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.

Recalled Hip Implants: An International Trend

The companies that sell metal-on-metal hip implants in the US sell the same implants in foreign countries. By the time the US government determines an implant is hurting patients, and recalls it, the same thing has usually already happened in multiple foreign countries. Hip-implant manufacturers know their implants are hurting patients. And they know that foreign governments are recalling their implants for that very reason. But they keep selling them anyway here in the US.

Hip Implant Failure in the United Kingdom

The UK government has issued four safety alerts about metal-on-metal hip implants because those implants are hurting their patients.

1.      Metal Hip Implants Cause Adverse Tissue Reactions and Pain

  • The UK government issued the first safety alert on April 22, 2010.
  • Metal-on-metal hip replacement patients were experiencing adverse soft-tissue reactions and hip pain.
  • Required patients to undergo blood metal-level testing, and get follow-ups for five years.

2.      No More DePuy ASRs

  • The UK government issued the second safety alert on September 7, 2010.
  • DePuy voluntarily recalled the ASR in the UK because it was experiencing higher-than-expected failure rates after 5 years.
  • Although the UK government didn’t require patients with ASRs to get revision surgery, it did prohibit surgeons from implanting them in the future, require surgeons to return all un-implanted stock to DePuy, and require doctors to schedule appointments with ASR patients in order to test their blood metal levels.

3.      Metal Hip Implants Cause Metallosis

  • The UK government issued the third safety alert on February 28, 2012.
  • Concluded that some patients get metallosis from the metal wear caused by hip implants.
  • Recommended that most patients with metal-on-metal hip implants should get them removed if they show signs of rising metal blood levels, or other abnormal results.

4.      If Blood Metal Levels Rise, Then Get Implant Removed

  • The UK government issued the fourth safety alert on June 25, 2012.
  • Patients with metal-on-metal hip implants should get blood tests, and if they show signs of rising metal blood levels or other abnormal results, then they should get their hip implants removed.

Even though the UK government has only officially banned the implant of DePuy ASRs, some British surgeons have been calling for a total ban on metal-on-metal hip implants since 2012.

Hip Implant Failure in Canada

The Canadian government issued a health alert on April 11, 2012. It said that some patients with metal-on-metal hips were suffering from pain, implant loosening, and significant soft tissue damage. The alert stated that patients with any of the following attributes have an increased risk of harm:

  • Female
  • Misaligned components
  • Very active
  • Very overweight
  • Bilateral implants (both hips are implants)

The Canadian government told doctors to test patients for these symptoms, and to follow up with patients if they exhibit the following:

  • Groin, hip, or leg pain
  • Swelling at or near the hip joint
  • A limp or change in walking ability or range of motion

Further, the Canadian government said that if patients have any of the above symptoms, then revision surgery (removal of the implant) should be “seriously considered.”

Hip Implant Failure in Australia

The Australian government has been an international leader as a watchdog for metal-on-metal hip implant patients. It recalled the DePuy ASR metal-on-metal hip implant, and issued three warnings about metal-on-metal hip implants in general.

Australia was the first country to recall the DePuy ASR. It recalled the ASR in December 2009, because it said that patients with ASRs needed revision surgery (removal of ASR and replacement with a new implant) at a much higher than anticipated rate.

Its warnings had less bite than its recall, but they were also broader, and applied to more implants.

1.      If Blood Metal Levels Rise, Then Get Implant Removed

  • The Australian government issued the first warning on September 20, 2012.
  • If patients have increasing metal ion levels, then they should undergo revision surgery.
  • Patients without symptoms should undergo monitoring at a minimum of once per year.

2.      If 36 mm or Larger, Then Get Implant Removed

  • The Australian government issued the second warning on April 14, 2014.
  • If the patient has increased blood metal levels, or the patient got a total hip arthroplasty and the patient’s femoral head is 36 mm or larger, then they should undergo revision surgery.

3.      Consistency with the EU

  • The Australian government issued the third warning on March 12, 2015.
  • This warning is just a link to the EU’s recent report on metal-on-metal hips. The main point of that report is that metal-on-metal hip implants conclusively do cause metal poisoning.

Hip Implant Failure in the European Union

The Scientific Committee on Emerging Newly Identified Health Risks issued an opinion on metal-on-metal hip implants in March 2014. The Committee concluded that all types of metal-on-metal hip implants release metal particles into the bloodstream, and that the process is even more severe in implants with large femoral heads. The Committee did not ban metal-on-metal hip implants outright. Rather, it suggested that their use should be “carefully considered” on a case by case basis.

Why are other countries noticing the failure problems before the US?

Generally, foreign governments warn about and recall metal-on-metal hip implants before the US government. The reason why it works that way is because other countries have joint registries. A joint registry is a list of every patient who has received a certain implant in a certain country. It has each patient’s name, the type of implant they received, the date they received it, and among other things, whether they had to get the implant replaced. It takes lots of data to identify a pattern of failure. Joint registries help countries spot malfunctioning implants faster, because it puts more data in front of them, faster.

Foreign governments have been telling hip implant manufacturers that their implants are harming patients for more than 5 years (Australia in 2009), (UK in 2010), (Canada in 2012). Manufacturers keep selling their hip implants in the US even though multiple governments worldwide are recalling those same implants. Hip implant manufacturers need to be held accountable.