Manufacturer Warned For Developing Unapproved Medical Devices

Johnson & Johnson (J&J), a global pioneer and industry leader in the medical device industry, has witnessed several of their subsidiaries become the subject of intense criticism. Concerns regarding the safety and efficacy of their medical devices has tarnished their once pristine name and plagued further development. However, recent transgressions by J&J subsidiary DePuy have compounded their situation even further. According to a warning letter issued by the U.S. Food and Drug Administration (FDA), DePuy sold more than a dozen orthopaedic devices while simultaneously neglecting to obtain the appropriate approval from corresponding regulators.

Based in Warsaw, Ind., DePuy operates under the Johnson & Johnson family of companies. While one of J&J’s largest subsidiaries, DePuy is a global leader that prides itself on providing revolution healthcare solutions in orthopaedics, spinal care, sports medicine, and neurosciences. Their innovative medical devices have provided millions of patients with the retention, restoration, and improvement of otherwise deteriorated movement.

However, DePuy has recently been shrouded by an onslaught of litigation regarding several of its products. Most notably, DePuy also has received scrutiny for their ASR XL Acetabular Hip Replacement System, a once popular hip-replacement device. According to a United Kingdom database, the ASR XL Acetabular Hip Replacement System demonstrates a propensity for failure. Thirteen percent of patients who received this device experienced some sort of failure. Accordingly, DuPuy has since recalled the dangerous devices and is currently tasked with paying for subsequent surgeries.

Compounding what has already been a significant problem for DePuy, a warning letter issued by the FDA acknowledges that the medical device manufacturer made 14 products that have yet to receive pre-market approval from the agency.

According to the letter, the following devices have no premarket clearance or approval, or have been modified in ways that could impact the safety and effectiveness of the devices such that a new 510(k) is required in accordance with 21 CFR 807.81(a)(3) or a PMA Supplement is required in accordance with 21 CFR 814.39(a):

  • PFC Sigma Knee System with titanium components and Global Advantage Shoulder System with titanium heads
  • PFC Sigma Knee System components, sizes 2.5, 7, and 8
  • PFC Sigma Knee System, 30 mm – 40 mm thick inserts
  • Agility Total Ankle Prosthesis talar components with stems 0.35 inches and longer
  • Agility Total Ankle Prosthesis talar stems that are round in cross-section and taper
  • downwards
  • The Agility Total Ankle Prosthesis augments
  • Global humeral stems 18 mm in diameter
  • Global Humeral Stems shorter than 120 mm in length
  • TriFlange Acetabular Cups with outer diameters greater than 66 mm
  • TriFlange Acetabular Cups indicated for cemented use
  • Femoral heads that include a 14/16 taper
  • Femoral heads with offsets greater than +12
  • Acetabular hip system 14/16 taper adapters
  • Adapters to Stryker hip components

The company said it believed the devices were custom-made, requested by surgeons to match an individual patient’s anatomy and exempt from the approval process. However, the agency said they didn’t meet the criteria, in part because once the devices were finished, they might have been available to other doctors.

Such an excuse remains ambiguous in nature and fails to provide any evidence that the products in question were subjected to clinical trials. “The fact that the final specifications are tailored to match a patient’s anatomy does not preclude a clinical study or submission of a marketing application for the devices,” wrote the author of the warning letter.

Contradictory to the FDA’s warning letter, were the opinions of DePuy representative Lorie Gawreluk. According to Gawreluk, custom medical devices have been exempt from pre-market review since 1976, and the company believed it complied with the FDA’s requirements. “The company has made the decision at this time not to provide custom devices,” she said.