Category: MDL

Smith & Nephew Tried to Blame Jewelry for Hip System Failure Rate

By Emily Cox
Smith & Nephew Blames Jewelry for Female Hip Failure
Smith & Nephew Blames Baubles for Hip Debacle (Flickr/k4dordy)

According to a new product liability lawsuit, when reports of the Birmingham Hip Resurfacing (BHR) system premature failing started flooding in, Smith & Nephew wasted no time in placing the blame on surgeons and even women’s costume jewelry.

Lydia Constantini filed the complaint this past Monday in the Northern District of California. She claims that Smith & Nephew tried to cover up the metal-on-metal hip implant’s defects. These defects caused metal-poisoning, pseudotumors, and premature failure of the device, requiring additional invasive surgeries for countless individuals.

In September 2008, Constantini underwent right hip resurfacing surgery. Doctors implanted a 50mm BHR femoral head with a 56mm BHR acetabular cup. Following the procedure, Constantini indicates that pain and complications led to hip revision surgery in December 2013 when the implant failed.

Her surgeons noted that there was evidence of metallosis. The release of cobalt and chromium metal particles into the blood stream causes this type of metal poisoning. The BHR system employs both of these metals. Smith & Nephew BHR failure also prompted the growth of a pseudotumor in Constantini’s hip. This disrupted and compromised her abductor muscle, leading to additional pain and immobility.

Smith & Nephew Immediately Points the Finger for BHR Failures

When failure rates continued to escalate for the BHR system, Smith & Nephew finally conceded that there was problem… but not with the hip system. It immediately laid the blame on implanting physicians. However, the company never properly implemented an FDA-mandated training program. Widespread training of surgeons didn’t even start until more than three years after the BHR system’s release. The company admitted to the FDA that surgeons were implanting the device despite receiving absolutely no formal training on how to properly perform the procedure. Even then, many surgeons received training via satellite rather than hands on as the FDA had required. Smith & Nephew unabashedly used its own poor surgeon training protocol to hide the product’s defects in order to continue to generate profits from the hip system even as it continued to harm more and more patients.

Studies invariably show that female patients are up to more than four times more likely to experience BHR failure in comparison to their male counterparts. In fact, one of Smith & Nephew’s own paid researchers, Callum W. McBryde, performed a study showing a 4.68 times higher failure rate in female patients. Many companies would have tried to bury this information. Not Smith & Nephew. The company readily released the information along with an explanation for the high failure rate. The company asserted that the problem was unrelated to the implant. The problem was the patients and their “costume jewelry.”

The company claimed that female jewelry use pre-sensitized women to metal artificial devices. Even before Smith & Nephew failed to provide any scientific evidence for this intriguing theory, it came off as desperate at best.

Smith & Nephew Lawsuits

Constantini joins a growing number of individuals, charging Smith & Nephew with strict product liability, negligence, breach of express warranties, fraudulent concealment, and negligent misrepresentation.

In May, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all BHR before District Judge Caterine C. Blake in Maryland. Experts expect that ultimately hundreds of these cases will join the multidistrict litigation to take Smith & Nephew to task.


Manufacturers Press for Low Dose Xarelto Market Expansion

By Uzma Rahman & Emily Cox

Low Dose Xarelto ProposedIn the face of more than 18,000 lawsuits over alleged life-threatening bleeding from the controversial blood thinner, manufacturers are now taking strides to expand their billion dollar baby’s market share even further by seeking FDA-approval to treat recurrent venous thromboembolism (VTE) with low dose Xarelto.

10 mg Xarelto only currently has FDA-approval to treat deep vein thrombosis (DVT) prophylaxis after hip or knee surgery. Of course, Xarelto manufacturers claim that this market expansion is purely altruistic to give patients more treatment options. However, given these companies’ track records, it seems more probable that they just want a piece of the action. With an estimated 900,000 cases of VTE in the U.S. each year, Xarelto manufacturers have much to gain by getting low dose Xarelto into the portion of the market deemed at high risk for higher dosage amounts of the drug.

Manufacturer Announces Low Dose Xarelto

In its Wednesday press release, Johnson & Johnson’s Janssen unit stated the FDA granted priority review of the supplemental drug dispensation for low dose Xarelto. Janssen hopes to gain considerable ground for the blockbuster anticoagulant by expanding its indications. The blood thinner is already phenomenally popular. Unfortunately, as more people use it, more reports of uncontrollable bleeding occur. Doctors are unable to stop the bleeding and serious, sometimes fatal side effects occurred.

Will Low Dose Xarelto Actually Help?

The drug company asserts 10 mg of Xarelto is more effective than aspirin at preventing recurring VTE. VTE is a condition that can cause deep vein thrombosis and pulmonary embolism, both of which can be fatal.

A study sponsored by the drug company shows taking low dose Xarelto reduced the risk of blood-clot recurrence by 70 percent when compared with aspirin. However, the study randomized patients to 20 mg or 10 mg Xarelto or to aspirin 100 mg daily. Recurrent VTE occurred in 17 of 1,107 patients taking 20 mg and in 13 of the 1,127 treated with the 10-mg dose. Among 1,131 patients receiving aspirin, 50 patients reported VTEs. Interestingly, the major bleeding rates were similar in both Xarelto doses (0.5% and 0.4% for 20 mg and 10 mg, respectively). The rate was also low, 0.3%, in the aspirin control group.

The FDA’s priority review designation means that the agency believes the low dose Xarelto version could offer significant health benefits. However, it also shortens the review period of the drug from the standard ten months to only 6 months. This accelerated review advances the FDA’s target date to October 28, 2017.

Xarelto Bleeding Risks

The FDA approved Xarelto in 2011 to treat atrial fibrillation and reduce risks associated with blood clots. The agency has expanded its indications several times since then. It quickly became one of the manufacturers’ star performers. Xarelto made $582 million in sales during its first full year on the market. In 2013, this figure rose to $2 billion for the fiscal year. Xarelto is now Bayer’s top-selling product, bringing in $3.24 billion in sales in 2016 and $2.5 billion in 2015. It is third on Johnson & Johnson’s product roster, generating $2.29 billion for the company in 2016. Like many meteoric climbs to come before it, sacrifices were made. Unfortunately, these sacrifices may have been the health of the very patients Xarelto was purportedly designed to help.

In 2014, the Institute for Safe Medicine Practices (ISMP) reported 3,331 individuals suffered adverse Xarelto events. Of these, 1,647 experienced hemorrhagic bleeding. According to FDA reports, the drug is also responsible for at least 370 deaths.

Xarelto Lawsuits

Many of these are injuries are due to the fact that the companies released the drug without a readily available antidote to stop emergency bleeding. Whereas, vitamin K will reverse the effects of the standard blood-thinner Coumadin (warfarin). Consequently, more than 18,000 individuals have filed product liability lawsuits against the manufacturers over serious uncontrollable bleeding. Two early Xarelto trials ended in victories for the defense. However, the primary determining factor of these trials was a Louisiana doctrine that holds if the doctors claim to be aware of the risks at the trial, then the manufacturer is freed from liability. Both doctors depositions practically read like primers on how to testify for a defensive win with this doctrine.

Luckily, the next two trials will take the litigation out of Louisiana and hopefully away from this damaging piece of legislation. The next trial begins August 7 in Mississippi.


Testosterone Bellwether Cases Selected For Trial

By Uzma Rahman
Early Testosterone Trials Set for Everett McKinley Dirksen United States Courthouse
Early Testosterone Trials Set for Everett McKinley Dirksen United States Courthouse (Flickr/Ken Lund)

A U.S. District Judge will soon hear two testosterone bellwether cases. Bellwether trials refer to a small group of cases from a larger litigation pool that the court selects for early trials. These trials show how future litigation may play out. Consequently, they are very useful for potential mass torts.

Taking on Testosterone

In recent years, testosterone therapy underwent a popularity rise. Testosterone is a hormone that plays a critical role in the male reproductive system. But it is also key for muscle mass, bone health and energy levels. While heavily prescribed, testosterone therapy is not always the best solution. Studies suggest many men are in danger of heart attack, stroke, or wrongful death from testosterone treatments.

Moreover, 6,500+ claims against the makers of Axiron, AbbVie, Androgel, Testim and various other testosterone replacement drugs are on file in U.S. courts. The lack of adequate warnings of the potential risks appears most often in the allegations. Hence, the testosterone bellwether trials may help the other pending claims.

So far, the first testosterone bellwether resulted in a mistrial. The claim alleged Androgel caused a heart attack. A second Androgel bellwether trial is scheduled to begin early next month, with a third case set to begin on September 18, and a fourth case against AbbVie in January 2018.

Additional bellwether trials over injury claims from Auxilium Pharmaceuticals’ testosterone gel, Testim, should begin in early November 2017 and April 2018.

A Look at the Two Testosterone Bellwether Claims

Recently, U. S. District Judge Matthew Kennelly scheduled a series of early trial dates against each of the major drug makers involved in the litigation. The parties can then gauge how juries may respond to certain evidence and testimony.

Then on June 22, Judge Kennelly issued a case management order naming two complaints that will serve as  the two bellwether claims against Eli Lilly over Axiron. The trials will go to court in January and March 2018.

The first complaint was filed by Tracy Garner of Alabama in March 2015. His claim alleges he suffered a heart attack from Axiron after only three days of testosterone treatment.

The second complaint was filed by John Debroka, Jr. of Florida in October 2015. His claim alleges he suffered a deep vein thrombosis from Axiron side effects just a few months after beginning testosterone therapy.

Most importantly, while the results of these cases are not binding on the plaintiffs, they may be useful in establishing settlement agreements. Ultimately, settlements help resolve the issues without expending court resources.

Infection Caused by Ethicon Hernia Mesh Proves Fatal

By Emily Cox
Hernia Mesh Infection
Photo by Mike Licht

According to a new wrongful death lawsuit against Johnson & Johnson and its Ethicon unit over dangerous defects with its Physiomesh, the hernia mesh caused a massive infection that led to septic shock, respiratory failure, and other serious health problems that ultimately proved fatal for a Georgia man.

The wife of William Stanley Edwards filed the complaint this past week in the Northern District of Georgia. Kathy Edwards alleges that Ethicon’s Physiomesh design defects were directly responsible for the fatal injuries that claimed her husband’s life.

In June 2015, Edwards received a 10” x 20” Physiomesh patch to treat an incarcerated ventral hernia. However, a mere couple of weeks later, he was back in the hospital due to severe abdominal pain and other complications. After being readmitted twice that month, doctors determined that he was suffering a hematoma and related infection. Finally, in November 2015, Edwards had to undergo revision surgery to remove the severely infected hernia mesh. During surgery, doctors found that the patch never incorporated into his tissue. They then replaced the Physiomesh with a biologic form of hernia mesh.

However, serious problems persisted including portions of bowel and fecal matter hanging out of the wound. Edwards’ wound also refused to heal. As a result, he underwent continuous care with several hospitalizations from November 2015 until his untimely death. Edwards finally succumbed to septic shock, respiratory failure, and acute rental failure on January 31, 2017, after living this nightmarish existence for more than a year.

Defective Design Caused Hernia Mesh Infection

According to the lawsuit, Edwards’ infection and death were the direct result of Physiomesh’s defective design. The claim asserts that the design’s inherent risks outweighed any potential benefits of the design.

“As a result of the defective design and/or manufacture of the Physiomesh, there was an unreasonable risk of severe adverse reactions to the mesh or mesh components including: chronic pain; recurrence of hernia; foreign body response; rejection; infection; inadequate or failure of incorporation/ingrowth; migration; scarification; deformation of mesh; improper wound healing; excessive and chronic inflammation; adhesions to internal organs; erosion; abscess; fistula formation; granulomatous response; seroma formation; nerve damage; tissue damage and/or death; and other complications,” the lawsuit states.

Furthermore, the lawsuit alleges that Ethicon designed the hernia mesh to produce a higher profit margin rather than better surgical outcomes. Even more disturbing is that Ethicon allegedly knew of the disastrous probable outcomes of implanting the dangerous and defective hernia mesh but continued to market and sell the product, concealing the risks, in order to protect that profit margin.

In June 2015, as injury, infection, and death reports continued to escalate, Ethicon quietly pulled Physiomesh products from the worldwide market rather than bringing attention to the product’s serious problems with a recall.

As a result, Edwards joins the quickly growing number of individuals filing lawsuits against Johnson & Johnson and Ethicon, alleging serious harm from its defective mesh product. Consequently, experts expect eventually will join the multidistrict litigation (MDL) before District Judge Richard Story in the Northern District of Georgia.

Smith & Nephew Sold Hip System in Direct Violation of FDA

by Emily Cox
Smith & Nephew
Photo by Ezra Pucci

A new lawsuit alleges that Smith & Nephew failed to comply with numerous requirements of its Birmingham Hip Resurfacing (BHR) FDA Pre-Market Approval, concealing the hip system’s inherent flaws from the FDA and exposing countless patients to its dangerous defects.

Gary Lunsford filed the claim against Smith & Nephew on June 14th in the Eastern District of California. He alleges that he underwent left hip resurfacing with the BHR system in September 2010. By October 2016, the hip had already failed, requiring revision surgery. The surgeon noted metallic debris and a pseudotumor from the premature failure of the device.

According to the lawsuit, Smith & Nephew knew or should have known that Lunsford’s injuries were a probable outcome from its BHR system. However, the company continued to promote BHR as a safe alternative to other metal-on-metal devices. In fact, Smith & Nephew did not withdraw the device from US markets until 2015. Furthermore, due to PMA non-compliance, the company should not have been selling the device at all.

Smith & Nephew FDA Violations Voids Legal Protection and Approval Status

On May 9, 2006, the FDA granted conditional approval to Smith & Nephew to market the BHR. The agency set strict guidelines that mandated ongoing clinical studies, monitoring, reporting of adverse events, and post-marketing surveillance among other measures. Failure to follow these requirements is a violation of the Federal Food, Drug, and Cosmetic Act and voids any legal protection afforded by PMA status. Also, failure to comply with requirements is grounds for withdrawal of PMA. Furthermore, according to the FDA’s PMA-approval letter, this also disallows continued commercial distribution.

Smith & Nephew Hid Metal Poisoning Risk from FDA, Pointing the Finger

In the first several years after BHR entered the market, Smith & Nephew did not report the risk of metal poisoning, or metallosis, in its adverse events to the FDA. However, the company allegedly knew of dozens and possibly hundreds of such cases. Instead, Smith & Nephew went to great lengths to blame device failure on other sources, such as allergies, generalized pain, and implanting surgeons.

In fact, in August 2011, BHR inventor Dr. Derek McMinn published an article titled “Metal Ions Questions & Answers.” The article placed the blame for the hip system’s failures on surgeons improperly placing the device and even on the patients, themselves, particularly women, who experienced substantially higher failure rates.

Dr. McMinn claimed that women were “pre-sensitized” to metal due to wearing costume jewelry. Consequently, he wrote that their tissues may “over-react” to low levels of metal released from artificial devices. However, Dr. McMinn offered no scientific evidence for his theory about the connection between costume jewelry and BHR failure rates.

While Smith & Nephew tried to hide the true cause of the BHR’s failure rate, clinical data continued to pile up, showing a real risk for patients. For example, the National Join Registry of England and Wales shows the BHR 42mm femoral head component has a seven-year revision rate of 11.76 percent. This is well about the normal acceptable failure rate for this type of device.

Smith & Nephew Failed to Properly Train Surgeons

Smith & Nephew agreed to implement a training program as part of the PMA requirements. The company began a BHR training program as promised. However, it failed to achieve training milestones. In fact, the company didn’t begin widespread training until more than three years after releasing the BHR system. At this time, Smith & Nephew admitted to the FDA that surgeons were implanting the device despite receiving no training at all from Smith & Nephew on how to properly perform the procedure. While it was Smith & Nephew’s responsibility to train physicians, the company did not hesitate to lay the blame on these same inadequately trained surgeons for the device’s failings.

Smith & Nephew Did Not Comply with Clinical Study Requirements

In the first five years, tens of thousands of patients received BHR devices. However, Smith & Nephew only enrolled a small fraction of the required number of patients in its clinical study. Seven years after PMA approval, the company still had only enrolled 269 of the 350 patients in the study.

Men, who have a lower failure rate for resurfacing procedures, made up approximately seventy-five percent of study participants. This prompted the FDA to warn the company about bias in its study results. The agency issued a deficiency notice to this effect. The notice also addressed the company’s failure to reach the 80 percent target follow-up rate with study participants. Smith & Nephew didn’t even bother to respond to the FDA within the required time period.

Smith & Nephew also reported 35 deviations from the study protocol, resulting in poor patient follow-up. This was, in part, due to Smith & Nephew failing to adequately staff study locations with enough research coordinators. These and other problems prompted the FDA to write the medical device company, informing it that the agency was unable to review the adequacy of BHR studies and reports due to “inadequate” information from Smith & Nephew. On several other occasions, the FDA reported that the status of the BHR study was “progress inadequate.” The agency also noted that Smith & Nephew did not meet patient enrollment milestones and failed to submit mandatory reports on time.

The company abruptly closed the study’s US patient database in 2012 before the planned completion date.

Lunsford joins a growing number of individuals filing similar product liability lawsuits against Smith & Nephew, alleging serious harm from its BHR hip system. Experts expect that hundreds, if not thousands, of these lawsuits will eventually pass through the court system.




Ethicon Designed Hernia Mesh for Profit Not Patients

By Emily Cox
Mesh Only Profits Manufacturers
Photo by Pictures of Money

A new lawsuit alleges that Ethicon developed and designed Physiomesh to produce a substantially higher profit margin than other hernia mesh products even though the company was aware of the probability that this design would harm patients.

John Guerra filed the claim against Johnson & Johnson and its Ethicon unit this past Wednesday. He alleges that Physiomesh caused a severe adverse reaction. Furthermore, the mesh failed, causing additional severe injuries. Surgeons had to remove portions of the defective mesh. They also had to repair the hernia that the product was initially implanted to treat. After surgery, Guerra developed chronic seroma. Physicians excised the seroma cavity numerous times. However, while they accomplished reducing the seroma, doctors were unable to completely remove it. Guerra alleges the manufacturers knew outcomes like his own were likely. However, they continued to sell the product anyway due to its hefty profit margin.

Mesh Only Profits Manufacturers

According to the lawsuit, Ethicon designed its hernia mesh with the bottom line in mind rather than helping hernia patients.

“Defendants developed, designed and sold Physiomesh, and continue to do so, because the Physiomesh has a significantly higher profit margin than other hernia repair products,” the lawsuit states.  “Defendants were aware of the probable consequences of implantation of the dangerous and defective Physiomesh, including the risk of failure and serious injury.”

Physiomesh’s design is different than any other mesh product on the market. It has five distinct layers. Two layers of Monocryl film cover two underlying layers of polydioxanone, which in turn coat a polypropylene mesh. While this multilayer coating turns a substantially higher profit than other hernia mesh products, it prevents incorporation of the mesh in the body. This leads to a whole host of problems, not the least of which is additional invasive surgery. It also provides a breeding ground for bacteria that the body’s immune response cannot eliminate. When the multilayer coating degrades, the plastic mesh is exposed to nearby tissue and organs. It can become adhered to these organs and cause significant damage.

Despite escalating adverse reaction and injury reports, manufacturers continued to rake in the big bucks from this prized cash cow until May 2016 when they quietly removed the product from the market rather than issuing a recall.

Guerra joins the growing number of individuals filing lawsuits around the country, alleging similar or worse harm from the Physiomesh device. Experts expect that hundreds, if not thousands, of these lawsuits to go through the nation’s court system.




Second Trial Over Xarelto’s Bleeding Risks Results in Defensive Win

By Emily Cox
Xarelto Bleeding Risks
Photo by JouWatch

A federal jury cleared Johnson & Johnson and Bayer AG of failing to warn consumers of Xarelto’s bleeding risks in the second trial among thousands of lawsuits, alleging serious bleeding injuries from the controversial blood thinner.

The New Orleans trial centered on the 2015 death of Sharyn Orr. Joseph Orr and her children brought the lawsuit. She died about a year after she started taking Xarelto for atrial fibrillation. They allege the drug makers were responsible for her fatal hemorrhagic stroke. She died at the age of 67 after being in a coma for 10 days. Orr says his wife’s death was completely avoidable and that the drug manufacturers had a duty to warn patients and the medical community about Xarelto’s bleeding risks. Furthermore, he claims they knew and concealed this information for financial gain from the blockbuster drug. However, Orr failed to convince the jury, resulting in yesterday’s verdict.

Many legal experts thought that this outcome was a definite possibility based on the previous trial that had determined warnings about the drug’s bleeding risks were adequate. The defense in the first trial relied heavily on a Louisiana  learned intermediary doctrine to negate any label failings. It provides that as long as the doctor is aware of the risks, the manufacturer cannot be held liable for them.  Unfortunately, both doctors’ from these first two trials’ testimony deposition read like guides on “How a prescribing physician should testify to support a learned intermediary doctrine defense.” Furthermore, Johnson & Johnson and Bayer specifically selected this case for trial.

Xarelto Bleeding Risks

The FDA approved Xarelto in 2011 to treat atrial fibrillation and reduce risks associated with blood clots. It quickly became one of the manufacturers’ star performers. Xarelto made $582 million in sales in its first full year on the market. Sales skyrocketed to $2 billion in 2013. However, the companies released the drug without a readily available antidote to stop emergency bleeding. Whereas, vitamin K will reverse the effects of the standard blood-thinner Coumadin (warfarin). Unfortunately, this has led to exceptionally high rates of adverse event reports, regarding serious bleeding incidents.

Since then, about 18,600 individuals have filed lawsuits that contend Xarelto is unreasonably dangerous. They further allege that the manufacturers failed to warn about the serious risk of uncontrollable, irreversible bleeding.

The next two trials will take the litigation out of Louisiana and into Mississippi and Texas, starting in August. Maybe a change of scenery will be just the thing.




$553M Takata Air Bag Settlement Puts the Heat to Remaining Auto Companies to Settle in MDL

By Emily Cox
Air Bag Settlement
Photo by Steve P. Snider

Toyota, Subaru, Mazda, and BMW agreed Thursday to pay a combined $553.6 million to exit the pending multidistrict litigation (MDL) over allegedly dangerously defective Takata Corp. air bag inflators, sending a strong signal to the remaining three car makers to reach their own deals fast.

The automakers settling out of court ups the pressure on Ford, Nissan, and Honda to follow suit in order to avoid jury trials in light of the impact of the MDL on recalling and replacing the faulty air bag inflators.

There’s also the ever-present threat that Takata Corp may go bankrupt to consider. Its US subsidiary TK Holdings, Inc. is buried in debt due to the recall and litigation. If Takata goes bankrupt, automakers remaining in the MDL will be left holding the bag for the claims.

“It’s certainly something that everyone in the industry is concerned about, and from a litigation management perspective, you never want to be the next guy in line when the guy at the head of the line goes bankrupt,” Thomas Regan of LeClairRyan said.

The Race to Settle in Takata Air Bag MDL

Also, plaintiff attorneys tend to be more generous to defendants who settle first, significantly raising the stakes for those who stay in the litigation.

“It was a wise move on the part of the automakers,” said Rebecca MacPherson of Jones Day. “Any automaker should get out of this thing as fast as they can.”

Takata’s air bag inflators, when deployed, can eject dangerous metal fragments and chemicals. They have caused at least 11 deaths in the US and are subject of the largest auto recall in US history.

The four automakers deals will speed up removing the inflators from almost 16 million vehicles and compensate class members for economic losses from the recall.

Under the terms of their agreements, BMW of North America LL will pay $131 million. Subaru of America Inc will pay $68,262,257. Toyota Motor Corp. and Mazda North American Operations are on the hook for $278,500,000 and $75,805,050 respectively.

The car makers remaining in the MDL will likely face much higher settlement agreements or jury verdicts, especially Honda. MDL plaintiffs allege that Honda and Takata colluded to keep consumers in the dark. They concealed their knowledge of the defect, while conducting their own internal investigation. Consequently, reaching any settlement will be problematic for the company.

“The dollar amount for Honda is going to be very high,” MacPherson said.



“Balled-up, Rolled-up” Hernia Mesh Patch Required Extensive Surgery

By Emily Cox
Balled-Up Hernia Mesh Patch
Photo by Eric

A Texas woman claims she suffered debilitating complications from Ethicon Physiomesh when the hernia mesh patch balled up inside her body, necessitating complicated revision surgery and causing painful injuries.

Matreia Gentry and her husband filed the lawsuit this past Wednesday in the Southern District of Texas. They named Johnson & Johnson and its Ethicon unit as defendants.

Surgeons implanted Gentry with a 15cm by 20cm Ethicon Physiomesh hernia mesh patch in September 2013. However, less than a year later in June 2014, she had to undergo revision surgery to remove the defective medical device. The surgeon noted that he found “numerous balled-up, rolled-up, and incorporated old mesh.” He had to use cautery and sharp dissection to remove the hernia mesh patch in the difficult surgery.

Even after the hernia mesh patch removal, Gentry still continues to suffer from long-term health complications and significant pain. She claims that Ethicon misrepresented the safety and effectiveness of Physiomesh to the medical community and patients. Gentry alleges that Ethicon defectively designed the hernia mesh patch and that it was not reasonably safe. Furthermore, the design’s risks outweighed any potential benefit of the hernia mesh.

According to the lawsuit, the mesh’s defective design pose an unreasonable risk of severe adverse reactions including chronic pain, hernia recurrence, foreign body response, rejection, infection, migration, scarring, mesh deformation, improper wound healing, excessive inflammation, internal organ adhesions, mesh erosion, abscess formation, fistulas, granulomatous response, seroma formation, nerve damage, tissue damage, and other complications.

Hernia Mesh Patch Lawsuits

Gentry joins the growing ranks of individuals who have filed similar Ethicon Physiomesh lawsuits in recent months. These lawsuits all allege hernia mesh bowel adhesions and other serious complications. They claim Ethicon should have known about the risks. However, the company refused to issue a hernia mesh recall. Instead the company quietly removed the product from the market and ceased sales in the US in 2016.

Plaintiffs are calling for all Ethicon Physiomesh lawsuits to be centralized for coordinated discovery and pretrial proceedings. The Judicial Panel on Multidistrict Litigation will consider oral arguments on the motion during an upcoming hearing scheduled for May 25 in San Antonio, Texas. Ethicon opposes the multidistrict litigation, claiming that the cases are too individualized to call for consolidation in federal court.

Vena Cava Filters Not Effective at Preventing Pulmonary Embolism

By Emily Cox
Vena Cava Filter
Vena Cava Filter

As concerns and lawsuits continue to mount over the risk of complications with vena cava filters, a new study indicates that the filters are not as effective at preventing blood clots from reaching the heart and lungs as previously thought even though this is their primary purpose.

The medical journal JAMA Surgery published the research last week. According to the study, registry data suggests a substantial decline in vena cava filter use in recent years. If the filters were in fact doing their job, there should have been a corresponding increase in pulmonary embolism incidents. However, there was no such change in the rate of these injuries.

Researchers used data from the Pennsylvania Trauma Outcome Study (PTOS), involving 461, 974 patients from 2003 to 2015.  They also relied the National Trauma Data Bank (NTDB) with 5,755,095 patients from 2003 to 2014, as well as data from a staggering 24,449,476 patients from 2003 to 2013 in the National Inpatient Sample (NIS).

The data showed a significant decline in vena cava filters used during this time. However, pulmonary embolism rates remained stable. Researchers indicated that these findings suggest the filters may have “limited utility” in preventing pulmonary embolism. They warn that doctors shoul take measures to identify patients who would benefit the most from precautionary use of these filters.

Vena Cava Filter Problems

Vena Cava (IVC) filters are small devices, resembling spiders. Manufacturers marketed them as a means to prevent blood clots from travelling to the heart and lungs. Surgeons place them in the inferior vena cava to catch blood clots that may pose a threat if left unchecked. C.R. Bard, Cook Medical, and other companies designed these filters to be easily removed once the blood clot risk has passed. However, many serious and life-threatening vena cava filter side effects have come to light in recent years.

In May 2014, the FDA advised doctors to remove these filters within one to two months, as the risks appear to escalate the longer the filters are left in place. However, many filter manufacturers sold the devices for years without informing doctors about the risks associated with leaving the filters in place. Specifically, the devices may break inside the body and become irretrievable.

Currently, there are more than 1,800 Bard IVC filter lawsuits pending in a multidistrict litigation (MDL). Another 1,900 Cook IVC filter lawsuits are pending in a separate MDL. Both litigations raise similar allegations of problems associated with the filters.

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