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.

Stryker LFIT Settlement Reached – How to Make a Claim

By: Marilyn McGoldrick, Esq.

November 21, 2018

Stryker Femoral Heads Confidential Settlement

A settlement was announced this month in the Stryker MDL litigation. The settlement covers individuals with cases in the federal court litigation  and cases filed in New Jersey state court who had revision surgery to replace the faulty LFIT CoCr V40 Femoral Head components in their hip implants. The faulty LFIT Femoral Heads released dangerous cobalt and chromium metal debris into hip joints. As the metal on metal parts rubbed against each other when the hip moved, metal fragments were deposited into the surrounding tissue and blood. The tiny bits of metal can cause a condition referred to as metallosis, which in turn may cause irreversible muscle damage.

Stryker Recalled the LFIT V40 Metal Femoral Head Components In 2016

Stryker issued an urgent recall in August of 2016 for the hip replacement components known as LFIT CoCr [Cobalt Chrome] V40 Femoral Heads manufactured before 2011.  Higher than expected numbers of complaints had been made about the LFIT components. Here is a more detailed accounting of the recall including the exact implant items numbers of the recalled LFIT V40 Femoral Heads

Settlement Terms Are Confidential

The Judge overseeing the Stryker LFIT CoCr V40 Femoral Heads hip implant multidistrict litigation, Judge Indira Talwani of the U.S. District Court for the District of Massachusetts, has stayed (stopped temporarily) the litigation. The stay will allow  the parties to negotiate the final terms of the confidential settlement. In her order the Judge  described the reason for the stay as ‘…to resolve the claims of certain eligible patients who had surgery to replace their LFIT CoCr V40TM femoral head along with related hip system components.”

You Have A Defective Hip Implant. What Can You Do?

If you received a hip implant and later suffered  complications and were forced to undergo revision surgery, you may have a claim for damages.

We understand you likely do not know the type and manufacture of your hip implant.  The hospital where you had the implant surgery can provide you with that information (ask for the product identification sticker page) or, with written permission, we can obtain that information on your behalf.  We can determine exactly which hip implant device and components were used in your surgery and if there are any recalls related to those components.

Trust Our Stryker Hip Implant Attorneys to Help

Thornton Law Firm actively litigates cases against Stryker for its defective metal hip implants and hip implant components throughout the country.

If you are concerned that your hip implant has failed, that you have suffered injury because of a failed hip replacement, or have any questions about your implant, contact attorney Marilyn McGoldrick at 1-888-341-1405, or tell us your story HERE. The consultation is free and completely confidential.  The time limits for filing claims against Stryker and other hip implant manufacturers are short and strictly enforced. Call now for a consultation with an attorney with years of experience litigating defective hip implant cases.

Gas Explosions, Fires in Lawrence, Andover and North Andover

By: Marilyn McGoldrick, Esq.

Gas Explosions and Fires Devastate Our Neighbors in Lawrence, Andover and North Andover

Over-pressured gas lines serviced by Columbia Gas Company burst and caused explosions and fires over a wide swath of Lawrence, Andover and North Andover Massachusetts last week. The shocking and deadly chaos erupted in the afternoon as gas lines exploded inside homes, causing dozens of fires in homes in the area simultaneously. Fire departments from all over the state as well as New Hampshire and Maine responded with equipment and firefighters. One man was killed as he sat in his car next to a house that exploded; the chimney of the house fell on his car.  At least 25 people were injured. Over 8000 people were ordered to evacuate their homes, and National Grid cut off electricity to the area as a precaution to prevent sparks from creating additional fires.

What Caused the Explosions?

On the day of the explosions, Columbia Gas posted a notice on its website stating that on that very day they would begin the process of upgrading natural gas lines in neighborhoods across the state.

The cause of the over-pressurization is undetermined at this time.

What Happens Next?

Residents won’t have gas for several weeks, as all the pipes that were put under tremendous pressure during the incident have to be replaced. 48 miles of cast iron and steel pipes must be replaced before gas service can be restored to the majority of the homes affected.

All of those involved have our greatest sympathies, from the homeowners and residents to the first responders and repair crews.  Massive disasters like this are very wearing on everyone involved as everything in life like finding food and temporary shelter – taking showers and washing your clothes – getting your children to and from school – worrying about what will become of your belongings – dealing with insurance company representatives – all become stressful undertakings that sap the life out of you.

What Should I Do?

Here’s some excellent advice from the Massachusetts Attorney General:

Homeowners Who Suffered Damage

    • If your home has been damaged or destroyed, it is important that you make a list as soon as possible of valuable items in your home (furniture, jewelry, electronics, cash, etc.). This will help complete claims paperwork later.
    • Keep all receipts for any money you spend related to this emergency, such as hotel bills, monies paid to hospitals, replacement clothing or baby supplies, etc.
    • If possible, document any damage with pictures or videos and do not dispose of any damaged items unless instructed otherwise.
    • Use reasonable means to save and preserve property that has not already been destroyed. For example, if possible, board or tarp open areas exposed to the elements to prevent water damage.
  • Public adjusters may attempt to contact you and offer to handle your insurance claim on your behalf. Public adjusters are supposed to act as your representative in dealing with an insurance company in exchange for a percentage of your insurance settlement. There is no requirement that you hire a public adjuster to handle your claim, but if you decide to enter into an agreement with a public adjuster, please read the contract carefully before signing it. (emphasis added)

Displaced Renters

    • Many renters in the region may be unable to safely occupy their homes for days or weeks, depending upon the extent of the damage. Some housing may be permanently uninhabitable.
    • Renters should contact their landlord and notify them in writing about the extent of damage to rental units.
    • Residents may want to document damage with photographs from their unit, if the unit can be entered safely.
    • If units are uninhabitable, renters should discuss alternate housing that the landlord can provide or withholding rent while the renter finds other housing.
    • Renters should review the terms of their leases to hold informed conversations.
  • All rental housing in Massachusetts must meet state standards for health and safety.

However, you should be aware that the Massachusetts General Attorney’s office is not able to give you legal advice, nor act as your personal attorney.

Trust our Massachusetts Environmental Disaster Lawyers to Help

Thornton Law Firm has represented victims of catastrophic accidents and environmental disasters for four decades. Our team of environmental lawyers is ready to assist any person or family who suffered damages and losses in these recent gas explosions and fires in our state. Call 888-491-9726 or our local number 617-720-1333 to speak with an attorney about your claim, or use our  online contact form here to send us a message with your information. The gas company and the insurance companies already have lawyers. Protect your interests as soon as you are able and get the legal advice you need.

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.

Depuy Pinnacle Hip Litigation – Update

By: Marilyn McGoldrick, Esq.

Published on May 29, 2018

Defective Hip Replacement Lawsuits

Five plaintiffs were awarded a total of $502 million dollars in the 2nd test (bellwether) case to go to trial against Johnson & Johnson (J&J) relating to its Depuy Pinnacle hip implants, in January of 2016,  J&J appealed the verdict, which the trial judge reduced to $151 million dollars.  The 5th Circuit Court of Appeals heard oral argument on December 7, 2017, and issued their opinion  in April 2018. The Fifth Circuit overturned the entire verdict and remanded the case back to the Northern District of Texas and Judge Ed Kinkeade for a new trial.

While this ruling may be worrying to people who have been waiting for a long time with pending Pinnacle Hip claims, we believe the ruling confirmed  that the Plaintiffs prevailed on the merits and on nearly every underlying substantive legal issue set forth in J&J’s appeal.  The 5th Circuit focused on rulings specific to those cases on trial and held that Judge Kinkeade erred in allowing Plaintiffs’ lawyers to present certain inflammatory character evidence against J&J.  The 5th Circuit ruled that allowing that inflammatory evidence before the jury tainted the verdict, requiring a new trial for each of the five plaintiffs.

Despite the disappointing remand for a new trial, the Fifth Circuit’s decision contains excellent rulings in many key areas. Additionally, the character evidence the 5th Circuit ruled should not have been presented to the jury has not been allowed into evidence in any of the subsequent bellwether trials, and each of those resulted in large jury verdicts.  While we disagree with the 5th Circuit’s ruling, we agree with the decision of Plaintiffs’ counsel in this matter not to appeal the ruling and to move forward with a new trial as soon as possible.

The 5th Circuit is scheduled to hear oral argument next month relating to the September 2016 California bellwether trial which resulted in a $1 billion dollar verdict.   In the meantime, if you have a failed metal-on-metal hip implant made by Johnson & Johnson’s DePuy Orthopaedics, Biomet, Stryker Orthopaedics, Wright Conserve, or Zimmer Holdings, you may be eligible to file a claim for damages. You may be compensated for medical expenses from replacement, money damages for the pain, suffering, physical injuries,and any other losses, such as lost income,  that you suffered as a result of your injuries.  Contact the Boston law firm of Thornton Law Firm LLP online or call Attorney Marilyn McGoldrick at 1-888-341-1405 for a free consultation with a specialist in Massachusetts drug and medical device litigation. The consultation is completely confidential. Seek legal advice immediately. Courts apply strict time limits to all personal injury cases.

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 and Johnson Ordered to Pay $417 Million in Talc Ovarian Cancer Verdict

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

By: Marilyn McGoldrick, Esq.

UPDATE: The trial judge granted Johnson & Johnson’s motion for a new trial in this case, overturning the verdict and ruling that there were errors and jury misconduct. Plaintiff Eva Echeverria died after the trial; her estate has appealed the ruling vacating the award.

 

Published on September 20, 2017

The first California trial of a plaintiff claiming her ovarian cancer was caused by Johnson & Johnson talc powder ended in a $417 million award for plaintiff Eva Echeverria.

Previous talc lawsuits had been tried in state court in St. Louis, Missouri. Last year the Supreme Court ruled that cases must be tried in the state where the injuries occurred. Since then, Johnson & Johnson has worked to get the St. Louis cases dismissed, claiming that St. Louis is an over-friendly plaintiff’s jurisdiction. This California jury award of $367 million in punitive damages was more than was awarded in all four St. Louis talc verdicts put together.

Echeverria, age 63, was too ill to attend the trial.  She was initially diagnosed with ovarian cancer in 2007, when a softball sized tumor was removed by her surgeon. Her videotape deposition was played for the jury. She testified that she used Johnson & Johnson baby powder from age 11 until 2016 when she saw a story on the news about a woman with ovarian cancer who had used talcum powder.

As in previous trials, evidence was introduced to show that J&J has been aware for decades of studies linking use of talcum powder to cancer, and withheld that information from consumers. A 1982 study was introduced that showed a 92% increased risk for talc users of developing ovarian cancer. The study’s author, Daniel W. Cramer, later recommended that Johnson & Johnson put warning labels on talc powder products.

New evidence introduced at this trial included warning labels on bottles of talcum powder sold at Walmart and Dollar Tree, warning of the risk of ovarian cancer. Johnson & Johnson has never warned consumers of the risks of ovarian cancer from talc use. Echeverria also produced evidence that members of the Cosmetic Ingredient Review, an industry organization that has pronounced talc a safe ingredient, has received payments from Johnson and Johnson for speeches and other engagements.

Johnson & Johnson has appealed the verdict, claiming that passion and prejudice tainted the jury’s decision.

It is recommended that women who use talcum powder switch to cornstarch, arrowroot, or any other powder made without talc. If you or a loved one has developed ovarian cancer after using talc powder, call the talcum powder lawyers at Thornton Law Firm for a free and confidential consultation. Please  call Attorney Marilyn McGoldrick at 1-888-341-1405 or tell us your story online for a comprehensive evaluation of your legal rights. Seek legal advice as soon as possible. Legal claims have short time limits that are strictly enforced by the courts. Do not delay.

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

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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 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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