In early 2023, the U.S. Food and Drug Administration issued urgent warnings about several brands of over-the-counter eye drops contaminated with Pseudomonas aeruginosa, a drug-resistant bacterium. The outbreak sickened dozens of people in multiple states, caused permanent vision loss in some patients, and led to several deaths. The contaminated products came from a manufacturing facility in India that had a history of quality-control failures. For patients and their families, the legal question was straightforward: who pays for the harm when a product that is supposed to heal actually makes you worse? The answer lies in product liability law, and the case of contaminated eye drops provides a clear, ugly example of how the system works when medicine turns dangerous.

Product liability cases involving contaminated medicine or food do not require the victim to prove that the manufacturer acted with malicious intent. That is the single most important fact for a non-lawyer to understand. The legal system uses a concept called strict liability for products that are defectively manufactured. Strict liability means that if a product leaves the factory in a defective condition and that defect causes injury, the manufacturer is responsible regardless of how careful they were. In the eye drop outbreak, the defect was the presence of a deadly bacteria in a sterile product. The manufacturer cannot argue that they checked the bottles or that they followed standard procedures. If the bacteria was there, the product is defective, and liability attaches.

But strict liability is only one piece of the puzzle. Victims in these cases also typically bring claims for negligence. Negligence requires showing that the manufacturer breached a duty of reasonable care. In the eye drop situation, evidence emerged that the factory had unsanitary conditions, that employees failed to follow sterilization protocols, and that the company continued shipping products even after internal testing showed contamination. That is negligence in plain language: the manufacturer had a duty to produce safe, sterile eye drops, they failed to do so, and people got hurt. Negligence claims allow victims to seek compensation for medical expenses, lost wages, pain and suffering, and sometimes punitive damages meant to punish especially reckless behavior.

Another common legal claim in contaminated medicine cases is breach of warranty. Every product carries an implied warranty that it is fit for its ordinary purpose. The ordinary purpose of eye drops is to lubricate or medicate the eye without causing infection. When a bottle contains bacteria, it is not fit for that purpose. The warranty is automatically violated, and the manufacturer is on the hook. This claim is useful because it does not require proving the manufacturer knew about the problem. The warranty is broken the moment the contaminated product is sold.

The eye drop outbreak also highlights the role of government regulation and how it interacts with private lawsuits. The FDA issued import alerts and recalled specific lots, but government action is slow and often limited. The recall covered only the identified contaminated batches, but by the time the recall was issued, people had already used the drops and become infected. Private lawsuits do not wait for the government. Victims can file immediately when they discover their injury. The litigation forces the manufacturer to disclose internal documents, testing records, and communications that might have been hidden. In the eye drop case, those disclosures revealed that the manufacturer had known about sterility issues months earlier and did nothing.

One major issue that comes up in these cases is the concept of the learned intermediary. In most prescription drug cases, the manufacturer can defend itself by saying that the doctor should have warned the patient. But eye drops were sold over the counter. There was no doctor in the middle. The manufacturer had a direct duty to warn the consumer. The label said “sterile,” and that representation was false. This makes over-the-counter medicine cases simpler for plaintiffs because there is no learned intermediary to blame. The manufacturer’s responsibility is direct.

The damages in such cases can be substantial. Victims who lost vision may have lifelong medical costs, lost earning capacity, and permanent disability. Some patients needed corneal transplants. Others died. Under product liability law, the manufacturer is responsible for all of those losses. In many states, family members of deceased victims can also bring wrongful death claims. The total compensation in the eye drop litigation could run into the hundreds of millions of dollars, and that is the point. Large verdicts and settlements send a signal to other manufacturers that cutting corners on sterility is a financial disaster. The legal system serves not only to compensate victims but also to deter future harm.

There is a practical takeaway for anyone reading this. If you or someone you know has been harmed by a contaminated medicine or food product, do not assume that you need to prove the company was evil or that you must wait for a government investigation. Contact a product liability attorney immediately. Evidence gets lost, witnesses forget, and statutes of limitations expire. The law is on the side of the injured, but only if they act. The eye drop outbreak is a reminder that in a world of global supply chains and fast-moving consumer goods, your best protection against a contaminated product is accountability after the fact. And accountability, in the American legal system, comes through the courts.