Product Liability Attorneys Blog

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.

Continue reading "Johnson & Johnson Delayed Reporting Defective Product, FDA Says" »

Authorities worldwide are warning women who had breast implant surgery to get checks because the French company that produced the implants has been accused of using defective material.

Breast implants for years have come under scrutiny after problems emerged; implants have leaked and other health and welfare issues have been associated with defective breast implants.

Our defective product attorneys recognize that breast implant surgery is more common today than ever before since it has become more affordable. It is commonly done on women who have had breast cancer and require the surgery. Others decide to get the elective surgery simply to improve their looks or self esteem.

And as the product has become safer after years of testing and monitoring, there are still risks. The surgery itself can be dangerous, but the product can have long-lasting effects if it is defective.

The U.S. Food and Drug Administration warns women with breast implants have a small, but possible risk of developing ALCL, or anaplastic large cell lymphoma. Scientists examined cases of 34 women with implants on top of reading expert writings, manufacturer literature and other information.

Since there are five to 10 million breast implant recipients worldwide, such a small study can't say that implants cause the disease. While the case number is small worldwide and it's unclear how much of a connection there is, the agency warns women that silicone- and saline-filled implants can lead to the illness after noticing changes in the look or feel around the area of implant.

Czechoslovakia government officials have told women to undergo checks of their implants if theirs came from the French company Poly Implant Prothese SA, which is now defunct. Distribution of the implants were halted in 2010 after a woman died from cancer after having breast implant surgery.

The Australian consumer goods agency is now investigating PIP implants as well. The Australian Broadcasting Corporation reports that some 400,000 women worldwide ordered the implants. The company went bankrupt in 2010 after an investigation into the business found it was using an unapproved and less-expensive industrial grade silicone in some of its products. The gel was found to increase the risk of leaks and lead to cancer.

The Australian news report goes on to say that new information out of France states that the risk may be higher than once thought, though that hasn't been confirmed. It's also possible that France officials will pay for removal of the implants, but other countries haven't been as quick to act. Based partly on the FDA report that the cancer is rare and not conclusively linked to the breast implants, some experts don't necessarily agree that there is an increased risk of cancer.

Certainly, a leaking breast implant isn't a good thing because foreign objects would be introduced into the body. And given that there is even some evidence that women with breast implant leaks have gotten cancer, all women who have implants should take note. These defective products obviously come with a risk that can be avoided and it's on the manufacturer to make sure they are created properly.

Continue reading "French PIP Breast Implants Come Under Scrutiny Worldwide" »