The U.S. Food & Drug Administration's (FDA) black warnings on TNF (Tumor Necrosis Factor) Alpha Blocker drugs used to treat juvenile rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, inflammatory bowel disorder and Crohn’s disease will likely spur more failure to warn product liability lawsuits against the manufacturers of Remicade, Simponi, Humira, Enbrel and Cimzia.

More studies needed

As part of the FDA's recent black box warnings, the Administration has instructed pharmaceutical companies such as Johnson & Johnson, Abbot Laboratories, UCB Global Pharma, Amgen and Wyeth Laboratories to conduct additional testing after finding that the drugs may increase the risk of cancer in children and fungal infections. TNF Alpha Blocker Attorneys say that the manufacturers' studies may have been lacking.

Attorney Jason Richards

Jason Richards, a Florida Attorney whose firm represents injured TNF Alpha Blocker victims, says that pharmaceutical companies don’t want to conduct studies that are going to show a negative effect on their drug, so they do just enough to get past the FDA’s oversight. He explained:

Even in the studies that are conducted by pharmaceutical companies, they often seem to manipulate which study participants make the cut and which don’t. They often get healthy participants to participate in these studies and then, not surprisingly, you don’t find any rates of cancer. It’s not really a realistic setting for practical use. The studies don’t necessarily evaluate the real world scenarios where people have other risk health issues and are then placed on an alpha blocker, which causes even more problems.

This selective process has led to numerous failure to warn product liability lawsuits against the manufacturers – and more are likely.

More failure to warn cases likely

Most of these cases are failure to warn cases where the manufacturers probably knew sooner that there was an association between the drugs and cancer, according to Richards. He told us:

They [manufacturers] avoided informing the FDA or tried to downplay the risk because they didn’t want anything significant in the label that would scare off doctors from prescribing the drug. This would be particularly applicable to cancer, because doctors and patients are naturally hesitant prescribe or use a drug that could increase the risk of cancer. They should have warned about these risks sooner and they didn’t do it because they were looking to protect their market share.

If you've been injured by a TNF Alpha Blocker, contact an experienced TNF Alpha Blocker attorney for a free case review.