Parents Who Filed A Zofran Lawsuit Concerned About 21st Century Cures Act

March 09, 2016 – – ZofranLegal.com has reported that the parents involved in the growing Zofran litigation are concerned about the impact that the 21st Century Cures Act could have on the process the U.S. Food and Drug Administration uses to approve new drugs and medical devices.

The 21st Century Cures Act, which was passed by the House in July of 2015, was designed to streamline the approval process. While many insist that a faster process would save lives, like those of cancer patients who are waiting for drugs that are still in the trial stages, others believe that a faster process will mean less research performed and missed side effects.

Zofran plaintiffs are most concerned with the fact that Section 222 of the Act would allow the FDA to use studies published in peer-reviewed journals as a valid form of evidence to determine whether or not a drug or device is effective. It also states that “data collected in countries other than the United States…” would also be considered valid. Parents have pointed out that if the FDA had used evidence based on other countries studies when reviewing the drug thalidomide, thousands of American children could have been born with severe birth defects. However, thanks to the work of FDA medical officer Dr. Frances Kelsey, the administration was reluctant to give their approval of the drug as a treatment for morning sickness.

Requests have been made for the FDA to update the label on the anti-nausea medication Zofran, so that it warns doctors and patients that the drug has the potential to cause serious birth defects. Although the drug was approved by the administration in 1991, human clinical trials involving expectant mothers were never performed, and the label indicated that the drug was safe for patients undergoing anesthesia, chemotherapy, and radiation. Despite this fact, the drug manufacturer, GlaxoSmithKline, chose to advertise the drug as a “safe” and “effective” treatment for morning sickness, a condition commonly experienced during the first trimester of a pregnancy.

There are now more than 230 Zofran birth defect lawsuits filed against the company, alleging that the company unlawfully promoted the drug for “off-label” use and that as a result of this, unborn children developed birth defects they otherwise would not have had. Atrial septal defect, ventricular septal defect, transposition of the greater vessels, respiratory distress syndrome, clubfoot, ear deformities, cleft lip and palate, and kidney defects have all been claimed as birth defects caused by the drug.

For more information on the Zofran litigation please contact Attorney Michael Monheit by calling 877-620-8411.

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Contact ZofranLegal.com:

Michael Monheit
1-877-620-8411
michael@monheit.com
1368 Barrowdale Road, Rydal, PA 19046

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