More Trials Set For JNJ's Risperdal Despite Latest Settlement

The Legal Examiner

Posted by Derek T. Braslow
February 1, 2017 2:29 PM

Lawsuits against Johnson & Johnson (J&J) continued to increase in 2016, with new complaints filed over a mix of household items, drugs, and medical devices including Johnson’s Baby Powder, the DePuy and Pinnacle hip implants, the blood thinner Xarelto, and the antipsychotic Risperdal—a drug which now accounts for over 15,000 pending claims against the company.

Until recently, J&J’s strategy with many of these cases has been to go to trial rather than settle—a tactic that could be taking its toll, as it resulted in some of the largest jury verdicts of 2016. Juries awarded almost $200 million to talc users with ovarian cancer and $1.5 billion to individuals with failing artificial hips. One of the largest single verdicts against the company last year was for $70 million—handed down in July to a young Tennessee boy who claimed that taking Risperdal caused gynecomastia or the formation of female breast tissue.

J&J and its subsidiary, Janssen Pharmaceuticals, could be changing their approach for 2017. On January 9, just three days before another Risperdal case was to go to trial in Philadelphia, J&J agreed to a confidential settlement with the plaintiff—a New York boy who also suffered serious side effects while taking the drug. Ultimately, J&J has defended the settlement as an isolated decision rather than an indication of how remaining cases might be handled. Court documents show more than 2,000 lawsuits still pending as part of a mass tort litigation in the Philadelphia Court of Common Pleas—where the $70 million verdict was awarded last year.

J&J should be concerned with a continuous pattern of plaintiffs’ jury verdicts in Philadelphia Risperdal trials. Several additional Risperdal trials are scheduled for the first half of 2017, and more trials involving multiple plaintiff firms are to be set for trial by the end of the year. This is on top of additional trials scheduled in St. Louis over its cancer-causing baby powder claims.

The results of these upcoming trials will have a significant impact on the prospects for settlement.


Thank You Mr Braslow and The Legal Examiner.

J&J Jury Urged To Award $5 Million For Failed Metal Hip

Bloomberg has;
J&J Jury Urged To Award $5 Million For Failed Metal Hip
By Andrew Harris & David Voreacos - Apr 15, 2013 7:01 PM ET

Johnson & Johnson (JNJ)’s DePuy unit defectively designed a metal-on-metal hip implant and should award an Illinois nurse at least $5 million for harm caused by her device’s failure, her lawyer argued to a Chicago jury.

DePuy knowingly sold defective ASR hips before J&J, the world’s largest seller of health-care products, recalled all 93,000 of the metal-on-metal implants in August 2010, said Denman Heard, an attorney for Carol Strum, the plaintiff. Heard also urged jurors to award extra damages to punish the company.

“Shame on DePuy for allowing this to happen,” Heard said in his two-hour closing argument at a trial that began on March 11. “They could have saved and prevented so much harm.”

Continue reading Bloomberg coverage here.

Thank You Bloomberg, Mr Harris and Mr Voreacos

Witness: J&J Lowered Own Standards To Deem Metal Hips 'Safe'

Fierce Medical Devices has;

Witness: J&J Lowered Own Standards To Deem Metal Hips 'Safe'
January 29, 2013 | By Damian Garde

When Johnson & Johnson's ($JNJ) metal-on-metal hip implants failed an internal safety test, the company opted against fixing the issue and instead just changed its protocols, a witness testified in one of thousands of lawsuits the drug and device giant now faces.

As Bloomberg reports, a biomedical engineer told the court that J&J had ample opportunity to fix problems with its now-recalled ASR hip implants, and another witness testified that the device had a 44% failure rate over 7 years, citing Australian data.

J&J has already spent about $900 million to argue and settle suits since the ASR's 2010 recall, but analysts expect the 10,000 lawsuits now pending could cost the company billions.

And this week's testimonies did little to quell the bad press around the issue. Magnus Flett, who led the ASR design team, told the court that the company decided not to redesign the implant for financial reasons, Bloomberg reports, and J&J didn't tell surgeons that ASR failed nearly 8 times as often as other devices because "I don't believe that was clinically relevant."

The plaintiff in the case claims that his ASR implants failed to spur bone growth and abraded to deposit dangerous cobalt and chromium into his bloodstream. J&J contends that it followed procedure in getting FDA clearance for the tech, which the company maintains was not defective.

Meanwhile, J&J is dealing with mounting litigation over Pinnacle, its other, not-recalled metal hip implant. That device is said to fail at a rate of about 10%, which, while below the ASR, still exceeds what's commonly accepted by manufacturers.

And Johnson & Johnson isn't the only devicemaker facing all-metal-hip fallout. Stryker ($SYK) spent about $133 million to deal with its implant recall last quarter, and the company says the whole fiasco could cost $390 million before it's resolved.

None of this has escaped the notice of the FDA, which is proposing a sweeping change in its all-metal hip regulations, requiring manufacturers to prove the safety of their commercialized implants or have them yanked from the market.

- read the Bloomberg report

Related Articles:
Report: J&J knew of hip failure years before recall
FDA wants feedback on tighter hip-implant regs
J&J back in court over DePuy hip implants


Thank You Fierce Medical Devices and Mr Garde


J&J Study Predicted 37% Hip Replacement-Failure Rate

J&J Study Predicted 37% Hip Replacement-Failure Rate

Bloomberg has;
J&J Study Predicted 37% Hip-Failure Rate
By David Voreacos & Jef Feeley - Jan 23, 2013 12:01 A

One year after Johnson & Johnson (JNJ) pulled 93,000 metal hip implants from the market, the company internally estimated that 37 percent of the devices would fail within 4.6 years, according to newly unsealed court records.

J&J faces 10,000 lawsuits over its ASR hips, which it pulled in August 2010 after citing U.K. joint registry data showing that more than 12 percent failed within five years. The estimate of triple the failure rate publicly cited by J&J came in documents unsealed Jan. 18 in the lawsuit of Loren Kransky in state court in Los Angeles.

Enlarge image

J&J, based in New Brunswick, New Jersey, said in a November filing with the U.S. Securities and Exchange Commission that it increased reserves “due to anticipated product liability litigation and costs associated with” the ASR hips. Photographer: Emile Wamsteker/Bloomberg

Jurors are scheduled to hear opening statements on Jan. 25 in Kransky’s case, the first to go to trial against J&J, the world’s biggest seller of health-care products. J&J offered to pay more than $200,000 a case to settle most of the 10,000 lawsuits, according to five people familiar with the matter. The deal’s cost could exceed $2 billion if most plaintiffs accept the terms. Lawyers for hip recipients have so far rejected the offer, the people said.

The failure-rate estimate came in pretrial testimony of Paul Voorhorst, a biostatistician for J&J’s DePuy unit, which made the hips. A plaintiff’s lawyer, Brian J. Devine, asked Voorhorst about a graph showing the company’s review of 554 implanted hips through September 2011, and how many would fail, requiring follow-up replacement surgery known as revisions.

“That means that 37 percent are expected to fail at 4.57 years, correct?” Devine asked Voorhorst.

“The estimated revision rate at that time would be 37 percent,” Voorhorst said. “That’s correct.”

‘Patient Interests’

Lorie Gawreluk, a DePuy spokeswoman, said that the company was “looking out for patient interests by analyzing data” on the ASR hip system.

She said the analysis cited by Voorhorst “was based on a small, limited set of data that could not be used to generalize the revision rate for ASR, unlike published data from national joint registries that include large numbers of patients and detailed revision information.”

The J&J hips were made from a cobalt and chromium alloy used in two related models -- the ASR XL Acetabular System, and the ASR Hip Resurfacing System. In announcing its recall, J&J cited unpublished data from the U.K. showing that within five years, 13 percent of ASR XL hips failed and needed revision, and 12 percent of the ASR Hip Resurfacing System failed.

In March 2011, the British Orthopaedic Association and the British Hip Society said preliminary data put the ASR XL’s failure rate in the U.K. as high as 49 percent after six years.

Lawyers for patients claim that debris from the metal ball sliding against the metal cup causes tissue death around the joint and may increase the amount of metal ions in the bloodstream to harmful levels. Patients who sued typically cite pain and say they are immobilized by joint dislocations, infections and bone fractures.

Negligent Recall

Claims by Kransky include failure to warn, negligent recall and manufacturing defect.

At the Kransky trial, “DePuy will vigorously defend itself and believes the evidence to be presented will show the company acted appropriately and responsibly,” Gawreluk said.

Kransky, 65, is a retired prison guard who got a hip implant in 2007 and had it replaced in 2012. J&J’s lawyers asked Judge Stephen Czuleger to bar Kransky’s doctors from testifying their patient was “poisoned by the chromium and cobalt” released by the artificial hip, according to publicly filed court documents.

Thomas Trotsky, Kransky’s primary care doctor, said in a deposition that his observations of Kransky over the years led him to conclude that “something was poisoning Mr. Kransky, and, of course, we thought it was the hip,” according to a Jan. 7 court filing.

‘Metal Poisoning’

Trotsky said he and his medical colleagues suspected Kransky was suffering from exposure to “heavy metal poisoning” and they were “unable to identify any other factor besides the prosthetic hip” that could be causing it, according to the documents.

While J&J opposed the motion, the judge ruled Jan. 18 that the doctors can testify. J&J’s lawyers argued that Kransky’s attorneys are seeking to “inflame the jury or appeal to their emotions” by having the doctors testify the former prison guard had been poisoned by the hip’s components.

J&J, based in New Brunswick, New Jersey, said in a November filing with the U.S. Securities and Exchange Commission that it increased reserves “due to anticipated product liability litigation and costs associated with” the ASR hips. The company didn’t specify the amount of the increase.

The company said in January 2012 that it had spent about $800 million on hip recalls during the prior two years. J&J didn’t provide an estimate of its product-liability costs.

10,000 Suits

J&J faced 10,100 suits over the hips through September, according to the November filing. Most pretrial collection of evidence has been consolidated in federal court in Toledo, Ohio, where 7,240 cases are pending, and California state court in San Francisco, where more than 2,000 cases are filed. Other cases have been filed in state courts around the U.S.

In a Jan. 4 court filing, J&J said Kransky has smoked since he was 12, broke his back when he was 15, and was exposed to Agent Orange when he served as a U.S. Air Force mechanic inVietnam. He suffers from diabetes, coronary artery disease, high blood pressure, and kidney disease. He had two strokes and suffers from kidney cancer, according to the company.

Kransky’s case was chosen from those pending in the California Judicial Council Coordinated Proceeding before Judge Richard Kramer in San Francisco.

The Kransky case is Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County (Los Angeles). The consolidated federal case is In re DePuy Orthopedics Inc., ASR Hip Implant Products Liability Litigation, 10-MD-2197, U.S. District Court, Northern District of Ohio (Toledo).

To contact the reporters on this story: Jef Feeley in Wilmington, Delaware, atjfeeley@bloomberg.net; David Voreacos in Newark, New Jersey, at dvoreacos@bloomberg.net

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net

Thank You Bloomberg, Mr Voreacos and Mr Feeley

HT to Pharmalot