May 7, 2011

Johnson & Johnson Subsidiary Sued over Defective Hip Implants

Did DePuy Orthopaedics, subsidiary of New Jersey-based Johnson & Johnson, knowingly sell defective hip implant devices? That’s the basis of a federal class action lawsuit filed in Trenton late last month. (1)

According to the suit, North Jersey Municipal Employee Benefits Fund v. DePuy Orthopaedics, the Warsaw, Ind.,-based unit of J&J knew there were problems with its hip-replacement system but continued to sell the products anyway. (1)

The ASR XL Acetabular System and the ASR Hip Resurfacing Platform were intended to correct degenerative conditions of the hip caused by ailments such as osteoarthritis. These devices were marketed as superior, with a longer lifespan and more natural fit. It was stated that patients would require less serious corrective surgery and the devices would wear better. Instead, the Food and Drug Administration (FDA) received hundreds of complaints about the products from patients across the country. According to these complaints, the implants came loose, dislocated or misaligned. In addition, the friction of metal rubbing against metal produced metal debris that proved harmful to the patients. Among the symptoms experienced were swelling and inflammation, tissue and bone damage and pain. Corrective surgery, which was both painful and expensive, was required to correct the damage. (1)

The bulk of these complaints hit the FDA in early 2008. Still, DePuy continued to market and sell the implants through 2008 and 2009. It wasn’t until late 2009 that sales stopped, followed by a national recall in August 2010. (1)

In September of 2010, a California construction worker was one of the first to sue J&J over its subsidiary’s hip-implants, claiming the tissue and bone surrounding the implants he received became infected and damaged. In that suit, it was pointed out 93,000 patients who had received the implants required corrective surgery because of product defects. A study conducted in Britain found that recipients of DePuy’s implants required a second surgery after five years. Such devices have an expected lifespan of 15 years. (2)

This past February a teacher in Tasmania filed a lawsuit in Sydney claiming J&J and its subsidiary were negligent and violated Australia’s trade laws by selling the defective products. (3)

The most recent lawsuit is one of several actions being taken across the nation pertaining to the hip implants. According to reports, there were 139 federal lawsuits and 42 state lawsuits pending as of last December. (1)

(1) http://www.law.com/jsp/nj/PubArticleNJ.jsp?id=1202491747352&rss=nj&slreturn=1&hbxlogin=1
(2) http://www.nj.com/business/index.ssf/2010/09/johnson_johnson_sued_over_hip-.html
(3) http://www.bloomberg.com/news/2011-02-28/johnson-johnson-sued-by-australian-teacher-over-hip-replacement-device.html

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September 25, 2010

Did Johnson & Johnson Provide Enough Warning to Patch Users?

It was supposed to be the forgetful woman’s answer to birth control but now the Ortho Evra patch is the subject of an ongoing investigation and basis for numerous lawsuits against its manufacturer, New Jersey-based pharmaceutical company Johnson & Johnson. The question is whether or not Johnson & Johnson did enough to warn consumers about the higher risks associated with the patch. (1)

When it was first introduced in 2002, the patch was lauded as one of the year’s best inventions. But as popularity of the patch grew, so did evidence about the higher risks associated with the product. (1)

In 2005, the Food and Drug Administration (FDA) issued a warning to consumers that exposure to higher levels of estrogen put them at greater risks for serious side effects, including blood clots and strokes. A warning was then added to the label on the patch advising women that use of the product would expose them to approximately 60% more estrogen than if they used the pill. (2) Medical experts seem to think that is due to the fact that the patch delivers estrogen straight into the bloodstream on a continuous basis whereas, when in pill form, the hormone is dissolved and digested before entering the bloodstream in more diluted levels. (3)

Medical records from the period between 2002 and 2004 indicated that risks of strokes were higher than with the pill (by 12%), as were risks of blood clots (by 18%). Over 2,400 women have claimed injuries from the patch and about 24 deaths have been attributed to it. One of those who died was 17-year-old college freshman Adrianna Duffy. Her mother, Leslie Niedner, is currently involved with others in a lawsuit against Johnson & Johnson. Reports estimate that Johnson & Johnson already has paid an estimated $68 million in settlements to victims of the patch. Niedner vows not to settle but instead to see the case to trial. (1)

Separately, a former Johnson & Johnson vice-president, Dr. Joel Lippman, is suing the company for unlawful termination, claiming that he was fired after “blowing the whistle” on the product even before it was put on the market. (1)

Whether Johnson & Johnson’s warnings about the potential dangers of the patch were clear enough is now a question for the courts to answer.

(1) http://today.msnbc.msn.com/id/39306467

(2) http://www.cbsnews.com/stories/2005/11/11/earlyshow/health/health_news/main1037611.shtml

(3) http://www.aol/health.com/2010/09/23/did-johnson-and-johnson-hide-dangers-of-its -birth-control-patch/

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