A recent court filing indicates that more than 850 women have filed Taxotere lawsuits, alleging the controversial breast cancer drug’s manufacturer failed to warn about Taxotere’s permanent hair loss risk, while fraudulently marketing the drug as more effective than other treatments that do not have the same risks.
Parties in the litigation filed the joint status report March 17. The report indicates that there are already at least 857 Taxotere cases pending in the new multidistrict litigation (MDL). There are also additional cases proceeding in California, Missouri, and Delaware state courts.
These Taxotere lawsuits allege that Sanofi S.A. knew and concealed the drug’s permanent hair loss risk from American breast cancer patients. In fact, the company updated its warning labels in Canada and Europe in 2005 and 2012 respectively. Sanofi did not update U.S. warning labels until late 2015. Furthermore, the company actively promoted the high-potency taxane as more effective than other less toxic treatments, such as Taxol, even though research has shown that these less toxic treatments were equally effective and do not cause permanent hair loss. The FDA even had to issue a warning to Sanofi to stop fraudulently marketing Taxotere as being more effective than other treatments.
Hair loss is a known and accepted side effect of chemotherapy. However, plaintiffs claim that Sanofi provided false and misleading information that suggested hair regrows after Taxotere treatments. However, this is not the case for many women.
In October 2016, the U.S. Judicial Panel for Multidistrict Litigation (JPML) centralized all federal Taxotere lawsuits for pretrial proceedings before U.S. District Judge Kurt Engelhardt in the Eastern District of Louisiana. This centralization reduces duplicate discovery and conflicting rulings, promoting judicial efficiency. Experts expect that Taxotere lawsuits will number in the several thousands in the coming years.
Judge Engelhardt has scheduled the next status conference for all parties on May 12.
The U.S. District Judge presiding over the centralized Atrium C-Qur litigation has appointed some of the plaintiffs’ hernia mesh lawyers to various leadership roles for discovery and pretrial proceedings.
Judge Landya McCafferty issued the case management order March 13. The order appointed the Plaintiffs’ Lead Council, Liaison Counsel, and Executive Committee. According to the order, five hernia mesh lawyers will serve on the committee. Additionally, the judge designated one attorney as the Plaintiffs’ State Liaison Counsel. This attorney will coordinate status updates regarding cases filed at the state level. These lawyers will coordinate and manage discovery, as well as argue motions before the court.
Judge McCafferty also issued a Pretrial Order on March 13. The order approved a joint proposal from the plaintiffs and defendants on the collection, division, and preservation of pathological materials from Atrium C-Qur surgeries for trial evidence.
Atrium introduced its C-Qur hernia mesh patch in 2006. Atrium designed the mesh’s Omega-3 gel coating to reduce inflammation and scar tissue formation, while aiding incorporation of the mesh into the abdominal wall. However, plaintiffs claim that this coating actually promotes inflammation, causing bowel adhesions and other problems, while preventing proper abdominal wall incorporation.
Hernia Mesh Lawyers and MDL
Hernia mesh lawyers are continuing to file and review claims over problems with Atrium C-Qur. These claims allege that Atrium defectively designed its C-Qur hernia mesh and that the mesh is unreasonably dangerous. Consequently, plaintiffs suffered painful and debilitating complications such as allergic reactions, infections, and adhesions. Almost all of the plaintiffs required additional surgery to remove the mesh patch.
In December 2016, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all Atrium C-Qur lawsuits before Judge McCafferty in the District of New Hampshire. Federal Multidistrict Litigation (MDL) reduces duplicate discovery and conflicting pretrial rulings. As a result, all parties save both time and money. The JPML refers to this as “judiciary efficiency.” Hernia mesh lawyers think the MDL has the potential to swell into thousands of cases.
In response to a petition filed by pharmaceutical groups, the Food and Drug Administration (FDA) has delayed implementing a final rule that would give the agency greater leeway to regulate off-label marketing.
While drug makers requested an indefinite stay on the rule, the FDA delayed executing this final rule until March 2018. The rule would require drug makers to update product labeling if there is evidence that the company intended people to use its medicine for off-label uses or for an unapproved use. Doctors can prescribe drugs for any reason. However, court rulings have determined that pharmaceutical companies can only engage in off-label marketing if the information is truthful and not misleading.
The Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Biotechnology Innovation Organization (BIO), filed the Petition to Stay and for Reconsideration on February 8, 2017. These groups expressed outrage over the FDA’s unexpected publishing of the rule in January.
“FDA’s revisions were not communicated to the public prior to the Final Rule published on January 9, 2017, which deprived stakeholders of fair notice and an opportunity to be heard in violation of the Administrative Procedure Act (APA),” the petition states.
Furthermore, the trade groups claim the rule gives the FDA too much leeway.
“The final rule would give the FDA an extraordinarily wide leeway to gauge how a company intended its medicine to be used, which can then be used to assess whether illegal promotion occurred,” the groups said.
The FDA asserts that these groups misunderstood the ruling. However, the agency still relented, extending the March 21, 2017 deadline by almost a year.
Taxotere Off-Label Marketing Lawsuit
The ruling delay comes as Sanofi S.A. faces a Qui Tam lawsuit for off-label marketing of Taxotere. The lawsuit claims the company used fraudulent and illegal off-label marketing to drive sales and expand its market share. The FDA approved the high-potency taxane to treat advanced breast cancer when other treatments have failed.
Sanofi S.A. allegedly trained and directed their employees to misrepresent the safety and effectiveness of off-label Taxotere. This expanded its market into unapproved settings like first line treatment and less advanced cancer. The lawsuit claims that the company also paid doctors illegal kickbacks to get them to prescribe Taxotere for off-label uses. These kickbacks included entertainment, sports, concert tickets, sham grans, speaking fees, travel preceptorship fees, and fee reimbursement assistance.
These illicit measures dramatically increased the breast cancer drug’s revenue from $424 million in 2000 to $1.4 billion in 2004. It also exposed thousands of women to Taxotere’s increased toxicity and its more severe side effects, including permanent hair loss.
Additional civil lawsuits continue to mount rapidly as more women discover Taxotere unnecessarily disfigured them.
Taxotere side effects may be responsible for at least five deaths in France, leading the nation’s product safety agency to urge doctors to avoid using the controversial chemotherapy drug to treat certain cases of breast cancer.
All five women passed away since August 2016 and were 46 to 73 years old. Researchers began investigating the issue after the third death. As a result, they have concluded that Taxotere side effects played at least some part in these women’s deaths.
The French National Drug and Health Product Safety Agency (ANSM) issued a warning to oncologists last month. The letter indicated that Taxotere side effects may have caused several deaths. The chemotherapy treatment appears to have caused neutropenic enterocolitis. This condition causes inflammation of the mucosa of the colon and small intestines. The agency went on to recommend that doctors use Abraxane instead to treat localized, operable breast cancer.
Researchers note that all deaths were associated with generic Taxotere (docetaxel). However, they found no irregularities with the generic drug. Accord Healthcare, an Indian drug company, supplied the drug, and tests showed that it meets quality standards.
The ANSM is continuing this investigation. The agency expects to release the results on March 28.
Taxotere Side Effects Lawsuits
Sanofi-Aventis, the maker of brand-name Taxotere, is facing a growing number of Taxotere side effect lawsuits. These lawsuits allege that the company knew and concealed the risk of permanent hair loss from women and the medical community.
The company updated Taxotere warning labels in Canada and Europe to include this risk in 2005 and 2012 respectively. However, it didn’t update American warning labels until late 2015.
Sanofi-Aventis introduced Taxotere in 1996. It is a high-potency taxane cancer drug. The company marketed it as superior to existing low-potency taxanes like Taxol. However, researchers and the FDA have found that it is no more effective. Furthermore, it has been linked to permanent hair loss and other side effects not associated with other taxanes.
These women allege that they would have chosen a different breast cancer treatment if they had known about Taxotere side effects and true efficacy.
Court documents in the lawsuit against Monsanto involving its Roundup pesticide include emails that indicate the company had ghostwritten research on the pesticide’s active ingredient that was later attributed to academics.
NPR reports that Monsanto asked scientists to co-sign safety studies on glyphosate, the active ingredient in Roundup pesticide. In internal emails. Monsanto executive William Heydens suggested that the company “ghost-write” a paper.
“We would be keeping the cost down by us doing the writing and they would just edit & sign their names so to speak,” he wrote.
He indicated this is how the company had “handled” an earlier paper on glyphosate’s safety. While the paper from 2000 acknowledges Monsanto’s help in collecting data, it does not list any employees as authors.
The emails also suggested a collaboration between Monsanto and a senior regulator at the Environmental Protection Agency (EPA), Jess Rowland.
If I can kill this, I should get a medal,” Rowland said to a Monsanto regulatory affairs manager in April 2015. The manager recounted the conversation in an internal email. The company was trying to get Rowland’s assistance to stop an investigation of glyphosate by the Centers for Disease Control and Prevention (CDC) after the International Agency for Research on Cancer declared that glyphosate probably causes cancer.
Monsanto executives were concerned that Rowland could not stop a federal glyphosate review. However, it’s evident that they believed the EPA was on their side.
“I doubt EPA and Jess can kill this, but it’s good to know they are going to actually make the effort,” a Monsanto executive wrote.
Since Rowland retired from the EPA last year, he has become a central figure in more than 20 lawsuits. These lawsuits claim Monsanto failed to warn consumers of the risks associated with its glyphosate-based pesticide.
Roundup Pesticide Lawsuits
There are hundreds of individuals suing Monsanto, Roundup’s parent company. They cite a 2015 World Health Organization study that says glyphosate is probably carcinogenic and damages DNA in human cells. A California judge recently ruled that the state can legally require Monsanto to warn customers of Roundup’s cancer risks.
Atlanta, GA — A woman has filed a product liability lawsuit against Bayer after one of its controversial Essure birth control coils went missing inside her body.
Pamela Graves filed the complaint in the Northern District of Georgia earlier this month. She is claiming that Bayer sold a defective and unreasonably dangerous device and that the company failed to warn about the risks associated with the Essure birth control coils.
According to her lawsuit, Graves had the Essure birth control coils implanted in May 2009. Following implantation, she gained approximately 80 pounds and suffered constant intense pelvic pain. She also experienced heavy bleeding with large clots, painful intercourse, and headaches. Graves alleges she could feel the coils poke her when she would lay down on her stomach.
In April 2016, Graves underwent a hysterectomy to remove the Essure birth control device. However, doctors were only able to remove one of the coils. They could not locate the other coil, as it had migrated outside of the fallopian tube into Graves’ body. It remains inside of Graves to this day.
Essure Birth Control Complications
Essure birth control coils are implanted in the fallopian tubes. They cause scar tissue to form and prevent pregnancy. Bayer continues to market this device as a safe and effective form of birth control. However, tens of thousands of women have reported serious Essure complications to Bayer and the FDA. These complications include severe pain, unintended pregnancy, and allergic reactions, as well as coil migration and perforation. Furthermore, most doctors cannot remove only the coils, and insurance does not cover the procedure. Consequently, the only treatment option for most women is hysterectomy.
After receiving 10,000 Essure adverse event reports between November 2002 and December 2015, the FDA mandated Essure warning label changes in November 2016. Some of the most severe complications included four adult deaths, 15 lost pregnancies, and two infant deaths, as well as, 631 reports of unwanted pregnancies. In 96 of these cases, the
pregnancies were ectopic, which can be life-threatening.
These label changes included a “black box” warning, as well as a patient checklist that must be given to women considering Essure birth control to ensure future patients are aware of the severity of the risks associated with the device.
Graves joins several thousand other women who have filed similar lawsuits against Bayer, alleging that their birth control device caused serious harm and that Bayer misrepresented Essure’s safety and efficacy.
Washington, D.C. – As safety concerns continue to mount over the risks associated with morcellation, new research indicates that less invasive embolization is vastly underutilized for uterine fibroid removal even though it’s safer and less expensive.
The study’s lead author presented the research at the Society of Interventional Radiology’s annual meeting in Washington, D.C., earlier this month. Researchers found that the medical community vastly underuses a technique called uterine fibroid embolization, favoring more invasive and expensive laparoscopic hysterectomies that may involve the use of a power morcellator.
Power Morcellators Vs. Uterine Fibroid Embolization
Power morcellators are medical devices for minimally invasive hysterectomies. Surgeons use them to cut up and remove the uterus and uterine fibroids through a small abdominal incision. While they were exceedingly popular during the past decade, most doctors will not use the devices anymore as morcellators can spread undiagnosed uterine cancer cells. Consequently, this rapidly upstages aggressive cancers and shortens life-expectancy.
In comparison, embolization doesn’t require a surgical incision. Instead radiologist inserts a catheter into the artery at the groin or wrist. The doctor then guides the catheter to the fibroid’s blood supply where tiny particles are released to block the small blood vessels. This deprives the fibroid of nutrients, resulting in fibroid softening and shrinking, as well as less bleeding. Researchers estimate that nine out of 10 patients who undergo uterine fibroid embolization experience significant improvement or complete resolution of their symptoms.
Uterine fibroids are growths made of smooth muscle cells and other tissue that develop within the wall of the uterus.
According to the National Institute of Child Health and Human Development, the majority of women develop uterine fibroids. One study found that between 80% and 90% of African American women and 70% of white women develop fibroids by age 50. Research shows that 90% of these women will seek medical or surgical treatment within one year of diagnosis. While fibroids usually grow in women of childbearing age, women undergo hysterectomies most of the time. This new research indicates that women are not fully aware of their treatment options. It further suggests that these women would chose preserve their uterus and ability to bear children if given this choice.
Women Not Aware of Uterine Fibroid Embolization Benefits
Embolization allows women to keep their uterus and removes the risk of cancer upstaging. However, the study found there were more than 65 times as many hysterectomies performed for uterine fibroids than embolization. In 2013, there were approximately 78,200 hysterectomies for fibroids in 2013. While this is down from 168,000 in 2007, there were less than 2,500 embolization procedures during this time.
“These findings suggest there is a lack of awareness about this safe, effective and less invasive therapy for uterine fibroids,” said Prasoon Mohan, the study’s lead author. “Patients need to know about the major differences between surgical treatments and [uterine fibroid embolization], especially that this is a non-surgical treatment that preserves the uterus and has a much faster recovery time compared to hysterectomy.”
The data also showed the uterine fibroid embolization resulted in shorter hospital stays. Furthermore, it was less expensive than hysterectomy by about $12,000. Researchers are urging the medical community to educate patients about their choices and determine ways to increase access to this effective, less invasive treatment.
Power Morcellator Lawsuits
Lawmakers, consumer advocates, and families of cancer victims have pressured the FDA to recall power morcellators. Unfortunately, the FDA has decided not to recall power morcellators at this time. However, they did require manufacturers to add a prominent “black box warning” to device labels in April 2014. These labels clearly state that the devices may spread undetected cancer and decrease long-term survival. Since the FDA issued these warnings, Johnson & Johnson has faced dozens of morcellator cancer lawsuits. These women allege these devices are defective and dangerous and that the company failed to warn the medical community.
Johnson & Johnson’s Ethicon unit was previously the main manufacturer of morcellators. It has since stopped selling the medical device. But other companies continue to manufacturer and sell these controversial tools.
A new government report shows more than 45,000 malignant mesothelioma deaths from 1999 to 2015 with annual lives lost continuing to increase, especially among older Americans who came into contact with asbestos decades earlier.
The March 3 issue of the U.S. Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report (MMWR) indicates that the number of mesothelioma deaths continue to increase. However, prior projections suggested that the impact of asbestos should have peaked by now. Instead it increased 4.8 percent from 1999 to 2015.
“After 2005, mortality was projected to decrease,” the report stated. “Despite regulatory actions and the decline in use of asbestos, the annual number of malignant mesothelioma deaths remains substantial.”
These findings suggest that asbestos exposure is continuing at unacceptable rates. According to their research, 20 percent of construction industry air samples from 2003 exceeded the asbestos exposure limits. The CDC also found that many asbestos products remain in use with new asbestos products manufacturing continuing in the U.S.
The only known cause of the mesothelioma is asbestos exposure. The manufacturing and building industry used asbestos extensively until regulatory agencies banned most uses more than three decades ago. However, the time from exposure to developing malignant mesothelioma can be as long as 71 years.
Since it is usually not diagnosed until it’s in a very advanced stage, mesothelioma is almost always fatal. Consequently, there is a very short life-expectancy after diagnosis as well. Researchers found that patients have a median survival of approximately one year from the time of diagnosis.
Mesothelioma Deaths Litigation
More than 600,000 people have filed lawsuits against more than 6,000 defendants due to injuries caused by breathing asbestos fibers. This makes it the largest mass-tort in U.S. history. Besides people directly exposed to the toxic substance, a growing number of lawsuits involve second-hand exposure by individuals who inhaled asbestos from the hair or clothes of their parents during childhood.
Veterans who served at Camp Lejeune in North Carolina from the 1950s through the 1980s may be eligible to receive compensation payments if they suffered from certain cancers or other select diseases.
The federal Veterans Administration has acknowledged that the water at the camp probably caused many forms of cancer found in veterans who served at Camp Lejeune for 30 days or more. The contamination occurred between August 1, 1953 and December 31, 1987. Consequently, these veterans showered, drank, and ate food cooked in a poisonous stew of benzene, perchloroethylene, trichloroethylene, and vinyl chloride among other harmful chemicals that may cause breast cancer, adult leukemia, bladder cancer, non-Hodgkin’s lymphoma and Parkinson’s disease. Authorities think the water was contaminated by a nearby dry cleaning business leaking chemicals into the ground water.
Camp Lejeune Veteran Compensation
The U.S. government freed up about $2.2 billion Tuesday to compensate veterans who are struggling with at least one of the eight diseases linked to the toxic water they were exposed to while serving their country. However, several family members of veterans and civilians said they hope the compensation will grow to include more diseases as well as civilian employees who may have been exposed.
This will be the first time that the government will compensate veterans for harm done at home rather than foreign soil during wartime. Also, there is no requirement to prove a direct link between the water and any of the identified illnesses.
While there are nearly a million people eligible for this compensation, the government isn’t reaching out to them. Consequently, they are responsible for filing their own claims. But many veterans aren’t even aware of the water contamination or the health impacts.
Camp Lejeune Veteran Health Benefits
Per the 2012 Camp Lejeune health care law, the VA also provides free health care for certain conditions for vets who served at least 30 days of active duty at Camp Lejeune from January 1, 1957 and December 31, 1987. Qualifying conditions for free health care include:
A recent product liability lawsuit against the anticoagulant manufacturers alleges that Eliquis bleeding permanently damaged a New York man.
David Reed filed the complaint in Delaware Superior Court on February 27. He claims that Bristol-Myers Squibb and Pfizer misrepresented Eliquis as safe and effective, while concealing the significant uncontrollable bleeding risks.
According to the complaint, Reed began taking Eliquis on January 8, 2015, after vascular surgery. He was hospitalized for bleeding complications by January 26, 2015. He was hospitalized again March 30, 2015, due to gastrointestinal bleeding. Reed claims he has suffered severe pain and permanent damages that could have been avoided if the companies had provided adequate warnings and information about the risk of Eliquis bleeding.
“Had Plaintiff known the true facts with respect to the dangerous and serious health and safety concerns of Eliquis, Plaintiff would not have purchased, used, and relied on Defendant’s drug Eliquis,” the claim states.
According to the lawsuit, the drug makers concealed their knowledge of Eliquis’ defects, defrauding and deceiving the public, FDA, and medical community.
Eliquis received FDA approval in 2012. The lawsuit alleges that the ARTISTOTLE clinical trials were a determining factor for Eliquis’ approval. However, it further claims that the drug makers chose “incompetent and untrustworthy” agents in China to conduct the study to cut costs. Allegedly, the companies concealed side effects in test users, including Eliquis bleeding and a death. There are also allegations of major dispensing errors where subjects were not even receiving Eliquis, poor quality control, and record destruction, as well as changing and falsifying records. In a February 2012 meeting with the FDA and company executives, the FDA characterized the companies as showing a pattern of inadequate supervision.
Eliquis Bleeding Risks
Eliquis is part of a new group of oral anticoagulants, known as factor xa medications. This group also includes Xarelto and Pradaxa.
While manufacturers aggressively marketed these drugs as a replacement for Coumadin (warfarin), manufacturers released them without antidotes for bleeding incidents. Whereas vitamin K can reverse Coumadin’s anticoagulant effects. Consequently, a large number of individuals have reported Eliquis bleeding problems.
“Before and after marketing Eliquis, Defendants became aware of many reports of serious hemorrhaging in users of its drug,” the complaint states.
The claim asserts that the side effect data generated obvious signals that Eliquis bleeding was a serious concern. However, manufacturers never alerted the public and scientific community. They also never performed further investigation into Eliquis’ safety.
In February, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all Eliquis proceedings in the Southern District of New York.
Pradaxa and Xarelto Lawsuits
The JPML has centralized litigation for Xarelto and Pradaxa as well. Pradaxa maker Boehringer Ingelheim agreed to pay $650 million in 2014 to resolve about 4,000 cases. Xarelto has more than 15,000 lawsuits pending in its centralized litigation over uncontrollable bleeding.