On May 14, 2008, the Committee on Oversight and Government Reform held a hearing addressing whether Food and Drug Administration (FDA) drug and medical device regulation should bar injured patients from filing product liability lawsuits.

Patients can file damage lawsuits against drug and medical device manufacturers under state law, but the current administration is arguing that a company cannot be held liable for selling a drug or device that has been approved by a federal regulator.

The committee heard several testimonies, including one from actor Dennis Quaid and his wife Kimberly Quaid. In November 2007, the couples? newborn twins were given a nearly fatal overdose of the blood-thinner Heparin to treat a staph infection. The Quaids testified that Baxter Healthcare?s labeling of its Heparin product was not sufficient to protect against mistakes ? the bottle of 10-units of the Heparin product and the bottle of the 10,000-unit bottle were similar in labeling and size, and when stored were virtually indistinguishable.

Upon further research, the couple found that infant Heparin overdose had occurred one year prior, resulting in the deaths of three infants, with three additional infants suffering serious injuries.

After the incident, Quaid filed a negligence lawsuit against Baxter, alleging the company was negligent in packaging different doses of Heparin in similar vials, with similar labels. The actor cited a relabeling of the drug by Baxter before the birth of his twins, but said the company did not recall the drug vials that had already been shipped with similar labels.

After the Quaids filed the negligence lawsuit against Baxter, the company filed a motion to dismiss, citing that the FDA?s approval of the Heparin product label exempted the company from product liability lawsuits. Thus, the Quaids? lawsuit may not be heard.

Concluding their testimony, Mr. and Mrs. Quaid said a federal ban on product liability lawsuits against drug companies would deny victims the compensation they may deserve, in addition to relieving drug companies of their responsibility to ensure their products are as safe as possible.

Sources: ?Committee Holds Hearing on Whether FDA Regulation Should Bar Liability Claims,? Committee on Oversight and Government Reform Press Release, May 13, 2008; ?Dennis Quaid Tells Lawmakers How Drug Mix Up Nearly Killed His Newborn Twins,? Medical News Today, May 14, 2008.