Invokana Diabetes Drug Plaintiffs Seek Product Liability MDL in New Jersey

invokana-warning kidney-damageDozens of plaintiffs who suffered kidney damage or ketoacidosis have filed a motion to create new MDL 2750 for Invokana (Canagliflozin) Products Liability Litigation in federal court in New Jersey.

There are at least 56 actions pending in 11 different judicial districts against defendants Johnson & Johnson of New Brunswick, NJ, Janssen Pharmaceutical Inc. of Titusville, NJ (a J&J subsidiary) and Tanabe of Osaka, Japan.

The motion proposes that the Judicial Panel on Multidistrict Litigation (JPML) appoint Judge Brian R. Martinotti in the US District of New Jersey. He is already supervising 36 Invokana cases. The plaintiff’s attorneys are Christopher A. Seeger and Jeffrey Grand of Seeger Weiss in New York

Invokana went on sale in 2013 to treat type 2 diabetes by inhibiting renal glucose reabsorption with the goal of lowering blood glucose. Canagliflozin is a member of the gliflozin class of pharmaceuticals, also known as sodiumglucose cotransporter 2 (“SGLT2”) inhibitors.

Off label marketing

The defendants marketed and continue to market Invokana for off label purposes, including weight loss, reduced blood pressure, and improved glycemic control in type 1 diabetics.

In June 2016, the FDA released a safety announcement concerning canagliflozin and dapagliflozin, strengthening the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).

The FDA added a further warning for ketoacidosis, including “Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization have been identified in postmarketing surveillance in patients with type 1 and type 2 diabetes mellitus receiving sodium glucose cotransporter-2 (SGLT2) inhibitors, including INVOKANA.”

The FDA added even more warnings in August 2016. Also see: Health Canada Warns of Diabetic Ketoacidosis from Invokana Diabetes Drug

The federal court in New Jersey has been home to mass tort litigation involving the Zimmer Durom Hip Cup, Tropicana Orange Juice Marketing, Vytorin/Zetia Marketing, and Hypodermic Products Antitrust litigation.

Judge Martinotti was the mass tort judge in New Jersey state court in Bergen County from 2009 to 2016. In that position he supervised litigation involving Mirena Yaz, Yasmin, Ocella, and the DePuy ASR Hip Implant.

The motion will likely be heard at the JPML next meeting on Dec. 1.

 

 

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More Risperdal Cases Set for Trial in Philadelphia

Derek T. Braslow
Derek T. Braslow

Eight cases involving the antipsychotic drug Risperdal are set for trial against Janssen Pharmaceuticals in the Philadelphia Court of Common Pleas, with the company settling cases even as it denies that the drug causes disfiguring gynecomastia in boys.

Risperdal, a prescription medication used to treat schizophrenia and bipolar disorder, has caused gynecomastia, or the development of female breast tissue, according to leading plaintiff’s lawyer Derek T. Braslow of Pogust, Braslow & Millrood in Conshohocken, PA. This condition resulted from elevated levels of the hormone prolactin in the plaintiffs – which they allege is from their use of Risperdal.

Read these updates:

Risperdal Docket in Philadelphia Court of Common Pleas

Plaintiffs Settle Risperdal Case with Johnson & Johnson in Philadelphia Court

New Judge Knocks Out Plaintiff’s Expert, Abruptly Dismisses Risperdal Case

$70 million Verdict against Janssen Pharma in Risperdal Breast-Growth Case

The litigation has been continuing for three years, with 2,000 plaintiff cases filed in Philadelphia and the next trial set for January.  Another 16,000 case are consolidated in California Superior Court in Los Angeles with the first trials set for July.  Three earlier trials have resulted in verdicts in favor of the injured plaintiff in the amount of $2.5 Million, $1.75 Million, and $500,000.  In all the trials, juries have found that J&J failed to adequately warn of the risks of gynecomastia.

Fined $2.2 Billion

Janssen, a subsidiary of Johnson & Johnson, never got approval to market the drug for minors. Johnson & Johnson was fined more than $2.2 billion in criminal and civil fines in November 2013. It settled accusations that it improperly promoted the  drug to older adults, children and people with developmental disabilities, according to the Justice Department.

Kentucky Attorney General Jack Conway announced a $15.5 million settlement in December 2015 with Johnson & Johnson regarding Risperdal. The consumer protection lawsuit charged that Johnson & Johnson falsely marketed the drug and hid the side effects from consumers.

Former commissioner of the U.S. Food & Drug Administration (FDA) David Kessler testified in 2015 that the company hid information about the gynecomastia risk as early as 6 years before it changed the drug’s label to include the injury, which is characterized by abnormal breast tissue growth in adolescent boys and young men. He also told the jury that Janssen failed to inform physicians of the gynecomastia risk associated with the drug.

Scientific research supports claims that Risperdal may cause gynecomastia in boys. A study published in a 2006 issue of the Journal of Clinical Psychopharmacology indicated that risperidone, which is the generic of Risperdal, “administered to adolescents at doses commonly used for the treatment of psychotic symptoms can strongly increase prolactin levels, with clinical consequences such as gynecomastia.”

Braslow said that J&J has been settling Risperdal cases, but the amounts are not disclosed. The highest settlements are for boys who undergo double mastectomy.  He advised plaintiff lawyers to focus on cases involving prescriptions written from 2000 to 2006.

Risperdal has carried a black-box warning by the FDA since September 2006 to warn about the increased risk of death in elderly patients with dementia-related psychosis. In addition to the increased risk of death in the elderly, Risperdal has added warnings associated with Tardive Dyskinesia, which is the development of abnormal facial, shoulder and limb movements that a patient cannot control.

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Did Xarelto, the Drug Arnold Palmer Promoted, Lead to His Death?

One of the final images of beloved golfer Arnold Palmer is the 87-year old in a TV commercial wearing a pink sweater and saying, “Treatment with Xarelto was the right move for us.” Many people are wondering if that is true in the wake of his death on September 25, 2016, which was preceded in August 2016 by surgery for colon bleeding, according to Golf Digest.

Xarelto is the target of 10,769 federal and state lawsuits that charge, among other things, that the blood-thinning drug causes death from gastrointestinal and other internal bleeding. Palmer was hospitalized on Sept. 22 in preparation for heart surgery on Sept. 26 at Pittsburgh Medical Center. However, his conditioned steadily weakened and he died “due to complications from heart disease.”

Despite ongoing federal and state litigation, defendants Bayer HealthCare AG and Janssen Pharmaceuticals have broadcast a TV commercial for more than a year, where Palmer and other celebrities tout the dangerous drug.

Just 25 months ago Palmer underwent surgery to have a pacemaker implanted, according to Golf Digest. That procedure marked the first of a series of health issues including high blood pressure, for which he took pills daily. Palmer said in a 2015 interview that he was taking “a blood thinner,” which he attributed to a bout with deep vein thrombosis (blood clots). Deep vein thrombosis is linked with coronary heart disease. Had he been taking Coumadin he would not have needed surgery to stop the colon bleeding.

Defendants in the federal MDL, before US District Judge Eldon E. Fallon, In RE: Xarelto (Rivaroxaban) Products Liability Litigation, include Bayer Healthcare, the designer and manufacturer of Xarelto. Janssen Pharmaceuticals (a Division of Johnson & Johnson) currently sells Xarelto in the United States pursuant to a licensing agreement with Bayer. Plaintiffs involved in the MDL have suffered various harmful side effects, including:

  • Gastrointestinal Bleeding,
  • Intracranial Hemorrhage,
  • Hemorrhagic and Other Severe Internal Bleeding,
  • Stroke,
  • Death (due to one of the aforementioned injuries).

A complete set of federal MDL forms can be found online on the Mass Tort Nexus app.

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Judge Orders Bayer to Turn over Personnel Records to Xarelto Plaintiffs

xarelto internal-bleedingThe judge overseeing federal Xarelto product liability litigation ordered defendant Bayer to turn over the personnel records of two doctors on its payroll who can testify about plaintiff claims that the blood-thinner drug was rushed to the market.

The plaintiffs also seek the records because they may contain evidence of aggressive compensation schemes or rush-to-the-market liability, which is vital to their case-in-chief.

US District Judge Eldon E. Fallon ordered the company to turn over redacted copies the personnel files of Dr. Dagmar Kubitza, Head of Clinical Pharmacodynamics, and Frank Misselwitz, Corporate Vice President, both working in Germany. Excluded from the records are performance reviews, evaluations for promotion and self-assessments.

The court weighed five factors listed the Third Restatement, as referenced in Seoul Semiconductor Co. v. Nichia Corp., 590 F. Supp. 2d 832, 835 (E.D. Tex. 2008).

Evasiveness by Bayer

“The Court is concerned by the evasiveness exhibited by Bayer in certain depositions and is troubled by the possibility of further evasive responses by deponents,” Judge Fallon wrote. “As this is a nationwide MDL, the rights of thousands of American citizens hinge on the timely production of materials that fall within the scope of the Federal Rules of Civil Procedure.”

Thousands of case filings are increasing court dockets in the Xarelto mass tort litigation in federal court and also the Philadelphia Court Of Common Pleas. Only claims involving hemorrhagic strokes (caused by internal bleeding, not a blood clot) can be brought in the federal MDL. As a result, thousands of ischemic stroke cases have been filed in the Philadelphia before Judge Arnold L. New.

Defendants in the MDL include Bayer Healthcare, the designer and manufacturer of Xarelto. Janssen Pharmaceuticals (a Division of Johnson & Johnson) currently sells Xarelto in the United States pursuant to a licensing agreement with Bayer. Plaintiffs involved in the MDL have suffered various harmful side effects, including:

  • Gastrointestinal Bleeding,
  • Intracranial Hemorrhage,
  • Hemorrhagic and Other Severe Internal Bleeding,
  • Stroke, &
  • Death (due to one of the aforementioned injuries).

A complete set of federal MDL forms can be online on the Mass Tort Nexus app.

 

 

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Health Canada Warns of Diabetic Ketoacidosis from Invokana Diabetes Drug

invokana-warning kidney-damageHealth Canada, the country’s equivalent of the US Food and Drug Administration, warned healthcare professionals about the risk of diabetic ketoacidosis caused by SGLT2 Inhibitors, including Invokana, (canagliflozin), Farxiga (dapagliflozin), Xigduo (dapagliflozin/metformin), and Jardiance (empagliflozin).

The leading case is Arthur Portnoff V. Janssen Pharmaceuticals, Inc., Janssen Research and Development, LLC, Johnson & Johnson Co., and Mitsubishi Tanabe Pharma Corp., Case ID: 151200653, filed In the Philadelphia Court of Common Pleas. For more info read:

FDA strengthens kidney warnings for diabetes medicines Invokana, Invokamet, Farxiga and Xigduo XR

The warning was issued to healthcare professionals including internal medicine specialists, endocrinologists, cardiologists, nephrologists, general or family practitioners, emergency healthcare professionals, critical care physicians, certified diabetes educators and pharmacists.

Key messages

  • Serious, sometimes life-threatening and fatal cases of diabetic ketoacidosis (DKA) have been reported in patients on sodium glucose co-transporter 2 (SGLT2) inhibitors for type 1 and type 2 diabetes.
  • In a number of these cases, the presentation of the condition was atypical with only moderately increased blood glucose levels observed.
  • SGLT2 inhibitors are NOT indicated for the treatment of type 1 diabetes mellitus and should not be used in type 1 diabetes.
  • It is recommended that:
    • if DKA is suspected or diagnosed, treatment with SGLT2 inhibitors should be discontinued immediately.
    • SGLT2 inhibitors should not be used in patients with a history of DKA.
    • in clinical situations known to predispose to ketoacidosis (e.g. major surgical procedures, serious infections and acute serious illness), consideration be given to temporarily discontinuing SGLT2 inhibitor therapy.
    • patients be informed of the signs and symptoms of DKA and be advised to immediately seek medical attention if they develop them.
    • caution be used before initiating SGLT2 inhibitor treatment in patients with risk factors for DKA.

A life-threatening condition

Clinical trial and post-market cases of DKA, a serious, life-threatening condition requiring urgent hospitalization have been reported in patients with type 1 and type 2 diabetes mellitus on SGLT2 inhibitor treatment.

In a number of these reports, the presentation of the condition was atypical with only moderately increased blood glucose levels observed. Such atypical presentation of DKA in patients with diabetes could delay diagnosis and treatment.

Products affected
Brand Name Medicinal Ingredients Manufacturer
INVOKANA® canagliflozin Janssen Inc.
FARXIGA® dapagliflozin AstraZeneca Canada Inc.
XIGDUO® dapagliflozin and metformin AstraZeneca Canada Inc.
JARDIANCE empagliflozin Boehringer Ingelheim (Canada) Ltd.

Background information

Sodium glucose co-transporter type 2 (SGLT2) inhibitors are a class of drugs indicated as oral antihyperglycemic agents for the treatment of patients with type 2 diabetes.

The underlying mechanism for SGLT2 inhibitor-associated ketoacidosis is not clearly established. DKA usually develops when insulin levels are too low to prevent ketoacid accumulation. DKA occurs most commonly in patients with type 1 diabetes and is usually accompanied by high blood glucose levels (>14 mmol/L). However, the cases referred to above also concern patients with type 2 diabetes and in a number of cases blood glucose levels were only slightly increased, in contrast to typical cases of DKA.

The majority of the patients described in the above reports required hospitalization. To date, many of them have occurred during the first 2 months of treatment.  In many cases, just before or at the same time as the ketoacidosis occurred, patients experienced dehydration, low food intake, weight loss, infection, surgery, vomiting, a decrease in their insulin dose or poor control of diabetes.

A substantial proportion of the cases concerned use of SGLT2 inhibitors in patients with type 1 diabetes. SGLT2 inhibitors are NOT indicated for treatment of type 1 diabetes mellitus.

Who is affected

Information for consumers

Diabetic ketoacidosis (DKA) is a serious complication of diabetes caused by low insulin levels. Rare cases of this condition, including life-threatening and fatal ones, have occurred in patients taking SGLT2 inhibitors [INVOKANA®(canagliflozin), FORXIGA® (dapagliflozin), XIGDUO® (dapagliflozin/metformin), JARDIANCETM (empagliflozin)] for type 1 and type 2 diabetes.

A number of these cases have been unusual, with patients having blood sugar levels that are not as high as typically expected in DKA, which can lead to a delay in diagnosis and treatment.

Patients taking any of these medicines should be aware of the symptoms of DKA, including loss of appetite, nausea or vomiting, stomach pain, feeling very thirsty, rapid breathing, confusion, feeling unusual tiredness, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat.

Patients should immediately seek medical advice if they develop any of these symptoms. Patients should also inform their healthcare professional about medical issues or factors (see below) that may predispose them to ketoacidosis.

SGLT2 inhibitors are NOT indicated for treatment of type 1 diabetes mellitus and should not be used in type 1 diabetes.

Information for health care professionals

Before initiating treatment with SGLT2 inhibitors, factors in the patient history that may predispose to ketoacidosis should be considered. These factors include:

  • patients on a very low carbohydrate diet (as the combination may further increase ketone body production),
  • an acute serious illness,
  • pancreatic disorders suggesting insulin deficiency (e.g., type 1 diabetes, history of pancreatitis or pancreatic surgery),
  • sudden insulin dose reduction (including insulin pump failure),
  • alcohol abuse,
  • conditions that lead to severe dehydration,
  • hospitalization for major surgery or serious medical illness.

SGLT2 inhibitors should be used with caution in these patients. In addition, patients should be informed of these risk factors.

SGLT2 inhibitors should not be used in patients with a history of DKA.

A substantial proportion of the cases concerned off-label use in patients with type 1 diabetes. Prescribers are reminded that type 1 diabetes is NOT an approved indication for SGLT2 inhibitors.

Patients on SGLT2 inhibitors should be tested for ketones when they present with symptoms of acidosis in order to prevent delayed diagnosis and patient management.  If ketoacidosis is suspected, treatment with SGLT2 inhibitors should be discontinued.

Prescribers should inform patients of signs and symptoms of metabolic acidosis and advise them to immediately seek medical advice if they develop such signs and symptoms.

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7 Xarelto Cases Chosen for Trial in Louisiana Federal Court

XARELTOIn Case Management Order No. 5 on August 1, US District Court Judge Eldon E. Fallon ordered four categories of Xarelto cases for trial, and set deposition deadlines in the Eastern District of Louisiana.

The cases are in 4 categories in In Re: Xarelto (Rivaroxaban) products liability litigation consolidated in MDL No. 2592 in New Orleans, which includes a total of 400 cases. Another 739 cases have been consolidated in separate litigation in a Xarelto MDL in the Philadelphia Court of Common Pleas.

The federal cases in Louisiana are in 4 categories:

  1. One case in Category 2a from CMO 4 (“Plaintiff took Xarelto® in order to reduce the risk of stroke and systemic embolism due to nonvalvular atrial fibrillation and alleges a gastrointestinal bleed or death due to a gastrointestinal bleed and was between the ages of 50 and 90 at the date of the alleged event.”).
  2. Four cases in Category 2e from CMO 4 (“Plaintiff took Xarelto® in order to reduce the risk of stroke and systemic embolism due to nonvalvular atrial fibrillation and alleges a Brain bleed/hemorrhagic stroke or death due to a brain bleed/hemorrhagic stroke and was between the ages of 50 and 90 at the date of the alleged event.”).
  3. One case in Category 2b from CMO 4 (“Plaintiff took Xarelto® to treat deep vein thrombosis (DVT), to treat pulmonary embolism (PE) and/or to reduce the risk of recurrence of DVT or PE and alleges a gastrointestinal bleed or death due to a gastrointestinal bleed and was between the ages of 40 and 80 at the date of the alleged event.”).
  4. One case in Category 2a from CMO 4 where venue is proper in a federal district in the State of Texas (“Plaintiff took Xarelto® in order to reduce the risk of stroke and systemic embolism due to nonvalvular atrial fibrillation and alleges a gastrointestinal bleed or death due to a gastrointestinal bleed and was between the ages of 50 and 90 at the date of the alleged event.”).

Arguments held on August 4

Judge Fallon is presiding over 6,400 Xarelto lawsuits filed in federal court. In each category, the plaintiffs’ steering committee (PSC) and defendants exchanged via email a list of any cases that either side should be removed from the pool. On August 4, 2016, the Court heard arguments as to whether any cases in each category should be removed from the pool.

Xarelto is prescribed for atrial fibrillation (AFIB), deep vein thrombosis (DVT) and pulmonary embolism (PE). However, it causes brain/cerebral hemorrhage, death, gastrointestinal bleeding, heart attack, kidney bleeding, nosebleeds, rectal bleeding, respiratory failure, hemorrhagic and ischemic strokes, vaginal or uterine bleeding, and other internal bleeding.

The Defendants Include Janssen Research & Development F/K/A Johnson and Johnson Pharmaceutical Research and Development LLC, Janssen Ortho LLC, Janssen Pharmaceuticals, Inc. F/K/A Janssen Pharmaceutica Inc. F/K/A Ortho-Mcneil-Janssen Pharmaceuticals, Inc., Johnson & Johnson Company Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma Ag, Bayer Corporation, Bayer Healthcare LLC, Bayer Healthcare Ag, and Bayer Ag.

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New Study to Investigate Long-Term Xarelto and Pradaxa Use

xarelto bleedingA patient-centered research institute is conducting two studies that will compare the effectiveness of Pradaxa, Xarelto and other oral blood thinners to determine what the long-term effects are.

The Patient-Centered Outcomes Research Institute (PCORI) announced the $6.5 million studies to scrutinize anticoagulants including:

  • Warfarin
  • Dabigatran (Pradaxa, made by Boehringer Ingelheim)
  • Rivaroxaban (Xarelto, made by Janssen)
  • Apixaban (Eliquis, made by Bristol-Myers Squibb)
  • Edoxaban (Savaysa, made by Daiichi Sankyo)

The drugs are used to to treat clots and are often used for longer than the standard 3-month treatment period to prevent formation of additional clots, but the comparative safety and effectiveness of extended use is unclear, according PCORI.

Federal Xarelto Litigation is consolidated before US District Judge Eldon Fallon in MDL 2592 and the state litigation is consolidated in the Philadelphia Court of Common Pleas before Judge Arnold New. In the state MDL  Judge New has elected to allow “Efficacy Claims” to be filed in that MDL in addition to claims related to uncontrolled bleeding. Judge Fallon has yet to follow suit and may not.

Uncertainty about medications

Venous thromboembolism (VTE) causes more than half 500,000 hospitalizations and more than 100,000 deaths each year in the United States. VTE is typically treated with at least three months of an anticoagulant, or “blood-thinning,” medication. Afterward, patients are often given the option to extend anticoagulant treatment for a longer period to prevent VTE recurrence. Remaining on anticoagulants, however, can lead to serious bleeding complications and can be expensive and inconvenient for patients.

At present, there is much uncertainty about which medication is the best choice for extended VTE treatment, according to PCORI. Choosing the best anticoagulant strategy is particularly difficult when treating people of older age, people who have kidney disease, or people who have high bleeding risk, due to the scant evidence available on the relative benefits and harms in these populations.

The long-term goal of the project is to compare the benefits and harms of different anticoagulant options for the extended treatment of VTE, information that will be critical in helping clinicians and patients personalize their treatment decisions. The study focuses on people who have completed at least three months of anticoagulant treatment for VTE and compares the outcomes of 1) people who stay on anticoagulants with those who stop anticoagulants, and 2) those who are treated with extended warfarin compared with NOAC treatment. PCORI will also examine whether the benefits and harms of treatment differ by age, kidney function, or bleeding risk.

The study will be based in Kaiser Permanente Northern California and Kaiser Permanente Southern California, two large, integrated healthcare delivery systems that provide comprehensive medical care for more than 7.7 million patients in California. PCORI will identify in these health systems all adults treated for VTE from years 2010 to 2015 and collect information from electronic health records on their health history, anticoagulant treatment choices, and clinical outcomes. Next, PCORI will survey patients with VTE treated in more recent years (2014–2016) and measure their self-reported health, well-being, and satisfaction with treatment.

The main outcome of the study is the net benefit of one treatment strategy compared with another, measured in terms of the number of VTE events prevented and the number of bleeding complications induced. Because the study is an observational study of actual clinical care, PCORI will then apply advanced statistical techniques to maximize the validity of the results.

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