Hospitals Overdosing Patients on Drug Already Infamous
For Causing Liver Failure
Findings published in the November 12 edition of Archives of Internal Medicine reveal that hospitals may be overdosing a significant number of their patients who are being treated with the drug acetaminophen. More specifically, researchers found, in two carefully studied inpatient facilities, that overall, 6.6% of patients on acetaminophen received more than the recommended daily dose of the drug. Among older patients and patients already suffering from chronic liver disease, between 18% and 22% were given more acetaminophen than is deemed safe for these high-risk populations.
These statistics indicate a gravely serious breakdown in the care of inpatients, but they are particularly concerning in light of the fact that acetaminophen, best known as the active ingredient in Tylenol, poses unusually high risks for liver damage at any dose. Acetaminophen’s infamous capacity to poison the liver has been the foundation of many liver-injury lawsuits brought against Tylenol’s manufacturer over the years, and news of institutional acetaminophen overdosing lends a new urgency to claims such as those raised by Charlotte Lee Thompson, a Floridian who suffered serious liver damage while taking Tylenol in 2008, and whose case against Tylenol’s manufacturer was very recently moved from a Florida state court to a Florida federal District Court.
The Well-Known Dangers of Acetaminophen
As stated in Ms. Thompson’s lawsuit filing, acetaminophen is the leading cause of acute liver failure in the United States. The above mentioned Archives of Internal Medicine report confirms this, and adds that acetaminophen is linked not only to liver injury, but also to blood clotting disorders and deafness. It is particularly easy to overdose on acetaminophen because the drug is a common secondary ingredient in many other drug products, and patients who are unaware that one of their medications contains acetaminophen may add Tylenol (or a store-brand equivalent) to their drug regimens, unwittingly exceeding safe dosage levels. This accidental overdosing can become chronic or “staggered,” and according to the February 2012 edition of the British Journal of Clinical Pharmacology, staggered acetaminophen overdosing is particularly likely to cause liver toxicity with life-threatening effects such as multiple organ failure.
In 2009, the U.S. Food and Drug Administration (FDA) recommended that acetaminophen manufacturers place stronger warnings about the risk of severe liver damage on their products. In 2011 the FDA directed manufacturers of combination drugs containing acetaminophen to limit acetaminophen content to 325 mg per unit. Effective earlier this year, in response to FDA pressure and high rates of acetaminophen-related liver failure, Tylenol’s manufacturer lowered the maximum daily dose for Regular Strength Tylenol.
The Consumer’s Right to Adequate Warning
Lawsuits filed on behalf of acetaminophen victims are generally framed as product liability claims, in which injured individuals focus on the unusual dangerousness of the drug and the inadequacy of warnings placed on product packaging. In the Florida case brought by Charlotte Lee Thompson, Ms. Thompson explains that in February of 2008, she took Tylenol for several days, all the while keeping her dosage within the limits recommended on the product packaging. During this period, she was admitted to hospital, on an emergency basis, for severe liver damage. She required over 10 days of hospitalization, enduring substantial pain and suffering, and later suffered a loss of earning capacity.
Ms. Thompson asserts that Tylenol is defective, unreasonably dangerous to consumers, and not safe for its intended use. Her complaint also states that she should have been warned that Tylenol should not be taken on an empty stomach, and that at the time she took the Tylenol, the manufacturer-recommended dosage was too high. In addition to these claims, Ms. Thompson has alleged that Tylenol’s manufacturer breached the implied warranty of safety that goes with consumer products like Tylenol. Ms. Thompson hopes to recover damages to cover her medical expenses and economic losses, along with damages for physical and emotional injuries and punitive damages.