Category: Defective Products

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.

Depuy Pinnacle Hip Replacement Permanently Disables Florida Man

DePuy Pinnacle Hip
By Emily Cox

Bartow, FL — A new lawsuit alleges that the Depuy Pinnacle metal-on-metal hip replacement device caused a man to suffer extreme debilitating pain for years and lose the capacity to earn a living.

The complaint was filed Wednesday by James Underwood and his wife, Shelley Underwood, against Johnson & Johnson and Depuy Orthopaedics in the 10th Judicial Circuit Court. Underwood claims the companies knew about the high risks associated with the Depuy Pinnacle Hip System. However, they continued to market the device as superior to other safer hip systems.

In April 2002, Underwood underwent a left total metal-on-metal hip replacement. Surgeons used DePuy Pinnacle components in the procedure. In August 2005, he had a similar right total metal-on-metal hip replacement.

Underwood showed optimal conditions for a successful hip replacement. However, he began experiencing severe pain and discomfort at the prosthetic hip site in early 2016. His discomfort quickly worsened and became extremely painful and debilitating. Tests failed to show loosening or any sign of infection. Finally, in March 2016, blood tests indicated metalossis with elevated levels of heavy metals in his blood stream.

Underwood’s surgeon advised him that his right hip had failed. Consequently, he underwent revision surgery to remove the defective device in May 2016. Accordingly to the suit, Underwood continues to suffer and is now disabled as a result of his Depuy Pinnacle device.

DePuy Pinnacle Manufacturer Knew Risks and Continued to Sell the Device

Allegedly, manufacturers were aware that the Pinnacle devices result in the dangerous release of toxic metal ions into the bodies of hip implant procedures. As of 2011, there were approximately 1,086 adverse events reports with the FDA regarding failures or complications from DePuy Pinnacle devices. Despite patients reporting severe pain, complicated revision surgeries, and life-long health problems, the manufacturers continued to sell Depuy Pinnacle hip replacement components.

The lawsuit claims the friction from the metal components rubbing together releases heavy metal particles. Consequently, the Pinnacle device implantation results in near-immediate systemic release of high levels of toxic metal ions into recipients’ bodies.  These particles accumulate in the tissue around the implant. As a result, metallosis, pseudotumors, systemic toxic reactions, and other serious conditions can develop.

DePuy and J&J Ignored Regulatory Warnings and Studies

Numerous governmental regulatory agencies have acknowledged the problems caused by metal-on-metal implants like the Pinnacle device. Great Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) investigated the Depuy Pinnacle metal-on-metal total hip replacement system after receiving widespread reports of soft tissue damage and tumor growth in thousands of patients who received these implants. In April 2010, MHRA issued a Medical Device Alert. This alert required physicians to closely monitor cobalt and chromium levels in patients with metal-on-metal hips.

In May 2010, the Alaska Department of Health issued a bulletin on the Pinnacle devices. It warned of the toxicity of the DePuy metal-on-metal total hip replacement systems. Accordingly, this warning also urged close monitoring of heavy metal levels in patients.

Furthermore, older designs have a high success rate. Consequently, studies have shown that it is statistically impossible to run enough studies to prove metal-on-metal hip replacement systems superiority.

Despite these factors, manufacturers continued to misrepresent the metal-on-metal Pinnacle System as a high-quality, safe and effective hip replacement product in their marketing and promotional materials. As a result, these companies are facing almost 9,000 lawsuits accusing the company of illegally marketing the flawed metal-on-metal hips.

Talcum Powder Trial Closing Arguments Set for Friday

By Emily Cox
Talcum Powder Trial
Photo by Austin Kirk

St. Louis, MO — Jurors in Missouri’s fourth talcum powder trial against Johnson & Johnson are scheduled to hear closing arguments Friday, following three weeks of testimony and evidence, alleging that the company’s talc-based powders caused women to develop ovarian cancer.

According to a recent docket entry, jurors have heard evidence on behalf of defendant Imerys Talc since Monday.

Nora Daniels filed the case, following her ovarian cancer diagnosis after using J&J’s talcum powder for 36 years. The case’s caption is Valerie Swann, et al. v. Johnson & Johnson, et al. case number 1422-CC09326-01 in Missouri’s 22nd Judicial Circuit Court. Daniels is joined by 60 other plaintiffs, alleging that J&J knew about the connection between talc and ovarian cancer since the 1970s but chose not to warn consumers. Instead of providing warning labels or switching to safer formulas, these women claim J&J concealed this risk to protect profits generated by their Baby Powder and Shower-to-Shower brands. In fact, J&J continued to specifically target women to use the products for feminine hygiene despite the risks.

“The love of money results in all manners of evil,” a lawyer for the plaintiffs told the jury. “You’re gonna see it.”

This is the fourth talcum powder trial in Missouri state court and the fifth trial overall. In 2016, expert testimony resulted in massive verdicts by St. Louis juries of $72 million, $55 million, and $70 million.

However, the plaintiff team in this trial did experience a potentially significant shakeup early in the trial. The attorney who delivered key opening and closing statements at the previous three Missouri trials experienced a medical emergency while giving his opening statement at this talcum powder trial. Consequently, a new jury was selected, and a different member of the plaintiff team delivered the opening statement.

Talcum Powder Trial Evidence

The team for the plaintiffs alleged in court that evidence of the cancer risk from talcum powder was so strong that condom manufacturers stopped using it and that by 1994 at least nine additional published studies raised similar concerns. They specifically cited a 1982 study by Dr. Daniel W. Cramer that showed a connection between talc and cancer.

In 2006, the Canadian government classified talc as a very toxic carcinogen. In that same year, J&J’s talc supplier, Imerys Talc, started including warnings on the talc it supplied J&J. These warnings contained information from the International Association for the Research of Cancer and information on the Canadian government’s carcinogen classification. To this day, J&J still does not pass these warnings on to its consumers.

There are currently about 2,500 individuals with cases pending against J&J, alleging their talcum powder products caused ovarian cancer.

Metal Hip Replacements Can Poison Recipients

By Emily Cox
Stryker Metal Hip Poisoning
Photo by Andrew Kuznetsov

A new complaint claims that Stryker metal hip design defects with the Accolade hip stem and LFitv40 femoral head released metallic debris into a woman’s body, causing heavy metal poisoning and hip failure less than ten years after implantation.

The lawsuit was filed by Linda Regan in the District of Massachusetts U.S. District Court against Stryker Orthopaedics this past week. Regan claims that the company sold and manufactured metal hip replacement components that are likely to release metal ions into recipients’ blood. Consequently, patients have a high risk of catastrophic hip failures that often result in high risk hip revision surgery.

Stryker Metal Hip Replacement Poisoning

According to the claim, Regan underwent metal hip replacement surgery in July 2007. Surgeons implanted a Stryker Accolade TMZF Hip Stem and Stryker LFit Anatomic V40 Femoral Head. Stryker recalled the femoral head in 2016 due to high incidence of taper lock failure. However, there were also a growing number of heavy metal poisoning reports at this time as well. Regan alleges that all Stryker femoral heads are defective and should be recalled.

“Instead the Stryker defendants have intentionally downplayed the risk of harm and limited the scope of its recall in an effort to hide from surgeons, patients and the FDA the true extent of the problems with their defective hips,” the lawsuit stated.

Regan alleges that she began to experience pain and discomfort after implantation of the metal hip components. Doctors were unable to find an explanation for her symptoms. There was no evidence of infection, hip loosening, or faulty positioning. Finally, further diagnostic tests revealed that Regan’s blood had “markedly increased levels of metal ions.” Namely, these metal ions were cobalt and chromium. Overexposure to these metals can lead to nerve damage, respiratory diseases, kidney diseases, heart damage, and lung and respiratory tract cancer, as well as kidney, liver, and heart lesions.

Due to this and Regan’s declining health, she decided to undergo revision surgery on her hip in July 2014. During surgery, doctors discovered that there was substantial metallosis and trunnionosis in her hip, resulting in soft tissue damage. Her surgeon also noted corrosion at the taper junction between the Accolade stem and Stryker’s LFitV40 Chromium Cobalt femoral head.

Since undergoing revision surgery, Regan has endured extensive rehabilitation and continues to suffer physical and mental injuries because of the damages incurred from the Stryker metal hip, according to the claim.

Stryker Metal Hip Replacement Lawsuits

Regan’s case joins the ranks of a growing number of similar Stryker metal hip replacement lawsuits, alleging metal blood poisoning related injuries. Plaintiffs indicate that Stryker failed to provide adequate warnings or instructions to surgeons.

Hip replacement lawyers are not only pursuing cases for individuals who required revision surgery. They are also reviewing claims for individuals with recalled Stryker hip components still implanted. These could be releasing toxic levels of metal without these individuals having any knowledge that their hip replacement is corroding.

Ethicon Physiomesh Caused Woman’s Gastric Contents to Leak Through Opening in Skin

By Emily Cox
Ethicon Physiomesh Caused Gastric Contents to Leak
Photo by Jameel Winter

Tampa, FL — A new lawsuit alleges that Ethicon Physiomesh caused extensive damage throughout a Florida woman’s abdominal cavity, including a condition that causes the contents of the stomach or intestines to leak through an opening in the skin.

The lawsuit was filed Monday by Lillian Graham in the Middle District of Florida against Johnson & Johnson and its subsidiary Ethicon. According to the claim, Graham was implanted with two Ethicon Physiomesh devices. One was 20cm x 25cm. The other was 10cm x 15cm. Graham claims that Physiomesh’s defective design caused severe infections, abscesses, as well as extensive adhesions and fistulas among other serious complications. Adhesions are scar tissue that fuses organs together. Fistulas are abnormal connections between hollow organs such as the intestines and stomach.

Multiple Surgeries to Address Ethicon Physiomesh Complications

In June 2013, Graham underwent surgery to remove one of the Ethicon Physiomesh devices due to failure and hernia recurrence. Surgeons found extensive infections from the Physiomesh with abdominal wall abscesses and a fistulous connection from the stomach to the abscess cavity. Her small bowel was also densely adhered to an inflammatory mass.

“This was carefully dissected away and the inflammatory mass was entered revealing a cavity in the upper anterior abdominal wall containing very purulent foul-smelling wadded mesh material,” doctors stated in the lawsuit.

Doctors surgically excised the inflammatory mass and festering mesh material and took down the adhesions and gastric fistulas.

Ethicon Physiomesh Caused An Enterocutaneous Fistula
Photo by Camknows

In November 2013, Graham underwent another surgery to treat Ethicon Physiomesh complications. It took doctors about two hours to free up her bowel from the multiple, extensive adhesions inside Graham’s abdomen.

Since then, Graham has endured numerous additional surgical procedures to attempt to treat the enterocutaneous fistula caused by the failed, defective Physiomesh in her body. An enterocutaneous fistula is an abnormal connection that forms between the intestinal tract or stomach and the skin. As a result, the contents of these organs seep through to the skin.

Ethicon Physiomesh Lawsuits

Graham joins a rising number of individuals filing similar Ethicon Physiomesh lawsuits around the country. These lawsuits allege that Physiomesh’s design is to blame for the extensive reports of complications from the device. The device has five distinct layers with a multi-layer coating.  This feature is unique to the Physiomesh. Ethicon designed the multi-layer coating to prevent or minimize adhesion and inflammation. It also promises to help the mesh incorporate into the body. However, these lawsuits allege that it does the exact opposite. It also provides a breeding ground for bacteria that the body’s immune response cannot eliminate.

According to the plaintiffs, the Ethicon Physiomesh also has a high rate of failure. Furthermore, Ethicon designed the multi-layer coating to degrade inside the body over time. As this coating degrades, the exposed mesh adheres to organs, causing fistulas, bowel strangulation, and her hernia incarceration, as well as bowel perforation or erosion among other injuries. Consequently, they allege that the device’s benefits are nonexistent.

The lawsuits claim that Ethicon and Johnson & Johnson knew or should have known about these risks. However, instead of disclosing these dangers to the public, they concealed them to protect Ethicon Physiomesh’s substantially higher profit margin compared to other hernia mesh products.

Experts expect that hundreds, if not thousands, of individuals will file additional lawsuits in the coming months and years.

 

 

 

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