Category: Defective Drugs

Xarelto Manufacturers Cherry Picked Early Trial Venues

By Emily Cox
Xarelto Manufacturers Cherry Picked Early Trials
Flickr/Mihir

It appears that Xarelto manufacturers may have stacked the deck against early trial plaintiffs in the multidistrict litigation (MDL) over the companies’ failure to adequately warn about the blood thinner’s dangerous bleeding risks.

Xarelto manufacturers first sought to centralize the litigation on home turf in corporate-friendly New Jersey. However, the Judicial Panel on Multidistrict Litigation (JPML) chose to consolidate federal Xarelto lawsuits in Louisiana instead. Following this decision, Xarelto manufacturers quickly devised a way to regain the upper hand in the litigation, while limiting its scope.

Lexecon v. Milberg Weiss, 523 U.S. 26 (1998), holds that MDL district judges lack the authority to try cases that originate outside of the transferee court. However, this ruling strikes at the very judicial efficiency that is at the heart of MDL formulation and the bellwether trial process. Consequently, the ruling also provides for Lexecon waivers that must be signed by both plaintiffs and defendants so that the bellwethers represent patients across the country rather than just the MDL district. Generally, these waivers are signed with little fanfare. But, they are not compulsory. Consequently, Xarelto manufacturers Johnson & Johnson and its Janssen unit used these waivers to choose their battlefields for the bellwether trial process.

Xarelto Manufacturers Refuse to Sign Lexecon Waivers

Refusing to sign the Lexecon waivers was a calculated move to limit the scope of the early trial process. According to the Lexecon ruling, Xarelto manufacturers could have hypothetically limited the litigation to only Louisiana cases. However, in an effort to keep the court’s favor, the drug makers consented to allowing plaintiffs from the entire 5th circuit. This consists of Louisiana, Mississippi, and Texas. Judge Fallon noted this concession during oral arguments on limiting the bellwether trial pool so severely.

The associated case management order also indicated that plaintiff attorneys were free to choose seven plaintiffs from states of their choosing. However, this was more of a symbolic gesture. Without the defendants signing off on Lexecon, cases outside of the 5th circuit were inherently illegible for the bellwether process regardless. Judge Fallon indicated as much during the hearing. He indicated that he would simply wash his hands of these cases, remanding them back to their original courts.

“If they [Xarelto manufacturers] don’t agree, it doesn’t matter whether or not you should try a case filed in New York or whatever,” Judge Fallon said.

“I’m going to just send them back to wherever they came from, and let you try them.”

This put plaintiff attorneys between the proverbial rock and a hard place by essentially limiting their trial picks to the 5th circuit’s three states. Their only chance for success was to pick the best defendants from those states, rather than the best overall cases. Furthermore, in conceding to accept Texas and Mississippi cases, Xarelto manufacturers not only appeased the court enough to reject plaintiff attorney objections. They also ensured these cases landed in courts that may provide some of the more favorable outcomes for the defendants in the nation.

Xarelto Manufacturers Steered MDL Litigation Toward Favorable Outcomes

Allowing Mississippi and Texas cases into the bellwether process was by no means a gesture of goodwill. All three states in the 5th circuit have provisions that could ensure that the bellwether process goes smoothly for the drug makers.

The Louisiana Learned Intermediary Doctrine absolutely annihilated the first two bellwether trials. The doctrine holds drug makers only need to inform doctors of risks, negating labeling issues. Unfortunately, plaintiff doctors vigorously defended the Xarelto manufacturers rather than their patients. Testimony depositions from the doctors in both trials read like primers for “How a prescribing physician should testify to support a learned intermediary doctrine defense.” Doesn’t sound like the drug makers had a hand in that at all

In August, the MDL moves to Mississippi. While plaintiff attorneys stand a better chance at winning here, the victory will be marginal. Mississippi imposes a $1 million cap on noneconomic damages. Most of the plaintiffs are elderly and do not work. Consequently, noneconomic damages pretty much encapsulate the entirety of their compensation. Furthermore, these early trials help establish future settlement amounts. A Mississippi victory will undoubtedly lower the potential value of these settlements.

The final bellwether trial will take place in Texas. Unfortunately, the state requires evidence of FDA fraud to bring failure to warn claims. Granted, this is a product liability litigation. However, Xarelto manufacturers’ failure to warn is the very basis of the litigation.

Consequently, due to the drug makers’ maneuvers, the Xarelto bellwethers could very well paint a bleak, if incomplete, picture of the litigation’s potential.  Plaintiffs and attorneys would do well to remember that, regardless of the bellwether outcomes, they are only a fraction of the bigger picture.

Lawsuits Against Xarelto Manufacturers

The FDA approved Xarelto in 2011 to treat atrial fibrillation and reduce blood clot risks. The agency has expanded the drug’s indications several times since then despite the fact that the drug has no reversal agent to stop emergency bleeding. Other anticoagulants, like Coumadin (warfarin) have antidotes to reverse their blood thinning effects in emergency situations. However, patients were never warned of these life-threatening risks. Regardless, Xarelto still quickly became one of the drug makers’ star performers.

Xarelto made $582 million in sales during its first full year on the market. In 2013, this figure rose to $2 billion for the fiscal year. Xarelto is now Bayer’s top-selling product. It brought in $2.5 billion in sales in 2015 and $3.24 billion in 2016. It is third on Johnson & Johnson’s product roster, generating $2.29 billion for the company in 2016. Like many meteoric climbs to come before it, sacrifices were made. Unfortunately, these sacrifices may have been the health of the very patients Xarelto was purportedly designed to help.

More than 18,000 individuals have filed product liability lawsuits against Xarelto manufacturers after suffering from uncontrollable, life-threatening bleeding. They allege that the drug makers knew about the substantial risks of the anticoagulant but never warned patients. Instead, the companies downplayed the risks to boost sales.

Benicar Lawsuits Filed by Almost 2,000 Over Gastrointestinal Problems

By Emily Cox
Benicar Lawsuits
Benicar Litigation Continues to Grow. (Flickr/Martin Bowling)

Almost 2,000 Benicar lawsuits are now pending against Daiichi Sankyo and Forest Laboratories over the drug makers’ failure to warn the medical community, patients, and federal regulators about the popular blood pressure drug’s risk of chronic diarrhea and gastrointestinal problems.

According to this week’s docket update, there are now 1,942 Benicar lawsuits pending in the multidistrict litigation (MDL). However, historically, there have been 2,254 lawsuits against the drug manufacturers, and lawsuits continue to mount. These lawsuits all indicate that the drug makers knew about the connection between Benicar and gastrointestinal distress, including debilitating diarrhea. However, these companies concealed this risk for years in order to maximize profits at the expense of patients who might not have wished to incorporate uncontrollable diarrhea into their daily blood pressure regulation regimen.

Some plaintiffs allege that Benicar caused them to have 10 to 20 diarrhea attacks per day. Therefor, this led to malnutrition and the loss of up to 100 pounds. As a result, others experienced malnutrition complications such as cataracts and infections. A few have even died from the severity of their gastrointestinal issues and related complications.

Furthermore, gastrointestinal issues from Benicar may not surface immediately. It could take months, or even years, after patients start taking the drug. Consequently, many doctors didn’t recognize that Benicar was causing these issues. So, patients remained on the drug, increasing the risk of permanent intestinal damage, known as villous atrophy.

Benicar Lawsuits Litigation

Finally, in July 2013, the FDA mandated the drug manufacturers update Benicar warnings. The agency indicated that there was unmistakable evidence that the drug may cause severe diarrhea problems. As patients began to realize that Benicar was causing their gastrointestinal issues, they began seeking retribution for the harm these companies inflicted willfully on them for financial gain. In 2015, the Judicial Panel on Multidistrict Litigation (JPML) centralized all federal Benicar lawsuits in the District of New Jersey. District Judge Robert Kugler is presiding over the litigation.

The MDL presses forward this week with Daubert hearings to establish scientific grounds for plaintiff claims. Depending on the outcome of these hearings, the court will schedule a series of bellwether trials. These early trials will help gauge how future juries will likely react to evidence that is central to the litigation.

 

Manufacturers Press for Low Dose Xarelto Market Expansion

By Uzma Rahman & Emily Cox

Low Dose Xarelto ProposedIn the face of more than 18,000 lawsuits over alleged life-threatening bleeding from the controversial blood thinner, manufacturers are now taking strides to expand their billion dollar baby’s market share even further by seeking FDA-approval to treat recurrent venous thromboembolism (VTE) with low dose Xarelto.

10 mg Xarelto only currently has FDA-approval to treat deep vein thrombosis (DVT) prophylaxis after hip or knee surgery. Of course, Xarelto manufacturers claim that this market expansion is purely altruistic to give patients more treatment options. However, given these companies’ track records, it seems more probable that they just want a piece of the action. With an estimated 900,000 cases of VTE in the U.S. each year, Xarelto manufacturers have much to gain by getting low dose Xarelto into the portion of the market deemed at high risk for higher dosage amounts of the drug.

Manufacturer Announces Low Dose Xarelto

In its Wednesday press release, Johnson & Johnson’s Janssen unit stated the FDA granted priority review of the supplemental drug dispensation for low dose Xarelto. Janssen hopes to gain considerable ground for the blockbuster anticoagulant by expanding its indications. The blood thinner is already phenomenally popular. Unfortunately, as more people use it, more reports of uncontrollable bleeding occur. Doctors are unable to stop the bleeding and serious, sometimes fatal side effects occurred.

Will Low Dose Xarelto Actually Help?

The drug company asserts 10 mg of Xarelto is more effective than aspirin at preventing recurring VTE. VTE is a condition that can cause deep vein thrombosis and pulmonary embolism, both of which can be fatal.

A study sponsored by the drug company shows taking low dose Xarelto reduced the risk of blood-clot recurrence by 70 percent when compared with aspirin. However, the study randomized patients to 20 mg or 10 mg Xarelto or to aspirin 100 mg daily. Recurrent VTE occurred in 17 of 1,107 patients taking 20 mg and in 13 of the 1,127 treated with the 10-mg dose. Among 1,131 patients receiving aspirin, 50 patients reported VTEs. Interestingly, the major bleeding rates were similar in both Xarelto doses (0.5% and 0.4% for 20 mg and 10 mg, respectively). The rate was also low, 0.3%, in the aspirin control group.

The FDA’s priority review designation means that the agency believes the low dose Xarelto version could offer significant health benefits. However, it also shortens the review period of the drug from the standard ten months to only 6 months. This accelerated review advances the FDA’s target date to October 28, 2017.

Xarelto Bleeding Risks

The FDA approved Xarelto in 2011 to treat atrial fibrillation and reduce risks associated with blood clots. The agency has expanded its indications several times since then. It quickly became one of the manufacturers’ star performers. Xarelto made $582 million in sales during its first full year on the market. In 2013, this figure rose to $2 billion for the fiscal year. Xarelto is now Bayer’s top-selling product, bringing in $3.24 billion in sales in 2016 and $2.5 billion in 2015. It is third on Johnson & Johnson’s product roster, generating $2.29 billion for the company in 2016. Like many meteoric climbs to come before it, sacrifices were made. Unfortunately, these sacrifices may have been the health of the very patients Xarelto was purportedly designed to help.

In 2014, the Institute for Safe Medicine Practices (ISMP) reported 3,331 individuals suffered adverse Xarelto events. Of these, 1,647 experienced hemorrhagic bleeding. According to FDA reports, the drug is also responsible for at least 370 deaths.

Xarelto Lawsuits

Many of these are injuries are due to the fact that the companies released the drug without a readily available antidote to stop emergency bleeding. Whereas, vitamin K will reverse the effects of the standard blood-thinner Coumadin (warfarin). Consequently, more than 18,000 individuals have filed product liability lawsuits against the manufacturers over serious uncontrollable bleeding. Two early Xarelto trials ended in victories for the defense. However, the primary determining factor of these trials was a Louisiana doctrine that holds if the doctors claim to be aware of the risks at the trial, then the manufacturer is freed from liability. Both doctors depositions practically read like primers on how to testify for a defensive win with this doctrine.

Luckily, the next two trials will take the litigation out of Louisiana and hopefully away from this damaging piece of legislation. The next trial begins August 7 in Mississippi.

 

Testosterone Bellwether Cases Selected For Trial

By Uzma Rahman
Early Testosterone Trials Set for Everett McKinley Dirksen United States Courthouse
Early Testosterone Trials Set for Everett McKinley Dirksen United States Courthouse (Flickr/Ken Lund)

A U.S. District Judge will soon hear two testosterone bellwether cases. Bellwether trials refer to a small group of cases from a larger litigation pool that the court selects for early trials. These trials show how future litigation may play out. Consequently, they are very useful for potential mass torts.

Taking on Testosterone

In recent years, testosterone therapy underwent a popularity rise. Testosterone is a hormone that plays a critical role in the male reproductive system. But it is also key for muscle mass, bone health and energy levels. While heavily prescribed, testosterone therapy is not always the best solution. Studies suggest many men are in danger of heart attack, stroke, or wrongful death from testosterone treatments.

Moreover, 6,500+ claims against the makers of Axiron, AbbVie, Androgel, Testim and various other testosterone replacement drugs are on file in U.S. courts. The lack of adequate warnings of the potential risks appears most often in the allegations. Hence, the testosterone bellwether trials may help the other pending claims.

So far, the first testosterone bellwether resulted in a mistrial. The claim alleged Androgel caused a heart attack. A second Androgel bellwether trial is scheduled to begin early next month, with a third case set to begin on September 18, and a fourth case against AbbVie in January 2018.

Additional bellwether trials over injury claims from Auxilium Pharmaceuticals’ testosterone gel, Testim, should begin in early November 2017 and April 2018.

A Look at the Two Testosterone Bellwether Claims

Recently, U. S. District Judge Matthew Kennelly scheduled a series of early trial dates against each of the major drug makers involved in the litigation. The parties can then gauge how juries may respond to certain evidence and testimony.

Then on June 22, Judge Kennelly issued a case management order naming two complaints that will serve as  the two bellwether claims against Eli Lilly over Axiron. The trials will go to court in January and March 2018.

The first complaint was filed by Tracy Garner of Alabama in March 2015. His claim alleges he suffered a heart attack from Axiron after only three days of testosterone treatment.

The second complaint was filed by John Debroka, Jr. of Florida in October 2015. His claim alleges he suffered a deep vein thrombosis from Axiron side effects just a few months after beginning testosterone therapy.

Most importantly, while the results of these cases are not binding on the plaintiffs, they may be useful in establishing settlement agreements. Ultimately, settlements help resolve the issues without expending court resources.

Generic Invega Recall Issued Due to Dissolution Problems

By Emily Cox
Generic Invega Recall
Photo by Open Grid Scheduler / Grid Engine

The drug manufacturer has issued a generic Invega recall as testing indicates that its extended-release tablets may not enter patients’ systems at the correct rate.

Teva Pharmaceuticals and the FDA announced the generic Invega recall this past Thursday after some pills failed a dissolution test. This suggests that less of the medication may be absorbed and consequently, may not work correctly.

Paliperidone Extended Release Tablets, 3mg treat schizophrenia and shizoaffective disorders. Teva Pharmaceuticals distributes the medication nationwide in the US to wholesalers. The FDA and manufacturer warn that consecutive doses of the defective product could wreak havoc on a patient’s mental well-being. It could even pose a threat to those around the affected individual.

“Taking a product for the treatment of schizophrenia and schizoaffective disorders that has failed dissolution could result in less drug being absorbed,” the FDA cautioned. “If two or more consecutive dosing regimens are with affected product, a failure to maintain therapeutic levels could occur, which could reduce effectiveness in treating a patient’s mental and/or mood symptoms, including suicidal thoughts and behavior, self-injurious behavior, mental hospitalizations, assaults, aggressive behavior, as well as vocal and motor tics.”

Teva has determined that there is low probability of consuming two or more consecutive doses of the affected product. Furthermore, the FDA has not received any post marketing adverse event reports for lack of effectiveness of the recalled lot. However, Teva issued the generic Invega recall voluntarily to prevent the possibility of either scenario.

Generic Invega Recall Instructions

The generic Invega recall affects 360 90-count bottles of Paliperidone Extended-Release Tablets, 3mg. The Actavis Pharma Inc. label distributed them between December 12, 2016 and March 16, 2017. The recalled bottles have a 6/2018 expiration date. Their lot number is 1160682A, and NDC number is 0591-3693-19.

Teva issued an Urgent Drug Recall Letter to its buyers, asking them to return existing inventory and notify affected customer of the generic Invega recall. Consumers with questions should contact Teva by calling 888-836-2872, selecting option 3, and then option 4. They can also email druginfo@tevapharm.com. The FDA urges consumers to contact their healthcare provider and/or pharmacist if they experience any product-related problems.

Problems Beyond the Generic Invega Recall

Invega and a similar drug, Risperdal, have come under scrutiny in recent years. Scientific studies have linked the side effects of both antipsychotic drugs to an increased risk of breast growth in boys and young men. This rare medical condition is called gynecomastia. The resulting breasts often require surgical removal. Furthermore, hundreds of Invega and Risperdal lawsuits claim that the damage extends beyond physical injury. They assert that the psychological effects of young male breast growth can have a devastating impact, greatly diminishing overall quality of life.

 

Second Trial Over Xarelto’s Bleeding Risks Results in Defensive Win

By Emily Cox
Xarelto Bleeding Risks
Photo by JouWatch

A federal jury cleared Johnson & Johnson and Bayer AG of failing to warn consumers of Xarelto’s bleeding risks in the second trial among thousands of lawsuits, alleging serious bleeding injuries from the controversial blood thinner.

The New Orleans trial centered on the 2015 death of Sharyn Orr. Joseph Orr and her children brought the lawsuit. She died about a year after she started taking Xarelto for atrial fibrillation. They allege the drug makers were responsible for her fatal hemorrhagic stroke. She died at the age of 67 after being in a coma for 10 days. Orr says his wife’s death was completely avoidable and that the drug manufacturers had a duty to warn patients and the medical community about Xarelto’s bleeding risks. Furthermore, he claims they knew and concealed this information for financial gain from the blockbuster drug. However, Orr failed to convince the jury, resulting in yesterday’s verdict.

Many legal experts thought that this outcome was a definite possibility based on the previous trial that had determined warnings about the drug’s bleeding risks were adequate. The defense in the first trial relied heavily on a Louisiana  learned intermediary doctrine to negate any label failings. It provides that as long as the doctor is aware of the risks, the manufacturer cannot be held liable for them.  Unfortunately, both doctors’ from these first two trials’ testimony deposition read like guides on “How a prescribing physician should testify to support a learned intermediary doctrine defense.” Furthermore, Johnson & Johnson and Bayer specifically selected this case for trial.

Xarelto Bleeding Risks

The FDA approved Xarelto in 2011 to treat atrial fibrillation and reduce risks associated with blood clots. It quickly became one of the manufacturers’ star performers. Xarelto made $582 million in sales in its first full year on the market. Sales skyrocketed to $2 billion in 2013. However, the companies released the drug without a readily available antidote to stop emergency bleeding. Whereas, vitamin K will reverse the effects of the standard blood-thinner Coumadin (warfarin). Unfortunately, this has led to exceptionally high rates of adverse event reports, regarding serious bleeding incidents.

Since then, about 18,600 individuals have filed lawsuits that contend Xarelto is unreasonably dangerous. They further allege that the manufacturers failed to warn about the serious risk of uncontrollable, irreversible bleeding.

The next two trials will take the litigation out of Louisiana and into Mississippi and Texas, starting in August. Maybe a change of scenery will be just the thing.

 

 

 

AbbVie Hit with $15M Depakote Verdict in Birth Defect Trial

By Emily Cox
AbbVie Hit With Depakote Verdict
Photo by Nana B Agyei

A federal jury found that AbbVie Inc’s blockbuster bipolar drug Depakote caused birth defects in a California woman’s son, awarding $15 million in damages Friday.

Jurors in Illinois federal court awarded the compensatory damages to Stevie Gonzalez. Gonzalez was born with spina bifida. Jurors agreed that AbbVie did not adequately warn his mother, Christina Raquel, or her prescribing physicians of the increased risk of having a baby born with this condition. However, the verdict does not include punitive damages to punish the company for its behavior.

The 10-year-old boy’s mother took Depakote for bipolar depression during pregnancy. As a consequence of his condition, he’s undergone 12 surgeries and is confined to a wheelchair.

The Depakote label only indicated that the risk of spina bifida was one to two percent. However, the risk stands at more than 10 percent. Gonzalez’s legal team argued that AbbVie made a conscious decision to hide the elevated risks to protect profits generated by one of its star pharmaceuticals. Depakote was the first of AbbVie’s drugs to hit $1 billion in sales. According to his lawyers, company officials knew that Depakote was “one of the most toxic drugs to a human baby” and downplayed these risks.

“There was an avalanche of information,” one of his attorneys said during closings this past Wednesday. “And they just ignored it.”

The panel awarded the money to cover Gonzalez’s medical bills and future care. His lawsuit is one of about 700 pending against AbbVie over Depakote.

AbbVie Depakote Trials

This is AbbVie’s second Depakote loss so far. A St. Louis jury awarded $38 million to a girl afflicted with spina bifida in 2015. Unlike Gonzalez’s trial, this verdict also included $23 million in punitive damages. Another case settled in June 2016 during jury deliberations. Another trial hits St. Louis state court on July 24 with another in Illinois federal court in September.

AbbVie spun off Abbott Laboratories in 2013. The company retained liability for the Depakote lawsuits.

 

Louisiana Doctrine Scores Defensive Win in 1st Xarelto Trial

By Emily Cox
Doctrine and Doctors Secure Defensive Win in Xarelto Trial
Image by Mike Licht

Earlier this month, Johnson & Johnson, its Janssen Pharmaceuticals unit, and Bayer relied on a learned intermediary doctrine to dodge civil charges of withholding vital information about the blood thinner that could have saved lives.

Joseph Boudreaux filed the lawsuit. He claimed that he started taking Xarelto in 2014 to lower his risk of stroke due to atrial fibrillation. He suffered life-threatening gastrointestinal bleeding less than a month after starting treatment with the anticoagulant.

Boudreaux’s doctors succeeded in saving his life. However, he required multiple blood transfusions, resulting in medical bills totaling more than $100,000. He blamed the drug’s manufacturers of failing to provide adequate warnings about the risks associated with their drug. Furthermore, he sought to recover damages for his substantial injuries.

When the case ended in May 2017, the Louisiana jury returned a defense verdict. They found the drug makers were not liable for failure to warn. The next trial is scheduled to begin at the end of the month in Louisiana.

Former FDA Commissioner Testified on Boudreaux’s Behalf

During the trial, former FDA commissioner Dr. David Kessler testified on regulatory matters. He said that Xarelto manufacturers withheld essential information about the drug and its effectiveness. This information could have prevented excessive bleeding injuries and deaths.

Kessler criticized the drug makers for failing to provide doctors and patients with adequate warnings about the risks associated with the drug. According to Kessler, the manufacturers should have recommended regular blood monitoring to ensure patients’ safety. Instead, the companies overstated the convenience of Xarelto, telling doctors and patients that blood monitoring wasn’t necessary.

Boudreaux’s counsel also emphasized that Xarelto, unlike warfarin, has no readily available antidote for excessive bleeding, escalating the already significant dangers to patients. A hematologist even testified that Xarelto was a substantial factor in Boudreaux’s gastrointestinal bleed.

Defendants Rely on Learned Intermediary Doctrine

Unfortunately, despite incontrovertible evidence, Xarelto manufacturers emerged victorious. In Louisiana, drug makers only need to warn doctors of the potential side effects of a drug. The learned intermediary doctrine provides that as long as the doctor is aware of the risks, the manufacturer cannot be held liable for them. Boudreaux’s doctors testified that they were aware of the bleeding risks and were right to prescribe Xarelto. Consequently, the jury ultimately agreed with the drug makers.

Nearly 18,000 other Xarelto lawsuits are pending across the country.

 

Aspirin Used with Xarelto and Eliquis Linked to Deadly Side Effects

By Emily Cox
Aspirin Bleeding Reports
Photo by Paul Lim

A new drug safety report indicates that Xarelto, Eliquis and other blood thinners may have caused increased reports of bleeding problems with aspirin.

The most recent edition of the Institute of Safe Medication Practices (ISMP) QuarterWatch Report evaluated all FDA adverse event reports over a 12-month period, ending September 30, 2016. Researched noticed a marked increase in reports involving aspirin-related bleeding events, resulting in thousands of injuries and almost two hundred deaths. However, they suggest that patients using Aspirin while taking Xarelto and Eliquis may have caused these bleeding incidents. These anticoagulants have already gained notoriety for causing bleeding problems.

“Our interest was spurred when an unexpectedly large number of serious adverse drug events in 2016 Q3 were attributed to the ubiquitous and invaluable drug aspirin,” the report states. “For the most recent quarter, aspirin was the primary suspect drug in 2,134 reported cases, including 169 patient deaths and 1,137 gastrointestinal hemorrhages. In another ranking of the new quarter of data, aspirin accounted for more serious injuries to U.S. patients 75 years and older than any other therapeutic drug.”

Given aspirin’s time on the market and exceptional track record, the anomaly intrigued researchers. As a result, they took a closer look at the numbers. They found that the injured patients were taking aspirin with Xarelto, Eliquis, Pradaxa, and other prescription-strength blood thinners.

Researchers found that 87.4 percent of the case reports were bleeding events. They also noted that previous studies showed that using Xarelto and aspirin simultaneously increases the bleeding risk up to four times. Long-term use of similar blood thinners and aspirin caused bleeding injuries in 10 to 15 percent of patients each year. Life-threatening bleeding events occurred in two to four percent of patients.

Xarelto and Eliquis Pose Risk Even Without Aspirin

Xarelto, Eliquis, and Pradaxa are new novel oral anticoagulants. Manufacturers introduced them as superior alternatives to warfarin (Coumadin). Warfarin has been the go-to anticoagulation treatment since the 1960s.

Manufacturers marketed these drugs as easier to use. They claimed that they do not require the same monitoring to ensure proper dose like warfarin. However, unlike warfarin, manufacturers released these drugs into the stream of commerce without a readily available reversal agent. Vitamin K reverses warfarin’s blood thinning effects to stop bleeding in an emergency. Consequently, thousands of reports indicate that users experienced severe and uncontrollable bleeding incidents.

However, the drug makers’ did not warn about the lack of an effective reversal agent. As a result, tens of thousands of individuals have filed Xarelto, Pradaxa, and Eliquis lawsuits after suffering life-threatening bleeding.

First Invokana Trial Scheduled for September 2018

By Emily Cox

The first Invokana trial will begin in September 2018 and will Invokana Trial
help gauge how juries are likely to respond to allegations that the manufacturers failed to warn about the new-generation diabetes treatment’s substantial risks.

District Judges Brian Martinotti and Louis Goodman issued the case management order this past week. The order outlined the schedule for selecting initial trials. As a result, the judges indicated that the court expects that all pretrial motions will be complete for the first Invokana trial to begin in September 2018.

The judges are calling for all parties to submit a proposal to identify the process for selecting early bellwether cases by June 1. An agreement on the number of cases for the proposed trial pool is due by August 31. Furthermore, core discovery for these cases will take place between September 1 and December 15.

The order is also calling for both sides to provide case recommendations for the trial pool by January 5, 2018. Based on these recommendations, the court will select three bellwether Invokana trial cases by January 19, 2018.

If the manufacturers fail to reach settlement agreements or another resolution after these test trials, individual claims may proceed forward with separate trial dates.

Invokana Trial MDL

In December 2016, the Judicial Panel on Multidistrict Litigation (JPML) centralized all product liability lawsuits against Johnson & Johnson’s Janssen Pharmaceutical unit. Consequently, they consolidated all claims over serious injuries allegedly caused by the diabetes drug Invokana in New Jersey.

Currently, there are more than 230 Invokana claims in the multidistrict litigation (MDL). These allege that the manufacturers put their financial health before public health. These individuals claim that J&J and Janssen withheld key information about the medication’s serious health risks. These risks include diabetic ketoacidosis, kidney failure, heart attack, and other debilitating injuries. Allegedly, the very mechanisms that allow the drug to control blood sugar substantially elevate these risks. Invokana works by forcing the kidneys to excrete excess blood sugar through urination. Forcing substantial amounts of unmetabolized glucose through the kidneys places enormous pressure on the body. Consequently, many Invokana users have found themselves seriously injured. Most of these individuals’ injuries required hospitalization, and some of them will never recover.

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