Dallas Federal Court Trial Begins: J&J DePuy Pinnacle Hip

http://www.wfaa.com/story/news/health/2014/09/03/hip-implantspinnaclelawsuit/15041145/

National hip implant trial begins in Dallas

Byron Harris, 1:51 p.m. CDT September 4, 2014

Plaintiffs claim the DePuy Pinnacle hip was not properly tested before being marketed to orthopedic surgeons

DALLAS — A national court case involving thousands of hip implant patients suing a subsidiary of Johnson & Johnson is now underway in Dallas.

The focus is the DePuy Pinnacle hip, which the company quit selling in August 2013.

The pool of plaintiffs is so large that a handful of so-called "bellwether" plaintiffs have been selected from more than 6,000 people who have filed suit. This smaller pool of cases will be argued before juries, and the verdicts will be used to determine settlements against Johnson & Johnson.

Opening arguments in Kathleen Herlihy-Paoli vs. DePuy began Wednesday before U.S. District Judge Ed Kinkeade in downtown Dallas.

Paoli, of Missoula, Montana, got a DePuy Pinnacle implant in 2009. She has now had a combined total of five implants on both her hips, and was hurt by metal-on-metal wear in the DePuy devices that were placed in her body.

Metal-on-metal wear of chrome and cobalt components can create adverse health effects in some patients.

Paoli's attorney, Mark Lanier of Houston, argued that DePuy did not properly test the Pinnacle device before releasing it to the market. Under an FDA provision called 510K, medical devices that substantially resemble other devices already on the market can be released with less stringent testing than original designs.

Lanier told the jury that DePuy ignored failures of the Pinnacle device, and made hundreds of millions of dollars in profits while marketing the device to orthopedic surgeons.

DePuy's attorney, Richard Sarver of New Orleans, said Paoli's problems were caused by improper implantation of the device. He also contended that DePuy never improperly paid physicians to use its devices, and that the medical community has long known of the risks of metal particles.

Joleen Chambers of the Failed Implant Device Alliance has been arguing for increased scrutiny of medical devices for years.

"Before these companies get to market their product, they should have post-market surveillance in place so we can track the devices in real time, permanently," she told News 8.

Chambers has been a vocal opponent of the FDA's role in approving hip implants. "It's [the FDA] not working to prove that these devices are safe before they go to market," she said.

The trial is expected to continue for several weeks.

Last fall, Johnson & Johnson settled a case for $2.5 billion relating to another DePuy hip design involving 8,000 patients.

E-mail bharris@wfaa.com

COURTROOM RULES DO NOT ALLOW PATIENT ADVOCATE TO TAKE NOTES ON COMPUTER 

FOLLOW THE TRIAL HERE.

 _______________________________________________________________________________ 

https://www.linkedin.com/jobs2/view/19275115?trk=biz-overview-job-post

Director, Federal Affairs, Medical Devices

Johnson & Johnson - Washington, DC, US

Posted September 4, 2014

Job description

Director, Federal Affairs, Medical Devices-8659140703

Johnson & Johnson is currently recruiting for a Director, Federal Affairs, Medical Devices. This position is located in Washington, DC and requires up to 25% travel.

Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

With $71.3 billion in 2013 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 127,000 people in 60 countries throughout the world.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Director, Federal Affairs will be responsible to develop, implement and direct federal lobbying activities in support of the corporation’s medical device legislative and policy priorities primarily focused on J&J’s Global Orthopedics business (world’s largest orthopedics company).

A key component of the position is to represent the corporation both internally and externally on federal affairs matters relating to the Centers for Medicare and Medicaid Services, Food and Drug Administration, congressional relations, Administration outreach, relevant trade associations and affiliated patient and physician stakeholder organizations. Some of the official assignments may also require coordination with additional business partners including the pharmaceutical and consumer operations within the Enterprise.

The Director, Federal Affairs will work internally and externally on matters relating to the specific medical device & diagnostics businesses in collaboration with specific franchises as well as represent federal affairs on numerous broader-based healthcare issues and activities. He or she will also work on health care policy and corporate priority assignments within US Government Affairs as determined by managers, such as building relationships with identified stakeholders i.e.: congressional caucuses, patient, physician and other professional societies and stakeholder organizations.

This position requires the incumbent to interact with internal J&J colleagues including US Government Affairs, International, Health Policy Group, J&J Corporate Communications, Law, J&J operating company and Corporate personnel and senior management – specifically J&J’s Global Orthopedics business. External customers including: Members of the US Congress, Administration, state officials and additional J&J customers. This position will report to the Senior Director, Federal Affairs, Medical Devices & Diagnostics.

Qualifications

A minimum of a Bachelor’s Degree is required. An MBA, Masters, JD and/or equivalent graduate degree is preferred with concentration in healthcare policy, political science, communications or business administration preferred. A proven record of success in policy development and advocacy is required. A minimum of 10 years of experience in government affairs or public policy is required. A minimum of 5 years of health policy experience is required. Thorough knowledge of communications, Federal and/or State government policy and legislative process is required. Candidate must be a self-starter with exceptional initiative and ability to work effectively with minimal supervision. Excellent oral and written skills are required.

BE VITAL in your Career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-District of Columbia-Washington

Organization: Johnson & Johnson Services Inc. (6090)

Job Function: Government Affairs

Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.

Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

EEO is the Law

EEO is the Law GINA Supplement

About this company

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Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Our Family of Companies comprises:

The world's premier consumer health company.

The world's largest and most diverse medical devices and diagnostics company.

The world's third-largest biologics company.

And the world's sixth-largest pharmaceuticals company.

We have more than 250 operating companies in 57 countries employing 120,200 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

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         Johnson & Johnson J&J Careers is on Twitter. Follow us at @JNJCareers and @JNJuniversity for career tips, J&J news and inside information on what it is like to work at J&J.

        

         



                 

         


Lady Parts, Greg Abbott and JNJ Deceptive Trade Practices Mesh Up

 Greg Abbott Not Totally Afraid of Lady Parts,Takes on Big Pharma Over Vaginal Mesh

By Amy Silverstein

Published Fri., Jul. 11 2014 at 7:08 AM

Future Texas Governor Greg Abbott hates nothing more than he hates abortions, Planned Parenthood and other women's-health-related things, leading the Texas Democratic Party to describe him as "public enemy number one for women in Texas." But now, in a major national fight pitting women's health advocates against a corporate giant, Abbott appears to have jumped in bed with women and their bodies.

For the past two years, the Texas Attorney General's office has been quietly leading an investigation into Johnson & Johnson's Ethicon subsidiary, after thousands of women nationwide alleged in lawsuits and complaints to the FDA that the company's pelvic mesh products are defective.

As I reported in a recent feature story on mesh, Ethicon and other companies thought they'd discovered a new, easy way to cure poor bladder control and similar health ills common in aging women and women who have had babies. The fix, rushed to the market in the late 90s, is a surgical device made out of plastic surgical mesh, inserted through the vagina. Patients have complained en masse that the "fix" destroyed their sex lives, worsened their incontinence and caused horrendous pain. More than 17,000 lawsuits have been filed against Ethicon alone.

The FDA was slow to respond, but in 2011 regulators finally issued a warning that complications from some of the mesh surgeries are "not rare." The FDA has yet to issue a formal recall.

Abbott, meanwhile, is investigating Johnson & Johnson under the Texas Deceptive Trade Practices-Consumer Protection Act. In a demand letter sent in April, the Attorney General asked Johnson & Johnson for physical samples of the mesh, detailed data on the material it's composed of, a list of all websites sponsored by Johnson & Johnson discussing the mesh and other data. That's only the latest request for information, following up on a separate demand the Attorney General sent in March 2013. The whole investigation began two years ago, the AG's office tells Unfair Park.

The investigation became public after a group of Texas women wrote a letter to Abbott asking him to crack down on the company, only to find out that he's already looking into it, as WFAA reported.

Women's health aside, Texas and other states have its own reasons to investigate this. "You, as a tax-payer, you're paying for the Medicare patients who have had this thing in," Dr. Daniel Elliott, a surgeon at the Mayo Clinic who treats women suffering mesh complications, told us a few months ago. "Then the patient has all these complications, and you as the taxpayer are paying for their original surgery and you're paying for all these treatments afterwards. It's a huge financial burden on the system."

PUBLIC COST of J&J surgical mesh: will TX Attorney General act?

REQUEST FOR INVESTIGATION DELIVEREDTO TEXAS ATTORNEY GENERAL GREG ABBOTT  

FIDA Highlight

Post Date

June 25, 2014

June 25, 2014                         
By Facsimile:  512-275-2994



The Honorable Greg Abbott


Office of the Attorney General


State of Texas


300 W. 15th Street


Austin, TX  78701



Dear Attorney General Abbott,



As survivors of pelvic mesh implants and Texas taxpayers, we request that your office immediately begin investigating whether Johnson & Johnson (JNJ) should be held liable for expenses incurred by the state as a result of dangerous and defective pelvic mesh implants. Johnson & 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 Texas, which in turn is resulting in significant costs to the state’s public health systems.   

Specifically, we ask for you to investigate Johnson & Johnson and its CEO Alex Gorsky for criminal violation of the Texas Penal Code pursuant to Sec. 32.42 of the Deceptive Business Practices Act for the corporation’s knowledge of the inherent danger of the mesh implants as well as the document destruction.

 The pelvic mesh industry also should be held accountable to the Texas State treasury for those funds spent for pelvic mesh-attributable costs to the Medicaid Program, the State Employee Retirement System, the State Employee Group Insurance Program, and charity care.

 The State of Texas also operates a number of health care facilities that provide medical care to qualifying persons who are not eligible for Medicaid, including state hospitals and university health science centers. The State of Texas pays for all or part of this care. The State of Texas has expended and will continue to expend substantial sums of money due to the increased cost of providing health care services for treatment of pelvic mesh-related injuries. 

This request follows the recent revelation by a West Virginia court that Johnson & 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 Texas Attorney General’s Office 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.  

Only the Texas Attorney General, not consumers, can bring suit under the statute’s broad prohibition of deceptive acts.

 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 our ability as Texas 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 these 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, the 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

 The pelvic mesh industry led by Johnson & Johnson and its CEO Alex Gorsky may be in criminal violation of Texas Penal Code pursuant to Sec. 32.42 of the Deceptive Business Practices for both his corporation’s knowledge of the inherent danger of the mesh implants as well as the document destruction. 

The Texas Attorney General’s Office has the sole 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 deceptive business practices and is therefore unlawful under the Texas consumer protection laws by misrepresenting the safety of pelvic mesh implants. 

Johnson & Johnson also may have violated Texas Case Law pertaining to destroying physical evidence in an official proceeding [7].  After initial denials by top executives and their counsel, it is now clear that Johnson & Johnson destroyed thousands of documents related to Ethicon’s development and marketing of pelvic mesh implants [8]. 

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

Johnson & Johnson is one of the world’s largest corporations whose products are used throughout Texas.  This investigation is urgently needed as the lives and safety of so many women in Texas and elsewhere depend on it.

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



Sincerely,



Janet Holt – Floresville, TX


Kimberly Fox – Dallas, TX


Diana Coleman – Lavernia, TX


Debbie Mitchell – Red Oak, TX


Donna Hart — Pointblank, TX


Texas survivors of pelvic mesh implants.



[1] Consolidated case is In Re Ethicon Pelvic Repair System Products Liability Litigation, 12-MD-02327, U.S. District Court, Southern District of West Virginia (Charleston).

[2] http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm

[3] http://www.bloomberg.com/news/2012-03-21/j-j-sold-vaginal-mesh-implant-without-u-s-regulatory-approval.html

[4] http://www.accessdata.fda.gov/cdrh_docs/pdf7/K071512.pdf

[5] http://www.bloomberg.com/news/2013-12-04/j-j-lost-or-destroyed-vaginal-mesh-files-lawyers-contend.html

[6]http://www.investor.jnj.com/governance/managementdetail.cfm?bioid=38097

[7] Wal-Mart Stores, Inc. v. Johnson, 106 S.W.3d 718, 722 (Tex. 2003) and Sec. 32.47 of the Texas Penal Code

[8] http://www.bloomberg.com/news/2013-12-04/j-j-lost-or-destroyed-vaginal-mesh-files-lawyers-contend.html

http://www.wfaa.com/news/health/Texas-Attorney-General-Investigating-Pelvic-Mesh-266293941.html

addendum: 

The 9 other states include California, Colorado, Florida, Illinois,  Maryland, Ohio, Pennsylvania, South Carolina,Washington State

JjrkCh Texas Attorney General http://t.co/opGrIxRIBu #ptsafety #MedX #TEDMED #fda #s4pm 7/8/14, 5:39 PM

Taxpayers Lo$e: No Warrantie$ on Million$ of Hip Joint Replacement$

The Hip Generation:  Despite Failures and Recalls, Manufacturers Offer No Guarantees

by BYRON HARRIS  FiDA highlight

Bio | Email

WFAA

Posted on June 9, 2014 at 10:14 PM

Updated Monday, Jun 9 at 11:06 PM

Related:

•                The Hip Generation: Recalls, redoes agony for some with new joints

•                Study: 2 percent of Americans have new hips, knees

•                J&J to pay $2.5B to settle hip replacement suits

•                British doctors urge against metal hip joints

•                MORE: From News 8 Investigates

NEWS 8 INVESTIGATES

It's estimated that in 15 years, patients in the U.S. will be getting as many as 1 million hip implants a year.

The hardware is relatively simple, but the operation is expensive, ranging from about $15,000 to $60,000, depending on who's paying for it.

Despite the simplicity and the high cost, there are no guarantees for the product. And some people think there should be.

A hip implant consists of a cup implanted in the patient's pelvis, and a ball implanted into the end of a patient's thigh bone.

The hardware costs as little as $350 to manufacture, but the selling price can be as much as $6,000, doctors say.

But despite the markup and the simplicity, the parts of a hip implant are not guaranteed.

If a hip fails and gets recalled, who pays for the new surgery... and the hardware?

“You do, or your insurance company, Medicaid or Medicare,” said Suzanne Henry, a policy analyst for the Safe Patient Project, part of Consumers Union.

And hip implants do fail.

“I’ve got a scar 16 inches long,” said Mary Rodriguez, who lives in Frisco. “I've got so much scar tissue, it feels like knots. Every surgery you have, there's more.”

Rodriguez isn’t exactly sure what's wrong with her hip. Her first transplant three-and-a-half years ago was a disaster.

She found a second doctor to put in a new one last fall. It's a definite improvement. Her pain has been cut in half, but it's still tremendous, she says.

“I take Oxycontin twice a day,” Rodriguez said. “I take hydrocodone twice a day. And then I take Naproxen for the swelling.”

Some doctors tell their patients what brand of implants they provide. Many don't.

Doctors told Rodriguez the manufacturer of her first hip, but not for her second. She doesn't know exactly what's in her body, or what exactly was done to her hip.

Consumers Union surveyed implant patients about their operations.

“When we asked them, 'Do you know if your device is under a warranty,' or, 'Do you even know what kind of a device you have,' the vast majority responded and said they didn't know the device and they just assumed there was a warranty,” Henry said.

Consumers Union has asked hip manufacturers to provide warranties on their hardware.

“We simply want them to cover problems with the device. And I think they have the tools to do that,” Henry said.

When Consumers Union wrote to the six major medical device makers, asking them to respond to the warranty idea, only one replied favorably. But that company, Biomet, has since been bought by another, so its warranty policy is unknown.

Manufacturers know when their products are failing, but face little or no cost when they do.

The cost for new hardware, surgery and rehab is borne by insurance companies and Medicare — the taxpayers.

Do manufacturers know what their failure rate is... and do they keep it secret?

“They certainly don’t advertise it,” Henry said. “What we’ve seen in the past when there were problems with metal-on-metal hips is that the manufacturer — specifically DePuy, a subsidiary of Johnson & Johnson — was aware of the failure rate and did not inform the public.”

In the Johnson & Johnson case, the manufacturer has already settled one lawsuit for $2.5 billion.

Implant failure rates from Britain and Australia helped force the settlement. National failure rates are not kept in the United States.

And so far, there’s no sign of hip warranties.

“If one company starts, they might find that that's what separates them from other companies, offering a warranty,” Henry said.

About 95 percent of hip implants are successful. Only a portion of those that aren't are due to faulty hardware.

The hardware business is extremely profitable. And regarding warranties, the manufacturers’ answer to patients so far remains: “See you in court.”

E-mail bharris@wfaa.com

They recall cars: but not failed hips?

The Hip Generation: Recalls,redoes agony for some with new joints

by BYRON HARRIS

WFAA   FiDA Highlight

Posted on May 1, 2014 at 10:00 PM

Updated today at 7:30 PM

Your car may be a lemon. But is your artificial hip?

So many Americans have artificial hips that we could be called the hip generation. But, Americans may know more about their automobiles than what’s inside their bodies and as many as a million may be suffering damage they don't know about.

Generally, a hip replacement is very effective, but the process remains costly, unregulated and, some say, potentially harmful.

Right after her total hip replacement, Rebecca Thompson said she felt a “clicking” in her new joint. But, her DePuy hip had been on the market for years — tried and true, the company said.

Not until several years after Thompson, who lives in Burleson, got her hip did DePuy publicly admit it had a problem and recalled the device.

“It was like, ‘They recall cars, they don’t recall body parts. What’s going on?’” she recalled.

A total hip replacement consists of a cup and a ball. From the early 2000s until 2010, those components were often made of chromium cobalt metal in what's called metal-on-metal hips. As the parts grind against each other, they can produce particles of chromium cobalt that can cause a dangerous condition called metallosis in which metal debris builds up in the soft tissues of the body.

It’s a condition Dr. Stephen Tower of Anchorage Alaska knows firsthand.

As an orthopedic surgeon, he has replaced more than a thousand hips. An active outdoorsman, when his own real hip started bothering him, he had a new one installed in himself.

But soon the artificial hip was as painful as the real hip it replaced.

“The toxic effect of the cobalt destroyed all the ligaments around the hip,” he said. It also produced “pseudo tumors,” or non-cancerous fleshy growths.

He began studying the chromium cobalt levels in his own blood, as well as his patients.

“They were clearly experiencing neurologic toxicity or psychological toxicity or cardiac toxicity from that hip,” he said.

He said that in the last decade, up to “90 percent of the hips that have been replaced in the United States are potentially at risk for problems.”

Artificial hips are increasingly sold as products, with advertisements appearing in, among other things, national newscasts. And for most Americans, their new joints work very well.

“In the United States we perform about 400,000 hip replacements each and every year,” said Dr. Jay Mabrey, chief of the Department of Orthopedic Surgery at Baylor University Medical Center and a Professor of Orthopaedic Surgery at the Texas A&M School of Medicine.  He’s also former chairman of the FDA’s Orthopaedic Device Panel.

“Total hip replacement is one of the most successful orthopedic procedures,” he said.

That said, Mabrey added, “metallosis is a huge problem for certain types of implants.”

“I have a lot of patients with these metal on metal hips,” Mabrey said, and “when they move after sitting for a while, they get that click… That’s metal on metal. Just like your car engine, you really don’t want metal rubbing up against metal.”

Science is starting to view the amount of chromium cobalt in the bloodstream with more concern than in the past. The threshold for concentration in the bloodstream, Mabrey says, used to be 7 parts per billion of chromium cobalt. “Some people think you should be concerned at 2 to 3 parts per billion.”

On April 19, Texas Rangers fans got a firsthand look at what a successful hip operation can do.

Pitcher Colby Lewis got his first win on the mound since 2012. It was his second major league start since having his hip resurfaced, an operation similar to a total hip replacement. And it has, so far, helped turn around his career.

The price for miracles like this hard to determine – even for doctors.

“A lot of this is confusing to surgeons,” said Dr. Stephen Tower in Alaska. “A lot of this is funny money. People get these incredibly high bills and what actually gets paid is a percentage of that.”

A hip can easily cost more than a car.

Scott Abram has had three total hip replacements. One has been problem free; the other, a source of constant paint that ultimately had to be replaced.

Hospital records show his insurance company was billed more than $20,000 for his most recent hip. The total bill for that one was $60,000. He doesn't know how much was finally paid by his insurance company.

The price pales in comparison to the agony he’s endured for eight years.

“I'm in pain every minute of every day and all night long,” he said.

He’s an airline pilot, but the pain has kept him from working for nearly a decade. . 

“There wasn’t a great deal that was explained to me ahead of time,” he said. 

What he didn’t know was that his hip was never rigorously tested. Like other devices, it was approved by the FDA in a shortcut process called 510 k. 

“If they were similar to other products on the market then you could release these other models onto the marketplace, without adequate testing or data,” said Dr. Shezad Malik, a Dallas physician who is also a lawyer. He is suing the company that made Scott Abram’s hip.

Hips are failing, he says, at a rate higher than the public realizes.

“In Australia and the UK, they’ve found actually double digit failures,” Dr. Malik said. “And the failure rate can be as high as 50 percent at five years.” 

In the last 10 years, there have been 578 different recalls of hip implants from six major manufacturers, according to the Safe Patient Project, which is affiliated with Consumers Union.

The problem is, most patients don’t even know what kind of hip is in their body.

“We don’t know how many of those patients have died. Others may not be mobile. Families don’t know what’s going on,” Dr. Malik said.

One manufacturer, DePuy, has already settled a class action lawsuit for $2.5 billion. It faces another class action lawsuit for another of its artificial hip models. Other manufacturers are being sued as well.

But lawsuits won't solve the problem for the 1 million people with chromium cobalt in their hips across the country. Like owners of recalled cars, they could be headed for a crash and don’t know it.

Email bharris@wfaa.com