FDA Warns about Bone fracture risk from Invokana

invokanaThe U.S. Food and Drug Administration (FDA) has strengthened the warning for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet) related to the increased risk of bone fractures and added new information about decreased bone mineral density. Bone mineral density relates to the strength of a person’s bones. To address these safety concerns, it added a new Warning and Precaution and revised the Adverse Reactions section of the Invokana and Invokamet drug labels.

Health care professionals should consider factors that contribute to fracture risk prior to starting patients on canagliflozin. Patients should talk to their health care professionals about factors that may increase their risk for bone fracture. Patients should not stop or change their diabetes medicines without first talking to their health care professional.

Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. It is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet.

Earlier warning of bone fractures

Information about the risk of bone fractures was already in the Adverse Reactions section of the drug label at the time of canagliflozin’s approval. Based on updated information about bone fractures from several clinical trials, it revised the drug label and added a new Warning and Precaution. The additional data confirm the finding that fractures occur more frequently with canagliflozin than placebo, which is an inactive treatment. Fractures can occur as early as 12 weeks after starting the drug. In the clinical trials, when trauma occurred prior to a fracture, it was usually minor, such as falling from no more than standing height.

In addition, the FDA added new information about the risk of decreased bone mineral density to the canagliflozin label. A clinical trial that the FDA required the manufacturer of canagliflozin to conduct evaluated changes to bone mineral density over two years in 714 elderly individuals and showed that canagliflozin caused greater loss of bone mineral density at the hip and lower spine than a placebo. This new safety information has been added to the Adverse Reactions section of the drug label.

The FDA is continuing to evaluate the risk of bone fractures with other drugs in the SGLT2 inhibitor class, including dapagliflozin (Farxiga, Xigduo XR) and empagliflozin (Jardiance, Glyxambi, Synjardy), to determine if additional label changes or studies are needed.

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Plaintiffs 3-for-4 in Philadelphia Risperdal trials, confident punitive damages will be reintroduced

risperdal-infographicPHILADELPHIA – If the results of the first trials are any indication, Janssen Pharmaceuticals might find itself with a hefty price tag connected to more than 1,600 Risperdal cases currently pending in Philadelphia, even without the prospect of paying punitive damages – though an appeal might change that.

Risperdal, a prescription medication used to treat schizophrenia and bipolar disorder, has found itself the subject of lawsuits from male plaintiffs nationwide who were prescribed the drug and claimed to have suffered from gynecomastia, the development of female breast tissue.

This condition resulted from elevated levels of the hormone prolactin in the plaintiffs – which they allege is from their use of Risperdal.

Statistics recently issued by the Philadelphia County Court of Common Pleas Complex Litigation Center and its director Stanley Thompson stated a total of 1,606 Risperdal cases had been filed in the court system as of the end of November.

That figure will not be final either. The court will attract more cases in the future, as 95 were filed in November.

Three of the four trials that have concluded have resulted in victories for plaintiffs. Two have exceeded $1 million, and the other victory went for $500,000 – a total of $4.75 million to plaintiffs.

This is despite the fact that punitive damages have been disallowed in the cases, though plaintiffs attorneys have appealed that decision.

Speaking recently on behalf of fellow plaintiff liaison counsel Thomas Kline of Kline & Specter and Stephen A. Sheller of Sheller P.C., Christopher Gomez, also of Sheller P.C. expressed optimism that the ban would be lifted in the future.

“We are confident that at some point punitive damages will be reinstated,” Gomez said.

In February, the first of these cases to make its way through the CLC reached its conclusion. Alabama man Austin Pledger, who was prescribed Risperdal in 2002 as a teenager for treatment of mood swings related to his autism, developed size 46 DD breasts, allegedly as a result of taking the drug.

In 2002, Risperdal had not yet received Food and Drug Administration (FDA) approval for prescription to adolescents, but it would later receive such designation in 2006 – along with a causation warning that the drug may lead to gynecomastia in some male users.

Pledger asserted Janssen did not disclose the side effect to his doctors before he was prescribed Risperdal. A Philadelphia jury awarded Pledger $2.5 million in February, and post-trial motions are currently pending in the case.

However, Philadelphia County Court of Common Pleas Judge Arnold New ruled in June of last year that punitive damages were not applicable in cases involving Risperdal. In a post-trial motion in the Pledger case, New reiterated his stance in October of this year that punitive damages would not apply.

Though Janssen (a Johnson & Johnson subsidiary) is a Pennsylvania corporation, New stated the marketing and development for Risperdal, along with all relevant Food and Drug Administration correspondence regarding it, was addressed to Janssen’s principal business location in New Jersey – and was therefore bound by that state’s Product Liability Act.

Per that legislation, cases involving pharmaceutical manufacturers are only subject to punitive damages if it could be proven that the manufacturer knowingly concealed information about their product from the FDA.
In the case of William Cirba, the second plaintiff whose Risperdal case has reached the Philadelphia County Court of Common Pleas, Janssen emerged with a victory.

Cirba, 19, was prescribed Risperdal when he was six years old for the treatment of oppositional defiant disorder in 2002, and asserted he also grew breasts as a result of taking the drug.

Cirba added Janssen was aware of the presence of gynecomastia among a percentage of Risperdal users prior to 2006, but allegedly concealed the information from Cirba’s physicians.

In response, Janssen argued it provided sufficient caution of the risks associated with Risperdal to Cirba’s prescribing doctors and his gynecomastia wasn’t diagnosed until 2014, the year after he filed his lawsuit against Janssen.

In the end, the jury in Cirba’s case concluded his medical condition could not be connected to adverse side effects from Risperdal, though it further determined the company was negligent in warning of the risks of the drug.

A third trial, involving Maryland plaintiff Nicholas Murray, was recently decided in Murray’s favor for $1.75 million. Murray was prescribed Risperdal at the age of nine in 2003, for off-label treatment of symptoms associated with his Asperger’s Syndrome.

Like Pledger and Cirba, Murray also allegedly contracted gynecomastia as a result. The $1.75 million jury verdict represents damages for “disfigurement and mental anguish.” Post-trial motions in Murray’s case are also currently pending.

Stange v. Janssen Pharmaceuticals reconvened this month and resulted in a $500,000 jury verdict for the plaintiff, Timothy Stange.

Similar to the Cirba case, the jury found Janssen was negligent in failing to provide a warning about the drug. However, in this particular suit and unlike the Cirba case, the jury did conclude that same negligence directly caused Stange’s injuries. Stange is from Wisconsin.

“There have been three cases tried to jury verdicts. In each case the jury has found that Janssen failed to warn about the risk of gynecomastia in children and adolescents,” Gomez said before the Stange verdict.

“In two of the cases, there have been multimillion-dollar jury verdicts. We expect this trend to continue.”
When asked if counsel had any settlement talks with Janssen to this point, Gomez stated they had not and intended to continue to proceed with trials in each Risperdal case.

“There are no settlement talks at this time. We are prepared to continue to go and try the cases with Janssen/Johnson & Johnson,” Gomez said.

Gomez said Janssen’s Pennsylvania corporate base made Philadelphia an ideal venue for the cases to be heard.

Gomez explained 12 Risperdal cases are currently in discovery and heading to trial in 2016.

Defense liaison counsel in the Risperdal litigation – Kenneth Murphy of Drinker, Biddle & Reath and Stephen Imbriglia of Gibbons P.C., both of Philadelphia – offered no comment.

In an email statement, Janssen spokesperson Robyn Reed Frenze said the company “will continue to defend this litigation and will try cases where appropriate” regardless of where they were filed, and agreed with New’s decision to apply New Jersey law to these cases on the subject of punitive damages.

Frenze further commented, “Risperdal (risperidone) has helped and is still helping millions of patients with debilitating mental illnesses and neurodevelopmental conditions as part of a comprehensive treatment plan.”

An October Securities & Exchange Commission filing showed Janssen has created a reserve fund regarding pending product liability litigation.

From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at nickpennrecord@gmail.com

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Xarelto Lawsuit From Vermont Alleges Drug Caused Father’s Fatal Bleedout

XARELTOBloodThinnerHelp.com reports on a lawsuit filed in Vermont against the manufacturers of blood-thinning drug Xarelto: Bayer AG and Janssen Pharmaceuticals (a subdivision of Johnson & Johnson). This particular complaint was filed under case number 2:14-cv-00159-CR in a Vermont federal court by a young woman whose father died from uncontrollable bleeding complications. The lawsuit alleges that anticoagulant Xarelto caused the man’s uncontrollable bleeding and death.

The daughter’s complaint details that her father was prescribed Xarelto in an attempt to treat his atrial fibrillation. This is a fairly common heart condition which often makes the heart beat at a faster rate than normal. Atrial fibrillation can cause blood clots or strokes, so individuals diagnosed with the condition commonly use blood thinners as a preventative measure.

After using Xarelto for just a short time, the plaintiff’s father injured himself and began to bleed. He was rushed to the hospital, where doctors said he had suffered a parenchymal hemorrhage. Due to the active Xarelto in his system, the doctors were unable to control the man’s blood loss or get his blood to clot. They exhausted every attempt to keep him alive, which they were able to do for 6 days before he ultimately passed away.

Lack of antidote for the drug

Due to these circumstances, the daughter’s complaint directly addresses what many other Xarelto lawsuits do: the lack of antidote for the drug. Because Xarelto has no antidote, patients using the drug who begin to bleed have few options. In these circumstances, physicians simply cannot clot the blood, so they have to resort to extreme life saving measures such as surgeries to remove blood pools, or blood transfusions to replace lost blood.

Patients who use traditional blood thinners do not encounter these same issues. Traditional blood thinners have an antidote available in vitamin K. This means that when someone with a traditional blood thinner in their system begins to bleed, physicians can treat them with vitamin K, and this will counter the effects of the drug and allow their blood to clot.

In her complaint, the daughter states that had she and her father been previously aware of these dangerous factors concerning Xarelto, they would have chosen a safer alternative. Many plaintiffs involved in the current Xarelto litigation feel the same way. Lawsuits filed against Xarelto federally now number around 1,800 cases. They have been consolidated to form multidistrict litigation number 2592 in the Eastern District of Louisiana, and will be overseen by Judge Eldon Fallon.

Contact BloodThinnerHelp.com: Joseph Osborne, 866-425-8902, Boca Raton, FL

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Zofran Birth Defects Lawsuits Consolidated Before Judge Dennis Saylor, IV in the US District Court of Massachusetts

zofranBOSTON, Oct. 13, 2015 – Families across the country have filed 112 product liability lawsuits against GlaxoSmithKline (GSK) related to the pharmaceutical company’s blockbuster anti-nausea drug Zofran and congenital birth defects alleged to have been caused by their fraudulent misrepresentations to prescribing physicians about the safety profile of this drug for pregnant women.

Due to the large number of Zofran birth defects lawsuits against GSK, The United States Judicial Panel on Multidistrict Litigation (JPML) has ordered that all pending and future lawsuits be centralized in the District of Massachusetts before US District Court Judge Dennis F. Saylor, IV.  The lawsuits were consolidated into MDL No. 2657 on October 13, 2015.

An MDL is a special federal legal procedure that speeds up the process of handling complex cases, such as complex product liability lawsuits, by consolidating all of the cases before a single Judge to reduce the likelihood of duplicative discovery and conflicting pretrial rulings from different judges that could serve to slow a litigation down.  According to Walter Kelley, Managing Attorney of Kelley Bernheim Dolinsky’s Massachusetts office, “As a local law firm with one of the very first filed cases against GSK before Judge Saylor, we strongly advocated for Massachusetts to be the home court of this litigation. We look forward to moving these cases forward on behalf of the families who have entrusted us with protecting their rights and holding this company accountable.”

Zofran is a powerful drug developed by GSK and approved by the FDA in 1991 for use in cancer patients who required chemotherapy or radiation therapy.  Even though the only FDA approval for this drug was only for seriously ill patients, GSK began marketing Zofran “off label” as an established safe and effective treatment for  “morning sickness” without undertaking a single study establishing that this powerful drug was safe or effective for pregnant mothers and their growing children.

This lawsuit is not the first time GSK has been scrutinized in Court over Zofran.  In 2012, GSK pled guilty to criminal charges lodged by the United States Department of Justice, for its “off-label” promotion of its drugs for uses never approved by the FDA.  Around this same time, GSK also entered civil settlements with the United States that included more than $1 billion in payments to the federal government for its illegal marketing of various drugs, including Zofran specifically.  The civil settlement agreement reports GSK’s settlement of claims that GSK:

(a) “promoted the sale and use of Zofran for a variety of conditions other than those for which its use was approved as safe and effective by the FDA (including hyperemesis and pregnancy-related nausea)”

(b) “made and/or disseminated unsubstantiated and false representations about the safety and efficacy of Zofran concerning the uses described in subsection (a) [hyperemesis and pregnancy-related nausea]”

(c) “offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Zofran”

In one of the original Zofran Massachusetts lawsuits, Attorney Kelley alleges that as direct a result of GSK’s nationwide fraudulent marketing scheme, Plaintiff, a Massachusetts resident, gave birth in 20008 to a child who was born with congenital heart defects requiring immediate corrective surgery.  “Had Beth and her prescribing physicians known the truth about Zofran’s unreasonable risk of harm, long concealed by GSK, she would never have taken this drug, and her child would never have been injured,” said Kelley, who went on to say, “Sadly, it is too late to prevent this tragedy.  Our only recourse now is to hold GlaxoSmithKline fully accountable to this family for their actions; and we will work tirelessly to ensure they are financially able to provide the very best medical care available and help alleviate the lifelong burden that has needlessly been placed on their child.”

 

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222 IVC Filter Lawsuit Claims, and Rising

IVC FilterLegal-Bay LLC, The Lawsuit Settlement Funding Company, announced today that there has been a rise in IVC filter lawsuit claims against C.R. Bard Inc. and Cook Medical Inc. According to court records, the claims went from 189 in October to 222 in November. The lawsuits all have similar allegations, claiming that C.R. Bard Inc. and Cook Medical Inc. failed to let patients know that the IVC filters break, tilt, and migrate from the initial insertion position and then puncture the lungs, heart, or inferior vena cava. Different pretrial proceedings are already underway against the two manufacturers. The lawsuit claims against C.R. Bard over its Recovery and G2 IVC filters are consolidated in the U.S. District Court in the District of Arizona, while the claims againstCook Medical Inc. are pending in a multidistrict litigation (MDL 2570) in the U.S. District Court in the Southern District of Indiana.

IVCs are small filter devices designed to prevent blood clots from traveling from the lower body to the lungs, causing a pulmonary embolism. IVCs are intended to be temporary, but when left in place, the struts of these filters break loose. This breakage within the body can be life-threatening and has been known to cause serious injury and death. See Hundreds of Mass Tort Cases Filed Against Maker of IVC Filter

The IVC lawsuits also allege that Cook’s medical devices are defectively designed, are sometimes difficult to remove, and cause serious patient complications. Additionally, filings contend that Cook failed to provide sufficient warnings and instructions to physicians and their patients about the dangers and adverse effects caused by its filters.

The most commonly-claimed side-effects of the Cook IVCs are:

  • Perforation of the heart, lung or other organs
  • Punctured vena cava
  • Perforated aorta and fractured IVCs
  • Migration of filters from original position
  • Detached components of the device
  • Difficulty removing the IVC
  • Death

The Food and Drug Administration (“FDA”) is currently encouraging all doctors to remove IVC filters as soon as the risk of a pulmonary embolism is no longer necessary. The FDA issued warnings about the risk associate with the use of IVC filters in 2010 and again in 2014.

The cases are: In Re: Bard IVC Fliters Products Liability Litigation, MDL No. 2641 andIn Re: Cook Medical, Inc., IVC Filters Marketing, Sales, Practices and Products Liability Litigation, MDL No. 2570.

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$9.8 Million Judgment Against Johnson & Johnson and Ethicon Endo-Surgery for Defective Anal Stapler

anal stapler

A California jury awarded $9.8 million judgment against Johnson & Johnson’s subsidiaries Ethicon Endo-Surgery, Inc. and J&J Healthcare Systems for injuries to a retired policeman caused by a defective Ethicon PPH 03 hemorrhoid stapler. There was no offer of settlement.

The plaintiffs alleged, and the Alameda County Superior Court jury agreed, that during surgery on the plaintiff in January, 2012, the defective stapler misfired, sealing the client’s anal canal shut, leading her to suffer 21 days of emergency hospitalization, massive infection and major abdominal surgeries that resulted in a full laparotomy and a colostomy.

“This is a victory for all those who have been harmed by this known defective stapler,” said Richard Alexander, managing partner for the Alexander Law Group. “Our outstanding team included lead attorney Nina Shapirshteyn, and she was assisted by counsel Annie Wu. They did an outstanding job poring through more than 45,000 pages of documents and presenting the facts to the jury. But regardless of the amount of the verdict, nothing can replace the harm done to our client by this defective product,” Alexander added.

Forced to wear a colostomy bag

The primary plaintiff, Florence Kuhlmann, a retired San Jose police officer, continues to be plagued by external and internal scarring, continues to struggle with a deformed bowel, has been forced to wear a colostomy bag for the past four years and has had multiple medical procedures attempting to restore her damaged bowel and anal canal. Her husband, Dr. John Perkins, a Lawrence Livermore National Laboratory research scientist, was the other plaintiff.

“Our client has finally received justice,” said lead attorney Nina Shapirshteyn, who has been named one of the nation’s outstanding trial lawyers. “We were able to overcome a multi-billion dollar company and its high-powered legal team because the jury understood how this company deceived and harmed both the doctor and her patient with this defective medical device.”

The Ethicon PPH03 is used to allow general surgeons to perform a procedure known as a hemorrhoidoplexy that is not as drastic as a hemorrhoidectomy, which must be performed by a colorectal surgeon. Basically, the dangling hemorrhoids are pushed back up into the anus by the device, stapled against the rectal wall and then the excess hemorrhoidal tissues are cut above the staples by a circular knife in the device.

Defect known for 10 years

The jury found that the force to fire the stapler was in excess of its specifications and was caused by a defective manufacturing procedure that reduced the lubrication applied to the PPH 03, a defect which was known by Ethicon for more than 10 years before the product was recalled. Rather than changing the design and manufacturing process, Ethicon maliciously blamed the surgeons using the device when they reported repeated malfunctions.

“Doctors are only as good as the tools they are provided,” Ms. Shapirshteyn added. “In this case, the doctor was sold a defective product and the manufacturer knew it.”

During the procedure on the plaintiff, the surgeon, Dr. Rakhee Shah who was also a party to the lawsuit, inserted the PPH 03 and had difficulty firing it because of the lubrication defect. Not being able to remove the device, she fired it again, sealing the plaintiff’s rectal wall shut. The jury found Dr. Shah blameless because Ethicon and J&J Healthcare Systems never warned its customers that there were years of complaints from surgeons who used the device.

Eventually, Ethicon was forced to recall 144,693 PPH 03 units sold between 2011 and 2012 because of this dangerous defect. The stapler used on the plaintiff was from one of the lots later recalled.

Richard Alexander delivered a passionate and effective rebuttal to the defense attorney’s closing argument, convincing the jury that the defendant’s medical experts lied in several instances, that Ethicon covered up its culpability in not changing the manufacturing process to repair the force-to-fire defect and that Ethicon did not inform its hospital and surgery center customers of the dangerous defects reported by other surgeons.

The jury awarded the plaintiff and her husband $8.5 and $1.3 million respectively for past and future medical costs, pain and suffering, loss of consortium, embarrassment, humiliation and disfigurement.

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Upstate New York Trial Court Upholds $4 Million Jury Verdict for Mesothelioma Victim

 pleural-mesotheliomaNEW YORK, NY — A $4 million verdict in favor of a man who was exposed to asbestos while working as an internal grinder at a tool plant will stand, according to a Nov. 24 ruling by the New York Supreme Court for Oneida County, the law firm of Belluck & Fox, LLP announced today.

Attorneys from Belluck & Fox, LLP represented the plaintiffs in the case, which focused on liability for Nicholas Dominick’s exposure to asbestos that caused him to develop mesothelioma, a deadly form of cancer caused by asbestos exposure.

“Our client suffered greatly because of the presence of asbestos fibers in his workplace,” said Brittany Russell, the New York mesothelioma attorney who represented the plaintiff. “We are pleased for our client that the judge in this case properly upheld the jury’s verdict and substantial award of damages.”

Dominick worked as an internal grinder at the Chicago Pneumatic tool manufacturing plant from 1968 to 1973. During the course of his work there, Dominick was exposed to bags of asbestos and asbestos board supplied by Charles Millar Supply Co. The defendant, Pacemaker Steel & Piping Co., is Charles Millar’s successor in interest.

The jury in the case found Pacemaker 30 percent liable for the injuries Dominick suffered when he developed mesothelioma decades later due to his asbestos exposure at work. Jurors awarded the plaintiff $4 million.

Pacemaker asked the trial court to set aside the jury’s verdict or order a new trial on all issues. The trial court rejected that motion in its Nov. 24 order. The case is Dominick, et al. v. A.O. Smith Water Products Co., et al., No. CA2014-000232 (N.Y. Sup. Ct., Oneida Cty.).

The court rejected Pacemaker’s argument that it should have been allowed to call eight co-worker witnesses, finding that testimony from all eight would have been cumulative. The court also rejected Pacemaker’s arguments regarding causation, ruling that testimony from the plaintiff’s expert witness “afforded a rational basis for the jury’s verdict.”

The court also upheld the jury’s allocation of fault and award of damages. “There was significant evidence in the record as to Plaintiff’s past and future pain and suffering due to his mesothelioma,” the court said.

Brittany Russell, the New York City asbestos exposure attorney who represented the plaintiff, said the decision serves as reminder of the importance of legal assistance in mesothelioma cases. “The outcome of this case emphasizes how critical it is for victims of mesothelioma and other diseases caused by asbestos exposure to seek well qualified legal counsel to pursue a claim against the responsible parties,” he said.

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Recall of Pink Bikini Dietary Supplement – Undeclared Drug Ingredient

PinkBikini-Recall-121015Lucy’s Weight Loss System is voluntarily recalling all lots of Pink Bikini White powder Capsules, 30 white (750MG per capsule) to the consumer level. Pink Bikini has been found positive for diclofenac after FDA sampling and testing.

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). This medicine works by reducing substances in the body that cause pain and inflammation. Diclofenac can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. For those that are pregnant, taking diclofenac during the last three months of pregnancy may harm the unborn baby. This undeclared ingredient makes this product an unapproved new drug for which safety and efficacy have not been established. Lucy’s Weight Loss System has not received any reports of adverse events related to this recall to date. Lucy’s Weight Loss System is notifying its customers by Press Release and is arranging for return.

BACKGROUND: Pink Bikini is marketed as a weight loss dietary supplement and is packaged in clear bottle in
white powder capsules. The affected Pink Bikini and lots include the following expiration date 7/30/2017. Product was distributed nationwide to consumers via PinkBikini.BigCartel.com and Waisted With Lucy Retail store.

RECOMMENDATION: Consumers that have recalled Pink Bikini should stop using and discard.

Consumers with questions regarding this recall can contact Lucy’s Weight Loss System by phone (682)-308-0199 orpbfitme@gmail.com on Monday thru Friday 10:00am to 5:30pm CST.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Read the MedWatch Safety Alert, including a link to the firm Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm476499.htm 

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Diabetes Drug Invokana Linked to Serious Side Effects Including Kidney Failure and Ketoacidosis

invokanaFDA Revises Invokana Warning Label

According to the Invokana Legal Help Center, the most serious side effect concerns related to the Type 2 diabetes drug Invokana and other SGLT-2 Inhibitors involve a potential increased risk of diabetic ketoacidosis (DKA), a serious medical condition characterized by too much acid in the blood, but there have also been growing concerns about the potential for Invokana to cause kidney failure side effects in users.

For individuals who have been adversely affected by kidney failure side effects of Invokana, it is recommended to consult a knowledgeable Invokana attorney today for legal help. Victims may be entitled to financial compensation for injuries and medical expenses, which can pursued by filing a product liability lawsuit against Invokana maker Johnson & Johnson and its JanssenPharmaceuticals unit.

Possible Invokana Side Effects

Invokana (canagliflozin) is a prescription drug designed to control blood sugar levels in adults with Type 2 diabetes, which it does by inhibiting a protein called sodium-glucose cotransporter-2 (SGLT2), thereby preventing the kidneys from reabsorbing glucose and causing them to excrete more glucose in the urine. However, there have been dozens of reports of potentially life-threatening complications occurring in patients taking Invokana and similar SGLT2 inhibitors, and researchers have advised healthcare professionals to exercise caution when prescribing the diabetes medication, due to the risk that Invokana may increase a patient’s chances of suffering diabetic ketoacidosis or kidney failure complications.

Because Invokana is designed to act on the kidneys to lower glucose levels, the medication poses serious risks for patients who have pre-existing kidney problems. Even diabetes itself can cause damage to the kidneys over time, and patients with late-stage diabetes who take a drug like Invokana may significantly increase their chances of suffering kidney failure. In its QuarterWatch report released in May 2015, the Institute for Safe Medication Practices (ISMP) indicated that Invokana was named in more than 457 adverse event reports submitted during the first year the drug was on the market, including 54 reports of kidney damage or kidney failure. This report came on the heels of a drug safety communication from the FDA warning about the alleged risk of diabetic ketoacidosisside effects from Invokana.

FDA Revises Invokana Warning Label

In another FDA safety announcement issued in December 2015, the FDA added new warnings to the labels of SGLT2 inhibitors like Invokana, indicating that the diabetes drugs may increase the risk of complications like ketoacidosis and serious urinary tract infections, both of which can result in hospitalization. According to the December 2015 safety announcement, the FDA had also identified 19 cases of “life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections with the SGLT2 inhibitors reported […] from March 2013 to October 2014. All 19 patients were hospitalized, and a few required admission to an intensive care unit or dialysis in order to treat kidney failure.”

An Experienced Invokana Lawyer Can Help

In light of these serious risks, the FDA is requiring the makers of Invokana and other SGLT2 inhibitors to conduct post-marketing research to identify reports of spontaneous diabetic ketoacidosis and other side effects in patients treated with the diabetes drugs. If you took an SGLT2 inhibitor like Invokana, and you have since been diagnosed with diabetic ketoacidosis, kidney failure or another serious medical condition, an experienced Invokana attorney can help. With a qualified lawyer on your side who has experience handling Invokana injury claims, you can ensure that your legal rights are protected, and seek fair and timely reimbursement for your injuries, past and future medical costs, and pain and suffering.

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Lawsuits against VW to be consolidated in Northern California

VW-Emissions-300x200The Judicial Panel on Multidistrict Litigation on Tuesday consolidated more than 500 suits accusing Volkswagen of cheating emissions standards, saying California federal court in San Francisco is the best venue given that nearly one-fifth of the suits were filed in the Golden State.

The U.S. Judicial Panel on Multidistrict Litigation, which heard arguments last week on where to transfer more than 500 class actions filed by Volkswagen consumers in 60 federal courts. Volkswagen wanted the cases consolidated in Virginia or Detroit.

“Relevant documents and witnesses may be found in both the Northern District and throughout California, given the role played by the California Air Resources Board in uncovering VW’s use of defeat devices on its diesel engines,” the panel wrote in a seven-page order.

The JPML assigned U.S. District Judge Charles R. Breyer to oversee the MDL, saying the veteran federal judge is well-versed in complex MDLs, having presided over nine such cases.

“We are confident that Judge Breyer will steer this controversy on a prudent and expeditious course,” the order states.

Tuesday’s transfer order is the latest in a sprawling case that alleges that Volkswagen used defeat devices in some of its “clean” diesel vehicles in order to appear to comply with emissions standards while exceeding allowable levels of chemicals emitted into the air.

The vast majority of cases against Volkswagen are nationwide class actions filed by consumers alleging they were duped into paying premium prices for “clean diesel” cars that the U.S. Environmental Protection Agency has said emit as much as 40 times the standard for nitrogen oxides. Volkswagen has admitted that 11 million vehicles, including 482,000 cars in the United States, have a “defeat device” in them designed to cheat emissions tests.

The plaintiffs in the various suits are represented by Hagens Berman Sobel & Shapiro LLP, Quinn Emanuel Urquhart & Sullivan LLP, Heninger Garrison Davis LLC, Girard Gibbs LLP, Hellmuth & Johnson PLLC, The Schmidt Firm PLLC, Morris Polich & Purdy LLP, among many others.

Volkswagen is represented by Mayer Brown LLP.

The case is In re: Volkswagen Clean Diesel Marketing, Sales Practices, and Products Liability Litigation, case number 2672, before the Judicial Panel on Multidistrict Litigation.

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