Women’s Pelvic Mesh Use Suspended in England

(August 9, 2018)transvaginal mesh 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.

Related:   Transvaginal Mesh Lawsuit

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:

  1. Surgeons may perform an SUI operation only if they receive proper training and regularly perform surgeries.
  2. Surgeons must report every procedure to a national database.
  3. A surgeries registry will be maintained to note the type of procedure and the woman involved.
  4. Complication reports to the MRHA must be linked to the register.
  5. 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:

  1. Most trials are not randomized, but simply mesh vs. mesh; there’s no control group.
  2. Most trials are short term, roughly two years, shy of when most problems start.
  3. 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.
  4. Poor quality of life (QoL) studies fail to look at new onset of chronic pain, nerve damage, urinary infections, loss sex life, etc.
  5. Most QoL questions are based on the SUI pad test. Ludicrous!
  6. 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.”
  7. 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.

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IVC Filters Need Randomized Controlled Trials

Medscape Cook Blood Clot Filter Lawsuitscommentary 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.

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Physiomesh Hernia Repair Problems

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.

Related:  Physiomesh Lawsuit

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.

Physiomesh Complications

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  

  • Hernia recurrence
  • Mesh folding, bunching up
  • Adherence to organs
  • Integration failure
  • Pain
  • Inflammatory reactions

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.

Physiomesh Lawsuits

A federal panel combined the first 16 Physiomesh lawsuits in June 2017. Hundreds of people have since sued Ethicon over Physuiomesh.

Physiomesh Litigation

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.

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Bayer Can’t Keep Essure Cases in Fed. Court

(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.”

The case is McLaughlin v. Bayer Essure Inc. et al., case number 2:14-cv-07315, in the U.S. District Court for the Eastern District of Pennsylvania.

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New study questions IVC filters

(July 16, 2018)  Bard IVC Filter Lawsuit | Blood Clot Filter LawyerA 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 thought to treat DVT, deep-vein thrombosis; though their effectiveness in that regard has been questioned by several recent 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 also implant an inferior vena cava filter (IVCF) at the same time.  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 to support the IVCF theory; but it is scant, overall, 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.”

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Johnson & Johnson, Ethicon Mesh Losses Mount

(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).

Related:  Transvaginal Mesh Lawsuit

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.

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100,000 Women suing over Gynecological Mesh

(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.

Related:  Transvaginal Mesh Lawsuit | Pelvic Mesh

Gynecological Mesh Makers

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.

Related:  Johnson & Johnson Mesh Verdicts Mount 

More than two million American women have received gynecological mesh implants.  All the mesh makers claim their products are safe.

CBS News

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.

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Are Generic Drugs really the same as Brand?

Are generic drugs really the same as brand?  From a legal perspective, the answer is a resounding, “No, generic drugs are not the same as brand-name drugs.”  Not when it comes to liability for their respective makers, or the civil protections enjoyed by their users. Why is that? One might fairly ask. The answer is that five justices on the U.S. Supreme Court ruled in two landmark 5-4 votes that anyone injured by a generic version of a brand-name drug does not have the same civil protections as someone injured by the brand-name version of that same drug.  That can mean the difference between a $21 million jury award and nothing, which is what five members of the Supreme Court decided a woman’s injuries were worth after she was blinded and disfigured by a generic drug.

Supreme Court rulings on 5-4 votes in both Pliva v. Mensing (2010) and Bartlett vs. Mutual Pharmaceuticals (2013) gave generic drug makers virtual carte blanche to injure people at will without having to face the consequences of the drugs they make.  The latter ruling overturned a $21 million verdict for Karen Bartlett, who was blinded and disfigured by a generic version of sulindac, an anti-inflammatory drug.

Gross injustice like that in Ms. Bartlett’s case continues. The Supremes’ decision in favor of generic drug makers is a gift to drug companies that keeps on giving. Thanks to the high court, it is now either extremely difficult or virtually impossible for people hurt by the generic version of a drug to have their grievances heard in an American courtroom.

In addition to the fact that generic drugs fail to compare with branded ones in the American court system, there is much evidence to suggest that many generic drugs are not equivalent to brand name drugs from a medical perspective.

Fortune magazine reported in January 2013 on several controversies surrounding brand and generic drug “equivalence.”  Katherine Eban wrote a story which detailed how in 2012 the FDA took the rare step of declaring that a generic version of the antidepressant Wellbutrin – which the agency had previously approved – was not in fact “bioequivalent” to the name-brand version. In that case, the FDA withdrew its approval of that generic Wellbutrin.

Teva Pharmaceuticals (which made out like bandits in the Mensing v. Pliva decision over the generic version of Reglan), marketed the Wellbutrin generic in question.  Teva was forced to stop selling it.  Other drug companies are now testing their versions of Wellbutrin at the FDA’s request. Fortune reported that the episode brought momentum to a movement that was quietly building among many doctors and medical societies increasingly willing to ask whether generic drugs are in fact identical to the brands they try to copy.

Most people tend to think that generic drug versions are the same as their brand-name counterparts. Most people are happy to save some money at the pharmacy counter and not think past their pocketbook as they leave the drug store. Some people may be vaguely aware that generics are often much cheaper because generic drug makers don‘t have to spend as much money as brand-name drug makers to get their drug on the market. Most are likely unaware that the differences between brands and their generic versions can be significant.

The issue is a large one, because a whopping 80 percent of all U.S. prescriptions now dispensed are generic.  In 20112 alone, Americans saved $193 billion by buying generic drug versions, according to the Generic Pharmaceutical Association.

Generic drug makers may know some of the declared ingredients of a brand-name drug, but proprietary privilege helps the branders keep their processes secret. The patent that reveals the components does not explain how to make the drug. Consequently, generic drug makers must use reverse engineering to conjure their concoctions, hardly a panacea for perfection. The result is that a generic drug, is at best, an approximate copy, never a clean duplicate; and a generic drug will not behave in the same fashion as the branded drug will.

Though FDA rules acknowledge generic drugs’ duplication problems, the agency is a long way from solving them. The best the FDA can offer is a broad definition of “bioequivalence.” Fortune notes that “a generic’s maximum concentration of active ingredient in the blood must not fall more than 20% below or 25% above that of the brand name. This means a potential range of 45%, by that measure, among generics labeled as being the same.”

In addition, though the generic must contain the same active ingredient as the original, additional ingredients – excipients – can be different and are often of lower quality. Those differences can affect a drug’s bioavailability.  The American Heart Association has noted, “Some additives traditionally thought to be inert (may) alter a drug’s dissolution, thereby impacting its bioavailability.”

Are Generic Drugs really the same as Brand?

FDA standards also don’t regulate how quick medicine reaches peak concentration in the blood, and patients taking time-release drugs can be seriously affected by peak changes. Active ingredients releasing into the blood far more quickly can leave patients dizzy or nauseous.

The FDA is also somewhat hogtied by Chinese producers of generic drugs. The Chinese don’t allow U.S. FDA inspectors inside their plants. Officials from the U.S. can only show up at the plant, wait outside, and then accept (or not) whatever the Chinese generic drug makers give or tell them.

An estimated 80% of active drug ingredients and 40% of finished medications come from overseas, from some plants which the FDA has not inspected. In November 2013, generic Lipitor maker Ranbaxy Pharmaceuticals recalled some 480,000 bottles after tiny shards of glass were found inside pills. India’s largest generics company, Ranbaxy is the same entity for which the FDA granted permission to produce a version of Lipitor.  The approval came after a seven-year investigation in which the U.S. Justice Department concluded Ranbaxy had fabricated drug-approval data.  Ranbaxy agreed to pay $500 million and entered into a consent decree.

This is hardly the stuff which can help make people feel confident in filling their prescriptions with generic versions of brand-name drugs.

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Cook Medical loses $1.2 Million IVC Filter Verdict

(May 25, 2018)  .2 Million IVC Filter Verdict">Cook IVC Filter AttorneyCook Medical must pay $1.2 million to compensate a man who was implanted with a Cook Celect IVC filter, said a Texas jury Thursday.  Following a three-week trial, the jury of 12 ruled Cook must pay for injuries following a Celect filter’s implantation in Jeffrey Pavlock on March 3, 2015.   A 35-year-old Houston-area firefighter,  Mr. Pavlock sued Cook after its Celect inferior vena cava filter became stuck inside him and required open laparotomy surgery to remove.

Cook promoted its Celect IVC filter as retrievable, but the filter put into Mr. Pavlock’s inferior vena cava tilted, perforated his IVC, duodenum and aorta, and was pressing against his spine and renal artery.  That situation made it impossible to remove without major surgery. Two previous removal procedures had failed.

Much conjecture from both sides argued about how much the results of the removal surgery affected Mr. Pavlock now and could affect him in the future. For the present, despite the scar hidden beneath the button-down shirts he favored during the trial, the appearance of the burly firefighter and EMT appeared unremarkable.  He moved freely throughout the proceedings, without any apparent pain or visible injury, in full view of the jury just a few feet away.

One plaintiff’s expert in the case testified that Mr. Pavlock had a 90% chance of suffering future spinal stenosis from the surgery which involved cutting the metal filter into several pieces and digging them out.

”Spinal stenosis,” according to the Mayo Clinic, “is a narrowing of the spaces within your spine, which can put pressure on the nerves that travel through the spine.  Spinal stenosis occurs most often in the lower back and the neck. Some people with spinal stenosis may not have symptoms.”

Defense pounced on the Plaintiff side’s analysis that any spinal stenosis Mr. Pavlock may have is asymptomatic for now but could become symptomatic in the future. Nobody could say for certain whether or not Mr. Pavlock would suffer symptomatic stenosis in the future.

Attorney David Matthews argued for the plaintiff in closing that Cook knew its Celect had perforation problems before it was cleared by the FDA, yet pushed it to the market anyway.  He showed the jury several independent studies which found Celect had a perforation rate of greater than 79 percent, while the Cook-sponsored study the company presented to the FDA prior to Celect’s 510(k) clearance in 2008 showed a zero percent perforation rate.  Mr. Matthews also reminded the jury that he had showed evidence that as few as one percent of adverse events are reported by doctors to a medical device company.

Concerning the large gap between independent- and Cook-sponsored study findings, defense attorney John Mandler said, “They have their favorite studies and we have ours.”  Cook’s lawyers had also refuted trial evidence of doctors reporting only 1-5% of actual adverse events related to medical devices.  In closing, Mr. Mandler called the low-reporting evidentiary studies a “conspiracy theory.”

Cook issued a press release the next day vowing to appeal the jury verdict.

Cook Medical loses $1.2 Million IVC Filter Verdict

Freese & Goss and Matthews & Associates Law Firm represented the plaintiff. Cook Medical was represented by Faegre Baker Daniels of Minneapolis.  The actual jury award was $1,240,500.

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Medical Devices Wild West for Profits, Safety Problems

Dubious medical Cook Blood Clot Filter Lawsuitsdevices like IVC filters, heart stents, and metal-on-metal hip implants are allowed on the US market through some very questionable means. Most people assume the U.S. Food and Drug Administration extensively tests all medical devices before blessing them with the agency’s magic wand of approval. The fact of the matter is far different. The FDA performs no studies of its own. The FDA merely evaluates research that is usually submitted by medical device and drug makers with a vested interest in that research. The FDA hasn’t the time, the funding, or the personnel needed to do the job entrusted to it, the job that most Americans assume it is doing.

The FDA has – through budget cuts and restructuring of its funding, political pressures from Big Pharma lobbyists, and a revolving door which shuffles drug and medical device company employees in and out of FDA employment – now become little more than a pawn for medical device and drug makers. Medical device companies making billions of dollars on dubious devices – like overused IVC filters, over-prescribed heart stents, and dangerous metal-on-metal hip implants – use the FDA primarily as a cover. They use the agency to imply that it has verified the safety and efficacy of their medical devices, and to help them sidestep liability lawsuits.

Full FDA approval can and does help medical device makers sidestep many liability lawsuits; however, FDA approval does not verify the safety and efficacy of medical devices.

The Danger Within Us: America’s Untested, Unregulated Medical Device Industry
This is not Conspiracy Theory 101. This is the fact of the matter, and it is well documented in at least a dozen extensively-researched books. One of the latest, The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It, by Jeanne Lenzer, makes the case all over again.  Ms. Lenzer shows just how broken our medical regulatory system is.  The book should be required reading for the U.S. Supreme Court, which has ruled in some landmark cases that FDA approval grants medical device makers a free pass to harm people at will with poorly tested or even arguably worthless medical devices.

Despite the woeful state the FDA has been left in after billions of Big Pharma lobbying dollars have worked to undercut and weaken it, the U.S. Supreme Court has ludicrously ruled that FDA approval of a medical device gives its maker license to avoid legal responsibility for injuring people.

Riegel v. Medtronic:  Justice Denied by Preemption

In Riegel v. Medtronic and other miscarriages of justice, the highest court has ruled that medical device makers get a free pass when they make a device that injures or kills someone, if that device was approved by the FDA.  The ruse is called “preemption.” It adds an additional injury to people whose lives were taken entirely or perhaps only badly damaged by some dubious medical device. The preemption argument, in a nutshell, claims states can’t comply with both federal and state laws; therefore, federal laws “preempt” state’s rights.  Preemption is a Sophist argument easily refuted on both legal and ethical grounds by anyone (such as Justice Ginsburg) who believes in civil liberty, corporate responsibility, and the U.S. Constitution. But all is not lost, yet.

Medical devices which have not gone through the FDA’s full PMA approval process are still fair game for liability lawsuits. That is at least the case for now, though several bills written by medical device and drug company lobbyists are currently being pushed by Big Pharma’s lackeys in congress. The obvious goal for the Western medical “industry” is to remove all vestiges of remaining protections for people injured by dangerous drugs and medical devices. Unfettered profits with zero accountability has always been the goal of every corporation, of course, but in the case of the healthcare “industry,” that goal strikes one as especially unmoored from any basic semblance of human decency.

Related: 21st Century Cures Act a Disguised Handout to Drug Companies

The FDA 510(k) Clearance Process
But even in today’s wild west of a healthcare system broken both legally and morally, medical device makers can sometimes still be made to face some legal liability. Medical device makers can still sometimes be held accountable if, rather than gaining full FDA approval for the device in question, it was allowed on the market via the FDA’s 510(k) clearance process. The 510(k) clearance process has so lowered the bar to the open market that even the corporate-friendly judges of the high court have been forced to see that it does not even imply that the FDA has researched the product sufficiently to ensure its safety or effectiveness.

IVC Filter Lawsuits

Because IVC filters were allowed on the market via the FDA’s 510(k) clearance process, IVC filter makers like Cook Medical , C.R. Bard, Cordis, and Rex Medical can still be held accountable when their filters fail to perform as advertised.

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