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

Giant J&J quietly moves/'streamlines' annual meeting.

Johnson & Johnson Quietly Switches Venues, Shortens 2015 Shareholders Meeting

Brunswick-Based Pharmaceutical Company: "We Have Adjusted the Format of This Meeting to Better Align With Current Industry Practices"

ARTICLE | APRIL 14, 2015 - 11:30AM | BY DAVE SCHATZ

NEW BRUNSWICK, NJ–For the first time since April 26, 1989, Johnson & Johnson's annual shareholders meeting will be held at the historic State Theatre in New Brunswick.

After frequent protests at previous shareholder meetings, the consumer products giant has quietly moved the big meeting, coming up on April 23 at 10 a.m., from its usual location, the Hyatt Regency Hotel, and has significantly shortened the meeting to one hour.

Previous meetings included a free lunch and gift bag for all in attendance, but that won't be the case this year.

“We are pleased to be hosting the 2015 Annual Meeting at The State Theatre of New Jersey. Johnson & Johnson is a long-time supporter of this wonderful space, and it has hosted our Annual Shareholders Meeting in the past,” said a J&J spokeswoman.

J&J said they've adjusted the format of the upcoming meeting “to better align with current industry practices.” It will be webcast live, and also available for replay following the meeting. 

But the running time of the meeting is scheduled for only one-hour, while 2014's ran for at least an hour and one-half. According to J&J it will include the formal completion of items of business for the year, a brief update from Chairman/CEO Alex Gorsky, and an open question and answer session.

“The agenda for the meeting remains essentially unchanged, but the business highlights presentation has been streamlined,” J&J told NB Today.

“We conducted a benchmarking study of our peer companies to understand best practices for these meetings and have adjusted our program to align with those standards.”

A group of five individuals who were injured by one of J&J's products flew to NJ at their own cost and visited the Hub City to protest the mesh implants and request an internal investigation over the shredding of papers, at last year’s annual shareholders meeting.

The group held a news conference on the public sidewalk where many shareholders saw the demonstration.

Last year, police constructed a fire and set off an explosion after the meeting was over.

“It was exploded after everything was over, like they didn't need it anymore,” said journalist Jane Akre, who gathered the group for the trip to New Brunswick. She added that she thought setting up the explosion was “overreaction.”

“You have to believe they were surprised by our visit last year,” Akre told NB Today.

“They brought in the state troopers and angry German Shepherds and even had an explosion designed to designate as a diversion if necessary.”

J&J will report financial ratios in today's First Quarter Earnings Call, which will also be available as a Webcast. Its shares fell 1.5 percent to $100.55 yesterday.

“Investors and other interested parties may access the live audio webcast of the [annual shareholders] meeting by visiting the Company's website at www.jnj.com and clicking on the webcast icon,” reads a release.

http://newbrunswicktoday.com/article/johnson-johnson-quietly-switches-venues-shortens-2015-shareholder-meeting

About the Author

Dave Schatz

Reporter

Dave Schatz covers mostly business, but also enjoys sports reporting.

You can contact him at dschatz@newbrunswicktoday.com or @dave_schatz on Twitter.

Surgical Mesh Harmed Patients call on Attorney General: Dangerous Product

Injured Women Call on WashingtonAttorney General to Investigate

Posted: Monday, June 9, 2014 12:33 pm

Injured Women Call on Washington Attorney General to Investigate

Johnson & Johnson:

Washington Women Cite Injuries and Public Health Care Costs in Letter to AG Ferguson

Olympia, WA – Washington women who have been seriously injured by pelvic mesh implants asked Washington Attorney General Bob Ferguson to investigate Johnson & Johnson for its dangerous pelvic mesh implants, citing their personal health problems and costs incurred by Washington taxpayers.

“We ask that Attorney General Ferguson investigate Johnson & Johnson and its CEO Alex Gorsky for selling dangerous products to women throughout the state of Washington. The damage this product has caused already has cost taxpayers too much money through Medicaid and other state public health systems,” stated Jane Akre, who has been organizing survivors of pelvic mesh implants for more than five years.

“Across Washington, women are being hurt by Johnson & Johnson’s dangerous products, and the company’s top executive, CEO Alex Gorsky, needs to be held accountable for the women he has hurt,” added Akre. “Pelvic mesh implants are perhaps the most dangerous product to women’s health on the market today. Gorsky should immediately take this dangerous pelvic mesh product off the market.”

More than 70,000 separate lawsuits have been filed against manufacturers of pelvic mesh implants. Local survivors in Washington signed onto today’s request for an investigation.

"Johnson & Johnson should be investigated because too many have suffered too long, and they need to bring a stop to it,” stated survivor Danyelle Robinson of Washington. “Something has to be done to assure there are substantial penalties."

See the letter to Attorney General Ferguson directly below.

# # #

June 9, 2014

By Facsimile: 206-587-5636

The Honorable Bob Ferguson

Attorney General

Washington State Office of the Attorney General

1125 Washington Street SE

PO Box 40100

Olympia, WA 98504-0100

Dear Attorney General Ferguson,

As survivors of pelvic mesh implants and Washington taxpayers, we request that your office immediately begin investigating whether Johnson and Johnson should be held liable for expenses incurred by the state as a result of dangerous and defective pelvic implants.

Johnson and Johnson is the largest producer of pelvic mesh implants in the world. This product is creating a health crisis among women across the state of Washington, which in turn is resulting in significant costs to the states' public health systems.

Specifically, we ask for you to investigate Johnson and Johnson and its Chairman Alex Gorsky for possible violation of section 19.86.20 of the Revised Code of Washington for deceptive and fraudulent business for their knowledge of the danger of the mesh implants and the public health systems’ costs to the taxpayers of Washington.

This request follows the recent revelation by a West Virginia court that Johnson and Johnson destroyed numerous documents relevant to lawsuits filed against the company by thousands of women across the United States who have been seriously injured by the company’s pelvic mesh implants.[1]

It is critical that the Washington State Office of the Attorney General pursue this matter to recoup the state taxpayer dollars Medicaid and other public health systems have been and will be forced to spend to treat women who have been injured. Action by the state attorney general will also demonstrate that a major U.S. corporation should not destroy evidence in judicial proceedings. The destruction of this evidence undermines the ability of Washington women who have been hurt by Johnson & Johnson to receive justice.

Background

In the last few years, medical device manufacturers including Johnson & Johnson have come under fire for marketing dangerous medical devices, drugs and other consumer products, often without receiving proper regulatory approval. Many of these companies, including Johnson & Johnson, have paid billions of dollars in fines in litigation and settlement costs and made repeated pledges of reform, yet continue to display an indifferent attitude toward the harm they have caused as well as a willingness to evade the law.

Currently, Johnson & Johnson faces thousands of product liability lawsuits relating to the company’s pelvic mesh implants, marketed most commonly as treatment for pelvic organ prolapse and stress urinary incontinence. There are estimated to be hundreds of thousands of women that have been – and continue to be - implanted with these dangerous products. Women have suffered severe pain and injuries due to ineffective and dangerous implants.

Investigations into the pelvic mesh products produced by several companies, including Johnson & Johnson, date back to before October 20, 2008, when the FDA first issued a Public Health Notification.[2]

Beginning in March 2005, Johnson & Johnson sold one of its most popular devices, the Gynecare Prolift, without alerting the Food and Drug Administration for three years. When the FDA was made aware of the Prolift device, the agency informed Johnson & Johnson that the device required government approval.[3] In May 2008, the Prolift was cleared for sale under the 510(k) process under the claim of “substantial equivalence” to devices already on the market. It had never been rigorously tested nor demonstrated effective in clinical trials.[4]

Further indicating Johnson & Johnson knew how harmful pelvic mesh implants were but nevertheless continued marketing the defective product to unsuspecting women, the company destroyed thousands of documents regarding the implants. Although top company executives initially denied it, a magistrate judge found that Ethicon, a wholly owned subsidiary of Johnson & Johnson that manufactured the implants, destroyed documents pertaining to their effectiveness and safety as far back as 2007.[5] Alex Gorsky, the current Chairman and CEO of Johnson & Johnson, was named head of Ethicon in 2008, before most of the documents were destroyed, and has continued to oversee it in his climb through the company’s ranks.[6]

Apparent Violation of Law

Johnson and Johnson and its CEO Alex Gorsky may be in violation of section 19.86.20 of the Revised Code of Washington for unfair or deceptive business practices concerning both his corporation’s knowledge of the inherent danger of the mesh implants as well as the document destruction.

The Washington State Office of the Attorney General has the authority to conduct a comprehensive and thorough investigation into whether Johnson & Johnson, in the course of advertising, soliciting, selling, promoting and distributing pelvic mesh implants, has engaged in a course of trade or commerce that constitutes unfair or deceptive acts or practices, and is therefore unlawful under the Washington consumer protection laws by misrepresenting the safety of pelvic mesh implants.

The fact that Johnson & Johnson has offices and conducts business throughout Washington only adds to the importance of your office pursuing this matter.

Johnson & Johnson also may have violated Washington Case Law pertaining to destroying physical evidence in an official proceeding.[7] In Pier 67, Inc. v. King County, the Court held “where relevant evidence which would properly be a part of a case is within the control of a party whose interests it would naturally be to produce it and he fails to do so, without satisfactory explanation, the only inference which the finder of fact may draw is that such evidence would be unfavorable to him.”[8] Culpability turns on whether the party acted in bad faith or whether there is an innocent explanation for the destruction.[9]

After initial denials by top executives, it is now clear that Johnson & Johnson destroyed thousands of documents related to Ethicon’s development and marketing of pelvic mesh implants.[10]

Johnson & Johnson is one of the world’s largest corporations whose products are used not only by women but also children and men. This investigation is urgently needed as the lives and safety of so many women in Washington and across the United States depend on it.

Please do not hesitate to contact us if we can provide any further information. Thank you for your consideration.

Sincerely,

Patricia Buchanan – Seattle, WA

Danyelle Robinson – Spokane, WA

Mary Wakefield – Colbert, WA

Elizabeth Weber – Spokane, WA

Failed Implanted Medical Device 'phased out'

J.&J. Unit Phasing Out All-Metal Hip Devices

By BARRY MEIER   The New York Times

Published: May 16, 2013  FiDA highlight

The orthopedic unit of Johnson & Johnson said Thursday that it was phasing out production of all-metal replacement hips, a move reflecting an industrywide trend to abandon the once widely used implants because of high early failure rates.

In 2010, the company, DePuy Orthopaedics, recalled an all-metal model known as the Articular Surface Replacement, or A.S.R., because it was failing just a few years after implant. Typically, artificial hips made from materials like plastic and metal last 15 years or more before they wear out and need to be replaced.

But after that recall, the company continued to sell an all-metal version of a popular hip model called the Pinnacle. In doing so, DePuy insisted that the all-metal Pinnacle was safe and performing on par with other hip replacements, a position it reiterated on Thursday.

It is estimated that all-metal replacement hips — in which both the cup and ball of a device are made from metal — once accounted for about one in three hip implants used in the United States. However, the metal components rubbed against each other as a patient moved, creating tiny particles that could damage tissue, muscle and bone.

Johnson & Johnson is facing a wave of lawsuits from patients who say they were injured when all-metal implants sold by the company failed. It faces over 10,000 cases related to the A.S.R. and 3,300 cases related to the all-metal Pinnacle, according to a company filing with the Securities and Exchange Commission

In a statement Thursday, DePuy pointed to two factors behind its decision to drop the all-metal Pinnacle: sharply declining surgeon demand for all-metal devices and a recent ruling by the Food and Drug Administration affecting such products.

In January, the agency told producers of all-metal hips that any models that were cleared for sale through a regulatory route that did not require premarket clinical testing in patients would have to run such studies to continue selling them.

“DePuy has communicated to the F.D.A. its decision not to pursue” such studies for the device, the company said in its statement.

The company said it was also discontinuing sales of a metal component that can be used with a ceramic hip implant called the Complete. Sales of the metal component used in both the Pinnacle and the Complete will end in August, the company said
.