J&J Tramples on Basic Civil Rights to Jury Trial Verdict

J&J Faces High-Stakes Appeal to Toss Pinnacle Hips Judgment

By Jef Feeley

December 7, 2017, 10:16 AM CST  Bloomberg  FiDA highlight

• Challenge to $151 million judgment affects 10,000 other cases 
• Former Solicitor General Clement squares off against Ken Starr 

The stakes are high as Johnson & Johnson seeks an appeals-court ruling tossing out a $151 million judgment over its Pinnacle artificial hips in a case could foreshadow the outcome for thousands of lawsuits over the devices.

J&J and its DePuy unit, which makes the artificial hips, will have former Solicitor General Paul Clement arguing Thursday that the verdict should be reversed because there was insufficient evidence that the hips were defectively designed and deceptively marketed. The companies will also attack “highly inflammatory comments” at the trial by prominent plaintiffs’ lawyer Mark Lanier.

Kenneth Starr, the Clinton-era independent counsel, will defend the verdict in favor of five hip patients who won a $502 million verdict last year, only to see it slashed to $151 million by the trial judge. Starr will argue that there was enough evidence to support the verdict, including proof that J&J knew the metal-on-metal hips were flawed and would prematurely fail but concealed its knowledge to preserve billions in sales.

J&J, winner of only one of the four Pinnacle cases that have gone to trial since 2014, faces more than 10,000 patient suits blaming the company for selling faulty hips. The argument is scheduled for Thursday afternoon in the U.S. Circuit Court in New Orleans.

Juries in federal court in Dallas have ordered the company to pay a total of more than $1.7 billion in damages over the hips, but several of the awards were later cut by U.S. District Judge Ed Kinkeade, who is overseeing a consolidation of suits over the devices. One verdict was for more than $1 billion.

J&J Ordered to Pay $502 Million Over Pinnacle Hip Failures

J&J welcomes the court’s “review of the multiple legal issues presented by our appeal, many of which have implications for’’ the remaining Pinnacle cases, said John Beisner, a Washington-based lawyer for the company.

A central issue on appeal is whether Pinnacle’s hips were defectively designed and doomed to fail, forcing costly and painful follow-up surgeries. J&J argues that plaintiffs failed to meet a legal standard that the product was unreasonably dangerous, a safer alternative design existed, and the defect caused the injuries.

J&J also vigorously protests Kinkeade’s decision to let Lanier tell jurors at the trial about a litany of J&J’s bad acts that the company contends had nothing to do with the hips.

The judge allowed Lanier to “inflame the jury’s passions’’ by referring to almost $80 million in settlements J&J agreed to in 2011, amid claims that overseas officials bribed European doctors to implant the company’s hips and knees, the company says. Lanier should have also been barred from telling jurors that J&J paid kickbacks to “henchmen’’ of former Iraqi dictator Saddam Hussein under a United Nations program, the company argues.

The Dallas jury hit J&J with $360 million in punitive damages, which the judge reduced to $9.6 million under a Texas law limiting such awards.

Chamber Brief

The U.S. Chamber of Commerce filed a brief supporting J&J, which also argues on appeal that the plaintiffs failed to prove the company hid the risks from patients and that the trial court lacked jurisdiction.

The hip recipients say they proved a safer alternative design existed and the company’s warnings to patients were inadequate. They note that Lanier mentioned the J&J bribery scandal at the trial only after DePuy’s lawyers “opened the door’’ by hyping the company’s good works.

The plaintiffs are challenging Kinkeade’s decision to apply the punitive-damages cap, saying the measure unconstitutionally tramples on their equal-protection rights. The award was supported by the evidence, they say.

The case is Christopher v. DePuy Orthopedics, No. 16-11051, U.S. Fifth Circuit Court of Appeals (New Orleans).

— With assistance by Christie Smythe

https://www.bloomberg.com/news/articles/2017-12-07/j-j-faces-high-stakes-appeal-to-toss-pinnacle-hips-judgment

September 5, 2017: J&J Depuy Pinnacle hip fourth bellwether Dallas, Texas Federal jury trial begins

http://fortworth.legalexaminer.com/medical-devices-implants/depuy-pinnacle-hip-replacement-lawsuits-back-to-trial-in-texas/

New Jersey and New York residents are the plaintiffs 

http://www.txnd.uscourts.gov/mdl-2244-jury-trial-090517

3:11-cv-02460Kathleen Riedhammer | 3:12-cv-04647Claudia and Alan Heroth | 3:13-cv-00244Susan H. Cousin | 3:13-cv-04119Hazel Miura | 3:14-cv-01776Michael A and Audra L Stevens | 3:14-cv-02341Eugen Jr. and Yolanda Stevens | 3:14-cv-02750Denise Buonaiuto | 3:15-cv-03489Ramon and Carole Alicea | 3:16-cv-01245Uriel and Aviva Barzel | 3:16-cv-01526Karen Kirschner

American Healthcare Giant J&J Stonewalling in Australia: Transvaginal Mesh

Exposed: how Johnson & Johnson cut its risk in vaginal mesh lawsuit.

July 20, 2017  FiDA highlight

* The world’s biggest healthcare group has quietly cut its exposure to victims in its vaginal mesh class-action lawsuit.

* Seven Johnson and Johnson subsidiaries are in breach of the Corporations Act.

* With no explanation, J&J and its auditor PwC reduced accounting disclosures and transparency.

The 700 women suing Johnson and Johnson for faulty vaginal mesh implants will not be pleased to hear that the healthcare giant has quietly reduced its exposure to medical negligence lawsuits.

Buried in Johnson and Johnson’s disclosures to the corporate regulator is a letter from the group’s lawyers King & Wood Malleson to the corporate regulator which shows a Deed of Cross Guarantee between seven of the group’s subsidiaries has lapsed. By allowing the Deed to lapse, the company has effectively reduced the pool of assets which creditors can access in a legal claim.

Previously, this Deed had ensured that the seven Johnson and Johnson companies had, until this year, guaranteed each others’ debts. This no longer appears to be the case. In the event therefore of a successful class action lawsuit, a claim potentially worth hundreds of millions of dollars, the 700 women may have less access to the assets of the world’s biggest healthcare company.

The company, whose market value in the US is $US370 billion, refused to respond to questions for this story. Communications director Meshlin Khouri claimed, “We are endeavouring to respond to your questions in the timeframe that you’ve requested …”.

We extended the timeframe and Khouri failed to respond to all questions. Gavin Fox-Smith, managing director of Johnson and Johnson Medical Australia/NZ was approached for comment but also declined to respond.

Johnson and Johnson is being sued in a class action lawsuit in the Federal Court. The plaintiffs claim faulty pelvic implants have caused them debilitating pain and that Johnson and Johnson failed to properly test the devices. The case is expected to run for six months. It follows a successful class lawsuit last year in which a $250 million settlement was struck with victims of faulty Johnson and Johnson hip implants.

An analysis of ten years of Johnson and Johnson financial statements shows a swathe of irregularities. Unlike its Big Pharma peers Abbvie and Gilead, Johnson and Johnson pays a reasonable amount of tax. Over ten years, the company racked up $12 billion in revenues and paid $238 million in income tax. In comparison to aggressive transfer pricing culprits Gilead and Abbvie, Johnson and Johnson showed gross margins of 40 per cent in Australia over the period; an indication that it is not pillaging the Australian tax base quite as aggressively as its peers.

However, enshrining the trend towards increasingly shoddy accounting and poor financial disclosure by multinational companies and their Big Four auditors – PwC, Deloitte, KPMG and EY – the financial statements of Johnson and Johnson are littered with faults.

For a start, its seven subsidiaries which had been covered by the aforementioned Deed of Guarantee, have failed to file accounts and are now two and a half months late. We can safely assume that the Australian Securities & Investments Commission (ASIC) has failed to fine the company for these myriad breaches.

Without any explanation by its directors or by its auditor PwC, Johnson and Johnson quietly changed from lodging General Purpose financial statements to the inadequate and skimpy Special Purpose variety in 2009.

Here is a company therefore which deems there are no other “users” of its financial statements than its parent company in New Jersey. Here is a company, the world’s largest healthcare group, an institution which has attracted billions of dollars in taxpayer support from Australia’s Pharmaceutical Benefits Scheme, but which deems that no other party apart from its parent company could be interested in its financial statements.

That is, directors and their auditors at PwC deem the victims of Johnson and Johnson lawsuits, the company’s staff, its creditors and the taxpaying public which subsidises the PBS – none of these stakeholders are deemed to have any interest in its financial statements.

PwC, which cooly picked up $6.6 million over the decade for audit and tax advice can’t even get its numbers straight. According to its “Auditors’ Remuneration” note, PwC earned $1.07 billion in audit fees over the past two years, rather than $1.07 million.

Moreover the accounts are larded with completely spurious information about accounting policies relating to items which don’t exist. All this mirrors a systemic failure: a failure of the Australian Accounting Standards Board (AASB) a failure of successive governments and their Ministers for Finance, a failure of accounting peak bodies, a failure of ASIC to police the sector and above all a failure of the global accounting firms to which all these governments, agencies and peak bodies kow-tow.

If the government really had the backbone to fix this problem it could instruct ASIC to issue a guidance note requiring all foreign multinational companies to lodge General Purpose financial statements. This damaging failure of accountants to be accountable could be fixed in a week. Instead, the world’s largest companies operating in Australia, jagging billions in taxpayer subsidies, file inadequate financial statements which allow them to hide critical information and avoid tax.

michaelwest.com.au has been sponsored by GetUp! and the Tax Justice Network to conduct an investigation into the financial statements and tax affairs of 20 multinational companies. 

https://www.michaelwest.com.au/exposed-how-johnson-johnson-cut-its-risk-in-vaginal-mesh-lawsuit/

J&J Accused of Criminal Behavior: Pelvic Surgical Mesh

Protest Targets J&J CEO on Day of Annual Shareholder Meeting

Women Allegedly Harmed by Pelvic Mesh Express Disappointment with J&J

ARTICLE | MAY 11, 2017 - 9:48PM | BY DAVE SCHATZ   FiDA highlight

MAM co-founder Lisa Mason is seen here during a rally on April 27 outside the State Theatre. Mesh Awareness Movement

NEW BRUNSWICK, NJ–Members of  the Mesh Awareness Movement (MAM) want Johnson & Johnson’s (J&J’s) shareholders “to know they are investing in criminal behavior,” according to a statement.

The group, a grassroots effort to bring awareness to the harmful effects of mesh on the human body, held a rally against J&J in New Brunswick on April 27, during its annual meeting of shareholders. 

MAM has a Facebook group that's grown from about 20 to 700 people in just a year-and-a-half, according to co-founder Tammy Jackson, who said others have contacted her but aren't keen on taking part in social media due to their attorneys' advice.

Jackson said a couple woman in the group were recently offered $189 by the pharma giant to settle their cases, but declined, while five others she knows personally accepted $4,000, and seven received $200,000, in the past six to seven months.

“It’s hard to get people so badly injured to travel across the country and stand all day,” said Jackson, a 50-year-old resident of Kentucky, and former nurse, adding she also brought chairs to the rally for some of the women.

Yet during the hour-plus meeting of shareholders inside the State Theatre, where audio was streamed live on the internet, the women held a protest outside the theatre and say they feel their voices were heard.

Their chants included:

• “No more mesh…”
• “Stop the harm, No more profits.”
• “You are not going to be able to hide from us.”
• “Profit over lives.”

Jackson has had 17 mesh removal and reconstruction surgeries over the past four years, she said.

“Trying to remove mesh out of your pelvic is like removing rebar out of concrete," said Jackson. "Your bladder is angry."

J&J says "we are nothing more than a 'cost of doing business.' We say, we are a hundred thousand severely and permanently injured people who could just as easily be your wife, mother or sister," continues MAM’s statement.

"It doesn’t matter to [J&J] that they’ll have to spend, for example, $2.5 Billion in Litigation, Verdicts, Penalties and fines because they’ve already made $25.1 Billion,” added the statement.

Jackson’s 10-year-old daughter was interviewed for a documentary about patient safety while in the Garden State with her mother and father for the rally.

She told the producers, “I would say quit making mesh and help my mommy,” according to Jackson, who said many MAM members were also interviewed for the film. 

“Where's the media?” wondered one MAM member during the rally. “They need to tape this -- we should flood the TV stations.”

One journalist, Jane Akre, operates the Mesh Medical Device News Desk (MMDND), and was present for J&J's annual meeting of shareholders on the morning of April 27. 

She thought the presentation to J&J's stock holders was "rehearsed" and highlighted "the health of J&J's stock," as Alex Gorsky, J&J's chief executive officer, repeated the words "sustainable" or "people come first." 

Yet across the street, she writes, via an "orderly, heart-felt display," some 30 women and their families rallied.

But their signs indicated they didn't feel like they came first: “The Johnson & Johnson Credo: ‘Research must be carried on, innovative programs developed and mistakes paid for.' Pay the mesh injured for your mistake!”

“Mr. Alex Gorsky” was targeted by another sign that continued, “The highest form of ignorance is when you reject that which you know nothing about.”

A sign urged Gorsky to “Talk to the mesh injured,” while the message on another read: “#SerialKiller CEO. It’s time for you to go!”

"Each [woman] represents at least 10,000 [pelvic] mesh implanted women who can’t make it to a mesh rally, because they are too sick or broke from fighting to regain their health! And that doesn’t even begin to include the one million hernia mesh implants a year!” wrote Akre.

"All use polypropylene! Some day in the not so distant future, we may come to recognize that this cheap plastic is not an ideal, bio-compatible material for an implant, I believe."

"The legal facts have shown that [J&J] knew these mesh devices were unsafe, but they quickly put them on the market anyway... bypassing proper FDA approval, failing to conduct thorough testing and withholding serious risks and warnings,” continues MAM’s statement.

"Little did I know that [during the shareholders meeting], a Philadelphia jury was delivering the third verdict for a plaintiff in another mesh trial – $20 million, which included $17.5 million in punitive damages!"

http://newbrunswicktoday.com/article/protest-targets-jj-ceo-day-annual-shareholder-meeting#.WRTstHiim44.facebook

Akre wondered whether J&J might now be considering a "multi-billion dollar global settlement" and whether "fighting mesh-injured women in court" is worth it. 

The pharma giant is facing $34.5 million in punitive damages, plus other amounts awarded by juries in three separate mesh trials in Philadelphia state court, according to reports.

Akre noted that after half a decade of writing reports for MMDND, media coverage of mesh issues is gaining  some traction.

"Internationally, the media is less afraid to report of Pharmaceutical Giants," she writes citing front page stories in Scotland, Australia, New Zealand and the UK, for instance.

Though Akre provided coverage of the April 27 MAM rally, she said very few reporters were there.

“It was a powerful day," said one woman who took part in the event.

"J&J had a line of buses on the other side of the street to block the view of the rally. [The company] rented those buses with money they earned from harming us,” she added, saying that she felt like J&J owned New Brunswick.

J&J did not respond to a request for comment. 

http://newbrunswicktoday.com/article/protest-targets-jj-ceo-day-annual-shareholder-meeting#.WRTstHiim44.facebook

Deaf and Blind Medical Device Giant J&J: Harmed Patients Demand REAL Consumer Warranties!

How J&J’s Walmart relationship is inspiring its device business

By ARUNDHATI PARMAR  FiDA highlight

 Oct 31, 2016 at 6:02 PM

The Affordable Care Act has laid the groundwork for a seismic shift in the way the medical device industry operates.

Traditionally, large companies like Johnson & Johnson built up an army of sales reps who would have relationships with the same hospital customer but touting the New Jersey’s companies individual products — be it cardio, ortho or general surgery. As value-based care gains a footing, health systems are focusing on how they can lower costs and improve outcomes through services and solutions as opposed to buying more and more hardware and implants that device firms are known for.

J&J’s medical device business has been ill-equipped to adjust to this shift and its financial performance has been poor. Last year it garnered $25.1 billion, down 8.7% from 2014. The division has also restructured and announced it would be eliminating thousands of jobs earlier this year. In a phone interview, Gary Pruden, J&J’s executive vice president and worldwide chairman for medical devices, explained how the unit is undergoing a wholesale metamorphosis to take advantage of the opportunities afforded by value-based care. One inspiration has been to take a page out of the consumer business book and see how it manages a really large customer:Walmart.

Gary Pruden, worldwide chairman,                                               J&J Medical Devices

“I have more than a dozen companies in the U.S. for example and in the past, they would all go to the hospital system provider separately. They all have separate P&Ls, they all operate independently, they all go separately,” Pruden recalled. “We made a conscious decision and actually this year we integrated all the different business into one single P&L and I have one single strategic account management group in the U.S.”

This model is unlike how other large device firms are fulfilling their go-to-market strategy. For them, the product business and solutions business sit separately, Pruden declared referring to the likes of Zimmer Biomet and Stryker.

“They are trying to bring together a compilation of [offerings] and those solutions providers operate separately from those individual businesses,” Pruden claimed. “And when you talk to [hospital] customers, that’s a little challenging. They want to talk to one person.”

At J&J, that single account management group now has the power to speak on behalf of the product and service offerings of J&J Medical Devices with a single voice as well as to strike deals with hospital customers, partner with them and write contracts. The goal is not only to lower their costs but also share in the risk for clinical outcomes, Pruden said. If J&J  is able to achieve both, it wins with greater volume of products sold.

Pruden wouldn’t provide specifics about the value-based care offerings but said that there are certain demonstration projects with certain hospital customers, both U.S and globally. Through them, J&J’s medical device business can offer its expertise in providing end-to-end supply chain solutions for hospitals, perioperative efficiency, clinical standardization programs as well as in help in figuring out bundled payment programs.

In trying to create a model by which the devices team at J&J would be able to provide savings by managing a customer’s supply chain end-to-end, the inspiration came from the conglomerate’s consumer business.

“With Walmart, we have a very unique partnership where we have a large number of people working in Bentonville, on behalf of Walmart that help manage the end-to-end supply chain,” Pruden said.

This model is already being put to use in the U.S., but Pruden declined to identify the customer or customers with whom this program has rolled out. [In May, Pruden’s presentation to analysts showed the Medical Devices business had at least had eight such customers – or strategic partners. They include New England Baptist Hospital, OSF Healthcare, Saint Luke’s Health System, Grupo Angeles Servicios De Salud and Schulthess Klinic among others]

He was similarly elusive when asked about the types of products for which the corporation has taken on some risk. This is in direct contrast to other device companies that are not only providing full-throated support for alternative payment models that mean bearing more risk with hospitals but actually identifying the product at the heart of the matter.

Take Stryker for instance.

Earlier this year, the Kalamazoo, Michigan orthopedic company announced that it is providing no less than a “money-back guarantee” for customers who use its SurgiCount system to keep track of the surgical sponges that in some cases may inadvertently get misplaced, ending up inside surgical patients. Stryke said that it would offer up to $5 million in product liability indemnification to hospitals and an additional guarantee to refund the incremental cost hospitals bear to invest in its SurgiCount program compared with the hospital’s previous sponge spending for up to three years.

Medtronic, the largest pure-play device company, has also gone at-risk with its Tyrx absorbable antibacterial envelope. The mesh device is meant to encapsulate a pacemaker and ICD  and release antimicrobial agents over a period of seven days to prevent surgical site infections of such cardiac devices.

While Pruden didn’t provide any specific example of products that J&J Medical Devices, he was very emphatic about the need for device makers to assume some risk with their products as they become more of a strategic partner to hospitals than a supplier. And that can mean the difference between a supplier relationship always on the verge of being cut and a long-term strategic partner.

“That’s the essence of what I am doing – aggregating our businesses at scale, offering some willingness to take some risk and leveraging the enterprise and some of the things we can do to create some value,” he said. “Partnerships that only go one way don’t last very long.”

http://medcitynews.com/2016/10/jjs-medical-device-chief-taking-inspiration-consumer-business/

J&J relies on European registries for recall data: FDA fails to protect US citizens.

J&J’s Ethicon recalls Physiomesh flexible composite hernia mesh

JUNE 20, 2016 BY BRAD PERRIELLO   FiDA highlight

Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon last month recalled 1 of its surgical mesh products after studies showed higher revision rates after a type of minimally invasive hernia repair using its Physiomesh flexible composite mesh.

In a May 25 letter to healthcare providers, Ethicon said it’s pulling the mesh after a review of unpublished data from a pair of European registries revealed the discrepancy between Physiomesh flexible composite and the other meshes in the registries after laparoscopic ventral hernia repair.

West Somerville, N.J.-based Ethicon said it believes the higher revision rates are due to a “multifactorial issue,” possibly including “product characteristics, operative and patient factors,” but hasn’t been able to pin down a cause.

“Consequently, Ethicon [has] not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and [has] decided to recall Ethicon Physiomesh composite mesh from the global market,” according to the letter. “Ethicon will not return theEthicon Physiomesh composite mesh product to the market worldwide.”

Patients already implanted with the product should be followed as usual, the company said. The recall does not involve any other Ethicon meshes, including the Physiomesh Open flexible composite mesh, it said.

“Ethicon recognizes the voluntary product recall of the Ethicon Physiomesh composite mesh may be disruptive to your facility and apologizes for any inconvenience this may cause,” the company wrote. A list of the affected product codes can be found here.

http://www.massdevice.com/jjs-ethicon-recalls-physiomesh-flexible-composite-hernia-mesh/

Patient's sin is to rely on surgeon's advice! Surgical mesh trial.

Potential multimillion dollar mesh trial goes to jury

BY COURTENAY EDELHART The Bakersfield Californian cedelhart@bakersfield.com  Thursday, Feb 26 2015 05:47 PM  FiDA highlight

A jury of three women and nine men began deliberating late Thursday in a transvaginal mesh trial brought by a Bakersfield woman and her husband, a case that has garnered national attention.

Coleen Perry, 52, of Bakersfield, filed a lawsuit against New Brunswick, N.J.-based Johnson & Johnson and its wholly owned subsidiary, Ethicon Inc., over complications from a medical device implanted in her in March 2011 to treat stress-induced incontinence, or brief urination with coughing, sneezing, laughter or other exertion.

There has been a tidal wave of lawsuits over synthetic surgical meshes implanted through the vagina since the U.S. Food and Drug Administration issued a notification in 2008 that it had received high numbers of complaints about them. Three years later the FDA issued an advisory about serious complications.

In 2012, a jury awarded Christine Scott, also of Bakersfield, $3.6 million in a similar case against C.R. Bard Inc., which manufactures a rival device designed to treat the same condition.

Both women said after the implants, their incontinence did not improve, and they were left with chronic pain that had ruined their ability to have comfortable intercourse.

Perry is seeking at least $17.2 million for past and future medical expenses, pain and suffering and punitive damages.

Perry testified that her husband's penis has been left with abrasions by portions of the mesh that poked through her vaginal wall. She's had a follow-up surgery to remove the part that was sticking out, but the entire mesh cannot be removed because it is permanently intertwined with natural tissue.

Her attorneys argued that Johnson & Johnson knew it had a defective product and concealed those defects from doctors, consumers and the FDA, pointing to internal memos and emails in which employees cited concerns that went unheeded.

Johnson & Johnson said those emails had been "cherry picked" and produced other emails in which those same employees said they were reassured by testing.

Attorney William Gage asked jurors not to read too much into the exchange, saying it was a normal part of the development process.

"If your medical device company is not vigorously debating the safety of a medical device, we've got a real problem," he said.

Gage also said it was a coincidence that language describing the mesh as light weight was removed from a company website during the trial, putting a witness on the stand who said the website overhaul had been planned months ago and the timing was coincidental.

Over the course of the eight-week trial in Kern County Superior Court, Perry's lawyers argued that the company's laser-cut mesh was sharper and heavier than others on the market and therefore more prone to erosion and shrinkage.

Gage said no medical device is entirely without risk and Perry signed an informed consent form acknowledging a risk of erosion, among other things, prior to surgery. Moreover, he argued, she had a host of other medical conditions and procedures that likely were the source of her symptoms.

Perry's attorneys called that a red herring and put Dr. Hung Luu, who did the original surgery on Perry, on the stand. Luu started out as a defendant but was later removed as a party to the case, and testified that he would not have implanted the device had he known it was heavy (which Johnson and Johnson disputes) and had a lot of problems. Luu said he is no longer using the mesh in his practice.

The informed consent Perry signed wasn't actually informed, attorney Rich Freese argued, because all the facts weren't available to Perry or her doctor when Perry agreed to the surgery.

"Coleen relied on her doctor, and Dr. Luu was relying on Johnson & Johnson and Ethicon," he said. "That was Coleen's sin."

http://www.bakersfieldcalifornian.com/health/x406538764/Potential-multimillion-dollar-mesh-trial-goes-to-jury