Bill Clinton On The Opioid Crisis “Nobody Gets Out For Free”

“FORMER PRESIDENT BILL CLINTON SPEAKS TO THE OPIATE CRISIS ISSUES”

By Mark A. York (April 18, 2018)

 

Former President Bill Clinton Speaks On The Opioid Crisis

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Former President Bill Clinton pulled no punches as he focused directly and commented on how the opioid epidemic “creeps into every nook and cranny of our country” and needs to be addressed as both a huge national problem and a community-by-community tragedy, adding “this can rob our country of the future.”

President Clinton was the keynote speaker at the National Rx Drug Abuse & Heroin Summit, which drew more than 3,000 experts in fields such as addiction treatment, law enforcement and medicine from across the country recently in Atlanta. He shared his own personal experiences as well as voicing his opinions on opioid solutions and strategies that work and the many challenges facing the country in the future.

He was very clear when stating that there’s no room for stigma in the face of such an urgent and widespread problem. Nearly every family is touched by the issue — including his. Not only does he have family members who have struggled with drug abuse, he said at least five close friends have lost children and family members to overdoses, including two native Arkansans, first-generation immigrants from India and Kosovo and African-American preachers. This is the common thread in the opioid crisis fabric, there is no social or demographic group that is exempt from the epidemic.

“Nobody gets out of this for free,” which seems to be where most of the finger pointing and blame game issue of the highest importance. The checkbook to pull the country out of this national opiate epidemic will be in the hundreds of billions of dollars and even then, the costs of social and economic damage to date, will never be recovered.

From 2000 to 2016, government research data shows that more than 600,000 people died from drug overdoses — nearly 64,000 in 2016 alone. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

The former president referred to the work done by his Clinton Foundation, who’ve provided both training and resources to communities fighting addiction and makes the opioid antidote naloxone more available to the public at a low cost.

He discussed programs elsewhere that he believes work well, including a unique medical system in eastern Pennsylvania where no doctors prescribe opioids. When a patient comes in who may legitimately need the painkillers, a panel headed by a highly educated pharmacist looks at that option as well as other alternatives. The panel does all the opioid prescribing, he said, and opioid prescriptions have dropped dramatically.

Clinton praised community health centers, local county health units and faith based community groups who are spearheading efforts in in caring for people struggling with addiction. He said grass roots solutions often work best because each place is different, and its residents know it best.

He also added the United States as a whole faces many challenges, including the rise of the deadly synthetic opioid fentanyl, which is making its way “into the bloodstream of America” from China. He said the United States “ought to get the Chinese to help us” and must also do more to stop the heroin flowing in from Mexico. Many others in government have directed attention to the Chinese government for help, but to date, there has been very limited assistance from China on this.

He further stated that the country must do more to reduce demand for drugs. And that will mean addressing issues at the root of addiction, such as hopelessness and poverty. Many overdose victims, he said, are ultimately “dying of a broken heart.” How treatment programs can be more widely accepted as well as becoming approved as a disease treatment versus a “drug addict” problem, remains to be seen.

“The roots of this are deep in our soul,” Clinton said. “You know it and I know it.”

During the Clinton years in office, he enacted various drug control programs and strategies which primarily focused on drug abuse prevention, drug use education, drug treatment and enforcement. Clinton White House archives, show he elevated the position of “drug czar” to a cabinet-level post, expanded drug courts, provided funding across the country and stepped up drug-related enforcement efforts. To support these programs and efforts, overall funding for anti-drug efforts rose from $12.2 billion in 1993 to $18.5 billion in 2000.

Although there were critics the time, many were determined to be politically motivated and more of a rhetorical attack on Bill Clinton politics as a whole. These included the 1994 report by the conservative Heritage Foundation titled, “How the Clinton Administration is Abandoning the War Against Drugs,” which falsely claimed Clinton’s “new direction will allow more cocaine, heroin and marijuana to reach American streets, and it will cut federal enforcement personnel.” Which simply furthered the now misguided correlation between marijuana use and hard drugs. The group also said one of the first announced goals of then-Attorney General Janet Reno was to reduce mandatory minimum sentences for drug trafficking and other related crimes, sentences the group argued “put teeth in drug enforcement.” This has been proven to be inaccurate and a distortion of the attempts to bring crime and punishment more in line with the times and how criminal sentencing were applied in lower economic areas of the country.

Clinton said today’s fight against drugs must be a bipartisan effort that pulls together Americans from all parts of the political spectrum. Although this would be a sincere effort to bring political parties together to address a problem that is now firmly implanted across the United States.

 “We can do this. And it will be really good for us, because it’s about time we did something together again,” he said. “Last time I checked, anytime we did anything together, we never lost.”  Mr. Clinton’s stance on a joint effort to address the opioid crisis seems genuine, but based on the many views within the current DC political world, beginning with President Trump and his view that the problem is drug users versus taking a step back view that society itself along with Big Pharma are accountable for the current opiate epidemic.

What the solutions are for solving the Opioid Crisis across the country remain to be seen and as stated by President Clinton “nobody gets out for free.”

Read More

$35 Million In Punitives Added To Bard TVM Trial Verdict in NJ Court

“TOTAL VERDICT OF $68 MILLION IN SYNTHETIC SURGICAL MESH TRIAL”

Mark A. York (April 18, 2018)

SYNTHETIC MESH COMPANIES FACING THOUSAND OF LAWSUITS

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) C.R. Bard, Inc. was ordered to pay an additional $35 million in punitive damages, added to the $33 million the jury initially award for a total of verdict of $68 million in the first Transvaginal Mesh trial for Bard in New Jersey state court. Plaintiff Mary McGinnis was successful in her claims that Bard’s synthetic vaginal mesh implants are defective, asserting that Bard defectively designed the product, ignored warnings and related FDA notices about the numerous adverse events related to their synthetic surgical mesh products.

Bard, a subsidiary of global medical supplier Becton-Dickinson of Franklin Lakes, says it will appeal the verdict. In a statement, the company said McGinnis knew of the inherent risks in having the vaginal implants. This case docket can be found under Mary McGinnis and Thomas Walsh McGinnis v. C.R. Bard Inc., et al., case number BER-L-17543-14, Bergen County Superior Court, Judge James DeLuca.

The punitive damage award was added after the initial $33 million verdict was returned and the judge set a hearing to address the punitive damages award. The jury decided that there were grounds to award plaintiff Mary McGinnis and her husband the large verdict based on trial testimony and evidence that Bard was aware of the mesh product dangers and chose to ignore the thousands of adverse events reported related to post-surgery complications claimed by women across the country.

The Bard synthetic mesh products are designed to provide pelvic support for any number of medical issues primarily affecting women, with synthetic mesh recognized as often causing major medical complications and leaving patients in permanent pain. The jury held the company liable for two products that McGinnis had implanted in March of 2009: an Avaulta Solo mesh, and an Align Transobturator and Bard was forced to concede that both products have been taken off the market.

The verdict comes as Murray Hill, New Jersey-based Bard is pushing to a flood of litigation its surgical mesh implants , which have been criticized by women for damaging internal and often affecting or stopping normal sex lives. Bard has settled more than 13,000 cases since 2014, and as of September 2017, the company still faced more than 3,000 suits over allegedly defective synthetic mesh devices still in litigation. Those cases are part of the Bard-TVM-Litigation-MDL-2187 Briefcase, in front of Judge Goodwin, US District Court of West Virginia.  While Bard still faces another 150 lawsuits in New Jersey state court, which previously had been perceived as a favorable home court legal venue by the company.

McGinnis alleged Bard’s Avaulta and Align implants shrank after being implanted, causing nerve damage and leaving her unable to engage in sexual activity and that she was forced to undergo four surgeries in attempts to remove all the mesh from her body.

Bard took the Avaulta implants off the market in 2012 and did the same with the Align inserts in 2016. The company chose to remove the products the day after the U.S. Food and Drug Administration in 2010 ordered Bard and other mesh-manufacturers, including Johnson & Johnson (Ethicon), Boston Scientific and Endo (American Medical S), to review their mesh products, which also resulted in J&J removing four lines of synthetic surgical mesh products from the market.J&J’s Ethicon subsidiary is facing more than 50 thousand lawsuits regarding its synthetic mesh device in Ethicon (J&J) Pelvic Mesh TVM Litigation MDL-2327.

The Ethicon MDL is in the same West Virginia federal court as the Bard and other mesh manufacturer multidistrict litigation, which are all being heard by Judge Goodwin.  Judge Goodwin has previously expressed his frustration with the parties not engaging in substantive settlements discussions to resolve the thousands of cases, the one option he has is to begin remanding cases back for trial in court venues around the country, possibly forcing both sides to begin earnest settlement talks. Goodwin has held hearings with leadership attorneys from both sides appearing before the court to possibly kickstart settlements. He has gone so far as to warn mesh manufacturers that if they do not settle, U.S. juries appear poised to inflict hundreds of millions, or even billions, of dollars in compensatory and punitive damages on them in thousands of cases that would overload the federal judicial system for years to come.

Bard has been accused in many lawsuits of using a form of polypropylene mesh in the devices, that their mesh supplier and manufacturer had warned wasn’t suitable for human implantation. Bard officials countered that the mesh was a safe substance from which to make the inserts, ignoring the safety sheet warning issued by the polypropylene mesh product maker.

Last year, C.R. Bard was acquired by medical-device company Becton, Dickinson & Co. $24 billion, combining two of the world’s biggest health-care suppliers.  How the thousands of remaining mesh lawsuits affect the company business model and potentially moves them towards serious settlement discussions remains to be seen.

This case can be found at: Mary McGinnis v. C.R. Bard, Inc., Docket No.: BERL1754314, Bergen County, New Jersey Superior Court (Hackensack).

 

Read More

ETHICON, INC. AND J&J FACING THOUSANDS OF TVM AND HERNIA MESH LAWSUITS: WILL THEY SETTLE SOONER OR LATER?

“New Jersey State Court Opens Ethicon Hernia Mesh Consolidation”

Mark A. York (April 17, 2018)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Ethicon’s Pelvic Repair System litigation also known as Transvaginal Mesh (TVM) litigation, (see Mass Tort Nexus Ethicon TVM MDL 2327 Briefcase) and the more recent hernia mesh legal filings, are the latest in a series of ongoing legal battles facing Johnson & Johnson and its Ethicon subsidiary. Ethicon is facing over 50,000 mesh lawsuits in state and federal courts across the country where plaintiffs have filed suits over their synthetic mesh surgical implants. The numbers are increasing daily as the TVM plaintiffs are being joined by plaintiffs filing “hernia mesh” lawsuits, where the allegations are very similar to claims asserting that J&J’s failed to warn and choosing to ignore the thousands of FDA filed adverse events related to its hernia mesh products.

EMERGING NEW JERSEY STATE COURT ETHICON MESH CONSOLIDATION

Ethicon now faces a home state hernia mesh legal battle as the New Jersey Supreme Court posted the Application for Multicounty Litigation (MCL) status on April 11, 2018 regarding the emerging Ethicon/J&J multi-layered hernia mesh products litigation pending in New Jersey state courts. The filing requests the Ethicon hernia mesh cases be consolidated in Bergen County in front of Judge Rachell Harz, over litigation related to Ethicon’s Proceed, Physiomesh and Prolene synthetic hernia mesh products. For information regarding the New Jersey Ethicon Hernia Mesh Litigation see Mass Tort Nexus Briefcase Re: Ethicon Hernia Mesh New Jersey State Court Consolidation, adding another docket of mesh cases to the ever growing J&J/Ethicon defense of its synthetic surgical mesh products.

Ethicon TVM litigation has been underway for close to six years in MDL 2327, (MDL No. 2327 | In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation court link) currently pending in the U.S. District Court in West Virginia, where U.S. District Judge Joseph Goodwin is also overseeing seven other  multidistrict litigations (MDLs) established for cases against different manufacturers. When you add in other synthetic mesh manufacturer lawsuits besides J&J, there are more than 100,000 mesh lawsuits pending against Ethicon and other manufacturers, including Boston Scientific, C.R. Bard, American Medical Systems (AMS) acquired by Endo, Coloplast, Cook Medical, Neomedic and others.

Judge Goodwin has previously expressed his frustration with the parties not engaging in substantive settlements discussions to resolve the thousands of cases, the one option he has is to begin remanding cases back for trial in court venues around the country, possibly forcing both sides to begin earnest settlement talks. Goodwin has held hearings with leadership attorneys from both sides appearing before the court to possibly kickstart settlements He has gone so far as to warn mesh manufacturers that if they do not settle, U.S. juries appear poised to inflict hundreds of millions, or even billions, of dollars in compensatory and punitive damages on them in thousands of cases that would overload the federal judicial system for years to come.

Only American Medical Systems, Inc has resolved substantially all of their claims over their mesh products, agreeing to pay about $1.6 billion to resolve more than 20,000 claims.

PRIOR MESH SETTLEMENTS

While manufacturers have had some success in defending the safety of the products in a handful of cases, most of the claims that have gone before a jury so far have resulted in substantial damage awards, suggesting that TVM settlements will likely cost the companies several billion dollars.  There have been settlements by some mesh makers including End International, Inc. on behalf of American Medical Systems, Inc, where Endo agreed to pay $775 million in August 2017 to resolve the remaining cases, where there had been over 22,000 lawsuits filed over its vaginal mesh implants. They had previously agreed to a $400 million settlement of more than 10,000 mesh lawsuits (~$48,000 per case) in October 2014. This has been part of Endo’s decision to exit “substantially all” the remaining lawsuits against its AMS unit, with the $400 million being in addition to $1.2 billion previously pledged by Endo to cover mesh litigation. Including its $830 million settlement to resolve thousands of mesh lawsuits (~40,000 per case) in May 2014. That settlement came a day after the FDA said transvaginal mesh should be reclassified as a high-risk medical device and subject to stronger regulatory scrutiny.

ETHICON TRIAL VERDICTS

Although Ethicon attempts to defer blame and causation for the often life altering medical conditions that occur post mesh implant surgery, they are often found liable at trial with verdicts being anywhere from $1.5 million to more than $100 million and often include major punitive damages. The punitive damages, which are designed to punish Ethicon for conducting its business with malice towards women who were implanted with the products, finding that the company knew that the synthetic mesh products caused severe complications, but failed to warn the medical community.

With Ethicon (Johnson & Johnson) facing more vaginal mesh lawsuits than any other manufacturer. Here are trial verdicts from lawsuits that have resulted in major losses for Ethicon/J&J again and again:

  • In March 2018, a jury in Indiana awarded $35 millionto Barbara and Anton Kaiser. They’d sued Ethicon (a subsidiary of Johnson & Johnson) after Barbara Kaiser’s Prolift mesh allegedly caused her pelvic pain. They awarded her $10 million in damages and hit Ethicon with $25 million in punitive damages.
  • In December 2017, a Bergen County, NJ jury awarded$15 million to Elizabeth Hrymoc. Ms. Hrymoc said she received a defective Prolift mesh implant in 2008, which left her in such pain that she had to have it removed and replaced. She cried as the jury announced their verdict.
  • In September 2017, a Philadelphia jury awarded $57.1 millionto Ella Ebaugh, who says she suffered chronic pain and incontinence because of two Ethicon pelvic mesh implants that eroded into her urethra. Ms. Ebaugh says she required three surgeries to remove the mesh. Ethicon vowed to appeal.
  • In April 2017, a Philadelphia jury awarded $20 millionto a woman who claimed she was in constant pain because of her TVT-Secur transvaginal mesh, a product of Johnson & Johnson subsidiary Ethicon. A spokesperson for Ethicon said the company would appeal the decision, but it was the fifth major loss over the mesh products since 2014.
  • $13.5 million verdict awarded to Sharon Carlino of New Jersey in February 2016. According to the lawsuit, Carlino received Ethicon’s transvaginal tape (TVT) for stress urinary incontinence and it left her with constant pain and discomfort. Two surgical attempts to fix the device did not rid her of pain. $10 million of the verdict came in the form of punitive damages. The jury said that Carlino’s doctor would not have used the Ethicon mesh had the device risks been known.
  • $4.4 million jury award to Florida resident Tessa Taylor in February 2016. The jury found that ObTape sling (made by J&J subsidiary Mentor) caused Taylor’s back pain, bladder pain, and difficulty urinating over a 7 year period. Taylor received the mesh to treat urinary incontinence, but she was re-diagnosed with the condition in spite of the device. $4 million of the verdict was for punitive damages to “discourage others from behaving in a similar way.”
  • J&J agreed to pay $120 million to settle 2,000-3,000 mesh lawsuitsin January 2016. The settlement marked the first serious attempt by J&J to settle a significant number of mesh lawsuits. A regulatory filing at the time showed that J&J still faced more than 42,000 mesh cases.
  • $12.5 millionverdict awarded to Indiana resident Patricia Hammons, including $7 million in punitive damages. Hammons was implanted with Ethicon’s Prolift device, which she says caused severe pain, sexual difficulties, and incontinence–even after corrective surgery.
  • $5 millionsettlement reached in September with plaintiff Pamela Wicker, implanted with Ethicon’s Prolift mesh device. Wicker claims that Prolift eroded inside of her and necessitated numerous surgeries to remove the device. A law professor said that the large settlement showed the costs of dealing with mesh litigation would be a lot higher than expected.
  • $5.7 millionverdict awarded to Coleen Perry in March 2015 by a California jury. Perry was implanted with the J&J/Ethicon TVT Abbrevo and says she expects to have pain the rest of her life. The jury found that the TVT Abbrevo has design problems and that Ethicon failed to warn about potential health risks. The verdict included $5 million in punitive damages for conduct that amounted to “malice.”
  • Two confidential settlementsinvolving 115 mesh victims were reached in January 2015. One of the settlements resolved 4 cases in Missouri over Ethicon’s Prolift mesh device and the other resolved 111 cases in Georgia over the ObTape Transobturator Sling (made by J&J subsidiary Mentor). The Missouri women claimed that the mesh in Ethicon’s Prolift insert shrinks and damages organs, causing constant pain and making sexual intercourse difficult, while the Georgia women alleged that ObTape causes permanent injuries.
  • $3.25 millionverdict awarded to plaintiff Jo Husky over the J&J/Ethicon Gynecare TVT-O mesh device. The verdict was reached by a West Virginia jury in September 2014 following a two-week trial. Jurors found that the TVT-O was faulty and that Ethicon failed to warn of side effects.
  • $1.2 millionverdict awarded to Linda Batiste, implanted with the Gynecare TVT Obturator (TVT-O) mesh sling (made by J&J unit Ethicon) in April 2013. The jury concluded that the device’s design was flawed.
  • $11.1 millionverdict (including $3.35 million in compensation and $7.76 million in punitive damages) awarded to Linda Gross of South Dakota, who was implanted with J&J’s Gynecare Prolift vaginal mesh device. A New Jersey jury reached the verdict in February 2013, saying that J&J fraudulently misled Gross about device risks.

ETHICON MESH LITIGATION

Judge Goodwin is overseeing coordinated pretrial proceedings for all federal vaginal mesh lawsuits, as the cases involve nearly identical allegations that the products used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women are defectively designed and can cause severe and deforming complications, including infections, puncturing organs and eroding through the vagina.

The MDLs were established for cases against each manufacturer to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and serve the convenience of the parties, witnesses and the courts. However, as hundreds of cases become “trial ready”, and manufacturers continue to make little progress in settling claims, Judge Goodwin faces the prospect of remanding large numbers of lawsuits back to U.S. District courts nationwide for individual trials, which could take decades to complete.

Plaintiff complaints against Ethicon all consistently assert that Ethicon was and is aware of the dangers posed by their synthetic mesh products, and choose to ignore the thousands of adverse event reports filed with the FDA as well as the fact that more than 50,000 plaintiffs have filed lawsuits over Ethicon synthetic mesh implants. The legal claims assert injuries due to the defective design of the most every synthetic mesh product made by Ethicon regarding its vaginal mesh, including mesh erosion, mesh contraction, inflammation, pain during sexual intercourse, urinary incontinence, chronic pain, and recurring prolapse of organs.

As a result of the post surgical complications, plaintiffs have been known to undergo as many as four operations to have the mesh removed, often resulting in massive levels of pain as well as financial impact of repeated surgeries and rehabilitation.  There are many instances where the the surgeons were unable to remove all the mesh due to the mesh adhesion to internal organs and surfaces within the body that were never intended as a post surgical complication.

While the outcome of the MDL cases and other trials are not binding on other cases in the vaginal mesh litigation, Ethicon and its parent Johnson & Johnson should gauge how juries have responded to certain evidence and testimony via recent major trial verdicts in most every mesh trial they’ve faced in both federal and state courts. How Ethicon counsel views the recent trial verdicts and the impact on the thousands of other cases they face, and the potential for the trial results to be repeated throughout these cases, would seem to have an impact on J&J’s views of starting substantive settlement negotiations. To date, this has not been a significant part of the Johnson & Johnson legal business strategy, potentially resulting in an ongoing windfall for the thousands of plaintiffs for years to come.

 

Read More

Bard Loses $33 Million In Pelvic Repair Mesh Trial In New Jersey State Court: Punitive Damage Hearings Today

“New Jersey State Courts Not Legal Safe Haven Lately For Companies HQ’d There”

By Mark A. York (April 13, 2018)

C.R. Bard Avaulta Synthetic Surgical Mesh

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) In another win for plaintiffs, a jury in Bergen County, New Jersey awarded plaintiff Mary McGinnis $23 million and her husband Thomas, an additional $10 million in actual damages, with a hearing taking place today on how much in punitive damages will be be added. This $33 million verdict in New Jersey state court, where defendant C.R. Bard is headquartered, closely follows the $117 million verdict of last week against another New Jersey company, Johnson & Johnson in a baby powder trial.  This was the first C. R. Bard case to go to trial in the Bard consolidated New Jersey state court docket, where Bard is facing hundreds of additional lawsuits over its defective pelvic mesh implants, also known as Transvaginal Mesh or TVM.

The jury directed the company to pay the $33 million in compensatory damages over claims the business knew its pelvic mesh products were unsafe and failed to warn doctors about potential risks related to devices that caused a woman debilitating pain and related inability to enjoy life as she did prior to the surgical implant of the synthetic mesh device.  Bard and others makers of both TVM and hernia mesh products are under highly increased scrutiny and being hot with major trial verdicts over claims they ignored the dangers of implanting synthetic mesh products, primarily made from polypropylene, the same product most fishing line is made from, into the human body. This case docket can be found under- Mary McGinnis and Thomas Walsh McGinnis v. C.R. Bard Inc., et al., case number BER-L-17543-14, Bergen County Superior Court, Judge James DeLuca.

The jury took less than a day to decide on the verdict following the four-week trial, after finding that Bard was responsible for a defective design of the Avaulta mesh product and failure to warn doctors or consumers of the defective design. . Of note is that Bard had removed the Avaulta mesh line from the market by 2016.

The jury found that Bard’s Avaulta and Align synthetic mesh products, which were  implanted to treat McGinnis’s bladder prolapse and stress urinary incontinence were defectively designed and caused incapacitating injuries as well as impacting her relationship with her husband. Bard claimed repeatedly that they tested Avaulta extensively as well as their other mesh products, and Mrs. McGinnis’ unrelated medical conditions caused her injuries

Hearings over punitive damages and how much they should be are scheduled to start this morning. Bard is probably keeping in mind the $80 million in punitive damages awarded last week in a similar state court punitive damages hearing in the J&J talcum powder cancer trial in New Brunswick, which is less than 50 miles from the Bergen County court.

Bard has historically been hit with ongoing verdicts over its synthetic mesh line of products in trial across the country, as far back as 2012 where a previous Avaulta mesh trial in California state court ended in a $5.5 million verdict and in a 2013 West Virginia federal court trial, a verdict was returned for  $2 million verdict against Bard and its Avaulta mesh.

TVM MESH IS SUBJECT TO MAJOR LITIGATION

Surgical Mesh Makers Facing Litigation

 

 

 

 

 

 

 

Major litigation against CR. Bard/Davol, Ethicon (J&J), Boston Scientific and other surgical mesh manufacturers has been ongoing for few years in both federal and state courts and will continue into the foreseeable future, based on the hundreds of thousands of synthetic mesh implants used in surgical procedures in the United States over the last 15 years.

Bard has been known to settle mesh cases, in the Wise v. Bard, bellwether case selection, that was set for trial back on February 18, 2015, settled a week before the trail start date for a confidential amount. The Wise lawsuit was part of the Bard MDL 2187, see Bard-TVM-Litigation-MDL-2187 Briefcase, where thousands of lawsuits are still pending against C.R. Bard, additionally there are other MDL’s where every other synthetic surgical mesh manufacturer in the US marketplace is facing more than 50 thousand lawsuits over their synthetic mesh surgical products.” See Ethicon (J&J) Pelvic Mesh Litigation MDL-2327-TVM Briefcase.

OTHER TVM MESH VERDICTS

 There were $26.7 million and $18.5 million mesh verdicts against Boston Scientific see  Boston-Scientific-TVM-Litigation-MDL-2362 Briefcase, in two transvaginal mesh MDL trials. On November 13, 2014, a Miami, Florida jury awarded $26.7 million to four women implanted with Boston Scientific’s Pinnacle mesh devices. On November 20, 2014,  a Charleston, West Virginia jury awarded $18.5 million to four women implanted with Boston Scientific’s Obtryx mid-urethral slings. The Obtryx verdict included $4 million in punitive damages, with $1 million awarded to each plaintiff.

The women in the Florida Pinnacle trial were each awarded between $6.5 million and $6.7 million. Boston Scientific’s Pinnacle mesh devices were implanted during pelvic organ prolapse surgeries and are no longer on the market. The individual awards for the women in the Pinnacle mesh trial include:

Transvaginal Mesh Adverse Events

Transvaginal mesh and vaginal sling products have been linked to thousands of reported serious, life-threatening side effects or adverse events from seven surgical mesh manufacturers. The complications are associated with surgical mesh devices used to repair Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The mesh devices are typically placed transvaginally for minimally invasive placement.

Complications and Adverse Events Include:

  • erosion through the vaginal tissue
  • mesh contraction
  • mesh extrusion
  • inflammation
  • fistula
  • infection and abscess
  • pain
  • blood loss
  • chronic and acute nerve damage
  • pudendal nerve damage
  • pelvic floor damage
  • scar tissue
  • chronic pelvic pain
  • urinary problems and/or incontinence
  • recurrence of prolapse
  • bowel, bladder, and blood vessel perforation
  • dyspareunia or pain during sexual intercourse

Treatment of the complications includes additional surgical procedures to revise or remove the mesh, blood transfusions, drainage of hematomas, drainage of abscesses from infection, IV medication, pain injections, botox injections, physical therapy, among other treatments to alleviate the complications.

In July 1, 2012, Bard stopped selling the Avaulta Meshin the United States because the FDA required additional clinical trials and testing.

On June 4, 2012: Johnson and Johnson/Ethicon withdrewfour mesh products from the US Market, including its controversialGynecare Prolift, Prolift+ M, TVT Secur and Prosima systems.

History of Warnings

Surgical mesh is a metallic or polymeric screen surgically implanted to reinforce and support weakened soft tissue or bone. On the market since the 1950s for use in abdominal hernias, gynecologists in the 1970s began using surgical mesh to reinforce vaginal tissue to treat pelvic organ prolapse. In the 1990s, surgeons began using surgical mesh to treat stress urinary incontinence in women.

Transvaginal mesh was approved for sale through the 510(k) process simply by comparing it to the kind of mesh used to treat abdominal hernias. Most transvaginal mesh products on the market today are based on Boston Scientific Corp.’s ProteGen mesh, which the FDA approved in 1996 as the first surgical mesh to treat stress urinary incontinence. Two years later, the FDA approved Johnson & Johnson’s Gynecare TVT mesh through the 510(k) process after the company claimed the mesh was substantially equivalent to ProteGen.

However, in October, 1999, the FDA recalled Boston Scientific’s ProteGen sling due to the large number of complications experienced by women, including erosion of the vaginal tissues. The complete irony is that a majority of the transvaginal mesh are based upon this recalled defective device.

On October 20, 2008, the U.S. Food & Drug Administration (FDA) issued an urgent public health notification to physicians and patients regarding serious complications associated with transvaginal placement of surgical mesh in repair of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).

On May 16, 2011, the New England Journal of Medicine (NEJM) Study on Transvaginal Mesh Complications confirmed that the use of surgical mesh to treat pelvic organ prolapse carries the risk of serious side effects including bladder perforation and pelvic hemorrhaging.

On July 13, 2011, FDA issued an updated safety communication warning that surgical placement of transvaginal mesh to repair POP may expose patients to a greater risk of side effects than other treatment options. In addition to the increased risk of side effects, the FDA stated that vaginal mesh offers no greater clinical value or improved quality of lifeover other surgical methods.

On August 25, 2011, Public Citizen called on FDA to recall the vaginal mesh in response to a high number of reports linking vaginal mesh products to erosion, pain, bleeding and urinary incontinence.

Transvaginal Mesh Products & Manufacturers

Ethicon

  • Secure
  • Prolift
  • Prolift +M
  • Gynemesh/Gynemesh PS
  • Prosima
  • TVT
  • TVT-Obturator (TVT-O)
  • TVT-SECUR (TVT-S)
  • TVT-Exact
  • TVT-Abbrevo
  1. R. Bard
  • Align
  • Avaulta Plus™ BioSynthetic Support System
  • Avaulta Solo™ Synthetic Support System
  • Faslata® Allograft
  • Pelvicol® Tissue
  • PelviSoft® Biomesh
  • Pelvitex™ Polypropylene Mesh
  • PelviLace
  • InnerLace
  • Uretex

American Medical Systems 

  • SPARC®
  • Mini-Arc
  • Apogee
  • Elevate
  • Monarc
  • In-Fast
  • BioArc

Boston Scientific

  • Obtryx® Curved Single
  • Obtryx® Mesh Sling
  • Obtryx Transobturator Mid-Urethral Sling System
  • Prefyx Mid U™ Mesh Sling System
  • Prefyx PPS™ System
  • Uphold Vaginal Support System
  • Pinnacle Pelvic Floor Repair Kit
  • Advantage Transvaginal Mid-Urethral Sling System
  • Advantage Fit System
  • Solyx SIS System

Coloplast

  • T-Sling-Universal Polypropylene Sling

Read More

Update: Last Weeks J&J $37 Million Talcum Powder Mesothelioma Verdict—Add $80 Million In Punitive Damages

J&J TALCUM POWDER CAUSES MESOTHELIOMA – WHO KNEW AND WHEN?

By Mark A. York (April 12, 2018)

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) In a very loud and direct voice, Johnson & Johnson and their talc supplier, Imerys SA suffered an additional $80 million in punitive damages award on top of the initial $37 million jury verdict awarded last week. This brings the total trial verdict to $117 million they must pay to a retired New Jersey husband and wife, after a trial found that plaintiff Stephen Lanzo’s decades long use of J&J talcum powder products caused him to be afflicted with mesothelioma. A fatal form of cancer not often affiliated with use of talcum powder products.

The Middlesex County, New Jersey, jury ordered the companies to pay $80 million in punitive damages Wednesday, after post-trial arguments on punitive damages. Last week, the jury awarded the Mr. Lanzo $30 million in compensatory damages and his wife $7 million in damages.

Lanzo claims his use of Johnson & Johnson name brand products like Shower to Shower and Baby Powder for more than 30 years, and  that inhaling the powder caused his mesothelioma, an aggressive and deadly cancer that impacts the lining of the lungs. The $80 million in punitive damages in J&J’s home state of New Jersey, where traditionally they have avoided adverse trial verdicts, and enjoyed a “home team” sense of security, may now send a message J&J’s withholding of scientific data and information that shows their consumer product have dangers and the company has been aware for decades has come full circle.

Deposits of talc, one of Earth’s softest minerals are often located near deposits of the minerals that constitute asbestos, and studies have shown the risk of cross-contamination during mining. Johnson & Johnson said its talc products do not contain asbestos, which, it noted, has been a legal requirement since the 1970s.

SCIENCE SAYS TALC IS DANGEROUS

The debate over talc began decades ago. In the early 1970s, scientists discovered talc particles in ovarian tumors. In 1982, Harvard researcher Daniel Cramer reported a link between talcum powder and ovarian cancer. His study was followed by several more finding an increased risk of ovarian cancer among regular users of talcum powder. Cramer, who at one point advised J&J to put a warning on its products, has become a frequent expert witness for women suing the company. J&J ignored and suppressed Mr. Cramer’s attempts to show them the study data then publicly declared this research as flawed, which J&J still continues to this day.

As other talcum powder meso cancer cases are pending in courts across the country, with one set to go to trial in May in South Carolina, J&J and its affilaites may have to gear up to defend a flood of additional new cases if the talc-meso linked plaintiff verdicts continue,  jury in California found in favor of Johnson & Johnson in an asbestos-related case in November 2017.

Lanzo’s case was the first to go to trial in New Jersey, where of Johnson & Johnson is headquartered, with the trial taking place in a state court versus a more traditional federal venue, where J&J are more accustomed to defending their consumer, pharmaceutical and medical device product line. If all pending litigation against J&J and its affiliated divisions for their products are totaled, you will find that the number of lawsuits being defended by J&J easily surpasses 100 thousand individual lawsuits filed in federal and state courts across the country.

Johnson & Johnson and other talcum powder companies face thousands of talcum powder cancer lawsuits elsewhere that draw a connection between genital talc use and ovarian cancer, where there are been massive verdicts as high as $400 million last year in California and in a St Louis courtroom where talcum powder ovarian cancer verdicts have totaled over $300 million in the last three years.

Johnson & Johnson is facing hundreds of additional lawsuits in a federal multi-district litigation also in New Jersey, see Johnson & Johnson Talcum Powder MDL 2738 (USDC New Jersey), this litigation is related primarily to the ovarian cancer claims brought by women across the country, who claim that J&J talcum powder products cause ovarian cancer, which combined with the emerging talc mesothelioma lawsuits, would open an entire new area of mass tort litigation for J&J and its affiliates to defend.

The Lanzos’ lawyers accused the company of holding back information from its customers about the health risks of asbestos in its talc products since the 1960s. This has bene a key plaintiff legal strategy in most every case against J&J, as they have been found to have made concerted and boardroom facilitated efforts to suppress and change public opinion about their product dangers.

Efforts to conceal this fact included J&J’s paying respected medical, science and other respected researchers to write and publish article and research papers mitigation the adverse findings posted in independent journals alleging that asbestos was found in talc products. Trial testimony also showed that J&J had made multiple and unsuccessful attempts to remove asbestos from their talc products, dating back to the 1970’s, yet at trial they claimed there was no asbestos risk in their talcum powder products. With one defining trial comment being “Why do you try so hard to get it out, it’s because it is there,” which would seem to define plaintiff claims that J&J was aware of the risks long ago.

Johnson & Johnson argued that it did extensive testing to make sure its products were not contaminated. The science J&J relies on has been the subject of research since at least 1975 and many times the findings were found to be adverse to the consumer product giants sales and marketing agenda, and were often discredited by an organized corporate strategy.

“Johnson’s Baby Powder has been used for more than 120 years and it does not contain asbestos or cause mesothelioma,” the company offered. “After suffering multiple losses through court rulings and at trial, plaintiff’s attorneys have shifted their strategy and are now alleging that talcum powder is contaminated with asbestos, despite multiple independent, non-litigation-driven scientific evaluations which have found that our baby powder does not contain asbestos.

“Throughout this trial, we were prevented from presenting evidence we believe would have been important to the jury in their deliberations, which forced us to file multiple mistrial motions. We will continue to defend the safety of Johnson’s Baby Powder and immediately begin our appeal, and we believe that once the full evidence is reviewed, this decision will be reversed.”

The Lanzo trial started on January 29, 2018 and was closely watched as the first “talc” lawsuit to go to trial in Johnson & Johnson’s home state over allegations that talcum-based hygiene products like Baby Powder and Shower to Shower contained asbestos and that J&J failed to warn of the risk as well as hid data that showed asbestos was in its products. The asbestos allegations are now an evolving legal fight for J&J, as most prior litigation over its Baby Powder and Shower to Shower products were over claims that the products have caused ovarian cancer in women. Those 5 cases case have been in the Missouri and California state courts over the last 2 years, with plaintiffs winning all but 1 of those trials, see J&J Talcum Powder Litigation, Missouri State Court, St Louis County Docket.

J&J DID WIN 1ST CALIFORNIA MESO TRIAL

Of note is the California court trial verdict of November 16th where J&J did win a victory in the first mesothelioma trial; where J&J and co-defendant Imerys Talc America successfully defended claims by plaintiff Tina Herford that J&J’s Baby Powder caused

Suppressing adverse research findings and manipulating science related to discoveries that Johnson & Johnson products pose significant health risks are cornerstones of most litigation against J&J and its various medical products divisions, often resulting in much higher verdicts based on the intentional failure to warn and failure to disclose the dangers to consumers. Often the trial data shows that J&J has been aware of many dangers as far back as the middle 1970’s, and yet they went to extraordinary lengths to suppress this information from being released to the marketplace and consumers.

J&J was defended by the Chicago firm of Kirkland & Ellis LLP a highly respected and very aggressive defense firm, who are rather new to the J&J world of medical device litigation and were unsuccessful. They argued that any link between talc products and mesothelioma is based on the tried and sometimes untrue defense of faulty testing methods, and plaintiff claims of limited and outdated studies, defense counsel even went so far as to state that Lanzo was exposed to asbestos in his childhood home and at school.

Defense claimed that J&J’s products never contained asbestos, and that they have performed careful testing to confirm that, which based on the jury verdict fell on deaf ears.

WHO’S LIABLE IF MESO-TALC LITIGATION EXPLODES

While the ovarian cancer cases have dominated the headlines, the cosmetic talc asbestos contamination cases may present the bigger risk to defendants and a much greater reward to plaintiff counsel. Thousands of companies used cosmetic talc in their products over the last hundred years. The entire population could claim exposure, especially to defendants that sold personal care products that could be ingested, inhaled or exposed via air-borne contact. The risk is that the cosmetic talc defendants become the defendant of last resort when a plaintiff has no other convincing credible sources of exposure to asbestos, especially when the original product source is now a bankrupt entity.

Science of Cosmetic Talc Claims: While it may be difficult to challenge long-established trigger approaches if a talc claim involves a claim of asbestos contamination, ovarian cancer talc claims may require a new look at trigger issues because the underlying science of how talc exposure may cause ovarian cancer is different from how asbestos inhalation damages the respiratory system. Having learned from previous trigger battles in asbestos, the insurers are likely to challenge the science that the first exposure to cosmetic talc causes injury that can be associated with the development of ovarian cancer and characterized as “bodily injury” as required in their policies. They may seek out scientific opinion that ovarian cancer caused by cosmetic talc is not progressive in nature, and thus not warranting the imposition of a continuous trigger. And, generally, the insurers will likely seek to limit the spread of potentially triggered policies to as few years as possible, and as close to the manifestation of the disease as possible.

DOES J&J TALCUM POWDER CAUSE CANCER?

Johnson & Johnson has been ordered to pay nearly $1 billion in total damages after just 5 trials, alleging its baby powder is causing ovarian cancer, all jury verdicts have been in state courts in Missouri and California, see J&J Talc Trials St. Louis Missouri.

Talc, a mineral composed of magnesium, silicon, oxygen and hydrogen, is used extensively in cosmetics and personal care products. Women sometimes use talcum powder on their genital areas, sanitary napkins or diaphragms to absorb moisture and odor – contrary to the guidance of most physicians. (Asbestos, linked to lung cancer, was once an impurity in talc, but it has been banned for several decades.)  J&J is notorious for using any means possible to influence scientific data and opinion as well as manipulating research reports and public media commentary by industry experts. The recent California trial showed payments made to previously perceived impartial Science Council members, who were declaring publicly that J&J talcum powder does not pose a cancer risk, the Los Angeles jury did not agree with J&J and other pro-talc defense team members, as over $300 million of the total $417 million judgment was for punitive damages, usually awarded for intentional misconduct, see “New Evidence of Johnson & Johnson Bad Conduct Moved LA Jury to Award $417 Million Talc Verdict”.

His studies and the many others that have found a relationship used a case-control approach. A group of women diagnosed with ovarian cancer and a group without it were asked to recall their past diet and activities, and the results were then compared.

Critics say these kinds of studies have serious drawbacks, particularly “recall bias.” Women may forget what they did or, if diagnosed with cancer, might inadvertently overestimate their use of a suspect substance. People without a serious disease may be less motivated to remember details.

Three other studies – considered cohort studies – did not find any overall link. Unlike the case-control studies, these efforts began with a large group of women who did not have cancer and followed the progress of their health, with participants recording what they were doing in real time. The results of this approach, most scientists say, are stronger because they aren’t subject to the vagaries of memory.

One such study included more than 61,000 women followed for 12 years as part of the National Institutes of Health’s well-respected Women’s Health Initiative.

IS “MESOTHELIOMA TALC” THE NEW MASS TORT?

Two recent verdicts for asbestos contamination demonstrate the risk to cosmetic talc defendants. In October 2016, a Los Angeles County jury awarded $18M to Philip Depolian against Whittaker, Clark & Daniels finding it 30% responsible for his mesothelioma due to his alleged exposure to various cosmetic talc products used at his father’s barbershops that contained asbestos. The jury apportioned liability against various cosmetic talc defendants that had settled and several other cosmetic talc product defendants that sold products including Old Spice, Clubman, Kings Men and Mennen Shave Talc.

In 2015, another Los Angeles jury awarded Judith Winkel $13M against Colgate-Palmolive for mesothelioma allegedly caused by exposure to talc in its baby powder. The jury rejected Colgate and its experts’ claims that the cosmetic talc at issue was not contaminated by asbestos and that the talc in question were non-fibrous “cleavage fragments” unlikely to be inhaled or embedded in the lungs. Although details of the trial are not readily verified, at least one report indicated that evidence presented at trial showed that the talc contained 20% asbestos fibers.

These cases are particularly important because the defendants were held responsible for cosmetic talc containing asbestos and for having caused mesothelioma and not ovarian cancer as in the earlier J&J talc cases. Further, both juries found that the defendants acted with malice. However, the cases were confidentially settled before the respective punitive damage phases.

Will “Talc Mesothelioma” be the next mass tort against Johnson & Johnson and its affiliates? Mass Tort Nexus will continue to report on this as additional information becomes available.

The Stephen Lanzo case docket can be found under: Lanzo v. Cyprus Amex Minerals Co, et al., Docket No. L00738516 in Middlesex County Superior Court.

 

 

Read More

Second Xarelto Drug Trial Starts in Philadelphia Courtroom

Will this be a long hot summer of trials for Xarelto defense counsel?

 By Mark A. York (April 9, 2018)

 

XARELTO – a drug jointly created by Bayer and J&J subsidiaries Janssen R&D et al

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The second Xarelto bellwether drug trial over dangers related to internal bleeding linked to the anticoagulant blockbuster drug, started Friday April 6, 2018 in the Philadelphia Court of Common Pleas, in front of Judge Michael E. Erdos. This trial, where plaintiff Daniel Russell, of New Jersey claims that after being prescribed Xarelto, for Atrial Fibrillation or Afib, the drug caused massive internal bleeding and other serious medical complications. Mr. Russel’s trial follows the December 2017 verdict where a jury had awarded plaintiff Lynn Hartman $28 million for failure to warn of the dangers of Xarelto, a verdict later reversed in post trial arguments by Judge Erdos.

In opening statements by lead counsel Brian Barr of the Levin Papantonio firm,(see Russell v Bayer et al Trial Transcript Opening Statements April 6, 2018) the jury was told on Friday, that drug makers Bayer AG and Johnson & Johnson units (Janssen Pharmaceuticals, et al) failed to warn doctors about the risk the medication posed when used in combination with other drugs, which include internal bleeding, ischemic strokes and other adverse events. Offering that the companies had known that combining Xarelto with antiplatelet medications including Plavix and even aspirin, the combination would significantly increase the risk of internal bleeding, but that they ultimately opted to keep the information to themselves, and would not offer a formal FDA approved warning.

In the initial Phila bellwether trial, Lynn Hartman and her husband had filed their complaint against the drugmakers in 2015, (see XARELTO Case No. 2349 Philadelphia Court of Common Pleas briefcase) with claims very similar to Mr. Russell, resulting in the jury awarding $1.8 million in compensatory damages and $26 million in punitive damages. This verdict was seen as a high note for plaintiff counsel in the Xarelto litigation, after three prior trial losses, in the Xarelto MDL 2592 bellwether trials in Louisiana and Mississippi in 2017, which took place in federal courts.

The Phila Court Xarelto docket is the hot mass tort ticket now as Judge Fallon decided there will be no more MDL trials in front of him, and started the remand process in the Xarelto MDL 2592 cases, where he’s sending the cases back to original jurisdictions for trial.

The Lynn Hartman trial was just one of about 21,400 lawsuits against Bayer and Janssen pending in federal and state courts blaming injuries on Xarelto, and was the first case selected for trial from more than 1,400 Xarelto cases pending in the Complex Litigation docket of the Philadelphia court. Daniel Russel’s case is the second bellwether trial to go forward in the Xarelto docket, with several additional trials set to follow in the coming months.

The U.S. Food and Drug Administration approved Xarelto in 2011, to be prescribed for people with atrial fibrillation, a common heart rhythm disorder, and to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms, often after implant surgeries.

Plaintiffs in the Hartman trial as well as in thousands of other Xarelto lawsuits, alleged that the drug was unreasonably dangerous and that Janssen (J&J) and Bayer failed to warn patients about a serious risk of uncontrollable, irreversible bleeding in emergencies and were aware of adverse events for a long period of time. These allegations will be argued aggressively by defense in all forthcoming trials, as the defendants do not seem to be willing to bend on their winning trial strategy.

Bayer and Janssen have defended Xarelto’s label stating that the label adequately warns of bleeding risks. After four trials verdicts, all in their favor, defense seems to be using an effective trial strategy that has worked in venues across the country.

The three bellwether trials in the Xarelto MDL 2592, Xarelto MDL 2592 Briefcase (US District Court ED Louisiana) heard in front of Judge Eldon Fallon,  all resulted in defense wins for Bayer and Janssen, with this Philadelphia trial shifting the focus from the federal Xarelto docket to the Philadelphia court and the bellwether trials scheduled there. This trail will be closely watched by all arties, as the impact of the initial plaintiff’s trial win followed by the Judge Erdos reversal in January during post-trial hearings, was not anticipated by those on the plaintiff bench. Will the Hartman verdict reversal ruling, as well as the peripheral trial conduct issues that were also addressed post-trial by Judge Erdos have any impact on this current Russell trial and the remaining scheduled trials in the Phila Xarelto docket? That is a question that remains to be seen over the course of the upcoming trials in the Philadelphia Court of Common Pleas Xarelto docket

Mass Tort Nexus will be providing daily updates on the Russell vs. Bayer & Janssen trial.

 

 

 

 

Read More

Jury Finds Johnson & Johnson Talcum Powder Caused Mesothelioma With A $37 Million Verdict

J&J NOT FARING WELL IN 2018 TRIAL VERDICTS AS PLAINTIFFS WIN AT TRIAL AGAIN

By Mark A. York (April 6, 2018)

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Johnson & Johnson was hit again in a courtroom. This time for $37 million in New Jersey state court, where a jury found that J&J’s talcum powder based products contain asbestos and caused the male plaintiff Stephen Lanzo to develop mesothelioma, a fatal cancer. The “talc” verdict occurred late Thursday, April 5, 2018 before Judge Ana C. Viscomi, who presides over the state’s centralized asbestos docket, closely followed the March 8th trial verdict against J&J for $35 million in the J&J Ethicon Pelvic Mesh trial, which found that J&J hid the dangers of its synthetic surgical mesh products. In the Lanzo talc trial, Johnson & Johnson and its talc supplier were found to have caused the plaintiff to develop mesothelioma, after using the pharmaceutical giant’s asbestos-containing talcum powder over several decades. The case docket entry is Lanzo v. Cyprus Amex Minerals Co, et al., Docket No. L00738516 in Middlesex County Superior Court, Judge Anna C. Viscomi.

Johnson & Johnson is facing hundreds of additional lawsuits in a federal multi-district litigation also in New Jersey, see Johnson & Johnson Talcum Powder MDL 2738 (USDC New Jersey), this litigation is related primarily to the ovarian cancer claims brought by women across the country, who claim that J&J talcum powder products cause ovarian cancer, which combined with the emerging talc mesothelioma lawsuits, would open an entire new area of mass tort litigation for J&J and its affiliates to defend.

The Lanzo trial started on January 29th and was closely watched, as the first “talc” lawsuit to go to trial in Johnson & Johnson’s home state over allegations that talcum-based hygiene products like Baby Powder and Shower to Shower contained asbestos and that J&J failed to warn of the risk as well as hid data that showed asbestos was in its products. The asbestos allegations are now an evolving legal fight for J&J, as most prior litigation over its Baby Powder and Shower to Shower products were over claims that the products have caused ovarian cancer in women. Those five cases case have been in the Missouri and California state courts over the last 2 years, with plaintiffs winning all but one of the trials, see J&J Talcum Powder Litigation, Missouri State Court, St Louis County Docket.

J&J WON FIRST CALIFORNIA TALC MESO TRIAL

Of note, is the California court trial verdict from November 16, 2017 where J&J did win a victory in the first mesothelioma trial; where J&J and co-defendant Imerys Talc America successfully defended claims by plaintiff Tina Herford that J&J’s Baby Powder caused her to be stricken with mesothelioma, after 35 years of using their products daily..

The New Jersey trial was the first case that went to trial, where a male plaintiff has asserted cancer causing claims involving J&J’s talc products. Plaintiff Stephen Lanzo, 46, claimed that after using Johnson’s Baby Powder for decades and inhaling asbestos particles within the product, he developed mesothelioma.  The primary claims against J&J and their talc supplier Imerys Talc America is that the companies knew their cosmetic talc products contained asbestos, but failed to warn consumers and intentionally suppressed scientific research that showed asbestos was contained within their talc based products.

Suppressing adverse research findings and manipulating science related to discoveries that Johnson & Johnson products pose significant health risks are cornerstones of most litigation against J&J and its various medical products divisions, often resulting in much higher verdicts based on the intentional failure to warn and failure to disclose the dangers to consumers. Often the trial data shows that J&J had been aware of many dangers, as far back as the middle 1970’s, and yet they went to extraordinary lengths to suppress this information from being released to the marketplace and consumers.

J&J and Imerys defended against Lanzo’s mesothelioma claims by asserting that the his condition was caused by of exposure to asbestos from other sources, and that the talc used in J&J’s products never contained asbestos. During the trail Mr. Lanzo’s trial counsel described in detail, as well as by showing documents obtained from J&J and other legally accepted science and research sources, that talc and asbestos occur naturally together, and that J&J knew as early as the 1970’s that their cosmetic talc products contained asbestos.

Efforts to conceal this fact included J&J’s having paid respected medical, science and other prominent industry researchers to write and publish articles and research papers mitigating the adverse findings posted in independent journals alleging that asbestos was found in talc products. Trial testimony also showed that J&J had made multiple and unsuccessful attempts to remove asbestos from their talc products, dating back to the 1970’s, yet at trial they claimed there was no asbestos risk in their talcum powder products. With one defining trial comment being “Why do you try so hard to get it out, it’s because it is there” which would seem to define plaintiff claims that J&J was aware of the risks long ago.

J&J was defended by the Chicago firm of Kirkland & Ellis LLP a highly respected and very aggressive defense firm, who are rather new to the J&J world of medical device litigation and were unsuccessful. They argued that any link between talc products and mesothelioma is based on the tried and sometimes untrue defense of faulty testing methods, and plaintiff claims of limited and outdated studies. Defense counsel even went so far as to state that Lanzo was exposed to asbestos in his childhood home and at school.

Defense claimed that J&J’s products never contained asbestos, and that they have performed careful testing to confirm that, which based on the jury verdict fell on deaf ears.

DOES J&J TALCUM POWDER CAUSE CANCER?

Johnson & Johnson has been ordered to pay nearly $1 billion in total damages after just five trials, alleging its baby powder is causing ovarian cancer, all jury verdicts have been in state courts in Missouri and California, see J&J Talc Trials St. Louis Missouri.

Talc, a mineral composed of magnesium, silicon, oxygen and hydrogen, is used extensively in cosmetics and personal care products. Women sometimes use talcum powder on their genital areas, sanitary napkins or diaphragms to absorb moisture and odor – contrary to the guidance of most physicians. (Asbestos, linked to lung cancer, was once an impurity in talc, but it has been banned for several decades.)  J&J is notorious for using any means possible to influence scientific data and opinion,only as well as manipulating research reports and public media commentary by industry experts. The recent California trial showed payments made to previously perceived impartial Science Council members, who were declaring publicly that J&J talcum powder does not pose a cancer risk, the Los Angeles jury did not agree with J&J and other pro-talc defense team members, as over $300 million of the total $417 million judgment was for punitive damages, usually only awarded for intentional misconduct, see “New Evidence of Johnson & Johnson Bad Conduct Moved LA Jury to Award $417 Million Talc Verdict”.

SCIENCE SAYS TALC IS DANGEROUS

The debate over talc began decades ago. In the early 1970’s, scientists discovered talc particles in ovarian tumors. In 1982, Harvard researcher Daniel Cramer reported a link between talcum powder and ovarian cancer. His study was followed by several more finding an increased risk of ovarian cancer among regular users of talcum powder. Cramer, who at one point advised J&J to put a warning on its products, has become a frequent expert witness for women suing the company. J&J ignored and suppressed Mr. Cramer’s attempts to show them the study data, then publicly declared this research as flawed, which J&J still continues to this day.

His studies and the many others that have found a relationship used a case-control approach. A group of women diagnosed with ovarian cancer and a group without it were asked to recall their past diet and activities, and the results were then compared.

Critics say these kinds of studies have serious drawbacks, particularly “recall bias.” Women may forget what they did or, if diagnosed with cancer, might inadvertently overestimate their use of a suspect substance. People without a serious disease may be less motivated to remember details.

Three other studies – considered cohort studies – did not find any overall link. Unlike the case-control studies, these efforts began with a large group of women who did not have cancer and followed the progress of their health, with participants recording what they were doing in real time. The results of this approach, most scientists say, are stronger because they aren’t subject to the vagaries of memory.

One such study included more than 61,000 women followed for 12 years, as part of the National Institutes of Health’s well-respected Women’s Health Initiative.

WILL “MESOTHELIOMA TALC” BE THE NEW MASS TORT?

Two recent verdicts for asbestos contamination demonstrate the risk to cosmetic talc defendants. In October 2016, a Los Angeles County jury awarded $18M to Philip Depolian against Whittaker, Clark & Daniels finding it 30% responsible for his mesothelioma, due to his alleged exposure to various cosmetic talc products used at his father’s barbershops that contained asbestos. The jury apportioned liability against various cosmetic talc defendants that had settled and several other cosmetic talc product defendants that sold products including Old Spice, Clubman, Kings Men and Mennen Shave Talc.

In 2015, another Los Angeles jury awarded Judith Winkel $13M against Colgate-Palmolive for mesothelioma allegedly caused by exposure to talc in its baby powder. The jury rejected Colgate and its experts’ claims that the cosmetic talc at issue was not contaminated by asbestos and that the talc in question were non-fibrous “cleavage fragments” unlikely to be inhaled or embedded in the lungs. Although details of the trial are not readily verified, at least one report indicated that evidence presented at trial showed that the talc contained 20% asbestos fibers.

These cases are particularly important because the defendants were held responsible for cosmetic talc containing asbestos and for having caused mesothelioma and not ovarian cancer as in the J & J cases. Further, both juries found that the defendants acted with malice; however, the cases were confidentially settled before the respective punitive damage phases.

Who’s Liable if Industrial Talc Litigation Explodes

While the ovarian cancer cases have dominated the headlines, the cosmetic talc asbestos contamination cases may present the bigger risk to defendants and a much greater reward to plaintiff counsel. Thousands of companies used cosmetic talc in their products over the last hundred years. The entire population could claim exposure, especially to defendants that sold personal care products that could be ingested, inhaled or exposed via air-borne contact. The risk is that the cosmetic talc defendants become the defendant of last resort when a plaintiff has no other convincing credible sources of exposure to asbestos, especially when the original product source is now a bankrupt entity.

Science of Cosmetic Talc Claims: While it may be difficult to challenge long-established trigger approaches if a talc claim involves a claim of asbestos contamination, ovarian cancer talc claims may require a new look at trigger issues because the underlying science of how talc exposure may cause ovarian cancer is different from how asbestos inhalation damages the respiratory system. Having learned from previous trigger battles in asbestos, the insurers are likely to challenge the science that the first exposure to cosmetic talc causes injury that can be associated with the development of ovarian cancer and characterized as “bodily injury” as required in their policies. They may seek out scientific opinion that ovarian cancer caused by cosmetic talc is not progressive in nature, and thus not warranting the imposition of a continuous trigger. And, generally, the insurers will likely seek to limit the spread of potentially triggered policies to as few years as possible, and as close to the manifestation of the disease as possible.

Exceptional advancements in the science of diagnosing and predicting cancer in the last few years will provide plaintiffs, policyholders and insurers the opportunity to craft new trigger theories to their advantage and to circumvent past judicial decisions that were to their disadvantage. We have already seen the insurance industry using alleged advancements in asbestos science to attempt to limit the scope of historical “occurrence” policies. There is no insurance precedence with respect to trigger and talc ovarian cancer claims. Expect both sides to bring new experts and theories with respect to biologic and genomic issues, including molecular cancer experts opining about genetic alterations pre-existing before manifestation of a tumor. Resolution of these issues will be especially challenging because much less is known about females’ “defense systems” as opposed to airborne exposure through the lungs.

The science of ovarian cancer cosmetic talc claims is likely different from asbestos claims, but that will be a question for the experts and courts. Because plaintiffs will have an easy time in most cases demonstrating exposure to consumer products (e.g., for baby powder, theoretically from birth to present), both kinds of cosmetic talc claims generally would be linked together based on length and type of exposure.

Will “Talc Mesothelioma” be the next mass tort against Johnson & Johnson and its affiliates? Mass Tort Nexus will report on this as additional information becomes available.

The Stephen Lanzo case docket can be found under: Lanzo v. Cyprus Amex Minerals Co, et al., Docket No. L00738516 in Middlesex County Superior Court.

 

Read More

C. R. Bard, Inc., Hit With Multimillion Dollar IVC Filter Jury Verdict in Arizona Federal Court

Plaintiff Wins the First Bellwether Trial in Bard IVC Filters Products Liability Litigation MDL 2641

By Mark A. York (March 30, 2018)

Bard G2 Inferior Vena Cava Filter

 

 

 

 

 

 

 

 

 

 

 

 

(Mass Tort Nexus Media)  A Phoenix federal jury awarded $2 million in compensatory damages on Friday to plaintiff Sherr-Una Booker, in the first bellwether trial against IVC filter maker Bard, Inc. and affiliate company Bard Peripheral Vascular, Inc. finding that the clot-stopping vein filter known as a G2 model IVC filter, (an Inferior Vena Cava filter) manufactured by Bard broke apart in her body, and returned a verdict citing that the device maker was responsible for 80 percent of the harm. They also said that Bard is liable for punitive damages in addition to the $2 million in actual damages award, with the hearing on punitive damages taking place right after the initial verdict announcement.

The punitive damages phase of the first bellwether over the IVC device began immediately after the early Friday verdict in the Sherr-Una Booker v. C.R. Bard, Inc et al, Case No. 16-CV-0474-PHX-DCG litigation, US District Court of Arizona in front of Judge David G. Campbell.  The Booker trial is the first “bellwether trial” in the more than 3,500 other IVC filter lawsuits pending in the Bard IVC Filters Litigation MDL 2641, before Judge Campbell. The verdict came fairly quickly after just six-and-a-half hours of deliberations that started Thursday. The jury said Bard was not liable for strict liability, which will probably be appealed by Ms. Bookers counsel. We will update this article with the results of the punitive damage hearing as soon as they become available.

BARD IVC FILTER PROBLEMS

Bard’s IVC filters, including its Recovery, G2, Meridian, and Denali product lines, are the target of over 3,500 injury claims in the Bard IVC Filters Products Liability Litigation MDL 2641 currently pending before the court in the District of Arizona. The thousands of lawsuits  filed against the two Bard companies claim they concealed dangerous side effects associated with their retrievable IVC filters – including filter migration, fracture, organ perforation, embolization, and inferior vena cava punctures – and failed to warn doctors and patients about these risks. In addition to the Bard MDL 2641 cases, there is other litigation against smaller IVC manufacturers, Cordis Corporation Rex Medical, Argon Medical, and B. Braun who are all facing  IVC lawsuits in state and federal courts across the country.

BARD FAILURE TO WARN

IVC filters are implanted into the inferior vena cava – the body’s largest blood vessel – to intercept blood clots before they can travel to the heart and lungs. The devices are indicated for patients at risk for pulmonary embolism, and who are unable to use standard blood-thinning medications. The filters involved in the C.R. Bard and Cook Medical litigations are retrievable, and are intended to be removed once a patient is no longer at risk for pulmonary embolism.

Plaintiffs pursuing IVC filter lawsuits against C.R. Bard and Cook Medical claim that the companies failed to provide doctors with adequate warnings and instructions for removal. They also claim that the devices are defectively designed, and accuse the two companies of concealing the risks associated with their blood clot filters.

The FDA has issued two safety alerts about using retrievable IVC filters.

  • The first was released in August 2010, after the devices were linked to hundreds of adverse events, including reports of filters fracturing and migrating to other areas of the body. In other cases, pieces of the filters perforated organs and blood vessels.
  • The FDA issued a second alert in May 2014 to remind doctors of the importance of IVC filter retrieval. A year earlier, a paper published in JAMA Internal Medicine found only 8.5% of retrievable IVC filters were successfully removed.

“In conclusion, our research suggests that the frequent use of IVC filters for VTE treatment and prophylaxis, combined with a low retrieval rate and inconsistent use of anticoagulant therapy, results in suboptimal outcomes, such as mechanical filter failure and high rates of VTE,” the authors of the report concluded. “More comprehensive longitudinal data would likely identify additional complications.”

Additional research has shown in the last 30 years an estimated 30,000 IVC filters have been implanted. But it wasn’t until 2010, after they’d received thousands of adverse event reports, that the FDA finally issued a warning citing the risk of retrievable filter injuries. It took another four years for the FDA to strengthen the warning when in 2014 they implored doctors to remove IVC filters within about one to two months after the risk of a pulmonary embolism has lessened.

BARD KNEW OF DANGERS

In 2015 after the FDA issued the second IVC warning, a bombshell media report claimed C.R. Bard continued to market and sell their inferior vena cava (IVC) filters even after the company became aware the filters were failing and causing serious injuries and even death. The report went on to link at least 27 deaths and more than 300 injuries to failures associated with C.R. Bards Recovery Model IVC filters. The investigative report also uncovered that IVC devices made by C.R. Bard and Cook Medical had been linked to hundreds of adverse event reports where they punctured the vena cava, tilted out of position or migrated or broke apart and caused metallic fragments to travel to the heart or lungs – a condition known as embolization. Even after C.R. Bard was warned about the problems, they continued to sell the devices, without warning the doctors of the defects and injuries.

With 3,500 additional cases remaining the the Bard IVC Filter litigation docket, it seems that the Bard entities may need to prepare for a long and protracted legal fight, unless they determine settlement discussions are the best legal strategy to prevent future plaintiff wins.

 

Read More

Johnson & Johnson Hit With $35 Million Surgical Mesh Implant Verdict

$35 Million Verdict For Plaintiff In Ethicon Prolift Mesh Implant Trial Including $25 Million In Punitive Damages

ETHICON PROLIFT SURGICAL MESH

 

 

 

 

 

 

 

 

 

A jury trial in the US District Court of Northern Indiana returned a verdict against Johnson & Johnson and its Ethicon division, that included $25 million in punitive and $10 million in compensatory damages. The jury found that that Ethicon was negligent in the design of the Prolift surgical mesh implant device, as an unreasonably dangerous product, resulting in post-implant injuries to plaintiff  Barbara Kaiser of Valparaiso, Indiana.

This verdict is the latest plaintiff trial win in the ongoing Ethicon Pelvic Mesh MDL 2327 litigation (See Ethicon MDL 2327 Litigation Briefcase), which includes the overall master docket data which guided the Barbara Kaiser case, prior to being remanded back to the Indiana court for trial by Judge Joseph Goodwin, from the US District Court of West Virginia, where the Ethicon Pelvic Mesh MDL cases are docketed. The Ethicon pelvic mesh litigation still has thousands of remaining cases, where plaintiffs have asserted claims against Ethicon and J&J over their surgical mesh line of products.

The trial took place in the United States District Court for the Northern District of Indiana, where a nine-person jury returned a verdict against Johnson & Johnson et al., the industry leader in  pharmaceuticals and medical devices, after finding that Johnson & Johnson marketed, sold, and recruited physicians worldwide to implant the controversial “Ethicon Prolift” mesh device for Pelvic Floor Repair in women that suffered from pelvic prolapse.

The verdict was handed down after nearly a two-week jury trial that began on Monday, February 26th, concluding on March 8th, 2018.

The verdict confirmed claims that Johnson & Johnson and Ethicon are  liable for its defective product line, designed for use in surgical procedures where the Pelvic organ prolapse repair is used, confirming primary plaintiff claims that the Defendants were negligent in the design of Prolift as an unreasonably dangerous product, resulting in long term injuries to Mrs. Barbara Kaiser of Valparaiso, Indiana as a result of the surgical implant of the Prolift device. The jury found Ethicon deliberately failed to warn of the risks to Prolapse patients prior to consenting to the Prolift mesh implant surgery and sold a Prolift product in a defective and unreasonably dangerous condition.

“The $35 million verdict is one of the largest verdicts in the country,” said lead trial counsel Thomas Plouff, further stating “Ethicon defended an indefensible product and the jury stood up for Barb Kaiser. They were asked to send a message to Ethicon to deter future wrong doing and they certainly did, a company that sold a medical device without doing any clinical testing and caused thousands of women to suffer painful complications from mesh in their pelvic area.”

The trial in front of the Honorable Judge Philip P. Simon, in Northwest Indiana, in what is known as a fairly conservative court venue for plaintiffs seeking damages against manufacturers of products, with Northwest Indiana being a major manufacturing center and not being known for massive verdicts such as the Kaiser mesh award. The verdict requires the Johnson & Johnson corporate conglomerate to pay $35 million, which is $10 million for compensatory damages (for Mrs. Barb Kaiser’s dyspareunia, pelvic pain, levator myalgia, painful bladder spasms, and groin pain), and $25 million in punitive damages. The high punitive damage figure would seem to send a clear message to J&J that their conduct related to the design and marketing of the Prolift product was wrong and intentional, resulting in the very large punitive award.

The Kaiser mesh lawsuit is part of an ongoing legal battle between plaintiffs and surgical mesh makers across the country regarding the many thousands of injuries resulting from various mesh products being surgically implanted. The Ethicon Pelvic Repair MDL 2327 has been in existence since 2012 and the judge is moving toward resolution of those 40 thousand plus claims against many of the largest medical device manufacturers in the world. However, the currently evolving “hernia mesh” legal and medical issue are outline below.

 Hernia Mesh Injuries and Complications

Unlike sutures, which have relatively few and minor possible complications, hernia mesh frequently causes life-threatening complications. Hernia mesh can erode into the bowel, requiring multiple additional surgeries, weeks of hospitalization, partial bowel removal, colostomies, and more. The mesh failure frequently causes patients to experience a systemic infection. We recently observed high rates of dental infections associated with mesh failure. Many victims report all of their teeth suddenly rotting out. Even if there is a slightly lower rate of hernia recurrence when mesh is used, it doesn’t justify the risk of life-threatening complications.

Hernia mesh is used to repair both ventral hernias and inguinal hernias. Various injuries and complications can occur depending on what part of the body the mesh is placed. A coated hernia mesh is also more likely to cause injuries such as infection than a non-coated hernia mesh. The follow is a list of the array of complications we observed:

  • Infection, including sepsis. An infected hernia mesh almost always requires removal.
  • Adhesions form to connect the bowel to the hernia mesh. Adhesions frequently form when ventral hernias are repaired with a coated mesh.
  • Bowel Obstruction caused by adhesion formation. Evidenced by a change in bowel habits or the inability to defecate.
  • Abdominal Pain is a sign of possible adhesion formation, a bowel obstruction, infection, or nerve damage.
  • Rashes are commonly observed in association with hernia meshes such as the C-Qur V-Patch and Ventralex ST.
  • Leg, Groin, and Testicular Pain are all common to inguinal hernias repaired with mesh. This pain can be debilitating.
  • Pain with Sex (Dyspareunia) caused from the mesh used to repair an inguinal hernia attaching to the spermatic cord.
  • Testicle Removal may be necessary if the mesh erodes far enough into the spermatic cord.
  • Diarrhea can be an early symptom of the mesh attaching to the bowel.
  • Constipation can be a sign of a bowel obstruction. You should consult a doctor if your constipation persist for several days.
  • Nausea can be an additional sign of adhesions to the bowel and stomach.
  • Seroma is a fluid capsule surrounding the mesh. Seromas can be present with and without infection.
  • Fistula. An abnormal tunnel between two structures. Our attorneys observe many fistulas connecting to the bowel, which are associated with infections.
  • Dental Problems. Medical reviewers have observed a large number of patients who have lost their teeth after a hernia mesh infection.
  • Autoimmune Disorders. An alarming number of our patients have developed autoimmune disorders after being implanted with a pelvic or hernia mesh.
  • Neurological Changes. Several different patients that have been implanted with the same type of mesh have been diagnosed with unexplained neurological changes on a CT scan.
  • Severe Headache. Typically a sign of a larger problem, such as an infection.
  • Fever. Associated with both an autoimmune response to the mesh and infection.
  • Renal Failure has been observed in those implanted with large coated meshes. The coatings are absorbable and put a great deal of strain on the kidneys.
  • Liver Abnormalities have also been documented in those implanted with coated hernia meshes. The liver is also responsible for cleansing the body.
  • Joint Aches and Pain can be caused by increased systemic inflammation due to infection and an autoimmune reaction to the mesh.
  • Abnormal Sweating can be related to an autoimmune response or to an infection.
  • Meshoma is the migration, contracture, or bunching-up of an artificial mesh. Meshomas become hard, tumor-like bodies.

         SURGICAL MESH ISSUES

  • Composite Mesh: The Most Dangerous Type of Hernia Mesh
  • Any mesh with a coating is known as a composite mesh. Most of the manufacturers promote the meshes coating as a “barrier” and instruct surgeons to use the coating as a barrier. The FDA requires any “barrier” type of medical device to undergo Pre-Market Approval and pre-clinical studies to ensure the device’s safety. Instead of conducting safety studies, companies just told the FDA that they wouldn’t promote their hernia mesh as a “barrier.” A majority of the meshes currently being used in hernia repair are untested composite meshes that have only been on the market for a few years. There is currently no reliable data on these hernia mesh products. Medical reviewers are currently noticing a very high rate of complications associated with hernia meshes that are coated.
  • Big Profits Making Composite Mesh
  • Due to the complications that polypropylene was causing when it came in direct contact with the bowel, the demand for composite hernia mesh skyrocketed. Any company with a composite mesh could rapidly increase its nationwide market share. Mesh products were already one of the most profitable medical devices a company could manufacture, many making over $100,000,000 a year! A composite mesh also sells for approximately 15 – 20 times more than an uncoated polypropylene mesh. Suddenly, every device manufacturer rushed to get a composite mesh on the market. Many companies created and sold several different types of composite hernia mesh at the same time. If one type of composite mesh caused too many side effects, the company would simply quit manufacturing that particular composite mesh. There are currently over 350,000 hernia repairs in the United States each year.
  • There are many different hernia mesh products available, many of which are manufactured by different medical device companies. The strengths and weaknesses of a hernia mesh lawsuit are in part determined by which company manufactured the hernia mesh and the exact mesh that was utilized. Below is a list of products that have received a large number of complaints. Bookmark this page and check back soon, this list is growing and we continue to add more unique content every week!
  • Ethicon – Johnson & Johnson
  • Proceed Hernia Mesh
  • The Proceed hernia mesh came to market in 2003. The Proceed is a light-weight hernia mesh with an Oxidized Regenerated Cellulose (ORC) fabric covering the polypropylene. The cellulose is adhered to the polypropylene with polydioxanone (PDS). Ethicon touts the Proceed’s barrier as supporting “safe and comfortable healing.” Ethicon has previously issued limited recalls on the Proceed hernia mesh, because of the cellulose layer separating from the polypropylene and increasing the risk of bowel complications. The Proceed hernia mesh continues to delaminate and should be permanently recalled. Physicians have submitted 100’s of adverse event reports to the FDA and Johnson & Johnson regarding the Proceed hernia mesh being defective and injuring patients.
  • Physiomesh:
  • The Physiomesh was withdrawn from the market in May of 2016. Ethicon maintains that they did not recall the Physiomesh. The Physiomesh was a composite hernia mesh. Multiple studies revealed that Ethicon’s Physiomesh had high rates of complications, including subsequent hernias and additional surgeries. Ethicon admitted that they’re unable to determine why the Physiomesh is defective, or how to decrease complications for those who had a Physiomesh implanted. Part of the problem was likely that the Physiomesh had a coating on each side of the mesh. The coating prevented the Physiomesh from properly incorporating with the host tissue. Prior to removing (not recalling) the Physiomesh from the market, Ethicon created a new hernia mesh called Physiomesh Open.
  • Prolene Hernia System:
  • The Prolene Hernia System(PHS) was introduced to the market in 1997. The Prolene Hernia System is similar to polypropylene mesh plugs with a polypropylene onlay. In fact, the Prolene Hernia System cites Bard’s Perfix plug as a predicate device. Our hernia mesh lawyers have observed similar complications associated with the Prolene Hernia System and the Perfix plug. The Prolene Hernia System utilizes heavy-weight polypropylene. In 2007, Ethicon came out with the Ultrapro Hernia System, a light-weight version of the Prolene Hernia System. Light-weight polypropylene was believed to cause less complications than heavy-weight polypropylene. Injuries associated with the PHS include debilitating pain, nerve damage, and sexual dysfunction necessitating testicle removal.
  • Covidien – Medtronic
  • Parietex:
  • The Parietex hernia mesh was Covidien’s first polyester hernia mesh. The Parietex originally came to the market in 1999 as a heavy-weight polyester mesh. The original Parietex caused many problems similar to polypropylene based hernia meshes, such as adhesions, infections, and bowel complications. Like polypropylene, polyester also shrinks and contracts to a significant degree after it is implanted in the body. As the Parietex contracts, tension increases and the mesh has a tendency to tear where the tacks or sutures were used to secure it. Severe pain and a recurrence of the hernia typically result when the Parietex mesh rips apart. After the Parietex detaches it can migrate to other parts of the body.
  • Parietex Composite Mesh:
  • Parietex ProGrip/Plug and Patch System
  • The Parietex Composite(PCO) mesh is composed of a polyester base with a resorbable collagen barrier. The resorbable collagen barrier is intended to prevent the polyester base from adhering to the patient’s bowel. Covidien touts the Parietex as a unique material that “works with the body’s natural systems.” However, many of our clients would disagree. The collagen layer of the Parietex Composite hernia mesh is very thin and delicate. The collagen layer disappears quickly after implantation and does little to nothing to protect the bowel and underlying organs from the polyester base. Recently, Covidien came out with the Parietex Optimized Composite Mesh in an attempt to fix the problems associated with the collagen layer. The hernia mesh lawyers at the Hollis Law Firm frequently see severe adhesions, bowel obstructions, and infections associated with the Parietex Composite hernia mesh. Additionally, like the original Parietex, the Parietex Composite tears easily on sutures or tacks as it begins to contract post implantation.
  • The Parietex ProGripand the Parietex Plug and Patch System are made from polyester weaved together with a partially semi-resorbable polylactic acid (PLA) layer. The Parietex ProGrip is a “self-fixating” mesh because it has thousands of hooks that are intended to keep the mesh in place. However, the thousands of hooks also cause patients to experience severe pain and make the hernia mesh nearly impossible to remove. When the Parietex ProGrip fails and complications result, multiple surgeries are usually required to remove the underlying problem: the defective Parietex ProGrip hernia mesh. Covidien was recently acquired by Medtronic for nearly $50 billion. Covidien is also one of many defendant mesh manufacturers in the pelvic mesh litigation
  • Atrium – Maquet – Getinge Group
  • C-Qur Hernia Mesh:
  • The C-Qur is a composite hernia mesh that came to market in 2006, and was initially marketed by Atrium Medical Corporation. Maquet, a subsidiary of the Getinge Group, acquired Atrium in 2011 and now manufactures the C-Qur hernia mesh. The FDA has issued several warnings letters and even sued Atrium Medical Corporation for violations. Recently, the FDA shut down one of Atrium’s facilities that manufactured the C-Qur hernia mesh. Atrium has only issued recalls on the C-Qur’s packaging, not on the actual C-Qur hernia mesh itself.
  • The C-Qur hernia mesh has an Omega-3 Fatty Acid coating that causes severe allergic reactions. The C-Qur hernia mesh is also associated with life-threatening systemic infections. Removing the C-Qur mesh is extremely difficult and can result in further injury. The C-Qur hernia mesh remains on the market, even as lawsuits continue to mount. Our hernia mesh recall lawyers continue to receive frequent complaints related to the C-Qur hernia mesh.
  • Davol – C.R. Bard
  • Kugel Hernia Mesh:
  • The Kugel hernia mesh was one of first and most well known hernia meshes to be recalled. C.R. Bard recalled several lots of the Kugel hernia patch in 2005, 2006 and 2007. The Kugel hernia mesh patch has a ring in the middle of the mesh to help it keep it’s shape. Multiple lots of the Kugel hernia mesh were recalled due to a large number of reported ring breaks. Many patients have suffered bowel perforations as a result of the inner ring of the Kugel hernia patch breaking. Davol only recalled limited lots of the Kugel, claiming that certain lots had defective rings. Davol continues selling the Kugel hernia mesh to this day. The real problem with the Kugel hernia mesh is that it’s made of polypropylene, which shrinks over time. As the polypropylene mesh shrinks, more and more force is applied to the ring. Eventually, the ring breaks due to the shrinkage of the polypropylene.
  • 3d Max
  • The 3DMax is a bare heavy-weight polypropylene mesh used to treat inguinal hernias. In 2008, Bard released a light-weight version of the 3DMax called the 3DMax light. Patients nationwide have experienced severe, debilitating pain after being implanted with the Bard 3DMax mesh. The 3DMax mesh can erode through soft tissue and then attach to the spermatic cord in men, causing severe sexual dysfunction and testicle pain. Once the mesh is attached to the spermatic cord, there is a risk of losing the testicle when removing the mesh. The 3DMax is curved, and is intended to be implanted without any sutures or tacks. Our hernia mesh attorneys have identified many cases where the Bard 3DMax has folded over upon itself and migrated inside the patient. As can be seen in the picture, the outer sealed edge of the 3DMax also has a tendency to easily break and tear. The sealed edge is intended to help the 3DMax maintain its shape. Bard’s 3DMax simply is not fit for permanent, life-long human implantation.
  • PerFix Plug
  • The PerFix Plugis a bare polypropylene mesh used to treat inguinal hernias. The PerFix Plug looks like a double layer dart with an overlay patch. The polypropylene of the PerFix Plug has been observed to come unwoven over time. Many experience severe pain and difficultly exercising and even walking after being implanted with the Bard PerFix Plug. The PerFix Plug is another hernia mesh that has caused many men to loose a testicle. The PerFix Plug is not necessary to repair an inguinal hernia.
  • Ventralex (Supramesh)
  • In 2007, Bard bought the license to Sepramesh from Sanofi Genzyme. The Sepramesh was intended to “Separate the polypropylene from the bowel.” Bard then created the Ventralex ST hernia mesh by combining the Sepramesh and the Kugel mesh. Bard recalled several lots of the Kugel hernia mesh approximately a decade ago. Bard has yet to issue a recall on any lot of the Ventralex ST hernia mesh.Bard also claims that the Ventralex SThernia mesh’s coating is similar to the coating used on the C-Qur hernia mesh. Like with the C-Qur, researchers are seeing severe inflammatory reactions, infections, and adhesions related to the Ventralex ST. Please note that Sepramesh, Ventrio ST and Ventralight ST are also included in the Ventralex ST lawsuit.
  • Scientific Articles on Hernia Mesh
  • The below articles are on hernia mesh in general. Each hernia mesh subpage also contains additional case specific scientific articles.
  • August 2016: Evaluation of Long-Term Surgical Site Occurrences in Ventral Hernia Repair: Implications of Preoperative Site Independent MRSA Infection.
  • 632 patients were studied for two years after being implanted with hernia mesh. 31% experienced complications within just two years. Complications included cellulitis, necrosis, nonhealing wound, seroma, hematoma, dehiscence, and fistula. Patients with a preoperative MRSA+ infection from any site (urine, blood, surgical site), might be at an elevated risk for hernia mesh complications.
  • August 2016: Oral, Intestinal, and Skin Bacteria in Ventral Hernia Mesh Implants.
  • 36 patients with failed hernia mesh were studied. All participants were found to have gingivitis and 33% had infected gums and teeth. Oral bacteria was discovered on 43% of explanted hernia mesh. The study discusses the difficulty in knowing the real rate of hernia mesh infections, due to lack of standardized criteria to define infection, lack of follow-up exams, and lack of intervention when complications arise. It notes that hernia mesh infection is the most common reason for mesh removal.
  • June 2016: Sepramesh and Postoperative Peritoneal Adhesions in a Rat Model.
  • The study notes that “postoperative peritoneal adhesions occurred at the extremities of the mesh, where there was close contact between the polypropylene and viscera, or where the fixation suture was placed.”
  • August 2015:Previous Methicillin-Resistant Staphylococcus Aureus Infection Independent of Body Site Increases Odds of Surgical Site Infection after Ventral Hernia Repair.
  • 768 patients underwent hernia repair. 10% experienced a hernia mesh infection. 33% of patients with a preoperative MRSA+ infection experienced a hernia mesh infection.
  • May 2014: Comparison of Outcomes of Synthetic Mesh vs Suture Repair of Elective Primary Ventral Herniorrhaphy: A Systematic Review and Meta-Analysis.
  • 637 hernia mesh repairs and 1145 suture repairs were compared. Hernia mesh repair was associated with a slightly lower rate of recurrence, but a higher rate of severe complications. The authors admit that “further high-quality studies are necessary to determine whether suture or mesh repair leads to improved outcomes for primary ventral hernias.”
  • November 2013: Coated Meshes for Hernia Repair Provide Comparable Intraperitoneal Adhesion Prevention.
  • Uncoated polypropylene was compared to various types of coated polypropylene placed intraperitonally via laparoscopic procedure. The uncoated polypropylene hernia mesh resulted in significantly more adhesions.
  • October 2013: Biologic Meshes are Not Superior to Synthetic Meshes in Ventral Hernia Repair: An Experimental Study with Long-Term Follow-Up Evaluation.
  • The study notes that “In laparoscopic incisional hernia repair, direct contact between the prosthesis and the abdominal viscera is inevitable, which may lead to an inflammatory reaction resulting in abdominal adhesion formation.” The authors advise additional research is necessary, and to be wary of short-term experimental results on laparoscopically placed hernia mesh.
  • October 2013:Intra Peritoneal Polypropylene Mesh and Newer Meshes in Ventral Hernia Repair: What EBM Says?
  • The authors are concerned about using polypropylene mesh (PPM) for laparoscopic hernia repair. They question if paying 15-20 times more for a composite mesh is worth it. The study notes “Complications of intraperitoneal PPM (adhesions, infection, intestinal fistulization, sinus formation, seroma and recurrence) can occur with the newer mesh also. There is no statistically significant difference in the incidence of these complications between these meshes.”
  • August 2012: Ventral Hernia Repair with Synthetic, Composite, and Biologic Mesh: Characteristics, Indications, and Infection Profile.
  • The study notes that polypropylene “is unsuitable for intra-abdominal placement because of its tendency to induce bowel adhesions.”
  • August 2011: Complications of Mesh Devices for Intraperitoneal Umbilical Hernia Repair: A Word of Caution.
  • The surgeons note experiencing serious complications in several patients implanted with a composite mesh. Injuries included small bowel resections and mesh removal. The study notes “We think that, if preperitoneal deployment of such mesh devices is possible, this should be the preferred position, notwithstanding the fact that these meshes have a dual layer. There is a complete lack of convincing data on these mesh devices in the medical literature.No long-term data have been published, and, for three of the four mesh devices available, no publications on their use in humans were found.”
  • July 2011: Mesh Infection in Ventral Incisional Hernia Repair: Incidence, Contributing Factors, and Treatment.
  • The study discusses the need for a better identification, classification and reporting systems for hernia mesh infections. It notes part of the difficulty is that hernia mesh implants have a tendency to remain dormant for long periods of time. It can take years before a hernia mesh infection is identified.
  • January 2010: Oral Biofilms: Emerging Concepts in Microbial Ecology.
  • The overall health and biology of an individual is closely linked to which oral biofilms develop.
  • June 2009: The Problem of Mesh Shrinkage in Laparoscopic Incisional Hernia Repair. 
  • Laparoscopic hernia repair requires expanding the abdomen with approximately 3 liters of gas. The surface area of the abdominal wall is stretched by about 80% during laparoscopic repair. Surgeons must anticipate significant mesh shrinkage in laparoscopic hernia repair. Mesh shrinkage remains one of the unsolved problems of laparoscopic incisional hernia repair.
  • How Does the FDA Learn About Hernia Mesh Complications?
  • If a hernia mesh fails within a few years and the same surgeon that implanted the mesh removes the mesh, the surgeon will sometimes report the complication to the manufacturer. It is then the manufacturers duty to determine if the complication warrants notifying the FDA. Through our investigations, we uncovered that many manufacturers fail to report adverse events related to hernia mesh to the FDA. Surgeons will also occasionally file adverse event reports directly to the FDA, but the process is very time consuming. As a result, the FDA is only aware of a very small percentage of total hernia mesh complications. The manufacturers of hernia mesh then cite to low rates of hernia mesh complications reported to the FDA as evidence that hernia mesh is safe!
  • Are There Other Ways to Report Hernia Mesh Complications to the FDA?
  • If you have suffered hernia mesh complications, you can alert the FDA through a MedWatch Report. You can also alert the FDA by filing a hernia mesh lawsuit against the manufacturer of the mesh. When a manufacturer is notified of a pending hernia mesh lawsuit, the manufacturer must report the basis of the hernia mesh lawsuit to the FDA. Medical device companies are allowed too much discretion on if they have to notify the FDA when a surgeon reports a hernia mesh adverse event. The medical device companies do not have discretion on reporting a hernia mesh lawsuit to the FDA. The companies must report every single hernia mesh lawsuit to the FDA.

Read More

More Doctors Charged With Taking Opiate Rx Kickbacks From Insys Therapeutics, Inc.

“MD’s Paid To Write Fentanyl Based Subsys Prescriptions”

Subsys, a fast acting fentanyl spray

 

 

 

 

 

 

 

 

 

 

 

(Mass Tort Nexus Media) Following the indictments of the entire Insys Therapeutics, Inc. Board of Directors in late 2016, and then criminal charges against company founder John Shapoor in October 2017,  the US Attorney’s office in New York has brought federal charges against five New York doctors who accepted kickbacks from Insys in exchange for prescribing the company’s fentanyl-based cancer pain medication.

The multi-count indictment filed last week in Manhattan federal court charged physicians Gordon Freedman, Jeffrey Goldstein, Todd Schlifstein, Dialecti Voudouris and Alexandru Burducea with receiving payment from Insys to participate as speakers, in order to enable illegal fees paid for writing fentanyl based prescriptions. Under the guise of “educational events”, the speaking fees were simply a mechanism to pay the doctors, as Insysy has done across the country since mid 2015.

As far as how this “pay to prescribe Subsys” policy came about, here’s a look at what’s taken place at the Insys Therapeutics, Inc. executive level.

INSYS EXECUTIVES INDICTED

December 2016 saw Insys Therpaeutics CEO Michael Babich and five other senior executives indicted on criminal charges for paying kickbacks and bribes to medical professionals and committing fraud against insurance companies across the country for offering a highly addictive Fentanyl prescription product “Subsys” to the masses. The Insys boardroom was indicted in the US District Court of Massachusetts, where the entire team has engaged a stable of top national law firms to defend the indictments. The “Subsys” sales teams were charged in federal indictments across the country, including Arkansas, Connecticut, Alaska and New York and the indictments will only increase as these cases proceed and “cooperating witnesses” decide that prison isn’t an option.

To compound further harsh scrutiny for Insys, it’s new CEO Saeed Motahari, moved over from Purdue Pharmaceuticals, the Oxycontin maker, who’s also a major target of criminal and civil investigations across the country by local state and federal agencies. Purdue is charged with false marketing, off-label use and ignoring the Oxycontin highly addictive dangers for years, while bringing in literally billions of dollars in profits.

PRIOR DOCTOR INDICTMENTS

Doctors who’ve written massive numbers of Subsys prescription, under the “fee to speak” program have been indicted and they include pain clinics, medical centers and other healthcare facilities who now face federal criminal charges for fraudulent prescription writing, submitting false claims to insurance companies and numerous other federal charges and all face a minimum of 20 to 50 years in federal prison. Two of the busiest “Subsys” prescription writers in the country were Alabama doctors, John Couch and Xiulu Ruan, who earned over $40 million from Insys, and were charged with running a pill mill between 2013 and 2015, have been convicted and sentenced to 20 years each in federal prison.

The top “Subsys” prescriber of all, Dr. Gavin Awerbach, of Saginaw, MI pled guilty to defrauding Medicare and Blue Cross out of $3.1 million in improper Subsys prescriptions, his criminal sentence is pending. To show the far reach of Insys and its corporate plans to saturate the US market with opioids, in Anchorage, Alaska Dr. Mahmood Ahmad, was charged with a massive Subsys prescribing operation, which he denies, but immediately surrendered his Alaska medical license which caused the revocation of his license Arkansas.

THE OFF LABEL CAMPAIGN

The only people who are supposed to be taking Subsys are adult cancer patients, according to the FDA “Subsys” approval files, anything other than that is an “off label” indication. Now you can take a drug to treat something off label if you want to, but you have to get your doctor to get pass a prior authorization.

Anthem alleges that Insys has an entire unit to get around this requirement — it’s titled the “reimbursement unit.” Investigative journalists exposed this fraud initially as far back as 2015 on behalf of the Southern Investigative Reporting Foundation, see Insys Therapeutics “Subsys” Off Label Rx Fraud.

The Reimbursement Unit claim was basically the company’s fraudulent prescription approval factory, which helped participating doctors process claims (the doctors had so many they couldn’t handle them all). The unit falsified records to show patients had cancer and called insurers, pretending to be patients or other medical professionals, to facilitate approval of payment for off-label treatment.

This is the Unit’s script for obtaining off-label approval (taken from the Anthem suit):

The script read: “The physician is aware that the medication is intended for the management of breakthrough pain in cancer patients. The physician is treating the patient for their pain (or breakthrough pain, whichever is applicable).” The script deliberately omitted the word “cancer as applied to the patient treatment under discussion.”

Prosecutors also said that two former Insys employees who were first charged in 2016 in connection with the scheme, Jonathan Roper and Fernando Serrano, had secretly pleaded guilty and become cooperating witnesses. The five doctors were arrested last Friday morning and face charges including that they violated the federal anti-kickback law and conspired to commit fraud.

INSYS RX ABUSES WERE BLATANT

The case is the latest in a series of medical practitioners and former Insys executives and employees facing criminal charges related to Subsys, the company’s potentially addictive fentanyl-based spray.

Federal prosecutors in Boston are moving forward aggressively against the seven former Insys executives and managers as well billionaire founder John Kapoor, all accused of actively designing and participating in the scheme to bribe doctors to prescribe Subsys and to defraud insurers into paying for it. Insys has said it may need to pay at least $150 million towards part of a settlement with the U.S. Justice Department as well as numerous other state investigations around the country, not to mention the civil complaints filed against the company in the Opiate Prescription MDL 2804, see OPIOID-CRISIS-BRIEFCASE-INCLUDING-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION, where the Insys sales and marketing tactics are listed as prime examples of boardroom designed “profits over patients” policies are cited.

 

Insys is joined in the massive Federal Opioid MDL 2804, by other Big Pharma defendants including Purdue Pharmaceuticals, Endo Health, J&J’s Janssen Pharmaceutical and other opioid manufacturers who were allowed to place profits over patients for more than 15 years, while earning billions in profits.

UNETHICAL SALES TACTICS

According to the most recent and prior doctor indictments, the physicians have participated in Insys’ speaker programs, which were in reality social gatherings at high-end restaurants. They earned kickbacks ranging from $68,000 and $308,000 and were among the top 20 prescribers of Subsys nationwide at some point during the marketing campaign. A few doctors indicted as far back as late 2016 have already been sentenced to federal prison terms up to 20 years and forfeit of millions of dollars in assets. The Insys marketing tactics included trips with doctors to strip clubs with Insys sales managers; and often with Insys executives, where they covered lap dances and drinks which on one trip ran up a tab of over $4,100 which was apparently enough to convince physicians to write massive numbers of off-label fentanyl prescriptions.

Read More