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DePuy Attune Knee Implant Failure Lawsuit

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Rocky Thompson recently filed a product liability lawsuit filed against Johnson & Johnson the world’s largest pharmaceutical and medical device maker and it’s DePuy Synthes subsidiary.
According to lawsuit allegations, thousands of patients had to undergo painful extensive revision surgery to remove and replace defective DePuy Attune knee devices.Thompson claimed that the DePuy Attune knee replacement failed prematurely leading to painful revision surgery. Thompson filed in the U.S. District Court for the Middle District of Louisiana claiming that the popular DePuy Attune Knee implant is defectively designed and unreasonably dangerous.  According to Thompson, he underwent a knee replacement in 2015, with the DePuy Attune system utilizing a fixed tibial insert and fixed tibial baseplate. But within a few years, he developed severe pain and instability requiring revision surgery to remove the DePuy Attune knee. The DePuy Attune knee implant failed because of a lack of bond and failure at the tibial baseplate-cement interface. In other words, the “glue” or cement that was designed to hold the device together failed.

What is the DePuy Synthes Attune Knee system?

The DePuy Synthes Attune Knee system was approved by the FDA in 2010, and sold in early 2013. The DePuy Attune system became a blockbuster device, with over 400,000 DePuy Attune knee implants sold worldwide.

What is the problem with DePuy Synthes Attune Knee system?

According to lawsuit allegations, thousands of patients had to undergo painful extensive revision surgery to remove and replace defective DePuy Attune knee devices. Patients blame the faulty knee implant device for severe pain, swelling, and instability in the knee caused by loosening of Attune’s tibial baseplate part from the baseplate-cement interface. Many patients have developed serious side effects including fractures, infection, soft tissue injury and permanent damage after unavoidable revision surgery.

FDA bombarded with DePuy Synthes Attune Knee system failure reports

The FDA has already about 1,400 reports involving failure with DePuy Attune knee replacements, including at least 633 cases where patients have already had revision surgery.

Medical Report of early failure

The researchers in the Journal of Knee Surgery found that the DePuy Attune knee implant system had high rates of tibial loosening and premature failures, highlighting concerns about problems at the implant-cement interface. The issue is mechanical loosening, caused by the failure of the bond between the tibial baseplate and the implant-cement surface. The lawsuits allege that when the loosening occurs, the artificial knee can detach from the existing bone, causing knee implant failure. When the artificial knee replacement loosens, it can cause pain and chip away at the bones. This can lead to reduced physical movement because of severe pain, and ultimately the device fails, causing loss of knee function.

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‘Complete management failure’ led to Hollywood Hills nursing home deaths, CMS official says

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Recent hurricanes in Texas, Florida and Puerto Rico have led to the Centers for Medicare & Medicaid Services wanting to boost its emergency preparedness plans nationwide for future natural disasters, an official with the agency said Tuesday.

Kimberly Brandt, principal deputy administrator for operations at CMS, said the agency had to “think outside of the box” to come up with creative ways of supporting and communicating in providers in storm-hit areas. Brandt spoke during a hearing in the House Energy & Commerce Committee Oversight and Investigations Subcommittee on federal health programs’ preparedness and response to this year’s hurricane season.

But when asked by Rep. Gus Bilirakis (R-FL) how a Hollywood Hills skilled nursing facility could “be so unprepared for a medical emergency that 14 residents lost their lives” during Hurricane Irma, Brandt called the incident “a complete management failure.”

Reports on the Hollywood Hills incident shows “several of the failings” that led up to the residents’ deaths involved staff not being adequately trained on the emergency preparedness plan, or following proper emergency protocol, Brandt added.

“They did not meet our conditions for participation for keeping the temperature at a reasonable level; they did not provide adequate care to the patients,” Brandt said. “In terms of patient safety the management has the responsibility to ensure that they are meeting emergency preparedness requirements.”

Rep. Kathy Castor (D-FL) also tackled the Hollywood Hills deaths, as well as “why it has taken so long” to implement the emergency preparedness rules that came out of Hurricane Katrina in 2005. Surveys ensuring compliance with that rule, which was finalized last year, will begin on Nov. 15.

“[The rule] is something that we think goes a long way toward addressing a lot of the concerns that have been raised by Hollywood Hills, but in light of the event there was want to continue to look at it to see if we could do more,” Brandt said.

The hearing also included questions on whether nursing facilities will be reimbursed to comply with parts of the emergency preparedness rule, such as the requirement that facilities have generators. Brandt said CMS is looking at the possibility but declined to comment further.

Click here to view the full hearing on the Department of Health and Human Service’s hurricane response.

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New York State Risperdal Plaintiff Awarded $1 Million

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Syracuse, NYOne 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.

“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.

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First Trial Underway in Cook IVC Filter Mass Tort Case

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The plaintiff’s case is underway in the first of three mass tort trials on whether Cook Medical Inc. is liable for selling a defective IVC filter that migrated through a blood vessel and punctured the plaintiff’s intestine.

“Defendants know its Cook filter was defective and knew that defect was attributable to the design’s failure to withstand the normal anatomical and physiological loading cycles,” the complaint states. The case is Hill v. Cook Medical, Inc., et al, 1:14-cv-6016.

It is the first bellwether, or test case, of 2,897 cases before US District Chief Judge Richard L. Young of the Southern District of Indiana in MDL 2570, IN RE: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation. 

Cook Medical Inc. of Bloomington, Indiana, won FDA approval for its “removable” Celect blood clot filter in 2003 using the 510(k) shortcut procedure, as opposed to the more rigorous premarket approval (PMA) process. FDA approval through Sec. 510(k) of the Medical Device Amendments of 1976 merely requires that a new device is “substantially equivalent” to a predicate device — but not a review of its safety or efficacy as would happen in a premarket approval application (PMA).

Perforated intestine

Plaintiff Elizabeth Jane Hill of Dunnellon, Florida, had a removable Cook Celect filter implanted in her vena cava, a large vein carrying blood into the heart, before back surgery on Nov. 17, 2010. By March 23, 2011, doctors tried unsuccessfully to remove the filter. Hill developed severe gastrointestinal symptoms, fatigue, diarrhea, vomiting and abdominal pain.

She underwent an endoscopy that revealed the filter had perforated through her inferior vena cava and into her small intestine. She went to Penn State Hershey Medical Center, a specialized hospital where the filter was finally taken out. As a result, the vena cava was permanently narrowed at the removal site.

The FDA recommends removing temporary filters between 29 and 54 days after implantation. However, studies have found that 43 percent of Celect filters perforate the vena cava within two months.

Hill charges that Cook failed to tell doctors that the filter cannot be removed and that it poses a risk of migrating, perforating and damaging the major blood vessel.

“The Cook filter had a safety profile that was not as good as or better than its predicate device,” the complaint states. “Defendant’s statements regarding the safety of the filter were false and misleading yet defendants continued to promote the Cook filter as safe an effective even though the data available studies, literature and clinical trial did not support long or short term safety and efficacy.”

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Risperdal Judge Explains Reasons for Denying Janssen a New Trial

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Philadelphia, PA – As 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.”
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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California Jury Awards $417 Million Against J&J in Talc Cancer Trial

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Talcum Powder Trials: Sympathy versus Science?

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Los Angeles, CA – Despite lack of consensus in the scientific community directly associating talcum powder with the risk of ovarian cancer, jurors have sided with plaintiffs rather than Johnson & Johnson in four out of six talcum powder lawsuits that have gone to trial.

While the plaintiffs have presented studies dating back to the 1970s that show a link between talc and ovarian cancer, Johnson & Johnson has in its arsenal studies showing there is little or no link. As well, plaintiffs in the Fox lawsuit, which resulted in a $72 million settlement, cited internal memos indicating that J&J officials were aware of decades of research but chose not to warn consumers, rather choosing profit over people’s lives. Attorneys introduced as evidence a 1997 memo from a J&J medical consultant who said that, “anybody who denies [the] risks” between “hygenic” talc use and ovarian cancer would be publicly perceived in the same light as those who denied a link between smoking cigarettes and cancer.”

And talcum powder is far from the first product J&J has defended: a long string of litigation, from Motrin to hip implants to contact lenses has more than tarnished its reputation. The giant health-care company has already paid out several billion dollars in civil settlements and criminal fines, and now it’s shelling out millions of dollars to settle talcum powder lawsuits. Another nail in its coffin is the Campaign for Safe Cosmetics, a coalition of groups that, since 2009, has been hounding J&J to eliminate possible carcinogenic ingredients such as 1,4-dioxane and formaldehyde from its products, including baby products. J&J finally agreed to eliminate those ingredients(The New York Times, 1/17/14), but it took several years of campaigning and negative publicity to do so.

It would appear that J&J lost its credibility a long time ago.

Because there are many conflicting talcum powder/ovarian cancer studies, it’s no wonder that one Missouri jury (again in the Fox lawsuit, Hogan et al v. Johnson & Johnson et al) deliberated for three weeks, according to Reuters (Feb 2016). Frequent talcum powder use on the female genital area increases the risk of ovarian cancer between 30 – 60 percent, according to the International Journal of Gynecological Cancer. However, the American Cancer Society studies are mixed, with some reporting a slight increased risk and others reporting no increase. Meanwhile, the FDA seems to be in limbo. The Washington Post reported that, because the FDA continues to get “adverse event reports” involving talcum powder, it is taking another look at the evidence and launching its own laboratory research. In its summary of one study funded by the FDA’s Office of Women’s Health, the agency says that “talc’s effects on female genital system tissues have not been adequately investigated.”

But jurors are human: sympathy for women with ovarian cancer perhaps outweighs scientific evidence, so far.

Johnson & Johnson has stated that, although they sympathize with plaintiffs, they “firmly believe the safety of cosmetic talc is supported by decades of scientific evidence,” and J&J spokeswoman Carol Goodrich said the Fox verdict “goes against decades of sound science proving the safety of talc as a cosmetic ingredient in multiple products.” According to the LA Times(August 21, 2017), there are still more than 4,500 claims pending nationwide.

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Body wipes found shoved inside resident; ‘frustrated’ CNA arrested

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A nursing assistant at an Oklahoma nursing home has been arrested after confessing to stuffing care wipes inside a resident out of frustration, according to local reports.

Nicholas Cory Kanke, 24, was arrested last week after authorities say he jammed 12 to 15 8-by-12-inch wipes inside of a resident who was suffering from diarrhea. Kanke said he became frustrated after cleaning the man 10 times during his shift at Cleveland Manor Nursing Home in Cleveland, OK, and wadded up the wipes in an effort to “stop or slow the diarrhea,” police wrote in an affidavit.

Kanke demonstrated to police how he inserted the wipes — which formed an 8-inch long wad — “in a forceful manner,” The Cleveland American reported. The wipes were discovered and removed by another staff member, and the resident was taken to the hospital. The resident has since returned to the facility.

The facility’s director, Drew Martin, called police to report the incident. He declined to comment to the local newspaper due to the ongoing investigation, only confirming that he reported the incident as soon as he found out and that Kanke is no longer employed at Cleveland Manor.

As of this week, Kanke remained in jail in lieu of a $40,000 bond; he is scheduled to appear in court on Sept. 19.

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The Goss Law Firm Files Suit for Child Abuse

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Emporia, KS- August 15, 2017- Four Emporia, Kansas families filed suit against Emporia State University, the University’s Center for Early Childhood Education, the Center’s program director, Keely Persinger, and teacher Kimberly Schneider alleging physical and emotional abuse of four toddler-aged children. The families allege Kimberly Schneider:
1. Held the children’s faces down on their nap cots until the children cried themselves to sleep;
2. Restrained the children to their seat by use of a strap;
3. Tucked the children’s bodies so tight with their blankets they could not move except for their heads;
4. Pulled and yanked the children aggressively by their arms;
5. Forcibly sat the children down as a method of punishment;
6. Grabbed the children’s faces in a forceful manner and squeezed their cheeks;
7. Spoke to the children in a derogatory manner; and
8. Yelled in the faces of the children.

Philadelphia Judge Refuses to Overturn $2.5 Million Risperdal Plaintiff Verdict

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Philadelphia, PA

If there was ever any doubt that Risperdal gynecomastia was a compelling issue that too few knew about, that myth was dispelled when a Risperdal lawsuit landed squarely onto the pages of People Magazine in February, 2015.

That was when Risperdal plaintiff Austin Pledger, now 22, was awarded $2.5 million over Risperdal side effects that resulted in the young man, who is autistic, growing male breasts.

According to People (02/26/15), Pledger was prescribed Risperdal for his autism at age 8 in 2002. That was four years before Risperdal was formally approved by the US Food and Drug Administration (FDA) for use in children and adolescents.

However, since doctors have the legal, medical and ethical authority to prescribe drugs off-label (in other words, for uses other than those indications sanctioned by the FDA), it was perfectly within the doctor’s purview to prescribe Risperdal to the then-eight-year-old Pledger if the physician felt risperidone (Risperdal) would benefit his patient.

Risperdal and growing male breasts became a serious issue for the autistic Pledger. The Risperdal gynecomastia breasts were large – reported by People to be 46DD – and Pledger, in frustration, was known to smash his breasts on a table causing bruising,
according to testimony given by Pledger’s mother during the trial in the family’s Risperdal lawsuit. Benita Pledger also testified that her son would habitually cover himself with a large towel when he stepped from the shower, before he could bring himself to stand in front of the bathroom mirror.

A spokesperson for manufacturer Janssen Pharmaceuticals, the subsidiary of Johnson & Johnson, expressed disappointment in the verdict for the plaintiff. “We firmly believe this verdict should be overturned,” the statement said, as published in People. “Risperdal has improved the lives of countless children and adults throughout the world.” Janssen also said that prescribing labels detailing the potential association for Risperdal and growing male breasts were available at the time.

However the family’s physician testified at trial that he was unaware of Risperdal side effects that would lead to male breast growth. Benita Pledger also testified she was also unaware of the risk for Risperdal gynecomastia. Her son faced the potential for a double mastectomy in order to rid himself of his substantial male breasts.

Janssen appealed the verdict and sought a new trial in the case. However, their motions were denied, with a judge in State court in Pennsylvania upholding the original verdict and the $2.5 million award for the Alabama family.

The Risperdal lawsuit was PP et al v. Janssen et al, IN RE: Risperdal Litigation, Case No. 120401997, in the Philadelphia County Court of Common Pleas, Trial Division.

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