company will recall as much as 157,000 stapler devices after the U.S. FDA tagged the recall as class I, the most serious. 

The recall comes barely within two months of recent recall of the company’s Hemostatic Bone Putty, and  may not bode well for the company, which is grappling to revive its Medical Devices & Diagnostics division.

The company’s brand value took a hit following the DePuy metal hip implants recall and related lawsuits. With its $21 billion Synthes aquisition, Johnson & Johnson is hoping to recover from these setbacks.

For the full article – click here.

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Medical giant Johnson & Johnson is facing its third class action in Australia in as many years.

The case filed in the Federal Court today relates to a product called transvaginal mesh.

It has helped many women who have suffered prolapsed organs by assisting their muscles with support, but for a significant number it has caused life-changing harm.

Lawyers believe it could be the largest product class action in Australian legal history.

It has also cast fresh light on the system of approvals because the mesh was introduced without any pre-market testing, with surgeons leading the call for change.

When Julie Davis was younger she had a plan to travel the world, meet the man of her dreams and settle down to have a family.

She succeeded, but along the way she endured a traumatic birth and some terrible consequences.

“I’d had a very bad forceps delivery with my first child who’s now 10 and I had to wait until all my children were born to fix a very significant bladder prolapse,” Ms Davis said.

“From my understanding it was the worst kind of prolapse because the bladder was actually outside my body.”

The surgery itself was way more traumatic and devastating than I had imagined.

It is a common problem, but there was a relatively new product to Australia – transvaginal mesh – that could be stitched in near the top of the vagina to help the pelvic floor muscles support the internal organs, much like a sling.

“The surgery itself was way more traumatic and devastating than I had imagined,” Ms Davis said.

“I just felt unwell all the time, I was in pain, a lot pain, discomfort down below. I also had this feeling – lack of energy, like my body was fighting something all the time.”

While her husband shouldered the load of earning an income and running the household, Julie, who was only in her 40s, was forced to use a mobility scooter.

For her, walking was painful, so too was sex, and the emotional toll was almost too much.

“It did get to the point where I just actually was chronically depressed and I had to go to see a GP and go on antidepressants,” she said.

“There was one point [when] I was driving my car and I was just thinking, ‘jeez, it would be easy just to turn the wheel at Curl Curl headland and just go off’ because I felt that desperate.”

‘Adverse events’

It was after this that Ms Davis sought out a new surgeon, urogynaecologist Richard Reid.

He says the mesh was acting like a cheese grater in her body and had literally rubbed a hole in the wall of her vagina.

“When the mesh is put underneath the bladder, the bladder moves back and forth as it fills and it moves back and forth during intercourse,” Dr Reid said.

“Because mesh scar is fundamentally quite fibrous and the bladder is very soft, we call this compliance mismatch, which means the same as rubbing a piece of cheese over a metal grater; the metal grater is obviously harder than the cheese.”

Research published last May in the New England Journal of Medicine found mesh kits had “higher short-term rates of successful treatment” but also “higher rates of surgical complications and post-operative adverse events”.

Two months later, in July 2011, the Food and Drug Administration (FDA) in the United States issued a formal warning saying they were a “greater risk” with “no evidence of greater clinical benefit”.

Johnson & Johnson removed its product from sale earlier this year and class actions are already underway in America and Canada, and now Australia.

This prolapse mesh class action that we’ve commenced in the Federal Court today has the potential to be the biggest product class action that Australia has ever seen.

Rebecca Jancauskas, who is representing Ms Davis as the lead plaintiff in the class action, estimates as many as 20,000 Australian women may have had transvaginal mesh implanted, and that is despite the product having undergone no clinical trials.

“This prolapse mesh class action that we’ve commenced in the Federal Court today has the potential to be the biggest product class action that Australia has ever seen,” Ms Jancauskas said.

Certain classes of medical devices may be sold without adequate testing if they are going to be used in a similar way to existing products.

Mesh kits had already been very successful in treating urinary incontinence, an area where there is not the same friction from internal organs.

“So the system was set up and the device companies have used the system,” Dr Reid said.

“I think that with the wisdom of hindsight, it would have been more prudent for them to have done more testing before it was released, but in many I see the primary fault is the system didn’t think out what was going to happen.”

Previous class action

It is not the first legal trouble for Johnson & Johnson in Australia.

Last year a class action was launched over its DePuy hip replacement device which left hundreds of patients poisoned and seriously disabled.

In 2010 the company faced similar legal proceedings over its knee replacement products.

Just like the mesh kits, neither product had undergone pre-market clinical trials.

“Given that this is now the third product class action that Johnson & Johnson has faced in three years, it should raise some serious concerns about their product safety standards,” Ms Jancauskas said.

The company has issued a statement saying:

Johnson & Johnson Medical continues to have confidence in the safety and efficacy of these products.

The decision to discontinue these products was based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy.

This is not a product recall, and based on this notification it is not necessary for women who have received one of these products to take any action.

For more than a decade, our organisation has invested in the research, development and clinical study of products to treat a wide range of pelvic disorders.

We remain committed to advancing the standard of care for women’s health and will continue to offer safe and effective treatment options for women.

Some are angry at the Australian regulator, the Therapeutic Goods Administration (TGA).

Senator Nick Xenophon, who was part of a parliamentary inquiry into the hip devices, says he is concerned that similar problems are still happening.

“Well this is another instance of regulatory failure. The TGA is meant to be a watchdog of these devices but it’s failed time and time again,” Senator Xenophon said.

“This is the third serious instance in the last 12 months. After the problems with hip replacements, breast implants and now this, [it] indicates there are some serious systemic problems with the TGA.”

And while America’s FDA issued its warning to consumers last year, there has been no such move from the TGA.

In a statement, it explained that it held a detailed review in 2010 and found the complication rate was low and depended on the skill of the surgeon, but that it would continue to monitor the situation.

Ms Davis says “it’s been a tough road” and she has now had her mesh surgically removed.

She and husband Tim are desperately hoping that after four years and five surgeries, there is something to look forward to.

“I hope that we’re over the hill now and start rebuilding our lives again in the way that we planned to begin with,” Mr Davis said.

“We had great plans and great ideas of how we wanted to build our life, with the children et cetera, and I feel that life has been running away from us and we haven’t been able to sit back and enjoy some of it.”

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• Australia – Stuart Cain DePuy Tragedy Continues… (earlsview.com)
• Transvaginal Mesh Lawyer Adam Slater of Mazie Slater Katz & Freeman, LLP Discusses Johnson & Johnson’s Decision to Halt Sale of Vaginal Mesh Implants (prweb.com)
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DePuy ASR Hip Implant Settlements Reached Prior To Jury Trial

The first ever DePuy ASR hip implant cases set for a jury trial inNevada has recently settled. It was supposed to be the first courtroom battle in the Counrty of patients with the defective ASR hip replacement against Johnson & Johnson subsidiary DePuy Orthopaedics, manufacturer of said hip implant. In December later this year, a Las Vegas Nevada state court judge was scheduled to preside over a jury trial of three plaintiffs against DePuy Orthopaedics for problems that the DePuy ASR hip replacement caused.All three of the patients had their ASR hip devices removed and replaced (revised).

However, in what is breaking news, that Nevada trial is no longer going to go forward as originally scheduled because the parties have recently agreed to a confidential settlement.

December 2012 was to be the first time that Johnson & Johnson subsidiary DePuy Orthopaedics was going to appear in court and explain what caused their hip product to create so many problems for patients who had their product implanted. This DePuy ASR hip implant settlement ends any showdown that was supposed to occur inLas Vegas. Like many settlements involving larger corporations like Johnson & Johnson, the terms of this settlement remain confidential. It is unfortunate that without the threat of a trial, the defendants DePuy and J&J has not compensated harmed patients that have had to undergo surgery to replace the defective device that they manufactured.

While the December 2012 trial is no longer moving forward given the settlement, there is another jury trial set by a Maryland state court judge set to begin in January 2013. The Maryland trial is also on behalf of three patients with recalled DePuy ASR hip implant that had to be replaced. In the event that a settlement is not reached prior to January 2013, Johnson & Johnson subsidiary DePuy Orthopaedics will have to explain what caused the defective hip product.

Both the December 2012 lawsuit and the January 2013 lawsuits were filed because Johnson & Johnson subsidiary DePuy, led thousands of patients with damaged hips to believe that their now recalled ASR Hip Replacement System, which uses a metal-on-metal device, would improve the pain and mobility of their hip. However, the danger of a metal-on-metal device has proven to be just as harmful as a damaged hip, if not more so in many cases based on our investigations. The implant contains the elements cobalt and chromium, which can be hazardous, and promote an inflammatory response that damages the surrounding tissue and bone. Shards of this metal have been known to grind off of the ASR hip implant damaging surrounding tissues and muscles, resulting in an increased level of these dangerous metal ions in the body. This can cause intense leg, hip, or groin pains, and in many cases patients have reported pain to the point of immobility.

To date there are more than 8,000 claims pending in the federal court and state courts. Childers, Schlueter & Smith, LLC is a leading firm in Georgia handling and litigating DePuy ASR hip implant claims. To date, our office has filed more than 160 individual claims on behalf of Georgians and other ASR victims from around the County. It is unclear how many trials will have to be tried before DePuy and J&J will step up to do the right thing and acknowledge the harms and misery created by there ASR hip implant products and further agree to compensate the victims for the past, present and future harms expected from this recalled device.

For more information or assistance please visit CSSfirm.com or call us at 404-419-9500 for assistance or any questions in preserving a claim before any potential statute of limitations may run.

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Metal on metal hip replacement, should you be concerned?

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