Study finds drug company delays in reporting adverse events to FDA could endanger patient health

by John Chapman

A new study published by JAMA Internal Medicine has found that drug companies may delay reporting serious cases of pharmaceutical adverse events to the Food and Drug Administration, putting the safety of patients who take these medications at risk. The report found that drug companies may be even less likely to report adverse events to the FDA in cases involving a patient’s death.

The JAMA study found that about 10% of cases involving serious prescription drug complications are not reported to the FDA within the mandatory 15 day period. Under federal law, drug manufacturers are obligated to report any cases to the FDA involving “death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.”

Many of these late reports were delivered to the FDA by drug manufacturers weeks or even months after they learned of these incidents. Researchers say that these delays could further exacerbate the potential risks of dangerous medications for patients. “Everyone wants to be sure the drugs we’re taking are safe, and it is the FDA’s role to make sure the drugs we’re taking are safe,” said JAMA Internal Medicine editor Dr. Rita Redberg. “If adverse event reports are getting filed late, that means safety warnings are delayed and more people are taking dangerous drugs without knowing it.”

Researchers also found that drug companies were less likely to promptly file these Adverse Event Reports in cases involving the death of a patient. Drug companies delayed filing Adverse Event Reports in about 9% of non-fatal cases, compared to 12% of cases involving a patient death. Between 2004 and 2014, researchers found that drug companies delayed in reporting an astounding 40,000 cases involving the death of a patient involving prescription drug use. Delays occurred in an additional 120,000 cases that did not involve fatality.

The authors of the JAMA study speculated that the problem of delayed reporting of adverse events could be even worse than their research indicated. “Although [researchers] reviewed well over 1 million adverse events,” Redberg stated, “it’s estimated that only 2 percent of all adverse events ever get reported to the FDA.”

The FDA has warned several manufacturers about the consequences of failure to file Adverse Event Reports in a timely fashion. In May 2010, the agency sent a warning letter to Pfizer over repeated delays in filing AERs with the agency. According to the FDA warning letter, Pfizer had delayed reporting adverse events to the agency nine months to up to three years after incidents involving prescription drug side effects had taken place. In September 2010, the agency sent a warning letter to Actelion Pharmaceuticals for failing to report adverse events involving nearly 3,500 patient deaths.

Legal Help for Victims of Dangerous Drugs and Medical Devices

Despite the efforts of the FDA and other federal regulators, thousands patients are injured every year as a result of side effects from prescription medications. Far too often, the pharmaceutical industry puts profit ahead of patient interests, disregarding the safety concerns because of the enormous sales that “blockbuster” drugs and medical devices can generate.

If you or a loved one has been hurt by complications from prescription drugs or other medical products, you and your family are entitled to have a well-trained and experienced attorney fighting on your behalf. In order to successfully file a lawsuit against big and well-funded drug companies, you will need a law firm with the financial resources to take your case all the way to trial.

At Heygood, Orr & Pearson, we believe that when the actions of pharmaceutical companies and medical devices manufacturers jeopardize the safety or health of patients, they should be held accountable for their actions in a court of law. Our lawyers have the experience, expertise, and resources to take on any pharmaceutical liability case. Our law firm has tried hundreds of cases to verdict and has achieved settlements in hundreds more.

In just the last few years, our lawyers have collected more than $200 million on behalf of our clients in cases relating to defective pharmaceutical products. The lawyers at Heygood, Orr & Pearson have pursued claims involving injuries linked to a variety of pharmaceutical products, including the fentanyl pain patch, Yasmin, Actos, Avandia, Pradaxa and Xarelto, Zofran, and other drugs. We have also filed lawsuits on behalf of patients who were injured by medical devices such as hip or knee replacements and transvaginal mesh products used in surgical repair of damaged tissue.

If you or a loved one have been injured as a result of prescription drug complications, contact the lawyers at Heygood, Orr & Pearson to learn more about filing a case. For a free legal consultation from an attorney and to find out whether you may qualify to file a lawsuit, please call us toll-free at 1-877-446-9001. You can also reach us by following the link to our free case evaluation form and answering a few simple questions about your case to get started.

by John Chapman

John Chapman is a licensed attorney with experience in complex commercial litigation (including securities fraud, RICO, shareholder oppression, and derivative actions) and personal injury litigation.