(Jan. 7, 2019) The 3M company agreed to pay the U.S. government $9.1 Million last summer to settle a lawsuit over defective earplugs that allegedly caused our soldiers hearing loss and/or tinnitus. That sum included $1.9 Million for a whistleblower who said the company knew the plugs were defective.
Minnesota-based 3M made the earplugs for U. S. soldiers stationed mostly in Iraq and Afghanistan from 2003 to 2015. The Dual-Ended Combat Arms™ Earplugs (CAEv2) – now discontinued – were standard equipment for soldiers during those years.
Acting in good faith that the plugs would do what the company claimed, the U.S. Defense Logistics Agency distributed millions of dollars’ worth of them to thousands of service members, putting them at risk for permanent hearing loss or impairment.
The Defective CAEv2 Earplugs
The plugs featured a dual-ended design. They were meant to be used as either traditional earplugs, or they could be flipped over to provide normal hearing while protecting the wearer’s eardrums from gunfire noise and explosions.
The main complaint was that the earplugs were too short to be effectively inserted into a user’s ears. The too-short design led to the plugs gradually loosening in some ears, effectively rendering them useless to protect from hearing damage.
Whistleblower: 3M Knew Earplugs Defective
Though 3M has admitted no wrongdoing in the settlement, a whistleblower said 3M and its predecessor, Aearo Technologies, knew about the plugs’ design problems as early as 2000. The earplugs failed to pass safety tests then.
Defective Earplug Lawsuit
The defective earplug lawsuit’s allegations were issued under whistleblower provisions of the False Claims Act. That law allows private parties to sue on behalf of the U.S. government if they believe the lawsuit’s defendants submitted false claims for government funds. The law also allows whistleblowers to share in any funds recovered from a successful lawsuit.
As part of the defective earplug lawsuit resolution, the whistleblower will receive $1,911,000, according to the Department of Justice.
Legal Help for Soldiers with Hearing Loss
More than 2.6 million veterans are receiving disability compensation for hearing loss and tinnitus (ringing or buzzing in the ears), according to the Veterans Administration (VA).
Our law firm is investigating defective earplug hearing loss lawsuits. We are considering legal action for anyone who meets the following criteria:
Served in the military 2003-2015
Was issued earplugs during service
Suffers from permanent hearing loss or tinnitus
Contact Matthews & Associates for a free legal consultation in a potential defective earplug lawsuit. Our attorneys and legal assistants may be able to help you take legal action for your hearing loss.
The US FDA announced on August 29, 2018 that certain diabetes drugs can cause dangerous genital infections. The agency warned that people suffering from type 2 diabetes can be injured by a terrible “side effect.” These popular drugs – Invokana, Invokamet, Farxiga and Jardiance — can increase the risk of a flesh-eating bacteria infecting the genitals.
The FDA issued a warning about sodium-glucose cotransporter-2 (SGLT2) inhibitors, drugs commonly prescribed for treating type 2 diabetes. These drugs were linked, over a five-year period, to a dozen rare cases of genital infection known as Fournier’s gangrene or necrotizing fasciitis. This potentially lethal malady causes the skin to die. All 12 patients who developed it required hospitalization, according to the FDA. One person died.
SGLT2 Inhibitors linked to Flesh-eating Bacteria
The SGLT2 inhibitors have been linked to cases of a flesh-eating bacterial infection that attacks the perineum, the skin between the anus and the vulva or the anus and the scrotum. An infection of the perineum affecting this part of the body is called Fournier’s gangrene. It is a rare but potentially fatal condition.
Fournier’s gangrene is more common in men than women. It can spread to other parts of the body, according to medical experts. It can also rapidly progress to involve the entire genital area, and even infect the abdominal wall.
The 12 cases of this infection that the FDA saw spurned the agency into requiring that all SGLT2 inhibitors now include a warning about this risk in the prescribing information. The medications in this class include canagliflozin (Invokana & Invokamet), dapagliflozin (Farxiga), empagliflozin (jardiance) and ertugliflozin (Steglatro). The drugs are available as single-ingredient medications or in combinations, such as with metformin.
How do these infections occur?
Type 2 diabetes occurs when the body can’t remove sugar from the bloodstream. In a diabetic, the cells fail to respond to insulin, the hormone that helps move sugar into the cells. SGLT2 inhibitors can help lower blood sugar by causing the kidneys to remove sugar from the body through urine. This process can stabilize blood sugar levels.
Unfortunately, this process can also lead to infections, because anywhere there is higher blood sugar, there’s an increased risk of bacterial infection. Bacteria is all over us, and a sugary environment is a great breeding ground for bacteria. When one eliminates more sugar through urine, a greater concentration of bacteria reaches into the genital area. This area then becomes an inviting environment for bacteria.
Bacteria can become a problem only when there is an entry point to infect, such as a small cut from shaving or a skin ulcer near the genitals. When that happens, the infections can become serious and require many surgeries to remove all of the infected tissues, which is exactly what happened to the 12 people in the FDA report which led to the newly required warnings.
How Diabetes Drugs cause Dangerous Genital Infections
The FDA warning includes instructions for any patients taking these drugs to seek immediate medical attention if they experience any signs of swelling, itching or irritation in the genital area, or if they experience a fever above 100.4 degrees Fahrenheit (38 degrees Celsius). The bacteria that can cause necrotizing fasciitis can spread quickly, so it’s vital to seek immediate treatment at any sign of infection and a general feeling of ill being.
Type 2 Diabetes Treatment Options Exist
SGLT2 inhibitors are not the only game in town for those who suffer from Type 2 diabetes. Good hygiene can help minimize the risk of necrotizing fasciitis, and Type 2 diabetes can be controlled in ways which don’t involve taking SGLT2 inhibitors.
(Sept. 24, 2018)Diabetes drugs can cause Fournier’s gangrene. That was the shocking conclusion of the FDA last month after the agency said it received reports that 12 people contracted gangrene or necrotizing fasciitis after taking a popular diabetes drug.
Invokana, Farxiga, Jardiance, or Steglatro can raise the risk of a nightmarish flesh-eating bacteria that can infect the genitals and cause partial amputations.
A serious genital infection has been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT-2) inhibitors. The serous infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene.
The U.S. FDA announced the infection warning on August 8, 2018 after receiving a dozen reports of individuals who had been diagnosed with the potentially fatal gangrene or necrotizing fasciitis after using an SGLT-2 inhibitor. Several of those infected people required multiple surgeries, and one person died from the infection.
What are SGLT-2 Inhibitors?
SGLT2 inhibitors — sodium-glucose cotransporter-2 – are prescribed by doctors to help lower blood sugar in adults with type 2 diabetes. SGLT-2 drugs lower blood sugar by causing the kidneys to remove sugar through the urine. Brand-name SGLT2 inhibitor drugs (and their active ingredients) include Invokana (canagliflozin), Farxiga (dapagliflozin), Jardiance (empagliflozin), and Steglatro (ertugliflozino). Steglatro is also FDA approved to lower heart attack and stroke risk in adults suffering from type 2 diabetes and heart disease.
What is Fournier’s Gangrene?
Fournier’s gangrene is a life-threatening bacterial infection of tissue under the skin that surrounds the perineum’s muscles, nerves, fat, and blood vessels. The perineum is the space between anus and scrotum in the male, and the skin between anus and vulva in the female.
Diabetes raises Risk Factors
The FDA web site states that “having diabetes is a risk factor for developing Fournier’s gangrene. But this condition is still rare among diabetics. There’s a dearth of published literature regarding the occurrence of Fournier’s gangrene for men and women. Fournier’s gangrene occurs in roughly 1.6 out of 100,000 males annually in the U.S. It most frequently occurs in males aged 50-79 (approx. 3.3 out of 100,000).
At least 12 Diabetes Drug Gangrene Cases reported to FDA
In a five-year period since the first SGLT-2 drug was approved by the FDA — from March 2013 to May 2018 — the agency said it found 12 cases of Fournier’s gangrene in patients taking an SGLT-2 inhibitor. That number includes only reports submitted to FDA and found in the medical literature. The FDA admits there may be more cases about which it is not aware. Most experts generally agree that only 1-10% of a given drug’s adverse drug events ever get reported. That would put the actual number of people injured by Fournier’s gangrene or necrotizing fasciitis from SGLT-2 drugs somewhere between 120 and 1,200.
1.7 Million SGLT-2 Prescriptions in 2017
The U.S. FDA estimates that 1.7 million patients filled a prescription for an SGLT-2 inhibitor in 2017. The agency said the 12 Fournier’s gangrene cases it saw involved 7 men and 5 women. All the injured people developed Fournier’s gangrene several months after filling an SGLT2 inhibitor prescription.
Diabetes Drugs cause Gangrene
The FDA said that in the 30 years prior to 2013, it had received reports of just six cases of Fournier’s gangrene (all of which occurred in men) from all other antidiabetic drug classes.
(August 9, 2018) Women’s pelvic mesh use was suspended in England last month pending government review. English regulators suspended the surgical use of transvaginal mesh after listening to mesh-related horror stories from several women. The politicians listened as dozens of women detailed stories of how the mesh has caused them excruciating misery and endless pain.
The suspension means surgical mesh meant to treat stress urinary incontinence is not to be used again in England until the mesh meets five strict conditions which thousands of mesh-injured women campaigned to demand. Many of the women belong to a group of 6,100 people called ‘Sling the Mesh.’ Members have called attention to problems with both women’s pelvic mesh, hernia mesh, as well as rectopexy mesh, used to treat rectal prolapse.
Sling the Mesh
“This is incredible news,” said ‘Sling the Mesh’ founder Kath Sansom. “It is a testament to people power. Our members have written, emailed, attended Parliament and lobbied to get this result, and I am delighted.”
The government review of mesh is scheduled to conclude in March 2019. It will determine if the suspension of the plastic mesh used in people will become permanent.
Ms. Sansom brought the anti-mesh campaigners to Parliament, which led to an internal investigation by the National Health Services, as well as debates in the House of Commons. That action led to more public awareness of the severe complications surgical mesh can cause. In the U.S., widespread use of transvaginal mesh has led to a virtual catastrophe, with more than 100,000 women filing lawsuits at one time over plastic mesh complications.
In February 2018, the government announced a review of surgical mesh. Regulators planned to meet face-to-face with citizens around the UK. Health and Social Care Secretary Jeremy Hunt said the government’s final recommendation should be publicized next March.
Baroness Julia Cumberlege led the mesh review. Medical Mesh News Desk reported that she was so moved by the stories she heard that she suggested an immediate suspension in the use of surgical mesh for stress urinary incontinence (SUI). Ms. Cumberlege believes rectopexy mesh for rectal prolapse should also be suspended.
Human Suffering outweighs Benefits of Mesh
“We strongly believe mesh must not be used to treat women with SUI until we can manage the risk of complications much more effectively,” Ms. Cumberlege told the Daily Mail. “ We have not seen evidence on the benefits of mesh that outweighs the severity of human suffering caused by mesh complications. I have been appalled at the seriousness and scale of the tragic stories we have heard from women and their families.”
Baroness Julia Cumberlege
“We had to act now,” said Ms. Cumberlege. “My team and I are in no doubt that this pause is necessary. We must stop exposing women to the risk of life-changing and life-threatening injuries.”
Five Conditions Must Be Met
There’s no ban for now, but a “halt” to procedures pending five conditions:
Surgeons may perform an SUI operation only if they receive proper training and regularly perform surgeries.
Surgeons must report every procedure to a national database.
A surgeries registry will be maintained to note the type of procedure and the woman involved.
Complication reports to the MRHA must be linked to the register.
Specialized centers must be identified and accredited to deal with complications and removals.
As in the U.S., mesh proponents claimed that only prolapse surgeries should be banned. Health regulators, however, acknowledge that three-quarters of pelvic mesh surgeries are done to treat SUI, and they account for most of the horror stories.
An estimated 130,000 UK patients have had an SUI or POP procedure in the past decade. Complication rates have been found up to 42%, with 30% reporting a lost or reduced sex life, and urinary infections reported at 22%, with bladder perforation in 31 percent of cases.
Women across the globe have complained of pelvic mesh complications. Mesh-injured women in Scotland have also addressed their government directly and achieved a suspension on the mesh used for SUI. That suspension came in 2014 after a consistent talking campaign as well as extensive media coverage from an enterprising reporter, Marion Scott.
New Zealand also suspended mesh use for pelvic organ prolapse (POP) as well as incontinence, while Australia suspended mesh use for POP. Hundreds of Australian women have filed lawsuits against Ethicon over its mesh implants.
Sling the Mesh Reaction
Ms. Sansom, who is also a CambsTimes reporter, said, “I think the really positive thing about the suspension is the government is finally listening to us and realizing just how awful it is when these mesh implants go wrong.”
She noted the government is not suspending the use of mesh for rectal prolapse, which Ms. Cumberlege also called for. Ms. Sansom also noted the same plastic is used for hernia repairs and they are starting to get the same complications, pain loss of sex life, autoimmune conditions.
British Urogynaecology (BSUG) Disagrees with Mesh Suspension
The British Society of Urogynaecology (BSUG) strongly disagrees with the decision to suspend the use of surgical mesh for stress urinary incontinence recommended by the All Party Parliamentary Group (APPG).
The government’s decision is not based on any scientific logic or thinking, claim BSUG members. The statement is signed by Professor Jonathan Duckett chairman of the BSUG.
Kath Sansom: BSUG Deluded
Kath Sansom tells MND that the BSUG group is “Absolutely deluded, defensive, sounds very angry, totally not supportive to women and peddling the tired old myth that this is the most trialed procedure out there. These are the aggressive urogyn surgeons. It is very clear they have put a lot of pressure on Govt following Baroness C’s call to “pause.”
Government Trials Flawed
Ms. Sansom believes the government trials that are underway are flawed for several reasons:
Most trials are not randomized, but simply mesh vs. mesh; there’s no control group.
Most trials are short term, roughly two years, shy of when most problems start.
Tiny cohorts: One study of 90 women drops to 58 after 17 yrs., a drop of 22%. Even a 5% drop adds significant bias to a study.
Poor quality of life (QoL) studies fail to look at new onset of chronic pain, nerve damage, urinary infections, loss sex life, etc.
Most QoL questions are based on the SUI pad test. Ludicrous!
Many trials authors have conflicts of interest. In the Pt. 3 trial above, two authors were paid by Ethicon, which makes the mesh slings being “tested.”
Many trials come up with damning statistics and then ignore them. One by Brubaker et al shows a 42% risk, but the abstract/conclusion claims it is only short term and says mesh is an effective treatment option. (Ludicrous!) Busy doctors don’t take the time to read through every report so they believe the hype.
Medscape commentary published August 7, 2018 declares that IVC filters need randomized controlled trials (RCTs). Authored by Vinay K. Prasad, MD MPH – a hematologist-oncologist – the opinion piece explains exactly what RCTs are and why we need them for IVC filters and other medical devices.
Dr. Prasad penned the piece after reading a Twitter debate over whether we should run an RCT of the inferior vena cava (IVC) filter for patients with a venous thromboembolism (VTE) and a contraindication to anticoagulation. Like so many runaway Twitter debates and diatribes, it was apparently fraught with ill-informed people flinging knee-jerk opinions before even clarifying the terms which made them butt heads.
The associate professor of medicine at Oregon Health and Science University explained that there are two basic prerequisites for a product requiring a randomized control trial.
First, he explained, randomized controlled trials are for interventions that are thought, or hoped, to offer benefits. He contrasted them with devices or inventions which we know need no control group for comparison. He offered examples such as smoking, drinking battery acid, falling off a bicycle, or getting kicked by a horse. We don’t need a control group of people who don’t smoke, drink acid, fall off a bike, or get kicked in the head to know those things are bad. By contrast, we run randomized trials when we don’t know whether or not an invention, like an IVC filter, leaves us better off by using it than if we had avoided using it.
Second, Dr. Prasad points out, randomized trials are run for interventions that, at best, offer modest to medium benefits. Again by contrast, if we know a light switch is beneficial, then we don’t ask or run RCTs. Or if jumping from a plane with a parachute saves us vs. not using a chute, then we don’t need an RCT to test parachute vs. non-parachute jumpings.
RCTs in Medicine
To run or not to run an RCT gets most controversial when we consider medicine and medical devices. RCTs are mentioned so often in medicine, explains Dr. Prasad, because “medicine lives in the ‘RCT zone.’” Dr. Prasad explains, “Most of what we do involves offering interventions thought to benefit our patients, and most of what we offer confers a modest benefit, at best.”
Here’s where it gets interesting, and troubling. The evidence shows that most medical practices are not beneficial for mortality.
1 in 80,000 Medical Practices Benefit Mortality
Dr. Prasad wrote: “Data support the idea that medical treatments rarely have large benefits. Researchers studied every medical practice in the Cochrane database and found that only 1 in 80,000 practices had a very large, consistent benefit on all-cause mortality.” Extracorporeal membrane oxygenation (ECMO) for neonates was the only one in 80,000 practices that showed a benefit for mortality!
Meanwhile, doctors have for years touted a list of practices with overwhelming benefit but lacking RCTs; that list includes just a few hundred items. That woeful number starkly contrasts with the hundreds of thousands of interventions and practices performed in biomedicine.
However, says Dr. Prasad, that doesn’t stop experts from pretending their “pet intervention” is an indispensable parachute and touting it as such. The IVC filter is one such medical invention touted as a parachute, though no studies have proven that it is, or has ever been anything of the sort.
Dr. Prasad points to a recent paper in JAMA Network Open, in which Turner and colleagues found the IVC filter associated with an increased risk for death when used in patients with venous thromboembolism and a contraindication to anticoagulation. That is especially troubling because that is the one group for which guidelines consistently recommend IVC filter use.
After adjusting for a common problem in observational data called immortal time, the authors found IVC filters associated with increased mortality (hazard ratio, 1.18; 95% CI, 1.13-1.22; P < .001). Dr. Prasad acknowledges that this study has limitations like all observational studies, but says we don’t have RCTs to guide us on this question.
Three randomized trials of IVC filter placement to date have included at least 100 participants, and none show a mortality benefit, even with extended follow-up. Curiously, all trials excluded patients with a contraindication to anticoagulation, which is again the only group which guidelines consistently recommend use IVC filters. Additionally, said Dr.Prasad, “[O]ne of the three trials used an odd methodology that screened patients for symptoms of pulmonary embolism (not letting clots present on their own).
Studies Show No Benefit for IVC Filters in Any Setting
“[T]he available evidence base for IVC filters is lousy,” declares Dr. Prasad. “All observational studies have limitations—in this case, the patients who got filters may be different from those who did not; and these differences, and not the filter itself, may be responsible for any findings—and we may not be able to adjust for all of these factors. Moreover, all of the relevant RCTs are small and limited, and none show a clear benefit for filters in any setting. And there are no studies in the setting of contraindication to anticoagulation—a common reason why filters are placed.”
IVC Filters Need Randomized Controlled Trials
RCTs are needed for IVC filters because we only hope, but do not know, whether they benefit people. IVC filters are costly, invasive, and harmful; and they’ve now been shown to offer no mortality benefit to the only group of people for which they are consistently recommended by common medical practice.
Something is terribly wrong with a system that allows a product to be implanted by the hundreds of thousands into people with no evidence of benefit. Consequently, problems with IVC filters have led to IVC filter lawsuits being filed all across the country.
Physiomesh used for hernia repair has caused serious problems for many people. As a direct result, Johnson & Johnson subsidiary Ethicon removed Physiomesh from the market in 2017. Complications from Physiomesh include hernia recurrence, mesh folding, bunching up, adhering to body organs, failing to integrate, causing pain, inflammatory reactions, and more. These problems have led to Physiomesh lawsuits.
What is Physiomesh?
Physiomesh Flexible Composite Mesh is a partially absorbable surgical mesh used for hernia repair. The mesh is made from polypropylene, a plastic, set between two synthetic film layers. Over time, a body absorbs the coating on the laminated layers, a controversial process that can lead to different bodily injuries.
FDA Clearance via 510(k)
The U.S. FDA cleared Physiomesh in 2010 under the auspices of its 510(k) program. By this path, Ethicon had only to claim the mesh was “substantially similar” to products already on the market. This truncated path to market saved Johnson & Johnson and Ethicon lots of money and time, but it also leaves the maker of Physiomesh subject to liability for problems caused by the device. By contrast, medical devices approved through the FDA’s regular Premarket Approval Process (PMA) are typically exempt from liability when they hurt people. Makers of those devices were made exempt from liability via the U.S. government’s gift to corporations known as the Medical Device Amendments of 1976.
Physiomesh Hernia Repair with Laparoscopic Surgery
The Physiomesh version removed from the market was for laparoscopic surgery, a minimally-invasive technique. A surgeon makes several small incisions through which surgical tools are inserted. The surgeon then uses the tools to implant and secure (in theory, at least) the mesh in place around the hernia.
Foreign Body Reaction
Like many plastic meshes, Physiomesh depends on the human body’s own defense mechanism to attack and destroy foreign bodies in order to “mesh” with the patient’s body. Therein lies both the genius and the idiocy of implanting plastic mesh in the human body. Ethicon designed Physiomesh with a coating to prevent adhesions. In theory, the body absorbs the coating over several weeks and stops absorbing where it “should” to strengthen the hernia-weakened tissue. However, the human body doesn’t always stop absorbing when and where it “should,” and the mesh doesn’t always strengthen repairs. Sometimes it meshes uncontrollably and adheres to body organs, wreaking dangerous havoc.
The most common Physiomesh complication appears to be hernia recurrence, when the hernia comes back after the mesh implant surgery.
A Polish Hernia Study Group ran a clinical trial on Physiomesh in 2015, which included included Physiomesh Flexible Composite Mesh for laparoscopic surgery. The Polish group halted the trial for ethical reasons when researchers noted a high rate of hernia recurrences.
Ethicon removed the Physiomesh laparoscopic model from the market, but doctors and patients reported even more complications to the FDA.
Physiomesh Complications Reported to the FDA
Mesh folding, bunching up
Adherence to organs
Physiomesh Recalls and Market Withdrawals
Ethicon pulled all units of Physiomesh for laparoscopic surgery from the global market in May 2016, then sent out an Urgent Field Safety Notice. The notice explained why Ethicon ordered the market withdrawal. The notice also affected Ethicon Laparoscopic Hernia Kits. Ethicon wrote:
“The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.”
Ethicon later discontinued laparoscopic versions of Physiomesh.
FDA Actions re: Physiomesh
The FDA began receiving reports of Physiomesh failures shortly after the 510(k) clearance. Those reports detailed recurring hernias, adhesions, infections, and other problems.
A federal panel combined the first 16 Physiomesh lawsuits in June 2017. Hundreds of people have since sued Ethicon over Physuiomesh.
A federal court in the Northern District of Georgia oversees Physiomesh lawsuits. The presiding judge set the first trial date for Sept. 16, 2019. There were 1,279 Physiomesh lawsuits pending as of July 2018.
Physiomesh lawsuits accuse Ethicon of failing to warn people of Physiomesh risks. The suits also accuse Ethicon of negligence and putting a defective product on the market.
(July 25, 2018) Bayer can’t keep Essure cases in federal court, said a Pennsylvania federal judge on Monday. The judge ordered 16 consolidated Essure lawsuits back to state court. The cases were brought by women who allege they were hurt by Bayer’s Essure birth control / sterilization device. The judge found Bayer had failed to establish federal jurisdiction over the lawsuits. The Big Pharma giant – now trying to buy the much-despised Monsanto juggernaut – had filed a petition in an attempt to keep the Essure cases in federal court.
In his ruling against Bayer, U.S. District Judge John R. Padova cited a piece of the U.S. Supreme Court’s controversial Riegel v. Medtronic decision. The judge said that ruling made clear that Congress intended the state courts to resolve cases like those of the women suing Bayer over Essure. The women’s suits claim Bayer AG violated state laws that parallel federal requirements for medical devices. According to the high court’s Riegel opinion, under the 1976 Medical Device Amendments Act — which regulates medical devices for safety and effectiveness — state claims in medical device cases are barred only if they seek to impose non-federal requirements.
Judge Padova said, “[U]nder the congressionally-designed scheme, the MDA permits individuals to bring state law causes of action alleging violations of duties that parallel the federal requirements. (It) would be entirely inconsistent with this structure to conclude that Congress intended all such state law causes of action to be brought in federal court.”
The judge’s using Riegel v. Medtonic to rule against a corporation’s wishes is more than a little ironic; the Riegel ruling by the nation’s highest court virtually erased liability for most medical device makers, if their device had been approved by the FDA. In a scheme known as “preemption,” Medtronic had argued – in a nutshell – that it was impossible to fulfill both state and federal obligations regarding a warning label. It was a specious argument at best, but it was enough to give a majority of the U.S. Supreme Court cover to back corporate immunity at the expense of injured U.S. citizens.
Judge Padova’s ruling in this case recalls Macbeth’s hesitation in pondering the murder of Duncan. He wisely worries, “That we but teach bloody instructions, which, being taught, return to plague the inventor.” Thus Riegel v. Medtonic has returned to plague the inventors, corporations angling for total immunity from liability.
Judge Padova sent the 16 Essure lawsuits back to the Court of Common Pleas of Philadelphia County, where they had first been filed.
Bayer Halts Essure Sales
Bayer’s Essure birth control — or sterilization — device is a medical coil placed in a woman’s fallopian tubes to prevent pregnancy. On July 20, 2018, Bayer said it had decided to stop selling or distributing Essure in the U.S. by the end of the year. The company said in a statement that it had concluded its Essure business was no longer sustainable after years of declining U.S. sales, though Bayer was quick to note that it still stood by the safety and efficacy of Essure.
In April 2018, the FDA required an unusual limitation on Essure sales. The agency said Essure can be used only if patients are directly informed of its potentially serious side effects. Essure’s most serious risks – including perforation of the uterus or fallopian tubes – are listed on a black box warning which has appeared on Essure’s label since 2016.
The 16 women in these cases claim Essure migrates from the fallopian tubes and then breaks into pieces. The claimants allege that they’ve suffered severe and permanent injuries.
The women also charge that Bayer negligently trained doctors to implant the Essure device. They claim Bayer failed to tell the FDA about Essure’s adverse event reports, and failed to include them in the company’s own risk analysis.
Bayer Can’t Keep Essure Cases in Fed. Court
The judge also rejected Bayer’s argument that the cases present substantial disputes of federal law. He said Bayer didn’t elaborate on what those would be.
Judge Padova said, “Moreover, it has not established that the resolution of any dispute would have ramifications in federal cases outside of the Essure context or is otherwise important to the ‘federal system as a whole. (We) conclude that Bayer has failed to identify any federal issue that holds significance for anyone other than the parties.”
(July 16, 2018)A new study questions the use of IVC filters in DVT patients undergoing CDT, catheter-directed thrombosis. The study led by Temple University showed no in-hospital mortality benefit, and worse. It showed IVC filters associated with increased procedure-related hematomas, and it also showed that using IVC filters led to lengthier hospital stays and higher bills.
IVC filters are alleged by their makers to help treat DVT, deep-vein thrombosis. They are advertised – by Cook Medical, C.R. Bard, and other IVCF makers – to be indispensable, life-saving devices. But their effectiveness in every regard has been questioned by thousand of IVC filter lawsuits.
DVT occurs when blood clots develop in the deep veins of the legs, thigh, or pelvis. These clots can break loose, travel to the lungs, and cause life-threatening pulmonary embolism (PE). Proximal DVT – a clot in the thigh or pelvis – has been linked with a higher risk for post-thrombotic syndrome.
Post Thrombotic Syndrome (PTS) and Catheter-Directed Thrombosis (CDT)
PTS is a painful condition characterized by swelling, redness, and leg sores. In hopes of reducing the high incidence of PTS in patients treated solely with a blood thinner, many doctors today use catheter-directed thrombolysis. CDT is a minimally invasive procedure in which an infusion catheter delivers clot-busting drugs directly into the clot. Fluoroscopically guided, CDT can potentially reestablish blood flow through a newly-blocked vein.
In hopes of preventing clots from breaking loose and migrating to the lungs during a CDT procedure, some doctors choose to simultaneously implant an inferior vena cava filter (IVCF). IVCFs are wire-basket-like devices inserted into the inferior vena cava, a large vein that returns blood from the lower body to the heart and lungs. IVCFs are used on the theory that they capture blood clots which would otherwise reach the lungs. There is some evidence, which has been produced by IVC filter makers, to support the IVCF theory; but it is scant, at best, and far from convincing, which has led to IVC filter lawsuits.
Any IVC Filter Benefit is Unclear
A research team led by Riyaz Bashir, MD, FACC, RVT, Professor of Medicine at the Lewis Katz School of Medicine at Temple University (LKSOM), and Director of Vascular and Endovascular Medicine at Temple University Hospital (TUH), sought to address the question of whether there is any benefit of IVCF placement at the time of CDT. The team began by examining nationwide utilization rates of IVCFs in patients undergoing CDT. They wanted to assess contemporary trends and compare outcomes with patients who do not undergo IVCF placement. The team’s findings were published online July 16, 2018 and also in the July 23rd issue of the journal JACC: Cardiovascular Interventions.
Limited Data for IVCF Patients – 7 Years
“Limited data exists on the effectiveness of IVCF use in patients undergoing CDT for the treatment of proximal DVT,” said Dr. Bashir. “This study is noteworthy because it is the first to evaluate national trends and comparative outcomes related to this practice.”
The research team used the National Inpatient Sample database to identify every person in the U.S. with DVT who underwent CDT (with and without IVCF placement) from January 2005 to December 2013.
The team’s findings include these conclusions:
IVCF used in patients undergoing CDT for DVT was not associated with any significant in-hospital mortality decrease compared to patients who did not receive an IVCF.
IVCF used in patients undergoing CDT for DVT was associated with an increase in procedure-related hematoma formation (3.4% vs. 2.1%), in-hospital costs ($104,049 vs. $92,881) and length of stay (7.3 days vs. 6.9 days) compared to patients who did not receive an IVCF.
Dr. Bashir said that based on these results, his team believes, “IVCFs should not be routinely placed in patients undergoing CDT.” Dr. Bashir also called for more well-designed, randomized control trials “to elucidate the implications of IVCF placement in patients undergoing CDT.”
(July 10, 2018) – In 31 transvaginal mesh (TVM) trials so far, 22 have concluded with verdicts in favor of plaintiffs. Eleven (or half) of those verdicts have gone against Johnson & Johnson and Ethicon, which has seen its mesh losses mount faster than any other TVM manufacturer. J&J has lost five verdicts over its Gynecare Prolift mesh, three for its TVT-O mesh, one for TVT-Abbrevo, one for TVT-Secur, and one for its polypropylene tape used to treat stress urinary incontinence (SUI).
In 2016, the FDA reclassified transvaginal mesh for prolapse repair (but not SUI) as Class III (high risk) medical devices. The reclassification made TVM implants ineligible for FDA’s 510(k) clearance program. That program had previously allowed mesh products on the market without prior clinical trial testing on human beings. But 510(k) clearance does not amount to FDA approval. TVM or pelvic mesh devices are not FDA approved.
Johnson & Johnson, Ethicon Mesh Losses Mount
Besides fighting TVM cases in the courts, Johnson & Johnson and other defendants have also quietly settled hundreds of them. As with most settlements, terms are not disclosed and the companies that pay admit no wrongdoing.
Johnson & Johnson (Ethicon) Trials have yielded at least eleven (11) wins for plaintiffs so far. These include:
March 8, 2018 – $35 Million for Plaintiff (Gynecare Prolift)
A U.S. District Court for Northern Indiana jury hit Johnson & Johnson’s Ethicon with a $35 million verdict over its Prolift pelvic mesh. ($10 million in damages and $25 million in punitive damages). Barbara Kaiser and her husband Anton Kaiser sued Ethicon in March 2012 after learning that the Prolift mesh her doctor implanted in 2009 to treat pelvic organ prolapse might be causing her low pelvic pain. The lawsuit petition accused J&J and Ethicon of concealing Prolift problems that included high failure, injury and complication rates, as well as “frequent and often debilitating re-operations.” Prolift “caused severe and irreversible injuries, conditions, and damage to a significant number of women, including plaintiff,” said the complaint.
The Kaisers also alleged that “[Ethicon] consistently under-reported and withheld information (about) Prolift’s propensity to fail and cause injury and complications, and have misrepresented the efficacy and safety of the products through various means and media, actively and intentionally misleading the medical community, patients, and the public at large.”
The Kaisers also alleged. “Defendants actively and intentionally misled and continue to mislead the public, including the medical community, health care providers, and patients, into believing their Prolift is safe and effective. . .”
Dec. 14, 2017 – $15 Million for Plaintiff (Prolift)
A New Jersey woman was awarded $15 million by a Bergen County (New York) Superior Court jury in her transvaginal mesh lawsuit. The verdict followed 2 ½ weeks of trial testimony and nearly a day of jury deliberation. The woman testified that she had been in constant pain since receiving an Ethicon mesh implant. Jurors found the Johnson & Johnson subsidiary had failed to adequately warn her of the risks associated with Ethicon’s Prolift mesh implant. They awarded her $4 million in compensatory damages and $10 million in punitive damages, as well as awarding her husband $1 million for his loss of conjugal affection.
The jury also found Ethicon had failed to provide the woman with adequate safety warnings in regards to the TVT-O mesh implant, but they determined the Prolift mesh alone was responsible for her injuries. (Case No. L-13686-14)
September 6, 2017 – $57 Million for Plaintiff (TVT-Secur)
A Philadelphia jury awarded a woman $57.1 million in damages over a TVT-Secur mesh implant. Ella Ebaugh accused Johnson & Johnson unit Ethicon of making a defective pelvic mesh implant that scarred her urethra and left her incontinent. Her award included $50 million in punitive damages. The jury unanimously backed her claims that two negligently and defectively designed mesh devices had “mutilated” her urethra and left her with little control over her urinary flow.
May 26, 2017 – $2.16 Million for Plaintiff (Prolift)
A Pennsylvania jury awarded $2.16 million to a woman who suffered serious complications from Ethicon, Inc.’s Gynecare Prolift mesh. The verdict came in the Philadelphia Court of Common Pleas. It was the fourth straight loss for Johnson & Johnson and its Ethicon division in a Pennsylvania transvaginal mesh lawsuit. (Case No. 130603835)
April 28, 2017 – $20 Million for Plaintiff (TVT-Secur)
A state-court jury in Philadelphia ordered Johnson & Johnson to pay a New Jersey woman $20 million over a TVT-Secur pelvic mesh. The woman blames J&J’s vaginal-mesh inserts for leaving her in constant pain. The jury concluded that the TVT-Secur was defectively designed and caused Margaret Engleman’s injuries. They awarded her $2.5 million in damages and then hit J&J and Ethicon with $17.5 million in punitive damages.
February 2016 – $13.5 Million for Plaintiff (Polypropylene tape)
A jury in Philadelphia hit Johnson & Johnson subsidiary Ethicon with a $13.5 verdict in the second case involving its pelvic mesh products to go to trial in the city. The Philadelphia Court of Common Pleas jury awarded Sharon Carlino $3.5 million in compensatory damages, $10 million in punitive damages. It found Ethicon transvaginal polypropylene tape implanted during a 2005 hysterectomy was defective. It also found that Ethicon failed to adequately warn of its risks. Ms. Carlino required three revision surgeries to remove the eroded mesh.
March 4, 2015 – $5.7 Million for Plaintiff (TVT Abbrevo)
A California jury in Los Angeles hit Johnson & Johnson’s Ethicon Inc. unit with a $5.7 million verdict. The jury sided with a woman who claimed her doctor had given her an older, heavier version of a pelvic mesh product that will cause her a lifetime of pain. The jury awarded plaintiff Coleen Perry $700,000 in compensatory damages and $5 million in punitive damages. Ms. Perry had been implanted with Ethicon’s TVT Abbrevo mesh.
December 2015 – $12.5 Million for Plaintiff (Prolift)
A Philadelphia jury ruled Johnson & Johnson must pay $5.5 million to a Pennsylvania woman over its Ethicon unit’s Gynecare Prolift mesh implant. The jury found J&J liable based on the negligence of its scientists in relation to its Prolift pelvic mesh implant. They cited the mesh as the root cause of plaintiff Patricia Hammons’ inability to have sex after it was implanted. The jury later added $7 million in punitive damages.
A Pennsylvania state court judge ruled in 2014 that Johnson & Johnson and other pelvic mesh makers like Boston Scientific and Bard will need to challenge more than 860 product liability lawsuits on a case-by-case basis.
September 2014: $3.3 Million for Plaintiff (TVT-O)
In West Virginia, a federal jury in the MDL court hit Ethicon with a $3.3 million verdict over its TVT-O transvaginal sling. The jury found in favor of plaintiff Jo Huskey on all counts, which included strict liability, design defect, failure to warn, negligence.
April 3, 2014: $1.2 Million for Plaintiff (TVT-O)
A Dallas jury ordered Johnson & Johnson to pay a Texas woman $1.2 million for a defective plastic sling – the TVT-O – which J & J’s Ethicon division makes and markets for stress urinary incontinence. Freese & Goss and Matthews & Associates represented the woman, Ms. Linda Batiste.
February 2013 – $11.11 Million for Plaintiff (Prolift)
A New Jersey jury awarded Linda Gross an $11.11 million verdict in her lawsuit against Johnson & Johnson’s Ethicon over the company’s Prolift vaginal mesh product. Ms. Gross suffered 18 surgeries in repeated attempts to remove the failed mesh and resultant scar tissue. The jury found J&J had failed to warn patients and doctors about the risks of its mesh products and that the company made fraudulent misrepresentations.
Johnson & Johnson TVM Court Wins
Johnson & Johnson settled at least one Prolift trial which had reached the MDL courtroom, and it has won two TVM trials so far. In February 2014, company lawyers were able to have Judge Goodwyn dismiss the case of a Texas woman against Ethicon and J&J (Lewis v. Ethicon/JJ) in a TVT-O case, and a Texas jury awarded nothing in a Nov. 2015 case over a Prosima device that reached trial (Cavness v. Ethicon/JJ). J&J also settled with the plaintiff in at least one TVM case which reached trial in March 2015 (Bellew v. Ethicon/JJ).
Transvaginal Mesh Lawsuits
Today, many thousands of TVM cases remain unresolved, parked in various state courts across the U.S. and in the federal MDL in West Virginia. The overseer of the federal MDL court, Justice Joseph Goodwyn, announced in June 2018 that he will no longer accept new mesh cases. Judge Goodwin has overseen several MDL trials and still has more than 100,000 cases on his books. He has urged the defendants to settle, some have occasionally obliged, but the sheer number of cases in the MDL makes it the largest federal court docket for mass tort litigation since asbestos.
(July 7, 2018) The mainstream media has finally recognized that a huge number of women are suing mesh manufacturers over their plastic products. A CBS news story reported last month that nearly 50,000 women are suing one mesh maker alone over gynecological mesh. The polypropylene (plastic) mesh is often used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), which affect millions of women. At least 100,000 women across the country are suing over gynecological mesh. Many have filed their cases in the multidistrict litigation court in West Virginia. Several other pelvic mesh lawsuits have been filed in various state courts throughout the country.
The CBS news story mentioned only Boston Scientific as a defendant in transvaginal mesh (TVM) cases, though several other gynecological mesh makers also face lawsuits. Other defendants include Johnson & Johnson (Ethicon), American Medical Systems (AMS), C.R. Bard, Coloplast, and Cook Medical.
Sixty Minutes reported that Boston Scientific faces some 48,000 lawsuits in what has generated the largest multi-district litigation since asbestos. The suits claim mesh can inflict life-changing pain and injury. Suits against Boston Scientific also claim the company used a mesh product never meant to be put inside the human body.
More than two million American women have received gynecological mesh implants. All the mesh makers claim their products are safe.
CBS News reported the story of one woman implanted with a Boston Scientific gynecological mesh for stress urinary incontinence and also to lift organs that shifted after pregnancy. Gwyn Madsen had a Boston Scientific implant in 2012.
Gwyn Madsen told CBS that the mesh “felt like a cheese grater inside of me.”
Ms. Madsen said she suffered pain which left her barely able to sit or play with her children. She said, “It felt like the material was pulling on the muscles and I’d get shooting pains. You almost felt like there was something inside of you that was like sandpaper back and forth, every time you’d walk.”
Boston Scientific, which lost a $73 million verdict over one of its TVM products following a 2016 trial in Texas, has fought allegations like Ms. Madsen’s for years. The company told CBS: “Nearly one million women have been successfully treated. (We) have extensively tested the [plastic] resin to confirm its composition, safety and performance.”
100,000 Women suing over Gynecological Mesh
The American Urogynecological Society – which has embraced the plastic mesh because it is easier to apply than the gold standard suture method for repairing POP or SUI – has also claimed plastic mesh is “safe and effective.” Many doctors, however, disagree.
Dr. Michael Margolis testified for the woman who won a $73 million verdict in the Texas case. He told CBS that the women’s mesh causes a chronic inflammatory reaction. He has removed more than 350 mesh implants.
“The slings I’ve removed are substantially altered in their architecture,” Dr. Margolis told CBS. “They are shrunk by at least 50% in width. They are encased in scar tissue. The pores [in the mesh] shrunk substantially.”
Dr. Margolis showed CBS a mesh he removed which had been implanted. It had shrunk substantially, he said, had folded, contracted, embedded in scar tissue, and was choking off the woman’s urethra. He said it was half the size it had been upon implant.
Dr. Margolis told Scott Pelley the implant is “not supposed to change.”
Missing from the CBS story and interviews was the fact that Boston Scientific, as well as Johnson & Johnson (Ethicon, American Medical Systems (AMS), and Bard have all lost multi-million-dollar verdicts to women implanted with the companies’ transvaginal mesh products.
FDA: Serious Adverse Events “not rare”
The story did include the fact that the FDA has issued a damning report regarding TVM mesh. In 2011, the FDA said that it found mesh used to support organs after pregnancy had resulted in nearly 4,000 “reports of injury, death, and malfunction” and complications including “pain, infection, urinary problems, bleeding and organ perforation.” The FDA wrote that, “Serious adverse events are not rare.”
Indeed. At least 100,000 women would apparently agree with that statement.