Monsanto Tried to Use EPA Collusion Allegations to Venue Shop for Roundup Cancer Lawsuits

by Emily Cox
Roundup Cancer Lawsuits
Federal Judge Warns Monsanto to Stop with Inane Transfer Theories (Flickr/Donna Cleveland)

In a bizarre move, Monsanto tried to use EPA collusion allegations to move state-level Roundup cancer lawsuits to more corporate-defendant friendly federal court, claiming that this collusion transforms the corporation into a federal officer despite the company’s contradictory denial of this very collusion.

The District Judge overseeing all federal Roundup cancer lawsuits slammed Monsanto’s attempt to venue shop, indicating that the company may face penalties if it continues to file “flimsy theories of removal in the future.”

Overwhelmingly, companies perceive federal courts as more corporate-defendant friendly. Consequently, it’s no surprise that Monsanto filed a notice of removal earlier this year to send a California complaint representing more than 40 people to the federal litigation. The Judicial Panel on Multidistrict Litigation (JPML) centralized the federal litigation in the Northern District of California this past October. Judge Vince Chhabri is presiding over these discovery and pretrial proceedings.

However, Monsanto also faces large numbers of Roundup cancer lawsuits in various state courts where the agrochemical giant has adequate contracts to establish local jurisdiction. Some of these states like California and Missouri are notoriously plaintiff-friendly. In fact, California and Missouri top the American Tort Reform Association’s list of “Judicial Hellholes” for tending to side with injured plaintiffs rather than corporate America. These associations have made Monsanto desperate to move these claims to friendlier federal ground.

Monsanto’s Strange Move to Transfer Roundup Cancer Lawsuits to Federal Court

In a perverse twist, Monsanto even tried to use serious allegations against itself to help its cause. Grasping at litigious straws, the weed killer’s manufacturer tried to claim federal jurisdiction based on plaintiff allegations of EPA collusion to influence the regulation of Roundup. Monsanto went so far as to claim that EPA collusion allegations somehow convert the corporation into a federal officer. Unsurprisingly, Roundup cancer lawsuit plaintiffs struck back, contending that Monsanto had no grounds to transfer the case to federal court.

Judge Chhabria agreed wholeheartedly with the plaintiffs and reprimanded Monsanto’s behavior. He issued a caustic order this past week, renouncing Monsanto’s federal jurisdiction theory as “baseless.” He pointed to the absurdity of Monsanto trying to claim federal officer status based on a relationship with the federal government that the company denies even exists. If the courts permitted this, then Monsanto is blatantly admitting to collusion. The judge went on to warn that the Court may consider fee shifting if the company continues with similar transfers.

“To be sure, evidence that Monsanto influenced the EPA may be indirectly relevant to the [question about the cancer risk with Roundup], as collusion could undermine the value of the EPA’s scientific conclusions,” wrote Judge Chhabri in the order. “But an issue is not ‘necessary’ to resolve for the purposes of federal-question jurisdiction simply because it has relevance. In this case, collusion is, at most, a means for the plaintiffs to impeach certain evidence they disagree with.”

The order and its tone may have wide-reaching implications for hundreds of Roundup cancer lawsuits currently pending in state courts. Consequently, Monsanto may have to face state court juries far before the federal litigation’s own bellwether trials.

Roundup Cancer Lawsuits

In 2015, the International Agency for Research on Cancer (IARC) classified Roundup’s main ingredient, glyphosate, as a probable carcinogen. After this announcement, lawsuits over the Roundup cancer risk began to emerge. Many agricultural workers assert that the chemical caused non-Hodgkin’s lymphoma. Furthermore, Monsanto allegedly went to great lengths to hide Roundup’s risks.

Monsanto continues to defend the safety of Roundup. The company goes as far as to assert that the chemical is “safer than table salt.”

However, worldwide experts are investigating the effects of glyphosate-based herbicides, questioning Roundup’s lack of safety warnings. In fact, earlier this month California regulators moved to require a Roundup cancer warning label as soon as next year.

Three Defective Hernia Mesh Products Implanted to Treat One Hernia

By Emily Cox
Mesh Products Lawsuits
Mesh Products’ Day of Reckoning is Coming (Flickr/Blogtrepreneur)

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.

Adult ADHD Checklist Is More Like an ADHD Cheat Sheet

By Emily Cox
Adult ADHD
Big Pharma Brands Adults with ADHD Label to Increase Sales (Flickr/Leo Brunvoll)

Attention Deficit Hyperactivity Disorder (ADHD) is a breeze to diagnose these days. Physicians owe thanks to the handy-dandy Adult ADHD Checklist. This essentially tells patients how to guarantee a prescription by indicating “correct” answers with gray shading. Many physicians rely on this checklist to make a diagnosis after a  5 to 20-minute conversation with the patient. This apparently is adequate justification for subsequently prescribing addictive stimulant medications. Furthermore, Big Pharma may have had substantial influence in the Adult ADHD Checklist to ensure that as many people as possible are diagnosed with the disorder.

Big Pharma’s extraordinary two-decade campaign to publicize ADHD has paid off big time. These efforts resulted in prescription stimulant sales soaring from just below $2 billion in 2002 to almost $13 billion in 2015. ADHD diagnosis is now within a hair’s breadth behind asthma as being the most commonly diagnosed chronic childhood disease.

As pharmaceutical companies began realizing that the childhood market had already met and surpassed its potential, they set their gaze to expand market share by funding studies to substantiate adult ADHD diagnosis. And they have been monumentally successful in the endeavor. Given that the adult ADHD market has grown 8 percent each year since 2010, expert project this growth will continue at an approximate 6 percent rate, reaching $17.5 billion by 2020. Furthermore, the physicians working with the World Health Organization (WHO) to develop the Adult ADHD Checklist all had substantial ties to the pharmaceutical companies that stood the most to gain from breaking down barriers to the adult market.

Big Pharma Created Adult ADHD Checklist to Expand Market Share

Two of ADHD’s heaviest hitters funded the very research that prompted WHO to validate the Adult ADHD Checklist. ADHD royalty Adderall manufacturer Shire Pharmaceuticals supplied an unrestricted educational grant to make the report a reality. Pharmaceutical giant Eli Lilly, ADHD drug, Straterra, manufacturer, funded secondary analysis and the managed health plan survey itself.

WHO purportedly developed the Adult ADHD Checklist in conjunction with the Workgroup on Adult ADHD. However, this workgroup’s body of work is relegated solely to this checklist. They haven’t produced any research or literature beyond the checklist. In fact, it appears to be an honorary title bestowed upon three researchers to add legitimacy to the short questionnaire.

Furthermore, the three sole members of the group all have substantial ties to the big players in the adult ADHD market. Dr. Lenard Adler, Dr. Ronald C. Kessler, and Dr. Thomas Spencer have all received substantial financial compensation through their overt loyalties to Big Pharma’s interests.

Dr. Adler is a consultant for Eli Lilly and Shire Pharmaceuticals, as well as Ritalin manufacturer Norvatis, and receives substantial compensation for being on the companies’ speaker’s bureaus to endorse their products. His adult ADHD research has also received substantial funding from these pharmaceutical conglomerates. Dr. Spencer is also a consultant and speaks for these companies’ drugs. In fact, he actually helped conduct clinical trials for Eli Lilly’s ADHD medication. Furthermore, Dr. Spencer came under federal scrutiny for not disclosing at least $1 million in earnings from drug companies between 2000 and 2007. If these undisclosed earnings are any indication, these researchers had much to gain by helping increasing ADHD prescriptions. While Dr. Kessler does not appear to have any ties to Norvatis, his financial and professional ties to Eli Lilly and Shire are almost analogous to his fellow researchers.

Adult ADHD Checklist Gets a Makeover to Expand Big Pharma’s Net

Despite explosive growth in adult ADHD prescriptions, Big Pharma decided that the 18-question checklist with shading to indicate what answers will provide a prescription was still allowing too many patients to slip away. Consequently, ADHD manufacturers tasked Dr. Adler, Dr. Spencer, and Dr. Kessler, along with additional researchers, with establishing adult ADHD as a common impairment.

To combat this disease, threatening to overtake the nation, they cut down indications of the affliction to six to make sure that physicians could medicate as many people as possible.

  1. Do you have difficulty concentrating on what people say to you, even when they are speaking to you directly?
  2. How often do you leave your seat in meetings and other situations where you should remain sitting?
  3. Do you have difficulty unwinding and relaxing when you have time to yourself?
  4. When you’re in a conversation, how often do you find yourself finishing the sentences of the people you are talking to before they can finish them themselves?
  5. How often do you put things off until the last minute?
  6. How often do you depend on others to keep your life in order and attend to details?

This adjusted scale still has “correct” answers highlighted in gray and gives the response options of “never,” “rarely,” “sometimes,” “often,” or “very often.” However, physicians believe that this expanded ADHD definition could lead to over diagnosis, as many people who have these tendencies do not necessarily have the underlying condition.

 

 

 

Three of America’s Forefathers Died on the Fourth of July

By Emily Cox

In an eerie coincidence, three out of five of America’s first presidents’ lives faded on the Fourth of July, reflecting celebratory fireworks burning out against the nation’s sky.

Thomas Jefferson and John Adams both signed the Declaration of Independence…on August 2, 1776, despite the prevailing belief that the Forefathers signed this document on the Fourth of July.  Adams actually believed the day that America declared independence, July 2nd, would mark the anniversary of the nation’s birth rather than the day when the Continental Congress approved the drafting of the Declaration. Teenage James Monroe, who many historians consider a Founding Father, dropped out of college in 1776 to fight in the Revolutionary War. All these early American presidents passed away on July 4th. In fact, Jefferson and Adams died within hours of each other on the Fourth of July’s 50th anniversary.

Exactly five decades after the Continental Congress meeting in Philadelphia to approve the Declaration of Independence, Adams and Jefferson died on July 4, 1826. The second and third presidents passed away within hours of each other with puzzling last words. While Adams spoke of Jefferson, Jefferson’s focus remained on the Fourth of July before rejecting his medicine and sending away his physician.

John Adams’ Final Fourth of July

On July 4, 1826, 90-year-old Adams summoned a clergyman. The History News Network reports that the former president instructed the cleric to tell the celebratory crowd, “Independence forever!” when he addressed them later. Adams died several hours after this. Eulogizers claim his last words were “Thomas Jefferson survives” or “Jefferson survives.”

However, the one person present for these words has a slightly different story. Louisa Smith, the 53-yeard-old niece and adopted daughter of Adam’s wife, later told Boston’s mayor’s wife “that the last words he distinctly spoke was the name ‘Thomas Jefferson.’” She was unable to decipher the rest of the sentence. So, while Adams mentioned Jefferson on his deathbed, eulogists may have supplied the word “survives.” Regardless, mysteriously enough, Adams uttered the man’s name moments after Jefferson died 500 miles away.

Thomas Jefferson May Have Chosen His Final Fourth

Jefferson slept through the day July 3, 1826. According to the Thomas Jefferson Foundation’s Monticello website, three men wrote on the events following his daytime slumber. Jefferson’s attending physician Robley Dunglison wrote that Jefferson asked him, “Is it the Fourth?” when he awoke that evening. Dunglison replied, “It soon will be.”

Nicholas Trist, Jefferson’s granddaughter’s husband, recorded Jefferson as asking, “This is the Fourth?” Trist wrote that he nodded, pretending that it was. In another slight variation, Jefferson’s grandson, Thomas Jefferson Randolph, stated that Jefferson woke and simply said, “This is the Fourth of July.”

Despite the nuances in the accounts of Jefferson’s final hours, he was clearly fixated on the Fourth.  At about 9 p.m. on July 3rd, Jefferson refused to take his medicine and sent his attending physician packing, saying “No doctor, nothing more.” At about 4 a.m., Randolph wrote that Jefferson called out to his servants and spoke with them. However, there are no records of these final goodbyes. Consequently, historians have chosen to accept his statements about the Fourth as his last words due to their implications. Once Jefferson believed he had made it until the Fourth of July, he gave up fighting and accepted a different kind of independence.

Fourth of July 1831 Sees the End of James Monroe

James Monroe, the fifth American president and the last of the Founding Fathers to hold the office, passed away five years after his brethren. He finally succumbed to heart failure and tuberculosis at his daughter’s house in New York City on July 4, 1831. Monroe was attempting to write an autobiography but found himself unable to complete it in the face of his deteriorating health after his wife died the year before. He uttered no ominous last words. However, people could not ignore that Monroe was the third president and Founding Father to die on the Fourth of July. Many Americans believed that the timing of these deaths went far beyond mere coincidence.

“Again our national anniversary has been marked by one of those events, which it may be scarcely permitted to ascribe the chance,” the Boston Traveler newspaper reported July 8, 1831.

“Three of the four presidents who have left the scene of their usefulness and glory expired on the anniversary of the national birthday, a day which of all others, had it been permitted them to choose [they] would probably had selected for the termination of their careers,” the New York Evening Post wrote the day after Monroe’s death.

Americans Saw the Hand of God in Fourth of July Presidential Deaths

Religion was prominent in the lives of many Americans during the 1800s. In fact, during the late 1820s and early 1830s, an era known as the Second Great Awakening took off. Consequently, many Americans saw religious significance in the timing of the presidents’ deaths.

For example, in 1826, Massachusetts Representative Daniel Webster delivered a two-hour eulogy in Boston on the matter. He indicated that these deaths were a sign of God’s intervention to protect the country.

“As their lives themselves were the gifts of Providence, who is not willing to recognize in their happy termination, as well as in their long continuance, proofs that our country and its benefactors are objects of His care?” Webster said.

Generally, scholars don’t approach unexplained phenomena. However, in 2005, historian Margaret Battin toyed with the meaning behind the same-day deaths of Adams and Jefferson. She offered six possibilities:

  • Coincidence
  • Suicide
  • Allowing one’s own death
  • Murder
  • “Hanging on” until July 4
  • Divine Intervention

However, all of these theories are purely speculative and lack historical evidence. Regardless, it’s been 186 years since the last U.S. president died on the Fourth of July. So, it appears that this particular fate was reserved for our Founding Fathers. Interestingly enough, the only president born on the Fourth of July initially secured the position when the current president died. When President Warren G. Harding passed away unexpectantly, Vice President Calvin Coolidge assumed the presidency.

 

 

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.

 

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.

 

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.

 

 

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