On July 26, a jury found Abbott Laboratories’ specialized formula for premature infants caused an Illinois baby to develop a dangerous bowel disease, ordering the health care company to pay $495 million in damages. The verdict in Missouri state court is the second of such trials. The first was against Mead Johnson.
Hundreds of similar cases are pending in courts around the country. The tort floodgates are open, and there are dangerous consequences, not the least of which are that these lifesaving products could cease to exist in the United States. These low-margin products are manufactured by only two companies, Abbott and Mead Johnson.
Common sense and basic economics point to these companies leaving this crucial product category, leaving high-risk premature infants (along with their parents and health care providers) with nowhere to turn except prayer — and triggering a public health crisis. Dr. Benjamin D.
Hoffman, president of the American Academy of Pediatrics, said: “Courtrooms are not the best place to determine clinical recommendations for the care of infants. Feeding decisions should be made by clinicians and families. These need to be individualized in the context of human milk availability, specific patient needs, and individual family preferences.
” These products are safe and effective from a medical risk-benefit proposition. And according to the Academy of Pediatrics, “These special formulas provide an essential source of nutrition for preterm infants.” But that hasn’t stopped the tort bar from pushing bogus litigation.
This is causing confusion and uncertainty in the marketplace, and the Food and Drug Administration should immediately and publicly vouch for the veracity of the labeling and safety of the products. If, as President Biden has so often said, “science is back,” then it’s time for the White House and our nation’s leaders to act. After the FDA publicly comments, leaders should resuscitate the agency’s Food Advisory Committee, with its first order of business being a high-level, expert discussion of the safety, effectiveness and labeling of specialized formula for premature infants.
The agenda should also include a review of the agency’s relevant Final Rule for Preventive Controls for Human Food. But restarting an FDA advisory committee is mired in bureaucracy and won’t happen quickly. So, in addition to beginning this process, the FDA should ask an independent third-party organization — such as the National Academies of Sciences — to create a blue-ribbon panel to discuss the best path forward for the FDA to take.
After the recent baby formula shortage, the FDA asked the NAS to convene a similar panel to address the vulnerabilities in the infant formula market to mitigate future shortages. Another route is for Congress to step up and recognize the dangers of a nation without any domestic manufacturers of specialized formula for premature infants. Considering the aggressive tort bar, perhaps legislation similar to federal vaccine liability protection is in order.
All of these solutions, however, will take time. In the meantime, the FDA and the administration cannot sit silently while plaintiffs’ lawyers upend decades of established science. Left unchecked, the greed of the tort bar will result in a predictable consequence: dead babies.
Policymakers must not allow this to happen. In the words of Confucius, “Be not ashamed of mistakes and thus make them crimes.” Copyright © 2024 The Washington Times, LLC.
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