Category: MDL

Taxotere Lawsuits Over Permanent Hair Loss Swell to More Than 850 Cases

By Emily Cox
Taxotere Lawsuits
Photo by Skye D.

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.

Taxotere Lawsuits

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.

 

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.

 

Taxotere Side Effects Linked to Five Deaths in France

By Emily Cox
Taxotere Side Effects
Photo by Matt Bachelor

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.

Eliquis Bleeding Permanently Damages Man

By Emily Cox
Eliquis Bleeding
Photo by gurmit singh

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.

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.

Eliquis Shown to Have Higher Risks of Stroke and Embolism than Warfarin

By Emily Cox

While manufacturers have promoted the new-generation blood thinner Eliquis as more effective than the long-standing treatment warfarin, new research indicates that the anticoagulant may actually increase the risk of stroke and embolism.

The study, published this month in The BMJ medical journal, compared various new atrial fibrillation blood thinners, called novel oral anticoagulants (NOACs), with warfarin. The risk of ischaemic stroke is already elevated in atrial fibrillation patients. Warfarin has long been the traditional treatment to prevent strokes from the common heart condition. However, since Eliquis, Xarelto, Pradaxa, and other NOACs require less monitoring to maintain proper dosage than warfarin, manufacturers have aggressively marketed them as easier to use.

Researchers compared data from more than 55,000 patients in national registries to determine the benefits and risks of Eliquis (apixaban), Xarelto (rivaroxaban), and Pradaxa (dabigatran) compared to warfarin.

After one year of treatment, 4.8 percent of Eliquis patients suffered either an ischemis stroke or systemic embolism. This is almost 30 percent higher than the 3.7 percent risk found with warfarin. Researchers also found the risk for all cause mortality with Eliquis to be dramatically higher at 25.4 percent than warfarin’s 8.6 percent risk. Xarelto did not perform much better in this respect with a 21.2 percent all cause mortality risk.

NOAC Bleeding Risk Compared with Warfarin

Along with the elevated stroke risk, reports have linked all NOACs to uncontrollable bleeding problems. When Eliquis, Xarelto, and Pradaxa were introduced, there were no safe and effective antidotes to stop bleeding when it occurred. Whereas, vitamin K reverses the effects of Warfarin

to stop bleeding.

Based on these factors, researchers suggest that a reevaluation of safety concerns for NOACs might be necessary.

“Along these lines, it might be important to review concerns about safety of oral anticoagulant treatment in atrial fibrillation: ineffective or insufficient treatment for stroke prevention should be viewed as a safety issue itself, while the increase in the risk of bleeding is an inevitable consequence of a necessary treatment,” the study stated.

As NOACs increase in popularity and use, patients, doctors, and thousands of lawsuits have raised safety concerns regarding these drugs.

In 2014, Pradaxa manufacturer Boehringer Ingelheim agreed to pay $650 million to settle about 4,000 lawsuits involving dangerous bleeding. In 2015, the FDA approved Praxbind to reverse the effects of Pradaxa, making the drug significantly safer.

A series of Xarelto bellwether trials are expected to begin next year. These may influence eventual settlements from Bayer and Janssen Pharmaceuticals.

The Judicial Panel of Multidistrict litigation consolidated the growing number of Eliquis lawsuits before U.S. District Judge Denise L. Cole in the Southern District of New York. The consolidated pretrial proceedings will help prevent duplicative discovery and conflicting rulings, saving all parties time and money.

Bard IVC Filter Lawsuit Expert Reports Deadline Extended

By Emily Cox

The judge presiding over all Bard IVC filter lawsuits has extended the deadlines for plaintiffs to produce expert reports for Bard Meridian and Denali filters.

During last week’s case management conference, U.S. District Judge David G. Campbell granted the plaintiffs’ request for more time to file these reports. The case management order extended the deadline from March 3 to April 7, 2017. Bard will have until May 12 to respond to these reports with plaintiff rebuttal reports due by June 9, 2017. Experts will give their depositions between June 9 and June 14, 2017.

The order also directs Bard to file any motion for summary judgement by March 17, 2017. Both parties will confer on the next course of action then. However, Judge Campbell will make a determination at the next status conference meeting May 3, 2017. Joint status reports for this meeting are due April 28.

Bard IVC Filter MDL

Currently, there are almost 1,600 Bard IVC filter lawsuits centralized before Judge Campbell in the District of Arizona for coordinated pretrial proceedings. These combined proceedings help prevent duplicate discovery and avoid conflicting rulings, saving time and money.

The lawsuits in the Bard IVC filter multidistrict litigation (MDL) all involve similar claims. Plaintiff

Bard IVC Filter
IVC Filter

s claim that these devices, implanted to prevent blood clot injury, are prone to failure. They can tilt out of position, puncturing the vein or fracturing, sending small pieces into the heart and lungs.

While most of the cases involve Bard G2 or Recovery filters, people who experienced complications with Bard Meridian or Denali filters have also filed complaints.

Judge Campbell is already preparing a small group of cases to go to trial by the end of 2017. These early trials will help gauge jury reactions to evidence and testimony that will likely be repeated in most cases. They also may assist in reaching an IVC filter settlement, eliminating the need for hundreds of individual trials nationwide.

In addition to the cases against Bard, hundreds of individuals have filed similar lawsuits against Cook and Cordis IVC filters. Cook IVC filter bellwether trials should begin in October 2017.

Sanofi S.A. Taxotere Lawsuits Move Forward With Approved Plaintiff Fact Sheet

By Emily Cox

New Orleans, LA — The U.S. District Judge presiding over Taxotere’s multidistrict litigation (MDL) approved the fact sheet that plaintiffs will use going forward against Sanofi S.A., the manufacturer of the controversial breast cancer drug, alleging that they experienced permanent hair loss, or alopecia, because of the drug.

While hair loss is expected with any chemotherapy, it is usually temporary. Plaintiffs claim that Taxotere caused permanent and disfiguring hair loss, and Sanofi S.A. did not warn them of the risk. Although studies show there are equally effective breast cancer treatments without Taxotere’s risks, plaintiffs claim Sanofi S.A. overstated the effectiveness of the drug while minimizing risks.

U.S. District Judge Kurt Engehhardt issued the pretrial order February 14. It includes a copy of the approved fact sheet. The MDL’s fact sheet will provide details about each plaintiff, including medical information, Taxotere use, and descriptions of alleged injury. The court requires plaintiffs to provide this information under oath.

Master Complaint in Sanofi S.A. Taxotere MDL

Judge Engelhardt approved the form days after he set a March 31 deadline to create a Master Complaint to streamline proceedings. The Master Complain allows future Taxotere plaintiffs to use the much faster Short Form Complaint. The Short Form Complaint lets plaintiffs adopt factual allegations and legal claims from the Master Complaint as they relate to their individual claim.

This practice is common in multidistrict litigations (MDLs) like Taxotere, where all pending lawsuits have similar allegations and are centralized in one U.S. District Court in order to reduce duplicate discovery into common issues and conflicting pretrial rulings, saving time and money.

The Judicial Panel on Multidistrict Litigation (JPML) centralized Taxotere proceedings under Judge Engelhardt in the Eastern District of Louisiana in October 2016. In December 2016, 267 lawsuits were pending in the MDL. Since then, the MDL has swollen to more than 850 cases.

Taxotere Hair Loss Risk and Effectiveness

Sanofi S.A. Taxotere Alopecia
Photo by S.A. Ledie

Studies indicate that one out of every 10 patients treated with Taxotere experiences alopecia complications. Sanofi S.A. knew about this risk since at least 2005 when the company updated its warning labels in Canada to include it. Sanofi S.A. didn’t update U.S. warning labels until late 2015.

The lawsuits allege permanent hair loss can substantially affect a woman’s overall quality of life and mental health.

Clinical studies showed Taxotere was no more effective than other less toxic treatments. However, Sanofi S.A. continued to aggressively market the breast cancer drug’s superiority.

In 2009, the FDA issued a warning to Sanofi S.A. to stop using promotional materials that suggested that Taxotere was better than any other taxane, including Taxol. The FDA called the company’s claims of superiority “false and misleading” and accused Sanofi S.A. as misbranding Taxotere.

The lawsuits claim that these women may have chosen a different treatment if they had known all the facts.

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