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.

Stryker Bellwether Trial Categories Established in Federal MDL

Federal MDL in Minnesota Establishes Stryker Bellwether Trial Categories

A small group of Stryker hip cases are being prepared for early trials, which are known in mass tort as “bellwether trials.” Bellwether trials are a way for the parties to determine how each case might be resolved if it were brought to trial. Thus, the results of a bellwether trial often have a significant impact on the potential value of the rest of the cases in the litigation.

The cases that are selected for bellwether trials must represent the diversity of cases in the litigation. Since the type/severity of injuries can vary, as can the risk factors for those injuries, both plaintiffs’ and defendants’ attorneys typically establish categories into which the test cases will be divided.

On May 9, 2014, Judge Frank, who oversees the Minnesota Stryker MDL, issued a pretrial order that indicated that there will be five categories for Stryker bellwether trial cases. One of the categories will be dedicated to the ABG II system, which was recalled at the same time as the Rejuvenate for similar problems. The other four will pertain to the Stryker Rejuvenate, which is the subject of the majority of the lawsuits that have been filed.

The four Rejuvenate categories will be divided according to the date the Stryker Rejuvenate hip was implanted (before or after January 1, 2011) and whether the revision was complicated or uncomplicated. Judge Frank had already established that only cases that involved a revision surgery (a second surgery to replace the defective hip) would be considered for a Stryker bellwether trial.

According to an order issued in March 2014, the first Stryker bellwether trial will begin during the summer of 2015.

New Jersey Cases

In New Jersey State Court, cases are coordinated under Superior Court Judge Brian R. Martinotti as part of a Multi-County Litigation, or MCL.  Judge Martinotti established a mediation process last year to see if a settlement could be reached before a lengthy and expensive trial process. The first phase involved a group of 10 cases that were selected for early negotiations before a court-appointed mediator. One of the cases was delayed, and eight of the remaining nine cases were successfully resolved.

Now, a “phase 2 mediation” is in the works. The group of cases will involve plaintiffs aged 78 years or older, among other plaintiffs who sustained serious injuries. The Court has selected five cases at random to be included in this mediation, and plaintiffs have identified another five.

Next Steps for Recalled Stryker Hip Recipients

If you currently do not have an attorney, it is important that you speak with one as soon as possible about your options. There are statutes of limitations that can bar you from bringing a claim if you do not do so by a certain deadline. The statute of limitations on your case requires a complex evaluation that only an attorney can accurately provide. Click here to contact our office.

If you are currently our client, please know that we are keeping up on filing deadlines of your case and any Broadspire reimbursement requests that you may be waiting on. If we have any concerns or questions regarding your case we will contact you directly. Thank you for your trust.

Broadspire Reimbursement Program for Hip Devices

As we discussed in a previous post, Stryker Orthopedics and DePuy Orthopedics have both hired Broadspire, a third-party claims administrator, to issue reimbursements for out-of-pocket medical expenses related to the recalled Stryker Rejuvenate, Stryker ABG II, and DePuy ASR hips.

Our office has been pursuing defective hip device cases for several years now. We work with Broadspire on both the Stryker and the DePuy medical programs. These programs are optional, but they have helped our clients cope with the day-to-day expenses of monitoring and/or treating injuries from their failed hips.

What expenses does Broadspire reimburse?

1.            Medical expenses associated with the failed device. This includes prescriptions, such as for pain medication, or copays for a hip-related doctor appointment.

2.            Mileage traveled from home to your medical providers for related treatment.

3.            Other out of pocket expenses such as paying someone for snow removal, lawn care, parking, fitness or rehab facility memberships, in-home health care, etc.

4.            Wage loss. In some circumstances, we are able to make a request for time missed from work, whether a single day off for a doctor appointment or several weeks of recovery following a revision surgery.

Do you need to give them my medical records?

In order for Broadspire to process a reimbursement request, our office must release some of your records to Broadspire. They must see medical records that prove that you have the device. They will also need to see additional relevant documents so they know that the medical needs for which you are requesting compensation relate to the device failure.

It is important that they only get what they need in terms of medical records. Our office releases these certain limited medical records and controls what Broadspire receives at all points in time.

What if I already have health insurance?

Your medical insurance provider will remain your primary insurance on any previous or future related medical bills. Broadspire will be listed as your secondary insurance and will cover any expenses your primary insurance does not cover.

Do people actually get compensated?

We make sure that they do.

Obtaining reimbursement from Broadspire is a complicated matter. It requires persistence, follow-up, and a legal-minded approach toward evidence submission.  Members of our staff touch base with Broadspire several times a week, submitting and pushing through requests for reimbursement. Remember, Broadspire was hired by the defendants to manage these costs. Their program happens to be in the best interest of injured victims, but only because it also aligns with the best interests of the companies who hired them.

How do I participate?

After you become our client, we will give you the option to participate. If you do wish to participate, we will enroll you in the program and you will be assigned a claim number. If you have already been enrolled in Broadspire’s reimbursement program, you can give us your claim number or have us look it up.

Once you are enrolled, we will explain how to proceed.

Regardless of whether you choose to participate in the medical program, neither Broadspire nor the defendant (DePuy, Stryker) should contact you regarding your claim if you have representation. We will serve as the go-between to ensure that your privacy and the integrity of your claim are preserved.

How can I get help?

If you have not yet spoken with our office regarding a claim, contact us as soon as possible. We have been representing defective hip victims for several years and can help you.

FDA Publishes Guidelines for Chromium and Cobalt Testing

It is very important that patients with metal-on-metal implants are monitored and receive the appropriate chromium and cobalt testing. As we pointed out in a post last fall, definitive answers to metal-on-metal questions are difficult to come by:

Since the manufacturers of MoM devices did not study the effects of metal wear, people have likened the advent of metal-on-metal hips to a large, uncontrolled experiment. Thus, the studies that are now underway are reactive in nature and have minimal foundation to build from.”

The problems that have been reported relating to metal-on-metal wear can undoubtedly generate anxiety and worry for hip recipients and their families. Recently, the FDA released a set of guidelines to help establish uniform chromium and cobalt testing and diagnostic procedures for orthopedic doctors who are treating metal-on-metal hip recipients. This is a step in the right direction, as doctors have been forced to work off of little to no official guidelines when it comes to monitoring metal-on-metal hip recipients and interpreting results of various diagnostic methods.

FDA Guidelines for Chromium and Cobalt Testing

Soft Tissue Imaging

The first method discussed in the FDA report is soft tissue imaging. Depending on the individual circumstances, the FDA recommends one of the following:

  • Magnetic Resonance Imaging (MRI) with metal artifact reduction (MAR)

This technology offers the best visualization of soft tissue surrounding a metal-on-metal hip implant and uses non-ionizaing radiation. Panel members at the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel Meeting recommended this method over others that were discussed. However, this method is contraindicated for some patients with implants.

  • Computed Tomography Scan (CT) Scan

CT scans offer the best visualization of implant positioning and bony tissue. However, they use ionizing radiation and provide lower soft tissue visualization. Image artifacts from the implant may distort the images.

  • Ultrasound

Ultrasound allows soft tissue visualization without metal artifacts and uses non-ionizing radiation. However, it provides a lower resolution soft tissue image and has a limited depth penetration.

These tests will show the tissue surrounding the implant and any distortions in the imaging will alert your doctor to metal artifacts (particles of metal) around the implant. Your doctor can determine which test is most appropriate for your situation. Keep in mind that his or her decision may also be based on what types of tests insurance will cover.

Chromium and Cobalt Ion Tests

As you likely know, elevated metal ion levels (e.g. chromium and/or cobalt) are a concern for anyone who has a metal-on-metal hip. Ions are not visible on the imaging tests listed above, so a blood sample must be tested in order to detect them.

The FDA says that anyone who develops symptoms should be tested. However, a recent study provided evidence that blood metal ion tests can be used to measure the risk of early joint failure. The study also suggested that elevated metal ion levels, regardless of symptoms, warrant concern. This means that even symptomless patients who have undergone metal-on-metal hip replacement surgery could still have increased ion levels that predict implant failure. For this reason, we recommend that metal-on-metal hip recipients undergo chromium and cobalt testing regardless.

The FDA specifies blood test methods they believe will produce the most accurate results. These tests are rarely done in your doctor’s office; he or she will most likely send you to a lab to have them done. The FDA also specifies the criteria a lab should meet to generate the most accurate results. Many doctors have already been using labs that meet these criteria, but some may be using testing labs that are outside of the FDA’s new guidelines. Before you get tested at a lab, we recommend checking with your doctor to make sure the lab meets the FDA’s criteria for accurate chromium and cobalt testing.

Talk to your doctor

If you have any concerns or questions about your implant, do not hesitate to talk to your doctor. The FDA guidelines are not meant to replace the need to see your doctor; it is important that you keep he or she in the loop when it comes to your condition.

Do you have a Case?

If you have a metal-on-metal hip and have not yet spoken with an attorney, we recommend that you do as soon as possible. There are statutes of limitations that can bar your claim if it is not filed by a certain date. There could also be additional cut-off dates to file your claim based on settlements. Contact us for a free consultation.

Have you been told you need revision surgery?

The explanted device can be a crucial piece of evidence and it should be preserved with the surrounding tissue. We do this for our clients using a company that specializes in device preservation. If you have been told you need a revision surgery, it is best to contact us as soon as possible so that we have time to preserve the device.