The multidistrict litigation (MDL) will hold a Taxotere Science Day on May 3 to educate the court about the link between the chemotherapy drug and permanent hair loss.
Judge Kurt Engelhardt issued the pretrial order late last month. The order indicated that the May 3rd Taxotere Science Day presentations would be informative in nature rather than adversarial.
It is common for higher courts to schedule scientific presentations like the Taxotere Science Day when a large number of individuals have brought similar claims of injury from the same product. This allows all parties to explain issues that will come up throughout the litigation in a non-combative setting. These presentations are typically not on the record or subject to cross-examination.
In October 2016, the Judicial Panel on Multidistrict Litigation (JPML) centralized all claims against Taxotere manufacturer Sanofi S.A., alleging the company failed to warn about the link between Taxotere and permanent hair loss. JMPL consolidated all these cases to avoid duplicative discovery and avoid conflicting rulings, thereby saving everyone time and money.
Taxotere Hair Loss Risk
Hair loss is a widely known and accepted chemotherapy side effect. However, these women maintain that Sanofi S.A. provided false and misleading information that suggested hair regrows after Taxotere treatments. But this is not the case for many women. While Sanofi S.A. updated warning labels in other countries as early as 2005 to include the permanent hair loss risk, it did not provide this information to American women until 2015.
Furthermore, these lawsuits claim that the drug is actually no more effective at treating breast cancer. Yet, it carries the risk of permanent hair loss, or alopecia. This risk is not associated with less toxic treatments. However, Sanofi S.A. fraudulently overstated the effectiveness of Taxotere, making women believe that it was their best chance at survival.
Taxotere Science Day Hair Loss Link
The Taxotere Science Day is going to delve into the science behind Taxotere’s hair loss risk rather than Sanofi S.A.’s fraudulent and misleading statements pertaining to their breast cancer drug.
Taxotere (docetaxel) is a high-potency taxane-based cancer drug. Sanofi S.A. introduced it in 1996 as a “superior” alternative to low-potency taxanes like Taxol. After several studies showed less toxic treatments to be as effective or more than Taxotere, the FDA warned Sanofi S.A. to cease all claims of superiority to other cancer drugs.
As early as 2005, studies have found that Taxotere has a substantial risk of permanent hair loss. Some findings indicate that one out of every 10 Taxotere recipients experienced hair loss that lasted more than 10 years.
The growing number of Eliquis lawsuits involving individuals who suffered uncontrollable bleeding while on the controversial blood thinner are beginning to move forward in the newly established federal multidistrict litigation (MDL).
Following the MDL’s first conference last month, Judge Denise L. Cote issued a scheduling order. The order outlines how the Eliquis lawsuits will move forward. The plaintiffs will submit their proposal for a Steering Committee by Friday. This committee will play an important role in helping the plaintiffs during discovery and pretrial proceedings.
The order also calls for the parties to submit proposed plaintiff and defendant fact sheets, along with case management orders related to them, by April 14. A proposed protective order and proposed protocol for conducting electronic discovery is due at this time as well. A proposed coordination order for state and federal Eliquis lawsuits is due by April 28.
Following an initial exchange of interrogatories and document requests early next month, the parties will submit a proposed discovery schedule by June 2. This schedule will determine how information will be exchanged going forward in the litigation.
It’s likely that Judge Cote will establish a bellwether trial process in the future. These trials will involve a small group of Eliquis cases that will get early trial dates. They will help gauge how juries will react to evidence that will be repeated throughout the litigation. However, these cases probably will not go to trial until late 2018.
Eliquis is part of a new group of blood thinners that include Xarelto and Pradaxa. Manufacturers of these drugs aggressively marketed them as replacements for Coumadin (warfarin) to prevent blood clots. However, unlike warfarin, there was no an antidote to reverse the drugs’ blood thinning effects. Consequently, there are a disturbing number of serious bleeding reports involving Eliquis, Xarelto, and Pradaxa. These incidents often result in hospitalization or death.
Pradaxa and Xarelto hit the market first in 2010 and 2011 respectively. Both drugs quickly became the subject of thousands of lawsuits alleging the manufacturers failed to warn about the bleeding risks and lack of reversal agents. Xarelto currently has more than 15,000 lawsuits pending nationwide with plaintiffs who suffered severe and often fatal bleeding complications.
While Xarelto and Pradaxa gained widespread notoriety, Eliquis quietly became the most used member of the drug class despite similar bleeding risks. Consequently, there is now a rapidly rising tide of Eliquis lawsuits, claiming the drug maker failed to warn about the risks.
The staggering number of Johnson & Johnson lawsuits, alleging harm from product defects, suggests that the baby powder company does care but not about people. These lawsuits indicate the company was only looking after its financial interests instead of the consumers they purport to help.
In 2016, the company lost six of the seven largest jury verdicts in the U.S. over product defects. Comparatively, companies rarely have more than two to three product defect verdicts above $20 million in any given year. Johnson & Johnson lost six of more than $50 million. The company lost all three talcum powder cases that went to trial in 2016. These included verdicts for $72 million, $70 million, and $55 million. It lost two hip implant cases, as well. One was for $1 billion, and the other was for $500 million. It also lost the largest ever Risperdal verdict for $70 million. The previous record was $2.5 million.
While these lawsuits are for different products, they all allege that the company knew that these products were dangerous but chose to conceal the risks to continue to profit from them.
Johnson & Johnson is facing at least 17 trials in state and federal courts this year against these products.
Johnson & Johnson Lawsuits – Overview
Pinnacle hip implant cases allege that the company’s Pinnacle products fail, resulting in heavy metal poisoning, pain and additional replacement surgeries. Pelvic mesh plaintiffs claim the mesh erodes, necessitating additional surgery. Women with ovarian cancer are filing claims against the company’s flagship baby powder and Shower-to-Shower products. They allege the talc in these products caused their illnesses. Boys who took Risperdal claim the anti-psychotic drug caused them to grow female breasts. Finally, lawsuits over Xarelto allege the blood thinner can cause uncontrollable bleeding, resulting in hospitalizations and even death. Lawsuits over Xarelto have more than tripled in the past year from 5,000 to 16,900.
In all these Johnson & Johnson lawsuits, plaintiffs maintain that company knew the risks of its products but refused to disclose them, putting their own financial interests before human lives.
Johnson & Johnson denies any product liability and is refusing to settle. This isn’t necessarily because the company truly believes itself right. The longer it can draw out the process, the more likely of discouraging plaintiffs and whittling down claims.
Johnson & Johnson Lawsuits – DePuy Pinnacle Hip
The Pinnacle hip is a metal-on-metal hip replacement system. These lawsuits claim the friction from the metal components rubbing together results in the near-immediate systemic release of high level of toxic metal ions into patients’ bodies. As of 2011, there were approximately 1,086 adverse events reports with the FDA regarding failures or complications from DePuy Pinnacle devices. Despite patients reporting severe pain, complicated revision surgeries, and life-long health problems, Johnson & Johnson continues to sell Depuy Pinnacle hip replacement components.
Johnson & Johnson Lawsuits – Pelvic Mesh
Pelvic mesh, or transvaginal mesh, and bladder sling products are used to treat pelvic organ prolapse and female urinary incontinence by supporting internal organs. Ethicon is one of about a half-dozen different manufacturers of these products, facing product liability, with more than 100,000 lawsuits, alleging serious harm from the devices.
The U.S. Federal Drug Administration has received almost 130,000 adverse event reports regarding pelvic mesh products for complications including nerve damage, organ perforation, vaginal scarring, infection, severe pain, and fistulas, as well as mesh erosion and migration. Mesh erosion is one of the most serious complications related to pelvic mesh. It occurs when the mesh device moves through the vaginal wall and into other organs.
Johnson & Johnson Lawsuits – Talcum Powder
Since 1971, more than 20 studies have generated evidence that there is a significant connection between talc and ovarian cancer. In 1993, the U.S. National Toxicology Program published a study that showed talc was a carcinogen. Consequently, numerous organizations classified talc as a carcinogen in 2006. Due to this, Johnson & Johnson’s talc supplier began including warnings with its talc shipments that same year. However, Johnson & Johnson still does not pass these warnings on to its consumers. In fact, the company specifically targets women to use it on their entire bodies, including their genital region.
Johnson & Johnson Lawsuits – Risperdal
Currently, there are several thousand pending Risperdal lawsuits against Johnson & Johnson involving the occurrence of abnormal breast growth in young men and boys as the result of taking the atypical antipsychotic. Plaintiffs claim that Johnson & Johnson and its Ortho-McNewil Janssen Pharmaceuticals subsidiary knew or should have known about the abnormal breast growth, also known as gynecomastia, risk from Risperdal and willfully decided to hide this side effect from the general public and the medical community, failing to protect the consuming public.
Johnson & Johnson Lawsuits – Xarelto
The current lawsuits against the popular blood thinners claim that the manufacturers failed to warn that clinical trials had shown more gastrointestinal bleeds and more blood transfusions with Xarelto than warfarin. Warfarin was the most popular blood thinner on the market before the introduction of Xarelto.
While manufacturers indicated that there was a bleeding risk, plaintiffs claim they were not warned that there was no antidote to Xarelto to reverse uncontrolled bleeding caused by Xarelto. Whereas, uncontrolled bleeding with warfarin can be reversed with vitamin K. Consequently, even mild bleeding incidents can become exceptionally dangerous.
The Third Circuit appeals court breathed new life into about 5,000 Fosamax cases, alleging the manufacturer failed to warn patients about the osteoporosis drug’s femur fracture risk.
The Third Circuit issued the landmark opinion last week. The formerly quashed multidistrict litigation (MDL) questions whether Fosamax manufacturer Merck Sharp & Dohme had a responsibility to include a warning label about the drug’s femoral fracture risk.
However, Merck almost dodged the litigation entirely based on a previous Supreme Court ruling. A District Court applied a Supreme Court 2009 ruling to dismiss the Fosamax lawsuits based on preemption. In Wyeth v. Levine, the Supreme Court held that state failure-to-warn claims are preempted when there is clear evidence that the FDA would not have approved a warning label that a lawsuit claims was necessary. This goes a long way to insulate national corporations from state-law failure-to-warn claims. However, the appeals court’s opinion indicates that the lower court misapplied the ruling.
“Preemption is an affirmative defense, and Merck has not carried its burden to prove that it is entitled to that defense as a matter of law,” the opinion states. “The Wyeth ‘clear evidence’ standard is demanding and fact-sensitive. It requires the factfinder to predict a highly probable outcome in a counterfactual world and, therefore, requires a court sitting in summary judgment to anticipate both the range of conclusions that a reasonable juror might reach and the certainty with which the juror would reach them.”
Merck had proposed Fosamax label revisions to include the bone fracture risk in 2009. Consequently, the company held that the law was on its side. While the FDA rejected the 2009 proposal, the appeals court found that this does not absolve Merck of its responsibilities.
“The burden and the responsibility to correct a drug label rests with the manufacturer, not the FDA,” Judge Julio Fuentes wrote in the opinion. “Once the FDA rejected Merck’s proposal, the ball was back in Merck’s court to submit a revised, corrected proposal.”
The Fosamax plaintiffs showed that the FDA would have approved a properly worded warning about the thigh fracture risk. Consequently, the cases will go forward.
Merck introduced Fosamax in 1995. The company didn’t add a thigh bone fracture risk warning label to the drug until 2011. Plaintiffs claim Merck knew about the risk for years but concealed it.
Fosamax was a blockbuster drug, seeing annual sales over $3 billion prior to Merck losing patent exclusivity in 2008. Although generic variations are now available, the brand name drug still saw $284 in sales in 2016.
A new lawsuit indicates that the statute of limitations may have expired on some cases if breast cancer drug manufacturer Sanofi S.A. had come clean about the Taxotere’s permanent hair loss risk sooner.
Karen L. Greene filed the lawsuit Monday in the Eastern District of Louisiana. According to the lawsuit, Greene was diagnosed with breast cancer in April 2013 and received treatment with Taxotere. She is alleging that Taxotere caused disfiguring permanent hair loss. The lawsuit also indicates that Sanofi overstated the effectiveness of Taxotere. It cites studies that show less toxic treatment to be just as effective as Taxotere. Furthermore, she claims that she may have chosen a different treatment if she had known all the facts about Taxotere.
Cancer Drug Statute of Limitations Discovery Extension
The lawsuit indicates that normally it may have been too late for Greene to file a lawsuit against the cancer drug’s manufacturer. However, statute of limitations does not begin to run until an individual discovers that a certain product or drug caused an injury. Since the company concealed the cancer drug’s risks, Greene could not have realized Taxotere caused her injuries until much more recently.
While Sanofi S.A. disclosed the risk of permanent hair loss to foreign patients and regulatory agencies as e
arly as 2005, it did not disclose these risks to American patients until late 2015. This disclosure only applies to breast cancer patients receiving the drug from that time on. Former patients must come upon this information for themselves, which could be significantly later.
The lawsuit also alleges that Sanofi S.A. aggressively and fraudulently overstated the effectiveness of Taxotere. However, the company was aware that studies showed less toxic treatments were just as effective. Consequently, Greene could not make an informed decision regarding her cancer care. Also, she could not have known she had better options available until recently either.
Breast Cancer Drug Lawsuits
Greene’s case joins the rapidly growing multidistrict litigation against Sanofi. These breast cancer survivors alleging that Sanofi put profits before patients, unnecessarily exposing them to the increased toxicity of Taxotere in order to increase profits from the cancer drug.
A former groundskeeper is suing Roundup manufacturer Monsanto, claiming the weed killer gave him non-Hodgkin’s lymphoma.
Richard Aird filed the complaint March 22 in Delaware Superior Court. He is claiming that Monsanto withheld information from the public about glyphosate’s health risks. Glyphosate is the primary ingredient in the popular weed killer. Aird alleges he could have taken safety precautions to prevent the non-Hodgkin’s lymphoma if the company had been more forthright about its chemical.
Aird worked for approximately 10 years as a groundskeeper at Canyon Oaks Ranch in San Juan Capistrano, California. During that time, he used Roundup on a regular basis.
In March 2007, he was diagnosed with non-Hodgkins lymphoma. This caused him to undergo chemotherapy and requires ongoing oncology treatment.
Monsanto has represented Roundup as “safer than table salt” and “practically non-toxic” to mammals, birds, and fish. However, many organizations, including the World Health Organization, have found that the herbacide’s primary ingredient, glyphosate, may cause cancer. It also damages DNA in human cells. This lawsuit alleges that Monsanto was aware of Roundup’s carcinogenic properties as early as the 1980’s and withheld this information from agricultural workers. Furthermore, the lawsuit cites studies that show Roundup as considerably more dangerous than glyphosate alone. But the company continued to promote Roundup as safe anyway.
Roundup Lymphoma Lawsuits
Aird’s case joins hundreds of other similar lawsuits against Monsanto, alleging that the company failed to adequately warn the public about the non-Hodgkin’s lymphoma risk associated with Roundup. Aird, and other groundskeepers, farmers, landscapers, agricultural workers and others allege that they may have avoided non-Hodgkin’s lymphoma and other cancers if Monsanto had warned them of the risks.
Monsanto also faces allegations that it ghostwrote studies for the EPA that showed Roundup as safe. There is also evidence that they colluded with EPA officials to conceal Roundup’s risks in order to protect profits rather than people.
A group of seven plaintiffs filed a joint Invokana lawsuit against Johnson & Johnson and its Janssen Pharmaceuticals subsidiary, claiming that the diabetes drug caused diabetic ketoacidosis and kidney failure.
They filed the complaint March 16 in the District of New Jersey. The lawsuit includes plaintiffs Charles Pinkston, Pamela Gideon, Elia Lopez, Marie Luera, Opal Louise Simon, Anita Martinez, and Janice Brana. All of the plaintiffs are Texas residents. Their Invokana lawsuit claims that the drug manufacturers concealed Invokana’s risk of serious health problems from patients and the medical community.
Invokana Lawsuit History
The Food and Drug Administration (FDA) approved Invokana (canagliflozin) to treat type 2 diabetes in March 2013. The drug is part of relatively new class of diabetes drugs called SGLT2 inhibitors. These drugs work to control blood sugar in a unique way. They force excessive sugar to be excreted through urination. The medical community hailed these drugs as revolutionary when they first entered the market. However, this Invokana lawsuit claims that the drug puts too much pressure on the kidneys, leading to kidney injuries. Also, in the absence of blood sugar, the body turns to fat for energy. Consequently, this can lead to excessive ketones and ketoacidosis, which usually requires hospitalization to treat. Symptoms include abdominal pain, fatigue, nausea, respiratory problems, and vomiting.
In 2015, the FDA required all SGLT2 inhibitors to include new diabetic ketoacidosis warnings. The Invokana warnings told users to stop using the drug and seek immediate medical attention if they experienced any ketoacidosis’ symptoms.
In 2016, the FDA mandated another warning label update to add information about the Invokana’s kidney risks. Consequently, the labels now indicate the risk of acute kidney injury and other serious health problems.
This new Invokana lawsuit alleges that its manufacturers knew the severe health risks associated with Invokana but chose to conceal them. Instead, they continued to aggressively market the drug to increase Invokana’s sales despite the risks.
“Despite Defendants’ knowledge of the increased risk of severe injury among SLGT2 INHIBITOR users, Defendants did not warn patients, including Plaintiffs, but instead continued to defend SLGT2 INHIBITOR, mislead physicians and the public, and minimize unfavorable findings,” the lawsuit states. “Notwithstanding their actual knowledge of mounting concerns and documented patient problems, Defendants aggressively conducted nationwide sales and marketing campaigns to promote the sale of SLGT2 INHIBITOR and willfully deceived Plaintiffs, their health care professionals, the medical community, and the general public as to the health risks and consequences of the use of the SLGT2 INHIBITOR.”
This Invokana lawsuit joins a growing number of similar claims in the federal multidistrict litigation (MDL). The Judicial Panel on Multidistrict Litigation has centralized all these cases in the District of New Jersey.
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.
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.