Judge's Ruling May Impact SSRI Lawsuits

Indianapolis, INA federal judge reversed a prior decision to dismiss a Paxil lawsuit in a move that may have repercussions for SSRI birth defect lawsuits. In making his decision, which effectively re-opens a lawsuit against Paxil regarding a patient's suicide, the judge said that he, "failed to appreciate the fact that the ongoing ability, authority, and responsibility to strengthen a label still rest squarely with the drug manufacturer." He further noted, "[D]rug manufacturers have the authority to strengthen warnings without the advance permission of the FDA."

The judge went on to say that the clinical testing drugs undergo is not designed to show risks that are rare or that take a long time to appear. The ruling allows victims of negligent drug makers to file lawsuits against those drug companies.

Many drug companies argue that, because the FDA approves their warnings, they are not liable for any failure on the part of the warnings; for example a failure to warn against certain side effects. However, this ruling essentially says that the FDA approves the warning based on the information it has, but drug companies have the authority to strengthen their warnings should new information arise once the drug is on the market.

Many women who took Paxil and other SSRIs while pregnant are investigating lawsuits of their own, alleging GlaxoSmithKline, the maker of Paxil, new about the risks associated with the drug but did not adequately warn them. Many of these women have given birth to infants with serious birth defects, including persistent pulmonary hypertension and other congenital birth defects.

The heartache of having a child with birth defects, especially birth defects allegedly caused by a medication the mother took while pregnant, can only be understood by parents who endure it. Many of these children require multiple surgeries to repair their defects. Even with the surgeries, many of these children face a lifetime of difficulties, and must be closely watched for any signs of illness. Some of these children are prevented from doing the things other children do, such as playing sports.

These children born with SSRI-related birth defects are truly innocent victims. They did nothing to bring about their birth defects, yet they have to live with those defects their whole lives. Their mothers feel understandably guilty about the situation, even though there is nothing they could have done about it. After all, they were told by their doctors that the SSRIs were safe to take, and their doctors honestly believed that was true.

The tragedy is that many people believed SSRIs were safe to take during pregnancy, only to learn, through an FDA warning, that this was not the case. Now, many children and their families are dealing with the aftermath—and hoping to hold the makers of the SSRI drugs accountable for not properly warning them about the risks.

If your child was born with a birth defect linked to the use of an SSRI during pregnancy you may be eligible to join a lawsuit against the SSRI makers. Contact a lawyer as soon as possible to discuss your options.