Johnson & Johnson recently recalled its DePuy Synthes Radial Head Prosthesis System, a defective elbow implant that can cause serious complications and injuries for patients who have received it.

According to the official recall (dated December 30, 2016), the implant’s radial stem can loosen at the stem bone interface. J&J hasn’t been able to figure out which factors are causing the issue; as a result they have pulled the prostheses from the global market.

But a recall alone won’t help patients who have already suffered pain, soft tissue damage, or even post-op fractures as a result of these issues. Many recipients of DePuy elbow implants will want to file lawsuits to recover medical bills, lost wages, and other expenses.

If you have had a DePuy Synthes Radial Head Prosthesis System implanted at any point since December 2013, and you required or require a revision surgery on that joint replacement, you may be eligible for a lawsuit.

Hold DePuy Accountable

About DePuy Orthopaedics and Johnson & Johnson

Founded in Indiana in 1895, DePuy Orthopaedics is an international orthopedics and medical device company acquired by Johnson & Johnson in 1998. It is comprised of four brands:

  • DePuy Orthopaedics (joint replacements and other prostheses)
  • DePuy Spine (products that aim to fuse the spine and repair spinal fractures)
  • DePuy Mitek (products for sports-related injuries and soft tissue damage)
  • Codman (neurosurgical products)

DePuy Orthopaedics, which manufactures the Synthes Radial Head Prosthesis System that has just been recalled, is somewhat infamous for its hip replacement problems, which have generated more than 10,000 lawsuits.

Parent company Johnson & Johnson is no stranger to litigation, either. It currently faces a mountain of lawsuits over its talc products, as well as prescription drugs like Risperdal and Xarelto.

Elbow Implant Side Effects

This is a Class I recall, the most serious kind of recall by U.S. Food and Drug Administration (FDA) standards. The FDA defines Class I as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

This is not encouraging news for those patients with DePuy Synthes Radial Heads. Furthermore, the official recall states that the loosening of these radial stems can cause serious and painful side effects, including the following:

  • Device loosening
  • Osteolysis (the destruction or disappearance of bone tissue)
  • Poor joint mechanics
  • Pain
  • Post-operative bone fracture
  • Soft tissue damage
  • Soft tissue irritation

Many patients with these elbow implants will need revision surgeries to correct these problems. Thankfully, they may be able to force Johnson & Johnson to pay for these surgeries through legal action.

Precedents for Joint Replacement Recalls and Lawsuits

There is no shortage of joint replacement issues to highlight in terms of historical precedent, but most are hip and knee replacements, not elbow.

That said, in 2015 Stryker recalled 17,000 elbow replacements. But that recall was over damage to the implants that may have occurred during shipping. Moreover, it was a less severe Class II Recall, which denotes “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

In November 2013, J&J announced it would pay $2.5 billion to resolve about 8,000 ASR hip replacement lawsuits.

A more relevant example might be DePuy’s litany of hip replacement problems over the years. In August 2010, DePuy announced it was recalling two hip replacement systems—the ASR Hip Resurfacing System and the ASR XL Acetabular System—due to unwanted side effects like metal poisoning.

These hip issues led to thousands of lawsuits filed by affected patients. In November 2013, J&J announced it would pay $2.5 billion to resolve about 8,000 ASR lawsuits. (That settlement sum included $250,000 for each patient to cover a revision surgery.)

DePuy’s Pinnacle hip implants have caused similar side effects to the ASR models and generated thousands of lawsuits by affected patients. In March 2016, a jury in Dallas, Texas awarded $502 million to patients who said their failed Pinnacle devices had caused pain and would require (or had required) revision surgeries. (A judge later reduced this award to $150 million.)

In another bellwether trial that came to a close in December 2016, a Texas jury awarded $1 billion to six plaintiffs who needed revision surgeries because of painful side effects caused by their Pinnacle hip implants. According to Reuters, these side effects included tissue death and bone erosion. (A judge later cut this award in half.)

There are still about 8,400 more Pinnacle cases currently on trial in North Texas courts as an MDL (multi-district litigation).

Faulty Implants Spur Lawsuits

Due to the debilitating nature of these side effects, the possibility of revision surgeries, and Johnson & Johnson’s inability to pinpoint the cause of the problems, many patients will file lawsuits against J&J to recover medical bills, lost wages, and other expenses related to their faulty elbow implants.

If you have require(d) revision surgery because of a faulty DePuy elbow implant, you may be eligible for a lawsuit.

If you have had a DePuy Synthes Radial Head Prosthesis System implanted at any point since December 2013, and you required or require a revision surgery on that joint replacement, you may be eligible for a lawsuit.

(Note: At this time we are only interested in pursuing cases about elbow implants manufactured by DePuy, not other manufacturers.)

We Can Help You Recover Compensation

If you or a loved one has experienced pain, soft tissue damage or irritation, poor joint mechanics, or broken bones because of a faulty elbow implant—and require(d) revision surgery as a result of these side effects—please contact us today to learn your rights.

You may qualify for a lawsuit that could help you recover medical bills, lost wages, and other expenses related to your device’s unforeseen side effects. To date, our firm has recovered more than $2 billion for our clients. We can help you obtain justice and hold Johnson & Johnson/DePuy accountable.