In early 2022, the United States saw a sudden spike in infant infections from Cronobacter sakazakii, a rare but deadly bacteria that thrives in powdered infant formula. Two babies died, and several others required hospitalization. The manufacturer at the center of that outbreak, Abbott Nutrition, shut down its Sturgis, Michigan, plant and issued a massive recall. Parents panicked. Shelves went empty. And the legal fallout began. That real-world disaster is a textbook example of product liability when contaminated food or medicine causes harm.
Product liability law holds manufacturers, distributors, and retailers responsible when a product they put into the marketplace injures someone. In cases involving contaminated food or medicine, the legal claim generally falls into three categories: defective design, defective manufacturing, or failure to warn. The Cronobacter outbreak was a straight manufacturing defect. The formula was designed to be safe for healthy infants. But somewhere in the production line at the Sturgis plant, bacteria entered the powder. The company’s own internal testing had found Cronobacter in the facility multiple times before the outbreak, and inspectors later uncovered unsanitary conditions, standing water, and inadequate cleaning procedures.
For a non-lawyer, the core question is straightforward: who pays when a company’s product makes you or your baby sick? The answer usually comes down to negligence or strict liability. Negligence means the company failed to act with reasonable care. In the Abbott case, evidence showed that plant management knew about the contamination risks but did not shut down and fix the problem. They kept producing and shipping formula while children got sick. That is negligence on a wide scale.
Strict liability is a different legal concept that does not require proving the company was careless. Under strict liability, a manufacturer is automatically responsible for harm caused by a defective product, even if they took every reasonable precaution. The idea is that the company is in the best position to prevent defects and to absorb the costs when something goes wrong. For a parent whose infant suffered severe brain damage from a Cronobacter infection, strict liability means they do not have to climb a mountain of evidence about what exactly happened on the factory floor. They only have to show that the formula was defective and that the defect caused the injury.
The most common legal avenue for victims of contaminated food or medicine is a lawsuit for damages. Those damages can cover medical bills, ongoing care costs, lost income if a parent had to stop working, and compensation for pain and suffering. In infant formula cases, a child may require lifelong treatment for neurological damage or digestive problems. The total payout in a single lawsuit can run into the millions of dollars. When a contamination event affects thousands of families, companies often face class-action lawsuits, where many victims join together to sue the manufacturer as a group. In the aftermath of the 2022 recall, multiple class actions were filed against Abbott Nutrition, alleging that the company put profit ahead of safety.
One tricky aspect of product liability for contaminated food and medicine is proving causation. In an outbreak, many infants might develop diarrhea or vomiting from a virus that has nothing to do with their formula. A successful claim requires medical evidence linking the specific product to the specific illness. That means testing the leftover formula from the same batch and matching the bacterial strain found in the baby to the strain found in the plant. Public health investigators from the FDA and CDC do most of that work, and their findings often become the backbone of a lawsuit.
Another route for victims is to file a claim with the manufacturer directly, especially if the company has set up a compensation fund. But those offers are usually low and come with strings attached, such as a requirement to waive the right to sue later. A lawyer can help a family decide whether to accept a settlement or go to court.
The legal system also gives the government tools to act. The FDA can issue recalls, shut down facilities, and impose fines. The Department of Justice can bring criminal charges if a company knowingly shipped contaminated products. In the Abbott case, the company eventually agreed to a consent decree with the FDA, essentially promising to overhaul its safety practices under federal supervision. Criminal charges have not been filed, but the door remains open.
What does this mean for an ordinary person? If you or a family member suffers a serious illness after using a regulated product like infant formula, over-the-counter medicine, or packaged food, you have legal rights. You do not need to be an expert on manufacturing or bacteria. You need a lawyer who understands product liability. The key is to preserve the product itself, keep the packaging and receipts, and get medical records linking the illness to the product. State laws have strict deadlines for filing claims, so acting quickly matters.
The Cronobacter outbreak highlighted a brutal truth: contamination can turn a trusted product into a weapon. Product liability law exists to make the system safer by forcing companies to bear the cost of their failures. When a manufacturer cuts corners on cleanliness, the law says they must pay for every life they damage. That is not revenge. It is accountability.