Category: Defective Products

Power Morcellator Cancer Issues Expose FDA Post Marketing Surveillance Failings

By Emily Cox
Power Morcellator Cancer Reveals FDA Surveillance Failings
FDA’s Medical Device Surveillance Could Use an Update

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.

Prolift Pelvic Mesh Released Without FDA Clearance

By Emily Cox
Prolift Released Without FDA Clearance Despite Poor Clinical Trial Results
Ethicon can’t be bothered by trivial details like FDA clearance and clinical trial results (Flickr/Mick Licht)

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.

 

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.

 

Daily Roundup Exposure Could Be Life-Threatening

By Emily Cox
Roundup Exposure Can Be Deadly
Is Roundup Killing More Than Grass and Weeds?(Flickr/Mike Mozart)

According to one of the latest lawsuits against Monsanto over the popular weed killer, daily Roundup exposure for more than two decades caused an Oregon man to develop non-Hodgkin’s lymphoma.

Gary Couch filed the complaint in Delaware’s Superior Court this past Friday. He alleges that the agrochemical giant protected its economic interests rather than the public by misrepresenting the safety of Roundup, exposing countless innocent people to an unreasonably dangerous chemical. According to the lawsuit, Couch’s job as a project superintendent at Valenzuela Engineering involved almost daily Roundup exposure. Couch mixed and sprayed the chemical using a five-gallon backpack spray pump. In June 2015, Couch was diagnosed with non-Hodgkin’s lymphoma (NHL). Numerous studies have found that Roundup’s main ingredient, glyphosate, may cause this specific type of cancer. Couch is still undergoing treatment for the deadly disease. Even if Couch manages to survive NHL, he’ll never truly escape the cancer. The disease’s lasting effects will stay with him for the rest of his life.

“Plaintiff suffered, and continues to suffer, from serious and dangerous side effects including, but not limited to, NHL, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, diminished enjoyment of life, and financial expenses for hospitalization and medical care,” the lawsuit states.

“Further, Plaintiff suffered life-threatening NHL, and severe personal injuries, which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life.”

Round-up Exposure “Safer Than Table Salt”

In 1996, the New York Attorney General (NYAG) filed a lawsuit against Monsanto over Roundup product advertising misrepresenting the safety of the product line. Specifically, the NYAG challenged Monsanto’s assertions that its spray-on glyphosate-based herbicides, including Roundup, were “safer than table salt” and “practically non-toxic” to mammals, birds, and fish. The lawsuit named numerous other such false and misleading statements that the NYAG found deceptive and misleading about the products’ human and environmental safety.

In November 1996, Monsanto entered into an Assurance of Discontinuence with the NYAG. The conglomerate agreed, among other things, to stop publishing or broadcasting any advertisements in New York that imply that Roundup exposure is “safe, non-toxic, harmless, or risk-free.” This extended to assertions that the chemical is “practically non-toxic” as well. Monsanto also had to cease and desist all New York marketing that Roundup is “good” for the environment or known for its environmental characteristics, as well as claims that the chemical is safer or less toxic than common consumer products. Monsanto did not alter its advertising in this manner in any state other than New York.

In 2009, France’s high court ruled that Monsanto had been deceitful about the safety of Roundup exposure.

California officials announced this Monday that state regulators will add Roundup’s main ingredient, glyphosate, to a Californian list of potentially cancerous chemicals on July 7. While this won’t keep Roundup off fields or store shelves, it could mean a California warning label for Roundup. As early as next year, California could require Roundup to carry a warning label in the state. The label would warn that the chemical is known to cause cancer, birth defects, and reproductive harm.

Roundup Exposure Lawsuits

The World Health Organization classified glyphosate as a “probable carcinogen” in 2015. Since then, hundreds of NHL patients like Couch have come forward to file lawsuits against Monsanto. These farmers, landscapers, and other agricultural works allege that extensive Roundup exposure gave them cancer. They further claim that they may have avoided their injuries if Monsanto had provided warnings about Roundup exposure risks.

Unfortunately, if H.R. 1215 passes the Senate, the life-long suffering from Roundup exposure injuries will go largely unacknowledged by the U.S. court system. The Protecting Access to Healthcare Act would impose a $250,000 limit on noneconomic damages. This means that individuals can only hope for fair compensation for medical costs and lost wages. The courts will not take Monsanto to task for causing continued pain and suffering.

The bill passed the House on Wednesday. but you can still help it stop it at the Senate. Your elected officials need to hear from you before H.R. 1215 strips us of some of  our most essential rights and protections. Tell them to vote NO before this bill can cause irreparable harm. You can easily write and call members of Congress by visiting www.takejusticeback.com/protectpatients.

Roundup Warning Label May Loom in Monsanto’s Future

By Emily Cox
Roundup Warning Label
Roots might not be the only things Roundup is killing. (Flickr/Mike Mozart)

California regulators took a crucial step this Monday toward becoming the first state to require the popular weed killer to come with a Roundup warning label, indicating that the chemical is known to cause cancer, birth defects, and reproductive harm.

Officials announced that Roundup’s main ingredient, glyphosate, will be added to a Californian list of potentially cancerous chemicals starting next Friday. Inclusion on this list will not keep the chemical off fields or garden store shelves. However, it could come with a California Roundup warning label as early as next year. However, California’s success in this endeavor is not a given.

The weed killer’s maker, Monsanto, has filed an appeal after failing to block the Roundup warning label in court. The company claims that Roundup doesn’t cause cancer and will harm the its business. Monsanto, which is soon to be absorbed by agrochemical giant Bayer, accused the state Office of Environment Health Hazard Assessment (OEHHA) of “cherry-picking” the science to justify the warning label. A state Superior Court judge ruled against the company in Mach, clearing the way for Monday’s decision. State health regulators must also determine if the amount of the chemical in Roundup poses a human health risk. State officials have received more than 1,300 public comments regarding the matter.

California Roundup Warning Label Would Pack Big Punch

California Roundup Warning Label
More than 250 types of California crops use Roundup. (Flickr/Malcolm Carlaw)

Monsanto introduced the colorless and odorless chemical in 1974 as an effective way to kill weeds while leaving crops and plants intact. Today, more than 160 countries sell glyphosate. And, farmers use it on 250 types of California crops spread over 4 million acres. It is undoubtedly the most widely used herbicide in the state, according to the state Department of Pesticide Regulation. California is the nation’s leading farming state. Consequently, a warning label on Roundup there could pack quite a punch into Roundup’s impressive revenue stream. Burbank, Irvine, and Glendale school districts have already banned the chemical from their properties.

Is Roundup Warning Label Necessary?

Despite Monsanto’s claims that Roundup is “safer than table salt,” there is much evidence to the contrary. Since the World Health Organization classified glyphosate as a “probable carcinogen,” more than 800 non-Hodgkin’s lymphoma patients and their loved ones have come forward and filed lawsuits against the agrochemical giant, alleging Roundup gave them cancer after extensive exposure to the product. Furthermore, an internal Monsanto company email indicated that an EPA official had even offered to “kill” a separate investigation into glyphosate. Since his retirement, this official has become a central figure in many of the lawsuits against Monsanto. Further studies have shown a strong carcinogenic link in animal research.

Environmental groups cheered OEHHA’s move to list the chemical and push to require a Roundup warning label.

“California’s decision makes it the national leader in protecting people from cancer-causing pesticides,” said Nathan Donley, a senior scientist at the Center for Biological Diversity, one of the groups that has pushed to ban glyphosate. “The U.S. EPA now needs to step up and acknowledge that the world’s most transparent and science-based assessment has linked glyphosate to cancer.”

A Monsanto spokesman indicated that the company “will continue to aggressively challenge” the court’s ruling.

 

 

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.

 

 

 

Supreme Court Ruling Fallout Causes Talc Mistrial

By Emily Cox
Supreme Court Ruling Results in Talc Mistrial
Photo by angela n.

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.

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.

 

 

 

Breast Lymphoma from Implants May be Under-diagnosed

By Emily Cox
Breast Lymphoma
Photo by maf04

As more cases are confirmed worldwide, researchers are warning that breast lymphoma from textured breast implants is likely under-diagnosed and warrants further studies to determine the best treatment plans.

Following the first confirmed diagnosis in Finland, researchers took a closer look at the rare type of breast lymphoma known as breast implant analplastic large cell lymphoma (BI-ALCL). They reported their finding in a report published last week in the European Journal of Surgical Oncology. Researchers looked at the disease from diagnosis to treatment and found that it may be deadlier than previously thought.

Breast Lymphoma Prognosis

Compared with other forms of ALCL, which carry about a 40 percent survival rate, the prognosis for most BI-ALCL patients is favorable. Most cases of the breast lymphoma can be treated with surgical removal of the breast. However, researchers suggest that some of these patients develop serious conditions, making the cancer life-threatening.

“Most patients have an excellent prognosis when complete removal of the capsule and prosthesis with negative margins is achieved surgically,” they wrote. “Some patients, however, develop infiltrative disease with a potentially life-threatening clinical course. Treatment planning regarding the extent of surgery and role of adjuvant therapy, especially in advanced cases, requires further investigation.”

Breast Lymphoma From Implants Diagnosis

Doctors and health officials first detected the disease in 1977, but diagnosis has been on the rise in recent years with increasing frequency. The FDA issued a report earlier this year, indicating the agency was aware of 359 reports of the breast lymphoma and at least nine deaths. However, many still feel that it may be under-diagnosed.

When Australia’s Therapeutic Goods Administration (TGA) encouraged additional monitoring for BI-ALCL cases, the number of identified country more than doubled in Australia. However, the authors warn that determining the number of actual cases is problematic. They pointed out that not all laboratories have the equipment to perform necessary tests. Furthermore, not all cases are reported.

BI-ALCL Breast Lymphoma Awareness

Consequently, health officials have attempted to raise awareness among plastic surgeons. They are urging them to warn patients of this potential risk and to look for symptoms following surgery.

BI-ALCL symptoms include lumps, fluid buildup, and swelling around the implant site, as well as pain. These symptoms generally present after the surgical incision has fully healed. Most cases are diagnosed 8 to 10 years after the original implantation.

The underlying cause of this breast lymphoma remains elusive. However, researchers have noted that the risk seems higher with breast implants with textured surfaces. They suspect this could cause chronic inflammation and immune system reactions, leading to the development of the cancer.

 

 

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