Johnson & Johnson Delayed Reporting Defective Product, FDA Says

January 19, 2012

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Johnson & Johnson has come under scrutiny lately from the U.S. Food and Drug Administration, which reports that the company delayed reporting to consumers that insulin pumps they created were having problems, the Associated Press reports.

Our defective medical device lawyers recognize that not every product that comes out of the manufacturer's plant is going to be perfect. In fact, many are going to be flawed.

But many defective medical products and defective drugs could be made better if not for rushed production by companies trying to maximize their profits. While there are procedures and mandatory testing put in place, the system doesn't always do enough to prevent bad products.

And these rushed products can lead to major injuries for consumers. Any type of drug or product that a person puts into his or her body or uses to treat other problems can have side effects. Sometimes these side effects are worse than the original ailments and often can lead to major medical issues.

In this case, the Associated Press reports that this is Johnson & Johnson's seventh business that has come under scrutiny in recent months. The company was once seen as a pillar of consumer safety, when decades ago it recalled Tylenol bottles that had been poisoned. It now faces major problems.

A unit of the company produces insulin pumps for diabetics that are known to fail, and yet, Johnson & Johnson continued to sell them, the FDA said. Now, the government regulation agency could impose fines and other sanctions, not only because of the faulty pumps, but also because the company didn't disclose that information quickly enough.

The agency sent a letter to the company in late December asking why it didn't report a complaint about a serious patient injury and delayed reporting two other complaints. Those patients were hospitalized after experiencing high blood sugar, respiratory failure and coma and other life-threatening complications because of a lack of insulin.

Since September 2009, Johnson & Johnson has faced 30 product recalls, the latest coming in recent weeks. Millions of bottles of non-prescription medicines for adults and children, prescription drugs that treat HIV and seizures, hip implants and contact lenses have all been under scrutiny. The reasons for the recalls range from contamination with metal shards and glass particles to some patients experiencing nauseating smells and incorrect levels of active drug ingredients.

Company officials said the reason they didn't report the problems initially was because they believe patients used the pumps improperly, which caused their injuries. The company told the Associated Press it will report all problems from now on.

In 2010, Johnson & Johnson's recalls cost them more than $900 million in lost revenue when products were lifted from shelves. Millions more was lost for legal expenses and factory upgrades.

But these problems can cost patients their lives. This is why companies must be more diligent in their handling of these products and drugs. Defective products and drugs are a major problem in this country because so much research is being done to try to find cures. But a company's primary goal is typically to maximize profits.

This causes problems for consumers and the companies themselves. Do your research when using a new drug and look for side effects and other problems. Just because a product or medical procedure has been approved, doesn't mean it's safe.

The Ferraro Law Firm represents people injured by recalled or defective products throughout the country. Call 1-800-275-3332 for a free and confidential consultation. Offices in Miami, Washington, D.C., and New York City.

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