$37M Verdict in NJ Talc Mesothelioma Trial

A Middlesex County New Jersey jury awarded four sets of plaintiffs $37 million dollars against Johnson & Johnson for mesothelioma caused by talc baby powder. The consolidated trial lasted almost three months, and at the end, the judge struck the Johnson & Johnson attorney’s entire closing argument, ruling that the attorney had made improper comments on the evidence.

The jury’s unanimous verdict was that all of the plaintiffs had been exposed to asbestos by using Johnson and Johnson’s baby powder and Shower to Shower talcum powders contaminated with asbestos. The jury also unanimously ruled that J&J failed to warn the plaintiffs about the dangers of its talcum body powders. In a 5-1 vote, the jury ruled that those actions caused the plaintiffs’ mesothelioma. Mesothelioma is a rare and fatal cancer caused by exposure to asbestos.

The award is for compensatory damages only. Punitive damages may be awarded in a separate phase of the trial. Plaintiffs Douglas Barden and his wife, Roslyn Barden were awarded $7.25 million; David Etheridge and his wife, Darlene Etheridge were awarded $9.45 million; D’Angela McNeill was awarded $14.7 million; and William Ronning and his wife, Elizabeth Ronning. were awarded $5.9 million.

Johnson & Johnson had previously asked for a mistrial based on the trial judge striking its counsel’s closing argument from the record; after the verdict was announced, Johnson & Johnson said they intend to appeal the decision. Johnson & Johnson faces over 10,000 talc-related cancer claims in both federal and state courts. The Securities and Exchange Commission and the United States Department of Justice subpoenaed Johnson & Johnson in February for documents on talc powder safety. This followed a Reuters report published in December of 2018 entitled “Special Report: J&J knew for decades that asbestos lurked in its Baby Powder”.

If you or a loved one has been diagnosed with cancer – either mesothelioma or ovarian cancer – after using talcum powder (including Johnson & Johnson’s Shower to Shower Powder, baby powder, Colgate’s Cashmere Bouquet, or Avon’s body powder products), you may have a legal claim for damages. Call Thornton Law Firm’s female mesothelioma attorneys,  Leah McMorris or Leslie-Anne Taylor for a free, no obligation evaluation of your legal claim at 1-888-341-1405. Or tell us your story here. Seek legal advice immediately if you believe you may have a claim. Like all lawsuits, baby powder lawsuits must be filed within strict time limits.

J&J Hit With $300 Million Punitives Award in Talc Mesothelioma Case

A New York state court jury ruled in favor of a woman in her suit against Johnson & Johnson alleging her mesothelioma was caused by her many years of exposure to J&J’s asbestos-containing talc powder. The jury awarded plaintiff Donna Olson, 66, and husband Robert Olson $25 million in compensatory damages –  $20 million for her pain and suffering, and $5 million for his loss of consortium. The jury also found Johnson & Johnson’s conduct was wanton and reckless, warranting an award of $300 million in punitive damages.

The lawsuit was filed in 2017, alleging daily use of J&J’s baby powder and scented Shower to Shower products from 1953 through 2015. Donna Olson was diagnosed with pleural mesothelioma in 2016. As part of her treatment, one of her lungs was removed. She was too ill to attend the trial. Her husband testified that it was her daily ritual to use Johnson and Johnson’s baby powder after she showered.

The jury rejected J&J claims that there was no asbestos in its powders. Instead, the jury found the company had been aware of the presence of asbestos in talcum powder for decades, yet had failed to warn consumers.

Beginning in 2009, lawsuits were filed in state and federal courts throughout the country alleging talc-based powders caused cancer. Trials against Johnson & Johnson alleging its talc-based powders caused cancer first began in 2013. This New York verdict is the 10th win for talc plaintiffs. It is the largest verdict in a claim that J&J talc powder contained asbestos and that asbestos caused the deadly asbestos-related cancer mesothelioma.

Johnson & Johnson announced plans to appeal the verdict. They face over 14,000 talc-related cancer claims according to a regulatory filing in May. In February, J&J received subpoenas from the United States Department of Justice and the Securities and Exchange Commission seeking documents on the safety of its talc products.

If you or a loved one has been diagnosed with cancer after using Johnson & Johnson talc powder (including baby powder and Shower to Shower Powder), you may have a legal claim for damages. Call Thornton Law Firm’s mesothelioma attorneys,  Leah McMorris or Leslie-Anne Taylor for a confidential, no-obligation evaluation of your legal rights at 1-888-341-1405. Or tell us your story here to discuss your legal claim and how you should proceed. Do not delay seeking legal advice. Like all legal claims, talc powder lawsuits have short, strictly enforced time limits for filing.

Johnson & Johnson Prolift Vaginal Mesh: $80M Verdict in Latest Trial

By Marilyn T.  McGoldrick, Esq.

Published on May 28, 2019

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A Philadelphia jury ordered Ethicon, a subsidiary of Johnson and Johnson, to pay $80 million dollars to a woman who was injured by her Prolift transvaginal mesh implant. The verdict included an award of $50 million dollars in punitive damages. This is the 10th mesh-related case tried in Philadelphia and the 8th verdict in favor of plaintiffs.

Patricia Mesigian was implanted with Ethicon’s Prolift mesh in 2008 when she was 64. The implant was intended to treat her pelvic organ prolapse, a condition where the muscles supporting the organs weaken allowing the organs to drop down and press on or into the vagina. Instead of treating her condition, the implant caused her vaginal bleeding and pain, discomfort during sex, infection, and inflammation. Eventually the mesh eroded into her vagina and she endured 5 surgeries and two chemical burn treatments in an attempt to remove the mesh which was embedded in scar tissue.

The jury deliberated two days before reaching its verdict. They found the Prolift implant was defective and that the defendants failed to adequately describe the risks.  The jury awarded Ms. Mesigian $30 million in compensatory damages.

This is the second verdict against Ethicon in less than one month. An Altoona woman was awarded $120 million in April for the defective mesh she was implanted with to treat urinary incontinence. The verdict comes in the wake of the FDA’s decision to ban the last two manufacturers of pelvic mesh, Boston Scientific and Coloplast, from selling or distributing mesh products for transvaginal repair of pelvic organ prolapse in the United States. The FDA said that the manufacturers were unable to show that the products were safe or effective for the treatment of organ prolapse, compared to repair procedure using native tissues. Johnson & Johnson’s Ethicon unit stopped selling the Prolift transvaginal mesh implants in 2012.

J&J’s Ethicon issued a statement saying that the verdict was “inconsistent with the science” and that they plan to appeal.

Any woman who has mesh implanted to treat pelvic organ prolapse who is having any symptoms connected with the implant should contact her doctor immediately. The injuries caused by defective transvaginal mesh may include vaginal bleeding or discharge, severe pelvic or groin pain, infection, pain during sexual intercourse, urinary problems, or perforated organs from mesh eroding into surrounding tissues. Do not delay seeking medical attention if you have any symptoms you believe are related to your transvaginal mesh implant.

If you would like to explore your legal options regarding your mesh implant, call the transvaginal mesh lawyers at Thornton Law Firm at 888-491-9726 to talk with Attorney Marilyn McGoldrick. You can also tell us your story online for a confidential, free evaluation of your claim.

 

 

 

Johnson & Johnson Knew Its Talc Contained Asbestos, A Cancer Risk, For Four Decades

By: Marilyn McGoldrick, Esq.

Published December 17, 2018

Johnson & Johnson documents confirm they knew since at least 1971 that their talc powders contained asbestos

A new report by Reuters makes public the fact that cosmetics giant Johnson & Johnson knew since at least 1971 that its talc powders including baby powder contained asbestos.

Thornton Law Firm wrote on this blog last year about the cover-up revealed by many of the same documents Reuters reviewed. The documents were produced in talc powder cancer lawsuits against J&J over the past few years:  Johnson & Johnson Knew of Asbestos Risk In Talc For Over Forty Years. Since that blog post was published, an additional 6,000 claims have been filed against Johnson and Johnson alleging cancer developed after using their talc powder products.

For over 40 years, Johnson & Johnson has maintained that the talc in their powders including Baby Powder and Shower to Shower powder were asbestos-free. But Johnson & Johnson’s own internal documents present much evidence that this is just untrue.

J&J receives reports of asbestos in talc beginning in 1957

Johnson & Johnson’s earliest reports of asbestos in talc are from 1957 and 1958 when a consulting lab’s studies of the Italian talc used in J&J Baby Powder showed fibrous and “acicular,” or needle-like, tremolite. Tremolite is an amphibole asbestos, often found along with other minerals in nature.

Internal discussion of asbestos in talc, but never reported to authorities

Over the years, Johnson & Johnson executives, scientists, mine managers, doctors and lawyers discussed the asbestos problem internally but never reported it to federal authorities.

Johnson & Johnson failed to disclose tests by three separate labs between 1972 and 1975 showed asbestos in talc to the FDA, instead telling the FDA that all its powders tested asbestos-free. One of the tests reported the asbestos level as “rather high”.

J&J works to suppress the public’s knowledge of asbestos in their talc powders

Arthur Langer and Irving Selikoff, scientists well known to asbestos victims for their research on the dangers of asbestos, both told Johnson & Johnson that they found asbestos in its talc. In response, J&J put the two famous researchers on a list of “antagonistic personalities” in a November 29, 1972 memo.

In 1973 Johnson and Johnson considered getting patents for a process that would separate talc from tremolite, but decided against obtaining the patents. The director of research for J&J’s Central Research Laboratories in New Jersey, Tom Shelley,  wrote this explanation to a J&J lawyer:

“We will want to carefully consider the … patents re asbestos in talc. It’s quite possible that we may wish to keep the whole thing confidential rather than allow it to be published in patent form and thus let the whole world know.”

Johnson & Johnson rejected the most sensitive test for finding asbestos in talc, then based on the less sensitive tests claimed (and continue to claim) their talc is asbestos-free.

For years the American Cancer Society accepted the representations of industry that talc products were asbestos-free. The ACS website said flatly  “All talcum products used in homes have been asbestos-free since the 1970s.” But after being contacted by Reuters , in December the ACS revised its website. Now it says that under industry guidelines, talc products “should be free from detectable amounts of asbestos.” See the change on the website here.

Many talc samples and baby powder samples test positive for asbestos

Baby powders that when tested were found to contain asbestos included:

  • A bottle of 1978 baby powder from Johnson & Johnson’s own J&J museum;
  • Bottles from  plaintiffs’ cupboards;
  • Shower to Shower talc powder from the 1990s;
  • Bottles purchased on Ebay.

Judge Accuses J&J of “Misrepresentation by Omission”

This year a New Jersey judge, Middlesex County Superior Court Judge Ana Viscomi, upheld a jury verdict again Johnson & Johnson. In her ruling in favor of the plaintiff with cancer, she stated:

“Providing the FDA favorable results showing no asbestos and withholding or failing to provide unfavorable results, which show asbestos, is a form of a misrepresentation by omission,”

Johnson & Johnson has begun to change their statements on asbestos in talc powders

While Johnson & Johnson’s website used to say their talc powders have always been asbestos free, that statement has been changed. Now the site says  “Our talc-based consumer products are (we cannot say always) asbestos free, as confirmed by regular testing since the 1970s.”

What can you do?

If you or a loved one has been diagnosed with ovarian cancer or mesothelioma after using talcum powder (including baby powder and Shower to Shower Powder), you may have a claim for damages. Contact Thornton Law Firm’s defective product attorneys for a confidential, free evaluation of your legal rights at 1-888-341-1405. Or tell us your story here  to find out your legal rights and how you should proceed.

Trust our Massachusetts talcum powder attorneys to help

Call Attorney Marilyn McGoldrick at 1-888-341-1405  or tell her your story online  for a free consultation with a recognized leader in Massachusetts personal injury litigation. We offer a fair and accurate assessment of your case. You have nothing to risk.

Thornton Law Firm Notifies Shareholders Of Johnson & Johnson (JNJ) Of An Investigation Involving Possible Securities Fraud Related To Nondisclosure Of Asbestos In J&J Powder Products

By: Guillaume Buell, Esq.

Published December 14, 2018

Thornton Law Firm LLP is investigating potential violations of the federal securities laws on behalf of purchasers of the securities of Johnson & Johnson (NYSE ticker: JNJ) regarding recent revelations that J&J knew about asbestos in its baby powder and talcum powder products dating back several decades. Shareholders who purchased or acquired Johnson & Johnson (JNJ) securities, including common stock, may have a claim to recover losses against J&J based on recent revelations concerning asbestos in its baby powder and talcum powder products.

If you purchased Johnson & Johnson stock, ticker JNJ, you may have a claim for damages. Contact Thornton Law Firm’s shareholder attorneys immediately at shareholder@tenlaw.com or at (617) 720-1333, or toll-free at 1-800-431-4600.

We will respond immediately to your inquiry and diligently assist you in investigating whether J&J committed securities fraud, and determine if you are eligible to recover.

According to media reports, including Reuters, alleged J&J internal documents suggest the Company and its executives have known for decades that its baby powder or talcum powder products caused cancer and contained asbestos. Johnson & Johnson asbestos allegations are the focus of this potential lawsuit.

Thornton Law Firm’s securities attorneys specialize in representing individual shareholders and institutional investors in recovering damages caused by corporate fraud. Its attorneys have decades of experience litigating securities fraud cases in courts throughout the country and have a proven track record of recovering losses on behalf of shareholders. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics. Prior results do not guarantee any future outcome.

Talc Cancer: $4.69 Billion Dollar Verdict Against Johnson & Johnson

By: Marilyn McGoldrick, Esq.

UPDATE: The trial judge, Judge Rex Burlison, upheld the verdict on appeal, stating that “substantial evidence was adduced at trial of particularly reprehensible conduct” and that the jury was entitled to draw the conclusion from the evidence that Johnson & Johnson “knew of the presence of asbestos in products that they knowingly targeted for sale to mothers and babies, knew of the damage their products caused, and misrepresented the safety of these products for decades.”

Published July 18, 2018

Twenty-two women who had ovarian cancer were awarded a total of $4.69 billion dollars in their claims against Johnson & Johnson. All the cancer-stricken women had used Johnson & Johnson’s baby powder and Shower-to-Shower talcum powder for many years. This is by far the largest verdict against Johnson & Johnson in a talc cancer case to date. The Missouri state court jury awarded a total of $550 million in compensatory damages to the women, and added a punitive damage award of $4.14 billion dollars. It is the largest verdict in a jury trial in the United States in 2018.

The plaintiffs presented evidence about the carcinogenic properties of both talc and asbestos. A 1971 article about  talc and carcinoma of the ovary and cervix was introduced as evidence. The plaintiffs presented evidence that Johnson & Johnson’s talc products also contained asbestos. They disputed Johnson & Johnson’s tests showing its talc didn’t contain asbestos, presenting evidence that the tests were rigged by only finding asbestos if a certain level was present, or testing extremely small sample sizes. Evidence presented indicating that if tests did find asbestos, Johnson and Johnson then sent the talc to a different lab for testing. Memos and reports were introduced from Johnson & Johnson scientists going back decades showing concern over asbestos in the talc in J&J’s powders.

This verdict is the latest in a series of verdicts against Johnson and Johnson in talc cancer cases.  Five previous cases were tried against J&J in St. Louis, and four resulted in verdicts for the plaintiff. Individual verdicts in favor of the plaintiffs of $55 million dollars and $72 million dollars were reversed after the United States Supreme Court issued a new decision on the issue of personal jurisdiction. The other two verdicts, for $110 million dollars and  $70 million dollars are still on appeal. In California, a jury awarded the plaintiff a $417 million verdict, in a talc ovarian cancer case,  but that verdict was reversed by the trial judge.

One juror interviewed after this verdict stated that the punitive damages amount, $4.14 billion, was calculated by multiplying the annual revenue from baby powder ($70 million) by the number of years Johnson & Johnson had known talc was an issue. Punitive damages in Missouri are limited by state law to five times the amount of actual damages, so the punitive damage award will be reduced. Johnson and Johnson has indicated it will appeal the verdict.

It is recommended that women who use talcum powder switch to arrowroot, cornstarch, or any other non-talc powder. If you or a loved one has been diagnosed with ovarian cancer after using talcum powder, call the talc powder lawyers at Thornton Law Firm for a  confidential, no charge consultation. Thornton Law Firm has represented victims of asbestos exposure for 40 years. Call Attorney Marilyn McGoldrick at 1-888-341-1405 or tell us your story online for a thorough, comprehensive evaluation of your legal rights. If you have developed ovarian cancer, you should seek legal advice as soon as possible. Personal injury claims have very short time limits that are strictly enforced by the courts. Do not put off getting a legal opinion.

Johnson & Johnson Knew of Asbestos Risk in Talc For Over Forty Years

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Call 888-491-9726 for a free consultation with a recognized leader in toxic exposure litigation. You can also contact us online to discuss the details of your case.

By: Marilyn McGoldrick, Esq.

Published on September 25, 2017

Johnson & Johnson was alerted to the risk of asbestos contamination of its talc in a 1973 company report about J&J’s Windsor Materials talc mine in Vermont. The document was recently produced in a deposition of Johnson & Johnson’s chief medical officer, Joanne Waldstreicher, and reported by Bloomberg.

The 1973 report noted that J&J was working with federal officials to look for fibers that could indicate asbestos was present at the Windsor Materials talc mine.  The report goes on to discuss the significance of this:

A J&J official said in that report that the company’s baby powder “contains talc fragments classifiable as fiber. Occasionally sub-trace quantities of” two types of asbestos “are identifiable and these might be classified as asbestos fiber.’’

Concerned that asbestos may have tainted talc used in the company’s products, a J&J official suggested the company move toward using corn starch in its consumer products rather than talc, according to the report.

Another unsealed document shows that J&J pushed its Italian talc mine to stop distributing a booklet that revealed the presence of trace amounts of asbestos in the talc J&J was buying from them. The owners of the Val Chisone mine near Turin, Italy were persuaded by J&J to stop distributing the English version of the booklet so Johnson and Johnson could rewrite it. J&J’s Waldstreicher was asked about the rewritten booklet, from which all references to asbestos had been removed. She had never seen it.

Waldstreicher was also asked about whether Johnson & Johnson should have warned consumers:

“Would you agree that if asbestos is in the product, you all ought to be warning people?’’ [the plaintiff’s attorney] asked. At first, Waldstreicher responded that it was a “hypothetical question.” Eventually, she conceded.

“I would like to be warned before I were around any cancer-causing substance,’’

Johnson and Johnson has never warned consumers of any risk in using its talc powders. The unsealed documents show that instead J&J employees were trained to reassure anyone who asked about asbestos in Johnson & Johnson’s powders that asbestos “has never been found and it never will’’.

More than 5,000 lawsuits are pending nationally against Johnson and Johnson for  ovarian cancer caused by talc.

If you have been diagnosed with ovarian cancer or mesothelioma after exposure to talc, call Thornton Law Firm’s talc lawyers at 888-491-9726 for a free case evaluation, or tell us your story here.  Contact us today for a thorough, fair consideration of your legal claim.

Johnson & Johnson Hit With $57M Verdict in Pelvic Mesh Case

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By: Marilyn McGoldrick, Esq.

Published on September 6, 2017

Johnson & Johnson’s Ethicon subsidiary was ordered to pay plaintiff Ella Ebaugh $57 million dollars for injuries she suffered from their transvaginal mesh implants. The verdict, rendered in Philadelphia Common Pleas Court, was the largest verdict in the Philadelphia  mass tort litigation.

Ebaugh, 51, was treated for stress urinary incontinence (SUI) with J&J mesh implants called TVT and TVT-Secur. While the implants successfully treated that minor condition initially, later the mesh eroded into her urethra. Three surgeries were required to remove the mesh.  According to her lawsuit, Ebaugh’s injuries included extensive scarring to her urethra, intrinsic sphincter deficiency, chronic urinary tract infections, chronic pelvic pain and dyspareunia, or chronic pain during sex. She has been unable to work since the mesh eroded.

The jury awarded $7.1 million in compensatory damages, and $50 million in punitive damages. It is the fifth successive multi-million dollar award against J&J and its Ethicon unit in a pelvic mesh case. You can read more about the previous awards here: Belz ($2.16 million); Engleman ($20 million);  Carlino ($13.5 million);  and Hammons ($12.5 million).

J&J and Ethicon plan to appeal the verdict.

Attorney Marilyn McGoldrick leads Thornton Law Firm’s vaginal mesh injury team. We represent women in claims against Boston Scienific, Caldera, Coloplast, Cook Medical, C.R. Bard, Inc., Mentor Worldwide, and Sofradim/Covidien, as well as against Johnson & Johnson’s Ethicon unit. If you have pelvic mesh implant and have experienced side effects, including mesh erosion, mesh contraction, infection, pain, urinary problems, severe pelvic pain, bleeding, vaginal tightening or shortening, inability to engage in sexual intercourse, painful sexual intercourse, additional surgeries, or organ perforation, and would like a  confidential and fair evaluation of your legal claim, please call us at our toll free number 1-888-341-1405, or tell us your story on the online. Time limits for filing legal claims are short and strictly enforced. Seek legal advice immediately about your defective mesh implant.

 

J&J’s Ethicon To Pay $2.16 Million In Pelvic Mesh Verdict

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Call 1-888-341-1405 for a free consultation with a recognized leader in personal injury and medical device litigation. You can also contact us online to discuss the details of your case.

By: Marilyn McGoldrick, Esq.

Published on June 5, 2017

A Pennsylvania state court jury awarded $2.16 million in damages to a woman with an Ethicon ProLift +M  Pelvic Floor Repair System which eroded inside her body and cannot be removed.  This is the fourth consecutive win for plaintiffs in the Philadelphia Court of Common Pleas, and the fourth multi-million dollar award against Johnson & Johnson and its subsidiary Ethicon. It is the first time  punitive damages were not awarded.

The award is entirely compensation for the plaintiff’s injuries, including lost income, medical bills, and extreme pain and suffering. Diagnosed in 2006 with Pelvic Organ Prolapse (POP), a common condition in women who have had children,  plaintiff Sharon Belz was implanted with an Ethicon Prolift+M system.  The product, a large piece of polypropylene mesh, is used to help support pelvic organs which have prolapsed or fallen out of position. The ProLift+M  was recalled by Johnson and Johnson in 2012, seven years after it was first placed on the market.

After the mesh began deteriorating in Mrs. Beltz’s body, surgeons attempted to remove it, but were unable to do so.  As a result, she suffered and continues to suffer.  Court filings describe her condition:

“Mrs. Beltz’s problems are thus permanent. She may elect to undergo further pain injections, resection of the mesh, or start taking pain medications regularly, but these options at best will only mitigate her symptoms. She has to live the remainder of her life with constant pelvic pain, a sensation her bladder is pulling, urinary incontinence and retention, lower flank pain, urinary tract infections, and severe pain with sex that lingers days after she has intercourse, ….. She will be at risk for exposure of the mesh in her vagina and erosion of the mesh into her bladder, urethra, or other organs for the remainder of her life.”

The Beltz jury concluded that the risks presented by the mesh far outweighed the benefits, and that was the basis for their award of compensatory damages. However, the jury did not find that the ProLift+M mesh was defective, nor that Ethicon/J&J failed to warn the plaintiff and her doctors. In the three previous verdicts against Ethicon, the juries did rule that Ethicon’s mesh implants were a defective product, and that Ethicon and Johnson & Johnson failed to warn that the mesh was defective. In those cases, the verdict was included a punitive damages award: Engleman ($20 million);  Carlino ($13.5 million);  and Hammons ($12.5 million).

Thornton Law Firm’s pelvic mesh injury team represents women in claims against Johnson & Johnson’s Ethicon unit, as well as  against Boston Scientific, Caldera, Coloplast, Cook Medical, C.R. Bard, Inc., Mentor Worldwide, and Sofradim/Covidien. If you have a vaginal mesh implant and have experienced any side effects, including infection, pain, bleeding, mesh erosion, mesh contraction, urinary problems, severe pelvic pain, vaginal tightening or shortening, painful sexual intercourse, inability to engage in sexual intercourse, additional surgeries, or organ perforation, and would like a  confidential and fair evaluation of your legal claim, please call us at our toll free number 1-888-341-1405, or tell us your story on the online. The legal time limits for filing claims are very short and strictly enforced, so seek legal advice as soon as possible about your transvaginal mesh implant.

FDA: Canagliflozin (Invokana, Invokamet) Must Add Amputation Risk Warning

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Call 888-341-1405 for a free consultation with a recognized leader in personal injury and defective drug litigation. You can also contact us online to discuss the details of your case.

By: Marilyn McGoldrick, Esq.

Published on May 16, 2017

The FDA has added a boxed warning to the label of  diabetes drugs containing canagliflozin (Johnson & Johnson’s brand names Invokana and Invokamet) to warn that these drugs carry an elevated risk of leg and foot amputations.

FDA Confirms Doubled Risk of Lower Limb Amputation When Taking Canagliflozin Drugs

Today’s FDA Drug Safety Communication confirms the approximately doubled risk of  lower limb amputations for patients taking Invokana (canagliflozin) or Invokamet (canagliflozin with metformin). The warning is based on new data from two large clinical trials. CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) showed about double the rate of amputations from diabetes patients on canagliflozin drugs, as compared to patients taking a placebo. Amputations mostly affect the toes and the middle of the foot. Amputations of the leg, below and above the knee, and to both limbs were also observed.

Europe Requires Amputation Warning on All SGLT2 Inhibitor Drugs, Not Just Canagliflozin

Invokana and Invokamet are classified as sodium glucose cotransporter-2 (SGLT2) inhibitor drugs. SGLT2s trigger the kidneys to release blood glucose into the urine, thereby lowering blood sugar levels.  The European Medicines Agency issued a requirement in February of 2017 that the labels of every drug in the SGLT2 inhibitor class carry the amputation warning.  The other drugs included as well as canagliflozin (brand names Invokana, Invokamet) are dapagliflozin (brand names Farxiga, Xigduo XR) and empagliflozin (brand names Jardiance, Glyxambi, Synjardy).

FDA Recommendations for Diabetes Patients and Their Health Care Providers When Using Canagliflozin

The FDA issued the following recommendations to patients, and to health care providers:

Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your health care professional if you have questions or concerns. Do not stop taking your diabetes medicine without first talking to your health care professional.

Health care professionals should, before starting canagliflozin, consider factors that may predispose patients to the need for amputations. These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Monitor patients receiving canagliflozin for the signs and symptoms described above and discontinue canagliflozin if these complications occur.

Reporting Adverse Events While Taking Invokana and Invokamet

The FDA encourages patients health care professionals and patients to report adverse events or side effects related to the use of canagliflozin and other medicines to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. You can do this   by calling  800-332-1088 to request a reporting form; by using their online reporting form; by downloading an online form and submitting by mail, or by faxing the form to 1-800-FDA-0178.

What Can You Do?

If you have taken the canagliflozin-containing diabetes drugs Invokana or Invokamet, or any other SGLT2 inhibitor drug, and suffered an amputation, you may have a claim for damages. Contact the defective drug attorneys at Thornton Law Firm for a free, thorough evaluation of your legal rights at 1-888-341-1405. Or tell us your story using our online contact form. Like all lawsuits, Invokana claims must be filed within short time limits. Seek legal advice as soon as possible to protect your rights.

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