Thursday, May 2, 2019

Update: Senate Bill 1189

Senate Bill 1189 by Senator Dawn Buckingham has passed the Senate and the House Committee on Judiciary and Civil Jurisprudence. The bill would require advertisements to properly warn patients that it is dangerous to stop taking a prescribed medication before consulting with a physician.

“. . . [T]he ads can be confusing and misleading and sometimes a cause for needless anxiety,” said Rep. Giovanni Capriglione, author of the house companion to SB 1189. “That’s because in order to catch people’s attention and compel them to sign up for legal services, the ads sometimes use scare tactics, such as sometimes claiming a drug has been recalled when it hasn’t or is under investigation by the FDA when it isn’t.”

It’s important that we protect Texans from deceptive advertising of legal services and SB 1189 would do that. Texans Against Lawsuit Abuse continues to monitor and support SB 1189.

https://www.tala.com/update-senate-bill-1189/

About 2,000 Valsartan Injury Lawsuits Expected Over Cancer-Causing Chemicals in Widely Used Blood Pressure Drug

According to attorneys representing individuals diagnosed with cancer that was allegedly caused by side effects of recalled valsartan pills, it is expected that several thousand product liability lawsuits will be filed in the coming months and years, following widespread contamination that impacted most of the U.S. supply for the blood pressure drug in recent years.

While there are currently only a few dozen valsartan injury lawsuits filed throughout the federal court system, additional claims will be filed as individuals and families learn that a cancer diagnosis may be linked to impurities contained in certain generic valsartan pills, which were recalled in July 2018.

Each of the complaints raise similar allegations, indicating that a byproduct of the generic drug manufacturing process resulted in drugs being distributed by several different companies with cancer-causing impurities, including N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), which may increase the risk of liver cancer, kidney cancer, colon cancer, stomach cancer and other digestive tract cancers.

Given common questions of fact and law presented in lawsuits filed in various different U.S. District Courts nationwide, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings lawsuit earlier this year, which resulted in the transfer of cases pending throughout the federal court system to U.S. District Judge Robert B. Kugler in the District of New Jersey. The process is designed to reduce duplicative discovery, avoid conflicting pretrial schedules and serve the convenience of the parties, witnesses and the judicial system.

At a recent status conference, plaintiffs’ attorneys informed the court that they anticipate more than 2,000 cases eventually will be filed over the next two years, according to court records.

To facilitate the filing of new cases in the MDL, Judge Kugler has allowed the direct filing of valsartan injury claims, to avoid delays associated with transferring claims from different U.S. District Courts nationwide.

As part of the coordinated pretrial proceedings, it is expected that Judge Kugler will establish a “bellwether” process where a representative group claims will be prepared for early trial dates in the MDL, to help the parties gauge how juries may respond to evidence and testimony that will be repeated throughout the litigation, and promote potential valsartan settlements with the manufacturers and distributors of the contaminated pills.

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EPA Defends Glyphosate Safety For Bayer, As Roundup Juries Continue to Find Weedkiller Causes Cancer

In a move that is likely to cause even more controversy than resolution, federal regulators have rushed to the defense of the controversial weedkiller Roundup, saying that the active ingredient glyphosate is not a cancer-causing agent, despite a number of independent studies published in recent years, and internal memos obtained by the manufacturer that suggest Monsanto has exerted undue influence over the regulators, in what appeared to be an uncomfortably close relationship.

On April 23, the U.S. Environmental Protection Agency (EPA) released a “Proposed Interim Registration Review Decision” (PDF) on glyphosate, reiterating an earlier conclusion that the herbicide is not a carcinogen. The decision also answers public comments submitted since the agency’s original determination, defending its evaluation methods.

In 2015, the World Health Organization’s International Agency for Research on Cancer (IARC) announced that glyphosate is likely a cancer-causing agent. In particular, the IARC report linked the side effects of Roundup and other glyphosate-based herbicides with an increased risk of non-Hodgkin’s lymphoma.

In September 2016, the EPA disputed that finding, maintaining that the herbicide was safe and not a cancer-causing agent. The EPA continued to defend that decision in this latest review decision.

“The agency used the most current science policies and risk assessment methodologies to prepare a risk assessment in support of the registration review of glyphosate,” the review states. “The EPA thoroughly asses risks to humans from exposure to glyphosate from all uses and all routes of exposure and did not identify any risks of concern.”

However, the position of the EPA has been brought into question following the release of documents during ongoing litigation over Roundup, known as the “Monsanto Papers”, which many say show an inappropriate relationship between Monsanto and EPA, as well European regulators. In some instances, EPA personnel have boasted about squashing glyphosate safety reviews in the past.

At one point, former EPA official Jess Rowland reassured Monsanto that there would be no pesticide review for glyphosate, saying he should “get a medal” for protecting the company’s product, according to documents revealed as part of the ongoing litigation.

Bayer and it’s recently-acquired subsidiary, Monsanto, currently face more than 13,000 Roundup lawsuits brought by farmers, landscapers, and other consumers diagnosed with cancer following exposure to the controversial weedkiller.

In March, the first federal bellwether case ended in an $80 million verdict, after the jury found that Roundup was a substantial cause of the plaintiff’s non-Hodgkin’s lymphoma. Before that, a California state court jury reached a similar conclusion, resulting in a $78 million verdict for a former school groundskeeper diagnosed with cancer.

Another California trial is currently underway, where a jury is considering evidence about the link between glyphosate and cancer in aa lawsuit brought by a husband and wife who were each diagnosed with non-Hodgkins lymphoma following exposure to Roundup. The couple was granted an expedited trial date since they are both dying from the cancer, and the jury is expected to return within the next few weeks.

Despite the EPA assurances, a number of local governments and other countries are continuing to push for a ban on Roundup, and the safety of glyphosate remains in serious doubt in the minds of many independent experts.

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Railroad Crossing Accidents Caused 270 Deaths Last Year, NHTSA Warns

Federal highway and railroad officials have launched a multi-million dollar campaign designed to highlight the importance for motorists and pedestrians staying clear of railroad crossings when trains are coming, indicating that more than 250 railroad crossing accidents last year resulted in deaths.

The public safety awareness campaign, Stop. Trains Can’t began on April 18, and involves $5.6 million spent to warn Americans about the importance of exercising caution at rail-highway crossings.

U.S. National Highway Traffic Safety Administration (NHTSA) and the Federal Railroad Administration (FRA) indicate that there were at least 270 fatalities at railway intersections in 2018, with 99 of those deaths involving vehicle occupants who were killed after driving around lowered crossing gate arms.

The number of deaths involving motorists attempting to go around lowered crossing gate arms has reached a ten-year high, with approximately 798 fatalities occurring as a result of rail crossing accidents involving motorists since 2013. Officials estimate either a person or a vehicle is struck at a railroad crossing in the United States every four hours.

The Stop. Trains Can’t campaign urges drivers to always be alert for active warning devices such as flashing lights or gate arms descending or lowering, indicating a train is approaching.

Given the size and weight of either a freight or passenger train, a train traveling at 55 mph can take more than a mile to stop, even when the emergency brakes are applied, experts warn. Trains cannot swerve away from a vehicle on its tracks, leaving vehicle drivers responsible for making sure the tracks are clear when trains are approaching.

“Road safety is NHTSA’s mission, and too many lives are lost every year when drivers disregard safety warnings at rail crossings,” NHTSA Deputy Administrator Heidi R. King said in the press release. “Working with Transportation Secretary Elaine L. Chao and FRA, we want every American to understand the danger surrounding rail crossings and to act with safety in mind.  Trying to save a few minutes can cost you your life.”

The collaborative campaign between the NHTSA and FRA will run from April 16, through May 12, and include video spots on digital, radio and social media platforms, such as Facebook, Twitter, and Instagram. Officials have also released a Stop. Trains Can’t video depicting how deadly driving around train crossing arms can be.

While the campaign scope is national, the ads target high-incident communities which have experienced a high rate of train collisions, including Arkansas, California, Colorado, Georgia, Indiana, Illinois, Kentucky, Louisiana, Michigan, Mississippi, Missouri, New York, North Carolina, Oklahoma, Oregon, and Texas.

Motorists are being encouraged to always follow the seven simple steps when approaching a railway crossing that includes.

  • Stop and look both ways and listen before crossing because trains always have the right of way.
  • Always make sure you have room to get across the tracks without leaving your vehicle partially within the rail crossing area.
  • Stop 15’ away from crossing gates.
  • Never drive around a lowering gate and never ignore railway crossing signals.
  • Always wait for the crossing arm gates to raise all the way and the lights to stop flashing before crossing the intersection.
  • Never assume it is only one train passing.
  • If your vehicle stalls in a railroad crossing, get out of the vehicle immediately and call the number on the nearby crossing sign or 911.

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Glen Mills Reform School Abuse Problems Highlight “Broken Model” for Juvenile Delinquents: Editorial

Amid reports of mistreatment, exploitation and physical abuse at Glen Mills reform school in Pennsylvania, which has since been shut down by authorities, a recent editorial published in the Washington Post calls for an end of use for all such institutions for juvenile delinquents remaining in the U.S.

The editorial (subscription required) was written by Amber Armstrong, a graduate student at the University of Pennsylvania, who calls the ideology of such reformatories, which date back hundreds of years, are misguided and likely to result in similar reform school abuse problems to what was recently uncovered at Glen Mills School.

Following a recent report by the Philadelphia Inquirer, which described cases of serious violence and abuse at the boys reform school, an investigation by Pennsylvania’s Department of Public Welfare announced an Emergency Removal Order for Glen Mills Schools last month. At that time, there were only 64 students remaining at the reform school, down from a peak of more than 1,000 students.

The Glen Mills School was first opened in 1826, and has housed boys from across the nation, many of whom were sent to the reform school through a court order due to juvenile delinquent behavioral problems. However, the investigation revealed rampant reform school abuse problems, including physical violence, and efforts to threaten children attending the school into silence.

After the first Philadelphia Inquirer article was published, states and cities began withdrawing juvenile delinquents from the Glen Mills reform school, and Executive Director Randy Ireson stepped down, claiming a leave of absence for health reasons.

The Post’s editorial notes that the investigation revealed the school’s employees were not following state and internal policies, and had not for decades, but says it is the ideology behind the creation of such reform schools, which resulted from the belief that a rigid, incarcerated life would benefit juvenile delinquents, set up the potential, and perhaps inevitability, of such abuses hundreds of years before.

Armstrong calls for the nation to discard the “broken model” which was, ironically, originally designed to remove youths from the prison system before the advent of a juvenile court system. While believing reform schools to be more merciful than prison, originators actually just copied the prison model.

Armstrong postulates that the system targeted poor and minority children unfairly and failed to offer children any mercy or help them into adulthood, or even reduce the likelihood of repeat offenses, in addition to the risk of reform school abuse problems.

In the case of Glen Mills, state officials found that children were abused, assaulted, forced and goaded into fighting one another, had medical treatment withheld, were threatened into silence and were overall kept in an unsafe environment.

On April 8, state officials revoked all of the school’s licenses. Charges against two former Glen Mills school counselors, arrested in September 2018 before the investigation into the facility on charges of abuse, have been dropped in recent weeks.

Attorneys for the school have said all of the allegations are false and unsubstantiated claims filed by former students and staff members who had been fired for performance deficiencies.

As a result of the problems, former students are now pursuing Glen Mills school abuse lawsuits, some of which seek class action status to pursue damages for thousands of children who have been abused at the institution.

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Drug Poisoning Deaths Rose Sharply Among U.S. Children And Teens In Recent Years: Study

The number of drug poisoning deaths among teens and young adults has increased between 5% percent to 15% each year between 2006 to 2015, according to the findings of new research that highlights the impact of the continuing opioid epidemic in the U.S.

In a study published last week in the Journal of Studies on Alcohol and Drugs, researchers with the Pacific Institute for Research and Evaluation evaluated data from the National Vital Statistics System’s Multiple Cause of Death to analyze trends regarding drug overdoses and deaths.

The findings provide another indicator of a worsening opioid crisis across the country, as the powerful pain medications account for nearly 70% of all drug overdose deaths.

The rate of deaths from drug poisonings among teens and young adults increased from 8 per 100,000 people in 2006, to nearly 10 per 100,000 people by 2015.

Similarly, overdose deaths associated prescription painkillers and opioids, including heroin, increased 5% on average each year from 2006 to 2015. However, from 2013 to 2015, overdose deaths increased by more than 15% each year.

Overdose rates varied based on geographical regions. In the Midwest, overdose death rates increased 4.4% per year from 2006 to 2015. In the Northeast, death rates among teens and young adults increased by more than 11% from 2009 to 2015.

Additionally, the death rate in West Virginia was five times higher than the death rate in Nebraska, reaching 15 deaths compared to 3 deaths per 100,000 people. However, New York experienced the greatest increase in drug overdose deaths, with an annual increase of 9%.

Rates also increased at different levels for different racial and ethnic backgrounds. Overdose rates for African Americans increased by nearly 12% each year from 2009 to 2015. Comparatively, rates increased by 4.3% each year for Asian/Pacific Islanders and nearly 2% for Whites from 2006 to 2015.

The data indicates the increasing trend toward addiction and overdose of opioid painkillers. The opioid crisis has been largely driven by inappropriate doctor prescribing, especially without a documented pain diagnosis. Now, more people have easier access to prescription drugs and illicit drugs, including heroin or fentanyl.

Many drugs are laced with fentanyl, which increases the likelihood of unintentional overdose. Fentanyl accounts for more than 50% of fatal drug overdoses. Fentanyl is a powerful painkiller that is 50-100 times more potent than morphine,  which makes it more likely for a user to overdose and die. Fentanyl was recently labeled the most dangerous drug in American because it is linked to more overdose deaths than any other drug.

The new study also estimated the costs of drug poisoning deaths among teens and young adults at more than $35 billion in 2015, including costs for ambulance services, hospital stays, and autopsies. Similarly, more than $9 billion goes to work loss costs each year and $27 billion for quality of life loss.

To help combat the epidemic, researchers emphasize the need for widespread strategies like prescription drug monitoring, prescription drug disposal programs, naloxone distribution programs, and medication assisted treatment. These prevention strategies are often underfunded and underused nationally, researchers said.

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Wednesday, May 1, 2019

Johnson & Johnson Hernia Mesh Lawsuits Filed Over Problems with Ethicon Proceed System

A growing number of product liability lawsuits have been filed in New Jersey state court, indicating that hernia mesh complications have been linked to Johnson & Johnson’s Ethicon Proceed surgical patch, which plaintiffs claim was defectively designed and does not belong in the human body.

Complaints filed over the past week in the Superior Court of New Jersey in Middlesex County each involve similar facts, where painful and debilitating injuries occurred after hernia repair involving Ethicon Proceed Systems, alleging that users and the medical community were not adequately warned about the risk of problems from the multi-layered polypropylene Johnson & Johnson hernia mesh.

On April 25, Kelly Sanderson, of Alabama, filed a lawsuit (PDF) that indicates she received an Ethicon Proceed Surgical Mesh as part of an incisional hernia repair procedure in August 2010. However, in November 2016, a surgeon had to remove necrotic and nonviable tissue due to an abscess, and it was discovered that the mesh had become infected and part of it and part of her small bowel had to be removed in January 2017.

On the same day, another complaint (PDF) was filed in the same court by Rowena Combs, of Oklahoma, who experienced problems after receiving Ethicon Proceed mesh during a hernia repair surgery in November 2009. Years later, in January 2018, she required revision surgery to have the mesh removed and need to have the recurring hernia repaired.

Two other lawsuits, including a complaint by Maureen Bustin (PDF) and a complaint by John Schneider (PDF), both filed in the same court on April 23, tell similar stories of mesh failure, recurrent hernias and the need for revision surgery.

Each of the Johnson & Johnson hernia mesh lawsuits highlight what plaintiffs say was a failure by the manufacturer to disclose problems with their product, or adequately warn the medical community and patients about risks associated with the design of the hernia mesh.

“Defendants had the ability to inform surgeons, hospitals, or GPOs of developing problems or defects in its devices through e-mail, letter, recalls, warnings in product inserts, and/or through its product representatives, who work directly with the surgeon,” Sanderson’s lawsuit states. “The multiple layers of the Ethicon Proceed increase the intensity and duration of the inflammatory response. That response in turn increases dense adhesion formation from underlying organs to the Ethicon Proceed, resulting in bowel complications, mesh contracture, hernia recurrence, increased foreign body reaction, chronic severe pain, and more.”

The cases join a growing number of similar Ethicon hernia mesh lawsuits pending in courts nationwide, most of which involve problems with the previously recalled Physiomesh product, which is another multi-layer polypropylene hernia patch that was removed from the market after it was linked to reports of problems.

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