Author: massadmintort

Can Xarelto Trial Data Be Trusted?

Trepidations have been brought up that a medical device used in Xarelto’s clinical trial was defective, which may have influenced test results as more Xarelto lawsuits are added to the multidistrict litigation. Although Janssen Pharmaceuticals and the study’s authors maintain the study’s conclusions are accurate, their critics demand for an investigation to be done.

ROCKET-AF trial (Rivaroxaban Once Daily Oral Direct Factor XA Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) which was published in 2011 in the New England Journal of Medicine, is the study in question. That study discovered that both rivaroxaban (the generic version of Xarelto) and warfarin – the older-generation anticoagulant – each lessened the risk of systemic embolism or ischemic stroke. The study also found no substantial difference between warfarin and rivaroxaban in the risk of a major bleeding event, but found rivaroxaban was linked with a lower risk of bleeding in the brain and fatal bleeding.

Janssen and Bayer Pharmaceuticals banked only on ROCKET-AF when it applied for approval from the FDA and European regulators according to editors at The BMJ (2/3/16). The study utilised a device known as an INRatio Monitor System, which measures the period it takes for blood to clot and which was recalled in December 2014 due to “clinically considerably lower” test results than patients might see in laboratory testing.

“In terms of the trial results, it could make rivaroxaban seem safer than it was in terms of the risk of bleeding and throws doubt on outcomes used to support the use of the world’s bestselling new oral anticoagulant,” Deborah Cohen writes in The BMJ “A falsely low reading could mean that patients had their warfarin dose unnecessarily increased, leading to a great risk of bleeding.”

Various critics have asked for an independent investigation of the ROCKET-AF trial, to find out whether the results were lopsided by the faulty device. The BMJ claims the FDAhas promised to review relevant data. However, the makers of the recalled device claim their own analysis confirmed the results of the study.

According to reliable reports, the study’s authors studied data and discovered that the likely device’s malfunction “did not have any substantial clinical effect on the major efficacy and safety results in the trial.” The European Medicines Agency is also quoted to have said that the recalled device did not influence the ROCKET-AF trial results.

There were 2,826 lawsuits consolidated for pretrial proceedings in MDL-2592, In Re: Xarelto (Rivaroxaban) Products Liability Litigation before US District Judge Eldon E. Fallon as of January 15, 2016.

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Get Compensated By Filing Byetta and Januvia Lawsuits

Prescription drugs such as Byetta and Januvia are popular Type 2 diabetes treatments, but claims of perilous side effects including pancreatitis and pancreatic cancer bring up questions about whether the drugs’ health risks are greater than their benefits. Most individuals who have experienced these dangerous side effects have filed lawsuits against the manufacturers of these defective drugs of these drugs asking for financial compensation for the trouble they have been through after using their medications. Eli Lilly and Bristol-Myers Squibb and Merck have benefited tremendously from the sale of Byetta and Januvia respectively without considering the risks they are putting their consumers.

The U.S. Food and Drug Administration approved Byetta, and Januvia in 2005, and 2006 respectively. These drugs are classified as incretin mimetics. The FDA has already issued warnings associating the drugs to serious illness like pancreatic cancer since being approved. However, they are still on the market, putting diabetic individuals at risk.

Lawsuits claim the manufacturers of Byetta and Januvia sold these blockbuster drugs to unknowing patients when knowing to an extent of the drugs’ link to pancreatitis and pancreatic cancer. The argument here is that they failed to tell the public of these warnings so as to protect their investment as a result risking the lives of many people. If you or a loved one has experienced serious side effects from using Byetta and Januvia then you are entitled for financial compensation for you troubles to cover your medical bills and other related issues.

Status of Byetta and Januvia Lawsuits

It is believed these diabetes drugs have been prescribed to millions in the U.S alone since hitting the market. Countless patients were diagnosed with pancreatic diseases from using Byetta and Januvia and thus filed lawsuits against the drugs’ makers. Similar lawsuits are expected to increase similarly as people come into terms with the risks of using these diabetes drugs.

Actually, the state of California received so many lawsuits such that they had to organize them into groups. The U.S. District Court for the Southern District of California grouped hundreds of Byetta and Januvia personal injury cases together for discovery. The cases were filed against manufacturer and marketers of Byetta, Amylin Pharmaceuticals and Eli Lilly and Company as well as Januvia maker Merck & Co., Inc., and various Merck affiliates.

How We Can Help

Patients turn to medications such as Byetta and Januvia since the drugs’ manufacturer assure them that their treatments can assist keep diabetes in check. But, they fail to adequately warn them that they may develop diseases that are much dangerous than diabetes.

If you or a loved one has experienced serious side effects from using Byetta and Januvia then our lawyers at Injury Lawsuit Help can help you file a successful lawsuit against these unscrupulous companies. We will look at your case in depth to confirm that you are entitled to compensation without charging you a penny. Our personal injury lawyers are well acquitted with defective drugs lawsuits and offer abundant help when it comes to these cases.

 

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ISMP Questions Invokana Safety

In recent times, Janssen Pharmaceuticals has received numerous lawsuits filed by patients claiming to have suffered serious side effects after using Invokana. While the drug hasn’t been in the market that long, the Institute for Safe Medication Practices (ISMP) has already raised apprehensions about the risk of kidney problems and diabetic ketoacidosis (DKA) linked to Invokana (known broadly as canagliflozin).

In the lawsuit filed last December, the appellant claimed that he started using Invokana back in November 2013 to control his blood sugar levels according to the Legal Examiner (2/8/16). Upon using Invokana to treat his diabetic condition, he started having serious kidney problems, which eventually turned to kidney failure. The litigation claims that the drug makers failed to adequately warn patients about the risk of life-threatening side effects of Invokana, and the appellant claims he wouldn’t have taken the drug if he was made aware of its risks.

An ISMP Quarter Watch report looks at the safety of Invokana and probes “whether enough is known about this agent to be certain that its benefits prevail over its risks.” In March 2013 is when Invokana was approved, however ISMP says a key issue with the medication is that it causes “significant extents of sugar to be defecated in the urine.” The organization claims most of the antagonistic event reports could have been soundly predicted, given how the medication functions.

As a matter of fact, the ISMP notes that during the first year of approval, 457 serious adverse event reports were linked to Invokana – some of which may overlap in the same individual – including kidney stones (11 cases), urinary tract infections (50 cases), dehydration and fluid imbalances (54 cases), kidney failure or damage (54 cases), and anomalous or other weight loss (52 cases). Two types of hypersensitivity were also recognized: rapid swelling of the face, throat, lips, or tongue; or skin rashes.

“The unanswered question about canagliflozin – shared in part by other diabetes drugs – is whether it has medical benefits, and whether those benefits are greater than its risks,” ISMP writes. It points out the drug was approved when it hadn’t been tested in enough individuals within the required time scale to find out if it is safe to use.

The US Food and Drug Administration (FDA) issued a drug safety communication about SGLT2 inhibitors (the class of drug that includes Invokana) on May 15, 2015. The issuance contained warning about SGLT2 inhibitors links to keroacidosis, in which an individual’s body yields high levels of blood acids. The FDA updated that warning to include a risk of urinary tract infections by December of that year. The FDA also noted it had recognized “19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that began as urinary tract infections with the SGLT2 inhibitors reported to FAERS from March 2013 through October 2014.”

Individuals who have suffered serious side effects from using Invokana have filed defective drug lawsuits against the drug makers and marketers.

 

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What You Need To Know About Byetta and Januvia Lawsuits

Byetta and Januvia are drugs commonly used in the United States to treat Type 2 diabetes. While Byetta and Januvia have been approved for use by FDA since 2005 and 2006 respectively, numerous lawsuits have been filed claiming that these diabetes medications led to serious, sometimes life-threatening complications.

The lawyers at injurylawsuithelp.com have years of experience representing individuals in numerous personal injury cases including lawsuits for those you have experienced adverse side effects after using a particular defective drug. We have been successful in countless of lawsuits filed against international companies like Merck who decided to put profits before the safety of patients.

It is believed that Merck currently manufactures of Januvia made billions of dollars from the sale of this blockbuster drug. In fact, Januvia outperformed every other Merk product in terms of sales. While Byetta which is made by Amylin, Eli Lilly and Bristol-Myers Squibb, have earned millions in sales of the drug over the years. Our experienced personal injury lawyers assist patients who have been using these diabetes medications for years and experienced adverse side effects so that they could get compensated.

Byetta and Januvia– how do they work?

People who cannot produce enough insulin suffer Type 2 diabetes. Insulin role in a human body is transport sugar from blood into cells. Sugar is essential for cells’ growth and survival. On the other hand, when blood sugar is high, patients risk liver and kidney damage, blindness, heart disease and and other serious conditions.

Both Byetta and Januvia assist control the effects of an enzyme (called DPP-IV) that interferes with the body’s release of insulin. They belong to a class of drugs called incretin mimetics. Byetta evades DPP-IV by providing insulin-stimulating proteins that are immune to the enzyme’s effects while Januvia prevents the enzyme from working. In 2005, Byetta was approved by the FDA approved for patients whose blood sugar could not be properly regulated using existing medications. The FDA approved Januvia as the first so-called DPP-IV inhibitor in 2006. A DPP-IV inhibitor is a new type of diabetes medication that, in conjunction with diet and exercise, could assist individuals with Type 2 diabetes regulate their blood sugar levels.

Byetta and Januvia Complications

Both Byetta and Januvia have various side effects, some of which are quite insignificant. However, both medications have pancreatic cancer links, which normally forms the basis of Byetta and Januvia lawsuits.

Byetta’s Complications include:

  • Severe allergic reactions
  • Pancreatic cancer
  • Thyroid cancer
  • Acute pancreatitis
  • Kidney damage or failure

Januvia’s serious side effects include:

  • Pancreatitis (inflammation of the pancreas) that can be fatal
  • Kidney failure
  • Thyroid cancer
  • Pancreatic cancer

Talk to a Reputable Personal Injury Lawyer

Here at injury Lawsuit Help, our main aim has always been in helping injured individuals get their day in court. We believe that no one should have to risk life-threatening complications such as pancreatitis, thyroid cancer or pancreatic cancer simply because they use a certain diabetes medication. But if a person with diabetes does experience complications then they deserve full compensation.

 

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Asbestos Mesothelioma Widow’s $2.3 Million Award Postponed Once More

Back in April, 2015, an appellate court asserted a lower court’s verdict and ruling to grant $2.3 million in reparation upon the conclusion of an Asbestos lawsuit filed by Frank and Charlotte Vinciguerra against the drug’s makers.

The Asbestos lawsuit is Charlotte Vinciguerra v. Bayer Cropscience Inc. et al., Case number 447 EAL 2015, in the Supreme Court of Pennsylvania, Eastern District.

In spite of the appeal, the case isnt over since the Pennsylvania Supreme Court has decided to hear a challenge by a defendant to find out if a defendant might have the legal aptitude to ask jurors to agree whether or not a product purported to have contributed to a diagnosis of mesothelioma on the part of Frank Vinciguerra may have undeniably been “irrationally perilous.”

Having lost her husband, Frank, to asbestos mesothelioma, Charlotte Vinciguerra has no option but to endure the process alone after the latest setback.

According to court records, Frank Vinciguerra worked as a sheet metal worker for E.I. DuPont Nemours & Co. at its Chambers Works facility in Deepwater, New Jersey for more than 30 years.

In his Asbestos lawsuit, Mr. Vinciguerra claims he was often forced to fashion and set up gaskets made from Cranite, a component manufactured by Crane Co. and purported to have asbestos. Vinciguerra would later be diagnosed with malevolent asbestos cancer – Mesothelioma – and afterward loss his battle with the deadly malady.

Amongst other issues, Crane Co., it has been reported, set forth its position that the industrial products company was bigoted by the original trial court’s refusal to allow a jury instruction saying that a product is defective when the lack of instructions or warnings render it “not reasonably safe.”

In April, the appellate court disagreed with that notion.

“Upon review of the record, we conclude that the requested instruction was not justified by Crane’s notion of the case and the evidence it offered at trial,” the appellate court said in April. “Crane’s defense was not that Cranite was not ‘unreasonably dangerous.’ Rather, Crane affirmed that Cranite was not dangerous at all.”

Crane appealed the appellate court’s decision to Pennsylvania’s highest court, submitting numerous issues. It has been reported the Court dismissed Crane Co.’s petition in virtually every aspect save for one: whether the 2014 Tincher v. Omega Flex Inc. decision permits “a defendant in strict-liability claim based on a failure-to-warn theory [the] right to have a jury determine whether the product was ‘unreasonably dangerous.”

The Tincher verdict struck down the longstanding 1978 judgment in Azzarello v. Black Brothers Co., which barred all proof of negligence in strict liability cases. The Tincher verdict also adopted a shift in jury directives.

At the moment, there is no indication that Crane Co. will pursue the matter to a higher court if the Pennsylvania Supreme Court struck down its petition. However, there is no sign to suggest it will give up yet. Thus, Frank Vinciguerra’s widow has no choice but to continue seeking compensation for her loss.

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Zofran Judge Sided with Claimants, Rebuffs GSK Motion to Dismiss

Last December, GlaxoSmithKline (GSK) argued that all the federal Zofran lawsuits be thrown out of the court, but the federal judge sided with over 200 plaintiffs who claimed that GSK failed to give warning on their anti-nausea drug links to birth defects. They believe it was their responsibility to warn patients of Zofran’s links to birth defects so that users could decide whether to use the drug or not.

According to drugwatch.com, GSK claimed that the cases be dismissed since claimants’ allegations of failure to warn are centered on various state laws, not federal, and the FDA would have rejected a bid for label change. However, Judge Saylor gave a go ahead in the plaintiffs’ case against the Zofran manufacturer. As much as the judge verdict came as a victory for many plaintiffs, their lawyers have a real task on their hand.

Zofran was never approved by the FDA as it was deemed not necessary due to the fact that the drug was mainly used for morning sickness off label only. Moreover, there isn’t considerable public proof confirming Zofran causes birth defects when used by pregnant women. However, Zofran manufacturer, GSK may be telling us less than they know.

A California mother, Zinat Torres filed a Zofran lawsuit last December claiming that GSK carried out further animal studies after Zofran entered the US market that showed increased risks of harm to fetuses in animals exposed to ondansetron [Zofran’s active ingredient] prenatally. It is on the basis of this lawsuit that plaintiffs use to argue their case.

Claimants in their lawsuit (the case is In Re: Zofran [Ondansetron] Products Liability Litigation, case number 1:15-md-02657, in the U.S. District Court for the District of Massachusetts) argue that GSK carried out a couple of “animal teratogenicity studies” in Japan where pregnant animals gave birth to offspring with heart defects, i.e. ventricular septal defects. These studies were never made public by GSK. Instead, Zofran’s warning label reads as follows:

“Reproduction studies have been performed in pregnant rats and rabbits at I.V. doses up to 4 mg/kg per day and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron.”

Is GSK withholding important information?

While it is not the first time that GSK appears to be withholding information as far as Zofran is concerned, it could prove to be critical for those still using the anti-nausea drug.

Torres’s lawsuit (MDL No. 1:15-md-2657-FDS) also claims that GSK didn’t perform a few medical trials establishing the efficacy and safety of Zofran for treating pregnant women before it promoted Zofran off label for morning sickness. While studies are usually NOT conducted on pregnant women, GSK performed animal studies in the 1980s that caused malformations in offspring and, intrauterine deaths and also revealed that Zofran’s active ingredient could be passed to the fetuses from pregnant mammals. It isn’t rocket science to figure out that the same could happen in pregnant women.

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Xarelto Lawsuits Are Gaining Momentum by the Day

Xarelto lawsuits alleging patients suffered severe bleeding events after using the anticoagulant drug are gaining momentum, with over 2,000 lawsuits awaiting courts to listen. Accusers claim they were not warned Xarelto had no antidote and were not warned about the risks of a serious bleeding event while using the drug.

As of December 15, 2015, there were 2,400 lawsuits merged for pretrial proceedings in MDL 2592 (In Re: Xarelto (Rivaroxaban) Products Liability Litigation, before US District Judge Eldon E. Fallon) according to reports from the Judicial Panel for Multidistrict Litigation (JPML). While the growth of the MDL has slowed down somewhat from October, there is still a substantial number of lawsuits added to the MDL every month. Up to 2,266 lawsuits were consolidated as of November 16, 2015, which was up from the 1,698 lawsuits consolidated by mid-October.

Lawsuits claims users were not warned that Xarelto, unlike Coumadin, did not contain an antidote to the medication’s anticlotting property. Xarelto is an anticoagulant, used to lessen the risk of blood clots and strokes. However it, like its precursor Coumadin, is related with an augmented risk of serious bleeding events due to its anticlotting mechanism.

Having been in the markets for decades, Coumadin has an antidote in the form of vitamin K. Users who suffered a bleeding event and received medical care in time could end the adverse condition. However, individuals using newer anticoagulants such as Xarelto, presently have no recognized antidote. That means if they suffer a bleeding event, they have to wait for the drug to leave their system. Appellants claim that they wouldn’t have used Xarelto if they had known it didn’t have an antidote.

The first bellwether trials in the Xarelto lawsuit are not expected to go to court until early 2017. In a case management order (11/30/15), Judge Fallon noted that the two sides could not resolve differences regarding discovery pool appellants and bellwether trial appellants, and gave out orders about how cases could be carefully chosen for inclusion in the discovery pool. The judge also noted that four cases will be chosen as bellwether cases but did not issue an order on choosing bellwether trial cases.

Janssen Pharmaceuticals who manufactured Xarelto, maintains the medication is not perversely perilous and the warnings given on the drug usage are sufficient.

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