Dangerous Medication Interaction...



A Product Liability Case Study

The following case deals with a dangerous medication interaction and illustrates several important legal issues regarding product liability and manufacturer negligence. We'll review the incident, liability, injuries, settlement negotiations, and the final case resolution.

The Incident...

Gabby, a six year old child, had a history of medical problems. She was prescribed a long-standing medication to deal with her chronic asthma.

One afternoon, Gabby developed nerve symptoms similar to fibromyalgia, wherein Gabby's skin was extremely sensitive to the touch, which caused her parents to immediately take her to her regular pediatrician. He prescribed a new Food and Drug Administration approved medication called Famex (a fictional medication used for illustrative purposes in this case example) which was created, designed and distributed to control what he believed to be a neurological disorder.

Within 24 hours, Gabby developed a full body rash and had to be immediately hospitalized for debilitating pain. After one week in the pediatric intensive care unit, it was determined that Gabby's asthma medication and Famex have potentially life threatening medication interactions and the two drugs should never be prescribed together.

Liability...

Drug manufacturers must comply with the federal Food and Drug Administration (FDA) regulations regarding the fabrication, promotion, and sale of a product. However, if a drug does turn out to be defective, this will override the fact that the company followed all of the FDA guidelines. It remains the responsibility of the drug manufacturer to alert consumers of all potential side effects.

The drug that Gabby's pediatrician prescribed was defective and caused an adverse reaction in Gabby that her doctor could not possibly foresee. Even though there is often a fine line between a medical malpractice case and a products liability case for medical products and drugs, this is clearly a case where the doctor did not breach any duty to Gabby.

This is a products liability case because it was a defective drug and there were inadequate warnings on the label. A warning would have alerted both Gabby's parents and the pediatrician to the potentially dangerous medication interaction. Had the drug manufacturer placed the appropriate warnings on the label, Gabby's pediatrician would never have prescribed Famex to a child already taking an asthma medication.

Injuries...

Gabby was hospitalized for three weeks in total and her parents incurred $35,000 in medical bills above and beyond what the insurance company covered. She was also in extraordinary pain for one week as the doctors performed numerous painful tests to determine the underlying cause of her symptoms.

Finally, Gabby missed four weeks of first grade and her parents had to hire a tutor to get her caught up on work. This was an out-of-pocket expense of $650.

Negotiations...

Gabby's parents submitted a claim to the manufacturer of Famex, Phamcon Pharmaceutical Company. Initially, they ignored the claim but after two months, it was finally routed to Phamcon's in-house legal department who denied the claim.

Gabby's parents filed a products liability lawsuit naming all parties in the chain of production of Famex for defective design and inadequate product warnings as well as Microcon, the distributor of Famex. Products liability cases do not settle easily and often result in civil filings.

Microcon filed a summary judgment motion, a pre-trial motion alleging that there are no facts sufficient to support a cause of action against them. While all those in the chain of production are technically liable in a products liability action, it is questionable whether distributors are liable for inadequate warnings of dangerous medication interactions. Microcon prevailed in their summary judgment motion and they were dismissed with prejudice from the case.

As to Phamcon, trial was set 18 months after the case was filed and the defense attorney made a preliminary offer of $5,000 in hopes of settling the case beforehand. Gabby's parents, however had hired an attorney (spending $15,000) and were prepared to proceed.

Final Settlement...

Trial commenced and Gabby's parents received a jury verdict of $125,650 plus attorney's fees of $48,000. Gabby's parents had incurred $35,000 in medical bills, $650 in tutoring, $15,000 in experts and $50,000 in attorney's fees. The balance was placed in an account for Gabby until she reached the age of 18.

Important Points...

  • Products liability cases rarely settle without litigation.

  • Settlements received by children must be placed in special accounts until they are 18 years of age.

  • Manufacturers of drugs can still be liable even if the drugs have been approved by the Food and Drug Administration.

  • Medication interaction precautions can be checked on your own at sites such as www.drugs.com

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