A settlement has finally been reached in a class action lawsuit concerning E-Ferol, the drug pulled off the market 26 years ago after it was linked to the death of over 40 babies born prematurely.
E-Ferol, introduced in 1983, was touted for its purported ability to prevent retrolental fibroplasia, a blindness caused by a vitamin E deficiency that primarily affects premature babies.
The defendants -- manufacturer Carter-Glogau Laboratories and distributor O'Neal, Jones & Feldman Pharmaceuticals -- marketed E-Ferol as a vitamin supplement rather than as a drug, a decision that the plaintiffs said was designed to avoid testing mandated for all "drugs" by the U.S. Food & Drug Administration (FDA).
The defendants then undertook a deceptive marketing campaign, according to the plaintiffs, leading doctors and hospitals to use E-Ferol under the impression that it had been approved by the FDA.
A few months after E-Ferol's release, doctors began to notice a disturbing pattern of side effects in babies to whom the supplement had been administered. The symptoms in these babies -- which included brain damage, blindness, and, in some cases, death -- were caused primarily by liver and kidney failure. The symptoms were so widespread that they earned the collective nickname "E-Ferol syndrome."
The case led to the conviction and eventual imprisonment of the companies' presidents, and the settlement of over 100 other lawsuits. Despite E-Ferol's high profile history, many of the plaintiffs in this case weren't even aware that their babies had received the supplement until they were informed of the lawsuit.
The plaintiffs' attorneys used hospital records to discover who had received the drug.
Art Brender, the attorney representing the plaintiffs, called the E-Ferol saga "one of the worst cases of corporate greed and malfeasance in history." He estimates that at least 80 babies died from the drug, twice what other estimates have been.
The case was a wake-up call to the public, which was largely unaware that certain supplements could reach the market without FDA testing or approval. Ted Weiss, then a New York Congressman who chaired hearings on the subject, prophetically said that the E-Ferol tragedy was "the tip of the iceberg."
Despite the 20 years that have passed since that statement, non-FDA-approved drugs continue to cause problems. Most recently, the FDA recalled Hydroxycut -- a "dietary supplement" that doesn't require FDA approval -- after it was linked to several cases of liver damage.
In addition to its overall gruesomeness, the case was notable for the bizarre circumstances surrounding its settlement. Both of the defendant companies have been out of business for nearly two decades, according to their attorney David Taylor. The corporations' liability insurance will cover the costs of the settlement.
The suit was brought on behalf of everyone in the U.S. who received E-Ferol between November 1, 1983, and April 30, 1984, including the estates or heirs of people killed by the drug. Included in the class were the parents of 42 babies who died from the drug, as well as adults who received the drug during their infancy and were harmed as a result.