Pinnacle Hip Implant Plaintiffs’ Awards Reduced

Pinnacle hip implant patients have won two major cases against DePuy and its parent company Johnson & Johnson (J&J). In both of those cases, the judges upheld the juries’ verdicts, but reduced the punitive damages awarded.

Bellwethers Hugely Impact the Settlement Agreement

When many plaintiffs suffer the same injuries from the same product, they can consolidate their cases into one jurisdiction. This is called a “multidistrict litigation” (MDL). In an MDL, the plaintiffs and defense decide on a group of “test cases” to take to trial. The plaintiffs and defendant use those test cases to see what a jury thinks of their arguments. Those test cases are called “bellwether” cases. Whichever party wins the bellwethers has a stronger bargaining position. So if the plaintiffs win, they have an upper hand when negotiating a settlement with the manufacturer.

Pinnacle Hip Implant Plaintiffs Won 2/3 Bellwethers

DePuy won the first Pinnacle hip implant bellwether. The jury said that the plaintiff’s injuries were the implant surgeon’s fault, not the Pinnacle hip implant’s fault. The second and third bellwethers went much differently than the first.

Plaintiffs Won Big Despite Judges’ Reduced Awards

The plaintiffs won the second Pinnacle hip implant bellwether. The jury said that the Pinnacle hip implants were responsible for the plaintiff’s injuries, and consequently awarded the 5 plaintiffs a combined total of $500 million. The judge did not overrule the jury’s determination that the Pinnacle hip implants hurt the plaintiffs. However, the judge reduced the award from $500 million to $151 million.

The plaintiffs won the third Pinnacle hip implant bellwether. The jury again said that the Pinnacle hip implants hurt the patients, and awarded the 6 plaintiffs a combined total of $28 million in compensatory damages, plus $1 billion in punitive damages. The judge did not overrule the jury’s determination that the Pinnacle hip implants hurt the plaintiffs. The judge also did not overrule the compensatory damages award of $28 million. However, the judge reduced the punitive damages award from $1 billion total to $1.25 million total.

The Plaintiffs’ Victories Put Pressure On J&J to Settle

Although the plaintiffs are receiving less money than they were initially awarded, these developments are not bad news. Again, DePuy won only 1/3 bellwethers, while the plaintiffs won 2/3. In the 2 cases plaintiffs won, DePuy appealed, trying to get the appellate courts to reverse the juries’ decisions. But the judges refused to reverse the juries’ decisions. All the appellate courts did was reduce the punitive damages awards as required under Texas law. Despite the reduction in punitive damages, this record-setting verdict should continue to put pressure on J&J to sit down at the negotiating table and resolve these cases.

Biomet M2a Hip Implants Cause High Metal Levels

Zimmer Biomet (Biomet) is a medical device manufacturer founded in 1977, and  headquartered in Warsaw, Indiana. Its official name was simply “Biomet” until “Zimmer” purchased it in 2015. Biomet M2a hip implants are hurting patients in the US and United Kingdom (UK).

The Magnum M2a Hip Implant Has a High Revision Rate

The M2a Magnum is a metal-on-metal brand of cup and head. This means that both the cup and head implants are made of cobalt-chromium. Studies show that between 6% and 7% of patients who receive the M2a Magnum need revision surgery within 5 years. Those patients needed revision surgery because their implants were poisoning their blood with high metal levels. High metal levels in the blood can cause a host of problems including:

  • Bone death (osteolysis)
  • Tissue death (necrosis)
  • Pain
  • Infection
  • Psuedotumor

One somewhat unique side effect patients experience from the M2a Magnum is clicking. In some cases, as the M2a Magnum wears out it can cause an audible clicking noise. Unfortunately, all of these problems eventually necessitate revision surgery.

Biomet Paid Out Big in the US

On April 15, 2014, Biomet signed a settlement agreement with hundreds of implant patients. Patients are eligible to receive a base award of $200,000 if they meet the following conditions:

  • Had a Biomet M2a Magnum hip implant
  • Filed a lawsuit against Biomet on or before April 15, 2014
  • Had the Biomet M2a Magnum hip implant removed more than 180 days after it was implanted

If you meet those conditions, then you may be entitled to at least $200,000.

Biomet Tried to Cover Its Tracks in the United Kingdom

Biomet hasn’t recalled M2a Magnums in the US, but it has recalled a close cousin of the M2a Magnum – the M2a 38 mm – in the UK. On April 12, 2016, Biomet issued an Urgent Field Safety Notice (FSC) regarding M2a Magnums in England and Wales. An FSC is an official communication in the UK which has two purposes:

  • Warning—tells doctors that something is wrong with the company’s product
  • Recommendation—tells doctors what to do with patients who were or are exposed to that product

Here is a breakdown of Biomet’s FSC.

  • Warning—patients with M2a 38 mms need revision surgery far more often than they should because they are getting high metal levels in their blood.
  • Recommendation—doctors should test patients with M2a 38 mms, and if the test results are abnormal, then the doctors should remove the M2a 38 mms and replace them with different, safer implants.

Biomet M2a Hip Implants Are Dangerous

Here in the US, Biomet is paying out millions of dollars over the M2a Magnum. In the UK, Biomet issued an urgent warning over a similar device. Clearly something is wrong with these dangerous products.

metal hip replacement

Stryker Agrees to Second Settlement of Metal-on-Metal Hip Implants

Today (December 19, 2016), Stryker announced it will participate in a second global settlement agreement with patients who were implanted with either of two of its products. The products are both metal-on-metal neck-stem hip implant components: the “Rejuvenate” and the “ABGII” models. Each of these models was recalled in July 2012.

Both the Stryker Rejuvenate and ABGII hip devices consist of a modular stem and femoral head. Individuals who received a Stryker Rejuvenate or ABGII implant and then required removal of the device due to metal-on-metal failure are potentially eligible to participate in the settlement. The removal, or revision, surgery must have occurred no later than December 19, 2016.

This settlement agreement follows a prior global settlement announced in 2014 where individuals requiring removal of the Stryker Rejuvenate or ABGII device before November 3, 2014 qualified. The current settlement, announced just over two years after the first, is an effort to compensate those individuals requiring removal of the products after the November 3, 2014 deadline.

Stryker has paid over $1 billion in settlements stemming from its Rejuvenate and ABGII hip devices and is now projected to pay another billion dollars or more in the second settlement.

Following a recall of the DePuy ASR hip devices in 2010, it became apparent to the public that metal-on-metal hip devices could cause severe injuries to patients. The acetabular components of the ASR device, the cup and ball were made of metal. These two pieces, positioned next to each other, rubbed together, causing metal ions to be released in the body.

The suspected mechanism of failure in the Stryker Rejuvenate and ABGII products was not of the acetabular parts, but of the neck and stem femoral components. These two pieces, locked together upon implantation, could result in metal-on-metal wear. We began to see the Rejuvenate and ABGII fail at very high rates in 2012 due to corrosion between the stem and neck.

Pinnacle Plaintiffs Win Big

On December 1, 2016, a jury in the Northern District of Texas awarded six plaintiffs harmed by DePuy Pinnacle metal-on-metal hip implants a whopping $1.04 billion dollars.

In 2009, it became evident that DePuy and Johnson and Johnson’s Pinnacle hip device was failing at a higher than expected rate. This device is made up of a metal cup, metal head, and metal liner. While some doctors used a poly (plastic) liner, many used the metal liner. A high number of recipients of the DePuy Pinnacle Hip System experienced unexplained hip pain, difficulty standing or walking, loss of mobility, loosening of the joint, and dislocation. Failure of the device is often due to metallosis and its side effects.

Though it was never recalled, plaintiffs were able to present a wealth of evidence showing that the DePuy Pinnacle Acetabular Cup System has similar defects to the recalled DePuy ASR system and therefore that DePuy knew the damage Pinnacle hip systems could cause in hip replacement patients. Evidence at trial showed that DePuy paid royalties of over $200 million to doctors who helped design and promote the Pinnacle hip systems. Plaintiffs also pointed out that DePuy is worth over $72 billion dollars and if the jury truly wanted to send a message to DePuy, they would have to award the plaintiffs enough money to make an impact. The jury heard the plaintiffs loud and clear. The jury sent DePuy that message earlier today when it delivered its verdict.

Next on the horizon is the question of settlement. Will DePuy be more willing to settle future lawsuits rather than risk another gigantic loss at trial? Stay connected with GoldenbergLaw for updates.

$240 Million Wright Medical Global Hip Settlement Announced

Wright Medical Settlement

Wright Medical Settlement Reached

Wright Medical Group has reached a $240 million master settlement agreement (MSA) with attorneys representing approximately 1,292 plaintiffs who sued for damages caused by three of the company’s defective hip replacement products. Plaintiffs eligible for the settlement must have had a CONSERVE, DYNASTY, or LINEAGE hip replacement revision surgery occurring within eight years of their initial hip replacement surgery.

The Wright CONSERVE, DYNASTY, and LINEAGE are all acetabular systems. An acetabular system is a particular type of hip replacement device where a metal ball (femoral head) connects to a metal hip socket (acetabulum), forming the hip joint. The metal-on-metal design was initially developed to serve as a more durable hip replacement option for younger, physically active patients. Unfortunately, this turned out to not be the case for many hip replacement patients receiving a Wright metal-on-metal hip device. Patients made reports of debilitating injuries as a result of their hip replacement. These injuries include:

  • Severe pain and swelling
  • Metal poisoning (metallosis)
  • Loosening of hip components
  • Need for revision surgery
  • Early device failure

A multidistrict litigation (MDL) for Wright Medical’s metal-on-metal hips was formed on February 8, 2012 in the Northern District of Georgia. Soon after a state consolidated action in the form of a Judicial Council Coordination Proceeding (JCCP) was formed in California. According to Robert Palmisano – President and CEO of Wright Medical – the settlement should cover approximately 85% of known U.S. claimants with pending or tolled cases in the MDL or JCCP.

Wright Medical's Past Hip Device Problems

Wright Medical Technology had not been having an abundance of luck since the initial MDL was formed back in 2012. Since that time, the company’s problems have mounted:

  • In 2013, it became known that the Wright Profemur Neck (a component of Wright’s modular hip device) began failing at a higher than anticipated rate. The neck was failing at the neck-head or neck-stem interface due to metal wear between metal components. The device also had durability issues and often fractured in the femur. Various cases were filed throughout the country.
  • In November 2015, the first bellwether case was tried with the jury awarding the Plaintiff $11 million. This amount was eventually reduced by the court to $2 million.
  • In June 2015, the first Wright Profemur case was tried. The jury awarded the Plaintiff $4.5 million. Notably, in 2009, Wright changed the neck material from Titanium to Cobalt-Chromium (CoCr). The CoCr was supposed to be safer, but that product is also now having problems.

Fortunately a settlement has been reached concerning the Wright CONSERVE, DYNASTY, AND LINEAGE products after years of lawsuits and litigation for 1,292 plaintiffs. However, the company insists it will not give up in defending the estimated 600 other metal-on-metal hip claims not settled under the recent MSA.

DePuy Pinnacle Trial Update Weeks 2 and 3

DePuy Pinnacle Trial Updates

Week 2

DePuy Pinnacle Trial Update

Day 4

DePuy’s former head of marketing is cross examined. The cross examination lasts the entire day.

Day 5

Plaintiffs call an English orthopedic surgeon to the stand. The surgeon had previously been compensated by DePuy to teach surgeons, conduct research, and give lectures. He was the surgeon who began sounding the alarm on both ASR and Pinnacle. DePuy attempted to have his testimony excluded, but the motion was denied.

Day 6

The surgeon’s time on the stand consumes most of the day. DePuy’s former VP for Clinical Research and Development will be taking the stand on Monday. She was supposed to testify via satellite, but decided last minute to come to Dallas to give her testimony in person. Court adjourns until then.

DePuy Pinnacle Trial Updates

Week 3

Day 7

DePuy’s former Vice President for Clinical Research takes the stand this morning and is called by the plaintiffs adversely. We learn she has a PhD in Chemistry and she spends the entire day on the stand. Her direct examination consumed the entire day.

Day 8

Cross examination of DePuy’s former Vice President for Clinical Research is delayed so plaintiffs are able to call an expert witness to testify from Los Angeles, California via satellite transmission under subpoena. The expert witness is an orthopedic design surgeon who had entered into a consulting agreement with Depuy on January 1, 1996. He refused to appear at the trial in person. Plaintiffs concluded direct examination and defendants began cross examination which will continue tomorrow.

Day 9

Plaintiffs resume the direct examination of the expert witness via satellite transmission. His examination proceeds to mid-morning, but is put on hold to finish the cross examination of DePuy’s former Vice President for Clinical Research. The cross examination of the orthopedic design surgeon will continue next week.

DePuy Pinnacle Trial Updates Week 1

Read more about what happened during the first week on the DePuy Pinnacle Trial in Dallas, Texas.

DePuy Pinnacle Trial Updates: Week 1

DePuy Pinnacle Trial

Day 1

October 3, 2016

Plaintiffs discuss the history of problems with metal-on-metal hip implant devices dating back to the 1970s. They argue that DePuy knew about the dangers associated with metal-on-metal hips yet they continued to develop and sell metal hip devices so the company didn’t lose market share. It is pointed out that Pinnacle hip devices were never tested in humans before they became available on the market. Following the release of the product, plaintiffs accuse DePuy of falsely marketing Pinnacle to surgeons, stating that the device had a 99.9% success rate – a number based off fraudulent studies. When DePuy was confronted by doctors with concerns about the design and safety of the Pinnacle device, the company down played the reports.

DePuy argues that metal-on-metal hip devices were developed in response to issues with metal-on-plastic hips. The company explains that although the Pinnacle was not tested in humans before its release, it was tested in simulators. They argue that the testing in a simulator generates more accurate results. The results in this case led them to believe that the Pinnacle was a good product. DePuy took the overall stance that doctors and surgeons using the Pinnacle device in their patients were the guilty parties in this case arguing that doctors have an obligation to know the risks associated with medical devices they use on their patients.

DePuy Pinnacle Trial

Day 2

October 4, 2016

Plaintiffs call on a bio-mechanical engineer with over thirty years of experience designing and inventing prosthetic devices and other surgical tools. The witness explains the importance of testing products in humans before becoming available on the market. If a problem is brought to the manufacturer’s attention, it is their duty to immediately disclose that information to doctors. Evidence is presented showing DePuy had a viable plastic option available on the market, yet metal-on-metal was still used in the Pinnacle device. DePuy raised concerns about the safety of plastic hips, but the expert witness argued metallic ions were much more toxic to the body than plastic ions.

DePuy Pinnacle Trial

Day 3

October 5, 2016

Plaintiffs call DePuy’s former head of marketing to testify about his time and work with the company during key periods pertinent to the litigation.

Stryker V40 Femoral Heads

Stryker V40 Femoral Heads

The Stryker V40 Femoral Head is an interchangeable part used in various types of hip replacements. The head is made of cobalt and screws on to a chromium femoral neck forming the taper lock portion of the artificial hip. In the past, hip device manufacturers have faced lawsuits over metal-on-metal hip device failure and the V40 may follow suit in that trend.

Concern surrounding the safety of Stryker V40 Femoral Heads continues to grow on a world wide scale:

August 24, 2016 – Health Canada Recall

“Stryker has received higher than expected complaints of taper lock failure for specific lots of certain sizes of LFIT Anatomic COCR V40TM Femoral Heads manufactured prior to 2011.”

August 29, 2016 – Urgent Recall Notification

Stryker Orthopaedics reportedly sends an urgent recall notification to orthopaedic surgeons across the nation of the dangers associated with particular sizes of Stryker V40 Femoral Heads manufactured before 2011.

September 27, 2016 – Safety Alert Issued in Australia

“Stryker Orthopaedic has written to orthopaedic surgeons who have implanted affected LFIT Anatomic CoCr V40 femoral heads to provide further information about this issue.”

HOW DOES THE STRYKER V40 FEMORAL HEAD WORK?

The V40 femoral head is one component of an artificial hip system. When doctors perform hip replacement surgeries it is often difficult to tell what size components will be needed until surgery is underway, therefore it can be helpful to have an interchangeable component available in various sizes, such as the metal Stryker V40 femoral head, during an operation. Once the appropriate size is determined, the  V40 is screwed onto a femoral neck, acting as the end of the femur bone free to move and rotate within the hip socket.

WHAT’S THE PROBLEM?

In the past, metal-on-metal hip implant failure has occurred when the metal surfaces of the femoral head and acetabular cup rub against one another. Or, in the case of the Stryker Rejuvenate and ABG II recall, the failure occurred in the stem-neck interface. With the Stryker V40 femoral head the problem occurs between the metal head and metal neck. According to the Australian safety alert, “The increased incidence of taper lock failures relates to possible taper lock interface inconsistency.” When the metals react with one another, the device components begin to corrode, leading to taper lock failure. When corrosion occurs, metallic ions are released into the patient’s blood stream, chances for infection of soft tissue greatly increases, and the device can eventually dissociate (dislocate) altogether. This failure can require removal of the head and stem device parts. This is, unfortunately, a very invasive procedure.

WHAT ARE THE INJURIES?

  • Metallosis (metal poisoning)
  • Loss of mobility
  • Inflammation
  • Severe pain
  • Infection
  • Dissociation and dislocation
  • Need for revision surgery

WHY GOLDENBERGLAW?

If you have suffered any of the above injuries as a result of your Stryker V40 Femoral Head hip replacement component you have the right to seek compensation. Your consultation is free and you pay nothing unless our firm recovers for you and your family.

Manufacturers of medical devices have a legal duty to make products that are reasonably safe. For over 30 years, GoldenbergLaw has successfully represented thousands of injured people around the country in defective drug and device cases against some of the world’s largest corporations. We have the national experience, the resources and the desire to hold these companies accountable for their actions. We will fight for you to obtain fair compensation for your, pain, disability, medical bills, wage loss and the terrible effect this has had on the quality of your life

Pinnacle hip litigation verdict

Jury Gives Pinnacle Verdict of $497.6 Million

Johnson & Johnson has been hit hard with a $497.6 million Pinnacle hip replacement verdict

A $497.6 million verdict was awarded to five individuals with defective Pinnacle hip implants. Out of the $497.6 million, approximately $360 million of damages were punitive. The Pinnacle hip replacement verdict came today out of a bellwether trial in Dallas, Texas heard in front of Judge Ed Kinkeade of the U.S. District Court for the Northern District of Texas. All five plaintiffs suffered from severe pain, bone erosion, tissue loss, and metallosis (metal poisoning) among other problems.

“The victims further claimed that DePuy’s design was defective; the company failed to give adequate warnings; and Johnson & Johnson aided and abetted in misrepresentations that rose to the level of fraud.” – MarketWatch Press Release: Dallas Jury Awards Nearly $500 Million Against J&J Unit in Bellwether Hip Implant Trial

Pinnacle hip replacements are metal-on-metal (MoM) hips. MoM hips have had significant problems with metal poisoning and loosening failures. This often requires revision surgery. The Depuy ASR hip was recalled.  Pinnacle metal-on-metal hips were manufactured from 2002-2012. While never recalled, they had many of the same issues which often required revision. Depuy actually pulled the Pinnacle metal liners off the market in 2013.  Depuy ASR hips and Pinnacle hips are both owned by Johnson & Johnson.

GoldenbergLaw has successfully represented victims of hip replacement failures for over four years.  This includes Pinnacle, Stryker, ASR, Wright Medical, Biomet, Durom Cup and Smith & Nephew.  These metal-on-metal hips continue to fail and require revision surgery. Please contact GoldenbergLaw attorney Laura Pittner at 612-436-5027 for more information or referrals.

Answers to Metal-on-Metal Hip Questions Come Slowly but Surely

In many ways, the rise and fall of metal-on-metal hips has been like an uncontrolled experiment. Manufacturers performed minimal testing on the devices prior to releasing them into the marketplace. As metal-on-metal hips began to fail in patients, manufacturers took measures to delay – or avoid altogether – any acknowledgement that there was a problem with the metal-on-metal design. Doctors had little information to rely on and were forced to put the pieces together based on their experiences with patients. As a result, patients and doctors alike have been waiting for answers to their questions regarding the effects of metal-on-metal hip implants.

A recent information statement released by The American Academy of Orthopaedic Surgeons (AAOS) helps answer some of those questions and provides up-to-date recommendations on how to monitor these devices. The document is not intended to dictate the exact method of treatment, but it serves as a guideline that is based on the state of the published literature available.

In it, the authors discuss the intrinsic (caused by the implant) and extrinsic (something outside of the implant) causes of painful total hip arthoplasty (THA). In any case of painful THA, a thorough clinical history, a detailed physical examination, and select radiographic and laboratory tests are all essential to determining the cause(s) of pain.

The statement also provides a systemic risk stratification recommendation, which can be used to determine if a certain patient is at high-, medium-, or low-risk for hip failure. The data is consistent with some other studies in the past, which have reported trends such as a higher risk for females with metal-on-metal devices that have large-diameter femoral heads. However, this statement goes into more detail on what doctors should look for in determining a patient’s risk level and treatment options.

Having a metal-on-metal device in you can cause significant anxiety.  At GoldenbergLaw, we understand that the most important thing to anyone who has been affected by metal-on-metal hip failure is feeling better and getting back to normal life. We will continue to update our clients and others about important developments in litigation and in treatment of metal-on-metal hip failures.