J&J Talc News

Ovarian cancer injuries are not the only injury of which plaintiffs have filed against Johnson & Johnson concerning their talcum based powder, generally known as baby powder. Earlier this month, a California jury on Thursday sided with Johnson & Johnson and its talc supplier of any liability for a woman’s terminal mesothelioma, an asbestos-related cancer, holding that there was no evidence that the companies’ talcum powder was unsafe. The jury deliberated for nearly two days after an almost four-week trial.  The jury found that J&J did not negligently design or sell its talc, that the talc did not fail to perform as safely as a reasonable consumer would have expected, that the talc was not defective, and that J&J did not fail to warn of any potential risks, "known or knowable based on general scientific knowledge at time of sale." 

Most of the cases we have seen so far involve claims that the talcum-based powder causes ovarian cancer. In one of those cases, a Missouri state judge upheld a jury’s $110 million verdict against Johnson & Johnson for selling ovarian cancer-causing products, saying the conduct on which the claims are based occurred in Missouri even though the woman who brought them is from Virginia. 

Since J&J used a Missouri-based company, Pharma Tech, to "manufacture, mislabel and package" the talc products at issue, Judge Rex M. Burlison found that the verdict for the plaintiff was within the jurisdictional standards laid out by the U.S. Supreme Court in its June decision in Bristol-Myers Squibb Co. v. Superior Court of California. This finding means that non-Missouri plaintiffs may continue pursuing their cases in Missouri, which has been home to a large amount of talc litigation in recent years.

Booth Samuels and the attorneys at Pittman, Dutton & Hellums, P.C. are currently accepting talc-injury cases. If you or someone you love is a female that regularly used J&J Baby Powder or Shower to Shower and, since the year 2000, have been diagnosed with ovarian cancer, please contact Booth Samuels at 1-866-515-8880 or by email at booths@pittmandutton.com for a free consultation.

Johnson & Johnson Hit Third Time Over Pinnacle Metal-on-Metal Hips

A Dallas federal jury on Thursday found in favor of six plaintiffs and against Johnson & Johnson and its DePuy Orthopaedics unit. The $247 million verdict is the third loss J&J has had in four civil jury trials. The verdict includes $78 million in compensation for the plaintiffs’ injuries and more than $168 million in punitive damages.

J&J won the first Pinnacle test trial in 2014, but subsequent juries determined the companies to be liable. A jury in March 2016 awarded five Texas plaintiffs $500 million in damages. That award was later cut to $150 million. 

J&J and DePuy were also found liable at a trial in March, during which a jury awarded six California patients $1 billion - a verdict that was later reduced to $543 million. 

Six New York residents implanted with the devices said they experienced tissue death, bone erosion and other injuries they blamed on design flaws. The jury found that the metal-on-metal hip implants were defectively designed and that the companies failed to warn consumers about the risks. 

J&J faces more than 9,700 Pinnacle lawsuits in state and federal courts across the United States. It is more likely than not that J&J will appeal the verdict, as they have the other three. Three more bellwether trials have been scheduled. These gigantic losses could weaken the company’s position in any settlement talks with plaintiffs in the MDL. A previous DePuy hip-implant settlement cost the company billions. Johnson & Johnson agreed to resolve more than 9,800 lawsuits over DePuy’s ASR hip implants for $4.4 billion in 2013 and through a settlement extension in 2015.

The ASR model was recalled. The Pinnace model was never recalled, however DePuy ceased selling the metal-on-metal Pinnacle devices in 2013 after the U.S. Food and Drug Administration strengthened its artificial hip regulations.

Pittman, Dutton & Hellums is actively filing cases on behalf of individuals allegedly injured by both types of artificial metal-on-metal hip implants- ASR and Pinnacle models. If you would like a free case evaluation, please contact Booth Samuels toll free at 1-866-515-8880 or at booths@pittmandutton.com.

Jury Finds For Victims of DePuy Pinnacle Hips

Today, a jury found Johnson & Johnson liable with a $497.6 million verdict in the second bellwether trial in the multidistrict litigation over allegedly defective Pinnacle hip prosthetics manufactured by its DePuy Orthopaedics Inc. unit. The case involved five separate plaintiffs. The first bellwhether case tried last fall was a defense verdict.

The trial took place in Texas after hearing 37 days of testimony. The jury received the case late in the afternoon on March 10th and deliberated for four more days before reaching the verdict.

This is the second major defeat for Johnson & Johnson in a little over a month. The first defeat resulted a St. Louis jury awarded an injured plaintiff $72 million against Johnson & Johnson for their talc-based powders. That theory involved the powder creating an increased risk of ovarian cancer.  

Our firm has been handling Pinnacle and ASR hip cases for nearly six years. If you or a loved one were implanted with a DePuy Pinnacle or ASR metal-on-metal hip and suffered injuries, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.

JPML To Hear Xarelto Arguments Today

The Judicial Panel on Multidistrict Litigation (“JPML”), sitting in Charleston, South Carolina, will hear arguments today for and against the consolidation of Xarelto lawsuits. Lawyers for those injured by Xarelto are arguing for a Xarelto MDL, while Bayer and Johnson & Johnson, the manufacturers of Xarelto, are fighting consolidation.

Patients who took Xarelto, a blood-thinning drug, accuse the drugmakers of downplaying the medicine’s bleeding risks and asked that the cases be sent to U.S District Judge David Herndon in East St. Louis, Illinois. Judge Herndon is the same judge who is presiding over the Pradaxa MDL, which settled earlier this year. That settlement is estimated to reach $650 million.

Bayer’s lawyers are arguing that should an MDL be formed over their objections, that the cases  be consolidated in New Jersey under U.S. District Judge Freda Wolfson. Judge Wolfson is located in Trenton and is already presiding over two Xarelto case. Another argument for consolidation in New Jersey is that it is located near corporate headquarters.  

In court filings, it is claimed that 65 deaths have been linked to bleeding caused by the drug, which has no antidote. So far, there are 21 cases filed in 10 federal courts.

As I have posted many times on this blog, MDL’s are a great mechanism for consolidating cases and can save time and money on pretrial discovery, depositions and dispositive motions.

U.S. regulators originally approved Xarelto in 2011 to prevent blood clots in patients undergoing knee and hip surgeries. The drug’s use has been extended to patients with irregular heartbeats and potentially deadly leg and lung blood clots. It is similar to Coumadin, or warfarin, used to thin stroke victims’ blood for nearly 50 years.  Xarelto was marketed as more effective at preventing strokes than Coumadin and easier to use since Xarelto patients did not need frequent tests to monitor their blood-plasma levels.

In court filings, Xarelto patients argue the companies did not properly test the blood thinner before putting it on the market, hid the fact the medicine had no antidote, and overstated the drug’s effectiveness.

The case is Xarelto Products Liability Litigation, MDL No. 2592, U.S. Judicial Panel on Multidistrict Litigation. A decision by the JPML will be issued in the coming weeks.

Pittman, Dutton & Hellums, P.C., is currently investigating Xarelto cases. If you or a loved one were prescribed Xarelto and suffered an irreversible internal bleeding that lead to hospitalization and/or death, contact Booth Samuels at toll free 1-866-515-8880 or by email at booths@pittmanudutton.com.

Jury Finds For J&J DePuy In First Pinnacle Bellwether Case

Yesterday, a nine member panel found for the defendant Johnson & Johnson and their subsidiary DePuy Orthopaedics in the first MDL bellwether case to go to trial over the Pinnacle Metal-On-Metal hip replacement device. The jury deliberated for a little more than two days. The trial lasted eight weeks.

In what is a huge blow to the nearly 6,000 other claimants in the MDL, the jury found that the devices were safe when used and implanted properly. Lawyers for the defendants basically blamed the surgeons who implanted the plaintiff’s devices for not properly positioning them when implanted.

The plaintiff in the trial claimed that the metal-on-metal wear from the device resulted in exposure to extremely high levels of cobalt and chromium which affected poisoned her blood and caused soft tissue damage. She ultimately had to have bi-lateral hip surgeries to remove to the devices.

The Pinnacle device is different than DePuy’s ASR Metal-On-Metal hips in several facets, although they appear to be extremely similar. The ASR was recalled by J&J, whereas J&J just stopped selling the metal-on-metal version of the Pinnacle hip in August 2013 after the FDA said it would require device makers to submit new versions of the artificial hips for pre-market approval. J&J settled the ASR MDL last year for an estimated $4 Billion.

Of course, this is just the first chapter in what will most likely be a long and drawn out fight. J&J and DePuy face several other Pinnacle trials in different jurisdictions that are set soon, and there were will most likely be several other bellwether trials coming out of the MDL. 

J&J Recall 13,500 Bottles of Xarelto

Johnson & Johnson's Janssen unit is recalling approximately 13,500 bottles of its top-selling anticoagulant Xarelto because of microbial contamination discovered in a sample.

According to a recall notice in an FDA Enforcement Report, the drug manufacturer said that it confirmed that a sales sample of the drug was contaminated after a customer complaint, and so initiated a nationwide, voluntary recall. The company reported that the product came from a plant in Puerto Rico. The plant was among four on the island that J&J slated two years ago for $225 million in upgrades.

To view the notice, click on the link below:

http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0006-2015&w=10152014&lang=eng

Xarelto came to market in the U.S. three years ago behind Boehringer Ingelheim's Pradaxa, but which has since eclipsed it in sales. Like Pradaxa, Xarelto has come under scrutiny based on accusations that the drug causes bleed outs and deaths. Lawsuits have been filed against the manufacturer across the country, and a motion has been filed to consolidate cases into an MDL.

Pittman, Dutton & Hellums, P.C., is currently investigating Xarelto cases. If you or a loved one were prescribed Xarelto and suffered an irreversible internal bleeding that lead to hospitalization and/or death, contact Booth Samuels at toll free 1-866-515-8880 or by email at booths@pittmanudutton.com.

Endo Agrees To Settle Remaining TVM Claims

Earlier this month, Endo International announced it had reached agreements to settle up to 20,000 legal claims from women who said they were harmed by transvaginal mesh devices, ending nearly all of the U.S. cases against it and its American Medical Systems unit. The proposed settlement is valued at $400 Million.

Endo, which did not admit liability, said it would increase the amount of money it had set aside to cover vaginal mesh claims from $1.2 billion to approximately $1.6 billion in connection with the latest agreements.

Earlier this year in April, Endo announced it reached agreements to settle up to approximately 21,700 additional mesh claims. Last year, it settled an undisclosed number of cases for $54.5 million. See my previous blog posts for more on those settlements.

Transvaginal mesh manufacturers have faced a wave of litigation in the last few years over the devices, which are used to treat stress urinary incontinence and pelvic organ prolapse. The women suing the companies have accused the companies of selling subpar devices that caused injuries such as chronic pain, incontinence, bleeding and infection. Besides Endo, C.R. Bard Inc., and Johnson & Johnson's Ethicon are facing tens of thousands of lawsuits over similar products, with several trials scheduled for the fall.

Many of those cases have been consolidated before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia, who is overseeing more than 60,000 mesh cases against seven manufacturers.

In 2008, the U.S. Food and Drug Administration notified transvaginal mesh manufacturers about reports of potential complications stemming from the devices. In 2012, the agency ordered AMS and other manufacturers to conduct post-market safety studies and monitor the rate at which adverse events were reported. The FDA announced earlier this year it is considering a proposal to tighten safety standards for mesh used to treat pelvic organ prolapse.

Two Pelvic Mesh Juries Give Two Differing Results

Over the last two weeks, two strikingly different results have occurred involving transvaginal mesh trials.

A jury in a West Virginia federal court slammed Johnson & Johnson subsidiary Ethicon Inc., with a $3.27 million verdict last Friday in a bellwether trial. The jury found Ethicon's transvaginal sling was defectively designed and the company failed to warn of its potential risks. 

It was reported that the jury returned the compensatory damages verdict after deliberating for just three hours and found for the plaintiff on all counts. The trial lasted two weeks.

Johnson and Johnson faces nearly 33,000 similar lawsuits.

On August 29, the previous Friday, a Massachusetts jury sided with Boston Scientific Corp., in the second bellwether trial involving the company’s pelvic mesh devices. The jury found that a transvaginal sling was not defectively designed and the company adequately warned of risks associated with the device. That trial lasted two weeks and the jury deliberated for over two days. This trial was heard in state court.

These bellwether trials illustrate the multitude of different outcomes in transvaginal mesh litigation on both the state and federal level. On one hand, we have seen summary judgment granted for the defendants, while on the other we have seen near Billion dollar settlements (see my previous blog posts regarding such). The MDL system and bellwether trials are designed to help both sides of the aisle evaluate their positions reasonably. These latest bellwether trials will probably do little to help either side assess their positions and instead push them to keep trying cases.                                         

First Pinnacle Bellwether Trail To Start Today

Jury selection is set to begin today in the first bellwether case in the DePuy Pinnacle MDL. It is among more than 6,000 cases currently pending in the MDL. The cases have been consolidated before U.S. District Judge Ed Kinkeade in Dallas. Judge Kinkeade will preside over the trial.

Depuy is a subsidiary of Johnson & Johnson (“J&J”). The plaintiffs allege metal-on-metal version of the Pinnacle hip was defectively designed and caused metal debris to leech into patients’ bloodstreams. 

J&J had heavily touted the metal-on-metal implants, first sold in the U.S. in 2005, as a design that would last 20 years and offer greater range of motion. However, J&J stopped selling the metal-on-metal version of the Pinnacle hip in August 2013 after the U.S. Food and Drug Administration said it would require device makers to submit new versions of the artificial hips for pre-market approval.

The Pinnacle line of hips wasn’t covered by J&J’s $2.5 billion settlement of claims that its ASR hip devices shed chromium and cobalt debris from the metal-on-metal which caused tissue death and increased metal ions in the blood. Other complications from the ASR hip devices included dislocations, pain, and required surgical removal.

It is estimated the trial will last up to six weeks.

Risperdal Lawsuits on the Rise

Risperidone, sold under the brand name Risperdal, has recently come under major legal scrutiny and been the subject of Risperdal lawsuits over the issue of male breast growth. The drug, manufactured by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, is a prescription drug classified as an anti-psychotic. It was designed to treat schizophrenia without the sedating effects on the patient that so many older anti psychotic drugs caused.

Like other drugs designed to treat maladies of the brain, the drug was found to be helpful against several other disorders, and it was subsequently approved by the U.S. Food and Drug Administration (FDA) to treat bipolar disorder, as well as aggression and irritability associated with autism.

However, Risperdal has been found to cause a number of serious side effects. This allegedly includes a condition called gynecomastia, or male breast growth. The condition is obviously an emotionally scarring disability, and can be very stigmatizing. Additionally, Risperdal is associated with weight gain and diabetes, which may initially camouflage gynecomastia.

Lawsuits over Risperdal side effects have been consolidated into a multidistrict litigation (MDL) in Pennsylvania state court. It is yet to be determined if there will be a Federal court MDL created. For more information on MDL’s, please see my previous blog posts. Over 360 lawsuits have been filed on behalf of plaintiffs who have been injured by Risperdal.

The Risperdal Gynecomastia MDL is In re: Risperdal Litigation, Case No. 100300296, in the Philadelphia Court of Common Pleas.

Pittman, Dutton & Hellums, P.C., is currently investigating Risperdal injury claims. If you or a loved one were injured as a result of taking Risperdal, please contact Booth Samuels at 1-866-515-8880 or by email at booths@pittmandutton.com.

J&J Staple Accessory Kit Recall

Johnson and Johnson has recalled more than 157,000 surgical stapler devices and accessories used in hemorrhoids treatment procedures due to potential malfunctions that pose a serious safety risk. The recall is a Class 1 recall, the most serious classification of recalls. Class 1 recalls are only issued when a defective medical device is likely to cause serious health problems or death. 

These products are commonly referred to as “Staple Accessory Kits” or “Internal Hemorrhoid Staples”. They are manufactured by J&J's Ethicon Endo-Surgery division. 

The recalled products are:

Transtar Circular Stapler Procedure Set

Proximate HCS Hemorrhoidal Circular Stapler and Accessories

Proximate PPH Hemorrhoidal Circular Stapler and Accessories

The FDA issued a recall based on issues related to the firing of the device which may result in incomplete staple formation. An incomplete staple formation is similar to when you attempt to staple too many pieces of paper together and the staple does not puncture through all of the pieces and does not fasten correctly.

Failure of an incomplete staple formation can result in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, occlusion of the rectal canal, and splitting of rectal wall staple line and bleeding.

The affected products were manufactured and distributed between April 2011 and July 2012.

J&J said its Proximate HCS hemorrhoidal circular stapler and accessories with product code "PPH01" have been discontinued in the U.S. However, the Proximate PPH stapler remains available.

Pittman, Dutton & Hellums, P.C. is currently investigating “Staple Accessory Kit” injury claims. If you or a loved one were injured as a result of this product, please contact Booth Samuels at    1-866-515-8880 or by email at booths@pittmandutton.com.

Johnson & Johnson ASR Hip Settlement Announced

The much anticipated Johnson & Johnson Depuy ASR Hip settlement agreement has been announced. The agreement was announced during an open court hearing in Judge Katz’s courtroom. Of course, the agreement has to be approved by Judge Katz. Another caveat for the agreement to go through is that 94% of all claimants must opt-in and agree to the settlement.

Details of the agreement are now readily available for the general public. In what was rumored to be a $4 Billion settlement, in actuality is more in line with a $2.5 Billion settlement. The settlement only covers those claimants who have had a revision surgery on their DePuy ASR metal-on-metal hip prior to August 31, 2013. This number is estimated to be close to 8,000 claimants.

Those claimants who have not yet had a revision surgery are technically shut out of receiving any compensation in this agreement. It is anticipated that another round of settlements will occur as the device fails in these claimants and they need revision surgery.

The base payment for a revision claimant will be about $250,000. That payment will fluctuate based on a number of factors including age, weight, length of time the implant was in, and if the claimant smoked. There will also be a pool of $475 Million for the most severely injured.

J&J to Pay Huge Fine Over Risperdal

Johnson & Johnson is paying the third-largest pharmaceutical settlement ever to settle civil and criminal fines that it improperly marketed and promoted the antipsychotic drug Risperdal.  Much of the conduct occurred when current J&J CEO Alex Gorsky was vice president for sales and marketing or president of the pharmaceutical unit.

 

The United States Attorney General said that the company "recklessly put at risk the most vulnerable members of our society."  In response, J&J's vice president and general counsel said "This resolution allows us to move forward and continue to focus on delivering innovative solutions that improve and enhance the well-being of patients.

 

Federal officials said the company knew that Risperdal posed serious risks for older adults, such as an increased risk of strokes, but played them down.  J&J also knew that children were susceptible to certain health risks from taking the drug, including the possibility that boys could develop breasts through elevated production of the hormone prolactin, federal officials said.  Despite this, J&J told its sales representatives to visit child psychologists and mental health facilities that mainly focused on children and to promote the drug for defecit hyperactivity disorder and obsessive-compulsive disorder.

Rumored $4 Billion Settlement in DePuy ASR Reached

Major news outlets are reporting breakthrough in settlement negotiations in the DePuy ASR hip litigation. DePuy, a subsidiary of Johnson & Johnson, is rumored to have agreed in principle to a $4 Billion agreement to settle lawsuits over their metal-on-metal hip product.

Neither the Plaintiff or Defendant leadership committees-nor the Court for that matter-has confirmed these reports.

The reports claim that the settlement will resolve more than 7,500 lawsuits in federal and state courts against J&J. The 7,500 number is an estimate for how many filed lawsuits are for Plaintiffs who have had a revision surgery. That number is important because as of right now, it appears the settlement would only be for those Plaintiffs who have already had a revision surgery, with an average payout of $300,000-$350,000. It is rumored that the agreement does not bar Plaintiffs whose artificial hips fail in the future from seeking compensation from J&J. Of course, there are many different factors to this agreement including those Plaintiffs who cannot have a revision surgery because of their current health conditions.

There is an open court hearing next week in the MDL Court in Ohio, where many people think the settlement will be announced.

The settlement will be the second multibillion-dollar agreement this month for J&J, the world’s largest seller of health-care products. The corporation agreed on November 4 to pay $2.2 billion to resolve criminal and civil probes into the marketing of Risperdal and other medicines. I will be posting a blog on that subject in the next few days.

J&J has spent about $993 million on medical costs and informing patients and surgeons about the recall. J&J set aside an undisclosed amount for litigation, which it increased before June 30. See my previous blog posts regarding that subject.

Details of the rumored are sketchy, but it has been reported that 94 percent of eligible claimants must sign up for the settlement or J&J can withdraw from the deal. This is often times referred to as a Defendant’s ‘Opt-out clause’ and is very common in mass tort global settlement agreements.

J&J recalled 93,000 ASR hip implants worldwide in August 2010, saying 12 percent failed within five years. About one-third of that number were sold in the United States. The product went on the market in 2003.

J&J had touted the metal-on-metal implants, first sold in the U.S. in 2005, as a new design that would last 20 years and offer greater range of motion. DePuy officials have long insisted that they acted appropriately in recalling the device when they did. However, internal company documents disclosed during the discovery phase of the ongoing litigation showed that DePuy officials were long aware that the hip had a flawed design and was failing prematurely at a high rate. Those documents revealed that internal DePuy projections estimated that it will fail in 40 percent of patients in five years-a rate eight times higher than for many other hip devices. Other documents showed that the head of DePuy’s orthopedic unit, Andrew Ekdahl, oversaw the introduction of the hip and was warned by a company consultant in 2008 that the implant appeared to have a design flaw.

As failures mounted, patients complained in lawsuits that the metal-on-metal implant caused soft tissue necrosis, pseudo tumors, metalossis, pain and follow-up surgeries known as revisions. They claimed that debris from the chromium and cobalt device caused tissue death and increased metal ions in the bloodstream.

Claims by unrevised Plaintiffs may be handled in a second round of settlements.

The $4 billion settlement will provide compensation to hip patients based on factors including age, extent of injuries and whether they had one or more surgeries to replace defective implants. Typically, a matrix-type grid is used to categorize Plaintiffs based on these factors.

The accord also provides more compensation to hip recipients who suffered “extreme injuries” from the device’s failure, or endured long hospital stays after removal surgeries.

Also reported was that J&J also has agreed to set aside funds to reimburse Medicare and other insurers for claims paid on behalf of hip-implant patients, which could add hundreds of millions of dollars to the value of the settlement.

Of course, any proposed settlement would have to win Court approval.

DePuy continues to face thousands of lawsuits involving another all-metal hip that it no longer sells called the Pinnacle.