Defective Products

Philips sleep and respiratory care devices have been recalled, as they have been linked to serious lung injury or cancer in consumers. Philips’ bilevel positive airway pressure (BiPAP), continuous positive airway pressure (CPAP), and mechanical ventilator devices help provide breathing assistance to patients dealing with sleep apnea and other respiratory problems. However, the U.S. Food and Drug Administration announced that Philips issued a voluntary recall for models of the ventilator devices in April 2021, and an updated recall on June 14, 2021. This recall affects millions of products that people with respiratory issues use on a daily basis.

Philips Sound Abatement Foam

The Philips CPAP and BiPAP ventilator devices have been recalled after it was discovered that the sound abatement foam, located inside the ventilator devices, have been linked to serious respiratory illnesses, lung injury, and even cancer. The foam is a polyester-based polyurethane foam, and is used in the products that may disintegrate, resulting in the user inhaling the toxic chemicals, or contaminants. Philips determined that foam may degrade into particles that enter the air path of the devices, which then gets inhaled by the user. The sound abatement foam can cause skin, eye, and respiratory tract irritation, leading to asthma, headaches, adverse effects of many organs, or carcinogenic effects. Users reported to Philips that they were suffering headaches, cough and chest pressure, upper airway irritation, and sinus infections following the use of the device.

Philips Awareness

Studies state that Philips was well aware of the risks that stem from the ventilator devices before the recall, although they failed to alert users of the product. In their company’s quarterly report in 2021, they mentioned that users had reported they were experiencing adverse health effects after using the products, leading to Philips discovering the issue with the sound abatement foam. This recall involves million ventilator devices, most of which are a first-generation device and are within the 5-year service life. Philips may be facing multiple lawsuits filed by users of the device who experienced injury or cancer after using a Philips sleep apnea ventilator.

Risks Associated With the Devices

There are many health risks that are associated with the use of these ventilator devices, ranging from skin irritation to various types of cancer. There are many related injuries that people have already been diagnosed with, such as airway inflammation, breathing difficulty, lung damage, asthma, pneumonia, lung cancer, kidney cancer, liver cancer, colon cancer, heart attack, respiratory failure, stroke, liver disease, and kidney disease. Although the company has received many reports of serious injury or cancer, no deaths have occurred. The FDA recommends that users of BiPAP and CPAP devices talk to their health care providers for alternative treatments.

Philips has advised users to stop using the devices and consult with their physician to determine the benefits and risks of continuing therapy. However, they warned users to not discontinue their prescribed therapy without having a conversation with their physician to determine the appropriate steps moving forward. Philips stated that they are researching for a permanent corrective action to address and solve the problem.

This lawsuit covers anyone in the United States who purchased a Philips ventilator device that has been recalled for personal or business use between the applicable statute of limitations period through June 14, 2021. If the lawsuit keeps moving forward, the affected users will receive a notice of the settlement, making them entitled to claim compensation. If you or a loved one has been diagnosed with serious lung damage or cancer due to a Philips CPAP, BiPAP, or mechanical ventilator device, it is important you file a claim. At Richard Harris Personal Injury Law Firm, our goal is to handle these cases and ensure compensation for users of the Philips devices. Our trusted attorneys have had years of experience dealing with faulty devices, and know how to handle your specific case in court.

The heartburn medication Zantac has been recalled within the United States and in other countries worldwide, because its active ingredient Ranitidine, mixes with common substances within the human body causing formation of high levels of the probable human carcinogen NDMA.  The recalls apply both to the over the counter (OTC) and prescription strength versions of the drug.

What is NDMA?

N-nitrosodimethylamine (NDMA) is a biproduct of industrial and natural chemical processes which has been shown to do nothing more than cause cancer.  NDMA was a chemical bi-product of making rocket fuel in the early part of the 20^th century.  Its only current use today is to induce tumors in lab animals for research experiments.  Other than for that purpose, NDMA is no longer produced in the United States.

The U.S. Food and Drug Administration (FDA) has set a level of 96 nanograms (ng) per day as the highest permissible intake limit for NDMA.  Recent testing has found NDMA levels in the human body after digesting the ranitidine molecule in excess of 3,000,000 ng.  NDMA has been linked by the World Health Organization (WHO) to gastric or colorectal cancer in humans.

In 2018, the high blood pressure medications Valsartan, Losartan, and Irbesartan were recalled by the FDA due to unacceptable levels of NDMA.  NDMA was found to be present in some, not all Valsartan products at levels up to 20,190 ng per tablet.  This levels in those products were caused by an impurity in the manufacturing process, however NDMA is actually a bi-product of the ranitidine molecule during the digestion process.

NDMA is a poison and should not be found except in trace amounts within the human body.  Studies suggest that humans are especially sensitive to the carcinogenic effects of NDMA.

Regulatory Actions

Due to findings of high NDMA levels after taking Zantac in several studies, in September 2018, a citizen group sent a petition to the FDA requesting that Zantac be recalled.  In October 2018 the FDA issued a recall to all manufacturers and distributors of Zantac to recall the product and initiate testing for high NDMA levels.  Since the recall, several retailers have removed Zantac from their shelves, including CVS, Walgreens, Walmart, and Kroger among others.

The FDA approved Zantac for distribution in 1983 in the U.S.  Two years previously, a study by Dr. Silvio de Flora of the University of Genoa, Italy, had been performed which preliminary concluded that ranitidine when exposed to human gastric fluid showed “toxic and mutagenic effects.”  In 1983, Dr. de Flora published the full findings of this study and confirmed his preliminary conclusion as to the formation of toxic bi-products of ranitidine in the body

Glaxo-Smith Kline (GSK), the inventors and manufacturers of Zantac in 1983, chose to minimize the study results and moved forward with introduction of the product, which shortly became a billion-dollar seller.  Zantac has been owned by several other pharmaceutical manufacturers since then, the most recent being Boehringer Ingelheim, and at no time during its distribution was a warning added to the product labels indicating potential cancer danger from taking the drug, in spite of repeated studies finding linkage between ranitidine ingestion and formation of NDMA within the human body.

Legal Action

December 2, 2019, a San Diego California man, named Gary Hart, filed suit against all current and previous owners of the Zantac brand since its inception, for causing his colon cancer.  The suit alleges that his cancer was caused from taking Zantac over an 8-year period.  He is suing the manufacturers of Zantac on the basis of the drug being defective, negligence, failure to warn of potential side effects of the drug, and breach of express and implied warranties.

At least 45 other lawsuits have been filed to date at the federal level, and it is expected that several thousand cases may be filed due to the long availability and widespread use of Zantac.  Plaintiffs have moved to consolidate all federal level cases into a Multi-District Litigation which will unify pre-trial discovery and motions under the direction of a single judge.

The Richard Harris Law Firm represents those injured by Zantac

Companies who manufacture and distribute drugs have a legal obligation to make sure the product is safe, and to warn medical providers and patients of potential side effects.  Companies who bring a defective product to market, and fail to warn of potentially dangerous side effects, especially when numerous independent studies confirm the dangers over the lifetime of the drug, are liable for both real and punitive damages.  If you have used Zantac, and have been diagnosed with colon, rectal, or gastric cancer, call our office today to discuss your potential case at (702) 444-4444.

Learn More:

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sanofi-provides-update-precautionary-voluntary-recall-zantac-otc-us#recall-announcement

https://www.fda.gov/about-fda/medical-product-safety-information/zantac-ranitidine-safety-information-ndma-found-samples-some-ranitidine-medicines

https://www.aarp.org/health/drugs-supplements/info-2019/zantac-recall.html

https://blog.uvahealth.com/2019/10/08/zantac-recall/

https://www.usatoday.com/story/money/2019/10/02/walmart-halting-zantac-sales-over-possible-cancer-link/3839963002/

Walk-in bathtubs are specifically marketed towards the aging population, with promotional materials promising peace of mind and that the product has been engineered for safety and comfort. But what has been the real-life experience of users of this product? For Sherry Cunnison of Las Vegas and others, it was deadly.

The target market for these products are consumers who are elderly, overweight, or have other physical limitations. Marketing materials specifically state that the product is safely engineered to provide a luxurious and comfortable bathing experience. Older Americans have an increased risk of falling, but the product is designed in such a way that when a user falls or slides off the seat of the tub, they have limited to no ability to right themselves, nor to drain the tub. The door, which opens inwardly, is next to impossible to open, because the user is trapped in the space that the door opens into.

In a sworn deposition, Jacuzzi’s chief engineer admitted that no medical doctors, physical therapists, or occupational therapists were consulted in the design of the product. Furthermore, he states that the product is nothing more than “a bathtub with a door in it.”

Attorney Ben Cloward of the Richard Harris Personal Injury Law Firm represents the family of a victim who died while using the product and says, “I think its death trap.” Jacuzzi has responded to the lawsuit, saying, “Jacuzzi cannot control how people use or misuse its products.”

Real Life Experiences With the Jacuzzi Walk-In Tub

Sherry Cunnison, Las Vegas NV

In 2014, Ms. Cunnison, 67, of Las Vegas, had a Jacuzzi brand walk-in tub installed at her residence. Within three weeks, she fell in while using the tub and was trapped in the small space in front of the seat. She could not pull herself up, drain the tub, or open the door, and she remained there for two to three days.

After several unanswered phone calls, a well check was performed, and she was found alive. She was then transported to the hospital where she later died. First responders had difficulty rescuing her from the tub and even broke her arm while pulling her out of the tub. Eventually, firefighters at the scene were only able to remove the inward opening door by use of a Sawzall.

Mack Smith, Houston TX

Mack Smith, a retired sheriff’s deputy in his 60s, installed his Jacuzzi tub in 2013. While using the tub in 2016, he slid off the seat and landed on his back in the confined space at the bottom of the tub. His feet were extended into the air, with his body covering the drain and blocking the inward opening door to the tub.

His wife Barbara, who was home at the time, could not remove her husband from the tub, reach the drain, open the door, or remove enough water from the tub to prevent Mack from drowning. She called 911 and first responders transported Mack to the hospital, where he died of cardiac arrest due to drowning.

Anna Cullen, Chicago IL

Anna Cullen had problems with her newly installed walk-in tub in 2011. The second time she used the tub after it was installed, she fell and became wedged in the tub. She attempted to pull the drain, but the chain attached to the drain plug broke since the drain was under her body. She remained there for 30 hours until her daughter found her unconscious in the tub.

Ms. Cullen survived, but was hospitalized for 4 days and remained in a nursing home for three months. She says the tub was the “lousiest $12,000 I ever put out.”

Nevada Walk-In Bathtub Attorneys

The Richard Harris Personal Injury Law Firm represents those who were injured or lost their lives due to the use of Jacuzzi and other defectively designed walk-in bathtubs. Manufacturers are required to design and market products that are safe to use and must warn of dangers that they knew or should have known existed with products that they sell. Most walk-in tub companies represent themselves as leaders in safety and comfort in their marketing materials and target their marketing to the older population or those with significant physical limitations. If you or a family member were injured or died due to the use of a walk-in bathtub, call our firm today to discuss your case at (702) 444-4444.

Learn More:

https://www.click2houston.com/news/jacuzzi-tubs-pose-safety-concern-for-elderly

https://consumerist.com/2016/02/09/lawsuit-defective-plug-draining-system-turned-walk-in-jacuzzi-into-death-trap/

https://blogs.findlaw.com/injured/2016/02/walk-in-jacuzzis-are-they-safe.html

https://www.huffingtonpost.com/2011/08/16/stuck-anna-cullen-sues-ba_n_928437.html

For patients suffering from chronic diseases, pain, and lost mobility, prescription medications and corrective surgeries aren’t the only options in 2018. Many healthcare providers now recommend that patients receive implantable medical devices to help reduce their symptoms and improve their quality of life.

But medical devices aren’t always safe. “The Bleeding Edge,” a 2018 Netflix documentary, follows the stories of several patients who received medical devices and then suffered serious health problems due to complications. The documentary also highlights the growing influence that medical device manufacturers have when it comes to getting their products approved and keeping them on the market.

At Richard Harris Personal Injury Law Firm, our Las Vegas defective product lawyers aren’t afraid to go toe-to-toe with big medical device manufacturers when their negligence and greed cause innocent people to suffer.

Hurt by a Medical Device? We’re Here to Help.

The medical device industry brings in $200 billion per year, according to industry analysts. It’s clear that medical devices are big business, but that doesn’t mean the major players can get away with promoting their products when they cause harm to innocent people like you.

Having an experienced law firm on your side can help you level the playing field and increase your chances of getting the compensation you deserve. When you choose the Richard Harris team to handle your case, we achieve that by completing three important steps:

1. We’ll prove your injuries or complications were caused by your medical device.
2. We’ll prove the medical device manufacturer knew of the risks posed by its device.
3. We’ll calculate how much your medical device-related injury will cost you.

Medical device manufacturers and their insurance companies are reluctant to pay out settlements to victims who pursue claims on their own. Having an experienced lawyer advocating on your behalf can make all the difference. Call us today for a free consultation.

The first case brought by plaintiffs against Monsanto Corporation regarding their weed killer product Roundup has resulted in the jury awarding damages to the plaintiff of $39 million in compensatory damages and $250 million in punitive damages against Monsanto for failure to inform users of the potential risks of using the product. The case was heard in California Superior Court, and the jury found in favor of Dwayne Johnson, 42 years old, who developed non-Hodgkins lymphoma (NHL) after using the product for years as school groundskeeper. Mr. Johnson was diagnosed with NHL in August 2014 and was granted an early trial because of his failing health. His body is 80% covered with lesions, and pain keeps him bedridden most of the time.

Roundup Regulation Worldwide

Monsanto has vowed to appeal the California case and has maintained that Roundup and its active ingredient, glyphosate, are safe for consumer use, and that it does not cause cancer. Many consumer groups worldwide have come to a contrary conclusion, most notably the International Agency for Research on Cancer (IARC), a division of the World Health Organization (WHO), which found in 2015 that glyphosate was a “probable human carcinogen.” In June 2017, the State of California announced that Roundup sold in that state will require a warning label stating that the product is a known carcinogen. In July 2017, California, reflecting the IARC findings, added the product to its list of potentially cancerous chemicals.

The European Union (EU) Parliament banned Monsanto lobbyists from Parliament grounds and forbade them from meeting with Members of Parliament (MEPs) or attending committee meetings. Additionally, the legislative body has voted to ban Roundup by 2022. However, this non-binding vote by the EU Parliament placed pressure on the European Commission (EC), who recently voted to re-license glyphosate to a reduced term of five years. The EC initially proposed a 10-year license renewal.

In October 2017, the Journal of the American Medical Association (JAMA), published a study tracking 1,000 people, over 50 years old, in California between 1993 and 2016. The study reviewed levels of glyphosate in the urine of the study subjects over the 23-year period. It was found that the number of people testing positive to glyphosate in the urine was up 500% during the time period and that the levels of the chemical in the urine were also elevated by over 1200%. The study did not track the health of the participants; results do not indicate what affect this may have on human health. But the study makes clear that use of the product on crops is resulting in increasing body concentrations of glyphosate.

Legal Developments

We’ve reported on the growing number of cases in regard to Roundup previously, and since that time, the number of lawsuits in state and federal courts in the United States have increased to over 4,000. The 508 cases at the federal level have been consolidated into a multi-district litigation (MDL), designated case MDL 2741 in the district of Northern California.

Monsanto recently moved for a summary judgement for all federal level Roundup cases, which would effectively end those cases. Judge Vince Chhabria, denied the motion, ruling that plaintiffs had presented sufficient evidence of the risk of NHL due to use of Roundup to survive a summary judgement. Federal cases are now set to move to the bellwether trial phase, in which a small number of cases will be heard, to gauge jury reaction to evidence presented.

The Richard Harris Law Firm Represents Those Injured From Using Roundup

The majority of Roundup cases are from people who work with glyphosate in an agricultural environment and are therefore more highly exposed to the chemical. There are a large number of cases from homeowners who use the product to weed their lawns regularly. We are interested in your story. If you have been a regular user of Roundup and have been diagnosed with non-Hodgkins lymphoma, we are interested in speaking to you about your case. Call the Richard Harris Personal Injury Law Firm today to discuss your case at (702) 444-4444.

In July 2018, a jury in a trial before a Missouri state court awarded $4.69 billion to 22 women who have claimed injury due to use of Johnson & Johnson’s (J&J) talcum powder products. This is by far the largest settlement to be awarded in the thousands of cases nationwide against the personal and medical products giant for failing to warn customers of potential dangers from use of the products Johnson’s Baby Powder and Shower to Shower. This amounts to $213 million per plaintiff. After eight hours of deliberation, the jury made the award, which consists of $550 million in compensatory damage and $414 billion in punitive damages.

Six of the 22 plaintiffs receiving the award have died from ovarian cancer. Five of the plaintiffs were from Missouri, while the others resided in Arizona, New York, North Dakota, California, Georgia, North and South Carolina, and Texas. We have previously discussed talcum powder cases on this blog, with the largest previous verdict amounting to $417 million to a California woman in August 2017 who developed ovarian cancer after using J&J talc products for decades.

Other Juries Have Awarded Large Settlements

Earlier in 2018, a different trial jury awarded $117 million to Stephen Lanzo, who claimed that J&J’s Baby Powder contained asbestos and caused him to contract mesothelioma. J&J has repeatedly denied that the talc used in Baby Powder or Shower to Shower contained asbestos, although the mineral talc, the main ingredient in both products, is known to naturally contain asbestos. Since the 1980s, J&J has maintained that it only used asbestos-free talc in its products. However, an article in the St. Louis Dispatch reported that evidence presented in the Missouri trial showed documents to the jury stating that J&J knew the products contained asbestos but failed to warn customers of that fact.

Verdict to be Appealed by Johnson & Johnson

Spokesperson Carol Goodrich vowed to appeal this lawsuit as they have all previous cases, saying, “Johnson & Johnson remains confident that its products do not contain asbestos and do not cause ovarian cancer and intends to pursue all available appellate remedies.”

Lead plaintiff’s counsel, Mark Lanier, released a statement that J&J has known and covered up evidence of asbestos in talc for over 40 years. He stated, “We hope this verdict will get the attention of the J&J board and that it will lead them to better inform the medical community and the public about the connection between asbestos, talc, and ovarian cancer. The company should pull talc from the market before causing further anguish, harm, and death from a terrible disease.”

Status of Current Lawsuits

At the federal level, over 8,000 lawsuits against J&J regarding talcum powder products have been consolidated into a multi-district litigation (MDL). Hundreds more are being heard in state courts across the country. While some of the previous verdicts have been declared mistrials on appeal, juries appear to not find J&J’s defense credible and continue to award large verdicts in similar cases. While this most recent verdict along with the previous verdicts may act as a “bellwether” of sorts, it remains to be seen if J&J will to seek to settle the thousands of talcum powder cases brought against them

The Richard Harris Personal Injury Law Firm Represents Those Injured Due to Use of Talcum Powder Products

If you have used Johnson’s Baby Power or Shower to Shower and have later been diagnosed with ovarian cancer or mesothelioma, our firm wants to discuss your case. Call us today at (702) 444-4444.

Learn More:

https://www.consumersafety.org/news/safety/talcum-powder-lawsuit-billion-dollar-verdict/

https://nypost.com/2018/07/12/nearly-4-7b-awarded-in-suit-linking-cancer-johnson-johnson-baby-powder/

https://www.stltoday.com/news/local/crime-and-courts/jury-awards-million-to-plaintiffs-in-talcum-powder-lawsuit/article_c15e7f98-fce0-5a74-80ee-45371d5e98b1.html

https://www.asbestos.com/news/2018/04/06/johnson-johnson-asbestos-talc-damages/

The Mirena^® intrauterine device (IUD) has a storied legal history. Originally approved by the U.S. Food and Drug Administration (FDA) in the year 2000, the contraceptive device gained some popularity due to its five-year lifespan and convenience compared to a daily birth control pill. However, it became a common occurrence for women who used the device to have irregular and sometimes heavy bleeding after device implantation. The FDA has received nearly 50,000 reports of bleeding complications from use of the device, some of which have been life threatening.

Bayer Healthcare Pharmaceuticals, the manufacturer of the device, warned in product labeling that the device could cause some injury to the uterus upon insertion, but failed to mention that the device could migrate after insertion and puncture uterine walls, causing damage to other nearby organs.

What is a Mirena^® IUD?

The Mirena IUD is a T-shaped plastic device that is inserted into a woman’s uterus by a doctor to prevent conception. The device releases levonorgestrel, a synthetic hormone, and is intended to prevent pregnancy. While IUDs are the most popular form of reversible birth control worldwide, IUDs comprise only about 10% of all contraceptives prescribed in the U.S.

What complications occur from use of the Mirena^® IUD?

Besides bleeding complications, women who used the device reported weight gain, abdominal and pelvic pain, acne, tenderness of the breasts, mood swings, nausea, ovarian cysts, and vaginal discharge. Extreme complications include device migration, spontaneous device expulsion, breast cancer, complications in pregnancy, pelvic inflammatory disease (PID), and pseudotumor cerebri (PTC).

In addition to the above, some women had complications having the device removed. In some extreme cases, surgery was required to find and remove the device, since it had migrated from its original position.

Pseudotumor cerebri (PTC) is a condition that causes an increase in fluid pressure in the fluids surrounding the brain. This increased pressure may cause nerve damage in nerves directly connected to the brain, especially the auditory nerves and optic nerves. Untreated, this condition can cause tinnitus and vision impairment or even permanent blindness.

Legal History of the Mirena^® IUD

Due to the above complications, nearly 2,000 lawsuits were filed nationwide by women experiencing difficulties from use of the device. At the federal level, most lawsuits were consolidated into a multi-district litigation (MDL) in 2013. This MDL, designated MDL 2434, was based on the device’s tendency to migrate after insertion. Due to a legal technicality raised by Bayer, this MDL was dismissed in 2016.

A smaller portion of federal cases related to the Mirena IUD had to do with its active ingredient, levonorgestrel, causing a condition called pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension, which causes symptoms similar to a brain tumor. The side effects of PTC include vision loss and vision-related problems, severe headaches, and ringing in the ears (tinnitus).

This group of Mirena IUD cases was consolidated into a different MDL, designated MDL 2767, in the Southern District of New York, presided over by U.S. District Judge Paul A. Engelmayer. Approximately 500 cases make up this MDL, with new cases being brought and joining this MDL on a daily basis.

Case Studies Report Risk of PTC From Use of Levonorgestrel

As early as 1995, studies began to show a relationship between levonorgestrel implants and PTC. One such study published in the New England Journal of Medicine (NEJM) reports the relationship between severe headaches, vision problems, and levonorgestrel use.

Nevada Mirena^® IUD Lawsuits

The Richard Harris Law Firm represents women who were prescribed the Mirena contraceptive device and later developed tinnitus or vision loss due to pseudotumor cerebri (PTC). If you were prescribed and used this form of birth control and at some later time were treated for complications such as tinnitus or temporary or permanent vision loss due to PTC, you may be entitled to compensation. Call our office today to discuss your potential case at (702) 444-4444.

Learn More:

https://www.nejm.org/doi/full/10.1056/NEJM199506223322519#t=article

 

 

The Bair Hugger Forced-air Warming (FAW) Normothermia System was invented by Dr. Scott Augustine, and introduced to the market in 1988. The device was manufactured and distributed by his company, Augustine Medical. After a successful launch and acceptance by the medical community, Dr. Augustine resigned his positions as CEO and Chairman of the Board of Augustine Medical in 2002. The company was reorganized and renamed Arizant in 2003. 3M purchased the company in 2010 for $810 million, and continues to manufacture and distribute the Bair Hugger system.

Today, Dr. Augustine claims his invention causes infections, especially when used as a body warmer in joint replacement and other orthopedic surgeries. Many patients agree with Augustine, and have filed over 4,200 federal lawsuits against 3M and Arizant, for injuries they allege were caused by the device. The first such lawsuit was filed in 2013, by Tommy Walton, who had hip replacement surgery in 2011. He developed an infection after the surgery, requiring 15 additional surgeries, removal of the hip implant, and resulted in permanent damage to his leg. He is suing 3M/Arizant for more than $1 million in damages.

What is the Bair Hugger System?

The device is designed to prevent hypothermia in patients undergoing surgery, and works by using a warming unit which blows warmed air through flexible tubing connected to a disposable blanket filled with baffles to conduct the warmed air through the blanket, which is placed over, or under the patient during surgery. Dr. Augustine believes that the warmed air exhaust of the warming unit creates convection currents in the operating room (OR) that can lift bacteria and other contaminants from floor level and cause them to float around the OR, exposing incisions to increased contamination.

Dr. Augustine’s new company, Augustine Temperature Management, began marketing an alternative warming device, called the Hot Dog, which uses conductive fabric to warm patients, similar to a home electric blanket. The new product claims to eliminate the problems associated with forced air exhaust.

Regulatory Activity and Research Studies

The U.S. Food and Drug Administration (FDA) approved the Bair Hugger System through the 510(k) premarket clearance program. This program allows products to be released without the need for proof of safety, if the product is similar enough to a device or product already approved. The FDA approved the product under this program another 12 times through 2002, and has twice more issued clearances to Arizant in 2004 and 2006.

During this same time period, the FDA has received many adverse event reports through their Adverse Event Reporting System (AERS). FDA has not recalled the device, but did issue a Safety Alert in October 2015, which recommends following manufacturer instructions for cleaning and use of the device.

Both sides cite studies to support their positions. A study was done in 2011, published in The Journal of Bone and Joint Surgery, which concluded, “…a significant increase in deep joint infection, as demonstrated by an elevated infection odds ratio … was identified during a period when forced-air warming was used compared to a period when conductive fabric warming was used.”

In 2012, a report published in Bone & Joint Journal found, “…waste heat from the poorly insulated forced-air warming blanket increased the air temperature on the surgical side of the drape…” increasing the number of particles found on the surgical side.

A report published in the medical journal, Anasthesia, in 2013, concluded that convection currents could pull particles from below the table to the surgical site.

However, another report published in 2013 by the ECRI Institute concluded, “…demonstrating that airflow patterns change when FAW is used does not establish that it results in increased bacterial contamination or increased rates of SSI (surgical site infection) and PJI (prosthetic joint infection) as compared to use of other methods of patient warming.”

3M has published a pamphlet, “Let’s spread good Science” which concludes that there is, “…insufficient evidence to establish that the use of FAW systems leads to an increase in SSIs (surgical site infections) compared to other warming methods.”

Legal Action

Cases against the manufacturer at the federal level, have been consolidated into a Multi-District Litigation (MDL) in order to unify pre-trial discovery and motions for all similar cases. The number of cases involved in the MDL as of January 2018 number 4,215.

Two cases involved in the federal MDL, designated bellwether cases by the MDL court, are scheduled to begin April 30, 2018. These test cases will test what jury reaction is to the evidence presented at trial. The manufacturer could propose a settlement with any or all of the plaintiffs prior to that time, or determine that they have better chances in court.

The Richard Harris Law Firm Represents those Injured by the Bair Hugger System

Manufacturers have an obligation to only sell products that do not present a danger to their customers. They also have an obligation to warn patients and medical providers if it becomes apparent that their product is defective, or that it’s use presents a danger. Lawsuits filed in this case maintain that 3M has not upheld their obligations as the manufacturer of the Bair Hugger system. If you had joint replacement surgery with complications such as bacterial infection, or MRSA, and your medical provider used a Bair Hugger product during the surgery, call or text our firm today to discuss your case at (702) 444-4444.

Read More:

http://www.startribune.com/lawsuits-turn-up-heat-on-3m-s-bair-hugger-warming-blankets/348191741/

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm467151.htm

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm574053.htm

https://www.ncbi.nlm.nih.gov/pubmed/25237035

We published our first article on the Essure permanent birth control device in November 2016. Since that first article, several new developments have occurred. Most recently, Bayer has withdrawn the product from the market in Canada.

Bayer has issued a statement on the matter:

“In light of the change in patient demand, Bayer has decided to voluntarily discontinue the sale and distribution of Essure in Canada over the next few months. This decision was taken for commercial reasons, and the favourable benefit-risk profile of Essure remains unchanged. This is not a recall of the product from the market.”

This product has always had its largest user base in the United States. In fact, it’s estimated that nearly 750,000 women have used the device worldwide with 70 percent of those patients in the U.S. The U.S. Food and Drug Administration (FDA) required Bayer to add a Black Box Warning, the FDA’s strongest warning label, in November 2016. In the interim, several countries outside the U.S. have had the product withdrawn, or have banned the device from sales. Brazil banned the device, and the product has been discontinued in Finland, the Netherlands, and the U.K. Bayer continues to deny that the device is unsafe.

What is the Essure Device?

Designed to be a permanent form of birth control, the Essure device is made up of metallic coils which are inserted in a doctor’s office, into a woman’s fallopian tubes. The coils cause the formation of scar tissue, which then closes the tubes and prevents eggs from passing into the uterus. The process takes three months to complete, at which time the patient is tested in a follow-up visit to a radiologist to make sure the tubes are closed.

What Problems Have Occurred by Using the Device?

Some women reported immediate abdominal pain immediately after implantation, heavier and irregular menstrual cycles, hemorrhaging, fatigue and weight gain. Allergic reactions were also reported. Surgery has been required to remove the device, and in some cases, hysterectomies were required to remove the device. Migration of the device and, in some cases, perforation of the fallopian tube have been reported.

Has Anyone Sued for Damages?

The FDA has received over 4,000 complaints on the product, and a bill was introduced in the U.S. Congress to reverse the FDA’s approval of the product. At this point, there are several thousand Essure lawsuits in the court system.

As indicated in our previous article, the device was actually introduced to the market by a company called Conceptus, which Bayer purchased in 2013. Conceptus had received 16,000 complaints from users of the device prior to the Bayer buyout.

The lawsuits in the U.S. are based on an inadequate warning from Conceptus and Bayer, who have known or should have known that the device was linked to several serious side effects.

The Richard Harris Law Firm Represents Women Who Have Had Essure Complications

If you were one of the over half million women who had the Essure device implanted and then suffered serious complications, such as unwanted pregnancy, or additional surgery to have the device removed, device migration, or hysterectomy after implantation, call our firm today to discuss your potential case, at (702) 444-4444.

Read More:

https://www.thestar.com/life/health_wellness/2017/06/17/controversial-essure-birth-control-device-will-no-longer-be-sold-in-canada.html

http://www.legalreader.com/canada-celebrate-as-essure-pulled/

http://www.reuters.com/article/us-bayer-essure-fda-idUSKCN0RO2QQ20150924