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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Testimony Sheds Light on Role of Science in California Talc Litigation

David H. Schwartz, Ph.D.
David H. Schwartz, Ph.D., a founding partner of Innovative Science Solutions, LLC, a consulting firm that specializes in assisting counsel with litigation involving complex scientific issues.

By Nathan A. Schachtman, Esq. and David H. Schwartz, Ph.D.

“Science Day” hearings have become commonplace in complex state and federal litigations around the country. A California state court judge recently held such a hearing in consolidated litigation dealing with the alleged link between talcum powder and ovarian cancer. With a bellwether trial scheduled for July, the closely-watched hearing was webcast and recorded by Courtroom View Network, which has also streamed three of the previous talc powder trials in St. Louis, Missouri.

The major impetus for science tutorials seems to have come from the United States Supreme Court’s decision in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). The holding of Daubert, now incorporated into, and extended by, Federal Rule of Evidence 702, requires trial judges to act as gatekeepers of the relevance and reliability of expert witness opinion testimony in their courtrooms.

One of the first tests of the judiciary’s performance to perform this role came in the silicone gel breast implant litigation. The federal silicone cases were consolidated before Judge Pointer Sam C. Pointer, Jr., in MDL 926. Judge Pointer believed that trial judges in the transferor courts should conduct whatever review of expert witness opinion was needed to satisfy the then recent Daubert decision.

Nathan Schachtman, Esq., has lectured and published widely on expert evidence issues.
Nathan Schachtman, Esq., of New York has lectured and published widely on expert evidence issues.

Some of the first federal silicone lawsuits remanded from the MDL went to Judge Robert Jones in Portland Oregon. These cases involved complex issues of immunology, clinical rheumatology, epidemiology, toxicology, surgery, and polymer and analytical chemistry. In large measure because of Judge Jones’s case management and exclusion of expert witness testimony, the silicone MDL court appointed a panel of neutral expert witnesses, in the fields of epidemiology, rheumatology, immunology, and toxicology.

One of the first requests received from the Science Panel in MDL 926 was for what turned out to be a series of Science Days in which the parties’ expert witnesses would present to them, and explain their interpretation of the vast array of evidence, from different disciplines. These proceedings, along with extensive submissions of articles and briefings from the parties led to the Report of National Science Panel, on November 30, 1998.

Every Day is Science Day, Somewhere

Since the breast implant litigation, many MDL and other courts have faced complex causation claims in litigation involving pharmaceutical products, medical devices, consumer products and a host of chemical exposures. Appointment of independent, neutral expert witnesses remains unusual, but trial judges have welcomed tutorials in the form of “Science Days,” to help them learn the methodologies and vocabularies of the scientific disciplines that are involved in the litigations before them.

For some reason, the parties, the judges, and the legal media often reference Science Days in scare quotes, signaling that perhaps other Science takes place in these proceedings. Whether the scare quotes are warranted remains to be determined.

“Science Days” have become a tradition in mass tort litigation. In the last few years, there is a Science Day somewhere, in some courtroom, going on, perhaps not daily, but with sufficient frequency that the phenomenon should receive more critical attention.

Federal judges with multi-district litigation, or state judges with multi-county cases, set aside time to permit the parties a chance to educate them about the scientific and technical aspects of the litigations before them. Judges know that Daubert and Rule 702, or their state analogues, require them to act as gatekeepers. Furthermore, myriad motions in the discovery and trial phases of a case will require judges to make nuanced but accurate decisions about scope and content of discovery, and admissibility of documents and testimony,

Talc Science Goes Bicoastal

John Milton: We negotiating?
Kevin Lomax: Always.
The Devil’s Advocate (1997).

There are no federal or state rules that set out procedures for science tutorials for judges or their appointed expert. The form and substance of Science Days depend upon a three-way negotiation among the plaintiffs, defendants, and the trial judge. Although the parties are often left to work out a plan for science day, most courts tend to weigh in by imposing time limits, and they may even rule in or rule out live witness testimony.

In 2007, the American Bar Association set out Civil Trial Practice Standards, which included an entire section on the use of tutorials to assist the court. [The relevant standards for tutorials is set out below, as an appendix.]

This year, two trial judges have entertained Science Days in talc cases, on both coasts of the United States. In the federal talc litigation, MDL 2738, Judge Freda L. Wolfson conducted a Science Day on January 26, 2017. In the coordinated California state court talc cases, Judge Maren E. Nelson, of the Superior Court of California, Los Angeles County, conducted a Science Day, on March 7, 2017.

Federal Talc MDL 2738

In the federal cases, Johnson & Johnson, one of the defendants, initiated the Science Day, in November 2016, when it asked Judge Wolfson to set aside a day in “which the parties and their experts can outline their positions/arguments regarding the medical and science issues at play.” In Case Management Order No. 1 (Jan. 23, 2017), Judge Wolfson apparently agreed, and the parties had their talc Science Day on January 26, 2017. The Science Day took up over five hours of presentations to Judge Freda L. Wolfson, and Judge Lois H. Goodman.

California Coordinated Docket

In the California cases, plaintiffs’ counsel filed a formal motion, in early December 2016, to request a Science Day tutorial. The plaintiffs’ motion requested that each side be permitted two hours to present their views of the scientific evidence in support of their litigation positions on causation and liability in talc ovarian cancer cases. The plaintiffs argued that a Science Day would be “significant benefit to the Court and the parties.”  Judge Nelson granted the request, and held Science Day on March 7, 2017.

Evaluation of the California Talc Litigation Science Day

Plaintiffs’ Presentations

The presentation by the plaintiff lawyers was eerily reminiscent of the scientific case made by plaintiffs in the silicone breast implant ligation. Their arguments ranged from highlighting anecdotal evidence to emphasizing the implicit sinister nature of talc migration from the vaginal opening to the ovaries. Plaintiff counsel focused heavily on the alleged role of talc in the inflammatory process and strong but disputed implications that anything that enhances inflammation must necessarily cause cancer.

As one would expect, plaintiff counsel placed strong emphasis on the published epidemiological studies linking talc exposure to ovarian cancer. It is important to highlight that most of the studies demonstrating an association between talc and ovarian cancer are case-control studies by design (as opposed to a cohort design). Plaintiff counsel offered very little distinction between these two study designs and, instead tried to make the case that the sheer volume of studies made their argument.

Finally, it should be noted that at many times throughout the plaintiff presentations the attorneys made reference to industry lobbying efforts aimed at preventing a potential classification of talc as a carcinogen by regulatory agencies. Defense counsel made objections throughout that seemed to be based upon first amendment protections for the defendants’ ability to speak to agencies about the scientific evidence. For example, the last presenter for the plaintiffs described alleged industry “lobbying” efforts at NTP. Defense counsel objected on first amendment grounds, and the judge semi-sustained the objection on the basis that it had little or nothing to do with the science. The plaintiffs’ emphasis on “lobbying” contained no examples of misrepresentations of scientific data.

Defendants’ Presentations

 In general, the defense presentations struck a more disinterested tone. For example, many of the defense slides could stand on their own in a scientific or medical society presentation. The defense lawyers attempted to provide a solid foundation for the judge on the different types of ovarian cancer as well as the myriad uncertainties that exist in terms of the known causes of the condition. Many of the slides contained direct quotes from notable scientists and regulators on topics that were directly relevant to answering critical questions in the litigation.

Nevertheless, the defense presentations were not without their problems.

First, an important defense point was the fact that epidemiology is a measure of aggregate risk – it does not provide a measure of an individual’s risk. In attempting to make this point with a quote from plaintiffs’ own expert (Dr. Graham Colditz), the defense oversimplified the point. Specifically, while risk is indeed a measure to estimate the broader population it does not mean that there are no reasonable inferences that can be made from the group measure to the individual member of the sample or population.

The defense seems to want to make the seemingly unreasonable point that even if an increased risk were appropriately demonstrated by the epidemiology, that that measure of risk does not tell us anything about what caused an individual claimant’s ovarian cancer. This point might be correct when the magnitude of the increased risk is small (as is alleged in the talc ovarian cancer litigation), but the sweeping generality of the defense’s assertion is jarring.

Interestingly, Graham Colditz has elsewhere asserted that an increased risk of disease cannot be translated into the “but-for” standard of causation:

“Knowledge that a factor is associated with increased risk of disease does not translate into the premise that a case of disease will be prevented if a specific individual eliminates exposure to that risk factor. Disease pathogenesis at the individual level is extremely complex.”

Graham A. Colditz, “From epidemiology to cancer prevention: implications for the 21st Century,” 18 Cancer Causes Control 117, 118 (2007). Defense may have wanted to highlight this assertion even recognizing that it is somewhat controversial, and quite dependent upon the magnitude of the measured risk.

Second, the defense’s claim that cohort studies are larger and therefore better than case- control studies is somewhat problematic. This is because the comparative power of a case-control study and a cohort study to detect a reliable association is a complex matter and is not solely affected by the number of subjects in each of the designs. For example, the power of a case-control study — indeed, the very rationale to implement the case-control study design in the first place – is highly dependent on the rate of the disease condition in the general population. If a disease condition is sufficiently rare, then a cohort study may be entirely untenable and a case-control design may be the only possible study design to consider. Other considerations about the relative power of a cohort study include how young the subjects were are study inception, and how long they were followed. At the end of the day, the key to the study’s rigor and strength is revealed in the width of the confidence intervals, or power (post hoc, or pre-specified) of the studies.

Finally, it seems to us that the defense did not adequately incorporate into their presentation the important concept of causal inference (or how evidence from disparate sources is synthesized into a judgment of causation, or into a rejection of such a claim). Specifically, defense counsel never explicitly set forth the importance of the Bradford Hill factors, or the techniques of proper and rigorous systematic review methodologies. The defense did hit many of the key considerations of the Bradford Hill factors, but there was no discussion of how these factors are considered after the identification of an association that is not likely the result of bias and that is beyond the play of chance. With respect to meta-analysis, the defense, like the plaintiffs’ presentation, provided no guidance or insight into the problems that arise in conducting, reporting, and interpreting quantitative syntheses of a body of epidemiologic studies.

The Trial Court’s Role

Most trial judges, sadly, come to cases such as the talc ovarian cancer cases without any training in statistics, epidemiology, toxicology, or an adequate understanding of the role that clinical medicine plays (or doesn’t play) in assessing important questions of causation. Judge Nelsen seemed to listen carefully, but asked few questions to suggest that Her Honor understood the discrepancy in statements made in the parties’ presentation.

Perhaps a starting point for Science Day should be an Order that sets out the procedures for the Day, as well as a statement: “The Court has read and studied the relevant chapters in the Reference Manual on Scientific Evidence (3d ed. 2011), and all materials submitted by the parties.  The parties should not recreate a tutorial that covers material in the Reference Manual, unless they wish to contest its contents. Specific references to the Manual, in connection with the parties’ presentation would be very helpful to the Court.”

Conclusion

Every February 28th, India celebrates National Science Day in honor of the Indian physicist Sir Chandrashekhara Venkata, who discovered the Raman effect. The United States has no equivalent celebration, but Science Day hearings play a critical role in

American mass tort litigation. Stakeholders involved in any talc-related litigation would benefit from reviewing the hearing before Judge Nelson, since the scientific information and arguments used by the parties at the hearing may provide a valuable preview of potential arguments presented to jurors in upcoming trials.


About the Authors

Nathan Schachtman, Esq., has lectured and published widely on expert evidence issues. His interests include access to underlying research data, the use of statistical and epidemiologic evidence in court, medico-legal causation and screenings, the reliability and admissibility of scientific evidence, and historian expert testimony. He is an elected member of the American Law Institute, a fellow of the American Bar Foundation, and a lecturer-in-law at the Columbia Law School.

David H. Schwartz, Ph.D. is a founding partner of Innovative Science Solutions, LLC, a consulting firm that specializes in assisting counsel with litigation involving complex scientific issues, including toxic torts, pharmaceutical and medical device cases, consumer fraud cases, and patent disputes.

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APPENDIX

American Bar Association’s “Civil Trial Practice Standards” (August 2007).

7. Use of Tutorials to Assist the Court

a. Pretrial Use of In cases involving complex technology or other complex subject matter which may be especially difficult for non-specialists to comprehend, the court may permit or require the use of tutorials to educate the court. Tutorials are intended to provide the court with

background information to assist the court in understanding the technology or other complex subject matter involved in the case. Tutorials may, but need not, seek to explain the contentions or arguments made by each party with respect to the technology or complex subject matter.

b. Selection of Type of Tutorial.

  • In any case in which the court believes one or more tutorials might be useful in assisting it in understanding the complex technology or other complex subject matter, the court should invite the parties to express their views on the desirability of one or more
  • Once the court decides to permit or require one or more tutorials, it should invite the parties to suggest the subject matter and format of each
  • If the parties cannot agree on the subject matter and format, the court should invite each party to submit a description of any tutorial it proposes and to explain how that tutorial will assist the court and why it is preferable to the tutorial proposed by another The court may approve one or more tutorials proposed by the parties, or the court may fashion its own tutorial after providing the parties with an opportunity to comment on the court’s proposed subject matter and format.

c. Procedures for Presentation. A court may consider the following procedures for the presentation of tutorials:

  • An in-court or recorded presentation by an expert jointly selected by the
  • An in-court or recorded presentation by one or more experts on behalf of each
  • An in-court or recorded presentation by counsel for each
  • A combined in-court or recorded presentation by counsel and one or more experts on behalf of each
  • An in-court or recorded presentation by an expert appointed by the court, which may include cross-examination by counsel for each
  • Recorded presentations that have been prepared for generic use in particular kinds of cases by reliable sources such as the Federal Judicial

d. Trial Use of Tutorials. In cases involving complex technology or other complex subject matter which may be especially difficult for non-specialists to comprehend, the court may permit or require the use of tutorials to educate the court or jury during one or more stages of the trial. Trial tutorials are intended to provide the court or jury with background information to assist in understanding the technology or other complex subject matter involved in the case.

Tutorials may, but need not, seek to explain the contentions or arguments made by each party with respect to the technology or complex subject matter.

e. Selection of Type of The court should use the process set forth in 7.b. above.

f. Procedures for Presentation.

  • In a bench trial, the court may consider using any of the procedures set forth in 7.b.
  • In a jury trial, the court should consider the use of tutorials in connection with interim statements and arguments as provided in Standard
  • In both bench and jury trials, the court should provide parties with a full opportunity to present admissible evidence in support of their cases that may differ from or quarrel with information presented in a tutorial and to argue that the information presented in a tutorial should be rejected by the court or jury.

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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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Plaintiffs Seek MDL in Ethicon Physiomesh Hernia Repair Product Litigation

As we predicted, the plaintiffs in Physiomesh Flexible Composite hernia mesh filed a motion to create a new MDL No. 2782 in either Illinois or Florida to hear lawsuits filed against Ethicon and Johnson & Johnson.

More than 330,000 Physiomesh devices have been sold worldwide, and the plaintiffs believe about 50% of those products were sold in the United States. It is expected that hundreds of additional cases will be filed in the near future.

So far, 18 actions are pending in 9 federal district courts.

Unique 5-layer design

Physiomesh is a synthetic mesh hernia repair device is an implantable synthetic surgical mesh product sold for use in hernia repair implanted through laparoscopic herniorrhaphy.

Physiomesh has a unique design incorporating five distinct layers: two layers of polyglecaprone-25 (“Monocryl”) film covering two underlying layers of polydioxanone film (“PDS”), which in turn coat a polypropylene mesh. This design has never been used in any other hernia repair product sold anywhere in the world.

The multi-layer coating was promoted by the defendants to prevent or minimize adhesion and inflammation and to facilitate incorporation and fixation of the mesh into the abdomen. However, the 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.

Additional surgeries needed

In addition, the polypropylene mesh portion of the Physiomesh was insufficient to withstand normal abdominal forces, which often resulted in herniation through the mesh itself, recurrent hernia formation and/or rupture and deformation of the mesh itself. The defendants ultimately voluntarily withdrew the Physiomesh device from the market in May 2016, which the plaintiffs intend to establish was a direct consequence of the frequency and severity of the complications experienced with this product worldwide.

The lawsuits charge that the devices implanted in their bodies were defectively designed or manufactured, and that the defendants failed to provide appropriate warnings and instructions regarding the dangers posed by these devices. The plaintiffs suffered serious and often permanent physical injuries from the implantation of the Physiomesh, often requiring additional surgeries, additional medical expenses, and unresolved medical complications. Where applicable, these implant plaintiffs’ spouses have alleged claims for loss of consortium.

The Judicial Panel on Multidistrict Litigation has previously created MDLs for similar implantable surgical mesh devices:

  • In re Protegen Sling and Vesica Systems Prods. Liab. Litig., MDL No. 1387 (J.P.M.L. 2001)
  • In re Kugel Mesh Hernia Patch Litigation, 493 F.Supp.2d 137, MDL No. 1842 (J.P.M.L. 2007)
  • In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., 588 F. Supp. 2d 1374, MDL No. 2004 (J.P.M.L. 2008)
  • In re Avaulta Pelvic Support Sys. Prods. Liab. Litig., MDL No. 2187 (J.P.M.L. 2010)
  • In re American Medical Systems, Inc., et al., Pelvic Repair Systems Prods. Liab. Litig., 844 F.Supp.2d 1359, MDLs Nos. 2325, 2326, 2327 (J.P.M.L. 2012) (3 separate pelvic mesh MDLs)
  • In re Coloplast Corp. Pelvic Repair Support Sys. Prods. Liab. Litig., 883 F.Supp.2d 1348, MDL 2387 (J.P.M.L. 2012)
  • In re Cook Medical, Inc., Pelvic Repair Sys. Prods. Liab. Litig., 949 F.Supp.2d 1373, MDL 2440 (J.P.M.L. 2013)
  • In re Neomedic Pelvic Repair Sys. Prods. Liab. Litig., 999 F.Supp.2d, MDL 2511 (J.P.M.L. 2014)
  • In re Atrium Medical Corp. C-Qur Mesh Prods. Liab. Litig., MDL 2753 (J.P.M.L.2016).

Recommended judges

If the Panel transfers the cases to the Middle District of Florida, the plaintiffs recommended Judges Paul G. Byron, James D. Whittemore and Susan C. Bucklew. In the Southern District of Illinois, the plaintiffs recommended Judge David R. Herndon who is presiding over two MDLs, In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Prods. Liab. Litig., MDL 2100, and In re Pradaxa (Dabigatran Etexilate) PL, MDL 2385.

In the Praxada MDL, Judge Herndon helped to facilitate a global settlement of over 2,600 constituent cases in under 22 months. Judge Herndon managed this settlement quickly and efficiently. Similarly, in the Yaz MDL which involved nearly 12,000 cases, Judge Herndon facilitated a mass settlement initiative in under 27 months.

The plaintiffs’ attorneys include:

  • Henry G. Garrard, III, James B. Matthews and Josh B. Wages of  Blasingame, Burch, Garrard & Ashley, in Athens, GA.
  • Douglas A. Kreis, Bryan F. Aylstock, and Daniel Thornburgh D. Thornburgh of Aylstock, Witkin, Kreis & Overholtz in Pensacola, FL.
  • Donald A. Migliori of Motley Rice in Mount Pleasant, SC.
  • Jonathan D. Orent of Motley Rice LLC in Providence, RI.
  • Joseph A. Osborne of Osborne & Associates Law Firm in Boca Raton, FL.

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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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