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New Jersey manufacturer markets implant without approval

It is important for New Jersey companies to obtain the necessary legal permissions before selling government-regulated products. However, this does not seem to be the case in a recent headline-grabbing story concerning New Jersey-based firm, Johnson & Johnson.

According to a national media report, Johnson & Johnson sold a vaginal mesh implant to consumers three years before the U.S. government regulators tendered approval. Unfortunately, the missing green-light from the FDA may have prevented over 550 lawsuits that were filed by women saying they were injured by the product -- leading to exorbitant business litigation.

The Gynecare Prolift device was launched in March 2005. J&J stated that the product was an "innovative and effective surgical option" for a woman with weakened pelvic muscles. However, the U.S. Food and Drug Administration (FDA) stated it became aware of the product two years later when the manufacturer was seeking approval for a related product, according to the media report.

Ethicon, J&J's business entity that marketed the device, asserts that the company's actions were "responsible, appropriate and consistent" with the regulatory guidelines of the FDA -- prompting many to question the established standards. The FDA's current approval process permits businesses to market devices that haven't been tested on humans if similar devices have already been approved by the agency.

The New Jersey manufacturer has faced financial woes due to problems with other products. These include recalls for OTC drugs and artificial hip implants. Due to these recent issues, the second largest global maker of health care products has experienced many legal problems in a relatively short period of time.

Any product liability lawsuit could result in years of litigation expenses. For example, what initially appears to be a minor setback with a faulty product can actually develop into a class action lawsuit if enough people are adversely affected. As a preventive measure, a company should act in good faith to ensure products are safe for consumers and meet or exceed regulatory conditions.

For the problems with the vaginal mesh implant, which is a product liability case, a company needs to have a good legal team. Whether a business is as large as Johnson & Johnson or a company just getting off the ground, skilled legal advice can ensure that important steps are not overlooked that can lead to costly litigation in the future.

Source: Bloomberg.com, "J&J marketed vaginal mesh implant without U.S. approval," David Voreacos and Alex Nussbaum, March 21, 2012

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