Category: Personal Injury

Ethicon Hernia Mesh Case Centralization Requested

3/21 Update – This article was updated to reflect that Ethicon Physiomesh was not recalled. It was a voluntary market withdrawal.

By Emily Cox
Ethicon Hernia Mesh Case Centralization
Photo by Tim Green

A group of plaintiffs are requesting Ethicon hernia mesh case centralization due to the increasing number of cases, alleging that Physiomesh caused serious complications and additional surgery.

The plaintiffs filed the motion to transfer with the U.S. Judicial Panel on Multidistrict Litigation (JPML) on March 9. They are requesting that the JPML transfer all lawsuits involving the Ethicon hernia mesh to the Middle District of Florida. The centralized proceedings will help avoid duplicate discovery and conflicting rulings, saving time and money for all parties.

According to the motion, there are at least 18 product liability lawsuits pending in nine separate federal courts. These individuals claim that the Ethicon hernia mesh caused severe harm that often required additional invasive surgery. Furthermore, in some cases, this harm is irreparable. The motion also noted that six of the cases were already in the Middle District of Florida. This is the most of any one district.

Ethicon Hernia Mesh Design Defect

Ethicon Physiomesh is a hernia mesh patch Ethicon released in March 2010. Up until its May 2016 market withdrawal, surgeons widely used this product to repair hernias. The hernia mesh allegedly caused severe complications, including adhesions, mesh erosion, perforation, and infections. Many of these conditions require additional invasive surgery to treat.

The motion alleges that this voluntary market withdrawal was a direct consequence of the frequency and severity of the complications experienced with the hernia mesh worldwide.

Plaintiffs claim that the hernia mesh’s design caused many of the complications. Ethicon Physiomesh has five distinct layers with a multi-layer coating. No other hernia repair product in the world uses this design.

Plaintiffs allege Johnson & Johnson and its Ethicon subsidiary promoted the coating to prevent or minimize adhesion and inflammation while helping the mesh incorporate into the abdomen.

“However, Plaintiffs intend to demonstrate that the multi-layer coating instead prevented adequate incorporation of the mesh and caused or contributed to a variety of serious complications,” the motion went on to state.

It also seems to have caused severe inflammatory and foreign body responses. In turn, these responses cause scar tissue that starts to connect organs, which is a severe complication that requires surgery.

Given the popularity of the Ethicon hernia mesh with surgeons before its market withdrawal, experts expect the size of this litigation to grow dramatically.

Cook IVC Filter Settlement Conferences Scheduled

By Emily Cox
Cook IVC Filter Justice
Photo by Bri

A judge has ordered a series of three Cook IVC filter settlement conferences to try to resolve lawsuits against Cook Medical before the first bellwether trials begin later this year.

U.S. Magistrate Judge Tim A. Baker issued the order March 7. He scheduled the first conference for the plaintiffs’ counsel July 26. There will be subsequent conferences for the defendant’s council August 4 with a follow-up for the plaintiff’s August 9.

The conferences will propose Cook IVC filter settlement frameworks that may eliminate the need for additional trials later this year. There will also be confidential discussions on case status, discovery, and trial preparation. Judge Baker will make assessments of the relative strengths and weaknesses of both sides of the litigation.

While previous Cook IVC filter settlement conferences have convened, parties have not been able to reach an agreement.

Cook IVC Filter Complications

Cook designed and sold IVC filters to prevent blood clots from travelling to the heart and lungs. However, these lawsuits allege that these filters caused various serious complications. A 2012 study, published in CardioVascular and Interventional Radiology medical journal, indicated that all Cook Celect and Gunther Tulip filters showed some degree of IVC perforation. Researchers found that full perforation occurred in 86 percent of the cases, while 40 percent of filters tilted out of position. Furthermore, while these filters are temporary, doctors rarely remove them. When the filters are left in for extended periods of time, they can break. This can allow pieces of the filter to get lodged in other parts of the body, usually the heart or lungs.

In May 2014, the FDA issued a safety communication regarding IVC filters. The agency released the report due to excessive reports of IVC filters breaking and damaging the heart, lungs, and other organs.

There are currently about 1,500 cases against Cook IVC filters with plaintiffs alleging these and other problems. Bard IVC filters have similar complications, along with associated litigations pending against them.

Class Action Restriction Bills Passed by House

By Emily Cox
Class Action
Photo by Joey Gannon

Washington, DC — Despite Democratic objections that class action restrictions would hurt the public’s ability to hold corporations accountable, the House of Representatives passed a pair of bills Thursday to make it harder to bring class actions and keep suits in state courts.

The Fairness in Class Action Litigation Act of 2017 and Innocent Party Protection Act radically limit the scope for class actions, while expanding the scope for finding fraudulent joinder in suits.

Republicans claim these bills will adjust the balance between “abusive plaintiffs” and “innocent defendants.” However, Democrats argue the bills are designed to protect corporate wrongdoers by making it harder for victims to band together. Democrats allege that these bills would make it almost impossible for victims injured by consumer rip-off, fault product design, and pharmaceutical drug mistakes, as well as lead and asbestos poisoning to bring class-action lawsuits.

“I oppose these misguided legislations, because it sends another huge valentine and wet kiss to large corporate polluters and tort-feasors but gives the finger to millions of American citizens who suffer injuries from these defendants,” Rep. Jamie Raskin (D-Md) said.

Democrats are joined by a large group of legal, environmental, disability, labor, civil rights, and consumer protection organizations in their opposition. They claim the bills would limit the ability to join a class action suit against defendants with exponentially greater resources.

“Christmas has certainly come early for corporate-America,” said Teddy Basham-Witherington, a spokesman for The Impact Fund, a nonprofit public interest law organization.

He went on to that, if passed, the class action restriction bills would “restrict ordinary people from accessing justice, emboldening the worst actors in corporate America.”

Class Action Restriction Bill (H.R. 985)

The class action bill would require plaintiffs to prove potential members have the same type and scope of injury. It also requires asbestos trusts to make details of trust claimants public.

“This doesn’t formally abolish the class-action mechanism,” Rep. Jamie Raskin (D-MD) said. “It’s not the guillotine, but it’s a straight jacket.”

Opponents also argue that the bill provides easy access to asbestos victims’ personal information for scam artists, employers, potential insurers, and debt collectors to potentially exploit.

The bill’s predecessor, the Fairness in Class Action Litigation Act of 2015 (H.R. 1927), passed the House but was not even considered by the Senate. According to opponents, this bill was far less damaging than the current legislation. Basham-Witherington described the new bill as “H.R. 1927 on steroids.”

Innocent Party Protection Act

This bill would prevent attorneys from adding defendants to a lawsuit to keep the case in state court. Democrats like Jerrold Nadler (NY) feel that it gives corporations another tool to transfer suits to corporate-friendly federal courts.

“The preliminary determination of jurisdiction would become a baseless time-consuming mini-trial before a second trial on the merits,” Nadler said. “While large corporations can accommodate such costs, injured workers, and parents cannot.”

Take Justice Back

The American Association for Justice has established a movement to help individuals take a stand against class action restriction. Take Justice Back has numerous websites to help people act against this unconstitutional legislation.

 

Judge Approves $12M Caldera Pelvic Mesh Deal Despite Protests

By Emily CoxCaldera Pelvic Mesh Deal

Despite 36 objectors, a California federal judge approved Federal Insurance Company’s $12.25 million deal to resolve insurance claims, alleging that Caldera pelvic mesh implant injured more than 2,700 women.

Federal Insurance agreed to distribute $10.58 million among the 2,710 claimants and to pay $670,020 in attorney fees and costs. In return, the plaintiffs agreed to release Caldera and Federal Insurance from all future claims.

In his order, issued March 6, U.S. Judge Stephen V. Wilson pronounced the deal as fair, reasonable, adequate, and “consistent with due process.”

Caldera Pelvic Mesh Federal Interpleader Suit

Federal Insurance first launched its federal interpleader suit against Caldera and a class of claimants in January 2015 after Caldera started filing insurance claims to pay for damages awarded to plaintiffs over the pelvic mesh product designed to treat pelvic organ prolapse and stress urinary incontinence in women.

The plaintiffs claimed that Caldera knew or should have known that its transvaginal mesh devices were hazardous and dangerous. Consequently, they sought damages from Caldera, which turned around to file insurance claims to pay for these settlements.

According to Federal Insurance’s complaint, Caldera was depleting its $25 million policy by fighting these lawsuits in state court. The complaint also noted that it had already paid out more than $6.3 million in settlements with thousands more claims still pending. Federal Insurance requested the court to identify a class of claimants and stop them from pursuing future suits that would affect the insurance policy.

Caldera Pelvic Mesh Deal

In December 2015, the parties reached a $12.25 million lump sum deal with a $500,000 holdout to resolve pending claims and end its policy with Caldera. The deal stipulated that claimants could not opt out of the settlement.

But, three dozen women objected in June 2016. They wanted evidence that showed if the payout would be greater if Caldera liquidated. They requested an independent audit to make sure Caldera was offering the maximum amount possible to women injured by the pelvic mesh device.

Caldera and Federal Insurance argued an audit wasn’t necessary as Caldera had already produced financial records. The records indicated that the company was cash-poor, had no profit, and only had its insurance to settle the lawsuits. Furthermore, there was nothing that showed the liquidated value of the company would exceed the current settlement.

In July, Judge Wilson sided with the objectors and ordered Caldera to submit supportive evidence.

In September, Caldera filed an expert report. It showed any attempt to liquidate Caldera would result in a net loss. The company also filed another motion for final settlement approval. However, objectors challenged the deal and the export reports findings. At least, one objector requested exclusion from the deal.

However, Judge Wilson refused to excuse the objectors from the settlement. He found that the report sufficiently addressed concerns and approved this past Friday.

The deal is a victory, according to plaintiff attorneys. They said that since Caldera’s only real asset is its insurance policy, this was the only way that the claimants were going to get anything.

Transvaginal Mesh Lawsuits

In 2011, the FDA issued a warning after receiving almost 2,900 reports of problems with vaginal mesh products between January 2008 and December 2010. The FDA concluded that there was no evidence that transvaginal mesh provides any additional benefits when compared totraditional treatments.

In early 2012, the FDA sent a letter to several pelvic mesh manufacturers. The letter ordered that they conduct additional studies and trials to evaluate these products’ safety, and establish whether they pose an unreasonable risk of injury for women.

However, many of the manufacturers did not follow-through with the safety studies. Instead, they removed the products from the market.

Tens of thousands of women have filed pelvic mesh lawsuits against about half a dozen manufacturers. Thousands of cases have been settled out of court, and a number of cases have resulted in multi-million dollar jury verdicts for women who suffered permanent and debilitating injuries.

Stryker Metal Hip Corrosion Linked to Design

By Emily Cox

Stryker Metal HipA new product liability lawsuit claims that the design of Accolade and LFitV40 components caused a  Stryker metal hip to corrode and fail, resulting in metal blood poisoning and additional invasive surgery.

The lawsuit was filed by David Campbell on March 3. He indicates that Howmedica Osteonics Corp, doing business as Stryker Orthopaedics, sold defective hip components that were likely to corrode and fail.

In April 2010, Campbell had a Stryker Accolade TMZF Hip Stem and Stryker LFit Anatomic V40 femoral head implanted. The artificial hip failed within a few years due to wear and corrosion where the cobalt and chromium femoral head rubbed against the metal hip stem.

Stryker metal hip corrosion can cause loss of mobility, soft tissue damage, and severe pain and discomfort, as well as heavy metal poisoning. Per the claim, Campbell experienced all of these side effects, and some of the damage may be permanent. Consequently, he required hip revision surgery in March 2015 to remove the faulty components.

The lawsuit suggests that revision surgeries are more invasive and complex than original hip replacement surgeries. They also take longer than the original surgeries and have a higher rate of complications.

Campbell alleges that he will require years of additional medical treatment. This may include potential additional revision surgeries due to Stryker metal hip corrosion.

In August 2016, Stryker issued a Stryker LFitv40 hip recall. At this time, Stryker admitted to a high number of individuals reporting problems with hip failure, metal wear, adverse tissue reactions, metal poisoning, and other complications.

Stryker Metal Hip Lawsuits

Campbell joins the growing ranks of individuals filing similar Stryker hip lawsuits due to problems of the metal-on-metal implant.

Legal experts expect that thousands of individuals will file additional lawsuits as Stryker metal hips continue to injure recipients. Hip replacement lawyers are also accepting cases for individuals who still have these components in their bodies. These materials could be releasing toxic levels of metal as their hip replacement corrodes unknown to them.

Ethicon Physiomesh Eroded into Man’s Intestines

By Emily Cox
Physiomesh Eroded Into Intestines
Photo by Jason Wilson

According to a new product liability lawsuit, an Ethicon Physiomesh eroded into a man’s intestines, causing severe injuries and complications.

The complaint was filed by Henry Lee Brown in the Northern District of Georgia in late February. Brown alleges that Johnson & Johnson’s and its Ethicon subsidiary’s Physiomesh is prone to erosion, adhesions, perforation, fitulas, bowel strangulation, and hernia incarceration among other problems.

The suit states that Brown had a 15cm x 20cm patch of Ethicon Physiomesh implanted in his abdomen for hernia repair. However, the patch failed and the Physiomesh eroded into his intestines. Mesh erosion is one of the most serious complications of hernia mesh products. It occurs when the mesh patch moves into surrounding organs. Brown required invasive surgery to remove the Physiomesh. Surgeons removed a portion of Brown’s small bowel to eliminate adhesions. Scar tissue unnaturally connecting organs causes these adhesions.

Physiomesh Eroded Due to Defective Design

No other hernia mesh patch on the market uses Physiomesh’s unique design. It has a total of five distinct layers. Ethicon designed the multi-layer coating to prevent adhesions and inflammation, while helping the mesh incorporate into the body. However, reports have linked it to a high rate of intense inflammatory and chronic foreign body responses, causing problems like Brown’s.

“The multi-layer coating provides a breeding ground for bacteria in which the bacteria cannot be eliminated by the body’s immune response, which allows infection to proliferate,” his lawsuit states. “The multi-layer coating of Defendants’ Physiomesh is cytotoxic, immunogenic, and not biocompatible, which causes or contributes to complications such as delayed wound healing, inflammation, foreign body response, rejection, infection and other complications.”

In May 2016, Ethicon issued a voluntary product recall of certain Physiomesh products. Ethicon classified this as a market withdrawal. However, the company said it would not return any of these devices to the market.

“Consequently, Ethicon [has] not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and [has] decided to recall Ethicon Physiomesh composite mesh from the global market,” the letter stated. “Ethicon will not return the Ethicon Physiomesh composite mesh product to the market worldwide.”

Brown’s lawsuit joins a growing number of similar lawsuits, asserting serious injuries from Ethicon’s Physiomesh. However, experts expect that the company may face thousands of cases in the future.

 

 

 

Hip Fractures in the Elderly More than Double Mortality Risk

By Emily Cox
Hip Fractures Double Risk of Mortality in Ederly
Photo by Jeremy Engleman

New research indicates that elderly individuals with hip fractures may face double the mortality risk when compared with their peers.

The Journal of Internal Medicine published the study in its March edition. Researchers saw a significantly higher risk of all-cause mortality among elderly subjects who fractured their hip.

Eight separate Europian and American studies provided the date from 122,808 elderly individuals. The mean follow-up time was 12.5 years. During this time, the studies reported 27.999 deaths and 4,273 hip fractures.

According to the data, the risk of dying after a hip fracture almost tripled during the first year after the incident. While this number declined in the following years, it still stayed at more than double of others followed in the study.

“In this large population-based sample of older persons across eight cohorts, hip fracture was associated with excess short- and long-term all-cause mortality in both sexes,” researchers wrote.

However, researchers found that hip fractures resulting in death were highest among men. Regardless of sex, they identified post-operative complications as the true culprit.

Hip Fractures and Hip Replacement Lawsuits

Metal-on-Metal Hip Failure
Photo by Cindy Funk

These findings come amidst a firestorm over metal-on-metal hip replacements, resulting in thousands of lawsuits against the allegedly faulty products. Manufactures have marketed these metal-on-metal hip replacements as superior to more traditional systems. However, the metal-on-metal friction causes the release of metallic debris into the body. This can cause heavy metal poisoning and premature failure of the artificial hip, requiring additional risky surgery.

Heavy metal poisoning can lead to lung cancer, nerve damage, kidney diseases, heart damage, respiratory tract cancer, and respiratory diseases, as well as kidney, liver, and heart lesions.  Consequently, recipients can be exposed to toxic levels of metal and not even know it before it’s too late.

While a judge recently reduced a $1 billion verdict against Johnson & Johnson’s DePuy Pinnacle hip implant by $500 million, the company still faces more than 9,000 additional lawsuits. Similarly, Stryker is facing a growing number of lawsuits, following the recall of its metal-on-metal LFitV40 hip replacement component.

 

Walgreens Implicated in New Talcum Powder Lawsuit

By Emily Cox
Walgreens Named In Talcum Powder Lawsuit
Photo by Mike Mozart

A Chicago woman in suing Walgreens and Johnson & Johnson, claiming that J&J’s talc-based products caused ovarian cancer.

Andrea Harris and her husband, Bart Harris, filed the lawsuit in the Circuit Court of Cook County, Illinois on March 1. According to the lawsuit, Harris purchased J&J’s Baby Power and Shower-to-Shower products from Walgreens between 1980 and 2006. She was diagnosed with ovarian cancer in 2015 and is still undergoing treatment.

The couple claim that Walgreen’s involvement extended beyond being a supplier of these products. According to the claim, Walgreens shares an office with J&J in Buffalo Grove, Illinois. This office creates business plans to market J&J products, including talcum powder, to Walgreens’ customers.

“J&J and Walgreens implement strategies to influence consumers’ purchase of J&J baby powder products from Walgreens, including through data analytics of customers’ purchases and loyalty and rewards programs,” the complaint states.

The lawsuit alleges that Walgreens assessed J&J’s products for safety, efficacy, and suitability from this office. The company also created labels, marketing campaigns, and promotional materials with J&J to encourage using J&J’s talc-based products on the genital area. Furthermore, the couple allege that the companies knew about the increased risk of ovarian cancer and continued to market J&J’s talc-based products over safer cornstarch formulas to protect profits generated by these flagship brands.

Talcum Powder and Ovarian Cancer

Talcum Powder Linked to Ovarian Cancer
Photo by Sprogz

Since 1971, more than 20 studies have generated evidence that there is a significant connection between talc and ovarian cancer.  In 1993, the U.S. National Toxicology Program published a study that showed talc was a carcinogen. Consequently, numerous organizations classified talc as a carcinogen in 2006. Due to this, J&J’s talc supplier began including warnings with its talc shipments that same year. However, J&J still does not pass these warnings on to its consumers.

Ovarian cancer ranks fifth in overall cancer deaths among women and first in female reproductive system cancers. The American Cancer Society estimates that 22,440 women will receive a new ovarian cancer diagnosis and 14,080 women will die from it in 2017.

While J&J won the most result trial this past Friday, it lost the previous three with damages totaling $195 million awarded to defendants, alleging the company knew and concealed the cancer risk of its talc-based products. There are currently more than 2,500 lawsuits, claiming that J&J’s talc-based products caused ovarian cancer, pending across the country.

 

 

 

 

Talcum Powder Trials Lose Winning Streak to J&J

By Emily Cox
Talcum Powder Trials
Photo by the.mutator

St. Louis, MO — Johnson & Johnson finally scored a defensive victory in Missouri on Friday after a string of loses in talcum powder trials when a jury found its baby powder did not cause a Tennessee woman’s ovarian cancer.

The company has only had one other defensive win in New Jersey, facing allegations that the company did not warn consumers about talc’s carcinogenic properties. However, the company lost verdicts of $55 million, $70 million, and $72 million in Missouri in 2016.

The verdict disappointed plaintiff attorneys. However, they noted that the case was specifically selected by J&J for trial, which may account for the outcome.  Consequently, this verdict has not discouraged them, and they vow to press forward.

“As always, we will learn from the experience of this trial, and we are committed to carrying on the fight forward with the legal claims of thousands of innocent victims whose lives have been shattered by ovarian cancer,” lawyers for the plaintiffs said. “We look forward to the upcoming trial in April, which has its own distinctive set of claims and circumstances.”

The talcum powder trial centered around Nora Daniels, a 56-year-old Tennessee resident. She alleged that her use of J&J’s baby power for 36 years caused her ovarian cancer in 2013. After a hysterectomy and five months of chemotherapy, she is now in remission.

Talcum Powder Trials and Lawsuits

Currently, there are about 2,500 individuals with talcum powder trials pending against Johnson & Johnson’s talc-based products. These plaintiffs allege that their popular baby powder and Shower-to-Shower products caused ovarian cancer.

Allegedly, J&J knew about the connection between talcum powder and ovarian cancer since the 1970s. However, the company reportedly concealed this information and even formed a special interest group to prevent its dissemination. In other words, rather than protect people, J&J has fought to protect profits from its flagship brands.

In 2006, several organizations acknowledged talc as a cancer-causing agent. As a result, even J&J’s talc supplier began including carcinogenic warnings in 2006. J&J has yet to pass on these warnings to its consumers.

Taxotere Illegal Marketing Lawsuit Receives Another Extension for Written Discovery

By Emily Cox

The judge overseeing the Taxotere illegal marketing lawsuit issued an order Thursday, extending the deadlines for written discovery from March 13 to May 12.

The original deadline was July 11, 2016. Mitigating circumstances have pushed this deadline back four times now. However, this is the shortest extension that U.S. District Judge Lawrence F. Stengel has granted.

Qui Tam Lawsuit

A former employee is joined by the U.S. in the Qui Tam lawsuit against the manufacturers of Taxotere, Sanofi S.A.. A Qui Tam lawsuit is brought on behalf of the government against companies that may have defrauded the government.

In this case, Sanofi S.A. is accused of defrauding Medicare and Medicaid programs to approve payments for off-label Taxotere treatments. Medicare and Medicaid will only pay for FDA-approved applications of med
ications.

Taxotere is a highly potent breast cancer chemotherapy treatment. The drug has recently come under fire for not disclosing its severe side effects, including permanent baldness, also called alopecia. It has also received scrutiny from the FDA. It received a warning from the agency for claiming superiority over other treatments when studies clearly show less toxic treatments to be just as or more effective than Taxotere.

Furthermore, the FDA only approved Taxotere to treat advanced breast cancer where previous chemotherapy had failed. However, Sanofi S.A. allegedly embarked on an aggressive, fraudulent, and illegal marketing campaign to expand Taxotere’s market share beyond its indicated use.

Taxotere Illegal Marketing

The Taxotere illegal marketing lawsuit is accusing the manufacturer of engaging in fraudulent marketing, providing illegal kickbacks, and providing other illegal incentives to encourage doctors to use Taxotere as a first line treatment for less aggressive cancers since 1996.

Allegedly, Sanofi S.A. trained and directed employees to misrepresent the safety and effectiveness of off-label Taxotere use. The company also paid healthcare providers illegal kickbacks such as entertainment, sports, concert tickets, sham grants, speaking fees, travel, preceptorship fees, and free reimbursement to get doctors to prescribe Taxotere for off-label uses.

Taxotere’s fraudulent marketing increased the drug’s revenue from $424 million in 2000 to $1.4 billion in 2004. Consequently, it exposed thousands of women to the increased toxicity of Taxotere and its more severe side effects, including permanent baldness, also called alopecia.

Taxotere Lawsuits

Taxotere Illegal Marketing Exposed Women to Permanent Side Effects
Photo by Christina Spicuzza

The number of Taxotere lawsuits against Sanofi S.A. has exploded recently. These women allege that Sanofi S.A. knew about the alopecia risk for more than a decade. However, the company cho
se to hide it from American consumers until 2015. Sanofi S.A. updated its warning labels to include permanent alopecia in Canada and Europe in 2005 and 2012 respectively. The company didn’t update U.S. warning labels until late 2015.

Many of these plaintiffs claim that they may have chosen a different treatment if they had known about the side effects and that other, less toxic treatment were equally or more effective.

 

 

 

 

 

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