May 14, 2008 – Actor Dennis Quaid testified before the Congressional Committee on Oversight and Government Reform in a hearing entitled, “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?” The issue was whether FDA approval of a drug or medical device should prevent private persons from suing the manufacturers of those drugs or devices, a doctrine called “preemption.” Other notable testimony against preemption came from New England Journal of Medicine editor Gregory Curfman and former FDA commissioner David Kessler, but Quaid was the most high-profile person in attendance.
In November of 2007, the Quaids’ eleven-day-old twins were hospitalized for staph infections at Cedars-Sinai Medical Center. They were given an intravenous blood thinner, Heparin. However, instead of receiving ten units, they received ten thousand units. This caused their blood to flow freely internally and from all external wounds. At one point, blood from a wound in son Thomas’ spine “spurted six feet across the room and splattered on the wall.” In September of 2006, a hospital in Indianapolis had experienced a similar mix-up and three infants died. Three other infants were seriously injured.
These incidents were due to a mix-up caused by the packaging of the Heparin, manufactured by Baxter Healthcare Corporation as Hep-Lock. The ten-unit bottle and ten thousand-unit bottle were similar in size and both colored in shades of blue. In the right lighting, it is difficult to tell them apart. Baxter eventually changed the labels and bottle coloring (it took them over a year, until October of 2007) in order to prevent these problems. However, Baxter did not recall the old bottles of Hep-Lock. As a result, hospitals still used the poorly-labeled bottles of Hep-Lock, leading to the horrifying experience of the Quaid children.
Dennis Quaid testified that these events opened his eyes to a systemic problem with the fields of medicine and pharmaceuticals:
“I have also learned a lot about the legal system – and it was surprising, I have to tell you. Like many Americans, I believed that a big problem in our country was frivolous lawsuits. But now I know that the courts are often the only path to justice for families that are harmed by the pharmaceutical industry and medical errors. Yet the law is stacked against ordinary people. For instance, in my home state of California, a 1975 law caps compensation to malpractice victims. The cap has never been raised for inflation. The practical effect is that people without the wealth to pay legal fees up front are unable to get their cases before a judge or jury.
“Now we face something with potential to be even more sweeping and even more unjust: federal preemption. The Supreme Court is about to decide whether to bar most lawsuits over drugs and their labeling, as long as the drug was approved for marketing by the FDA. After many years of rejecting arguments that FDA actions should preempt lawsuits involving injuries from products regulated by the FDA, White House appointees at the FDA reversed that position in 2002, and now argue that FDA approval immunizes the manufacturers of dangerous products from liability for the deaths and injuries they cause.
“We sued Baxter Healthcare Corporation in November 2007. Baxter has filed a motion to dismiss the case, relying on the same preemption argument that the drug industry and the FDA has made before the Supreme Court – that when the FDA allowed its Heparin drug onto the market, it gave Baxter the government’s seal of approval – a “get out of jail free” card that denies us the right to hold the company accountable. (Of course, Baxter never mentions the FDA regulations that encourage and sometimes require manufacturers to fix their drug labels immediately, without getting the FDA’s permission first.) So, says Baxter, our suit may not be heard by a judge or jury.”
Dennis Quaid’s full testimony before the Committee on Oversight and Government Reform can be found here: https://oversight.house.gov/documents/20080514103204.pdf
The Quaids have set up a non-profit foundation, The Quaid Foundation, dedicated to reducing human error and increasing public awareness of medical errors. Few people are aware of the extent of the damage caused by avoidable human error in the medical community.
According to the Institute of Medicine, a non-profit component of the National Academy of Sciences, there are up to 98,000 deaths annually caused by medical error. According to the Institute for Healthcare Improvement, that number is in excess of 122,000.
The FDA should be attentive to the IOM’s findings, especially because the FDA itself recently requested an assessment of drug safety from the IOM. The IOM determined that the credibility of FDA and the pharmaceutical industry has been compromised for quite some time and that they fail to communicate safety concerns in a timely and effective fashion. Furthermore, the Institute found that the drug safety system is impaired by unclear and insufficient regulatory authorities and insufficient resources that weaken the quality and quantity of science brought to bear on drug safety. One would hope that the FDA would take these findings to heart and accept its own limitations with respect to protecting the safety of American citizens.