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…
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.
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.
Hernia is a tear or break in the muscle wall surrounding the organs of the abdomen and upper leg and groin areas of the body. When the muscle wall weakens due to overexertion, persistent cough, prior injury, surgery, among other causes, the organs within the abdomen may protrude through the weakened muscle tissue, in many cases causing pain. Hernias may or may not have symptoms but are likely to get worse or cause other symptoms if not repaired and will not go away without treatment.
Treatment of hernia is accomplished usually by surgery to mend the muscle tear, and in many cases, surgeons will use a mesh product imbedded within the muscle tissue to reinforce the torn muscle tissue. Mesh products may also be used to strengthen tissues in lung, chest, open heart, and other surgeries. Over 100,000 procedures per year employ hernia mesh to repair body tissues. With this level of usage, over 2-3 decades, problems have surfaced with the use of certain hernia mesh products which have had serious side effects in many cases requiring additional treatments including surgery to repair.
Mesh products are made of processed animal tissue or synthetic plastic products such as polypropylene. Animal tissue mesh products will be absorbed by the body over time and have few side effects but may allow for recurrence of the original hernia.
Synthetic mesh products are more permanent, but due to introducing a non-organic material into the muscle tissue, complications have surfaced. To mitigate the effects of synthetic mesh, the mesh may be coated with an organic material to insulate body tissues from the plastic material making up the mesh. These composite mesh products have the highest potential for causing additional complications.
Synthetic and composite mesh has been known to cause allergic reactions, to irritate internal tissues, and, and may migrate out of position coming in contact with and even damaging internal organs. When this occurs additional treatment or removal of the mesh may be required.
Symptoms of Mesh complications may be serious and include:
Recurrence of hernia
Fistula – organs connecting abnormally
Scar tissue forming adhesions
Migration of mesh
Obstruction of the large or small intestine
Products which have caused complications
While many mesh products are used with few complications, several manufacturers and brands of mesh have created significantly higher numbers of complications than others. The brands which have had the highest number of regulatory and legal actions are:
Ethicon Physiomesh Mesh
Ethicon Proceed Mesh
Atrium C-Qur (pronounced “see-cure”) Mesh
R. Bard Kugel Hernia Mesh
R. Bard 3DMax Mesh
R. Bard Ventrolex Mesh
R. Bard Perfix Mesh
R. Bard 3DMax Mesh
Coviden Medtronic Parietex Composite Mesh
Recent Legal Developments
There are over 8,000 lawsuits involving hernia mesh in the federal system, and thousands more in various state courts in the United States. The federal lawsuits have been consolidated into 3 Multi-District Litigations (MDL) , by manufacturer. The largest MDL involves C. R. Bard/Devol products. The most recent actions of the court in the MDL involves the scheduling of three imminent bellwether cases to take place this year.
The first of these cases is scheduled to begin in May 2020, with a second case beginning in July 2020, and the third beginning September 2020. While these bellwether cases will settle on their own merits and are not binding on the settlements of other plaintiffs, they will show how juries react to arguments on this subject matter, and are expected to have impact on the manufacturer, C. R. Bard and its willingness to offer a global settlement for injured parties in thousands of remaining cases.
The Richard Harris Law Firm sues when Medical Products Manufacturers injure their users
Manufacturers of medical products must ensure that their products are safe and will not cause additional complications which may require additional expensive treatments or surgeries to correct. Manufacturers should know whether a product they sell may have such potential to cause side effects, and when known, must communicate those potential side effects to medical providers and patients through product communications and labelling, so that users can make an informed decision before use. When this does not occur, patients may be entitled to obtain compensation through the legal system, by way of a lawsuit. If you have suffered additional complications after the use of a one of the surgical mesh products listed, you may have a cause of legal action. Call our firm today to discuss your potential case at 702-444-4444.
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 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 20th 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.
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.
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.
In the third jury verdict within a year, Alva and Alberta Pilliod, were awarded $2 billion in punitive damages, as a settlement for cancer which the couple maintains was caused by using Round-Up weed killer…
In the third jury verdict within a year, Alva and Alberta Pilliod, were awarded $2 billion in punitive damages, as a settlement for cancer which the couple maintains was caused by using Round-Up weed killer on their Northern California property. The case revolved around a claim that the product’s manufacturer, Monsanto, which was purchased in 2018 by Bayer AG, failed to warn users of the product that it could cause cancer.
What’s happened in previous Round Up trials?
Three verdicts from the from the first three trials against Monsanto for this product, have all found the company liable and the verdicts have been increasing in each case. Over 13,000 additional cases for the same or similar claims are pending in state and federal courts throughout the United States.
In the two previous trials, a state court in San Francisco in August 2018, awarded $289 million in a claim that Round Up caused Non-Hodkins Lymphoma (NHL), which was reduced by the judge to $78 million. Monsanto is appealing that verdict. In March 2019, a federal court jury, also in San Francisco, awarded $80 million to another man claiming that he also developed NHL from use of Round Up.
What is the aftermath of this verdict?
The Pilliod’s used the product on their property for decades. Mr. Pilliod learned that he was diagnosed with NHL in 2011. Mrs. Pilliod received the same diagnosis in 2015. In their trial, the jury saw documents which demonstrated that Monsanto was never interested in finding out whether Round Up was a safe product. While the previous two trials involved professional use of the product, it was noted that perhaps homeowners are more at risk from using Round Up, due to not being warned to wear protective gloves or clothing when using the product. The jury reached their verdict in less than 2 days of deliberation.
A Bayer spokesman responding to the verdict said, “Bayer believes the punitive verdicts is excessive and unjustifiable.” They continued that while they have great sympathy for Mr. and Mrs. Pilliod, there is no scientific evidence that Round Up, or its active ingredient Glyphosate is the cause of their illnesses. Bayer’s statement claims that the couple have long histories of illnesses known to be risk factors for developing NHL. Bayer plans to appeal this verdict.
It is likely that the award will be reduced in this case, due to U.S. Supreme Court rulings which limit punitive damages to no more than 10 times the compensatory damages awarded in a trial of this kind. The Pilliod’s received $55 million in compensatory damages in this verdict. Lawyer Brent Wisner who represented the Pilliod’s, stated that a huge sum was needed in this case to punish Monsanto for “45 years of lying to the public.”
The Richard Harris Law Firm represents Round Up victims
If you have been a Round Up user and later developed Non-Hodkins Lymphoma, you may be entitled to significant compensation. Call our firm today to discuss your potential case at (702) 444-4444. We represent victims of other dangerous products as well.
Zofran Birth Defect Cases Moving Forward Zofran (ondansetron) was approved by the U.S. Food and Drug Administration (FDA) in 1991 as an anti-nausea medication for chemotherapy and post-surgical patients. At no time in its history…
Zofran (ondansetron) was approved by the U.S. Food and Drug Administration (FDA) in 1991 as an anti-nausea medication for chemotherapy and post-surgical patients. At no time in its history has Zofran been approved to be marketed to pregnant women for the treatment of morning sickness, however, the manufacturer, Glaxo Smith-Kline (GSK) marketed the drug for that purpose, in spite of evidence that the drug was linked to birth defects in new born children that GSK knew about as early as 1992 according to cases against the manufacturer.
GSK has made billions of dollars from the drug over its lifetime. Between 2008 and 2013 the prescription rate for the drug jumped from 50,000 monthly prescriptions to over 110,000 monthly prescription in 2013. Out of 4 million pregnancies in the U.S., its estimated that 1 million women are exposed to the drug annually.
Litigation History of Zofran
Department of Justice Lawsuit-2012
Prior to any personal injury lawsuits begin brought against GSK for birth defects, the U.S. Department of Justice (DOJ) sued the company for fraud and illegal promotion of Zofran, and the company pleaded guilty to the charges in 2012. In the settlement of that case, GSK agreed to pay $3 billion to DOJ. This was the largest health care fraud in the history of the U.S., and as part of the settlement DOJ found that GSK:
Knowingly promoted the sale and use of Zofran for conditions other than those for which it was approved by the FDA including pregnancy related nausea
Made false statement about the safety of Zofran for pregnancy related nausea
Paid illegal kickbacks to doctors to prescribe the drug for pregnancy related nausea
Regardless, GSK continued to market the drug for treatment of pregnancy related nausea, and to this day is still prescribed for that purpose.
First Birth Defects Case filed – 2015
Cheri Flynn files lawsuit in U.S. District Court in Eastern Pennsylvania, alleging that her use of Zofran during her two pregnancies in 2004 and 2006, left both babies with heart problems. Her first daughter had surgery in 2011 to repair a hole in her heart, and her second daughter had a congenital heart defect. The case alleges that GSK knew in 1992 that Zofran presented “unreasonable risk of harm” to unborn children because it passes through the placenta to the developing fetus.
Several additional cases within days – 2015
Several more cases were filed in short order, alleging that GSK failed to warn expectant mothers of the possible side effects to their unborn children resulting in a range of serious birth defects, such as heart defects, facial dysmorphia, missing kidney, reproductive issues in the new born, cleft palate, cleft lip, and various learning and developmental challenges.
By the end of 2015, after over a hundred cases had been filed in several states, the cases were consolidated into an MDL in the district of Massachusetts, designated MDL 2657. GSK immediately moved for dismissal, which was overruled by the MDL judge. Today over 600 cases have been filed, of which there are currently 448 cases still active. The MDL is moving quickly to move cases into their bellwether cases, which should take place in late 2019. All cases allege that GSK failed to warn expectant mothers of the risks of causing birth defects in their unborn children.
The Richard Harris Law Firm sues drug companies who market dangerous drugs
If you were prescribed the anti-nausea preparation Zofran during your pregnancy and your child was born with birth defects, you may be entitled to significant compensation. Our office wants to discuss your case and may represent you against Glaxo Smith-Kline for failure to warn patients and medical providers of the significant risks associated with use of the drug. Call our office today to discuss your case.
Behind the Valsartan Recalls Valsartan becomes the third high blood pressure/heart failure medication to be recalled from the market within the last year. It joins losartan and irbesartan, all of which are of a class…
Valsartan becomes the third high blood pressure/heart failure medication to be recalled from the market within the last year. It joins losartan and irbesartan, all of which are of a class of generic hypertension drugs called angiotensin II receptor blockers, or ARB’s, which have been previously recalled due to contamination with a cancer-causing ingredient which has been found present in the drugs.
The U.S. Food and Drug Administration (FDA) has found that two ingredients called N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) exceeded acceptable safety levels in the drugs – both ingredients are considered probable carcinogens. So, in addition to finding new hypertension drugs, sometimes a tedious process, patients using ARB’s now need to be concerned with exposure to potential cancer-causing agents.
Over 60 million prescriptions were written between the three drugs in 2016 alone. Recalls of contaminated lots of the drugs have been so extensive, that there is now a nationwide shortage of valsartan, causing prices to spike, and possibly causing other potential replacement drugs to increase in price as well. The Wall Street Journal reported that as many as two million patients may have been exposed to the cancer-causing ingredients.
Several different manufacturers supply these drugs to the U.S. market, but the contamination is coming from raw material suppliers in China and India. The FDA is investigating how this contamination entered the drug supply and is working to stop the flow of tainted drugs from foreign suppliers. In particular, FDA has stopped imports of medications and drug ingredients from Zhejiang Huahai Pharmaceuticals in China.
The drugs have been on the market in the U.S. for about four years. The FDA estimates that even if patients have taking the drugs since their introduction to the U.S. that their exposure to the tainted ingredients should be minimal, since some supplies of the drugs have shown acceptable levels of contamination.
However, in the meantime a number of class action lawsuits have been initiated nationwide to compensate patients for the increased costs of the recalled drugs and medical care needed to find replacement therapies. Cases are being reviewed by attorneys, for those diagnosed with liver, kidney, pancreatic and stomach cancers.
Dangerous Products Lawyers of the Richard Harris Law Firm
Its early in the process to evaluate the long-term effect of the contamination of the ARB drugs. However, the lawyers of the Richard Harris Law Firm are here to provide legal recourse for injury from this and other dangerous products which may be on the market. If you’ve experienced a negative outcome from the use of a dangerous drug, contact our office today to discuss your potential case.
A 28-year-old woman went to the emergency room reporting a pain in her lower back on the right side. After an examination, a CT scan was performed which found a fractured IVC Filter which had been implanted 10 years earlier. The remnants of the device had moved and lodged near her heart and her right ureter. The filter was removed, but it was decided the fragments would be left in place due to the risks of removal.
This patient is not alone. Many who have had this medical device implanted have had similar experiences. It appears that some of the devices implanted over the years were defective. Many of these patients have sued, with more than 12,000 lawsuits filed at the federal level against two manufacturers of this device.
What Are IVC Filters?
Inferior vena cava or IVC Filters are small cage-like devices designed to be placed inside the main vein (the inferior vena cava) returning deoxygenated blood from the lower body to the heart. These devices are used to prevent pulmonary embolism (PE) or blood clots from moving through the heart and lodging in the lungs, which can be life threatening. IVC Filters are intended for those who have difficulty using anticoagulants.
IVC Filters are about one inch long and have small metal legs or struts that spread out to the vein walls when placed to prevent movement of clots beyond the filter while still allowing acceptable blood flow.
There are about 11 companies which manufacture IVC Filters in the U.S., but two have shown a high failure rate. They are C. R. Bard, who manufactures the Recovery and G2 and Denali IVC Filters; and Cook Medical who makes the Celect and the Gunther Tulip IVC Filters.
Potential Complications of IVC Filters
When an IVC filter fractures, the pieces of the filter can move through the body due to blood pressure and lodge in other areas. This includes the heart and lungs, and the fragments can cause other problems. These include:
Perforation of veins
Perforation of the heart or lungs
Hemorrhaging of the heart
Excess fluid in the heart (causing disruption of heart function)
Regulatory History of IVC Filters
In August 2010, the U.S. Food and Drug Administration (FDA) issued a warning to medical providers of problems with certain types of IVC Filters and recommended removing the devices after the risks of PE had passed.
After receiving hundreds of adverse event reports about IVC Filters in May 2014, the FDA advised doctors that the longer the IVC Filter remained in place, the risk of fracture increases. They advised removal of the devices as soon as possible after implantation.
Many studies have found the IVC Filters manufactured by these two companies had more complications than other products on the market. In August 2015, the Journal of the American Medical Association (JAMA) warned that the risks of using IVC Filters may outweigh any health benefit provided by the device.
Legal Status of IVC Cases
As the volume of cases for these devices mounted at the federal court level, cases were consolidated into Multi-District Litigations (MDL) against the two manufacturers. Currently there are about 6,700 cases against C. R. Bard and about 5,400 cases against Cook Medical. Cases are ongoing.
Nevada IVC Lawsuits
The Richard Harris Personal Injury Law Firm is reviewing defective product cases due to the use of IVC Filters. If you or a loved one was injured or died due to the use of a C. R. Bard or Cook Medical IVC Filter, contact our office today to review your case at (702) 444-4444.
Surgical or hernia mesh has caused significant complications for some patients. We’ve discussed these issues previously, however, much has occurred since that article was published. One particular manufacturer, C.R. Bard and their Davol Inc, subsidiary,…
Surgical or hernia mesh has caused significant complications for some patients. We’ve discussed these issues previously, however, much has occurred since that article was published.
One particular manufacturer, C.R. Bard and their Davol Inc, subsidiary, has had an order filed in their Multi District Litigation (MDL) #2846, in which plaintiff’s lawyers expect up to 3,000 new cases to be filed against them this year alone. This filing simplifies the procedures for those filing cases with the court in order to have their cases added to the MDL. This MDL is maturing and will be hearing bellwether cases in early 2020.
When is Hernia Mesh Used?
As a review, mesh products are used in many cases as part of the medical repair of hernia for both men and women. Hernias have a high recurrence rate, and in those cases, doctors may use the mesh to strengthen the repair and/or to reduce the recurrence of hernia. Surgical mesh is either made of synthetic plastic products or animal tissue. The synthetic mesh can be absorbable, non-absorbable, or a combination of both. Non-absorbable mesh will remain in the body indefinitely and is considered a permanent implant.
Mesh is most commonly implanted in the abdomen in cases involving hernia but can also be used for reconstructive surgery in the thoracic area. In all areas, allergy to the mesh material can cause irritation and pain, and mesh contact with internal organs can cause additional discomfort and sometimes serious problems.
What Are the Potential Risks of Hernia Mesh?
According to the U.S. Food and Drug Administration (FDA), the most common complications for a hernia repair with mesh are pain, infection, hernia recurrence, adhesion, and bowel obstruction. In some cases, the mesh will migrate or shrink. There have been reports of bowel perforation, painful or bloody urination, renal failure, and sexual dysfunction such as painful intercourse after implantation due to the presence or migration of the mesh. In at least one case, a man required removal of a testicle due to complications from mesh migration.
History of Litigation
There are nearly 100,000 mesh implantations in the United States each year. Mesh lawsuits have been ongoing for a number of years as the negative side effects have manifested. There are currently over 3,200 hernia mesh cases in the federal courts among several manufacturers. If the plaintiff’s lawyers in the current C. R. Bard lawsuit are correct, that number is expected to more than double in the next year.
The Richard Harris Personal Injury Law Firm Represents Mesh Injury Victims
Most lawsuits involving hernia mesh involve more than minor irritation. Many victims have suffered additional injuries which required expensive additional medical procedures to correct. Some have been permanently injured by the use of defective products. If you have had complications after the implantation of surgical or hernia mesh products, call our office today to discuss your case at (702) 444-4444.
Doctors and surgeons rely on a variety of medical devices and other products to support them during surgical procedures and routine checkups. While many of those products serve their purposes without adverse effects, not all…
Doctors and surgeons rely on a variety of medical devices and other products to support them during surgical procedures and routine checkups. While many of those products serve their purposes without adverse effects, not all of them are safe for patients. In fact, some may cause more harm than good, resulting in worsening health complications and additional operations for many patients.
One of those dangerous products is hernia mesh. This loosely woven material is used to reinforce the muscle wall and hold internal organs in place during surgeries. Thousands of patients have reported severe complications after receiving hernia mesh implants, including:
Mesh breakage or failure
Migration of mesh
You expect surgeries to improve your health—not make it worse. At Richard Harris Personal Injury Law Firm, we investigate defective products and medical devices when they cause harm to innocent people like you. Product and device manufacturers can be held liable for damages when they release products to the market that aren’t safe to use, and we’re here to hold them accountable.
We Are Your Las Vegas Injury Attorneys
You shouldn’t have to go it alone after a drug or product injury in Nevada. At Richard Harris Personal Injury Law Firm, we’re committed to holding negligent manufacturers accountable when their products cause harm, and we’re ready to fight for you after a defective product injury. Contact our Las Vegas defective drug and product attorneys today for a free case review.
If you served in the U.S. military and saw combat operations between 2003 and 2015, you may have been issued Combat Arms™ Earplugs, Version 2 (CAEv2). These plugs are identifiable by having one dark olive…
If you served in the U.S. military and saw combat operations between 2003 and 2015, you may have been issued Combat Arms™ Earplugs, Version 2 (CAEv2). These plugs are identifiable by having one dark olive end and one yellow end. The plugs were reversible and meant to be inserted into the ear canal. The dark ends of the plugs created near total sound blockage, while the yellow ends provided protection from combat sounds while still allowing users to hear voice commands.
Unfortunately, the devices were designed poorly and didn’t fit tightly into the ear canal, allowing loud noises to go past the earplug and into the ear drum. In fact, the design of the device prevented a snug fit in the ear canal. Many who used this product are now suffering from headaches, ear aches, hearing loss, and tinnitus—or ringing in the ear.
History of Usage
Aearo Technologies was awarded the contract by the U.S. Department of Defense (DoD) as the exclusive supplier of earplugs for military use in 2003. This contract continued until late 2015 when the product was discontinued. In 2008, 3M purchased Aearo Technologies and continued supplying the product with no change to design and little to no testing to determine the effectiveness of the device.
The device discloses a Noise Reduction Rating (NRR) of 22 when the olive end is inserted into the ear. However, this rating does not consider that the third flange of the device needed to be folded back in order for the device to seat correctly, and this instruction was never included with the device. Without folding the flange, the device would not seat and effectively block sounds according to its disclosed NRR rating.
3M/Aearo knew that the devices did not meet the disclosed standards and in July 2018 settled a case with the U.S. Department of Justice (DoJ) agreeing to pay $9.1 million to resolve allegations that it knowingly sold the duel-ended Combat Arms Earplugs, Version 2, to the U.S. military without disclosing defects that hampered effectiveness of the product.
On February 4, 2019, a veteran, Matthew Cote, filed the first product liability lawsuit against 3M/Aearo claiming that use of the product while in the military has left him with significant hearing loss and tinnitus. This is expected to be the first of thousands of cases associated with hearing loss and injury as a result of using the Combat Arms™ Earplugs, Version 2.
There are already many cases in the federal courts, and a request has been filed that the cases be consolidated into a Multi-District Litigation (MDL). This will allow unified pretrial discovery and motions to proceed, although cases may settle in their original jurisdictions.
The Richard Harris Personal Injury Law Firm is Holding 3M/Aearo Accountable for Veterans’ Injuries
If you were issued the Combat Arms™ Earplugs, Version 2, during your military service, the product was defective and did not block sound as stated. If you have been diagnosed with hearing loss or tinnitus (ringing in the ear), after using this product during your military service between 2003 and 2015, you may have a claim against 3M. The Richard Harris Personal Injury Law Firm would like to know more about your case and is interested in representing you. Call our office today to discuss your potential case at .
You’ve probably seen the Juul and other e-cigarettes in your local convenience store. According to some industry observers, e-cigarettes are especially prevalent around high schools and college campuses. Some see these trends as troubling, and…
You’ve probably seen the Juul and other e-cigarettes in your local convenience store. According to some industry observers, e-cigarettes are especially prevalent around high schools and college campuses. Some see these trends as troubling, and the history of this product’s use reveals unexpected dangers which the manufacturer should have known and warned its audience about before bringing the product to market.
Lawsuits have been brought against Juul and other e-cigarette (E-Cig) manufacturers across the country as those dangers have manifested themselves. While the number of federal cases have not grown to the point of being consolidated into a multi-district litigation (MDL), the seriousness of the allegations against the manufacturers has sharpened.
Types of E-cigarette Lawsuits
Personal injury or potentially wrongful death lawsuits have been filed against Juul and other e-cigarette manufacturers. These cases center around the claim that vaping devices are defective. Lithium-ion batteries and heating elements don’t play well together in the same space, and there have been cases of the batteries exploding in user’s faces, causing severe injury and even death. Considering these scenarios, the tubular design of the vaping device makes it a literal loaded gun.
Personal injury and failure to warn cases have to do with how, and to whom, the product is marketed. Juul e-cig pods have a concentrated amount of nicotine—up to 25% greater than that of cigarettes in some cases. This is more addictive than smoking regular cigarettes, with the manufacturer becoming the only source to continue the fix due to the proprietary nature of the pods. Other chemicals within the vapor have unknown long-term effects, and little to no testing has been performed to confirm the safety of the devices.
The manufacturers seem to be targeting a younger demographic with advertising campaigns such as Juul’s website touting their product as the “iPhone of E-cigs,” thus appealing to the younger generation’s desire to be hip and cool. Some lawsuits also question the flavor choices of the pods, such as Cool Mint and Fruit Medley, as targeting the younger market with pleasant flavors that are ultimately addictive due to their high concentrations of nicotine and other substances.
The U.S. Food and Drug Administration (FDA) is the federal agency which has used its authority in regulating the tobacco industry to also bring Electronic Nicotine Delivery Systems (ENDS), i.e. e-cig systems, under its purview. The FDA finalized rules for manufacture, distribution, and marketing of ENDS systems, as well as the consumables (pods), in August 2016.
In September 2018, the FDA launched a campaign to warn children of the potential dangers of e-cigarettes, including the risk of addiction and other dangers associated with use of ENDS systems. Additionally, the FDA performed an unannounced inspection of the Juul Labs San Francisco headquarters, during which they acquired documents related to the company’s sales and marketing efforts.
Settlements to Date
While there are several hundred cases related to e-cigarette claims working their way through federal and state courts, only a few have settled to date. This list will increase as further cases are litigated.
$1.9 million was awarded by a jury in September 2015 to Jennifer Ries, due to burns received in her car from her recharging e-cig, when the device’s battery exploded. Ms. Ries suffered burns to her legs, hands, and buttocks which left scars.
$2 million was awarded by a jury in April 2018 to J. Michael Hoce, due to injuries received when his e-cig battery exploded during normal use, knocking out four front teeth and causing severe bleeding which required emergency room care.
The Richard Harris Law Firm Represents Nevada E-Cigarette Victims
If you used the Juul or another brand of e-cigarette and experienced a battery explosion that left you injured, you may be entitled to significant compensation. Call our firm today to discuss your potential case at .
Sales of Roundup Pro 360, a Monsanto product used for largely commercial weed control, were banned on January 15, 2019 in France. An administrative tribunal in Lyon, France, ruled that the French food and environmental safety…
Sales of Roundup Pro 360, a Monsanto product used for largely commercial weed control, were banned on January 15, 2019 in France. An administrative tribunal in Lyon, France, ruled that the French food and environmental safety agency, ANSES, should have given more weight to potential safety risks when they authorized the use of the product in March 2017. This court action does not ban all Roundup sales in France, only this specific product.
As of November 2017, French President Emmanuel Macron had already committed to totally discontinue use of the herbicide in the country by 2021, effectively rejecting a relicensing agreement between Bayer-owned Monsanto and the European Commission, which had extended licensing rights for the product until 2022 for the European Union countries. France joins a growing list of countries and municipalities worldwide to curtail the use of products containing Glyphosate, the active ingredient in Roundup.
Regulators in several countries worldwide, including the Netherlands, Brazil, and Sri Lanka, have banned use of Roundup, but have been challenged in the courts by Monsanto. For the time being, those bans are lifted.
Roundup Developments in the U.S.
In the United States, many cities and counties are banning the use of Roundup for publicly maintained parks and thoroughfares. In 2017, California added glyphosate to its list of potential carcinogens and planned to require warning labels on the product, but a California court ruled that the labels were unnecessary.
In August 2018, a court jury awarded $289 million to a school groundskeeper who used Roundup for years and was diagnosed with Non-Hodgkin lymphoma (NHL) in 2014. This was the first settlement from the more than 4,000 cases in the U.S. at the state and federal levels, linking glyphosate use with NHL.
The Richard Harris Personal Injury Law Firm Represents Nevada Roundup victims
Our firm is taking inquiries from agricultural and municipal workers who have been exposed to Roundup for extended periods and who now have been diagnosed with Non-Hodgkin lymphoma. Call our office today to find out if you have a case at (702) 444-4444.
Jacuzzi walk-in tubs are ideal for people who want the relaxing and therapeutic effects of jacuzzi-style baths but have mobility problems that make it difficult to get in and out of standard tubs. Walk-in tubs…
Jacuzzi walk-in tubs are ideal for people who want the relaxing and therapeutic effects of jacuzzi-style baths but have mobility problems that make it difficult to get in and out of standard tubs. Walk-in tubs are designed to be easy to enter and exit, as they’re much higher off the ground and can be entered by opening and closing doors on their sides. In addition to being installed in many homes, they’re also being installed in places like nursing homes, physical rehabilitation clinics, and more.
Unfortunately, jacuzzi walk-in tubs can still pose threats to people who use them. Drowning deaths have occurred in walk-in style tubs due to the amount of water they hold—often up to 80 gallons—and their inward opening doors, which can become defective or inoperative if the water is unable to be drained, potentially trapping bathers inside. Another potential risk involves heated seats becoming stuck in the “on” position, putting users at risk of burn injuries.
We’re Here to Help
At Richard Harris Personal Injury Law Firm, our Las Vegas defective product attorneys are here to help anyone who was harmed by a dangerous jacuzzi walk-in tub. Although these products may seem safe and even optimal for people with mobility problems, design flaws and negligent testing practices can make them extremely dangerous to the people who use them.
You or your loved one shouldn’t have to pay out of pocket if you suffered an injury related to a jacuzzi walk-in tub. It was the manufacturer’s negligence that resulted in your injuries, and they should be held liable for their mistakes and carelessness. Call us today for a free consultation to find out how we may be able to put our experience to work for your family.
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…
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.
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…
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:
We’ll prove your injuries or complications were caused by your medical device.
We’ll prove the medical device manufacturer knew of the risks posed by its device.
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…
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.
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.
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…
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.
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…
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.”
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.
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…
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.
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.