Category: Defective Products

Physiomesh Lawsuit Alleges the Hernia Mesh Provides No Benefit

By Emily Cox
Physiomesh Lawsuit
Patients Might As Well Put This in Their Bodies.
–Photo by frankieleon

A new Physiomesh lawsuit alleges that the manufacturer defectively designed its hernia mesh to the point that it provides literally no benefit to patients – only the possibility for dire consequences.

Ronald Keller filed the claim earlier this month. He alleges that Ethicon Physiomesh caused extensive harm that required multiple surgical interventions to repair, while providing absolutely no benefit.

Keller underwent hernia repair surgery in November 2010. Surgeons used a Physiomesh to treat his umbilical hernia. However, Keller’s condition wasn’t remedied by the procedure. In fact, his health steadily declined with persistent abdominal pain and a small bowel obstruction.

In May 2011, Keller sought surgical treatment. The surgeon noted a massive amount of adhesions throughout the entire small intestine and removed a portion of Keller’s small intestine to relieve the obstruction. However, Keller continued to experience abdominal pain and a partial small bowel obstruction only a month later.

In September 2014, doctors found adhesions to the mesh and decided that another surgical intervention was necessary. Doctors performed extensive lysis of adhesions. Less than a week later, Keller required further surgery as the bowl was densely adhered to the mesh. Surgeon excised the mesh, noting it was the origin of significant adhesions. Lysis of the adhesions took more than 45 minutes. Doctors found additional mesh adhered to the small intestine that had to be “meticulously cut off.” Then, Keller had to undergo open incisional ventral hernia repair to repair thee original hernia the Physiomesh was supposed to fix.

Physiomesh Lawsuit Allegations

Keller’s Physiomesh lawsuit against the hernia mesh manufacturer claims that any purported benefits of the mesh’s design are non-existent and that it significantly increases the risk for serious harm to patients.

Ethicon designed and marketed Physiomesh’s multi-layer coating as a barrier against adhesion to internal organs. However, it is only temporary. It is intended to degrade over time inside the body, eventually leaving the “naked” polypropylene mesh exposed. Furthermore, the degradation of this coating can cause or intensify an intense inflammatory and foreign body reactions. Also, the exposed polypropylene mesh will inevitably adhere to internal organs, starting a chain reaction of adverse consequences.

“Any purported beneficial purpose of the multi-layer coating (to prevent adhesion to the internal viscera and organs) was non-existent,” the lawsuit states. “The product provided no benefit, while substantially increasing the risks to the patient.”

Despite the risks and non-existent benefits, Keller asserts that Ethicon continued to sell its defective product due to the fact that it has a significantly higher profit margin than other hernia repair products.

Keller’s Physiomesh lawsuit joins a growing number of similar lawsuits. All these lawsuits assert serious injuries from Ethicon’s Physiomesh. Experts expect that the company may face thousands of cases in the future.

Talc-Ovarian Cancer Link Verified by Harvard MD at Latest Trial

Talc-Ovarian Cancer Link
Photo by Steven Lam
By Emily Cox

A Harvard epidemiologist verified the talc-ovarian cancer link Monday, telling a Missouri jury he has reached “medical and scientific certainty” that a woman’s daily use of Johnson & Johnson’s talcum products for four decades was the primary reason she developed ovarian tumors.

Lois Slemp’s case is the fifth case to go to trial in St. Louis, alleging that Johnson & Johnson’s talcum powder products caused ovarian cancer. Johnson & Johnson’s talc supplier, Imerys Talc America Inc, is a co-defendant.

During the 10th day of the St. Louis trial, Slemp called epidemiologist and gynecologist Dr. Daniel Cramer to the stand. Epidemiologists are specialized professionals who investigate patterns and causes of human diseases and injury. Cramer testified that he had evaluated Slemp’s medical and lifestyle factors to assess the likely cause of her ovarian tumors. He noted that Slemp’s obesity, family history of several different cancers and decades of smoking all could have had some impact. However, he determined that her talc use was the most substantial.

Talc-Ovarian Cancer Link

“First of all, she used talc daily for 40 years. That’s a lot of talc,” he testified. “It was my opinion to a reasonable degree of medical and scientific certainty that Ms. Slemp’s genital use of talc was the major contributing cause and substantial cause in the development of her serious borderline tumor.”

Cramer also noted that Slemp had undergone genetic testing . However, she was negative for genes BRCA1 and BRCA2. These genes increase the risk of ovarian cancer.

Furthermore, Cramer added that the talc particles found in the ovarian tissue removed from Slemp “almost speaks for itself.” The only reason these particles were there was due to her use of Johnson & Johnson talc-based Baby Powder and Shower-to-Shower products.

Cramer is one of the first scientists to suggest a connection between genital-area use of talcum powder and ovarian cancer, starting with a 1982 study. Cramer also discussed an article he published in 1985 in a medical journal, urging doctors to warn their patients against using talcum powder on their genital area.

Talc-Ovarian Cancer Link Cross-Examination

During cross-examination, Johnson & Johnson attorneys suggested that there were significant differences between Cramer’s opinion as an expert for the plaintiff and the results in the studies he published in academic journals. However, Cramer maintained that the differences were purely semantic, not substantial.

“Nowhere in the published scientific literature, did you or your colleagues, ever publish, ever publish, that genital talc use causes serious borderline tumors, the disease Ms. Slemp has. Isn’t that a correct statement, sir?” Richman asked.

“We certainly made a powerful case for there being an association,” Cramer stated. “We may not have used the word ‘causal,’ if I had known how important that word was, I would have used it a long time ago.”

Previous Talc-Ovarian Cancer Link Trials

After losing its first three trials in St. Louis with verdicts totaling more than $200 million, Johnson & Johnson saw its first victory last month.

The first talc-ovarian cancer link trial focused on the death of Jacqueline Fox from ovarian cancer. Jurors awarded Fox’s estate $72 million in February 2016. Then, the second trial saw a verdict of $55 million for Gloria Ristesund in May. In the third trial, plaintiff Deborah Giannecchini received $70 million in damages in October. This was the only trial that jurors found Imerys liable as well.

However, Johnson & Johnson broke its losing streak in March 2017. The company was finally able to convince jurors that Nora Daniels’ daily use of talcum powder over several decades did not cause her ovarian cancer.

More St. Louis talc-ovarian cancer link trials will take place in June and July. The first California trial will go before jurors in July.

 

Vaginal Mesh Complications Cause Almost 1,000 UK Women to Sue NHS

By Elizabeth de Moya
Mesh Complications
Photo by Leon

Over 800 women in England, Scotland, Wales and Northern Ireland are suing the National Health Service (NHS) and several corporate manufacturers over vaginal mesh complications.

 The NHS is the public health service in the UK where the government covers the costs of most medical treatments. Approximately 11,500 women in the UK had vaginal mesh implanted between April 2007 and March 2015. About one in 11 have experienced health issues.

Doctors commonly use transvaginal mesh implants, also known as pelvic or vaginal mesh implants, to treat female urinary incontinence, or to prevent organ prolapse after childbirth or hysterectomy.

This follows a wave of lawsuits over pelvic mesh complications in the US, in which Johnson & Johnson agreed to pay $120 million to settle 3,000 pending vaginal mesh lawsuits. Collective settlements paid out by transvaginal mesh manufacturers number in the billions.

Charges of Gross Negligence and Misconduct

Johnson & Johnson and its subsidiary are named in the claim against the NHS. The companies have promised to mount a vigorous defense. Ethicon engineers, manufactures and markets surgical mesh within the global giant Johnson & Johnson.

The BBC reports that Johnson & Johnson knew about the dangers of pelvic mesh as early as 2004 via a leaked email. In relation to pelvic mesh risks, the email mentioned the necessity of “starting a major control offensive because the competition would have a field day.” However, company spokesmen argue that this is out of context.

According to the Medicines and Healthcare Products Regulatory Agency (MHRA), a government body in the UK, they are, “committed to help address the serious concerns raised by some patients. The greater proportion of the clinical community and patients support the use of these devices in the UK.”

“We encourage anyone who suspects they have had a complication after having a mesh device implanted to discuss this with their clinician and report to us via the Yellow Card scheme regardless of how long ago the implant was inserted,” the agency added.

Meanwhile MHRA statistical data, obtained by the Belfast Telegraph, suggests there have been more than 1,000 adverse incidents regarding vaginal mesh complications in the past five years in the UK. This means 9% of users reported problems.

Some of the UK Women Affected by Pelvic Mesh Complications

  • Claire Cooper – Cooper started experiencing severe abdominal pain about three years after receiving a vaginal mesh implant. Doctors gave her a total hysterectomy as treatment. When her problems persisted, they told her she was imagining things. She has experienced loss of consortium with her husband and has considered suicide due to the pain.
  • Dawn Martin – Martin says she knew something was wrong as soon as she woke up from surgery. “It felt like I had broken glass down there,” she told the Telegraph. About a year later surgeons discovered that the mesh had shrunk more than expected. They had to remove the implant, because it was cutting into her bladder.
  • Kate Foley – Foley began having problems with incontinence about two years after her operation. Her doctors convinced her to have another piece of mesh implanted as treatment. But on the operating table they discovered the original implant had pierced her bladder. Since surgeons removed the mesh, Foley dreads going to the bathroom.
  • Kate Langley – Langley had to give up her job in childcare after having a vaginal mesh implant. She says the mesh protrudes from her vaginal wall “like cheese-wire.” She has been to the hospital 53-times for complications related to the mesh. Surgeons have taken out part of it, but it has migrated too close to a nerve to remove entirely.
  • June Smith – Smith had a transvaginal mesh implanted in 2012. In 2014, she discovered a small piece of surgical mesh floating in her bath water. Doctors informed her that the mesh implant had disintegrated inside of her. They were able to remove a portion, but much of the device remains causing her chronic pain. She still takes antibiotics to prevent a reoccurring infection.

 

 

Missouri Man Joins Growing List of Ethicon Hernia Mesh Lawsuits

by Elizabeth de Moya
Ethicon Hernia Mesh Lawsuits
Photo by Jason Taellious

A new lawsuit charges that Johnson & Johnson and its subsidiary Ethicon failed to adequately warn consumers about Ethicon hernia mesh implant risks.

Missouri resident, Robert Asplin, filed the complaint against the global medical conglomerates this past week. He claims the defendants did not issue a proper recall once they knew about the dangers of the Ethicon hernia mesh implant. Furthermore, they allegedly deliberately designed, manufactured, sold and distributed the product, despite these inherent concerns.

Asplin Ethicon Hernia Mesh Lawsuit

Asplin had a Physiomesh implanted in his abdomen to repair a hernia in July 2015. In December 2016, he was admitted to the hospital due to severe pain in his stomach after he had another hernia. Doctors found multiple infected adhesions and told him that the mesh implant had folded in half inside of him. They also discovered a hole in the middle of the mesh. Furthermore, the implant had moved backwards and embedded itself into the flesh.

The lawsuit requests at least $75,000 plus costs, attorney fees, interest, or any other relief to which he is due for the medical bills incurred during treatment.

Ethicon Hernia Mesh

Ethicon is a subsidiary of pharmaceutical giant Johnson & Johnson. The company designs and manufactures surgical implants, such as Physiomesh. Consequently, they are in charge of the design, development, promotion, marketing, testing, training, distribution and sale of the hernia repair mesh products to doctors and hospitals.

Ethicon Physiomesh has a unique multi-layer coating. No other hernia mesh uses this design. Ethicon promoted this design to reduce adhesions and inflammation, while facilitating incorporation of the mesh into the body. However, it appears to do the opposite. Instead the human body rejects the implant, causing tissue damage and infection. This can lead to further complications, such as organ perforation or abscess formation. Furthermore, evidence shows that the coating wears away overtime.

Although Ethicon marketed Physiomesh as a means of treating hernias, it actually causes further complications. Furthermore, its unique coating made its profit margin considerably higher than other mesh products.

Johnson & Johnson never officially recalled Ethicon Phisiomesh by informing the affected patients. Instead they pulled the product off the shelves quietly, and recommended that doctors continue to treat these cases as they would a normal patient. Ethicon stopped distributing Physiomesh in February 2015.

Toy Recall Affects Easter Toys at Target

By Emily Cox
Easter Toy Recall
Photo by Joshua Houzvicka

Target toy recall due to serious health risks affects toys that could potentially be in hundreds of thousands of Easter baskets tomorrow.

The U.S Consumer Product Safety Commission (CPSC) announced the toy recall Thursday. It impacts more than 500,000 water-absorbing toys sold by Target across the country. These products include Easter eggs, Easter grow toys, and dinosaur toys.

No one has reported any injuries or incidents in relation to the recall. However, if swallowed, these expandable toys can be life-threatening. They could potentially cause internal obstructions, vomiting, dehydration, and other serious complications. Furthermore, the CPSC warns that removing the toys from the body would most likely require surgery.

Hatch & Grow Easter Eggs, Easter Grow Toys, and the Hatch Your Own Dino toys all expand several times their initial size upon contact with water.

Both Easter toys have the model number 234-25-1200. It is located on the back of the packaging. The dinosaur toys’ model number 234-09-0016 can be found on a label inside the product’s packaging.

The Hatch & Grow Easter egg comes in pink, blue, or purple. They include a butterfly or a bunny. The Easter Grow toys have a bunny or yellow chick. The Hatch Your Own Dino Eggs are purple or yellow/green. The recalled product line features 11 different dinosaurs.

Target sold the Easter and dinosaur toys in February and March 2017 for $1. Target sold more than 560,000 toys during this time. China manufactured the toys.

Consumers who purchased these toys should return them to Target for a full refund. They can also contact Target at (800) 440-0680 for more information about recall.

Expanding Toy Recall

Expanding toy ingestion has been a growing concern for several years. In December 2012, the CPSC issued a similar expanding toy recall after an 8-month girl ate Dunecraft Water Balz, requiring emergency surgery to remove the expanding toy from her intestines. Consequently, the agency warns that the Easter and dinosaur egg water toys pose the same threat to children.

 

Bard Hernia Plug and Ethicon Hernia Mesh Permanently Disables a Man

By Emily Cox
Hernia Plug and Mesh Permanently Disabled a Man
Photo by Joshua Zader

A new product liability lawsuit claims that a hernia plug and mesh caused extensive medical damage that required multiple surgeries and continues to debilitate a Texas man.

Matthew Ochoa filed the complaint in the Southern District of Texas in March. He named C.R. Bard, Bard Davol, Inc, Johnson & Johnson, and its Ethicon subsidiary as the companies responsible for damage incurred by their hernia mesh products.

Ochoa Hernia Plug and Mesh Difficulties

Ochoa indicates that he first received a Bard Perfix plug in March 2015. His medical complications began mere days after the surgery. He immediately developed groin pain and a spreading rash. Tests revealed that the hernia mesh had folded on itself. Ultimately, the hernia ruptured, requiring repair surgery.

In June 2015, Ochoa underwent hernia repair. Dr. Christopher Shin repaired the hernia with an Ethicon prolene mesh, stapling it all the way around. He didn’t remove the hernia plug, placing the new mesh under the defective device instead. After the surgery, Ochoa felt a sharp, excruciating pain in his lower right abdomen. He continues to feel this debilitating pain to this day.

Ochoa underwent yet another hernia surgery to remove the original, defective hernia plug in August 2015 despite significant risks. Dr. Shin had warned Ohoa that nerve damage and the possibility of losing his right testicle. However, Ochoa accepted the risks. Unfortunately, due to extensive complications, Dr. Shin was unable to remove all the mesh.

“During the operation, Dr. Shin found that the original mesh had been tangled with the nerves and 2% of the mesh concreted onto Matthew’s spermatic cord, which he was unable to remove,” the lawsuit notes. “The operation took 25% longer than anticipated due to the complications that arose from the entanglement.”

Ochoa’s condition continued to deteriorate dramatically. Dr. Shin determined that the defective mesh was causing severe adverse reactions in Matthew’s body. However, not surgical action was taken at this time.

Ongoing Hernia Plug and Mesh Complications

By December 2015, the pain in his testicle was unbearable. In January 2016, the mesh shifted, which only heightened his already substantial pain. When he became light headed, Ochoa pled Houston Methodist West Hospital to help. However, he was released when doctors could not determine a cause for his fever and physical state. Two days later, Ochoa lost his equilibrium and was unable to stand. He was admitted to St. Joseph’s Hospital in downtown Houston where he lost his ability to walk. Then, Ochoa started slurring his words and passed out. Surgeons determined that mesh removal was the best course of action. However, the hospital released him with the mesh still intact and paralyzed from the waist down.

Surgeons finally attempted to remove the mesh in February 2016. They found that 40 percent of the original mesh was tangled around the spermatic cord. The severity of Ochoa’s injuries shocked doctors.

“Dr. Bertini did his best to remove the mesh tangled around the cord, as Dr. Cramer found that the Prolene mesh Dr. Shin put in place, because of its defectiveness, tangled around a lot of nerves and tissue near the groin and lower right belly area,” the lawsuit states. “Once the surgery was over, Dr. Bertini and Dr. Cramer came into the room to explain out of all their collective years of practice, they had never seen a case as bad as Matthew’s.”

Ochoa’s hernia injuries eventually resulted in the loss of his tentacle and liver problems from his hernia mesh infection. Doctors believe some of the mesh is still in his body, causing ongoing severe pain and health problems.

 

Stryker LFit V40 Hip Replacement Lawsuits Centralized for Pretrial Proceedings

By Emily CoxHip Replacement Lawsuits

A judicial panel has ordered that all U.S. Stryker LFit V40 hip replacement lawsuits be brought before
one judge for coordinated pretrial proceedings.

The Stryker LFit V40 is a metal femoral head implant. Surgeons used it in combination with several different types of Stryker hip replacement systems. However, Stryker issued a recall last year for certain sizes and lots of the femoral head due to the growing number of individuals reporting taper lock failure with the metal head, requiring additional painful surgery.

A group of LFit V40 hip replacement plaintiffs filed a request for centralized litigation in January. The motion asked the Judicial Panel on Multidistrict Litigation (JPML) to transfer all LFit V40 cases to one judge for pretrial proceedings. These coordinated proceedings help prevent duplicate discovery and conflicting pretrial orders. According the JPML, this serves judicial efficiency, saving all parties time and money.

LFit V40 Hip Replacement Lawsuits Multi-District Litigation (MDL)

The JPML issued the transfer order April 5, following oral arguments March 30. While all parties supported centralization, they differed on the location of the consolidation. The order calls for all LFit V40 hip replacement cases to go before a judge in the District of Massachusetts.

“After considering the argument of counsel, we find that the actions in this litigation involve common questions of fact, and that centralization in the District of Massachusetts will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation,” the JPML ruled. “While any number of the parties’ proposed transferee districts would be suitable, we are persuaded that the District of Massachusetts is the appropriate transferee district for this litigation. Five LFIT V40 cases in the District of Massachusetts are pending before Judge Indira Talwani, who has not yet had an opportunity to preside over an MDL docket.”

There are currently six LFit V40 lawsuits pending in three different districts. However, the panel noted 27 additional possible cases.

The JPML established similar centralized proceedings after the 2012 Stryker Rejuvenate and ABG II voluntary recall. These centralized proceeding resulted in thousands of lawsuits.

Following coordinated discovery in that MDL, Stryker agreed to pay more than $1 billion to settle the hip replacement lawsuits. This settlement was to resolve cases where individuals required revision surgery when the recalled implant failed.

Bair Hugger Infection Bellwether Cases Chosen

By Emily Cox
Bair Hugger Infection Justice
Photo by Dan4th Nicholas

Patients and 3M identified about 30 Bair Hugger infection bellwether trial cases Friday in the multidistrict litigation (MDL) against 3M’s patient-warming device’s alleged tendency to cause infection after orthopedic surgery.

The patients and 3M each identified 16 cases from the 150 that the court randomly selected in January. The sides identified one common case. Consequently, this brings the total number of federal case nominations to 31. The parties selected these nominations from cases involving either a hip or knee implant procedure.

These early trials will help gauge how juries are likely to react to evidence that will be present throughout the litigation.

Bair Hugger Infection Background

Hypothermia is a common side effect of anesthesia during the first hour. 3M designed the Bair Hugger Forced-Air Warming system to prevent and treat unintended hypothermia during surgery. However, patients claim the warming device caused them to develop post-surgical infections. The device blows hot air into a specially designed blanket covering the patient. Consequently, this allegedly spreads bacteria from the hospital floor or from inside the device itself. In at least one instance, the Bair Hugger infection was drug-resistant and resulted in amputation.

The Judicial Panel on Multidistrict Litigation (JPML) first consolidated the cases in 2015 in the District of Minnesota. At that time, 3M claimed the lawsuits were nothing more than a smear campaign by Bair Hugger inventor Scott Augustine. Augustine also founded Augustine Medical, which eventually became 3M’s Arizant Healthcare. Arizant also manufacturers Bair Hugger.

According to 3M, Augustine left the company in 2003 when his company was being investigated for Medicare fraud. Augustine ended up pleading guilty to one misdemeanor count of Medicare fraud and agreeing to pay the government $2 million in 2004. His company also pled guilty to criminal charges. The government dropped charges against Arizant. 3M bought Arizant from private equity company Court Square Capital in 2010.

3M continues to assert that it will vigorously defend the Bair Hugger device’s safety. However, with almost 1,600 patients claiming Bair Hugger infections, the company has an uphill battle ahead.

Farmer Claims Monsanto Weed Killer Caused Cancer

By Emily Cox
Monsanto Weed Killer May Cause Cancer
Photo by Daniel Lobo

A new product liability lawsuit alleges that exposure to the popular Monsanto weed killer Roundup caused non-Hodgkin’s lymphoma.

Thomas Taylor filed the complaint March 29 in Delaware Superior Court. The complaint alleges that Monsanto deceived farmers and other agricultural workers about Roundup’s safety. The company claimed that the weed killer and its active ingredient, glyphosate, were “safer than table salt” and did not recommend protective clothing while using the herbicide.

“For nearly 40 years, farmers across the globe have used Roundup, unaware of its carcinogenic properties,” the lawsuit states.

According to the lawsuit, Taylor used Roundup routinely for three years while working on a northern Michigan farm. Taylor maintains that he both mixed and sprayed the weed killer around eight times per month from June to September each year, following all safety and precautionary warnings.

Taylor was diagnosed with large non-Hodgkin’s Lymphoma in April 2013. Consequently, Taylor underwent chemotherapy, resulting in gallstones. Furthermore, he continues to be monitored by his oncologist.

“As a result of his injury, Plaintiff has incurred significant and continuing economic and non-economic damages,” the claim states.

Monsanto Weed Killer Lawsuits

Taylor’s case joins the rising tide of similar individuals who suffered from non-Hodgkin’s lymphoma after extended exposure to the Monsanto weed killer. These individuals indicate that they could have avoided their cancers if Monsanto had adequately warned of the risks. They maintain that they could have taken proper safety precautions or used safer products to control weed growth.

“Plaintiff’s injuries, like those striking thousands of similarly situated victims across the country, were avoidable,” the claim states.

In 1996, the New York Attorney General (NYAG) filed a lawsuit against Monsanto for false and misleading advertising about the safety of Roundup products. By November 1996, Monsanto entered into an Assurance of Discontinuance with NYAG. In this assurance, Monsanto agreed stop publishing and broadcasting any advertisements in New York that implied that the weed killer was safe. Monsanto upheld its end on this assurance. However, the company has not altered its advertising in any other state to this day. Consequently, Monsanto continues to assert that the chemical is “practically non-toxic” everywhere except New York.

In March 2015, the World Health Organization’s International Agency for Research on Cancer (IARC) determined that Roundup’s active ingredient, glyphosate, was likely a cancer-causing agent. The agency’s report specifically links Roundup with non-Hodgkin’s lymphoma.

 

 

Physiomesh Manufacturer Allegedly Knew the Hernia Mesh was Defective

By Emily Cox
Physiomesh Manufacturer
Photo by Johnny Silvercloud

A new lawsuit alleges that Physiomesh manufacturer Ethicon knew that their hernia mesh was defective prior to its market release but introduced and marketed it anyway, hiding the dangers from the public and medical community.

George Holloway filed the complaint Monday in the Northern District of Alabama. According to the lawsuit, Holloway received a Physiomesh Composite mesh implant to repair a hernia in October 2012. The severity of his complications from the defective mesh necessitated additional invasive surgeries. Holloway claims he continues to suffer physical pain and mental anguish as a result of his injuries and additional surgeries. The claim directly attributes this to how the Physiomesh manufacturer designed its product.

Physiomesh’s defective design is not used with any other hernia mesh.  Ethicon promoted its unique multi-layer coating as minimizing adhesion and inflammation, while aiding incorporation of the mesh into the body.  Instead, this coating prevented incorporation of the mesh into Holloway’s body. This caused an intense inflammatory and chronic foreign body response. Consequently, Holloway suffered an adverse tissue reaction, as well as mesh migration. This severely damaged surrounding tissue and promoted improper healing. Furthermore, the impermeable Physiomesh coating prevents fluid escape. This leads to infection, abscesses, and other serious complications. It also provides a breeding ground for bacteria. However, the mesh prevents the body’s immune response from eliminating the bacteria. This allows infection to proliferate. The lawsuit classifies these defects as “cytotoxic, immunogenic, and not biocompatible.”

Physiomesh Manufacturer Allegedly Knew About These Defects and Concealed Them

Holloway’s claim alleges that Physiomesh manufacturer Ethicon knew about these risks even before releasing the product on the market.

“Defendants knew or should have known of the cytotoxic and immunogenic properties of the multi-layer coating of the Physiomesh prior to introducing it into the stream of commerce,” the lawsuit states.

The lawsuit alleges that the Physiomesh manufacturer concealed these risks from Holloway and his doctor. Consequently, Holloway could not make an informed decision regarding his care. Ethicon profited from this uninformed decision to the detriment of Holloway’s heath and countless others. According to previous lawsuits, Physiomesh has a substantially higher profit margin than other hernia meshes. These lawsuits allege that the Physiomesh manufacturer was protecting this margin rather than patients who depended on the company to help them.

As reports of serious injuries continued to mount, Ethicon issued an Urgent: Field Safety Notice in May 2016. The notice requested the return of all Ethicon Physiomesh Composite Mesh products but was vague on Ethicon’s culpability in the hernia mesh’s many failures.

Holloway’s case joins the growing number of individuals filing claims over serious injuries caused by Ethicon’s Physiomesh.

 

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