lindamcsherry

[lindamcsherry]

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/

[lindamcsherry]

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.

The post About 2,000 Valsartan Injury Lawsuits Expected Over Cancer-Causing Chemicals in Widely Used Blood Pressure Drug appeared first on AboutLawsuits.com.

[lindamcsherry]

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.

The post EPA Defends Glyphosate Safety For Bayer, As Roundup Juries Continue to Find Weedkiller Causes Cancer appeared first on AboutLawsuits.com.

[lindamcsherry]

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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[lindamcsherry]

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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[lindamcsherry]

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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[lindamcsherry]

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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[lindamcsherry]

Uloric Heart Attacks, Deaths Likely To Result in Failure to Warn Lawsuits

A number of product liability attorneys are now looking into potential Uloric lawsuits, suggesting that the controversial gout medication may be the target of mass litigation following recent revelations of that users were not adequately warned about the risk of heart problems and death.

In late February, the FDA announced it would require a new boxed warning be added to all Uloric labels, alerting consumers and the medical community about the risk of cardiovascular injury and overall death from combining medications or existing health problems while taking Uloric. It is the strongest warning the agency can require a drug maker to place on their product.

Uloric (febuxostat) is a Takeda Pharmaceuticals medication that is designed to lower the blood uric levels among adults diagnosed with gout, which has rapidly become a blockbuster drug since it was introduced in 2009. However, recent research suggests that side effects of Uloric may carry serious heart risks when compared to alternative drug treatments.

In the wake of the warning, concerns are being raised that the manufacturer failed to adequately warn the medical community and patients about the true side effects of Uloric, despite warning signs that have existed for several years.

A few different plaintiffs’ attorney groups have organized meetings or conferences in the coming months about the potential Uloric litigation, to discuss criteria for claims that can be maintained and develop plans for the litigation.

While there were some warning signs and even FDA concerns when Uloric was first released, it appears that the agency did not understand the true scope of Uloric heart problems until Takeda released the results of a post-marketing clinical trial the FDA required the drug maker to complete when approving Uloric in 2009. However, growing evidence suggests that Takeda knew or should have known about the risks, yet continued to market the drug without adequate warnings.

The FDA has now required that a prominent label warning be placed on Uloric, and doctors are advised to only consider use of the drug if patients are not able to tolerate allopurinol, an older and safer gout treatment.

Result from the Takeda clinical trial compared Uloric and allopurinol, finding that for every 1,000 patients treated for a year with Uloric there were 26 deaths, compared to only 22 with allopurinal. However, when examining the risk of heart-related deaths, there were 15 Uloric deaths for every 1,000 patients treated for a year, compared to 11 with allopurinol.

Although a Uloric recall was urged by some critics, the FDA decided to allow the drug to remain on the market, with severe limitations approved uses.

Plaintiffs lawyers suggest that if Takeda has provided earlier warnings, many consumers may have avoided suffering a heart attack, stroke or wrongful death by using other gout treatments.

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[lindamcsherry]

Sleep Walking Risks with Ambien, Lunesta, Sonata Draw FDA “Black Box” Warning

Federal health officials are requiring the manufacturers of Ambien, Lunesta and other insomnia medications to add the strongest label warning available, following continuing reports of injuries and deaths resulting from complex sleep behaviors while under the influence of the drugs, including sleep walking, sleep driving and other activities that pose serious risks when not fully alert.

The U.S. Food and Drug Administration (FDA) announced the new “boxed” warning on Tuesday, indicating that new information will be placed in a black box placed prominently on the label.

The move comes after dozens of serious injuries and at least 20 deaths linked to patients engaging in activities while in a sleep-state following use of the popular sleep aid drugs.

The warnings will be added to eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist), which are commonly prescribed to adults to treat insomnia and help individuals sleep at night. These drugs are categorized by officials as sedative-hypnotic medications and have been approved by the FDA for patient use for many years.

Over the last decade, a growing body of evidence has confirmed dangerous sleep activity linked to Lunesta, Sonata, Ambien, Ambien CR, Edluar, Intermezzo and Zolpimist. These incidents have resulted in injuries, fatalities, and in at least two scenarios individuals who committed murder of their spouses had no memory after mixing sleep aid medications.

Officials indicate that the black box warning represents an accumulation of research, which has shown patients using sleep aid prescription medications were found to experience complex sleep behaviors including sleepwalking, sleep driving, using a stove or oven while asleep and having no recollection of the dangerous activities they were involved in.

The FDA has become aware of at least 46 non-fatal serious injuries after patients began actively using a prescription sleep drug. Of the injuries recorded patients have reportedly injured themselves by accidental overdoses, falls, burns, near-drowning, over-exposing themselves to cold temperatures, loss of limbs, gunshot wounds, and apparent suicides.

Of the 20 fatalities recorded from patients using prescription sleep aids, causes of death included carbon monoxide poisoning, drowning, fatal falls, hypothermia and severe automobile accidents.

According to the U.S. Centers for Disease Control, an estimated 50 million Americans are believed to suffer from some sort of sleep disorder, and roughly 4% adults consistently use a prescription insomnia aid to sleep at night.

Previous research has found many users of these prescription sleep aids do not adhere to the FDA’s recommended safety guidelines designed to prevent injuries and accidents due to drowsiness caused by the drug.

According to a sleep aid study issued by the Institute for Safe Medication Practices (ISMP) in 2018, approximately 77% of users of Ambien, Edluar and Zolpimist, which all use the active ingredient zolpidem, failed to follow two or more FDA recommendations on using the drug safely. Most common unsafe use of the drugs involved taking two or more types at once, long-term use, and taking higher than recommended doses; particularly among women and older patients.

According to the ISMP report, the U.S. Centers for Disease Control and Prevention found that Ambien and its generic zolpidem equivalents were the drug most linked with emergency room visits, according to adverse event data received by the FDA. According to the report, there are an estimated 10,212 emergency department visits each year linked to Ambien use, with 25% of those requiring the person be hospitalized.

In 2014, the FDA received 1,030 serious adverse event reports where Ambien was the primary or secondary drug suspected of causing the problem.

A black box warning issued by the FDA is the strictest warning put on the labeling of prescription drugs and drug products, indicating there is reasonable evidence that the use of the products may cause a serious hazard to consumers.

Patients using sleep medications such as Ambien and Lunesta or other prescription drugs with the active ingredients eszopiclone, zaleplon, and zolpidem are being encouraged to stop taking the medication if they experience complex sleep behaviors where you engage in activities while you are not awake or you do not remember. Those who experience these situation should contact their health care professional right away.

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[lindamcsherry]

Amid Zostavax Concerns, Demand for Newer Shingles Vaccine Shingrix Soars

As a growing number of doctors move away from Zostavax, due to concerns about the side effects of the shingles vaccine, GlaxoSmithKline indicates that it plans to spend $100 million to boost the production of Shingrix, as demand for the newer shingles vaccine skyrockets.

The drug manufacturer issued a press release on April 24 announcing it was making a massive investment into a Hamilton, Montana facility to increase production of Shingrix. The decision comes after company officials announced in December that Shingrix vaccine shortages may occur throughout 2019.

Shingrix (recombinant zoster vaccine; RZV) was the second vaccine approved for prevention of shingles among adults, which involves two doses for inoculation. When it was introduced, Zostavax (varicella zoster vaccine; VZV) was the only shingles vaccine on the market, involving a single dose. However, unlike Zostavax, Shingrix does not involve the use of a live virus, which has been linked to reports of problems among patients who received Zostavax.

Merck now faces hundreds of Zostavax lawsuits brought by individuals nationwide who experienced severe shingles outbreaks or auto-immune disorders after receiving their version of the shingles vaccine, involving allegations that the live virus was “under-attenuated” and not sufficiently weakened to avoid the risk of reactivating the dormant virus in many individuals.

Amid rising Zostavax concerns, CDC researchers have indicated that the Shingrix success rate is above 90%, which has led to increasing demand. The success rate with Shingrix is in line with most vaccines, leading doctors to conclude it is safer.

In November 2018, a study published in The BMJ, which found that Shingrix is 85% more effective at preventing shingles than Zostavax, further accelerating the move away from Zostavax by many doctors.

“For more than a decade, our Hamilton facility has supported GSK’s adjuvant system development program,” Jack Bailey, President, US Pharmaceuticals, GSK, said in the press release. “By expanding the adjuvant system production capabilities in Hamilton, we will continue to deliver long-term and sustainable supply for key vaccines, including SHINGRIX.”

The relative safety of Shingrix compared to Zostavax is likely to be a main focus of the litigation filed against Merck, which also includes allegations that the drug maker knew about the safer alternative design, but placed desire for profits before consumer safety.

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[lindamcsherry]

Unsafe Sleeping Environments Still Cause Significant Percentage Of Infant Deaths: Study

Despite years of warnings about the importance of creating safe sleeping environments for infants, babies continue to suffocate and die after parents place them to sleep on their stomach, or in a crib with soft bedding, according to the findings of new research.

In a study published in the medical journal Pediatrics, researchers from the U.S. Centers for Disease Control and Prevention (CDC) analyzed data from the Sudden Unexpected Infant Death Case Registry from 2011 to 2014, and concluded that placing infants to sleep on their stomaches or sides was linked to 92% of incidents.

The data included sudden infant deaths (SIDs) stemming from all causes, and researchers specifically focused on cases categorized as suffocation with unsafe sleep factors. These cases were then assigned a method of suffocation, including soft bedding, overlay, or wedging.

Of the SIDs deaths classified as suffocation, nearly 70% were attributed to soft bedding, such as blankets, pillows, crib bumpers, sleep positioners, or couch cushions. In nearly all of the deaths, the infants were not sleeping on their back, but instead placed on their stomach or side to sleep.

Another 19% of deaths were attributed to overlay, which is when someone was on top of the infant when they died. This can include inadvertently rolling onto the infant during sleep. In most cases, it was a parent; however, in 22% of cases it was a sibling. Two-thirds of overlay deaths occurred in an adult bed.

In addition, 12% of suffocation deaths were due to wedging. This is when the infant becomes trapped between the mattress and the wall or the bed frame. Three-quarters of these types of deaths occurred in an adult bed, not a crib.

Soft bedding deaths occurred most often in an adult bed, nearly half the time, and 82% of deaths attributed to soft bedding occurred when the infant was on their stomach. One-third of the time a blanket was obstructing the infant’s airway.

The average age of infants who suffered sudden deaths due to soft bedding was 3 months, 2 months for overlay deaths, and 6 months for wedging.

Researchers said two factors played a significant role in infant deaths: Infants being put to sleep on his or her stomach or side and infants sleeping in adult beds.

Nearly 90% of babies between 0 and 4 months and 70% of babies 5 to 11 months who died of suffocation were found on their stomach. If safe sleep habits were followed during the study period, the death rate would have dropped from 87 infants per 100,000 deaths to 75 infants per 100,000 deaths.

Infant Suffocation Risks

Unintentional suffocation is the leading cause of injury death among infants under one year old in the U.S. More infants die each year from accidental suffocation than any other type of injury.

A study published in 2018 indicated despite national campaigns to advocate safe sleeping positions, many infants are still placed in dangerous conditions, including on the stomach and with blankets.

Researchers recommend parents follow the American Academy of Pediatrics infant sleep recommendations, which emphasize placing a baby on his or her back to sleep, using a firm mattress or surface, and keeping pillows, crib bumpers, blankets, and soft toys out of the baby’s sleeping area.

Many parents want to keep their baby near them when they are still infants. The AAP recommends when infants sleep in the parent’s room, they sleep in a crib, not in the parent’s bed.

Earlier this month, nearly 5 million Fisher-Price Rock’n’Play Sleepers were recalled after the U.S. Consumer Product Safety Commission received reports of 32 infant deaths. Babies placed in the sleeper rolled onto their stomach, leading to suffocation on the soft cushion covering the device.

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[lindamcsherry]

Core Discovery Underway in Lawsuits Over Valsartan Contamination

The U.S. District Judge presiding over all valsartan contamination lawsuits has issued an order establishing the rules for core discovery in the litigation, which involves claims brought by individuals nationwide who say they developed cancer after receiving recalled versions of the generic hypertension drugs that were tainted with carcinogenic impurities.

There are currently about 50 product liability lawsuits filed against various generic drug manufacturers and distributors, each raising similar claims that versions of the hypertension drug valsartan were distributed for years with cancer-causing contaminants, including N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), which appear to be a by-product of the generic drug manufacturing process.

Many of the complaints involve allegations that users of the recalled valsartan drugs developed liver cancer, kidney cancer, colon cancer, stomach cancer and other digestive tract cancers, pursuing damages against Zhejiang Huahai Pharmaceutical Company of China and other defendants that manufactured and sold the tainted pharmaceutical ingredients, which were widely distributed throughout the United States in recent years.

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 for the valsartan contamination lawsuits in February, 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.

Following a status conference last week, Judge Kugler issued an order (PDF) on April 29, setting rules for the production of “core” discovery documents for the litigation.

The order calls for defendants to produce information concerning the facilities that manufactured the active ingredient for generic valsartan, or which produced finished products linked to the litigation. It also limits the production of core discovery to valsartan; meaning the discovery will not include other hypertension drugs that have been recalled due to tainted ingredients, such as generic losartan and irbesartan.

The order lays out which specific documents responding defendants will produce and indicates core discovery will run until June 17.

As more individuals discover that they may have received contaminated valsartan pills, a growing number of lawsuits are likely to be filed by individuals nationwide.

Following coordinated discovery and any early “bellwether” trials held in the MDL, if the manufacturers fail to negotiate valsartan settlements or another resolution for the litigation, each individual case may ultimately be remanded back to the U.S. District Court where it was originally filed for a future trial date.

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[lindamcsherry]

Prolia Discontinuation Increases The Risk Of Vertebral Fractures, Study Found

The side effects of Prolia may increase the risk of vertebral fractures when consumers stop using the osteoporosis drug, according to the findings of a study by Israeli researchers.

In research published in the journal Calcified Tissue International last year, serious concerns were raised about the impact of Prolia discontinuation, adding to a growing body of evidence about the fracture risk associated with the medication.

Prolia (denosumab, or DMAB) was introduced by Amgen in 2010, and was the first drug approved by the FDA for the treatment of postmenopausal osteoporosis.

According to the researchers, the drug was approved after showing a reduction in vertebral and hip fractures over the course of three years, and keeping the risk reduced up to 10 years. However, they noted that a number of reports raised concerns about the risk of fractures once users discontinued the drug, due to rapid bone density declines and reports of multiple vertebral fractures.

The researchers conducted a phone survey of doctors engaged in bone metabolism in nine Israeli hospitals. They looked at clinical data on patients with vertebral fractures after Prolia discontinuation and found nine elderly female patients, most of who had prolonged exposure previously to Fosamax or another bisphosphonate drug.

According to the findings, the women collectively suffered 36 vertebral fractures, eight of whom had multiple fractures; most of which were spontaneous.

“In line with previous reports, the timing and severity of the fractures raise concern of DMAB discontinuation effect,” the researchers concluded. “Care providers, patients, and regulatory authorities should be aware of the possible risk of DMAB treatment interruption.”

Prolia Bone Fracture Concerns

In 2013, the prominent consumer watchdog group Public Citizen raised concerns about the Prolia fracture risks, noting that the drug has been linked to reports of bone brakes following little or no trauma. The group indicated that Prolia appears to interfere with bone metabolism and the body’s immune system, resulting in breaks that may occur in situations that would not typically result in such an injury.

Although Amgen issued warnings about the link between Prolia and bone fractures in Canada as early as 2012, concerns have been raised that insufficient warnings are still being provided in the United States.

Earlier this month, Public Citizen filed a petition with the FDA calling for the agency to require a “black box” Prolia fracture warning, which would be the strongest warning the drug maker could be required to add to the label.

As more consumer learns that problems suffered in recent years may have been avoided with stronger warnings, it appears likely that Amgen may face Prolia bone fracture lawsuits, raising allegations similar to those presented in several thousands Fosamax lawsuits in prior years.

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[lindamcsherry]

Superbug Evolution Outpacing Antibiotic Development, U.N. Warns

Overuse of antibiotics is leading to a worsening problem of drug-resistant bacteria and infections, resulting in hundreds of thousands of deaths globally each year, according to the findings of a new international report.

The Interagency Coordination Group on Antimicrobial Resistance put together the report, “No Time to Wait: Securing the Future From Drug-Resistant Infections”, for the secretary general of the United Nations and released the findings this month, warning that widespread drug resistance is becoming a global crisis.

Antibiotics, antivirals, and antifungals are critical tools used to fight infection, but these methods are becoming ineffective because of their overuse in humans and animals, researchers warn. One recent study found that more than half of antibiotics are prescribed without an infection diagnosis.

There are high levels of antibiotic resistance reported in countries around the world at all income levels. Infections once easily treated are now becoming untreatable, such as antibiotic resistant tuberculosis and gonorrhea. Additionally, lifesaving medical procedures, like surgery, are becoming riskier due to the chance of contracting antibiotic resistance infections.

Drug resistant diseases cause nearly 700,000 deaths globally each year. More than 230,000 people die from drug resistant tuberculosis alone yearly. In the U.S., roughly 2 million Americans develop antibiotic resistant infections each year, leading to 23,000 deaths.

The report emphasizes the One Health concept which focuses on the interconnection of the health of people, animals, and the environment. This concept aims to work to focus on interconnected health to achieve optimal health for the globe.

The findings indicate the concept is especially important because six out of 10 infectious diseases found in humans are spread from animals. The interconnected nature of humans, animals, and the environment is how drug resistance worsens and spreads.

Emerging Threats

The report highlighted three urgent threats of antibiotic resistance: C. difficile (C. diff), Carbapenem-resistant Enterobacteriaceae (CRE), and N. gonorrhoeae.

C. diff infects more than 500,000 people yearly and leads to life-threatening cases of diarrhea and colitis. It often poses a high risk of infection for other patients. CRE is one of the most drug resistant bacteria and is typically acquired in healthcare settings. It causes nearly 9,000 infections each year leading to 600 deaths. Gonorrhea is a sexually transmitted disease. Many strains have become nearly untreatable with antibiotics.

Other things that spread the development of drug resistance include inadequate access to clean water, sanitation and hygiene; poor infection and disease prevention; and lack of access to affordable antibiotics and vaccines.

The report warns that the number of drugs in development to combat resistant bacteria simply is not enough. To that end, the group offered five recommendations: accelerate progress of the One Health National Antimicrobial Resistance Action Plan, focus on innovating new antibiotics, collaborate for better action plans to treat disease, invest in sustainable response plans, and strengthen accountability and global governance.

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[lindamcsherry]

“Glyphosate-Free” Certifications Being Offered Amid Roundup Cancer Concerns

Amid increasing concerns about the side effects of exposure to Roundup and other glyphosate-based pesticides, which have been linked to reports of non-Hodgkins lymphoma and other cancers, a growing number of food manufacturers are seeking certifications designed to assure consumers that their products are “Glyphosate-Free”.

The Detox Project, a Europe-based research and certification group, is providing Glyphosate Residue Free certifications for ingredients, as well as single and multi-ingredient food products, and a growing number of companies in the U.S. and around the world are taking part in the program.

To date, about 30 brands and 300 products have received a “Glyphosate-Free” certification, and at least two dozen more are undergoing the process. Many of the companies with certifications are organic food or dietary supplement companies, such as Tosi, Heavenly Organics and Purium.

The Detox Project certification project calls for products to undergo testing by a third-party accredited laboratory three times a year. The products must be free of glyphosate residue down to government-recognized limits of detection for food, commodity and supplement samples, which is usually 0.01 parts per million.

The group certifies single ingredients from suppliers, single-ingredient food and supplement products sold to consumers, and multi-ingredient food and supplement products sold to consumers.

The growing interest in glyphosate-free certification comes as Bayer and it’s recently-acquired subsidiary, Monsanto, face more than 11,000 Roundup lawsuits brought by farmers, landscapers, and other consumers diagnosed with cancer following exposure to the controversial weedkiller.

Last month, 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.

That verdict came only a few months after a California state court jury awarded $289 million in damages to a former school groundskeeper diagnosed with non-Hodgkins lymphoma following regular exposure to Roundup. While the judge presiding over that case subsequently reduced the verdict to $78 million, the two awards have provided a clear indication about the extent of liability Bayer may face if it fails to negotiate a settlement or resolution for the claims.

In addition to the federal cases, Bayer and Monsanto are still expected to face a number of state court trials throughout the remainder of 2019.

In California, a trial is currently underway involving 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 a verdict early next month.

A number of cases are also expected to go before Missouri juries this summer and fall, as the vast majority of Roundup claims are currently pending in Missouri state court, where Monsanto’s U.S. headquarters were located.

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[lindamcsherry]

Honda Recall Issued Over Timing Belt Problems That Could Increase Crash Risks

Nearly 100,000 Honda and Acura vehicles have been recalled due to a manufacturing defect that may cause the timing belt to separate, increasing the risk that the vehicle may stall and become involved in an accident.

The Honda timing belt problems were disclosed in a recall announcement posted by the U.S National Highway Traffic Safety Administration (NHTSA) on April 24, following several consumer reports indicating the rubber teeth separated from the belt, causing the vehicles to stall. To date, no crashes or injuries have been reported in relation to the recall.

The recalled Honda and Acura vehicles are equipped with a timing belt that may have been improperly hardened, causing it to become susceptible to premature deterioration and separation. In the event of a timing belt separation, the engine valve timing will be adversely impacted, causing the engine to stall and increasing the risk of a crash.

Honda first learned of the potential problems in August 2018, when a customer reported an engine stall from a defective timing belt separating. Honda and its timing belt supplier, Gates Unitta Asia Company of Japan, opened an investigation to determine the root cause of the separation.

Throughout the investigation, Honda and its supplier determined the particular mold used in the mass production of the belts was not given the appropriate amount of time to vulcanize and harden. The analysis of the data determined the rubber teeth on the belts could deteriorate.

As of April 4, 2019, Honda is aware of at least 15 warranty claims related to the timing belt separation problems and made the decision to conduct a voluntary safety recall.

The recall impacts approximately 93,946 model year 2018 through 2019 Acura MDX and Honda Pilot vehicles and 2019 Acura RLX, RLX Sport Hybrid, TLX and Honda Odyssey and Ridgeline vehicles.

The vehicles were manufactured by American Honda Motor Company inTorrance, California. They were distributed for sale throughout the U.S. to licensed dealers.

Honda has announced they will begin notifying owners of the recalled vehicles and will provide instructions on how to schedule repair appointment at their local dealer, who will be instructed to replace any affected timing belt free of charge. Customers receiving a replacement timing belt will also receive an engine inspection and any damaged components will be replaced free of charge.

The recall is expected to begin on June 1, 2019 when replacement parts become available. Customers with additional questions or concerns regarding the recall may contact Honda customer service at 1-888-234-2138 and reference the recall number L4M for Honda vehicles, and Z4L for Acura models.

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[lindamcsherry]

Status of Talcum Powder Cancer Lawsuits To Be Reviewed With MDL Judge

Lawyers for Johnson & Johnson and plaintiffs pursuing talcum powder lawsuits in the federal court system will meet today with the U.S. District Judge presiding over the litigation, which involves more than 10,000 cases brought by women throughout the U.S. who allege they developed ovarian cancer, mesothelioma or other injuries following years of exposure to Johnson’s Baby Powder or other products.

Given similar questions of fact and law raised in complaints filed throughout the federal court system, all talcum powder cancer cases are consolidated for pretrial proceedings as part of a multidistrict litigation (MDL), which is centralized before U.S. District Judge Freda L. Wolfson in the District of New Jersey.

In advance of a case management conference scheduled for today, the parties submitted a joint report (PDF) that outlined the status of the talcum powder litigation, and an agenda for topics that will be addressed with the court, including the status of expert discovery, challenges to the admissibility of certain scientific evidence, pending motions and the growing number of complaints filed in state and federal courts nationwide.

According to the report, there are currently at least 10,556 Baby Powder lawsuits and Shower-to-Shower lawsuits filed in the federal court system, each raising similar allegations that Johnson & Johnson failed to warn consumers for decades about the serious health risks associated with their talc-based products, which have been linked to the development of ovarian cancer and mesothelioma. In addition, there are about 2,400 additional cases filed in state courts nationwide.

While Judge Wolfson is expected to rule on Daubert challenges to the admissibility of expert witness testimony this summer before setting the first federal cases for trial, a number of trials have already gone before juries at the state court level, with several resulting in multi-million verdicts in favor of women diagnosed with ovarian cancer or mesothelioma.

While Johnson & Johnson obtained a defense verdict recently in one California trial, last month another case resulted in a $29 million verdict for failing to warn about the risk of mesothelioma from talcum powder. In addition, last year a Missouri jury returned a landmark $4.7 billion verdict for 22 women diagnosed with ovarian cancer.

Johnson & Johnson is appealing each of the prior verdicts, and previously indicated that it intends to continue to fight the cases at trial. However, it was recently reported that the company reached settlements to resolve at least three talcum powder cancer claims that were either in the middle of trial or set to begin in the coming weeks.

If Judge Wolfson determines that plaintiffs have sufficiently reliable evidence about the link between talcum powder and cancer to proceed to trial under federal rules, it is expected that a small group of “bellwether” cases will be set for trial in the U.S. District Court for the District of New Jersey. However, unless is able to negotiate additional talcum powder settlements or otherwise resolve the litigation, it is expected that large numbers of cases will eventually be remanded back to different federal district courts for individual trial dates in the future.

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