The U.S. Food and Drug Administration has one of the most extensive new product test regimens in the world. On average, it takes 10 years for a pharmaceutical company to bring a new drug to market. This development usually involves several rounds of human trials.
Obviously, these human trials are incredibly risky for test subjects, especially during the early drug development phases and drug companies usually demand test subjects sign extensive waivers. Such waivers make it difficult, but not impossible, for a Rockford personal injury attorney to obtain compensation in drug injury cases.
This compensation generally includes money for economic losses, such as medical bills, and non-economic losses, such as pain and suffering. Additional punitive damages also are often available.
In wrongful death claims, the plaintiff is usually entitled to pecuniary losses. Illinois law broadly defines this term to include funeral and burial costs, future lost wages and future lost emotional support. Furthermore, the Prairie State is one of the few jurisdictions which allow wrongful death plaintiffs to recover “damages for grief, sorrow, and mental suffering, to the surviving spouse and next of kin of such deceased person.” Your Claim for Damages
Generally, manufacturers are strictly liable for the aforementioned damages in drug injury cases. It does not matter whether the FDA has approved the product or not. These defects could be:
- Design Defect: Many artificial hips were defectively designed. Johnson & Johnson recently agreed to settle thousands of such claims for $1 billion. Since the hip is a cup-and-socket joint, the metal parts rub against one another every time the victim takes a step. The tiny metal fragments cause metallosis, or metal poisoning.
- Manufacturing Defect: Other hip implants have other issues. Some manufacturers outsourced production to China and other overseas locales. These products often contain high levels of chromium, cadmium and other dangerous heavy metals. These substances can cause permanent brain injuries.
Other medical trial claims rest on negligence. Many times, manufacturers rush clinical trials to meet shareholder-imposed deadlines. As a result, these trials may not be as safe and as well-supervised as they should be. If the drug trial’s structure failed to meet industry standards – and that failure substantially caused injury, the company may be legally responsible for damages.
The Assumption of the Risk Defense
Signed waivers essentially create a presumption that favors the assumption of the risk defense. Document or no document, drug companies must still establish both prongs of the assumption of the risk defense, which are:
- Voluntary Assumption: Many signed waivers are not voluntary contracts. Instead, such documents are often take-it-or-leave-it contracts of adhesion. Unless both parties had bargaining power, the waiver may be legally invalid.
- Known Risk: Many waivers are over-specific. They name all the known side-effects. If a victim suffers from a non-listed side effect, the victim did not assume a known risk. Furthermore, these waivers usually do not cover negligent trial setup as well. These injuries are hardly ever the result of a known risk.
Affirmative defenses like this one are separate and apart from negligence and causation. Generally, the drug company must establish assumption of the risk, and any other defenses, by a preponderance of the evidence (more likely than not).
Contact Assertive Attorneys
If a drug trial killed one of your loved ones, the drug company may be legally responsible for that death. For a free consultation with an experienced personal injury lawyer in Rockford, contact Fisk & Monteleone, Ltd. Our main office is conveniently located in downtown Rockford across from the federal and state courthouses.