Johnson & Johnson (J&J) and its subsidiary DePuy has been ordered by a federal jury in Dallas to pay more than $1 billion to settle allegations that the company hid flaws in its Pinnacle hip implants that had to be surgically removed. [1]

Source: CNN

The jury concluded that DePuy, the maker of the artificial hips, knew the devices were defective, but failed to warn doctors and patients that the implants could fail. The verdict includes more than $30 million in actual damages for the 6 plaintiffs and more than $1 billion in punitive damages, court filings show. [2]

It is likely that the $1 billion award will be reduced. In July, the judge presiding over this case reduced a $500 million verdict in an earlier Pinnacle implant case to $151 million, citing a Texas law that limits punitive damages awards.

The 6 individuals involved in the case allege they suffered “serious medical complications caused by defective” metal-on-metal (MoM) Pinnacle implants. Each of the patients had to undergo revision surgery to replace the devices and repair tissue damage and bone erosion. At least 1 patient had received double implants. [1]

The lead attorney in the case said:

“Once again, a jury has listened to the testimony of both sides, and returned a verdict affirming what we’ve known all along: a responsible company would settle these cases and take care of their injured consumers, rather than forcing them through expensive and vexatious litigation just to delay justice.

This jury spoke loud and clear, and I hope J&J will finally listen.”

Metal-on-Metal Hip Implants: A Timeline

Source: Daily Mail

Prior to 1976, the FDA had no control over medical devices. However, thanks to the Food, Drug, and Cosmetic Act, that changes, and the agency gains full authority over metal-on-metal hip implants. [3]

Since the devices were marketed prior to the passage of the act, MoM hips are classified as “high-risk” (Class III). Despite the classification – and despite concerns over potential metal ion toxicity even before 1976 – the FDA still allows medical device makers to employ the 510(k) “fast-track” regulatory process for the implants.

Over the years, many changes are made to the design of metal-on-metal hip implants. One of those major changes occurs in 2004, and is quickly approved using the FDA’s 510(k) expedited approval system. Studies later reveal that this design change contributed to high rates of failure, metal ion debris, and increased wear.

Artificial hips were designed to last about 15 years. However, in 2010, DePuy recalled 2 of its hip implants – the ASR XL Acetabular System and ASR Hip Resurfacing System – after data from the National Joint Registry in England and Wales revealed that 12-13% of patients needed additional surgery within the first 5 years.

In 2009, Japanese surgeons contacted DePuy Orthopedics to express concern over health risks associated with the device. The hip system, as it turned out, had a flawed design which caused it to generate metal debris (metal ions) and cause tissue to necrotize.

By January 2013, there were more than 3,000 hip replacement lawsuits pending against DePuy over bodily harm allegedly caused by the Pinnacle device. That same year, the subsidiary stopped selling the metal-on-metal hips after the FDA strengthened its artificial hip regulations. [3] [2]

As of the end of 2016, J&J and DePuy have been slammed with more than 8,400 lawsuits over the device.

Metallosis

Metallosis is a fancy word for metal poisoning. It occurs when microscopic metal particles are shed by devices like hip and knee implants into the blood stream and surrounding tissues. These particles – made up of a blend of different metals including chromium, cobalt, nickel, titanium and molybdenum – can cause toxic levels of metal to build up in the body. [4]

Read: 6 Foods for Natural Heavy Metal Chelation

Metallosis commonly causes:

  • Cardiomyopathy (heart problems), including heart failure
  • Psychological status change (depression, anxiety and other mental problems)
  • Visual impairment that may lead to blindness
  • Cognitive impairment
  • Nerve problems
  • Thyroid problems
  • Auditory impairment that may lead to deafness
  • Skin rashes
  • Noise coming from the hip
  • Infection
  • Implant loosening

Sources:

[1] CNN

[2] Reuters

[3] Parker Waichman LLP

[4] Drugwatch

CNN

Daily Mail


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Post written byJulie Fidler:
Julie Fidler is a freelance writer, legal blogger, and the author of Adventures in Holy Matrimony: For Better or the Absolute Worst. She lives in Pennsylvania with her husband and two ridiculously spoiled cats. She occasionally pontificates on her blog.