Pharmaceutical Drug Defects


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So many of us rely on prescription or over-the-counter drugs to keep our health in check these days. We take drugs to regulate blood pressure or cholesterol, or to maintain healthy blood sugar levels, or to alleviate the twinges in our backs and knees. It seems like just about any time we talk to a physician about an ailment, we walk out with a prescription. We trust that the drug has been thoroughly vetted to make sure it’s safe, and that it will make us feel better instead of worse.

But how often do you turn on your television and see a commercial or a news story about people who have been harmed by prescription drugs? Even when a drug has been approved by the federal Food and Drug Administration, it sometimes turns out to be unsafe for long-term use and causes more harm than good, such as a popular weight loss drug that caused serious health problems in many of its users and was pulled from the market. The FDA’s recall page is filled with drugs that the agency says shouldn’t be sold to consumers because they’re mislabeled or contain ingredients they shouldn’t or weren’t approved for use.

When there is some defect in the process of creating, manufacturing, or marketing a prescription drug and you get hurt because of that defect, you may have a product liability claim. Through a product liability claim, you may be able to obtain compensation for your injuries and other damages, including your medical costs, lost income, disability and disfigurement, pain and suffering, and loss of normal life. In some limited cases, you may be able to get punitive damages if the company recklessly or intentionally pushed the drug to market when it could harm someone.

If you’ve been injured by a defective pharmaceutical drug, you should consider talking to an experienced Chicago injury attorney about your options for a claim.

Types of Defects

Defects involving pharmaceutical drugs may fall into one or more of these categories:

  • Design Defects — If there were flaws in the process of formulating the drug that resulted in it having dangerous side effects, you may have a product liability claim.
  • Manufacturing Defects — This encompasses a pretty broad range of possible errors that could make the product harmful. Manufacturing defects could include circumstances like a manufacturing plant allowing contaminants into the drug or mislabeling the drug before shipping it out to distributors.
  • Failure to Warn — If a manufacturer or someone else in the supply chain releases the drug for public consumption without including a warning about known possible side effects, that may result in a claim based on failure to warn.

Liability for Defective Prescription Drugs

There are many hands involved in formulating, manufacturing, distributing, and marketing pharmaceutical drugs, and a defect can happen anywhere in that process. Because so many people or companies may be involved, product liability cases can be large and complex, which is another reason to have a good product liability lawyer by your side. It’s important to identify all of the parties that may be responsible for the harm you suffered. In the case of a defective prescription drug, that may include:

  • Manufacturers — The people or companies that formulated and made the drug
  • Testing Labs — The people or companies that put the drug through trials to determine whether it was safe to market to consumers
  • Pharmaceutical Sales Companies — The sales reps who marketed the drug to doctors and pharmacies as safe for use for patients
  • Medical Providers — The doctors or hospitals that gave you the drug
  • Pharmacies — The retail outlets that sold you the drug

What You Have to Prove in a Product Liability Case

When you pursue a claim involving a defective prescription drug, it’s your responsibility to prove your case. What you have to prove to be successful in your claim breaks down like this:

  • You used the drug
  • You were injured
  • The drug was defective or you weren’t warned about any dangers
  • The defect or failure to warn caused your injuries

Under Illinois law, you have to prove your case by what’s known as a preponderance of the evidence, or basically that it’s more likely than not that you were harmed because of the defect. Preponderance of the evidence might sound like an easy standard to meet, but there are some hurdles you’ll have to overcome, such as:

  • FDA Approval — Because pharmaceuticals go through a process of approval by a federal government agency and a number of factors involved in production, labeling, and advertising of the drug are regulated by the FDA, the manufacturer is likely to argue a legal principle known as preemption, which basically comes down to “The FDA told us our drug was OK.” Unfortunately, you can’t sue the FDA if a drug the agency approved turns out to be unsafe because the government has general immunity from lawsuits.
  • Scientific Support — To prove the drug caused you harm, you may need more than simply demonstrating that you took the drug and then got sick. You may need reliable, peer-reviewed science to back you up. For example, if you claim that you took an arthritis drug that caused bone cancer, you’d need scientific studies that show a link between the drug and incidences of bone cancer and expert witnesses to testify about those studies in court.
  • Learned Intermediary Doctrine — In a failure to warn claim, this basically says that the manufacturer isn’t responsible for your injuries because the doctor or pharmacist had the information about the side effects and either didn’t read it or didn’t tell you. In other words, the manufacturer will say the doctor, hospital, or pharmacy is to blame. In that event, you may have a medical malpractice claim against the medical provider.

2 Replies to “Pharmaceutical Drug Defects”

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