The U.S. recently reached a record-high one million new COVID-19 cases in a day. And in some other countries, including the Philippines, flu cases are surging. It resulted in almost every drugstore running out of branded paracetamol stocks.

Many argue that COVID-19 cases wouldn’t soar if more people just got vaccinated. However, most unvaccinated Americans insist on defending their rights to stay vaccine-free. They all have their reasons, with the common ones including the vaccines’ side effects. Unvaccinated Americans appear to believe unproven claims, such as the vaccines causing infertility. The rare cases of blot clots also scare them away.

Meanwhile, in the Philippines, people could’ve bought generic paracetamol, but branded ones are always at the top of their minds. Generic drugs aren’t as popular because most consumers believe branded ones are more effective. Hence, Generika President and CEO Josette Abarca assured the public that generic medicines have the same efficacy as branded ones.

But what happens then if a vaccine or drug gives someone severe side effects? Is the pharmaceutical company liable?

Vaccine Companies Can’t Be Sued

The federal government has granted vaccine companies like Pfizer and Moderna immunity from liability if a person experiences side effects from the COVID-19 shots. No one can sue the Food and Drug Administration (FDA) for authorizing a vaccine for emergency use, either. And lastly, no one could hold their employer liable they required their employees to get vaccinated.

Instead, a government fund is available for people harmed by a “covered countermeasure,” such as vaccines. But lawyers say the fund has only compensated less than 6% of the claims filed in the last decade.

Therefore, the public can’t just expect vaccine companies to be liable for side effects experienced. They can’t expect the government to compensate them either. So if someone suffers debilitating side effects from the vaccines, they can only be covered by their worker’s compensation program. The side effects can be treated as an on-the-job injury, especially if the person has been mandated by their employer to get vaccinated.

Can Drug Companies Face a Lawsuit?

A person getting irreparably harmed by a drug may have grounds for product liability. It’s a case in which retailers or manufacturers face legal consequences for selling defective products. But the complainant must show sufficient evidence to hold a drug company liable.

According to the legal professional association O’Connor, Acciani, and Levy, a complainant must prove their injury, the drug’s defective qualities (improper design, no warning labels, manufacturing issues), and the injury was due to the defective drug. If there was a warning on the drug’s packaging, the complainant must prove that it was inadequate. For example, the side effect they experienced wasn’t mentioned in the warning, or the side effects were more severe than the warning stated.

Failure to show these pieces of evidence will prevent a drug company from being held liable.

How Does a Drug Go Bad?

If a customer claims that a medication they bought “went bad,” there are many possible reasons for it. Here are the common ones:

• Exposure to Heat

Medicines must be stored in a cool and dry place. That’s why drug manufacturers and retailers use specialized medical storage carts for their stocks. It protects the drugs from the elements, especially heat. This protection is crucial because the active chemicals in any drug can alter its molecular form when exposed to different temperatures. The medication could get decomposed as a result. While it won’t necessarily cause side effects, decomposition can reduce a medication’s potency.

• Expiration

An expired drug isn’t automatically unsafe. In fact, a study has found that 90% of more than 100 drugs remained safe for use 15 years past their expiration dates. The expiration dates merely ensure that buyers get everything they paid for when they take the drug.

Still, the FDA advises against taking expired medication. Time can alter a drug’s composition, just like temperature alters a drug’s molecular form. If someone keeps medicine inside a bathroom cabinet for a long time, chances are it won’t acquire moisture. That’s another decomposing factor. Moisture can reduce a drug’s potency.

Expired drugs also pose a risk to children and pets. Since they’ve been stored and neglected for an extended period, children or pets could stumble upon them and mistake them for food. The CDC reports that 50,000 children are rushed to the ER every year because they took an expired drug while an adult wasn’t looking.

All of these considered, drug companies must put adequate labels and warnings on their packaging. They should clearly indicate the expiration date as well. And finally, they should spread information about a drug’s potential side effects and the steps to take should anyone have them. This way, all parties can be responsible, and legal disputes can be avoided.