Immigration Detention Centers Forcing Drugs on Migrant Children

By Emily Cox
immigration detention centers
Flickr/Esparta Palma

According to a new lawsuit, U.S. government youth immigration detention centers are routinely and forcibly giving migrant children a range of psychotropic drugs to manage the trauma of detention and separation from their parents in some cases.

The Los Angeles-based Center for Human Rights & Constitutional Law filed the lawsuit April 16. This was mere days after the Trump Administration introduced its “zero tolerance” policy to separate children from parents who crossed the U.S.-Mexico border illegally. Amid public and political outcry, Trump abandoned the policy Wednesday.

According to the lawsuit, immigration detention centers like the Shiloh Treatment Center in Texas indiscriminately administer the drugs to essentially all children, regardless of their condition and without their parents’ consent.

“If you’re in Shiloh then it’s almost certain you are on these medications. So if any child were placed in Shiloh after being separated from a parent, then they’re almost certainly on psychotropics,” said Carlos Holguin. He is one of the lawyers representing the Center for Human Rights & Constitutional Law.

Serious Health Implications of Immigration Detention Centers Drug Policies

According to the filing, taking multiple psychotropic drugs simultaneously can seriously injure children. This highlights the dire necessity for oversight to prevent these centers from using medications as “chemical straight jackets” rather than to treat real mental health problems.

Office of Refugee Resettlement (ORR) centers are blatantly disregarding state laws that require either a parent’s consent or a court order when they unilaterally administer these dangerous drugs to children.

The lawsuit hopes to incite a shift in ORR policies to comply with state laws and prevent the prolonged detention of children.

Some migrant children at Shiloh have reported receiving up to nine different pills each morning and six at night. They said officials told them that they would remain detained if they refused the drugs. Some even recounted being held down and given injections when they refused to take the medications, according to the lawsuit.

One mother said that Shiloh never consulted her or any other family member about medications it was giving to her daughter even though the center had their contact information. Another mother said her daughter received such potent anti-anxiety medications that she collapsed several times.

 

 

Shingles Vaccine Lawsuit Consolidation Under Consideration

By Emily Cox
Shingles Vaccine
Flickr/Mike Mozart

The Judicial Panel on Multidistrict Litigation (JPML) will hear oral arguments next month to determine if all Zostavax lawsuits pending in the federal court system should be consolidated before a single federal judge to streamline pretrial proceedings as all the cases raise similar allegations that the shingles vaccine caused a persistent strain of the infection instead of preventing it.

Merck introduced Zostavax in May 2006 to prevent shingles among individuals 60 years and older. It’s a more potent version of Merck’s chickenpox vaccine, Varivax. However, numerous reports have emerged that the shingles vaccine causes longer and more painful shingles outbreaks.

According to plaintiffs, Merck used a live strain of varicella zoster virus (VZV) in Zostavax that was not weakened enough to prevent the virus’s reactivation. Rather than the body developing a proper immunological response, the live virus merged with the old virus in some patients, creating a more virulent strain of shingles.

Shingles Vaccine Lawsuit Centralization

In April, Merck filed a motion to consolidate all federal Zostavax lawsuits. The company proposed District Judge James S. Moody to preside over the litigation’s pretrial proceedings in the Middle District of Florida. This type of centralization is known as a multidistrict litigation (MDL). MDLs help streamline the pretrial process in large, complex litigations that otherwise could bog down the judicial system. They reduce duplicative discovery and sidestep conflicting pretrial schedules and rulings from different courts to serve the convenience of the judicial system as a whole.

Currently, there are at least 55 shingles vaccine lawsuits pending throughout nine different federal court districts nationwide.

The JPML issued the hearing session notice on June 15. In the notice, the panel scheduled oral arguments on the transfer motion to determine if it will establish a Zostavax MDL following the hearing on July 26 at the Santiago E. Campos United States Courthouse in Santa Fe, New Mexico.

The virus, varicella zoster, that causes chickenpox can reactivate later in life and cause shingles. Shingles is a painful rash that generally appears as a stripe of blisters. However, the pain can continue after the rash clears. Shingles can also cause hearing loss, vision problems, scarring, encephalitis, bacterial infections, and other serious complications.

According to the shingles vaccine lawsuits, Zostavax does not perform as advertised. Furthermore, the use of a live virus even increases the risk of developing the infection.

 

IVC Filter Plaintiffs Push to Remand Older Bard Lawsuits in MDL

By Emily Cox
IVC filter plaintiffs
Flickr/Daniel X. O’Neil

As the Bard bellwether trials continue to steam forward in the ongoing multidistrict litigation (MDL) over serious and sometimes life-threatening injuries caused by the company’s allegedly defective and dangerous blood clot filters, IVC filter plaintiffs are compelling the court to remand older cases back to their original U.S. District Courts. They indicate there is no reason to delay giving these individuals their chance at justice when their cases are ready for trial.

Currently, there are more than 3,500 cases over IVC filter complications pending against C.R. Bard in the federal court system. These IVC filter plaintiffs allege that Bard defectively designed several of its retrievable blood clot filters. Consequently, they are prone to moving out of position, puncturing internal organs, or fracturing, which causes metal shards to travel throughout the body.

Given the striking similarities between federal IVC filter cases, the courts centralized the litigation in August 2015 to streamline pretrial proceedings. District Judge David G. Campbell is presiding over the MDL in the District of Arizona. The MDL process reduces duplicative discovery into common case issues and circumvents conflicting pretrial rulings and schedules. However, at the time of the federal MDL’s establishment, there were already numerous “mature” cases that were already on the cusp of being ready for trial.

As part of these pretrial proceedings, the court selected a group of representative bellwether cases for a series of early trial dates. These early test trials help gauge how juries may respond to certain evidence and testimony that appears throughout the litigation. However, these cases did not necessarily include the litigation’s oldest claims. The court based its selections on their ability to help parties on both sides of the v. evaluate the relative strengths and weaknesses of claims that are common to the litigation.

IVC Filter Plaintiffs Request for Remand

The IVC filter plaintiffs filed their remand request on June 15. They are asking for the court to remand a previously identified group of ten “mature” cases back to their original U.S. District Courts for individual trial dates. Meanwhile, the MDL will continue with the bellwether process.

“Plaintiffs believe that the previously identified ‘mature’ cases should all be remanded to their courts of original jurisdiction at this point,” said the filing. “All common discovery, expert disclosure, and discovery has been completed; and this Court has ruled on all summary judgment issues, Daubert issues, and other generic issues that apply to all the cases in the MDL. Simply, further participation of these cases in the MDL will not provide any additional benefits to the parties and there is no reason to delay remand.”

The same submission included the plaintiffs’ proposed selections for the fourth, fifth, and sixth cases to proceed to trial in the MDL over the coming months.

Bard has indicated that it does not agree to the immediate remand of the ten “mature” cases. The medical device manufacturer contends that it will disrupt the bellwether process. However, plaintiffs counter that the parallel trial schedules will actually yield more data for all parties involved. Additionally, these ten cases are likely the oldest cases in the litigation. Consequently, plaintiffs point out that they would have had trial dates several years ago if it were not for the MDL’s establishment.

IVC Filter Litigation

The first Bard IVC filter bellwether trial went before a jury in March. The jury returned with a $3.6 million verdict that Judge Campbell recently upheld during post-trial motions. The second trial ended in a defense verdict earlier this month, and a third bellwether goes to trial September 18. The outcome of these bellwether trials has no real bearing on remaining MDL claims. But, the parties involved are closely watching them as they may influence IVC filter settlement negotiations in the future, sidestepping the need for thousands of separate trials nationwide.

Bard is not the only manufacturer that injured individuals are holding to task for patently defective and dangerous IVC filter designs. There are another 3,750 Cook IVC filter lawsuits pending in a separate MDL over substantial design defects that have severely harmed patients nationwide. Last month, a Texas jury awarded $1.2 million in damages to a firefighter who suffered serious injuries from a Cook Celect filter.

 

Physiomesh Failure Results in Irreparable Damage

By Emily Cox
Physiomesh Failure
New Jersey Superior Court – Bergen County (Flickr/Ken Lund)

According to a new hernia mesh lawsuit, Physiomesh failure resulted in debilitating pain and other serious complications that even future risky surgeries may be unable to resolve.

Merlene Jordan filed the complaint June 13 in New Jersey Superior Court. Jordan indicates that the patently dangerous and defective design of the hernia mesh caused Physiomesh failure, leading to severe reactions from which she may never recover. Johnson & Johnson and its Ethicon subsidiary pulled the hernia patch from the market in 2016 amid reports of similar and worse complications, including death.

Jordan indicates that she received a 15 x 20cm Physiomesh patch to repair an incarcerated ventral incisional hernia in September 2012. However, Jordan had to undergo additional invasive surgery in July 2014 to have a portion of the mesh removed after the defective device failed, leaving relentless severe pain, bloating, diarrhea, and constipation in its wake.

When doctors removed additional portions of the mesh in November 2014, they discovered that the mesh had literally fallen to pieces inside of Jordan’s body. The damage was so extensive that future surgeries may not even be possible to repair the wreckage the Physiomesh failure has left behind.

“Upon visualizing the Ethicon Physiomesh, [Jordan’s doctor] encountered fragmenting of previously placed Physiomesh to the point where it was difficult to recognize the mesh at all,” the lawsuit states. “Merlene Jordan continues to suffer complications as a result of her implantation with the Ethicon Physiomesh. Merlene Jordan is at a higher risk of severe complications during an abdominal surgery, to the extent that future abdominal operations might not be feasible.”

Physiomesh Failure Litigation

Jordan joins a growing number of individuals filing lawsuits nationwide due to similar complications from Physiomesh failure. They allege that J&J and Ethicon actively hid life-threatening risk factors to preserve profits at the peril of patients. While Jordan filed her case in state court, most complaints are pending in federal courts throughout the country.

Given the overwhelming similarities raised in lawsuits filed in nationwide district courts, the federal courts have consolidated all these Physiomesh cases. District Judge Richard Story is presiding over the multidistrict litigation (MDL) in the District of George to help streamline the complex litigation. The MDL process serves to reduce duplicative discover and avoid contradictory pretrial rulings that would further hold up the judicial process for these egregiously harmed individuals.

Currently, there are almost 1,000 claims pending in the federal Physiomesh MDL. Furthermore, a petition was filed earlier this year in New Jersey state court, requesting the establishment of similarly centralized management for all Ethicon hernia mesh lawsuits. If the court establishes a New Jersey Multicounty Litigation (MCL), Jordan’s lawsuit will be consolidated with dozens of other claims pending in the state court system where J&J’s U.S. headquarters call home.

MRI Gadolinium Deposits in Marine Life Could Cycle Back to Humans

By Emily Cox
Gadolinium
Flickr/Warren Lynn

Given the painful and debilitating health problems associated with gadolinium, concerns continue to mount that the MRI contrast dye could accumulate in patients. Now, a new study indicates that the toxic metal may be filtering through humans into the rivers and seas, impacting marine life. Consequently, it could come full circle back to humans eventually.

The medical journal Environmental Toxicology and Chemistry published the study. Polish researchers indicate that they found “hotspots” of gadolinium deposits in bodies of water. They cautioned that these could be dangerous for these aquatic environments. Furthermore, this could lead to the MRI dye cycling back into humans through the consumption of fish and other seafood.

Doctors commonly use gadolinium-based contrast agents (GBCAs) to enhance magnetic resonance imaging results. Patients receive them through an injection, and they eventually pass through the kidneys before the body expels them. But recent studies suggest that sometimes gadolinium can accumulate in the brain, tissues, and bones of patients over time. This leads to a painful and debilitating condition known as gadolinium deposition disease (GDD).

This latest study suggests that, when gadolinium successfully passes through the body, the toxic metal goes into the wastewater system, ending up in rivers, streams, and oceans. Researchers used a number of techniques, as well as previous literature and samples, to estimate how much of the metal is accumulating in the environment.

Gadolinium Study Findings

According to the study’s findings, the natural level of gadolinium (Gd) in river water is approximately 1-4 ng/L. However, researchers found it in surface waters, primarily rivers, in the U.S., Europe, Japan, Australia, and South Korea at levels as high as 181 ng/L. Wastewater treatment plant discharge points levels can reach 200-1,100 ng/L. Furthermore, researchers found that the concentrations were highest in river systems that were in regions with highly developed healthcare systems.

“Previous studies indicate that most of the Gd applied in MRI diagnosis is completely excreted out of the patient’s body. On the other hand, it was observed that a portion of Gd complexes breaks down under in vivo conditions and that this can be accumulated in patients’ tissue, bone, and probably brain,” the researchers noted. “Further researcher shows that even aquatic plants and organisms are able to take up Gd from water solutions. Because of negative effects for humans, these observations are important because Gd complexes may reach the human food chain via terrestrial plants growing in areas irrigated with polluted water or plants and animals growing in contaminated aquatic ecosystems.”

Gadolinium Health Threats

In December 2017, the FDA required a new Medication Guide to ensure patients were aware about the risk of MRI gadolinium injection deposits to accumulate in the body and brain. The FDA indicated that it has not been able to identify any direct evidence connecting gadolinium injections to serious health problems for individuals with normal kidney functions. However, numerous reports have emerged about individuals experiencing chronic pain, cognitive issues, skin problems, and other serious complications that appear to be toxic reactions to MRI contrast injections. Experts are now classifying these reactions as “gadolinium deposition disease.”

Independent reports indicate that these toxic reactions could result in painful and debilitating injuries. These include bone, joint, tendon, and ligament pain, as well as thickening of soft tissues, brain fog, and headaches among other issues. Experts consider the condition incurable and progressive. This means it gets worse over time, raising substantial concerns about the safety of GBCAs that are extremely common during MRI and MRA examinations.

Now, manufacturers are facing a growing number gadolinium lawsuits for failing to warn about the risk of gadolinium retention among those with normal kidney function.

The FDA mandated black box warnings on GBCAs like Gadavist, Omniscan, Magnevist, and others approximately 10 years ago. These warned doctors to ensure that patients have properly functioning kidneys before undergoing an MRI with contrast. However, individuals without pre-existing kidney problems claim that these dyes have also left them with permanent injuries.

 

 

 

Neonatal Abstinence Syndrome Study Suggests a Better Treatment Option for Babies Born with Opioid Addiction

By Emily Cox
neonatal abstinence syndrome
Flickr/David Herholz

As the opioid epidemic continues to ravage the nation, about one baby is born with neonatal abstinence syndrome every 20 minutes. However, doctors still have few proven options to treat infants who come into this world in opioid withdrawal.

“Despite the fact that we have seen increases in NAS in recent years, there is still significant uncertainty about who to treat, when to treat and what agents to use,” said lead researcher Dr. Jonathan Davis, vice chair of pediatrics at Tufts Medical Center. “And then there are questions about how fast to increase the dose, and how fast to take the babies off the medications.”

Now, a new government-funded study suggests that methadone has a slight edge over morphine in treating neonatal abstinence syndrome. Researchers indicate that methadone modestly reduces the length of treatment and hospitalization. Currently, about 80 percent of these cases are treated with morphine and 20 percent with methadone. Methadone is also a narcotic. However, it is less addictive than opioid painkillers such as morphine and oxycodone.

Neonatal Abstinence Syndrome Study

JAMA Pediatrics published the landmark study Monday. The National Institute on Drug Abuse funded the study, which is the largest of its kind. In the study, Davis first evaluated mothers who were in treatment for opioid addiction and taking medications like methadone and buprenorphine to aid their addiction recovery. However, commercial methadone solutions are not approved for pediatric use and contain alcohol as a preservative. Consequently, the FDA directed researchers to develop a custom formulation for the eight participating hospitals.

“In commercial methadone solutions, 15 percent is alcohol,” said Davis. “That’s double the amount of alcohol in a glass of wine. Most people I tell about this, they’re dumbfounded, partly because no one looks at the label.”

Researchers followed 116 babies born with neonatal abstinence syndrome for about a month. Those randomly assigned to receive the custom methadone treatment left the hospital about three days before those treated with morphine. The babies receiving methadone could stop their medication two days earlier, as well. Furthermore, methadone is longer-acting than morphine. Consequently, the babies only needed three doses a day compared to six doses of morphine. Researchers hope the study’s results will help establish a uniform strategy for treating neonatal abstinence syndrome.

“We hope people will look at these results and see the success and think, ‘that’s something we can also adopt’ so we don’t have hundreds of different approaches throughout the US for treating these babies,” said Davis.

Neonatal Abstinence Syndrome Study Result Implications

Methadone can be an effective way to ease adults off opioids by using drugs without the same high. However, some regulators and law enforcement officials remain skeptical about the safety and efficacy of drugs like methadone and buprenorphine. They question whether these drugs are simply substitutions for opioids. However, emerging studies suggest that people who use methadone or buprenorphine tend to go into remission sooner than those who don’t use these treatments. Davis is hoping that this holds true for newborns who became addicted to the painkillers in utero.

The new study did not consider costs associated with the methadone infants’ reduced hospital stays. But reducing hospitalization by even a day or two could mean big healthcare savings. A recent study found that hospital care costs for the about 23,000 infants a year who go through withdrawal was $1.5 billion. And that number is going up all the time. For example, in Pennsylvania, the number of drug-exposed newborns skyrocketed from 788 in 2000 to 3,289 last year. According to a Pennsylvania Health Care Cost Containment Council, about 60 percent of these babies suffered from neonatal abstinence syndrome. And since some hospitals are getting overwhelmed with these cases, some are even starting to send mothers home with methadone treatment kits. This is not an option with morphine due to its high abuse potential. Home treatment could compound these healthcare savings even further.

“Our study suggests methadone is a more effective agent,” Davis said. “And three times a day is a better approach than six times a day. There’s less chance for error. But I’d love to see a safer formulation.”

 

 

 

Opioid Settlement Talks to Include DOJ

Opioid Settlement
Flickr/Ryan J. Reilly
By Emily Cox

The Ohio federal judge presiding over the sprawling multidistrict litigation (MDL) over the pharmaceutical industry’s maniacal cash grab that fueled the ongoing opioid crisis decided Tuesday that the federal government may participate in opioid settlement discussions.

District Judge Dan Aaron Polster’s ruling will allow the U.S. Department of Justice (DOJ) to aid the court regarding nonmonetary settlements. In April, the DOJ indicated that its nationwide perspective on the opioid epidemic will ensure a resolution that is “structured to the serve the public interest.”

“The United States has expertise and information that can assist the parties in carefully crafting nonmonetary remedies that will effectively combat the opioid crisis on a nationwide basis,” the government claimed in its bid to participate in opioid settlement discussions.

According to its April filing, the DOJ’s participate in these discussions will also allow the government to recover some of the direct and indirect medical expenses stemming from the epidemic.

“The United States’ substantial financial stake in combating the opioid epidemic has implications for the proper allocation of any monetary settlement of the claims asserted in the multidistrict litigation,” the filing said.

Furthermore, plaintiffs’ lawyers reason that the government’s involvement in the prescription painkiller litigation could strengthen local governments’ negotiation position. However, they cautioned that it could also siphon off some of the restitution the look to claim.

Federal Government Opioid Settlement and MDL Interactions

The court handling the Opioid MDL has requested information from the government in the past. In March, the U.S. Drug Enforcement Administration (DEA) agreed to give the court the identities of drug makers and distributors responsible for 95 percent of opioid sales in every state from 2006 to 2014. Previously, the DEA would only release manufacturer data for 2012 and 2013. This data could affect which companies the court brings into the litigation and how it allocates damages among cities and counties. Consequently, this data is imperative to the MDL’s long-term goals.

The hundreds of lawsuits currently pending in the MDL allege that opioid manufacturers consciously overstated the drugs’ benefits while downplaying their significant risks when marketing them to doctors. Some of the claims are against the distributors for failing to monitor and report suspicious drug orders.

Heartburn Drugs Litigation in Delaware Seeks MDL Coordination

By Emily Cox
heartburn drugs
Flickr/Mike Mozart

As Nexium, Prilosec, and other claims over serious kidney injuries from popular heartburn drugs continue to flood courts nationwide, parties involved in the Delaware state-level litigation have put forward a plan to coordinate pretrial proceedings with the ongoing federal multidistrict litigation (MDL).

Delaware plaintiffs and the drug makers filed the proposed case management order on June 11 in the Superior Court of the State of Delaware. The order seeks full coordination and cooperation with the MDL and other coordinated state court litigations. The parties hope to avoid duplicative discovery while promoting the orderly handling of files.

Currently, there are approximately 4,500 cases pending in the federal litigation. These lawsuits assert that manufacturers failed to warn about the substantial risks of kidney problems from Nexium, Prilosec, and other proton pump inhibitor (PPI) heartburn drugs. However, state-level courts, including Delaware, continue to be overwhelmed by the magnitude of cases continuing to mount. Consequently, they are looking to the MDL to promote judicial efficiency.

“The Court and the parties are mindful of the desire for the efficiencies to be gained through the non-duplication of discovery between the Delaware PPI Actions and discovery taking place in the Other Consolidated Actions,” the proposed order states. “Accordingly, the parties shall not seek duplicative discovery between this action and discovery already taken in the Other Consolidated Actions.”

According to the order, parties should use all reasonable efforts to avoid or minimize duplicative motions, briefs, and discovery in a manner consistent with each parties’ individual interests. Consequently, this will require joint defense activities.

“[C]ooperation among the parties for purposes of this litigation shall not constitute evidence of conspiracy, concerted action or any other wrongful conduct,” the order notes.

Heartburn Drugs Kidney Risk Research

Plaintiffs with cases pending in courts across the country raise similar heartburn drug allegations. They indicate that manufacturers consciously concealed substantial kidney risks to maximize profits at the cost of people’s lives.

Manufacturers portrayed heartburn drugs as safe with few serious side effects, and, by and large, consumers have believed them. However, recent independent studies suggest that users face a greater risk for developing acute kidney injury, chronic kidney disease, renal failure, and other side effects.

In December 2014, the FDA required warnings about acute inerstitial nephritis (AIN), a form of kidney damage associated with PPIs, for the first time. AIN involves a sudden inflammation of the kidneys, which can lead to more serious problems.

Recent studies highlight the potential link between Nexium and kidney problems, indicating that the popular drugs may also cause acute kidney injury, chronic kidney disease, and end-stage kidney failure. These conditions often necessitate dialysis treatment, or even a kidney transplant.

In January 2016, the medical journal JAMA Internal Medicine published a study that found an increased risk of chronic kidney disease with the heartburn drugs. Researchers indicated that Nexium, Prilosec, and other PPI users may be 50 percent more likely to develop the condition compared to non-users.

In April 2016, another study supported these findings. Department of Veterans Affairs researchers found that users of PPIs may be 96 percent more likely to develop kidney failure and 28 percent more likely to develop chronic kidney disease after just five years of use.

Heartburn Drugs Litigation

Given the inherent commonalities in federal complaint allegations, the Judicial Panel on Multidistrict Litigation (JPML) centralized federal claims. District Judge Claire C. Cecchi is presiding over the entirety of the MDL in the District of New Jersey for coordinated discovery and pretrial proceedings. Eventually, the court should select a small group of cases for a series of early bellwether trials. The bellwether process helps litigation parties evaluate the relative strengths and weaknesses of their cases.  Furthermore, it serves as a gauge for how juries are likely to respond to evidence and testimony that appears throughout the litigation.

Given the widespread popularity and availability of these heartburn drugs, most are expecting that more than 10,000 individuals will eventually file PPI lawsuits nationwide. Following pretrial proceedings and the bellwether process, if parties still fail to negotiate settlements to resolve remaining cases, individual trial dates may be set in courts across the country throughout the coming years.

Ventralight Lawsuit Shows Gross Biological Incompatibility Associated with Mesh

By Emily Cox
Ventralight Lawsuit
Flickr/Simon Strandgaard

According to a new Ventralight lawsuit, Bard’s hernia mesh is biologically incompatible with human tissue, resulting in large numbers of serious and permanent injuries.

Florida resident Randell Rich filed the complaint June 8 in the District of New Jersey. He is naming C.R. Bard and Davol, Inc as defendants in one the most recent lawsuits in the sprawling hernia mesh litigation over debilitating injuries from the controversial implants. Reports of hernia recurrence, chronic pain, infections, adhesions, bowel obstruction, tissue necrotization, poor wound healing, additional risky surgeries, and death abound throughout the worldwide outcry against these patently dangerous medical devices.

On August 18, 2017, Rich underwent incisional hernia repair. He received a Bard hernia mesh during the procedure. His body immediately rejected the polypropylene product. Within two days, Rich’s debilitating symptoms necessitated revision surgery to remove the defective Ventralight mesh. The hernia mesh had already caused so much wreckage that he also had to undergo an abdominal wash, leaving him requiring home health care and a Wound Vac to repair just two days’ worth of damage.

Ventralight Lawsuit Alleges Negligence in Mesh Development

According to Rich’s Ventralight lawsuit, Bard blatantly ignored substantial scientific evidence and forewent proper testing to ensure the safety of its patients.

“The scientific evidence Defendant knew or should have known of demonstrates that the mesh is incompatible with human tissue and often causes a negative immune response in patients implanted with the Product, including Plaintiff,” Rich’s lawsuit states. “Defendant failed to perform proper and adequate testing and research in order to determine and evaluate the risks and benefits of the Product.”

Consequently, the product was made with ill-conceived materials and patients paid the price while Bard raked in the profits.

“The Product was made of materials which are biologically incompatible with human tissue and react negatively and sometimes dangerously with a large number of those on whom it is used,” Rich’s Ventralight lawsuit states.

Rich is presenting claims of design defect, manufacturing defect, failure to warn, negligence, breach of warranty, and violation of consumer protection laws.

Rich’s claims mirror those of a growing number of hernia patch lawsuits. He joins thousands of other individuals with permanent harm from the plastic mesh implants. They allege that recent mesh designs are far more dangerous than Bard and other manufacturers are telling consumers and the medical community. However, many of the more recent mesh designs carry a much higher profit margin. Consequently, manufacturers have actively concealed inherent risks.

In addition to Ventralight, thousands of injured patients are coming forwards against other polypropylene products, including Atrium C-Qur and Physiomesh.

Invokana Lawsuit Claims Manufacturer Misled Patients About Amputation Risks for Profit

By Emily CoxInvokana lawsuit

According to a new Invokana lawsuit, Johnson & Johnson and its Janssen subsidiary concealed circulation problems and other complications associated with their controversial diabetes drug, leading to a New Jersey man having to undergo multiple toe amputations due to these side effects.

David Bottner filed the complaint in the District of New Jersey on June 12. He indicates that the manufacturers knew that Invokana’s defects present substantial risks of lower extremity circulation problems, hindering the ability to heal and fight infections, which can spread to the bones and eventually necessitate amputations. However, J&J and Janssen actively concealed these risks to maximize Invokana’s marketing value, putting “profits over the safety and well-being of the consumers of Invokana.”

Bottner began taking Invokana in May 2016 to treat type 2 diabetes. However, Invokana’s side effects allegedly led to him having to undergo a partial amputation of his fifth toe in January 2018. He would lose the rest of the toe about a month later.

Bottner’s Invokana lawsuit indicates that the very mechanism that makes Invokana work, eliminating excess glucose through urination, causes the increase in amputation risks.

“One of the effects of the increased elimination via urination is volume contraction in the blood, which can reduce blood flow and thicken the blood plasma, creating circulation problems in the lower extremities,” the lawsuit states. “As circulation in the extremities worsens, the body is less able to heal and fight infections, which increases the risk of ulcers, and can lead to dangerous infections that may spread into the bones.”

Invokana Lawsuit Background

Invokana (canagliflozin) received FDA approval in March 2013. It was the first member of a new class of diabetes drugs, known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. These work in a unique way by altering normal kidney functions. Other SGLT2 inhibitors include Invokamet, Jardiance, Farxiga, Xigduo, and others. However, Invokana remains the biggest seller due to aggressive marketing.

In December 2015, the FDA required manufacturers to add new diabetic ketoacidosis warnings to Invokana. This serious condition typically requires emergency treatment to avoid life-threatening injuries. However, the previous labels failed to warn of the importance of seeking immediate medical attention for symptoms like abdominal pain, fatigue, nausea, respiratory problems, or vomiting.

In May 2017, the FDA mandated Invokana labels be updated once again to include leg and foot amputation risk warnings. Manufacturers of other SGLT2 inhibitors claim this risk is unique to Invokana.

Bottner’s Invokana lawsuit will join other similar claims pending in the ongoing federal multidistrict litigation (MDL) in New Jersey.

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