Mass Tort Report

RGLZ is currently looking for cases involving the following drugs and devices:

Ethicon Physiomesh, Atrium C-Qur, And Bard Ventralex Surgical Mesh Failures:
There are a variety of mesh products used to surgically treat hernias and other soft-tissue defects, with doctors using these products in more than 1 million operations each year. Many of these mesh products are associated with serious complications including mesh failures and high infection rates. Over the years there have been numerous recalls and litigations involving surgical mesh and the newer designs continue to be associated with serious medical complications, particularly mesh made from polypropylene.

Physiomesh, manufactured by Ethicon, was voluntarily recalled from the worldwide marker last year after reports of significantly higher complication rates causing recurrence and the need for reoperation. In 2012, the FDA issued a warning letter to Atrium after it failed to investigate reports of high infection and failure rates tied to its mesh product, the Atrium C QUR. The Bard Ventralux mesh has also been associated with serious complications including bowel obstruction, bowel perforation and high infection rates. RGLZ is currently representing clients injured by these products and welcomes the referral of clients of yours who have experienced a problem related to the use of hernia mesh products.

Proton Pump Inhibitors:
Proton Pump Inhibitors (PPIs) are drugs prescribed for the treatment of acid-reflux and other gastric-acid disorders of the upper GI tract. They include popularly known drugs such as Nexium, Prilosec, Prevacid and Protonix. For years there have been reports of issues with these drugs related to bone fractures and heart attacks, but new research suggests a link between PPIs and a form of kidney disease known as Acute Interstitial Nephritis. Adverse effects of PPIs appear to be more prevalent with long-term use of these drugs. RGLZ is currently handling a number of PPI cases and welcomes referral of any client of yours who used a PPI and has suffered an injury as a result.

IVC Filter Cases:
Inferior Vena Cava filters are medical devices implanted into a patient’s vena cava, the body’s largest vein which carries blood back to the heart from the lower body. IVC filters are designed to prevent blood clots from reaching the heart and lungs in patients at risk for formation of emboli who cannot be treated with blood thinners.

The devices are designed to be retrievable by the surgeon after short-term use, but in many cases the IVC filters are left in permanently. Retrieval of IVC filters is often not possible because the devices are prone to fracturing, migration and embedment in the wall of the vein. Bard and Cook are the most common brands of IVC filters and MDLs (Multi-District Litigations) have been established for coordination of cases in federal court. RGLZ is participating in the MDLs with a number of IVC filter cases in suit.

Diabetes Drugs:
Drug manufacturers continue to develop and promote new drugs for treatment of Type 2 Diabetes, many of which are associated with serious medical conditions. Invokana and Farxiga are two such drugs, known as SGLT2 Inhibitors, which work to lower the patient’s blood sugar by helping the kidneys remove excess sugar through their urine. Starting in 2015 the FDA required enhanced warnings for Invokana and Farxiga. Previously unreported side effects for which additional warnings are now required include the development of ketoacidosis, a serious condition related to excess acid in the blood, and acute kidney injuries tied to these drugs.

Zofran:
This drug was developed and approved by the FDA for treatment of nausea in chemotherapy patients. The manufacturer, GlaxoSmithKline, however, improperly began promoting the drug off-label for use in pregnant women suffering from severe cases of morning sickness. Virtually no research had been done, however, into the effects of Zofran in pregnancy, and reports soon surfaced of a variety of birth defects believed to be tied to the drug. These birth defects include cleft palette and severe malformations of the heart.

Medical malpractice cases also exist against Obstetricians who prescribed this drug to their patients off-label despite the lack of research into its effects when used during pregnancy. RGLZ is currently handling a case involving a baby born with severe heart defects and other serious medical issues related to the use of this drug.

3M Bair Hugger:
This medical device is a forced-air blanket used during surgery to maintain the patient’s body temperature. The system, however, recirculates air contaminated with bacteria, causing infections in the patient. Patients undergoing knee or hip replacement are at particular risk of deep joint infections, which are extremely difficult to treat.

Metal-on-Metal Hip Replacements:
Suits for defective and recalled artificial hips have been ongoing for years now, with several major settlements of litigations involving DePuy and Stryker hips. RGLZ is investigating any case involving metal-on-metal hips, including DePuy ASR Systems which were recalled in 2010, DePuy Pinnacle hips, and Stryker Rejuvinate hips which were recalled in 2012. Other metal-on-metal hips in litigation include those manufactured by Zimmer, Wright and Biomet.

Defective Carbon Fiber Bicycles:
High-end bicycle manufacturers charge a premium for bicycle frames made from carbon fiber, which are touted as being stronger and lighter than metal bike frames. Unknown to most consumers, however, is that despite their branding, these frames are not manufactured in Europe or the United States. Rather, they are made in China, with limited quality control. These defective carbon fiber frames can crack while riding, causing crashes and falls that have resulted in serious injuries and death.

Essure Birth Control Device:
The Essure Birth Control device is a metal coil inserted into a woman’s fallopian tube to provide permanent sterilization. The device, however, has been reported to be associated with a variety of complications, including perforation of the fallopian tube or uterus and migration into the abdomen or pelvis. Tom Valet handled one of the first cases involving this device, in which he successfully sued the implanting doctor who failed to recognize that the Essure device had migrated out of the fallopian tube and perforated his client’s uterus.

Elmiron Eye Damage Cases
Elmiron is a drug that has been on the market for decades. It is used to treat a bladder condition known as interstitial cystitis. Recently, physicians at Emory University School of Medicine saw a cluster of patients presenting with visual disturbances for which there was no known cause. Upon investigation of the patients’ histories, they discovered that each of the patients had been prescribed the drug Elmiron for many years. Retro- spective studies undertaken at Emory and subsequently at medical centers across the country determined that a large percentage of patients who had been prescribed Elmiron had also been diagnosed with vision problems, related to the deposit of pigments onto their retinas, a condition known as retinal maculopathy.

Any client who describes complaints relating to their vision should be asked about the use of Elmiron. The criteria for a case includes use of the drug for more than one year and a diagnosis of retinal damage (maculopathy). Since the relationship between Elmiron and retinal damage has only recently been discovered, many clients will have been misdiagnosed with eye disease thought to have been caused by other factors when their condition was actually related to the drug.

Roundup Weed Killer
Many of you will have heard reports in the news about a massive settlement in the Roundup litigation. Roundup’s manufacturer Monsanto and its parent corporation Bayer AG have agreed to pay more than $10 billion to settle these cases. This followed a string of Plaintiff’s verdicts against Monsanto, many of which awarded substantial punitive damages against the manufacturer based on its own internal documents demonstrating that the product was never adequately tested on humans.

The settlement is unusual in one respect in that Monsanto did not create a single “global settlement” plan in which all Plaintiffs could participate. Rather, Monsanto is negotiating separately with each individual Plaintiff’s law firm. We are currently in the process of negotiating settlements on our Roundup cases with Monsanto’s lawyers, and would be happy to assist anyone who may have a Roundup case that they want to resolve. Note that the settlement criteria is very strict, and Monsanto is only settling cases where the Plaintiff has been diagnosed with Non-Hodgkin Lymphoma and is not paying any settlements for any other type of cancer or disease.

Another unusual aspect of the Roundup cases is that Monsanto has not issued a recall and continues to sell the product. Presumably, people will continue to get sick from use of the product and cases will continue to be filed against Monsanto. As of now, however, these future cases are not eligible to participate in the current settlement, although it is likely that Monsanto at some point will open the settlement for “Round 2” claimants.

Baby Powder

Talc Powder/Cancer Cases
Similar to Roundup, there have been a series of Plaintiff’s verdicts in the Talc Powder litigation. Unlike Monsanto, however, Talc manufacturer Johnson & Johnson is vowing to continue to fight these cases, insisting that there is no link between its product and ovarian cancer. Thus far, however, juries have hammered J&J with large compensatory and punitive damages verdicts, again based on J&J’s own internal documents describing knowledge of the presence of asbestos in Talc Powder products but no disclosure of this fact to the public.

Whether a settlement of these cases takes place will ultimately depend on the results of appeals that J&J has taken of the verdicts against it, in which they assert that the cases should all be dismissed on Daubert grounds, asserting a lack of scientific evidence to support Plaintiff’s claims.

Earlier this year J&J decided to stop selling Talc based powder products. However, due to a long latency period between Talc product use and cancer diagnosis, we will continue to see new Talc cases, which remain eligible for suit. The criteria for a Talc case starts with a diagnosis of ovarian cancer, and then involves a more detailed analysis of the specific type of ovarian cancer as well as reviewing the client’s family history and genetic testing results.

3M Military Combat Earplugs
In 2018, the 3M Company agreed to pay a $9.1 million fine to the United States government to resolve allegations that it knowingly sold its Dual-End Combat Arms earplugs to the military without disclosing defects it knew about that hampered the effectiveness of the hearing protection devices, causing hearing loss in soldiers. Internal documents from 3M and the company that originally designed the earplugs showed that the earplugs had never been properly tested and that a design change made to accommodate the types of helmets U.S. soldiers were wearing interfered with the effectiveness of the earplugs.

Last month, the U.S. District Court Judge overseeing the 3M litigation denied 3M’s motion to dismiss based on the “Government Contractor Defense” finding that 3M’s failure to disclose known defects prevented 3M from utilizing the protections afforded by that defense. The first trials in this litigation are scheduled to begin in the spring of 2021.