Hernia mesh products won’t be receiving any medical Nobel Prizes anytime soon due to their widespread harm. However, a Louisiana man had especially bad luck with these products. James Bruce received three separate defective hernia mesh products from different manufacturers to treat one hernia, leading to excruciating pain that will require additional surgery.
Bruce filed the complaint late this past month in the Eastern District of Louisiana. He named C.R. Bard, Davol, Inc, Medtronic Inc, and Covidien as defendants. Davol is a subsidiary of Bard. In June 2016, surgeons used Covidien’s Parietex Progrip Mesh along with Bard/Davol and Medtronic products to repair a hernia. However, all three products proved to be defective. Bruce developed severe pain and swelling that has essentially debilitated him. The pain is so intense that he can barely walk. He will have to undergo additional surgeries to address his substantial injuries from these defective hernia mesh products. Furthermore, the claim asserts that these companies were fully aware of these defects. However, they continued to market the implants as safe to further their own financial agenda at the cost of countless patients’ suffering and lives.
“Defendants were aware of numerous defects in the Product,” the lawsuit states. “Despite being aware of the numerous defects and unreasonable ricks in the Product, Defendants designed, manufactured, marketed, and distributed the Product.”
“Defendants were aware or should have been aware that implanting the Product in patients was likely to cause injury and harm to the patients.”
Hernia Mesh Products Lawsuits
Bruce joins a growing number of individuals filing hernia mesh lawsuits against various mesh manufacturers. They claim that these companies were aware of serious design problems but sold the dangerous products anyway for financial gain. Allegedly, these companies never adequately informed the medical company or patients of these potential problems to protect their bottom line.
In addition to Bard, Davol, and Covidien Parietex Progrip Mesh lawsuits, similar allegations have come to light in Atrium C-Qur and Ethicon Physiomesh lawsuits.
Medical experts suggest that the FDA needs to revamp its medical device post-marketing surveillance, highlighting power morcellator cancer problems that the agency did not address until after hundreds of women had cancer cells spread by the device during hysterectomy and uterine fibroid procedures.
The Journal of the American Medical Association (JAMA) published the editorial this past week. JAMA’s editor, Dr. Rita Reberg, indicated the power morcellator cancer debacle is a prime example of the FDA’s failure to obtain necessary information from post-marketing surveillance. The agency needs this data to ensure the safety and efficacy of devices in the real world.
“The clinical community depends on high-quality evidence about medical products, and regulatory oversight is a key mechanism for ensuring collection of that evidence,” Redberg wrote along with fellow experts.
Dr. Alison Jacoby of the University of California, San Francisco’s Department of Obstetrics and Gynecology and Dr. Joshua Sharfstin of the Department of Health Policy and Management at Johns Hopkins Bloomberg School of Public Health joined Redberg in her review of the FDA’s surveillance failures.
“This point becomes especially apparent when important data to guide care are lacking, as illustrated by the recent example of power morcellators,” the editorial continued
Morcellators enjoyed widespread popularity during the past decade. They allow doctors to cut up and remove the uterus and uterine fibroids though a small incision in the abdomen. Surgeons valued the devices as a way to limit surgical complication risks, while reducing recovery time. However, the medical community discovered that these morcellators may spread undiagnosed uterine cancer cells. This led to rapid upstaging of leiomyosarcome, endometrial stromal sarcoma, and other difficult to treat cancers. Consequently, physicians have largely abandoned using these devices. Unfortunately, this discovery came too late for many women.
FDA Response to Power Morcellator Cancer Risks
In February, the U.S. Government Accountability Office (GAO) released a report regarding the FDA’s response to power morcellator cancer risks. The GAO found that the lack of data led the agency to underestimate the risk of morcellators spreading uterine cancer in many women. The FDA approved 25 of these devices before it detected these problems.
The FDA added a black box power morcellator cancer warning in November 2014. The agency also indicated limited circumstances that may warrant the device’s use. Regardless, the medical community is still divided over whether the FDA should have removed the devices from the market entirely. Furthermore, there are still conflicting views on how the FDA should handle products with emerging safety concerns. The editorial also noted that FDA needs to identify risks and benefits before approval to avoid these types of devastating problems. When the agency still fails to obtain adequate post-approval date, these problems are amplified. Despite thousands of women’s power morcellation experiences, the FDA still failed to identify the problems too late in the game to help many women. The editorial authors suggest that the FDA’s lack of a comprehensive system of data collection is to blame.
“Morcellators, like many devices cleared through the 510K pathway, entered the market based on their ‘substantial equivalence’ to prior devices; in this case, the equivalence was to a device used in arthroscopic joint surgery,” the editorial stated. “Even though the risk of potentially spreading cancer was known at the time of FDA clearance of the first of these devices in 1991, no clinical studies to assess the issue were required and no post-marketing requirements for data collection were put into place. Without such requirements, there was little incentive for the industry sponsors of the device to voluntarily gather such data.”
Power Morcellator Cancer Risks Prompt FDA to Reevaluate Post-Market Surveillance
Since the FDA first issued warning in April 2014, the medical community has mostly abandoned morcellation. In fact, the main manufacturer of the device, Johnson & Johnson’s Ethicon unit, stopped selling the device entirely.
In February, the FDA released a study indicating that a system of active surveillance would be better suited to detect medical device problems than the current voluntary reporting system.
Editorial authors suggest that post marketing surveillance studies are still infrequent and limited. They acknowledge that the FDA is trying to improve the system. However, it will take years to implement these measures. In the meantime, medical devices continue to harm countless individuals right under the agency’s nose.
However, the editorial does make some concessions toward federal regulators. Doctors also failed to ask enough questions and generally don’t fulfill reporting requirements. Furthermore, manufacturers often oppose stronger reporting requirements to keep patients safer.
Dozens of individuals have brought claims against Johnson & Johnson’s power morcellators. These claims allege that the conglomerate’s devices spread cancer, leading to serious illness and even death. Settlement agreements have resolved most of these claims. But, a number of morcellator manufacturers continue to face lawsuits over failing to warn the medical community over the device’s risks.
Expert testimony from the latest pelvic mesh trial indicates that the FDA wasn’t even aware of the Prolift device’s existence before Ethicon unleashed the defective product on unsuspecting patients despite poor clinical trial results.
In late May, a Philadelphia jury awarded Sharon Beltz $2.16 million for the pain and suffering that she will have to endure for the rest of her life as a result of the Prolift mesh. Surgeons are not even able to remove the defective mesh to address her corresponding injuries.
“Mrs. Beltz’s problems are thus permanent. She may elect to undergo further pain injections, resection of the mesh, or start taking pain medications regularly, but these options at best will only mitigate her symptoms. Mrs. Beltz has to live the remainder of her life with constant pelvic pain, a sensation her bladder is pulling, urinary incontinence and retention, lower flank pain, urinary tract infections, and severe pain with sex that lingers days after she has intercourse,” court papers said.
“She will be at risk for exposure of the mesh in her vagina and erosion of the mesh into her bladder, urethra, or other organs for the remainder of her life.”
In 2012, Ethicon withdrew four of its transvaginal mesh devices, including the Prolift device, from the market. However, the company maintains that this decision was the result of “changing market dynamics” rather than liability concerns. This isn’t an entirely inaccurate characterization. More than 54,000 pelvic mesh injury lawsuits against Johnson & Johnson and Ethicon is quite the “changing market dynamic” indeed.
FDA Wasn’t Notified of the Prolift Mesh’s Existence
Expert witness Dr. Peggy Pence produced a report heard at the trial, indicating that Johnson & Johnson and its Ethicon unit never applied for premarket clearance or even notified the FDA of the Prolift device’s existence before launching it in 2005. In her report, Dr. Pence claimed that the manufacturers misbranded and adulterated Prolift due to inadequate 510(k) premarket clearance. 510(k) is a premarket submission made to the FDA to demonstrate that a device is at last as safe and effective, or substantially equal, to a device that the agency has already approved.
According to court documents, the FDA approved another Ethicon product, the Gynecare Gynemesh PS, under 510(k) guidelines. This means that Gynemash was substantially equivalent to a product already on the market and performing satisfactorily. However, manufacturers never applied for 510(k) clearance for the Gynecare Prolift Pelvic Floor Repair System even though the companies characterized it as a line extension of the Gynecare Gynemesh PS. Consequently, Dr. Pence alleged that the FDA wasn’t notified of the Prolift’s existence. This eliminated the agency’s ability to regulate the device to ensure patient safety.
Ethicon Released Prolift Despite Dismal Premarket Study Results
Given the device’s performance in Ethicon’s premarket studies, it’s no wonder that the manufacturers didn’t seek FDA clearance. The agency never would have granted approval based on performance.
Ethicon performed two, non-randomized and non-controlled studies the year before it launched Prolift. The company conducted these studies at eight sites in France and three sites in the U.S. Twenty percent of the French study participants experienced painful intercourse after receiving the mesh implant. Overall, 25.6 percent participants in the French study experienced transvaginal mesh complications, and 65.9 percent of U.S. patients experienced similar adverse events.
Even knowing the high likelihood of complications from these studies, Ethicon Prolift entered the market in 2005 without FDA 510(k) clearance. Court records note that Ethicon tried to claim that Prolift pelvic mesh was a custom device and, therefore, exempt from 510(k) premarket clearance. However, Pence took exception to this characterization. She stated that neither the Prolift device, or instruments designed for Prolift implantation, were custom. Consequently, the device required 510(k) notification to enter the market.
“Ethicon marketed a product that violated safety and ethical standards,” she concluded.
Prolift and Other Pelvic Mesh Lawsuit Background
Pelvic mesh products treat female pelvic organ prolapse and/or stress urinary incontinence. In 2008, the FDA issued an alert that the devices were connected to at least 1,000 serious injury reports during a three-year period. These injuries include erosion, scarring, adhesions, infections, vaginal bleeding, organ perforation, and recurrent of prolapse or incontinence. And, this was just the beginning.
In 2011, the FDA reported that there were now more than 2,800 reports related to pelvic mesh. These reports included injury, death, and malfunction. The agency also indicated that there was little evidence that transvaginal mesh was more effective than non-mesh repair. Furthermore more, the products may expose women to unnecessarily to harm.
Since then, the FDA has strengthened transvaginal mesh requirements for pelvic organ prolapse repair. Among other safeguards, these devices are no longer eligible for the agency’s 510(k) clearance program.
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.
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.
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.
The drug manufacturer has issued a generic Invega recall as testing indicates that its extended-release tablets may not enter patients’ systems at the correct rate.
Teva Pharmaceuticals and the FDA announced the generic Invega recall this past Thursday after some pills failed a dissolution test. This suggests that less of the medication may be absorbed and consequently, may not work correctly.
Paliperidone Extended Release Tablets, 3mg treat schizophrenia and shizoaffective disorders. Teva Pharmaceuticals distributes the medication nationwide in the US to wholesalers. The FDA and manufacturer warn that consecutive doses of the defective product could wreak havoc on a patient’s mental well-being. It could even pose a threat to those around the affected individual.
“Taking a product for the treatment of schizophrenia and schizoaffective disorders that has failed dissolution could result in less drug being absorbed,” the FDA cautioned. “If two or more consecutive dosing regimens are with affected product, a failure to maintain therapeutic levels could occur, which could reduce effectiveness in treating a patient’s mental and/or mood symptoms, including suicidal thoughts and behavior, self-injurious behavior, mental hospitalizations, assaults, aggressive behavior, as well as vocal and motor tics.”
Teva has determined that there is low probability of consuming two or more consecutive doses of the affected product. Furthermore, the FDA has not received any post marketing adverse event reports for lack of effectiveness of the recalled lot. However, Teva issued the generic Invega recall voluntarily to prevent the possibility of either scenario.
Generic Invega Recall Instructions
The generic Invega recall affects 360 90-count bottles of Paliperidone Extended-Release Tablets, 3mg. The Actavis Pharma Inc. label distributed them between December 12, 2016 and March 16, 2017. The recalled bottles have a 6/2018 expiration date. Their lot number is 1160682A, and NDC number is 0591-3693-19.
Teva issued an Urgent Drug Recall Letter to its buyers, asking them to return existing inventory and notify affected customer of the generic Invega recall. Consumers with questions should contact Teva by calling 888-836-2872, selecting option 3, and then option 4. They can also email firstname.lastname@example.org. The FDA urges consumers to contact their healthcare provider and/or pharmacist if they experience any product-related problems.
Problems Beyond the Generic Invega Recall
Invega and a similar drug, Risperdal, have come under scrutiny in recent years. Scientific studies have linked the side effects of both antipsychotic drugs to an increased risk of breast growth in boys and young men. This rare medical condition is called gynecomastia. The resulting breasts often require surgical removal. Furthermore, hundreds of Invega and Risperdal lawsuits claim that the damage extends beyond physical injury. They assert that the psychological effects of young male breast growth can have a devastating impact, greatly diminishing overall quality of life.
A St. Louis judge declared a talc mistrial in the latest lawsuit alleging that Johnson & Johnson’s talcum powder products caused ovarian cancer after the Supreme Court levied a jurisdiction decision Monday morning.
The high court’s ruling could potentially obliterate St. Louis’ claims by women who reside outside the state. In August 2016, the California Supreme Court ruled that the state could preside over 86 residents and 575 non-Californians who brought Plavix claims. They allege that the blood-thinner actually increased their risk of heart attack, stroke, and internal bleeding. The California high court assumed jurisdiction based on Bristol-Myers’ national marketing campaign. It also claimed the company’s nearly $1 billion sales of the drug in the state strengthened this authority. However, in an 8-1 opinion, the Supreme Court struck down this ruling, siding with Bristol-Myers and the federal government.
Judge Rex Burlison declared the talc mistrial at the onset of the second week of the sixth Missouri trials over the connection between Johnson & Johnson’s talcum powder products and ovarian cancer with toxicology expert testimony slated for early this week. The case was brought by the families of three women who died of ovarian cancer after using the company’s talc products for years. While Johnson & Johnson affirmed that the state held jurisdiction over the one state resident’s claims, it held that the Virginia and Texas residents should not be allowed to bring claims in Missouri under the Bristol-Myer ruling.
Possible Talc Mistrial Loophole
Justice Samuel Alito wrote for the Supreme Court majority. He wrote that California could not hear the case “without identifying any adequate link between the state and nonresidents’ claims.” However, this doesn’t appear to be exactly the case with the St. Louis talcum powder trials. Johnson & Johnson and co-defendant Imerys Talc use Pharma Tech Industries to package and label talc products. This company has a plant in Union, MO.
Individuals can typically bring suit against companies in a state where they have headquarters or incorporations. This also extends to states where companies have important ties. Packaging and labeling may be grasping at straws but is still essential to the distribution process. Despite the talc mistrial, lawyers still believe they will be able to pursue claims. There are currently approximately 1,100 pending in St. Louis.
“We think we’re still alive in Missouri,” a lawyer, representing the plaintiffs, said.
He continued that Burlison’s ruling merely added Pharma Tech as a potential defendant to future claims.
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.
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.