217 Lawsuits Filed Against 3M for Bair Hugger Blanket

bair-hugger-infectionHundreds of hip and knee replacement infection lawsuits involving the 3M Bair Hugger forced air warming blanket continue to move forward in the centralized litigation now underway in Bair Hugger MDL 2666 in U.S. District Court in Minnesota.

Judge Joan N. Ericksen issued two new Pretrial Orders on May 24 :

  • Pretrial Order No. 9: Establishing Common Benefit Fee and Expense Funds. With Exhibit A (Participation Agreement) and Exhibit B (Time Report and Expense Forms).
  • Pretrial Order No. 8: Master Long and Short Form Complaints and Jury Demand. With Exhibit A (Master Long Form Complaint) and Exhibit B (Short Form Complaint).

“All three of these orders will facilitate the efficient progress of this litigation. We are currently investigating a number of forced air warmer lawsuits involving the Bair Hugger, and are pleased to see that the federal litigation is moving forward,” says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a law firm in New York.

217 lawsuits pending

The 3M Bair Hugger is used during surgical procedures to regulate a patient’s body temperature. Court documents indicate that at least 217 Bair Hugger lawsuits are now pending in the District of Minnesota, all of which were filed on behalf of hip and knee replacement patients who allegedly developed serious post-operative deep joint infections due to the use of the forced air warming blanket during their surgery.

Plaintiffs contend that the Bair Hugger suffers from a design defect that allows contaminated air from the operating room floor to come into contact with the surgical site, greatly increasing the risk that hip and knee replacement patients will develop dangerous and debilitating infections at the site of their implant. They further claim that the 3M Company and its Arizant Healthcare, Inc. subsidiary have been aware of this problem for years, but concealed the issue from regulators, patients and the medical community. Rather than alter the design of the Bair Hugger to correct this alleged defect, the lawsuits charge that the companies continue to aggressively and misleadingly market the forced air warming system as safe for use in orthopedic surgery.

 

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California AG Sues Johnson & Johnson for Deceptive Marketing of Surgical Mesh Products

Mesh-Vaginal-Slings-300x256California Attorney General Kamala D. Harris on May 24, 2016 filed a lawsuit against Johnson & Johnson (J&J) for false advertising and deceptive marketing of its surgical mesh products for women.  The complaint alleges that J&J neglected to inform both patients and doctors of possible severe complications and misrepresented the frequency and severity of risks.

Ongoing Ethicon (J&J) Transvaginal Mesh Litigation has been consolidated in MDL 2327 before Judge Joseph R. Goodwin, United States District Court for the
Southern District of West Virginia.

Does your law firm have a mass tort case in active litigation? Please send your press releases directly to attorney Larry Bodine, Editor, Mass Tort Nexus.

California co-led a multistate investigation, including 46 states and the District of Columbia, into J&J’s surgical mesh products for women, and is seeking injunctive relief and monetary penalties to ensure that J&J stops its deceptive practices.

Failing to provide critical information

“Johnson & Johnson put millions of women at risk of severe health problems by failing to provide critical information to doctors and patients about its surgical mesh products,” said Attorney General Harris. “Johnson & Johnson’s deception denied women the ability to make informed decisions about their health and well-being.  My office will continue to hold companies accountable for misleading consumers and patients for financial gain.”

The surgical mesh device is designed to treat common health conditions in women such as stress urinary incontinence and pelvic organ prolapse. The lawsuit alleges that J&J misrepresented the safety of these devices by concealing the possibility of serious and irreversible complications caused by mesh, including permanent pain with intercourse and/or loss of sexual function, chronic pain, permanent urinary or defecatory dysfunction, and potentially devastating impact on overall quality of life.

J&J also misrepresented the severity and frequency of common complications, and failed to disclose that its surgical mesh devices presented risks not present in alternative treatment options.

The suit further claims that J&J knew about potential risks and side effects prior to the launch of their mesh products, yet omitted that information from educational and marketing materials provided to doctors and patients.

J&J sold 787,232 devices nationally from 2008 to 2014, including more than 42,000 in California for that same time period.  Worldwide, more than 2 million women had been implanted with these mesh products.

In addition to the lawsuit filed today, J&J faces over 35,000 personal injury lawsuits in state and federal court related to its surgical mesh products.

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Despite Attacks, Strokes, Vision problems, Men’s Sex Dysfunction Drugs are Best Sellers

Side-Effects-of-ViagraThe global erectile dysfunction drugs market size was valued at over $4.39 billion in 2014. Key drivers of the market include an increase in patient awareness and education levels and growing base of geriatric population, according to Grand View Research, Inc.

However, reported side effects from the existing drugs are negatively affecting the industry growth. Availability of cost-effective counterfeit drugs is further expected to decrease the valuation of the branded erectile dysfunction drugs, according to Grandview, a U.S. based market research and consulting company, registered in the State of California and headquartered in San Francisco.

Litigation against Viagra has been consolidated in US District Court in Minnesota in multidistrict litigation docket MDL 2691.  Sr. Judge Paul A. Magnuson Judicial Panel on Multidistrict Litigation (JPMDL) on Dec. 29 denied a joint request by Pfizer Inc. and Viagra plaintiffs to place a motion for a skin cancer multidistrict litigation on the panel’s Jan. 28 agenda (In Re: Viagra Products Liability Litigation, MDL Docket No. 2691, JPMDL). The panel’s next hearing in March.

Heart attacks, strokes, vision problems

Does your law firm have a mass tort case in active litigation? Kindly send your press releases directly to attorney Larry Bodine, Editor, Mass Tort Nexus.

Since its release in 1998, the erectile dysfunction (ED) drug, Viagra brought in billions of dollars for drug giant Pfizer.  Men who suffered heart attacks, strokes, vision problems and hearing troubles filed lawsuits against the drug maker. In 2005, the U.S. Food and Drug Administration ordered that warnings about vision loss be added to the drug’s label.

Government reforms and public awareness initiatives in developing regions of Asia Pacific and Latin America are expected to drive market growth during the forecast period. Economic development, healthcare infrastructure establishment, and increasing target population are estimated to provide potential growth platforms for this industry in these regions.

Novel molecule combinations and drug delivery techniques such as the use of creams and pellets that show better efficacy and performance are expected to become an opportunity for the erectile dysfunction drugs industry.

North America erectile dysfunction drugs market, by product, 2012-2022, (USD Million)

Viagra is top-selling drug worldwide.North America erectile dysfunction drugs market

The main line of drugs for erectile dysfunction treatment includes:

  • Vitaros
  • Zydena
  • Stendra
  • Levitra
  • Cialis
  • Viagra.

Viagra (sildenafil citrate) is one of the most widely distributed products worldwide. Viagra’s primary competitors are estimated to be Cialis (tadalafil) by Eli Lilly & Co. and Levitra (vardenafil) by Bayer AG.

Key players of this market include Apricus Biosciences Inc., Bayer AG, Cristalia Dong-A Pharmaceutical Co. Ltd., Produtos Quimicos Farmaceuticos Ltd., Eli Lilly and Company, Pfizer, Inc., S.K. Chemicals Co. Ltd., Meda Pharmaceuticals, Inc., and Vivus, Inc. The industry for branded erectile dysfunction drugs is consolidated with key players involved in intense competition and rivalry.

Pfizer, Inc. accounted for the largest share at over 40.0% in 2012. However, the company’s market share is likely to decline over the forecast period owing to the patent expiry of Viagra in 2019. Generics are expected to boost industrial growth. In addition, post-patent expiration, mergers, acquisitions and collaborations activities, and geographic expansion are expected to keep industry rivalry at higher levels over the forecast period.

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Deceptive Testing Casts Doubt on J&J’s Xarelto Safety Claims

xarelto internal-bleedingAn investigation is underway into a clinical trial that the makers of Xarelto hired Duke University to undertake. Scientific trials for Xarelto, a blood-thinning drug, began in 2006 and reviewed the effects in a sample of 14,000 patients of a Xarelto compared to warfarin, a more traditional blood thinner, according to a new announcement.

Xarelto is manufactured by Janssen Pharmaceuticals, a subsidiary of the Johnson and Johnson Corporation, and Bayer AG.

Investigators are questioning the use of a defective testing device during the trials that would have influenced the results that ultimately indicated that Xarelto was more effective since the defective device in question allegedly gave patients the wrong dosage of warfarin.

Xarelto has become the focus of more than 5,000 lawsuits, as well as 500 allegations of fatalities. Plaintiffs in these cases and others now question whether the data would have made a difference in assessing the safety of the drug.

The mass tort litigation is consolidated in two courts: Xarelto MDL 2592 Federal Litigation and in the Philadephia Court Of Common Pleas

Intentional deception by J&J

Does your law firm have a mass tort case in active litigation? Please send your press releases directly to attorney Larry Bodine, Editor, Mass Tort Nexus.

Duke Researchers may have failed to provide all the requisite data of the trial for publishing in the New England Journal of Medicine (NEJM). As a result, the manufacturers, Janssen Pharmaceuticals, a subsidiary of the Johnson and Johnson Corporation, and Bayer AG, are being accused of intentional deception by not giving the NEJM all the necessary data for its assessment, which most likely led to FDA approval of the drug and its subsequent release on the market.

Lawyers in a legal briefing recently filed allege that the makers of Xarelto did not say anything after noticing Duke’s omitted data related to a recalled blood testing device used in the trial, as well as remaining quiet as the information about the drug was sent to US and European regulators. By doing so, Janssen and Bayer in effect misled the NEJM and the many readers who rely on the journal’s information, as well at the patients who would eventually use the drug.

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Bellwether Trials Set for Dangerous IVC Filters by Cook Medical

Bard IVC Lawsuit SettlementCook Medical Inc. and plaintiffs who have filed 400 lawsuits against it have agreed to bellwether cases that will be prepared for trial dates in September, 2016 according to news reports.

The cases will be tried in MDL No. 2570 IN RE: Cook Medical, Inc., in the Southern District of Indiana, assigned to Judge Richard L. Young and Magistrate Judge Tim A. Baker.

All federal product liability and personal injury lawsuits over complications with Cook Celect and Cook Gunther Tulip IVC filters have been centralized before U.S. District Judge Richard Young in the Southern District of Indiana, as part of an MDL, or multidistrict litigation.

The small, umbrella like devices are implanted for prevention of pulmonary embolism and they perforate the vena cava, migrated out of position or fracture, sending fragments or metal shards into the heart or lungs.

Court shoots down protective over

On May 12, Magistrate Baker denied Cook’s motion for a protective order. “Cook tries to distinguish Bard [Bard IVC Filters Products Liability Litigation, MDL 15-02641-PHX DGC (D. Ariz. April 1, 2016] on the basis that the defendant in that case had received an FDA warning letter, whereas Cook has not. This strikes the Court as the proverbial distinction without a difference. Warning letter or not, case law supports a finding that this information is relevant and discoverable,” he wrote.

The Court  heard argument on Defendant Cook Medical’s motion for protective orderOn April 27, 2016. Cook sought to bar Plaintiffs from seeking discovery concerning Cook’s alleged failure to report adverse events associated with its IVC filters to the United States Food and Drug Administration.

Cook’s motion was premised in part on the Supreme Court’s holding in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348 (2001), that state law fraud-on-the-FDA claims conflict with, and therefore are impliedly preempted by, the Federal Food, Drug, and Cosmetics Act. The FDCA gives the FDA sole authority to enforce compliance with the FDCA’s disclosure and other provisions. Thus, Cook argues that since Plaintiffs cannot enforce compliance, Cook’s report submissions to the FDA are irrelevant and inadmissible.

More on point is the recent case of In re Bard IVC Filters Products Liability Litigation, MDL 15-02641-PHX DGC, which stated: The Court views discovery relating to under-reporting or non-reporting of problems with retrievable filters to be clearly relevant to this case. Actual failure rates will be relevant to Plaintiffs’ negligence and product defect claims. Evidence regarding representations made by Defendants concerning failure rates will be relevant to Plaintiffs’ claims for fraud and misrepresentation.

The Court agreed with the analysis in Bard. Plaintiffs allege that Cook knowingly presents false information regarding the safety profile of its filters to physicians and the public, 4 and uses this false information as a promotional tool and in the labeling of its IVC products. Similar to Bard, Cook’s actual reports to the FDA are relevant to Plaintiffs’ claims and examination of potential liability. Cook’s reports to the FDA are particularly relevant to analyze the learned intermediary defense because they are what an intermediary would have relied on.

“Cook’s argument of limited relevancy is not enough to overcome the broad standard of relevance applicable in discovery. Fed. R. Civ. P. 26(b)(1); see Bank of Am., N.A. v. Wells Fargo Bank, N.A., No. 12 C 9612, 2014 WL 3639190, at *3 (N.D. Ill. July 23, 2014).”

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Attorney James Onder Attends Mass Tort Nexus Immersion Course

Attorney Jim Onder of Onder Shelton, O’Leary & Peterson LLC in St. Louis, attended a recent four-day immersion course by Mass Tort Nexus.

Mass Tort Nexus is the premier provider of information and education to attorneys representing Mass Tort Plaintiffs as well as those interested in expanding their practice to include Mass Torts. Contact Barbara Capasso at 954-383-9892 or barbara@masstortnexus.com for future course dates.

He discussed his recent $72 million ovarian cancer talcum powder verdict. “In coming, I didn’t know what to expect. But what I found was incredible,” Onder says. “I found a way for the typical – the single event lawyer – to enter the mass tort realm.”

Have 2 minutes? Watch this compelling video.

A smart move

Onder, one of the lead attorneys on the recent talc case which resulted in a $72 million plaintiffs verdict, spoke at the March 11th – 14th Four Days to Mass Tort Success Course. “If you are considering getting involved in the Talc Ovarian Cancer Litigation, getting to know James would be a smart move,” says John Ray.

John-Ray
John Ray

John Ray has been a leading consultant to the Mass Tort practice for over a decade. His unique skill sets make him well suited to both teaching and consulting in the Mass Tort arena.

As a 21 year old graduate of Brenau University in Atlanta, John graduated Magna Cum Laude and started a pharmaceutical and medical device company right out of school, selling it in an eight figure deal when he was 35.

John’s tenure in the pharmaceutical and medical device field allowed him to gain an in-depth understanding of FDA regulatory matters, as well as, a thorough understanding of the science and epidemiology related to gaining FDA approval to market pharmaceuticals and medical devices. John’s inside knowledge of how “Big Pharma” operates gives him a unique perspective and skill sets that are very useful to Mass Tort plaintiff firms.

Does your law firm have a mass tort case in active litigation? Kindly send your press releases directly to attorney Larry Bodine, Editor, Mass Tort Nexus.


Read Bodine’s article Behind the $55 Million Verdict: Johnson & Johnson Knew About Talcum Powder Cancer Risks Since the 1970s on the Huffington Post.

When John brought his “insider knowledge” and business acumen to the Plaintiff Mass Tort Space, one of the first things he recognized was a lack of common terminology and well defined metrics. John realized that firms were expressing the same concepts, but were not using the same terminology. As a result, John set out to define common terms and create methods for formulating important metrics for use by Mass Tort firms when evaluating litigations. The terminology and metrics John Ray developed are now commonly used by major Mass Tort Law firms.

Highly sought after

John is highly sought after and writes Whites Papers about both current and emerging torts, which are highly coveted in the industry. The accuracy of John’s analysis of emerging and ongoing litigations is unmatched.

The fact that John not an attorney has proven to be an asset. John thinks like a business person, employing creative problem solving and possesses an extensive set of business skills and industry specific knowledge. He assists Mass Tort firms in making sound business decisions before and during any litigation they are involved in or are considering becoming involved in.

John is an expert at evaluating cases and looks at each tort as an individual “investment,” which can be quantified resulting in risk mitigation for you and your firm.

 

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Lawsuits Increase as Phoenix Man Suffers Extensive Burns From E-Cigarette Explosion

Phoenix man burned by e cig batteriesA Phoenix, AZ man was hospitalzied with extensive burns after batteries from an e-cigarette exploded, According to a report from ABC15.com. David Garcia says he was driving down the road when two extra e-cigarette batteries exploded in his pocket inflicting significant burns to his legs and hands.

Once the batteries exploded, the victim began suffering extreme pain and discomfort and desperately called his wife. The victim’s wife told ABC15 that, “He called screaming saying he was on fire. My eight-year-old daughter is the one who answered the phone.” The victim is currently spending time at a local hospital, where he is being treated for his wounds.

Faulty lithium-ion batteries

The Federal Emergency Management Agency has indicated that there have been 25 reported e-cigarette explosions in the past 9 years that e-cigarettes have been available to consumers. Under-reporting is also widely speculated so the true number of incidents could be significantly higher. They have concluded that the likely cause for most of these explosions is the faulty lithium-ion batteries that some brands of e-cigarettes use to power their devices. The batteries, when overheated, sustain an overload of pressure which causes the energy inside the battery to explode through the cap.

Furthermore, this is not the first e-cigarette explosion and FEMA has concluded that as the popularity of these devices increase as does the likelihood of future explosions, according to Attorney Marc Freund of LipsigLawyers.com. Another e-cigarette explosion occurred in England, where an e-cigarette that was charging behind the bar was projected across the room at a local barmaid.

 

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Federal Racketeering Case Brought Against Johnson & Johnson

cipro, levaquin, Fluoroquinolone
A group of plaintiffs who were seriously harmed by the antibiotic Levaquin, have filed suit against Johnson & Johnson charging violations of the Racketeering and Corrupt Organizations Act (“RICO”).

The racketeering action, which is filed in the U.S. District Court for the District of Columbia, charges that Johnson & Johnson conspired to criminally influence the Commissioner of the Food & Drug Administration to mislabel and misbrand Levaquin.

The case charges that J&J defrauded consumers in order to acquire and reap financial gain, by:

  1. Driving up or maintaining the price of shares of Johnson & Johnson stock.
  2. Increasing the financial holdings and value of  Johnson & Johnson stock held by defendant Renaissance Technologies, L.L.C.
  3. Increasing defendant Renaissance Technologies, L.L.C.’s corporate income thereby increasing financial remuneration and gain to defendants Peter F. Brown, Robert L. Mercer, and James H. Simons by virtue of FDA Commissioner Dr. Margaret Hamburg ’s marriage to Peter F. Brown.
  4. Increasing corporate income of the officers of  Johnson & Johnson, Johnson & Johnson Pharmaceutical Research & Development, L.L.C, and Ortho-McNeil-Janssen Pharmaceuticals, Inc.
  5. Avoiding potential lawsuits against Johnson & Johnson.
  6. Increasing the combined wealth of defendants FDA Commissioner Dr. Margaret Hamburg and her husband, Peter F. Brown.

The FDA attributes 5,000 deaths and 8,000 injuries to Levaquin. Levaquin is considered dangerous to human health, unfit and unsuitable to be marketed as labeled and sold, misbranded, falsely advertised, promoted for off-label use, and introduced into interstate commerce. Levaquin causes mitochondrial toxicity, certain neuropsychiatric adverse events, increased risk of acquiring potentially fatal Carbapenem-Resistant Enterobacteriaceae, Fluoroquinolone-Associated Disability (“FQAD”), a term the FDA coined in 2015.

Johnson & Johnson has sold dangerous drugs and products including Tylenol, Motrin, Zyrtec, Benadryl, Risperdal, Invega, DePuy hip implants, Transvaginal Mesh, Xarelto, and Invokana. Multi-district litigation docket MDL 1943 has been organized against Johnson & Johnson in federal court in Minnesota.

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Case Filings Burgeoning in Xarelto Litigation

Blood Thinner

By Eleanor Smith.

Thousands of case filings are increasing court dockets in the Xarelto blood-thinner mass tort litigation in the Philadelphia Court Of Common Pleas and in federal multi-district litigation MDL 2592 in Louisiana.

The drug, which was originally approved by the FDA in 2011, was a popular alternative to other more traditional anticoagulants, largely because it required no drastic dietary alteration, little monitoring, and no adjustment to dosage. It has since received negative attention in the legal world, with more than 3,124 complaints filed or transferred into the multidistrict litigation docket.

Harmful Side Effects Experienced by Users

Multidistrict litigation (MDL) refers to a special federal legal procedure designed to speed the process of handling complex cases, such as air disaster litigation or complex product liability suits. MDL is helpful in mass tort cases like this because it allows attorneys to participate in discovery and litigate common factual issues efficiently and effectively for their respective clients.

Xarelto (Rivaroxaban) is a prescription anticoagulant medication that prevents the formation of blood clots by blocking certain clotting proteins in blood. Three additional indications of use for Xarelto are:

  • Used in people with atrial fibrillation (heart rhythm disorder) to reduce the risk of stroke caused by a blood clot.
  • Used to prevent/treat deep vein thrombosis (DVT) and pulmonary embolism (PE).
  • Used to reduce the risk of the formation of blood clots in the legs (DVT) and lungs (PE) after hip or knee replacement surgery.

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).

In January 2015, the U.S. Judicial Panel for Multidistrict Litigation consolidated MDL 2592 in the Eastern District of Louisiana (New Orleans) before Judge Eldon E. Fallon. Four bellwether trials have been selected and are slated to occur in early 2017. MDL developments will continue to be reviewed in monthly status conferences.

[sws_pullquote_right] See Also: Top 5 Mass Tort Cases for Plaintiff Lawyers Right Now [/sws_pullquote_right]

Bellwether trials are an increasingly common phenomenon in U.S. legal practice. Bellwether trials are especially common in MDL practice. In MDL cases, it is not practical to prepare every case for trial. For efficiency, several matters are selected as bellwether cases and prepared for trial. They are then settled or tried and the results are used to shape the process for addressing the remaining cases.

A bellwether trial is designed to be a value ascertainment function for settlement purposes or to answer troubling causation or liability issues common to a universe of claimants. For the tried cases to achieve these purposes, they must be similar and representative of all cases.

Case Filings Continue to Rise

Philadelphia has experienced a significant increase in Xarelto case filings in recent years. From March to October 2014, only a handful of cases were filed each month, the most being five in September 2014. However, in November 2014, the number spiked with 19 new cases filed. In December 2014, 26 cases were filed, followed by 17 in January 2015, 37 in February, and 50 in March.

Philadelphia is not the only state that has experienced a sharp increase in Xarelto MDL. In Louisiana, 2,800 suits were combined by the JPML as MDL No. 2592. Pennsylvania has also merged 550 plaintiffs’ cases to form a mass tort litigation program in the Philadelphia Court of Common Appeals. The majority of the cases consolidated into MDL No. 2592 allege that the drug places patients in danger of sudden and catastrophic bleeding events. Additionally, MDL plaintiffs claim that the makers of the drug concealed the negative traits of Xarelto through unsound business practices, while touting its positive attributes to the public.

The first bellweather trial is scheduled for February 6, 2017.

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FDA Warns that Invokana Causes Leg and Foot Amputations

Invokana Diabetic-KetoacidosisThe FDA is alerting the public about results of an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet).

It has not determined whether canagliflozin increases the risk of leg and foot amputations. FDA is currently investigating this new safety issue and will update the public when we have more information.

See the FDA Drug Safety Communication for additional details regarding the ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS) clinical trial. Mass Tort Nexus has an overview of litigation involving Invokana.

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. 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.

Defendants that manufactured Invokana are:

  • Janssen Research & Development
  • Johnson and Johnson
  • Janssen Pharmaceuticals,Inc.
  • Janssen Ortho
  • Mitsubishi Tanabe Pharma Corporation

Health care professionals should follow the recommendations in the canagliflozin drug labels. Monitor patients for the signs and symptoms described above and advise patients to seek medical advice if they experience them.

Patients should not stop or change their diabetes medicines without first talking to their health care professional. Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems, including blindness, nerve and kidney damage, and heart disease. Patients taking canaglifozin should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.

According to a lawsuit filed in Georgia, defendants’ warning information for Invokana does not address the increased risk of diabetic ketoacidosis or kidney failure, merely stating that a “possible side effect” of Invokana is “kidney problems.”

Due to the defective nature of Invokana, patiends who were prescribed and ingested it, for even a brief period of time, were at increased risk for developing serious, and sometimes life-threatening, complications, including ketoacidosis.

Defendants withheld and concealed their knowledge that Invokana can cause serious, and sometimes life-threatening, complications, including diabetic ketoacidosis from the Plaintiff, other consumers, their physicians, the medical community at large and the general public.

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