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Gomez Iagmin Obtains Jury Verdict of $8.3 Million in Related Metal-on-Metal Hip Device Lawsuits

On March 8, 2013, in the first of more than 10,000 lawsuits to go to trial, a Los Angeles County jury awarded $8.3 million to 65-year-old Loren Kransky for the injuries he suffered as a result of the recalled DePuy ASR artificial hip.  The DePuy ASR is similar to Stryker hip implants because both have metal on metal components that fret and shed toxic metal debris into the body.

A doctor surgically implanted Mr. Kransky with the ASR in December 2007.  Another surgeon removed the device four years later because, according to trial experts retained by Kransky, defects in the design of the ASR caused it to release toxic metal debris that killed bone and tissue around his hip joint.

DePuy began selling the ASR overseas in 2003 and in the U.S. in early 2006 without first conducting clinical trials.  Claiming the ASR was safer and more durable than competing artificial hips, DePuy charged a premium for the device and sold 95,000 devices worldwide, with about 35,000 implanted in Americans.  The company formally recalled the ASR in August 2010 after a British medical regulator publicly reported that the ASR failed at much higher rates than expected.  Similarly, Stryker announced the recall of its Rejuvenate and ABG II modular neck-stem on July 6, 2010.  The recall was due to fretting and corrosion at the junction of the modular and neck.

“The design of the ASR was deeply flawed, unproven and unsafe.  DePuy should have never sold a single one,” said our own John Gomez of Gomez Iagmin Trial Attorneys, during Mr. Kransky’s trial.

The suits are projected to cost DePuy Orthopaedics, a division of the medical products giant Johnson & Johnson, billions to resolve.

“This is a victory for Mr. Kransky and thousands of other badly injured ASR patients who have yet to get their day in court.  Jurors across the country will return similar verdicts until J&J takes full responsibility,” said attorney Brian Panish.

Jurors were shown internal company documents, including DePuy’s own confidential estimate that a staggering 37% of ASR patients will undergo a second operation to remove the ASR and replace it with a safe device in four and one half years or less.  The rate is expected to climb even more dramatically over time.  By comparison, the failure rate of some other artificial hips is less than 2% over the same period.

Jurors also learned that beginning in 2005, a number of individual surgeons reported to DePuy that they believed the ASR was flawed and hurting their patients.  DePuy executives responded by blaming their “surgical technique” for any poor outcomes, even calling one of the doctors a “hack.”

“DePuy has yet to reach out to these honest, caring and capable medical professionals and tell them, ‘We should have listened to you.  You were right.  We were wrong to blame you.’ ” said attorney Michael Kelly.

At trial, DePuy’s engineers admitted under cross-examination that they made mistakes when they designed the ASR, and that when they re-evaluated the ASR in 2007 they determined the device shed massive amounts of metal debris even when implanted as instructed.  Engineers recommended an emergency redesign to make the ASR safer.  Internal company documents, however, showed that DePuy’s marketing executives hid this information from surgeons and “killed” the redesign proposal because it would not be profitable.  They decided instead to quietly discontinue the ASR and convince surgeons to switch to other DePuy products as they sold off existing inventory.

Expert witnesses retained by DePuy testified that the ASR was safe, not defective and did not harm Kransky.  They attributed Kransky’s problems to his overall poor health and mistakes made by his surgeons.  One expert, toxicologist Dennis Paustenbach, testified that the metal debris shed from the ASR was not harmful to the body’s organs.  He admitted under cross-examination, that DePuy had paid his firm more than $5 million and that he was known as “industry’s go-to guy.”

As for current litigation underway for Stryker hip implants, it is moving forward in a coordinated proceeding  based in the New Jersey Superior Court.  Please contact the Gomez Iagmin Trial Attorneys today if you or a loved one may have been implanted with a Stryker hip implant.  We are aggressive and have experience in mass tort litigation.

Stryker Rejuvenate Hip Litigation and Recall Update

-Litigation arising out of the recent Stryker Hip Recall is moving forward in a consolidated proceeding based in the New Jersey Superior Court.  An initial conference has been scheduled for February 20th, 2013 at 10:00 am.

-Stryker announced the recall of its Rejuvenate and ABG II modular neck-stem on July 6, 2010.  The recall was based on the potential for fretting and corrosion at the junction of the modular and neck.  Symptoms included  pain, swelling, tissue death and the need for a revision.  The Rejuvenate stem was approved in June 2008 by the FDA as an extension to Stryker’s Modular Hip System Product Line.  It was approved through the FDA’s 510(k) Premarket Notification Process, which allowed it to circumvent certain testing.

-The Stryker Rejuvenate hip implant has been linked to an increased risk of metallosis, high early failure rate, and ultimately replacement of the device.  Even without a metal ball like other metal-on-metal implants, metallosis is caused by the metal neck piece rubbing against a metal stem, causing the metallic debris to come loose.  Metallosis is an adverse tissue reaction to heavy metals in the body.  This reaction can cause pain, restricted mobility, pseudo-tumors, bone dissolution, and failure of the hip joint.

-Please contact the Gomez Iagmin Trial Attorneys today to protect your legal rights.

Stryker Rejuvenate Modular Neck and Stem

Stryker has recalled its Rejuvenate Modular Hip Neck and Stem because wear and corrosion may cause pain, swelling, tissue death, and the need for a revision.  The Rejuvenate is a modular neck and stem system that was designed to be used with the company’s total hip replacement prostheses.

Total hip replacements are typically recommended for the following uses:

  • Non-inflammatory degenerative joint diseases, including osteoarthritis and avascular necrosis;
  • Rheumatoid arthritis;
  • To correct functional deformities;
  • Revision procedures where other treatments or devices have failed; and,
  • Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The Rejuvenate stem was approved by the FDA in June 2008 as an extension to Stryker’s Modular Hip System product line.  Stryker submitted the Rejuvenate stem through the FDA’s 510(k) Premarket Notification Process.  By submitting the Rejuvenate stem this way, the Stryker stem did not have to undergo FDA testing.  Instead, the stem was approved as an extension of Stryker’s Modular Hip System product line because it was substantially similar to other stems used by Stryker and approved by the FDA.

In May 2012, Health Canada announced a recall of Rejuvenate modular necks after Stryker reported that some patients required revision possibly caused by fretting/wear near the modular neck junction.  Health Canada is the Canadian federal department responsible for helping Canadians track health issues.  Click here to view the Health Canada recall.

What to do Now

What to do Now

If you have had a total hip implant procedure since 2009, then the prosthetic components of your hip may be defective.  Stryker has issued a voluntary recall of its Rejuvenate Modular Hip System and its ABG II Modular-Neck Hip Stem.  The company has recalled these products because corrosion and wear can damage surrounding tissue.  Patients may experience pain and/or swelling around the hip.  Metal debris can cause severe tissue damage.  Some may need a revision surgery to remove the defective device.  The Gomez Law Firm can help you determine whether you have a recalled Stryker hip and can help you determine your legal rights if you have a recalled Stryker device.

Determine Whether You Have A Depuy Implant

It is important to note that Stryker does not keep a record of the individuals who have received their Rejuvenate Modular Hip System and its ABG II Modular-Neck Hip Stem.  It is possible that your orthopaedic surgeon may inform you that you have received one of the recalled Stryker devices, but not all patients are notified by their surgeons.

The Gomez Law Firm can find out what type of device you have.

Do Not File A Claim Or Provide Any Information To Stryker

If you have received either of the recalled Stryker hip implants, you may be asked to contact Stryker to establish a claim. You are not required to file a claim with Stryker to pursue your legal rights. In addition, you should not sign any documents purporting to release Stryker from its legal responsibilities.

In some cases, Stryker may offer to pay some portion of a revision surgery or related expenses. However, Stryker will not pay medical expenses in all cases.  In addition, the amount covered by Stryker is limited to what Stryker independently determines is reasonable.  You are entitled to more if you pursue your legal rights.

Stryker Metallosis Problem

Stryker Metallosis Problem

The Stryker Rejuvenate Modular Hip Neck and Stem and the Stryker ABG II Modular Neck and Stem can destroy tissue and pollute the bloodstream with metal. In the Rejuvenate Modular Hip Neck, Rejuvenate Modular Hip Neck, ABG II Modular Hip Stem, or ABG II Modular Hip Neck, the metal neck and the metal head wear against one another.  This sends metal debris into the surrounding tissue and bloodstream. The Stryker necks are made of chromium and cobalt.  The Stryker stems are coated with titanium.  These hard metals grind against one another as the hip joint moves with regular activity.

This grinding causes metal shavings from the neck and stem to release into the surrounding tissue and bloodstream.  Metallosis occurs when the metal shavings deposit into the healthy tissue surrounding the implant.  This metal debris kills tissue.  Healthy, pink tissue becomes gray or black in color as the metal settles into the body.

Chromium and cobalt leach from the Stryker hip components into the tissue and bloodstream.  These chromium and cobalt levels can be detected in the urine and bloodstreams.  Most often, doctors use a blood test to determine whether patients have elevated chromium and cobalt levels.  Medical professionals and state health officials say that the chromium and cobalt are not naturally found in the body.  They say that the chromium and cobalt levels of a healthy person should be less than 1ppb, 1 ug/l, or 1 ng/ml.

Some people may notice lumps, or pseudo-tumors, form under their skin.  These fluid-filled sacs are the body’s attempt to isolate the poisonous metal.  Often, these pseudo-tumors do not appear on the skin’s surface and can only be identified through an MRI performed by a medical professional.

Once chromium and cobalt hip implants are removed from the body, it takes time for the chromium and cobalt to leave the system.  Research is currently being conducted on how long it takes for these toxic metals to leave the body.  Some people have toxic levels of these metals in their systems for more than a year after the hip implants are removed.

There is no consensus in the scientific or medical community about what long-term effects exposure to these metals may have on the body.  There has been some research on cobalt poisoning.  According to the Alaska Department of Epidemiology, cobalt levels of 5 are considered toxic.  That state says that signs and symptoms of cobalt poisoning can include visual impairment, cardiomyopathy, cognitive impairment, auditory impairment, hypothyroidism, peripheral neuropathy, rashes, blindness, deafness, heart failure, peripheral neuropathy, and hypothyroidism.

Stryker Hip Implant Complications

Stryker Hip Implant Complications

People who have the Rejuvenate Modular Hip Neck, Rejuvenate Modular Hip Neck, ABG II Modular Hip Stem, or ABG II Modular Hip Neck have experienced serious complications because of the wear and corrosion at the junction of the neck and stem components, including:

  • Excessive Metal Debris In The Surrounding Tissue And Bloodstream

Metal debris can destroy tissue and pollute the bloodstream with metal.  This can result in pain, inflammation, and metallosis and the need for a revision surgery.

In the Rejuvenate Modular Hip Neck, Rejuvenate Modular Hip Neck, ABG II Modular Hip Stem, or ABG II Modular Hip Neck, the metal neck and the metal head wear against one another.  This sends metal debris into the surrounding tissue and bloodstream. The Stryker necks are made of chromium and cobalt.  The Stryker stems are coated with titanium.  These hard metals grind against one another as the hip joint moves with regular activity.

This grinding causes metal shavings from the neck and stem to release into the surrounding tissue and bloodstream.  Metallosis occurs when the metal shavings deposit into the healthy tissue surrounding the implant.  This metal debris kills tissue.  Healthy, pink tissue becomes gray or black in color as the metal settles into the body.

Chromium and cobalt can be detected in the urine and bloodstreams.  Most often, doctors use a blood test to determine whether patients have elevated chromium and cobalt levels.

Some people may notice lumps, or pseudo-tumors, form under their skin.  These fluid-filled sacs are the body’s attempt to isolate the poisonous metal.  Often, these pseudo-tumors do not appear on the skin’s surface and can only be identified using an MRI.

Once chromium and cobalt hip implants are removed from the body, it takes time for the chromium and cobalt to leave the system.  Some people have toxic levels of these metals in their systems for more than a year after the hip implants are removed.

There is no consensus in the scientific or medical community about what long-term effects these metals may have on the body.  There has been some research on cobalt poisoning.  According to the Alaska Department of Epidemiology, cobalt levels of 5 are considered toxic.  That state says that signs and symptoms of cobalt poisoning can include visual impairment, cardiomyopathy, cognitive impairment, auditory impairment, hypothyroidism, peripheral neuropathy, rashes, blindness, deafness, heart failure, peripheral neuropathy, and hypothyroidism.

  • Excessive Fretting Can Cause Surrounding Bone to Dissolve

The neck and stem grinding and wear can cause a condition called osteolysis.  With osteolysis, the bone essentially dissolves around the metal hardware, and the implant loosens, resulting in the need for a revision surgery.

  • Pain And/Or Swelling Around The Hip

  • Difficulty Climbing Stairs

  • Difficulty With Hip Flexion

  • The Need For A Revision Surgery

 

Stryker ABG II Modular Neck and Stem

Stryker has recalled its ABG II Modular Neck and Stem because wear and corrosion may cause pain, swelling, tissue death, and the need for a revision.  The ABG II is a modular neck and stem system that was designed to be used with Howmedica Osteonics’ femoral heads and acetabular (cup) components.

The ABG II was used with Howmedica Osteonics’ acetabular (cup) components, including V40 Biolox Delta, Biolox Delta Universal Taper Heads and Sleeves, V40 CoCr Heads, V40 LFIT CoCr Heads, C-Taper Alumina Heads when used with the V40/C-taper Adaptor, C-Taper Delta Heads when used with C-taper Adaptor, and UHR Universal Head, Unitrax Heads when used with the Unitrax V40 Modular Adapter.

Total hip replacements are typically recommended for the following uses:

  • Non-inflammatory degenerative joint diseases, including osteoarthritis and avascular necrosis;
  • Rheumatoid arthritis;
  • To correct functional deformities;
  • Revision procedures where other treatments or devices have failed; and,
  • Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The ABG II stem was approved by the FDA in November 2009.  Stryker submitted the ABG II stem through the FDA’s 510(k) Premarket Notification Process.  By submitting the ABG II stem this way, the Stryker stem did not have to undergo FDA testing.  Instead, the stem was approved because it was substantially similar to the

Stryker Modular Hip System and the Rejuvenate Monolithic Hip Size 4 Stem.

 

Health Canada Recall Information

Health Canada Recall Information

Trade Name

A) Rejuvenate Modular Neck, 0 DEG
B) Rejuvenate Modular Neck, 8 DEG
C) Rejuvenate Modular Neck, 16 DEG
D) Rejuvenate SPT Modular Stem, Straight Press-Fit Texture TMFZ

Recall Posting Date

2012-05-28

Manufacturer

Howmedica Osteonics Corporation

Recall Start Date

2012-04-30

Recall Number

73679

Hazard Classification

Type II

Model or Catalog #

A) NLS-300000B, NLS-340000B, NLS-380000B, NLS-420000B
B) NLV-300800G, NLV-300800Y, NLV-340800G, NLV-340800Y, NLV-380800G, NLV-380800Y, NLV-420800G, NLV-420800Y
C) NLS-301600P, NLS-341600P, NLS-3816000P, NLS-4216000P
D) SPT-070000S, SPT-080000S, SPT-090000S, SPT-100000S, SPT-110000S, SPT-120000S

Lot or Serial #

A) All lots
B) All lots
C) All lots
D) All lots

Reason for Recall

Stryker Orthopedics has updated the instructions for use (IFU) for the Rejuvenate Modular Hip System. This is based on a reported rate of less than one percent for revisions potentially associated with fretting and/or corrosion at or about the modular neck junction.