11th Circuit Upholds $2.1 Million Verdict by Initially-Confused Jury in Wright Hip Case

The 11th US Circuit Court of Appeals upheld a $2.1 million judgment, excusing the initial confusion by a jury in the first bellwether trial in a multidistrict litigation involving over 500 cases about the Wright Medical Conserve “metal-on-metal” hip replacement device.

U.S. District Judge William S. Duffey Jr. of the Northern District of Georgia corrected the jury form, re-charged the jury, and ordered it to continue deliberating until it reached a final verdict on November 25, 2015, in Robyn Christiansen, v. Wright Medical Technology Inc., Case No. 16-12162.

Wright today faces 585 lawsuits over its metal-on-metal hip replacement in Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation.

A crunching sound

Christiansen received a Wright Conserve Hip Implant System in 2006. Six years later, she “felt and heard a crunching sound and then felt immediate, severe pain in her right hip and groin” while doing yoga. She was diagnosed with a loose and displaced acetabular cup, and forced to undergo revision surgery. During the procedure, her surgeon discovered “a metallosis reaction” in the joint around the implant.

At the trial, the jury initially filled out Question 1A incorrectly on the jury verdict form saying that the hip device was not defectively designed. Then it inconsistently awarded $662,500 in compensatory damages and $2.5 million in punitive damages. The judge told the jury to go back into the jury room and “please carefully read the instructions.”

Minutes later the jury returned and said it did not understand the verdict sheet. This time the judge added to the verdict sheet instructions: “If you answered NO to Question 1A, stop [regarding defective design]. Do not complete the remainder of the form.”

Half a day later the jury said one juror was refusing to deliberate. The judge interviewed the recalcitrant juror in open court, decided that the juror was unwilling to follow the instructions, and dismissed him or her. The seven remaining jurors returned to the jury room and reached the final verdict in 30 minutes:

  • The hip device was defectively designed and unreasonably dangerous.
  • It caused the plaintiff’s harm.
  • Wright did not meet its burden to prove that the device could not be made safe.
  • Wright made a negligent misrepresentation about the device.
  • Wright’s conduct was “willful and malicious,” “intentionally fraudulent,” or “manifested a knowing and reckless indifference towards, and a disregard of, the rights of others, including Ms. Christiansen.”
  • $1.1 million in compensatory damages.
  • $10 million in punitive damages, which the judge later reduced to $1.1 million.

Wright wanted judgment

On appeal Wright argued that the court failed to grant it judgment as a matter of law based on the jury’s first verdict sheet.

The 11th Circuit rejected the idea, because under Rule 49 of the Federal Rules of Civil Procedure the district court has authority enter judgment, order further deliberations, or order a new trial.

“From a review of the record, the district court acted in a neutral and non-biased manner in acknowledging and addressing the inconsistent verdict,” the appeals court said.

In November 2016 Wright agreed to settle 1,292 claims in consolidated litigation in Georgia federal court and California state court for $240 million, putting an end to the majority of the suits over the implants.

Patients who had revision surgery within eight years of their original Conserve, Lineage or Dynasty hip implant are eligible for the settlement.

  • Those implanted with the Conserve Cup —  the device with the most frequent failures — can receive $170,000.
  • Those who had the metal-liner Dynasty and Lineage devices can recoup $120,000, according to a statement from the plaintiffs’ leadership counsel.

Meanwhile, Wright also faces 74 lawsuits involving fractures of its Profemur long titanium modular neck hip device. It has been marketed by MicroPort Orthopedics, Inc. of Arlington, TN, since 2013.

On June 21, 2016, MicroPort recalled its Conserve Shell, Dynasty® Metal Liner, Procotyl® Metal Liner and Lineage® Metal Liner because of “an increasing overall trend in revisions from 2009 to present, and it was found that there was a specific hazard/harm for “suspected tissue reaction to metal debris.” The potential for a patient reaction when implanted with Metal on Metal THA is a known risk for this product technology. The typical impairment of tissue reaction is reversed by revision surgery to remove the old device and replace it with a new device.”

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New Research Shows that Roundup Herbicide Causes Liver Disease in Rats

Dr. Michael Antoniou, Head of the Gene Expression and Therapy Group at King’s College London in the United Kingdom, led the ground-breaking research.
Dr. Michael Antoniou, Head of the Gene Expression and Therapy Group at King’s College London.

New research published at Nature.com shows that an ultra-low dose of Roundup herbicide causes non-alcoholic fatty liver disease in rats.

“For the very first time we have established a causative link between an environmentally relevant level of daily ingestion of Roundup and a serious disease, non-alcoholic fatty liver disease,” Dr. Michael Antoniou, Head of the Gene Expression and Therapy Group at King’s College London in the United Kingdom, led the ground-breaking research, told The Organic & Non-GMO Report.

“Overall, metabolome and proteome disturbances showed a substantial overlap with biomarkers of non-alcoholic fatty liver disease and its progression to steatohepatosis and thus confirm liver functional dysfunction resulting from chronic ultra-low dose GBH (glyphosate-based herbicides) exposure,” states the research Multiomics reveal non-alcoholic fatty liver disease in rats following chronic exposure to an ultra-low dose of Roundup herbicide published by Scientific Reports 7, Article number: 39328 (2017).

Plaintiffs allege that Roundup causes non-Hodgkins’ lymphoma (cancer of the lymph nodes) in multidistrict litigation before US District Judge Vince Chhabria in In re: Roundup Products Liability Litigation, MDL 2741, U.S. District Court, Northern District of California (San Francisco).

Herbicide detected in food and water

“Glyphosate-based herbicides (GBH), such as Roundup, are the major pesticides used worldwide. Residues of GBH are routinely detected in foodstuffs and drinking water. Epidemiological data on the human body burden of GBH residues is very limited but evidence suggests that glyphosate and its metabolites are widespread,” the research states.

“A number of toxicity studies have shown that glyphosate and its commercial formulations have non-target effects on mammalian metabolism and provoke toxic effects, especially with respect to liver and kidney structure and function,” it states.

Antoniou said that the rats consumed a glyphosate-equivalent level of Roundup that is 75,000 times lower than what is permitted in Europe and 437,500 times lower than that allowed in the U.S.

“We used cutting-edge compositional analytical methods to determine the health status of rats’ livers. Protein and metabolite profiles are a direct measure of the composition of organs and give a direct readout of the health or disease status of organs. We found that these organs weren’t healthy. There were clear hallmarks of non-alcoholic fatty liver disease, which correlated with previous observations of an increased incidence of tissue necrosis or liver tissue replaced with scars.

Roundup causes disease

“We were able to make a direct statement that Roundup caused disease,” he told The Organic & Non-GMO Report.

  • Roundup is a previously unknown and unsuspected potential risk factor for non-alcoholic fatty liver disease that calls for further investigation.
  • Twenty-five percent of the U.S. population suffers from non-alcoholic fatty liver disease. Risk factors include obesity, diabetes, and high blood fat levels.
  • But there are risk factors for the disease that have not yet been identified, and it’s possible that exposure to Roundup could be one such missing risk factor.

“Our study results suggest that the permitted safety intake level of glyphosate-based herbicides needs to be revisited as they may have been set way too high,” he said. “The second point that this is a new risk factor for non-alcoholic fatty liver disease and needs to be taken into account by the medical establishment.”

In March 2015, leading cancer experts from the World Health Organization’s International Agency for Research on Cancer (IARC) declared that glyphosate is a “probable human carcinogen.” IARC reached its decision based on the research of 17 top cancer experts from 11 countries, who met to assess the carcinogenicity of 5 pesticides. The IARC review of glyphosate has led to the European Parliament calling for a complete ban on non-commercial public use of glyphosate and serious restrictions on agricultural use.

In contrast, on Sept. 12, 2016, the EPA’s Office of Pesticide Programs (“OPP”) issued a 227-page evaluation of glyphosate’s carcinogenic potential, concluding that “[t]he strongest support is for [the description] ‘not likely to be carcinogenic to humans’ at doses relevant to human health risk assessment.” See Glyphosate Issue Paper: Evaluation of Carcinogenic Potential.

Fresno County Superior Court Judge Kristi Kapetan ruled that California can require Monsanto to label its herbicide Roundup as a possible cancer threat.

California would be the first state to order such labeling for the weed-killer, which is used by farmers and home gardeners worldwide.

For further reading:

Corrupt EPA Official Bragged About Killing Study into Roundup Causing Cancer

Monsanto Colluded To “Ghost-Write” Studies on the Pesticide Roundup

Monsanto’s Deadly Harvest

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New Group of Plaintiffs Seek Stryker LFIT Hip MDL in New Jersey State Court

LFIT V40 Femoral Head Recall
LFIT V40 Femoral Head Device

As the federal courts weigh creating an MDL for litigation involving the Stryker LFIT V40 Hip Device, a different group of 25 plaintiffs is requesting that the New Jersey state courts create a multi-county litigation docket for the same device.

  • The New Jersey motion was filed Jan. 26 by attorney Ellen Relkin of Weitz & Luxenberg in New York. She estimates that more than 85 cases over the LFIT V40 Hip have been filed before Judge Rachelle Harz in Bergen County, NJ.
  • The federal MDL motion was filed Jan. 13 by attorney Walter Kelley of Kelley Bernheim & Dolinsky LLC in Plymouth, MA, requesting MDL No. 2768 be created in federal court in Massachusetts. The Judicial Panel on Multidistrict Litigation (JPMDL) will hear this motion on March 30 in Phoenix, AZ.

Separately, Stryker is the target 1,800 lawsuits in MDL 2441, supervised by US District Judge Donovan W. Frank in Stryker Rejuvenate in ABG II Hip Implant Products Liability Litigation and in Stryker Trident Hip Implants New Jersy State Court.

Defective hips

Defendant Stryker Howmedica Osteonics Corp. of Mahwah, NJ, recalled 42,519 of the defective hips on August 29, 2016. The company also issued a letter to orthopedic surgeons advising them of a “higher than expected” incidence of taper lock failure for certain sizes of its LFIT Anatomic CoCr V40 Femoral Heads.

Simultaneously, the Canadian public health agency issued a recall about the Stryker LFIT V40 and the Australian Government Department of Health published a Hazard Alert about the same devices.

The LFIT femoral head has been marketed fo ruse with a variety of femoral stems. Some medical literature says the problem arises when stems made of titanium or TMZF titanium alloy are combined with cobalt-chromium alloy femoral head and taper devices.

The problem involves fretting and corrosion in the junction where the femoral head connects to the femoral stem. Corrosion at this junction has led to the systematic release of metal particles into the surrounding tissue and bone, putting patients are risk of toxic metallosis, tissue death, bone death and elevated levels of cobalt and chromium in the blood.

Adverse events include loss of mobility pain, inflammation, adverse local tissue reaction, disassociation of the femoral head, dislocation, joint instability, broken bones and the need for revision surgery.

Furthermore, excessive corrosion at the head-neck junction causes the femoral head to break off the from neck, become loose in the body, and depart from the acetabular cup where it is supported to move.

Revision surgery

Adverse events include loss of mobility pain, inflammation, adverse local tissue reaction, disassociation of the femoral head, dislocation, joint instability, broken bones and the need for revision surgery. Many of the New Jersey cases involve patients who have needed revision surgery.

All the cases allege design defect, failure to warn, breach of warranty and manufacturing defect.

Judge Harz is presiding over the LFIT litigation, as well as the Stryker Rejuvenate and ABG II litigation, which involves similar issues.  “It is both logical and fair to the litigants for these cases to remain in Bergen County before Judge Harz,” attorney Relkin argues. She speculates that if a federal MDL were created in New Jersey, then “seamless coordination could occur between the federal MDL and state MCL litigation.”

The New Jersey Multicounty Litigation Center centralizes litigation over Accutane, Benicar, Talcum Powder, Stryker Hip/ABG II, DePuy ASR Hip Implant, Mirena, Pelvic Mesh, Stryker Implant, Yaz/Yasmin/Ocella, Asbestos, AlloDerm, Fosamax, Levaquin, Propecia, Reglan and Risperdal / Seroquel / Zyprexa.

A global settlement was announced December 19, 2015 regarding the Stryker Hip/ABG II litigation.

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FDA Warns that Allergan’s Viberzi Increases Risk of Serious Pancreatitis

Allergan advertizes Viberzi with a character "Irritabelle," and she is the personification of an irritable bowel.
Allergan advertizes Viberzi with a character “Irritabelle,” and she is the personification of an irritable bowel.

The FDA is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder.

An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasm of a certain digestive system muscle in the small intestine.

As a result, FDA is working with the Viberzi manufacturer, Allergan, to address these safety concerns.

See the FDA Drug Safety Communication for a Data Summary.

Not prescribe Viberzi

Viberzi is a prescription medicine used to treat irritable bowel syndrome in adults when the main symptom is diarrhea. IBS-D affects the large intestine and causes cramping, stomach-area or abdomen pain, bloating, gas, and diarrhea. The cause of IBS-D is not known. Viberzi works by decreasing bowel contractions, which leads to less diarrhea. In patients with IBS-D, Viberzi can help ease stomach-area or abdomen pain and improve stool consistency.

Health care professionals should not prescribe Viberzi in patients who do not have a gallbladder and should consider alternative treatment options in these patients. Hospitalizations and deaths due to pancreatitis have been reported with Viberzi use in patients who do not have a gallbladder. Symptoms of pancreatitis have occurred with just one or two doses of Viberzi at the recommended dosage for patients who do not have a gallbladder (75 mg), and who do not consume alcohol.

Patients should talk to your health care professional about how to control your symptoms of irritable bowel syndrome with diarrhea (IBS-D), particularly if you do not have a gallbladder. Stop taking Viberzi right away and get emergency medical care if you develop new or worsening stomach-area or abdomen pain, or pain in the upper right side of your stomach-area or abdomen that may move to your back or shoulder. This pain may occur with nausea and vomiting. These may be symptoms of pancreatitis, an inflammation of the pancreas an organ important in digestion; or spasm of the sphincter of Oddi, a muscular valve in the small intestine that controls the flow of digestive juices to the gut.

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Admitting Hip Replacements Cause Metallosis, Smith & Nephew Issues Urgent Recall

Smith & Nephew Modular SMF hip implant
Smith & Nephew Modular SMF hip implant

Admitting for the first time that its Modular SMF and Modular REDAPT femoral replacement hip systems cause toxic metallosis in patients, Smith & Nephew has issued an urgent field safety notice recalling thousands of the defective medical devices.

The recall affects 6,266 SMF and REDAPT hip systems in commerce, plus 13,671 modular neck hip prostheses in commerce — shipped from October 2008 through July 2016.

Based in Memphis, TN, Smith & Nephew has sold the Modular SMF and REDAPT implants for almost a decade. In its letter to doctors, the company admitted that “Smith & Nephew considers that patients implanted with the modular neck hip prostheses may be at greater risk of revision surgery than with comparable monolithic products.”

Metal-Related Adverse Events

The letter states, “We observed a rate of complaints higher than comparable monolithic hip prostheses. Metal-related complaints are trending upward year-on-year with an overall complaint rate (number of complaints/total implantations) of 0.527% for Modular SMF and 0.25% for Modular REDAPT Revision Femoral Hip Systems. Overall, the metal-related Adverse Events accounted for the highest category of complaints in both products.

“For patients that exhibit these symptoms, physicians may consider additional clinical follow-up which includes the following:

  • Cobalt/Chromium metal-ion level measurements in whole blood – metal ion levels in excess of 7ppb may indicate the potential for soft tissue reaction; and
  • Where appropriate and subject to the clinician’s assessment, further active evaluation of the potential soft tissue reactions either through ultrasound or cross-sectional imaging might be indicated.”

Hip litigation

In related litigation, plaintiffs who were injured by Smith & Nephew’s Birmingham Hip Resurfacing (“BHR”) system and R3 metal-on-metal liner (“R3”) have filed a motion with the Judicial Panel on Multidistrict Litigation to create new MDL No. 2775 in the US District Court for the District of Maryland.

The plaintiffs allege that the BHR and R3 devices have caused toxic levels of cobalt and chromium in the bodies of patients implanted with the devices, and caused other symptoms including metallosis, pain, adverse local tissue reaction, pseudotumor, bone and tissue necrosis, and other symptoms leading to revision surgery.

Modular femoral stems have been a big problem in orthopedics for years. Stryker Orthopedics had to recall two of its modular stems in 2012 because of very high failure rates. A total of 1,807 cases have been filed in MDL 2441 against Stryker before Sr. US District JudgeDonovan W. Frank in Minnesota.

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H.R. 985 Quietly Slipping Through Congress That Will Give Big Pharma Unlimited Power & Zero Accountability

 “So if your bank steals a $5 overdraft fee, and $10 from your neighbor, a class action could be dismissed because your injuries were different. Even if you file a lawsuit and get your $5 back, your friend would not.”
“So if your bank steals a $5 overdraft fee, and $10 from your neighbor, a class action could be dismissed because your injuries were different. Even if you file a lawsuit and get your $5 back, your friend would not.”

By Lisa Bloomquist. This article is reprinted from Collective Evolution.

H.R. 985, the 2017 Fairness in Class Action Litigation Act, aims to put more obstacles in the way of plaintiffs/victims who seek justice.

This justice-reform bill is a gift to the pharmaceutical industry, and other big corporations that hurt citizens (like big banks, big agriculture, big chemical, big oil etc.) from Congress men and women who receive millions of dollars in donations from those industries.

One of the most potentially damaging aspects of H.R. 985 is a provision that states that each plaintiff in a class-action lawsuit must “affirmatively demonstrate” that they “suffered the same type and scope of injury as the named class representative.” This means that all plaintiffs in a class-action lawsuit must have exactly the same injury. This provision will keep a large number of pharmaceutical class-action lawsuits from moving forward, and will rob the people who could otherwise be involved in a class-action lawsuit of justice.

How H.R. 985 could hurt people

Here is an example of how this provision in H.R. 985 could hurt people: The warning labels for fluoroquinolone antibiotics, including Cipro, Levaquin, and Avelox, have recently been updated to note that permanent peripheral neuropathy is a potential effect of those drugs. This opened the door to lawsuits, and many law firms are taking cases for those suffering from peripheral neuropathy caused by fluoroquinolones.

Peripheral neuropathy is a broad diagnosis though, and it presents in many ways. Some people with peripheral neuropathy may have pain that is debilitating, while others may have twitching muscles, others may experience numbness, others may have reduced balance or coordination, and others may have autonomic nervous system dysfunction that causes loss of digestive motility.

H.R. 985 could make it so that those plaintiffs cannot join together in a class-action lawsuit because their symptoms present differently, and, as noted above, without the possibility of a class-action lawsuit, there is no possibility for justice for many victims of pharmaceutical industry crimes.

In “House Judiciary Committee Passes H.R. 985: Fairness in Class Action Litigation” the following example is given to illustrate how this provision could hurt those trying to sue a bank: “So if your bank steals a $5 overdraft fee, and $10 from your neighbor, a class action could be dismissed because your injuries were different. Even if you file a lawsuit and get your $5 back, your friend would not.

This provision of H.B. 985 would keep cases like that of the people of Hinkley, California versus Pacific Gas & Electric (PG&E), that was featured in the movie Erin Brockovich, from moving forward. The people of Hinkley “suffered cancers, miscarriages and digestive and skin disorders as a result of the company (PG&E) dumping contaminated waste into ponds that seeped into the town’s drinking water.” If they weren’t allowed to join together in a class-action lawsuit because they didn’t have the “same type and scope of injury as the named class representative,” they wouldn’t be able to gain justice.

To continue reading, visit Collective Evolution.

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FDA Warns of 9 Deaths from Cancer Caused by Breast Implants

textured breast implantsThe FDA announced that nine deaths from a rare form of cancer are linked to breast implants with pebbly surfaces. As of Feb. 1, the agency received 359 medical device reports of anaplastic large-cell lymphoma (ALCL) with the implants.

In 2011, the FDA identified a possible association between breast implants and the development of ALCL cancer, a rare type of non-Hodgkin’s lymphoma. At that time, the FDA knew of so few cases of this disease that it was not possible to determine what factors increased the risk.

Textured implants

Of the 359 reports including nine deaths, 231 reports that included information on the implant surface. Of these, 203 were reported to be textured implants and 28 reported to be smooth implants. Most of the reports contained no information about the surface textures of any previous implants.

In 2016, a total of 290,467 women received breast implants, according to the American Society of Plastic Surgeons. ALCL is a very rare condition; when it occurs, it has been identified most often in patients undergoing implant revision operations for late onset, persistent seroma (a collection of fluid that builds up under the surface of the skin).

Because it has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended.

In 2016, there were several advances in the description of the disease and treatment recommendations:

  • The World Health Organization recognized breast implant-associated anaplastic large cell lymphoma as a rare T-cell lymphoma that can develop following breast implants.
  • The Australian Therapeutic Goods Administration (TGA) reported a detailed analysis of the 46 confirmed cases of BIA-ALCL in Australia, including 3 deaths. None of the cases occurred in women with smooth implants. TGA estimated the risk of developing BIA-ALCL to be between 1-in-1000 and 1-in-10,000 women with breast implants.
  • The French National Agency for Medicines and Health Products Safety (ANSM) asked manufacturers of textured breast implants to perform biocompatibility testing (testing to determine how living tissues react to textured implants) and to report their findings within a year.

Risk factors

significant body of medical literature has been published since 2011. Most of the cases in the literature reports describe a history of the use of textured implants. Several recent journal articles explore the risk factors for ALCL, including the methods used to create surface texture of the implant and the role of biofilm in causing disease, among others.

All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants. Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation.

The FDA advised doctors to consider the possibility of ALCL with patients with late onset, persistent peri-implant seroma. In some cases, patients presented with capsular contracture or masses adjacent to the breast implant. If a doctor suspects ALCL, the patient shoud be referred to an appropriate specialist for evaluation.See the FDA Update for more information, including a summary of Medical Device Reports and medical literature, and recommendations for patient care.

 

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$70 Million Talcum Powder Verdict Stands, as Missouri Court Denies J&J Post-Trial Motions

Johnson & Johnson has known about cancer risks since the 1970s.
Johnson & Johnson has known about cancer risks since the 1970s.

Johnson & Johnson and other talcum powder lawsuit defendants have been denied their bid to overturn the $70 million verdict awarded to the plaintiff in the state’s third ovarian cancer trial.

In orders issued last week, the Missouri 22nd Circuit Court in St. Louis denied all of the defendants’ post-trial motions, including those that sought a judgment notwithstanding the verdict, a new trial, and a reduction in punitive damages. (Case No 1422-CC09012-01)

On October 27, 2016, a third jury awarded more than $70 million in damages to Deborah Giannecchini, 62, of Modesto, CA, on her claim that her use of baby powder and other Johnson & Johnson talc products over 40 years caused her ovarian cancer. She was diagnosed with stage 4 ovarian cancer in 2012 and talc was found in her ovaries.

Internal J&J memos showed the company was aware of studies linking talc powder to an increased risk of ovarian cancer for decades.

The Oct. 27 verdict also held Imerys Talc liable. Imerys supplied talc to J&J and placed health warnings on the material safety data sheets for the talc. J&J, however, has never put a health warning on its Baby Powder or Shower to Shower products.

“We are pleased that the verdict was upheld, and are very encouraged with the Court’s determination that the punitive damage award was not grossly excessive nor arbitrary,'” says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective medical devices, drugs and consumer products.

Talcum Powder Litigation

More than 3,000 talcum powder lawsuits have been filed in U.S. courts, all of which claim that the long-term genital application of Johnson & Johnson’s products promotes the development of ovarian cancer. Missouri’s third trial concluded last October, and involved a 62-year-old woman who was diagnosed with the disease in 2012. In the decades prior to her diagnosis, Johnson & Johnson’s Baby Powder had been a regular part of the Plaintiff’s daily feminine hygiene routine.

Missouri’s 22nd Circuit Court has convened four talcum powder trials over the past year. Only one jury has found in favor of the defense. Plaintiffs in two other trials were awarded compensatory and punitive damages amounting to $72 million and $55 million.

Women who were diagnosed with ovarian cancer following the regular, repeated use of talc-based products for feminine hygiene purposes may be eligible to file their own talcum powder lawsuit.

Also see: Progress in Talcum Powder Multidistrict Litigation in NJ

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Direct Filing of Invokana and Atrium C-Qur Lawsuits Now Permitted in Federal MDLs

In separate pretrial orders, the courts overseeing federal multidistrict litigation for Invokana and for Atrium C-Qur both ruled that plaintiffs may file their claims directly in the proceedings.

Direct filing eliminates delays involved in the transfer or removal of cases from other federal district courts.

Invokana MDL

The US Judicial Panel on Multidistrict Litigation (JPMDL) created the Invokana MDL on December 12, 2016. Plaintiffs charge that taking Invokana or Invokamet may result in patients suffering various injuries, including diabetic ketoacidosis and kidney damage. The actions thus implicate many common issues about the development, manufacture, testing, regulatory history, promotion, and labeling of the drugs.

Direct filing does not stop the running of any statute of limitation or determine the choice of law. It does not constitute a waiver of Lexecon v. Milberg Weiss, 523 U.S. 26 (1998), which holds that MDL transferee judges lack authority to try cases that originated outside of the transferee court. Upon completion of pretrial proceedings to a directly-filed case, the court will transfer that case to the district court based on the district designated in the complaint.

Any attorney in good standing in any federal court is admitted pro hac vice in the litigation.

Atrium C-Qur mesh MDL

The JPMDL created the Atrium Medical Corp. C-Qur Mesh Products Liability MDL on December 8, 2016. The plaintiffs allege that defects in defendants’ C-Qur mesh products incite an allergic or inflammatory response that causes severe complications. All the actions involve factual questions about whether C-Qur mesh was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of C-Qur mesh to result in an allergic or inflammatory response, and whether defendants provided adequate instructions and warnings with the mesh.

Direct filing does not constitute a determination that venue is proper, has no impact on the choice of law including the statute of limitation.

Atrium is one of many hermia patch manufacturers facing lawsuits over making defective products. More hernia mesh MDLs may be created –  See MDL Motion Expected in Ethicon Physiomesh Hernia Repair Product Litigation.

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Attorneys Mistakenly Turn Down Xarelto Cases When Death Certificate Omits Internal Bleeding

John Ray has been a leading consultant to the Mass Tort industry for over a decade. His unique skill sets make him well suited to both teaching and consulting in the Mass Tort arena.
John Ray has been a leading consultant to the Mass Tort industry for over a decade. His unique skill sets make him well suited to both teaching and consulting in the Mass Tort arena.

By John Ray.

Even as Xarelto litigation grows ahead of the first bellwether trial in federal court MDL No. 2592, some plaintiff attorneys are mistakenly turning down cases if the death certificate does not specifically mention internal bleeding or ischemic stroke.

In our consulting practice at Mass Tort Nexus we are often asked if the cause of death listed on a death certificate does not mention bleeding or ischemic stroke deal — is that a fatal obstacle to filing a wrongful death case related to Xarelto, Pradaxa or Eliquis?

The simple answer is, possibly but often not.

Many mass tort lawyers see the upcoming bellwether trials on April 24 and May 30 as an opportune time to start or expand a Xarelto product liability practice. So far 15,611 cases lawsuits have been filed before US District Judge Eldon E. Fallon in Louisiana, up from 10,769 cases in September 2016. 

The federal lawsuits stem from allegations that the anticoagulant Xarelto could cause uncontrollable bleeding and hemorrhagic strokes. They accuse the drug’s manufacturers — Bayer Healthcare and Johnson & Johnson subsidiary Janssen Pharmaceuticals — of failing to warn about Xarelto’s potential risks. 

In parallel state court litigation in Pennsylvania, Judge Arnold L. New in the Philadelphia Court of Common Pleas amended the master and short form complaint to allow for Ischemic Stroke Claims to be made in that court.

What a death certificate is — and isn’t

A  death certificate is document that serves primarily as a public record of an individual’s death. These records are often used in a variety of statistical analysis.

The cause of death (COD) noted on a death certificate is not intended to be an expansive diagnostic review of all medical events that led to the death. In some cases, the person who issued the death certificate may not even be a medical practitioner.

In reviewing blood-thinners Xarelto, Pradaxa and Eliquis cases, the COD listed on the death certificate may not mention bleeding or any other condition known to directly occur as a result of using these drugs however,  this does not necessarily mean that it cannot be determined by a preponderance of the evidence that the given anticoagulant did not cause or contribute to the death.

Example: The cause of death on a death certificate may list heart attack, myocardial infarction or cardiac insult as well as other terms that fall under the more general term “heart attack.”

Should one automatically assume that the death, under this circumstance, cannot be attributed to the use of Xarelto, Pradaxa or Eliquis?  No!

Bleeding can cause heart attack

Do not allow the cause of death listed on a death certificate be the final determining factor in whether you continue to pursue a wrongful death action.

There is ample evidence in the medical literature “heart attacks” can be secondary to bleeding events. Heart attacks can be caused by sudden significant increases and decreases in blood pressure as well as the heart being deprived of oxygen, delivered by adequate blood flow.

If the death certificate lists any form of “heart attack” as the cause of death, further investigation is warranted to determine whether the use of any of the aforementioned drugs could have reasonably caused or contributed to the heart attack.

  • A significant bleed within two or three weeks before the heart attack resulting in death will have more likely than not caused or contributed to the heart attack.
  • A significant bleed can lead to permanent heart damage and can cause or contribute to a heart attack months or even years after the bleeding event. Obviously, the less time there is between the bleeding event and the heart attack makes for a less difficult argument.

It should be noted that in cases where the patient had a history of heart attacks or conditions which are known to lead to heart attacks such as late stage diabetes, for example, may make it more difficult to prevail in your argument.

When analyzing whether the bleeding event may have caused or contributed to the cause of death listed on the death certificate, it is important to understand a basic fact:

Bleeding is never the actual cause of death — events secondary to bleeding are the actual cause of death.

This statement can be difficult to wrap one’s head around as the term “bled to death” is so commonly used and is not inaccurate in the broadest sense. However, from a physiological perspective the true cause of death is always secondary to loss of blood. If insufficient blood volume exists vital organs that are highly dependent on oxygen and fluid volume can quickly fail resulting in death.

The takeaway from this article is: Do not allow the cause of death listed on a death certificate be the determining factor in whether you continue to pursue a wrongful death action.

Once you have a death certificate in hand, review the cause of death listed on the death certificate. After ascertaining the COD listed on the death certificate, as a first step simply Google “Can Bleeding Result in (insert cause of death listed).”

If the cause of death listed a condition that can be attributed to bleeding, then further review of the patient’s pre-death medical records is warranted to determine if there is a strong argument that the bleeding event caused or contributed to the condition listed on the death certificate.

Two Cautions

Late-stage cancers, particularly pancreatic and liver cancer, often result in bleeding regardless of whether the patient is receiving anticoagulant therapy or not. If the cause of death listed is a type of cancer that has a high mortality rate in late stages, then is would be far more difficult to argue that it was more likely than not that the anticoagulant caused the death versus the cancer.

In some cases, the cause of death may be listed as “natural causes” or even “old age.” Although no one dies of natural causes or old age, if such terms are listed as the COD, it may be more difficult, although not impossible, to show that the death was caused by the use of the anticoagulant. To demonstrate that the anticoagulant more likely than not caused or contributed to the death, medical records demonstrating a circumstance that would almost certainly lead to death would be needed.

This article is not intended to be medical or legal advice. Our goal is to provide issues to consider when evaluating Xarelto, Pradaxa and Eliquis cases as well as other cases in which the content of this article may apply.

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