Defective Drug Lawsuits: Why They Happen

Doug Mann

Have a question for a lawyer?
Get a Free Case Evaulation
Table of Contents
  1. What Makes a Drug “Unreasonably Dangerous”?
  2. Why File a Drug Lawsuit?  
  3. Does it matter if a drug is FDA approved?
  4. Special Features of Ohio Defective Drug  Law
  5. Defective Drug Lawsuits: In a Nutshell

According to the CDC, 48% of Americans have used a prescription drug in the last year. And while the vast majority benefit from taking doctor-prescribed drugs, on occasion, the pharmaceuticals we use every day are found to cause health problems that weren’t anticipated when the drugs were designed. 

For example, a few years ago, a blood-thinning drug called Xarelto, which is FDA approved to treat blood clots, was found to cause uncontrollable bleeding in a number of people who took the drug. As you can imagine, many lawsuits resulted from these injuries. 

Xarelto became part of a class of drugs that we classify as “defective.” 

When people are injured after taking a defective drug, the law allows them to take their claim to court. The focus of defective drug lawsuits is to compensate families for injuries they sustained as a result of taking the drug. 

In the case of the Xarelto defects, the drug makers, Bayer, and Johnson & Johnson, settled 25,000 claims by plaintiffs who experienced uncontrolled bleeding for a total of 775 million dollars. 

What Makes a Drug “Unreasonably Dangerous”?

An unreasonably dangerous product is a product that is more dangerous than a patient could reasonably expect. In the case of Xarelto, people who became ill with uncontrolled bleeding had no idea that side effects of that magnitude were possible. 

During clinical trials, a medicine might, for example, cause blood clots in 1% of the people who use it. In these cases, end-users need to be warned or the drug should be pulled from the market. 

The definition of unreasonable danger, that centers around unknown harm, of course, begs the question of exactly what constitutes a “reasonable” danger. Just about any drug will cause a severe allergic reaction in some people, for example. 

Ultimately a court will decide this question based on all the facts and circumstances of the case.  

In the Xarelto litigation, one of the primary claims of the plaintiffs was that the drug manufacturers failed to warn patients that uncontrolled bleeding was possible. Because patients hadn’t been warned about potential adverse outcomes, they were flying blind when taking Xarelto and couldn’t properly weigh the pros and cons when deciding to take the medicine, but even this fact pattern didn’t result in plaintiffs having their day in court. 

The cases settled out of court before the story ever reached a jury. This is not uncommon for defective drug cases. When there has been harm, most drug companies choose to settle rather than put the matter before a jury.  

In most cases, defective drug lawsuits are filed because someone has been injured. To stick with our Xarelto example, patients with blood clots could have suffered: 

  • Large medical bills 
  • Lost wages 
  • Pain and suffering 
  • Diminished quality of life 
  • Ongoing medical treatments 

The goal of the lawsuit is to make responsible parties pay for the harm they caused. 

Does it matter if a drug is FDA approved?

It doesn’t matter if the drug in question has already been approved by the US Food and Drug Administration (FDA). You can win your claim even if the drug manufacturer complied with all of the FDA labeling and manufacturing restrictions. In the case of Xarelto, Bayer and Johnson & Johnson paid 775 million in settlements without admitting fault and without pulling the drug off the shelves. 

However, the defective drug lawsuit forced drug manufacturers to develop an antidote, called Andexxa, which can stop bleeding in patients with bad reactions to Xarelto. Drug makers are also now required to warn consumers about the potential for uncontrolled bleeding should they decide to take Xarelto. 

Special Features of Ohio Defective Drug  Law

In most cases, defective drug cases can be filed in either state or federal court. This was true of the Xarelto litigation. 

Although every state has its own product liability law, these laws are broadly similar. Nevertheless, each state’s law includes its own unique aspects, and Ohio is no exception. Some of the special features of Ohio defective drug law include:

  • A drug will not be considered unreasonably dangerous unless the danger was foreseeable.
  • You can sue under Ohio product liability law if the product failed to conform to a warranty concerning its character, quality or safety. Note that this type of product liability requires you to prove fault on the part of the drug maker to conform to the product warranty. No-fault liability is also possible under a different theory of liability.
  • You must file a product liability claim within two years after you actually learn (or should have known) of the injury or harm upon which your claim is based. The reason for this leniency is that you might be unaware of the source of your injury until a doctor tells you. You might not even develop symptoms from a defective drug until years later. Some courts may stick to a deadline of two years after the injury itself, instead of two years after you discovered its relationship to your injury.
  • Ohio limits non-economic damages (pain and suffering, etc.) to $250,000 or three times the economic loss, whichever amount is greater. 
  • You cannot recover any damages at all if you are more than 50% at fault for your own damages

Depending on the circumstances, you might be able to sue the manufacturer under the law of another state.

Defective Drug Lawsuits: In a Nutshell

The most important facts you need to remember about pressing a defective drug claim in Ohio are:

  • If your claim is strong, most lawyers will take your case on a contingency basis This means you pay the law firm a portion of your winnings, but if you lose the case you pay nothing.
  • Drug companies will vigorously defend design defect lawsuits because if they lose the case, they will have to take the drug off the market. The same is not necessarily true for manufacturing defects and design defects.
  • You will probably need to use a professional expert witness to establish your claim.
  • The fact that you do not have to prove liability against a drug manufacturer (under most circumstances) gives you a huge advantage in both settlement negotiations and litigation.

If you or someone you love has been injured or impacted by a defective drug, contact an experienced attorney to get the help you deserve.

Get a Free Case Evaluation

Have a legal question? Email our team. We respond to all messages within 24 hours.