Cook IVC Filter Settlement Talks Fail

Cook Celect® IVC Filter
Cook Celect® IVC Filter

U.S. Magistrate Judge Tim Baker met with attorneys for both sides of the Cook IVC Filter litigation to discuss a settlement, but they did not find common ground, according to the Daily Hornet.

The conference ended “without further order,” according to a statement from the court.

There may be other settlement conferences, but the lawsuits will go to trial if negotiations fail. Large-scale settlements become more likely if a jury awards compensation. If not, the cases could be dismissed or sent to a lower court.

818 cases pending

As of August 15, Cook Medical was facing 818 federal lawsuits in Multi-District Litigation in Indiana. U.S. District Judge Richard Young ordered that three IVC filter cases pending against Cook Medical go to trial in 2017. The cases will be tried in MDL No. 2570 IN RE: Cook Medical, Inc., in the Southern District of Indiana.

Judge Young on July 19 identified three trial plaintiffs and types of filter:

  • Brand v. Cook Medical, Inc. et al., Case No. 1:14-cv-6018 (Celect)
  • Gage v. Cook Medical, Inc. et al., 1:14-cv-1875 (Günther Tulip)
  • Hill v. Cook Medical, Inc., et al, 1:14-cv-6016 (Celect)

Hundreds of Cook and Cordis IVC Filter cases are already filed, and hundreds of thousands of potential clients nationwide who need attorneys.

The cause of the litigation is the rapacious greed of the two companies competing to get market share, rolling out one defective product after another for the last 16 years, brushing aside reports of patient deaths and lying to the FDA about it.

  • Cordis IVC Filter Litigation is centered in the California state courts, where hundreds of cases are up for consolidation. Cordis Corporation is organized under the laws of Florida, with its principal place of business in Fremont, California.
  • Bard IVC Filter Litigation is consolidated in MDL 2641 (multi-district litigation docket) in US District Court in Arizona.
  • Cook Medical IVC Filter Litigation is consolidated in MDL 2570 in US District Court for the Southern District of Indiana. The defendants are Cook Medical, LLC and Cook Inc., both of Bloomington, IN, and William Cook Europe APS, Bjaeverskov, Denmark. The federal district court has created a short form complaint.
  • There is no MDL for Boston Scientific Corp IVC Filter Litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be formed in an effort to form an MDL,” says Mass Tort Consultant John Ray.



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Judge Sets 6 Bellwether Trials in Testosterone Mass Torts Litigation

testosterone2US District Judge Matthew F. Kennelly has set June 5, 2017, for the start of first of six AbbVie bellwether trials in MDL 2545, in the Testosterone Replacement Therapy Products Liability Litigation in the Northern District of Illinois.

Discovery deadlines start in September for more than 5,500 cases currently pending. All the actions involve plaintiffs (or their survivors) who used one or more testosterone replacement therapies and contend that their (or their decedent’s) use of the drugs caused their injuries, which include:

  • heart attack
  • stroke
  • deep vein thrombosis
  • pulmonary embolism

On January 31, 2014, the U.S. Food and Drug Administration announced that it was “investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.” Plaintiffs filed the actions in the wake of this announcement.

In March 2015, the FDA issued a safety communication, cautioning men against taking testosterone products for low testosterone levels associated with aging. The agency also required companies manufacturing these drugs to change their labels to clarify the appropriate usages for their products. Manufacturers were also required to add warnings about the risks of heart attack and stroke associated with taking these drugs.

All testosterone replacement therapy actions share factual questions about general causation and the background science regarding the role of testosterone in the aging body, as well as involve common regulatory issues in light of the FDA’s announcement and subsequent actions, if any.

The hormone has been used off-label to treat a range of symptoms such as loss of energy, decreased muscle mass and reduced libido.

The defendants include:

  • AbbVie Inc. and Abbott Laboratories Inc. (collectively Abbot)
  • Eli Lilly and Co. and Lilly USA LLC
  • Endo Pharmaceuticals
  • Actavis, Inc.
  • Auxilium Pharmaceuticals, Inc.
  • Pfizer, Inc.
  • Pharmacia

All of these cases involve Androgel, a testosterone drug manufactured by AbbVie.

The first case, which is slated to begin July 2017, was filed by Jeffrey Konrad. Konrad claims he suffered a myocardial infarction after taking Androgel. The order of the remaining cases will be determined at a later date. Once these trials are completed, Judge Kennelly is expected to select a second group of bellwether trials that will include Axiron, Testim, Androderm and other testosterone products.

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Philly Judge Adds $6.66 Million Delay Interest to $70M Risperdal Verdict

Risperdal causes gynecomastia, or enlarged breasts, in men.
Risperdal causes gynecomastia, or enlarged breasts, in men.

Philadelphia Court of Common Pleas Judge Paula Patrick ordered Janssen Pharmaceuticals to pay an additional $6.66 million in delay damages to plaintiff Andrew Yount and his family after they recovered a $70 million jury verdict last month.

The damages were calculated at 4.25% annually starting April 16, 2014, when the complaint was served, and increasing to 4.5% from April 16, 2016, to July 1, 2016, the date of the verdict.

The case is Andrew Yount, et. al., vs. Janssen Pharmaceuticals, Inc. et. al., Case No. 130402094.

Yount began taking Risperdal in 2003 to treat psychiatric problems. When the drug caused him to develop gynecomastia, or the abnormal growth of breast tissue, he filed suit in April 2013.

During the trial, plaintiff attorney Jason Itkin of Arnold & Itkin LLP in Houston argued that Jannsen knew at the time that Risperdal was associated with spikes of the prolactin hormone, which causes the gynecomastia.

It was the fifth Risperdal lawsuit tried in Philadelphia, and by far the largest verdict so far. Earlier verdicts ranged from $500,000 to $2.2 million. The jury also found that Janssen “intentionally falsified, destroyed or concealed records.”


Lawyers for the plaintiff demonstrated that Janssen, a subsidiary of pharmaceutical giant Johnson & Johnson, attempted to downplay the risks of the drug causing gynecomastia, a condition in which boys develop female breast tissue. While the drug was initially approved for a small market, those suffering from bipolar and schizophrenia-related disorders, Janssen reportedly worked to expand doctors’ recommendations of the drug to include treatments for dementia, behavioral problems, and autism. At the time the plaintiff began taking the drug the Food and Drug Administration (FDA) had only approved it for adult use.

Follow our continuing coverage:

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

Kentucky AG Settles Risperdal and OxyContin False Marketing Cases for $39.5 Million

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Attorney Mikal Watts acquitted in Gulf oil spill fraud case

Mikal Watts (right) was accused of padding a list of claimants seeking relief from BP for the 2010 oil spill. Photo: Amanda McCoy /Associated Press
Mikal Watts (right) was accused of padding a list of claimants seeking relief from BP for the 2010 oil spill. Photo: Amanda McCoy /Associated Press

A Mississippi jury has cleared prominent Texas attorney and Corpus Christi native Mikal Watts of charges that he tried to commit fraud after the 2010 BP Gulf oil spill, reports

Watts Watts, his brother David Watts and Watts law firm employee Wynter Lee were acquitted of all 66 felony counts of conspiracy, mail and wire fraud, and identity theft.

Prosecutors said they created a list of bogus plaintiffs, using names and Social Security numbers without permission. Defendants said prosecutors never proved they acted with criminal intent.

Jurors began delivering verdicts Thursday afternoon, according to Sheila Wilbanks, the spokeswoman for U.S. Attorney Gregory Davis in southern Mississippi.


The Watts brothers and Lee, though, said they themselves were victims of fraud by the Mississippi group and lost $3 million on the BP litigation.

“The first words I told you was ‘I got ripped off,'” Mikal Watts, representing himself, told jurors.

He said other actions that federal prosecutors alleged were criminal were just routine lawyering, such as sending out multiple letters to clients the firm was struggling to contact, and submitting claims to BP even after contact attempts failed. Watts said those claims were submitted to meet a legal deadline, but said phantom clients would never get paid.

“The proof had to be submitted before people were going to be compensated and I knew that,” Watts said.

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Are Your Personal Care Products Really Safe?

personal care products

Your skin is your largest organ, and anything you put on it should contain only the best and safest ingredients from nature. So before slathering lotion or body wash on your skin, take a look at this infographic on toxic chemicals found in personal care products. Discover these common yet deadly chemicals and how they can potentially sabotage your health and well-being.

<img src="" alt="personal care products" border="0" style="max-width:100%; min-width:300px; margin: 0 auto 20px auto; display:block;">

Your skin is your largest organ, and anything you put on it should contain only the best and safest ingredients from nature. So before slathering lotion or body wash on your skin, take a look at this infographic on toxic chemicals found in
personal care products. Discover these common yet deadly chemicals and how they can potentially sabotage your health and well-being.

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Kentucky AG Sues Johnson & Johnson for Deceptive Marketing of TVM Surgical Mesh

vaginal-mesh-TVM-Lawsuit seeks millions of dollars in civil penalties under Kentucky’s Consumer Protection Act

Kentucky Attorney General Andy Beshear today announced a civil lawsuit against Johnson & Johnson and its medical device unit, Ethicon, for its deceptive marketing of surgical transvaginal mesh.

The lawsuit seeks millions of dollars in civil penalties under Kentucky’s Consumer Protection Act that prohibits companies from false, misleading, deceptive or unfair acts or practice in trade or commerce.

Transvaginal mesh is a synthetic woven fabric implanted through the vagina to treat common pelvic floor conditions that 30 to 50 percent of all women experience.

In Kentucky, more than 15,000 women had transvaginal mesh implanted without Johnson & Johnson and Ethicon providing sufficient information about the known hazards so women and their doctors could make informed treatment decisions, according to the lawsuit.

“The way this company clearly chose profits over people is outrageous,” Beshear said. “My office has talked to victims whose lives have been devastated by this company’s deceitful practices. We may not be able to give them back the lives they once had, but my office will do everything we can to hold this company accountable.”

Warnings ignored

Beshear said Johnson & Johnson failed to follow recommendations by its own staff to include complete disclosures of the risk.

According to the lawsuit, in 2005 Johnson & Johnson’s medical director emailed the company to propose stronger warnings on the product for doctors and patients.

The email from the medical director proposed the following disclosure: “WARNING: Early clinical experience has shown that the use of mesh through a vaginal approach can occasionally/uncommonly lead to complications such as vaginal erosion and retraction which can result in an anatomical distortion of the vaginal cavity that can interfere with sexual intercourse.”

Another of the company’s medical directors noted in 2006 that post-operative patients were reporting that they did not believe they got adequate information prior to surgery on the possible adverse complications and that additional disclosures might be needed.

Johnson & Johnson failed to fully incorporate this information into any of its marketing or promotional materials, according to the lawsuit.

In fact, Beshear said the company purposely concealed and mispresented to doctors and patients many of the risks of adverse events associated with the devices, which include chronic pelvic pain, urinary and/or defecatory dysfunction, pain with sexual intercourse or total loss of sexual function.

The company also represented to doctors that the products were “FDA approved” when in fact they were only “FDA cleared” – a significantly different and less rigorous evaluation.

While the lawsuit doesn’t seek restitution for individuals, Beshear is asking women not already represented in litigation to contact his office at 502-696-5389.

Beshear filed his lawsuit this week in Franklin Circuit Court.

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Ethicon and J&J Move to Exclude Plaintiff Expert in TVM Litigation

Mesh-Vaginal-Slings-300x256Ethicon, Inc. and Johnson & Johnson filed a motion to exclude the general-causation testimony of Brian Raybon, M.D. in federal transvaginal mesh products liability litigation, arguing that he is not qualified under the Daubert standard.

Ethicon is a defendant in Transvaginal Mesh Litigation consolidated in MDL 2327 before Judge US District Court Judge Joseph R. Goodwin the Southern District of West Virginia. In pretrial order #235, Judge Goodwin scheduled a status conference and meetings in the MDL on September 13-14, 2016 at the Robert C. Byrd United States Courthouse.

Separately, the U.S. Attorney’s Office in Boston announced on July 22, 2016, that medical device manufacturer Acclarent Inc., has agreed to pay $18 million to resolve allegations that it caused health care providers to submit false claims to Medicare and other federal healthcare programs. Acclarent — a subsidiary of Ethicon, a Johnson & Johnson company — marketed and distributed the sinus surgery device, the Relieva Stratus, for use as a drug delivery device without U.S. Food and Drug Administration (FDA) approval of that use.

Incidentally, Dr. Rabon served as an expert witness for the defendant despite the fact that it appears he was also the implanting surgeon for some of the plaintiff cases that could be affected by his expert testimony on behalf of the defendant.

Working as an urogynecologist and pelvic floor surgeon, he implanted more than 300 of the Avaulta POP mesh kits, which are similar in design and implantation method to Gynecare’s Prolift devices. He also implanted more than 25 Prolift products, but stopped using the Prolift products in 2008 due to an unacceptably high erosion rate and personal knowledge of the fact that Gynecare did not exercise due diligence in ensuring that implanting physicians were adequately trained. In the years since, he has removed more than 75 of the Prolift products.

In his opinion, Dr. Rayborn says:

  • The Prolift +M was defectively designed and its risks outweighed any benefits.
  • Ethicon had at its disposal a number of safer feasible alternative designs that count have been utilized.
  • Ethicon failed to adequately warn physicians and patients about known problems with the Prolift +M.
  • Clinical trials demonstrated to Ethicon that functional outcomes are not superior with transvaginally placed armed mesh (TVM).

He says that he has personally observed and treated patients who have been implanted with Ethicon Prolift+M products that experienced 17 difference device-related complications.

“Based upon my education, training, experience and knowledge, and my familiarity with the literature relating to this subject, it is my professional opinion to a reasonable degree of medical certainty that the injuries and complications that I have personally observed, diagnosed, and treated relating to the Prolift+M are directly attributable to the defective design of this product as described previously. It is also my opinion that many if not all of these complications could have been prevented had Ethicon used safer feasible alternatives to the implant”s design or had completely and adequately instructed surgeons and warned surgeons and patients of significant known risks associated the implant,” he says.

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FDA Releases New Patient Info for Taxotere (Docetaxel) Cancer Drug

taxotere2The FDA Center for Drug Evaluation and Research approved new safety labeling changes for the Taxotere (Docetaxel) breast cancer drug in July 2016, adding the following to the list of adverse reactions:

  • Acute Myeloid Leukemia
  • Cutaneous Reactions
  • Neurologic Reactions
  • Eye Disorders
  • Asthenia
  • Alcohol Intoxication

The agency noted that additional of cases of permanent alopecia have been reported, and lawsuits are proliferating that the Taxotere cancer drug causes permanent hair loss.

Mass Tort Nexus has prepared a briefcase of files about Taxotere litigation.

The emerging litigation is ripe for a motion to consolidate them into a federal multi-district litigation docket, because complaints involving Taxotere (Docetaxel) have been filed in multiple jurisdictions, including US District Courts in Illinois, North Carolina, Florida, Mississippi, Kansas, Louisiana and Colorado.

  • Defendant Sanofi S.A. is a corporation or Société Anonyme organized and existing under the laws of France, having its principal place of business in Paris, France.
  • Defendant Aventis Pharma S.A. is a corporation or Société Anonyme organized and existing under the laws of France, having its principal place of business in Antony, France.
  • Defendant Sanofi-Aventis U.S. LLC is a Delaware limited liability company, which has its principal place of business at 55 Corporate Drive, Bridgewater, New Jersey.

Taxotere is a drug used to treat various forms of cancer, including but not limited to breast cancer. It is a part of a family of drugs commonly referred to as Taxanes.

Disfiguring permanent alopecia

A leading The California case is Ami Dodson v. Sanofi S.A, Case 4:16-cv-01251-PJH. US District Judge Phyllis J. Hamilton ordered that lead counsel shall confer and file a joint case management statement addressing jurisdiction and service, facts, legal issues, motions, amendment of pleadings and evidence preservation.

Following a March 3rd, 2010 left breast biopsy, Dodson met with her oncologist to discuss further treatment. Neither she nor her treating healthcare providers were aware of or informed by defendants that disfiguring permanent alopecia can occur following treatment with Taxotere. Accordingly, she  underwent chemotherapy that included Taxotere. Following the chemotherapy, she lost all of her hair as a result of receiving chemotherapy with Taxotere.

A study published in 2008 in the New England Journal of Medicine concluded that Taxol (paclitaxel) was more effective than Taxotere (docetaxel) for patients undergoing standard adjuvant chemotherapy with doxorubicin and cyclophosphamide. Despite the publication of these studies, the defendants continued to make false and misleading statements promoting the “superior efficacy” of Taxotere over the competing product paclitaxel Taxol, according to the complaint.

Defendants’ statements in a “reprint carrier” marketing the conclusions of the 2005 JCO study were false and misleading in light of the 2007 and 2008 studies finding that Taxotere was not more effective than paclitaxel in treating breast cancer. As a result of these false and misleading statements, in 2009, the FDA issued a warning letter to Sanofi-Aventis.

Defendants knew or should have known that the rate of permanent alopecia related to Taxotere was far greater than with other products available to treat the same condition as Defendants’ product. Permanent baldness (permanent alopecia) is a disfiguring condition, especially for women. Women who experienced disfiguring permanent alopecia as a result of the use of Taxotere suffer great mental anguish as well as economic damages, including but not limited to loss of work or inability to work due to significant psychological damage.

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Performance Marketing…When Economics Collide

The Sentinel GroupBy Adam Warren of The Sentinel Group®, Temecula, CA.

If you are deep into mass tort marketing or other forms of legal marketing such as single-event cases, there is no doubt that you have either tried or have been pitched on performance-driven media. There is a special attraction for law firms to this type of business that creates potential plaintiffs from phone calls on a fixed rate per call basis.

Yet, in this instance, you are not paying for the media spots that clear, but rather the phone calls you receive that reach the billable formula. Performance exists within some of these familiar metrics ranging from cost per call, cost per acquisition, cost per lead and so on.

Two different languages

Law firms and marketing firms are typically speaking two different languages when it comes to performance marketing techniques and law firm case acquisition ambitions. Why does a law firm care about the cost per call? Well, truth is they don’t! Further clarifying, they do not care about the cost per call as long as their cost per packet goals are met.

However, it is a conversation that the marketing firm must have in order to find an agreeable financial arrangement with media to secure ad inventory across various media inclusive of TV, radio, print or digital. What do the law firms care about? They care about their cost per packet out!

How do we make sense of these conversations when they collide? It is important that the marketing firm you choose understands the divide between packet- and call-based economics and how the come together when using the right firm. Whether you are talking about IVC, Xarelto, talcum powder, Nexium or single event catastrophic injury, the conversation that needs to take place is how you get to the packet cost while satisfying the media with the cost per call or other common media metrics. Sounds simple? Well, it can be.

An experienced marketing firm should have the technology to monitor call occurrences and tracking by 800 number. Information that can be derived from call occurrences includes but is not limited to the caller ANI (auto number identifier), zip code, media origin, intake quality control, listening features and so on. If technology is not at the core of the campaign, this marriage is close to impossible to achieve.

Campaign ROI

Firms should also understand how pricing can fluctuate and ways in which campaign ROI can be maximized to the media and the law firm client. If you wish to have an ongoing and scalable campaign, you must understand how to create wins on both sides of this coin. Data is an ever-moving target and it is imperative that data drives decisions.

If your marketing firm is not data-centric, how will they know what media bolsters the packet cost objectives vs. plummeting it? Does your marketing firm offer quality control? How will the marketing firm identify poor performing media or 800 numbers or protect you from spam and wrong dials? Not knowing how to spot potentially damaging campaign data that can quickly tank your packet costs makes it impossible for the law firm and marketing firm to come together on the mutual objective of marrying the performance economics with the packet economics.

Buyer beware! There are a lot of false guarantees and impossible promises out there in case acquisition. If it sounds too good to be true, it probably is! Make sure your firm of choice not only understands the case and your objectives but also has the means to execute from data to distribution to achieve your objectives and merge the economics of different languages to proceed in a decisive and informed manner.

For further information:

Contact Phone: 800.TSG.Tort (800.874.8678)

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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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