Zofran Birth Defect Fraud Claims to Proceed in MDL

By Emily Cox
Zofran Birth Defect Lawsuits
Photo by Nana B Agyei

The judge presiding over all federal Zofran birth defect lawsuits has struck down the drug maker’s attempt to have certain fraud-based claims dismissed, ruling that plaintiff allegations were sufficient to proceed on the basis that pregnancy warnings for the anti-nausea drug were false and misleading.

Judge Dennis Saylor filed the memorandum and order Monday in the District of Massachusetts. The order denied Zofran maker GlaxoSmithKline’s (GSK) motion to dismiss plaintiffs’ fraud claims. Judge Saylor acknowledged that the plaintiffs’ didn’t have grounds to claim fraud based on the drug maker’s marketing and advertising. He also noted that there were no allegations that specific GSK representatives had made false statements to prescribing physicians. Regardless, he found that fraud allegations based on product labeling satisfied federal rules’ mandates.

“Here, the master complaints allege generally that plaintiffs and their physicians relied on the misrepresentation in the label in prescribing and ingesting Zofran and/or ondansetron,” wrote Judge Saylor. “In this context, at least, that is sufficient. Pharmaceutical product labeling is highly regulated, and its very purpose is to advise prescribing physicians, who may reasonably rely on the representations in such labeling. Whether a particular physician did, in fact, rely on the representations in the labeling is of course a question of fact that cannot be resolved on the pleadings.”

Zofran Birth Defect Risk

Zofran is an anti-nausea medication. It works by inhibiting the body’s serotonin signaling. However, serotonin signaling regulates processes that are critical to normal embryonic development. Consequently, it has been linked to reports of children born with cleft palate and lip. It can also cause atrial septal defects, ventricular septal defects, and other birth defects.

According to at least 364 lawsuits, GSK knew and concealed the birth defect risk for decades. These complaints allege that GSK discovered the birth defect risk during pre-clinical studies in the 1980s. These studies showed that Zofran crosses the placental barrier during mammalian pregnancy, exposing the fetus to the drug. This exposure revealed clinical signs of toxicity. This led to intrauterine fetal deaths, stillbirths, congenital heart defects, craniofacial defections, incomplete bone growth, and other birth defects. Subsequent research has confirmed that Zofran also crosses this barrier during human pregnancy.

Allegedly, from 1992 to the present, there have been reports of Zofran birth defect risks that GSK was aware of.

Despite mounting scientific evidence that Zofran could cause harm to unborn children, GSK allegedly launched marketing scheme in 1997 to promote Zofran to obstetrics and gynecology doctors and patients as a safe and effective treatment for pregnancy-related nausea and vomiting. As a result of its aggressive marketing campaign, Zofran became the most frequently prescribed drug for treating pregnancy-related nausea and vomiting in the United States by 2002. However, GSK never warned of the substantial risk the drug posed to unborn children.

Zofran Birth Defect Study Statistics

In November 2011, Birth Defects Research Part A: Clinical and Molecular Teratology published a cleft palate study.  It showed Zofran may increase the risk for cleft palate by 2.37 times.

A 2013 review of 900,000 pregnancies’ data in the Danish Medical Birth Registry concluded that children were two to four times more likely to suffer a septal defect, involving holes in the heart, if their mothers had taken Zofran during pregnancy.

Reproductive Toxicology published a study in October 2014 that found that there was a 62 percent increase in risk for certain heart defects with early pregnancy Zofran use.

 

Eliquis Deaths Linked to High Percentage of FDA Adverse Event Reports

By Emily Cox
Eliquis Deaths
Photo by Michael Vines

According to a new lawsuit, Eliquis deaths constituted a sizable percentage of FDA adverse event reports involving the controversial new-generation anticoagulant, but the drug makers still neglected to warn patients of the uncontrollable bleeding risks regardless.

There were more than 1,000 adverse event reports filed with the FDA involving serious, irreversible bleeding in 2014 alone. At least 100 of these reports involved fatal bleeding. This constitutes at least a 10 percent mortality rate from Eliquis-related uncontrollable bleeding. Despite being aware of these irreversible bleeding events and Eliquis deaths, the drug’s manufacturers, Bristol-Myers Squibb and Pfizer, failed to adequately warn users and the medical community. To the contrary, they aggressively marketed and advertised the drug to convince consumers to use Eliquis without regular blood monitoring and instead of safer alternatives like Coumadin (warfarin).

Carol Woody filed the complaint Monday. In November 2014, Woody suffered a severe gastrointestinal bleeding event, requiring hospitalization. While Woody survived her uncontrollable Eliquis bleeding incident, it required extensive blood transfusions and an extended hospitalization.

Eliquis Deaths and Injuries Could Have Been Avoided

The lawsuit alleges that Woody could have avoided her injuries if the manufacturers had been forthcoming about the bleeding risks. It further asserts that the companies did not just hide this information but falsified it, providing false information about the safety of Eliquis. The claim maintains that the manufacturers knew or should have known that the drug could cause bleeding events that could become uncontrollable due to the lack of an antidote to reverse its blood thinning effects.

“These representations were made by Defendants with the intent of defrauding and deceiving the Plaintiff, the public in general, and the medical and healthcare community including Plaintiff’s prescribing doctor, and were made with the intent of inducing the public in general, and the medical community in particular, to recommend, dispense and purchase Eliquis, all of which evinced a callous, reckless, willful, depraved indifference to health, safety and welfare of the Plaintiff herein,” the lawsuit states. “The Plaintiff and the prescribing physicians were not aware of the falsity of these representations.”

This means that Woody could not make an informed decision on her care and medication. Bristol-Myers Squibb and Pfizer took that away from her and countless other patients.

Eliquis Deaths and Injuries History

Eliquis is part of a new generation of oral anticoagulants introduced recently, which includes Xarelto and Pradaxa. Their respective manufacturers aggressively marketed them as a replacement for Coumadin. Coumadin was the standard anticoagulation treatment since the 1960s. However, vitamin K will reverse Coumadin’s blood thinning effects in emergency bleeding situations. Unfortunately, there was no reversal agent for Eliquis, Pradaxa or Xarelto when they hit the market.

Since Eliquis’ 2012 approval, there has been a growing concern regarding the absence of guidance for dealing with Eliquis’ bleeds. According to the lawsuit, a 2014 noted that ‘[a] concern among clinicians is a virtual absence of guidance from clinical trials for reversing the anticoagulant effects of these drugs in clinical settings such as life-threatening bleeding or a need for emergent procedures that carry bleeding risk.”

Eliquis had a ballooning market share and a 400% increase in prescriptions in 2015. However, its makers still couldn’t be bothered to provide any specific information how to stop a potentially life threatening bleeding event in their clinical information.

Eliquis Deaths and Injuries Lawsuits

Woody joins a growing number individuals filing similar lawsuits nationwide. Many of these cases involve wrongful Eliquis deaths. These cases allege that the drug makers knew or should have known about the serious risks. However, they withheld information about the lack of an effective reversal agent to protect their own financial interests.

Dow Flexes Political Muscle and Contributions to Push Trump to Ignore Pesticide Risk Study

By Emily Cox
Dow Chemical Pesticides
Photo by Baker County Tourism

Dow Chemical is exerting pressure on an already anti-regulatory Trump administration to ignore the findings of a federal study that indicates lasting ecological damage from a family of widely used pesticides.

The Associated Press released its report last week. According to the exclusive, Lawyers representing Dow and two other chemical companies sent letters to administration Cabinet officials earlier this month. The companies asked the administration “to set aside” the results of an EPA organophosphate study that show the chemicals in a poor light. These studies concluded that the pesticides chlorpyifos, diazinon, and malathion were harmful to 1,800 critically threatened or endangered species.

Dow Chemical’s Influence in the Trump White House

The companies contend that these studies are fundamentally flawed. However, these contentions may be beside the point in light of Dow’s ties to the Trump administration. Dow CEO Andrew Liveris is a close adviser to Trump and heads a White House manufacturing working group. When Trump signed a February executive order, mandating the creation of task forces at federal agencies to roll back government regulations, Liveris was at Trump’s side.

“Andrew, I would like to thank you for initially getting the group together and for the fantastic job you’ve done,” Trump said as he signed the order. Then, the president handed his pen to Liveris as a keepsake of the occasion.

Furthermore, Dow spent more than $13.6 million on lobbying in 2016 and has long held significant political power in D.C. Moreover, Dow Chemical also wrote a $1 million check to help underwrite Trump’s inaugural festivities. Nothing says a party like deregulation of pesticides and other chemicals.

May feel that Dow’s letter to ignore the EPA’s extensive study of the environmental impact of these organophosphates is the company’s latest attempt to leverage its extensive White House influence to further its economic interests at the cost of the environment and public health.

The Study Dow Chemical Wants Pushed Aside

Researchers found the pesticides appeared to endanger any species that they tested them against. This could indicate that the chemicals pose substantial future risk to humans.

“Endangered species are the canary in the coal mine,” Brett Hartl, government affairs director for the Center for Biological Diversity.

Many of the threatened species in the study are aquatic. According to Hartl, they are often the first to show the effects of long-term chemical contamination in sources of human drinking water.

Dow Chemical’s Objections to EPA Study

However, Dow maintains that the EPA was selective in the studies it examined. The company claims the agency allowed some non-scientific studies to factor in while ignoring other studies that met inclusion guidelines. Furthermore, Dow ArgoSciences, which sells chlorpyrifos, accused that the study’s “scientific basis was not reliable.”

Hartl said Dow was trying to hold EPA to an unrealistic standard of data collection that could only be achieved under “perfect laboratory conditions.”

“You can’t just take an endangered fish out of the wild, take it to the lab and then expose it to enough pesticides until it dies to get that sort of data,” Hartl said. “It’s wrong morally, and it’s illegal.”

Environmental advocates were quick to say that Dow’s criticism of the study was unfounded. The National Academy of Science developed the EPA’s methods for biological evaluations.

A coalition of environment groups has fought in court for years for the EPA to examine the risks posed to humans and endangered species by pesticides, especially organophosphates. The resulting study encompasses almost four years of research and 10,000 pages of findings. Consequently, regulators at three federal agencies responsible for enforcing the Endangered Species Act are close to issuing these finding. This should result in new limits on how much and where people can use these highly toxic pesticides. However, if Dow has its way, the Trump administration will step in to intervene on behalf of the chemical giant’s financial interests.

Dow and Organophosphates

Nazy Germany originally developed organophosphorous gas as a chemical weapon. Dow has been selling Chlorpyrifos, an organophosphate, for spraying on fruits and other crops since the 1960s. It is one of the most popular agricultural pesticides in the U.S. Dow sells about 5 million pounds domestically annually.

Consequently, traces of the chemical are common in sources of drinking water. A 2012 University of California at Berkeley study found that 87 percent of umbilical-cord blood samples tested from newborns contained detectable levels of the pesticide.

The Bush administration ordered the end of the residential use of another organophosphate, diazinon. Households used it to kill yard pests until human health risks, particularly to children, became apparent. However, the agricultural sector still uses it.

Malathion helps control mosquitoes and fruit flies. Some lice treatment shampoos for children also contain the chemical.

 

 

Physiomesh Lawsuit Alleges the Hernia Mesh Provides No Benefit

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

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

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

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

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

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

Physiomesh Lawsuit Allegations

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

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

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

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

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

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

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

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

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

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

Talc-Ovarian Cancer Link

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

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

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

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

Talc-Ovarian Cancer Link Cross-Examination

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

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

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

Previous Talc-Ovarian Cancer Link Trials

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

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

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

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

 

Xarelto Failure to Warn Claims to Proceed Despite Summary Judgement Motions

By Emily CoxXarelto Failure to Warn

The judge presiding over all federal Xarelto lawsuits denied two partial summary judgement motions filed by the manufacturers of the oral anticoagulant to dismiss Xarelto failure to warn claims about the uncontrollable bleeding risks associated with the controversial blood thinner.

District Judge Eldon Fallon issued the order April 17.  The order denied partial summary judgement in two of the upcoming bellwether cases that would have dismissed claims filed by Joseph Boudreaux, Jr. and Joseph Orr, Jr.

Boudreaux’s trial begins today, followed by Orr’s on May 30. They will both take place before juries in the Eastern District of Louisiana. Additional bellwether trials will take place in Mississippi and Texas.

All these cases involve dangerous, irreversible bleeding, resulting in severe injuries, hospitalizations, and death, as a consequence of Xarelto not having an antidote to reverse its anticoagulant effects. Whereas, vitamin K will reverse the traditional blood thinner warfarin’s (Coumadin) effects in an emergency. These lawsuits all allege that Xarelto manufacturers knew about the risks but sought to conceal them in order to maximize profits at the cost of consumer health.

Xarelto Failure to Warn Motions

In a last ditch effort, Bayer Healthcare and Johnson & Johnson subsidiary Janssen Pharmaceuticals contended that Xarelto failure to warn claims should be excluded from litigation. The pharmaceutical giants indicated that plaintiffs could not prove that their doctors would have prescribed different medication even if Xarelto’s warning label was stronger. However, Judge Fallon ruled that applicable Louisiana law does not mandate proof that the doctors would have prescribed a different drug. The applicable law presumes that doctors will follow warning labels accordingly.

“This Court finds that Plaintiffs do not contend that prescribing physicians never should have prescribed Xarelto. Instead, they argue their claim survives merely by showing the doctor would have acted differently had they been adequately instructed, and that Plaintiffs’ injuries could have then been avoided,” Judge Fallon said in his ruling. “Louisiana law contains a presumption that if adequate warning is provided, that warning would have been followed, or ‘heeded.’”

Expert Exclusion Struck Down Along with Xarelto Failure to Warn

In addition from trying to dismiss Xarelto failure to warn cases, Xarelto makers also fought to exclude or limit testimony from key plaintiff experts. However, Judge Fallon ruled that four major experts were acceptable.

Dr. Suzanne Parisian is a former food and drug administration (FDA) Chief Medical Officer. She is also physician, author of FDA Inside and Out, and a Board Certified Pathologist. She is also the President of the clinical and regulatory consulting firm Medical Device Assistance, Inc. Dr. Parisian’s testimony will help the jury understand regulatory requirements applicable to the manufacturers and FDA drug labeling.

Former FDA Commissioner Dr. David Kessler has testified to Congress on multiple occasions. He has published many articles on the federal regulation of drugs and medical devices. His articles also cover federal regulation and state law. His testimony will be on the conduct of pharmaceutical companies.

Dr. Nathaniel Winstead is a gastroenterologist and hepatologist. He will testify that Xarelto probably caused the plaintiff’s gastrointestinal bleed.

Toxicologist and pharmacologist Dr. Laura Plunkett is a Diplomate of the American Board Toxicology and registered patient agent. She has extensive experience consulting and advising on regulatory matters including label content. She will provide testimony regarding drug pharmacology, general causation, regulatory measures, and the adequacy of labels for FDA-approved drugs.

 

Government Shutdown May Hinge on Trump’s Wall Demands

By Emily Cox
Trump Wall Threatens Government Shutdown
Photo by Ted Eytan

While nobody in Washington is pushing for a government shutdown Saturday, the new funding bill is contingent on funds for Trump’s border wall, and neither side is backing down.

The Washington Post reports that the President and his cabinet applied new pressure Sunday to include money for Trump’s U.S.-Mexico border wall in the critical government funding bill to prevent the impending shutdown when funds run out at the end of Friday. The shutdown would come into effect on Trump’s 100th day in office, capping off an intense start to the new administration, defined by a frenetic dash to kick-start the president’s agenda into high-gear despite possible dire political consequences.

Trump Takes Government Shutdown to Twitter – The Obvious Forum for this Discussion

Democrats said they will not approve any money for the border wall in a new spending bill.  In response Trump attacked Democrats for opposing the wall.

“The Democrats don’t want money from budget going to border wall despite the fact that it will stop drugs and very bad MS 13 gang members,” Trump tweeted Sunday.

Trump went on to suggest that Democratic opposition to funding the wall was myopic, indicating that Americans won’t be paying for it in the long run.

“Eventually, but at a later date so we can get started early, Mexico will be paying, in some form, for the badly needed border wall,” Trump tweeted.

However, Mexico strongly opposes the border wall. Mexican president Pena Nieto has said that the country “absolutely will not pay for” the wall ever. Nieto claimed the wall was an affront to Mexico’s dignity. This raises some fundamental questions on how Trump intends to fulfill this particular campaign promise.

Democratic Opposition to Trump Wall Despite Government Shutdown Threat

It remains unclear if GOP moderates will be able to sway the White House to avoid a shutdown. Meanwhile, Democrats continue to dig in their heels on the issue. They insist they won’t vote for any funding bill that gives Trump money to begin construction on his wall. They are saying that Republicans will either have to assume responsibility for the shutdown or abandon Trump’s demands.

“The burden to keep it open is on the Republican,” House Minority Leader Nancy Pelosi, D-Calif, said Sunday on NBC’s Meet the Press. “Building a wall is not an answer. Not here or any place.”

“The wall is, in my view, immoral, expensive, unwise, and when the president says, ‘Well, I promised a wall during my campaign,’ I don’t think he said he was going to pass billions of dollars of cost of the wall on to the taxpayer,” she continued.”

Government Shutdown isn’t Trump’s Only Bargaining Chip

Trump Threatens Government Shutdown and Healthcare
Photo by IoSonoUnaFotoCamera

The Trump administration isn’t only threatening a government shutdown to meet its agenda. In a nefarious twist, it appears to be holding American healthcare hostage as well.  Trump’s Office of Management and Budget director Mick Mulvaney has suggested the administration is willing to negotiate with Democrats. He said they would agree to fund insurance subsidies under the Affordable Care Act (ACA) in exchange for wall funding.

However, Democratic leaders took an affront to this negotiation tactic. Leaders feel that the administration is preying on the party’s interest at the expense of the American people.

“The White House gambit to hold hostage health care for millions of Americans, in order to force American taxpayers to foot the bill for a wall that the President said would be paid for by Mexico is a complete non-starter,” Matt House, a spokesman for Senate Minority Leader Charles E. Schumer, D-NY, said in a statement Friday.

The Senate has said that this statement still stands. In response, Trump issued a menacing warning Sunday morning to further the twist the arms of Democratic leaders.

“ObamaCare is in serious trouble,” Trump wrote. “The Dems need big money to keep it going – otherwise it dies far sooner than anyone would have thought.”

The thinly-veiled threat seems clear. Build Trump’s wall or he will tear Obamacare down, leaving millions of families without healthcare.

 

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

By Elizabeth de Moya
Mesh Complications
Photo by Leon

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

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

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

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

Charges of Gross Negligence and Misconduct

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

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

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

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

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

Some of the UK Women Affected by Pelvic Mesh Complications

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

 

 

Missouri Man Joins Growing List of Ethicon Hernia Mesh Lawsuits

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

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

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

Asplin Ethicon Hernia Mesh Lawsuit

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

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

Ethicon Hernia Mesh

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

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

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

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

$3M Verdict Awarded Against Paxil Manufacturer for Lawyer’s Suicide

By Emily Cox
Justice for Generic  Paxil Suicide
Photo by Captain Roger Fenton

An Illinois jury found GlaxoSmithKline (GSK) liable Thursday for Stewart Dolin’s suicide and ordered the company to pay $3 million to the lawyer’s widow, claiming that a generic version of GSK’s Paxil caused Dolin to take his own life.

Following five weeks of testimony, the nine-person jury agreed with Wendy Dolin that generic paroxetine, an antidepressant sold as brand-name Paxil, contributed to her husband’s 2010 suicide.

Dolin alleges that her husband would still be alive today if he hadn’t started taking paroxetine mere days before jumping in front of a downtown Chicago L-train. Dolin claims her husband was restless and agitated during his final days. These are symptoms of a Paxil side effect known as akathisia. GSK denies that akathisia can lead to suicide. However, Dolin contends that the side effect sometimes causes people to act impulsively and violently.

GSK Knew About Increased Paxil Suicide Risk

Furthermore, the lawsuit claims that GSK knew about the increased suicide risk in adults taking paroxetine. This is even more pronounced in the early days of treatment. However, the company allegedly hid this data from the FDA for decades. During the trial, the widow testified that her husband was sometimes anxious. But, he had developed coping mechanisms and was seeing a therapist at the time of his suicide.

The jury awarded Dolin $3 million. They allocated $2 million for the wrongful death of her husband. The jury awarded another $1 million for the pain he suffered in the days leading up to his untimely death. While this was far less than the $39 million Dolin had sought, she said it was about spreading awareness of the drug’s dangerous side effects instead of the money.

“I started a foundation, MISSD. I go to Washington, D.C., and I sit on consumer groups so this, for me, has not just been about the money,” she said. “This has always been about awareness to a health issue, and the public has to be aware of this.”

Paxil Manufacturer Continues to Assert Suicide Was Due to Work Anxiety

GSK tried to pin her husband’s suicide on his chronic anxiety, particularly as it related to his work. However, the managing partner at Reed Smith’s Chicago office testified that it wasn’t work that drove Dolin to suicide.

“He had challenging work, but we sorted it through,” Mike LoVallo, a close friend to Dolin for decades, testified.

After his death, LoVallo searched Dolin’s office. But he found no indication that his work was a contributing factor in his suicide.

Regardless, GSK continues to contend that since they did not manufacture the generic version of the drug that the court should not hold them liable. Dolin originally brought the suit against Mylan NV, the manufacturer of the generic version of Paxil. But District Judge James Zagel ruled that GSK, as the maker of the brand-name drug Paxil, was responsible for ensuring the label was accurate. The ruling still remains controversial.

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