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.

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.

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.

Should I be worried if I have a metal-on-metal hip but no symptoms of hip failure?

The most common symptoms of hip failure include severe pain, aching and swelling in the hip area. Upon examination, doctors will often find that these symptoms started due to the release of metal particles that can damage the surrounding tissue.

What if I have a metal-on-metal hip but do not have any problems right now?

If you have a metal-on-metal hip but no symptoms of hip failure, you should keep yourself informed. Metal-on-metal effects are still being studied, and more information will continue to come out.

This month, The Lancet reported a case study of a 55-year-old German man who had been diagnosed with severe heart failure caused by cardiomyopathy. He was deaf and almost blind. He also had a fever, hypothyroidism, and reflux oesophagitis. The doctor suspected cobalt intoxication based on these problems and the fact that his medical history indicated he had undergone hip replacement surgery a few years back. The radiograph of his hip showed evidence of metal debris. He also had enlarged lymph nodes on his left hip. A blood test confirmed that the levels were high, and he underwent revision surgery soon after.

Upon examining the explanted devices, doctors found damaged areas of the chromium and cobalt femoral head. They concluded that the high cobalt levels were due to the metal wear on the hip device. After revision surgery, his cobalt and chromium concentrations decreased, and the patient stabilized and everything but his hearing and vision improved.

Importantly, according to the publication, the symptoms the patient reported did not include hip pain or swelling. The doctor made the diagnosis based on the known effects of cobalt intoxication.

It is important to note that the scientific effects of metal on the body are still inconclusive. This man’s case may be an isolated event. Regardless, staying alert and receiving needed care is an important step to staying healthy.

So What Do I Do?

Bring up any concerns with your doctor. If you have not discussed monitoring your metal-on-metal device with your doctor, we suggest you make an appointment to do so.

Recently, the FDA released guidelines for physicians to follow when monitoring metal-on-metal hip recipients. Those guidelines identified various imaging tests that can be useful for doctors to identify problems. X-ray imaging was not listed as a reliable way to detect metal-on-metal damage, so do not assume your doctor is monitoring your device if he or she is only taking x-rays!

In addition to the imaging tests, the FDA recommends that metal-on-metal patients receive blood tests that record metal ion levels in the body. Although the FDA concluded there is not sufficient evidence that blood tests are needed for patients who do not have symptoms of hip failure, we recommend that anyone with a metal-on-metal device requests these tests. We have personally seen many cases in which high ion levels were recorded long before symptoms of hip failure presented. Additionally, a study published last year in the British Medical Journal found that high metal ion levels predicted hip device failure, even in symptomless patients.

Should I get an attorney if I do not have symptoms?

You should at least talk with one. There are statutes of limitations on product liability claims that can bar your case regardless of its merit. Our firm is pursuing these cases throughout the country. Our attorneys and staff are extremely knowledgeable and can answer any questions or concerns you may have. Contact us for a free consultation before it is too late to pursue your case.

Will the ASR Settlement Affect My Case?

You have another metal-on-metal hip. What should the recent ASR settlement mean to you?

With news of the DePuy ASR settlement, many recipients of other types of metal-on-metal hips have asked us what bearing, if any, the settlement will have on their case. This is a fair question, as the bases for other metal-on-metal lawsuits are similar to that of the ASR.

Other metal-on-metal hips include, but are not limited to:

  • Stryker Rejuvenate
  • Stryker ABG II
  • DePuy Pinnacle (with metal liner)
  • Biomet M2M Magnum
  • Wright Medical Conserve

Indeed, there has been a pattern in the trajectory of various metal-on-metal hip litigations. We are optimistic about the ASR settlement and hopeful that it will encourage negotiations on other metal-on-metal hip cases. However, the ASR settlement does not make other results any more predictable. Each hip device has individual traits and circumstances that can affect the outcome of litigation.

We will continue to pursue compensation for all of our metal-on-metal hip clients.

What Does it Mean to Have Elevated Metal Levels?

Hip devices containing cobalt-chromium parts have been used successfully in orthopedics for years and have been known to produce slightly elevated metal levels in patients who receive them1. Over the past decade, however, the profit-driven flurry of new metal-on-metal hip devices has left thousands of patients with much higher levels than previously observed.

Specifically, the inherent design of metal-on-metal devices often results in metal wear, which releases metal ions into the body and causes elevated metal levels. An unacceptable proportion of metal-on-metal hip recipients have needed revision surgery due to implant loosening, tissue necrosis, and pseudotumors – all of which have been attributed to elevated metal levels.

Since the DePuy ASR recall in August 2010, surgeons have been moving away from metal-on-metal implants. Many device makers have taken their metal-on-metal implants off of the market, either by issuing a recall or by “phasing them out.” It is apparent that the metal-on-metal design is causing high failure rates.

However, in relation to how widespread a problem this is, experts have come up with few definitive answers as to how interpret elevated metal levels found in patients.

Elevated metal levels can lead to hip necrosisWhy Don’t We Know More by Now?

Most metal-on-metal devices gained FDA approval through a regulatory shortcut known as the 510(k) approval process. This process requires the manufacturer to prove that the device is “substantially equivalent” to another that is already on the market. They are not required to conduct pre-market studies to prove safety and efficacy.

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.

As Nick Freemantle, professor of clinical epidemiology and biostatistics at University College London, pointed out, the studies should have been done before the product is used – not after.

“We shouldn’t be in this position where we don’t know and there’s so much uncertainty. The stability of a compound should have been ascertained before it was used widely in people. As yet, we don’t know the consequences of this.”

What do we know about elevated metal levels?

According to the Medicines and Healthcare products Regulatory Agency (MHRA), patients whose levels are above a threshold level of 7 μg/L should be further monitored and tested. However, it is unclear where they got this number, or if it is reliable.

Earlier this year, BMJ published a study that examined the association between elevated metal ion concentrations and early failure of hip devices. They did so by documenting the clinical course of patients who had elevated cobalt and chromium concentrations but were not experiencing symptoms of a failed device.

The results of the study provided the first real evidence that blood metal ion tests can be used to measure the risk of early joint failure. They also suggested that elevated metal levels, regardless of symptoms, warrant concern.

The study also noted differences in failure rates between men and women. Of men and women who had the same metal ion levels, women appeared to be at greater risk of joint failure than their male counterparts. This is not the first time that higher failure rates have been observed in female patients. Previously, however, the theory was that women were more prone to elevated metal levels due to heavier wear of smaller implants.

However, since the failure rates were still higher in women than men who had the same metal levels, the differences must also have a biological explanation. That is, females may be more likely to have an adverse immune response to the ions. Indeed, the prevalence of a number of immune conditions is higher in women, which, according to the study, further suggests that woman may be more likely to have problems than men.

An important conclusion to the BMJ study is that metal ion concentration levels are a useful clinical tool in predicting device failure. The data presented in the study will help doctors to develop standards and guidelines for future treatment and evaluation of metal-on-metal patients. The data also strengthens the link between the metal-on-metal design of a device and device failure, which manufacturers have contested by pointing to other potential reasons for failure.

If you have questions or would like to speak with an attorney about a potential case, contact us for a free consultation.

 

1BMJ

 

http://www.medpagetoday.com/MeetingCoverage/AAOS/37997

http://www.bmj.com/content/344/bmj.e1410#xref-ref-4-1

http://bmjopen.bmj.com/content/3/3/e001541.full

Is this considered a class action?

No, we are not pursuing any class action cases involving defective knee and hip devices. A class action assumes all damages are essentially the same, and then divides the money up evenly across the class.  The types of knee and hip injuries experienced by each person are unique.  Therefore, it would be unwise to resolve each claim for the same amount of money.   Defective knee and hip cases have been filed in federal court and many state courts. Most of them will be resolved in a consolidated action either at state or federal (multidistrict litigation) level. In consolidated state and federal actions, the cases are combined for pre-trial proceedings, such as discovery and depositions but are resolved as individual cases based on individual merits.

Statute of Limitations: Are there time limits to make a claim?

Yes, there is a statute of limitations that will bar your claim if it is not brought within a certain period of time. Many people want to know about their statute of limitations before they talk to us. Unfortunately, there is no universal answer. Setting the statute of limitations for these claims involves a very complex calculation, which we can only make after we have had time to investigate your case. Factors can include which state you are in, when your surgery was, when you found out there was a problem, etc.

The most important thing to take away is that time is of the essence. The statute of limitations is the date by which you must file your claim. Before we can do that, we need adequate time to open your file, order necessary records, go through and extract needed documents, and have them reviewed by an expert. It can take several months for hospitals to even get the records to us. Therefore, it is best to speak with us as soon as possible to avoid possible statute of limitations issues.

Why choose a GoldenbergLaw knee and hip attorney to handle my hip device claim?

Choosing a defective knee and hip attorney is an important decision. When you are speaking with a firm about you case, ask if they have other knee and hip cases. Ask what their plan is, and what you can realistically expect them to do for you. Most importantly, make sure to ask if the attorney is experienced in mass tort.

Mass tort is a very specialized area of law. Do not make the mistake of assuming that any attorney who agrees to take your case will achieve the same result. Many product liability attorneys do not necessarily have the experience or the resources to take on mass tort claims. Since this is not a class action litigation, outcomes of cases will vary.

GoldenbergLaw has been involved in many mass tort litigations and has been representing victims of defective medical devices for almost 30 years. We work with some of the top experts in the country and stay on top of developments in the litigation that can affect the outcome of your case. We carefully and efficiently review each case, taking time to give realistic expectations and updates to our clients. Before we expect you to retain us as your defective knee and hip attorneys, we will make sure all of your questions are answered to your satisfaction. Please contact us for a free consultation.