Category: Defective Products

Judge Appoints Hernia Mesh Lawyers to Leadership Roles in Atrium C-Qur Lawsuits

By Emily Cox
Hernia Mesh Lawyers
Photo by Marco Aurelio Martins Costa

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.

 

Stryker Metal Hip Components Caused Pseudotumor and Metal Poisoning

By Emily Cox

Stryker Metal Hip Components

A new lawsuit claims that recalled Stryker metal hip components poisoned a Texas woman and caused her to develop a pseudotumor.

Betty Sadler filed the complaint against Howmedica Osteonics Corp, doing business as Stryker Orthopedics, earlier this month in the Southern District of Texas.

The lawsuit states that Sadler underwent Stryker metal hip replacement surgery in October 2008. Surgeons implanted her with a Stryker Accolade TMZF Plus femoral steam and LFit V40 femoral head to treat left hip degenerative arthrosis.

In late 2015, Sadler began experiencing “significant left hip pain and discomfort.” A subsequent MRI revealed a left hip pseudotumor. Due to this, Sadler underwent revision surgery in January 2016. During her revision surgery, Sadler’s surgeon also found evidence of significant metal poisoning and substantial wear on the Stryker metal hip components, as well as bone loss. Consequently, the surgeon replaced the LFit V40 metal femoral head with a ceramic one.

Due to reports of similar problems with Stryker metal hip components, the company recalled the LFit V40 in August 2016. The recall impacted certain large-diameter femoral heads sold before 2011. Stryker acknowledged that a larger-than-expected number of individuals were experiencing metal wear, trunnion failure, adverse tissue reactions, and other complications from the metal hip component.

Stryker Metal Hip Components Lawsuit

Sadler joins a growing number of individuals filing similar Stryker metal hip lawsuits. These lawsuits allege that Stryker failed to use reasonable and due care for the safety and well-being of patients. They further claim that the Stryker metal hip components were defectively designed. According to the lawsuits, company knew that the titanium Accolade hip stem performed poorly with the cobalt/chromium head. However, Stryker marketed the pairing of these components anyway to the detriment of recipients.

Due to the success of Stryker’s malicious marketing practices, the Accolade and LFit V40 were an exceptionally popular combination. Consequently, experts expect thousands of individuals to file similar lawsuits in the future due to significant injuries from this combination.

 

FDA Bends to Big Pharma and Postpones Off-Label Marketing Final Rule

By Emily Cox
Big Pharma Off-Label Marketing
Photo by Mike Licht

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.

 

 

 

Pesticide Manufacturer Accused of Ghostwriting Chemical Safety Reports

By Emily Cox
Pesticide and GMO Protest
Photo by William Murphy

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.

Essure Birth Control Coil Goes Missing in Woman’s Body

By Emily Cox
Essure Birth Control Coil
Controversial Essure Birth Control Coil

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.

 

Uterine Fibroid Embolization Safer and Cheaper than Morcellation But Underused

By Emily Cox
Uterine Fibroid
Photo by Tom Blunt

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

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.

Mesothelioma Deaths Exceeded 45,000 During 15 Year Period

By Emily Cox
Mesothelioma Deaths
Photo by Martin Hesketh

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

Mesothelioma Deaths Caused by Asbestos
Photo by Aaron Suggs

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.

 

Ethicon Hernia Mesh Case Centralization Requested

3/21 Update – This article was updated to reflect that Ethicon Physiomesh was not recalled. It was a voluntary market withdrawal.

By Emily Cox
Ethicon Hernia Mesh Case Centralization
Photo by Tim Green

A group of plaintiffs are requesting Ethicon hernia mesh case centralization due to the increasing number of cases, alleging that Physiomesh caused serious complications and additional surgery.

The plaintiffs filed the motion to transfer with the U.S. Judicial Panel on Multidistrict Litigation (JPML) on March 9. They are requesting that the JPML transfer all lawsuits involving the Ethicon hernia mesh to the Middle District of Florida. The centralized proceedings will help avoid duplicate discovery and conflicting rulings, saving time and money for all parties.

According to the motion, there are at least 18 product liability lawsuits pending in nine separate federal courts. These individuals claim that the Ethicon hernia mesh caused severe harm that often required additional invasive surgery. Furthermore, in some cases, this harm is irreparable. The motion also noted that six of the cases were already in the Middle District of Florida. This is the most of any one district.

Ethicon Hernia Mesh Design Defect

Ethicon Physiomesh is a hernia mesh patch Ethicon released in March 2010. Up until its May 2016 market withdrawal, surgeons widely used this product to repair hernias. The hernia mesh allegedly caused severe complications, including adhesions, mesh erosion, perforation, and infections. Many of these conditions require additional invasive surgery to treat.

The motion alleges that this voluntary market withdrawal was a direct consequence of the frequency and severity of the complications experienced with the hernia mesh worldwide.

Plaintiffs claim that the hernia mesh’s design caused many of the complications. Ethicon Physiomesh has five distinct layers with a multi-layer coating. No other hernia repair product in the world uses this design.

Plaintiffs allege Johnson & Johnson and its Ethicon subsidiary promoted the coating to prevent or minimize adhesion and inflammation while helping the mesh incorporate into the abdomen.

“However, Plaintiffs intend to demonstrate that the multi-layer coating instead prevented adequate incorporation of the mesh and caused or contributed to a variety of serious complications,” the motion went on to state.

It also seems to have caused severe inflammatory and foreign body responses. In turn, these responses cause scar tissue that starts to connect organs, which is a severe complication that requires surgery.

Given the popularity of the Ethicon hernia mesh with surgeons before its market withdrawal, experts expect the size of this litigation to grow dramatically.

Cook IVC Filter Settlement Conferences Scheduled

By Emily Cox
Cook IVC Filter Justice
Photo by Bri

A judge has ordered a series of three Cook IVC filter settlement conferences to try to resolve lawsuits against Cook Medical before the first bellwether trials begin later this year.

U.S. Magistrate Judge Tim A. Baker issued the order March 7. He scheduled the first conference for the plaintiffs’ counsel July 26. There will be subsequent conferences for the defendant’s council August 4 with a follow-up for the plaintiff’s August 9.

The conferences will propose Cook IVC filter settlement frameworks that may eliminate the need for additional trials later this year. There will also be confidential discussions on case status, discovery, and trial preparation. Judge Baker will make assessments of the relative strengths and weaknesses of both sides of the litigation.

While previous Cook IVC filter settlement conferences have convened, parties have not been able to reach an agreement.

Cook IVC Filter Complications

Cook designed and sold IVC filters to prevent blood clots from travelling to the heart and lungs. However, these lawsuits allege that these filters caused various serious complications. A 2012 study, published in CardioVascular and Interventional Radiology medical journal, indicated that all Cook Celect and Gunther Tulip filters showed some degree of IVC perforation. Researchers found that full perforation occurred in 86 percent of the cases, while 40 percent of filters tilted out of position. Furthermore, while these filters are temporary, doctors rarely remove them. When the filters are left in for extended periods of time, they can break. This can allow pieces of the filter to get lodged in other parts of the body, usually the heart or lungs.

In May 2014, the FDA issued a safety communication regarding IVC filters. The agency released the report due to excessive reports of IVC filters breaking and damaging the heart, lungs, and other organs.

There are currently about 1,500 cases against Cook IVC filters with plaintiffs alleging these and other problems. Bard IVC filters have similar complications, along with associated litigations pending against them.

Class Action Restriction Bills Passed by House

By Emily Cox
Class Action
Photo by Joey Gannon

Washington, DC — Despite Democratic objections that class action restrictions would hurt the public’s ability to hold corporations accountable, the House of Representatives passed a pair of bills Thursday to make it harder to bring class actions and keep suits in state courts.

The Fairness in Class Action Litigation Act of 2017 and Innocent Party Protection Act radically limit the scope for class actions, while expanding the scope for finding fraudulent joinder in suits.

Republicans claim these bills will adjust the balance between “abusive plaintiffs” and “innocent defendants.” However, Democrats argue the bills are designed to protect corporate wrongdoers by making it harder for victims to band together. Democrats allege that these bills would make it almost impossible for victims injured by consumer rip-off, fault product design, and pharmaceutical drug mistakes, as well as lead and asbestos poisoning to bring class-action lawsuits.

“I oppose these misguided legislations, because it sends another huge valentine and wet kiss to large corporate polluters and tort-feasors but gives the finger to millions of American citizens who suffer injuries from these defendants,” Rep. Jamie Raskin (D-Md) said.

Democrats are joined by a large group of legal, environmental, disability, labor, civil rights, and consumer protection organizations in their opposition. They claim the bills would limit the ability to join a class action suit against defendants with exponentially greater resources.

“Christmas has certainly come early for corporate-America,” said Teddy Basham-Witherington, a spokesman for The Impact Fund, a nonprofit public interest law organization.

He went on to that, if passed, the class action restriction bills would “restrict ordinary people from accessing justice, emboldening the worst actors in corporate America.”

Class Action Restriction Bill (H.R. 985)

The class action bill would require plaintiffs to prove potential members have the same type and scope of injury. It also requires asbestos trusts to make details of trust claimants public.

“This doesn’t formally abolish the class-action mechanism,” Rep. Jamie Raskin (D-MD) said. “It’s not the guillotine, but it’s a straight jacket.”

Opponents also argue that the bill provides easy access to asbestos victims’ personal information for scam artists, employers, potential insurers, and debt collectors to potentially exploit.

The bill’s predecessor, the Fairness in Class Action Litigation Act of 2015 (H.R. 1927), passed the House but was not even considered by the Senate. According to opponents, this bill was far less damaging than the current legislation. Basham-Witherington described the new bill as “H.R. 1927 on steroids.”

Innocent Party Protection Act

This bill would prevent attorneys from adding defendants to a lawsuit to keep the case in state court. Democrats like Jerrold Nadler (NY) feel that it gives corporations another tool to transfer suits to corporate-friendly federal courts.

“The preliminary determination of jurisdiction would become a baseless time-consuming mini-trial before a second trial on the merits,” Nadler said. “While large corporations can accommodate such costs, injured workers, and parents cannot.”

Take Justice Back

The American Association for Justice has established a movement to help individuals take a stand against class action restriction. Take Justice Back has numerous websites to help people act against this unconstitutional legislation.

 

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