An orthopedic surgeon explains the problem (video)
When health care harms instead of heals, our courts have helped protect patients and hold medical providers accountable
One study showed one in 50 chemotherapy orders had a serious error. And errors in some classes of chemotherapy medications, especially those with complex dosing regimens, can lead to serious harm and even death. Take the case of 28-year-old Matthew Magargee, who was receiving two different drugs in his outpatient chemotherapy treatment for non-Hodgkin’s lymphoma, one through his abdomen and the other through his head. During one session the oncologist mistakenly switched the drugs, and within minutes the drug erroneously administered into his head caused irreversible brain damage. Matthew died two weeks later. After a lawsuit filed by Matthew’s parents, the hospital now stores the two drugs separately and no longer administers them on the same visit.
The manufacturer of the diet drug Fen-Phen knew it would put users at increased risk of developing a rare disease that can lead to heart failure, but they did not share that information with users. After lawsuits began getting at the truth, the federal Food and Drug Administration ordered Fen-Phen taken off the market, and the manufacturer has set aside $21 billion to resolve potential claims. This is just one of the more prominent cases of drug companies marketing medications either known to be dangerous or not adequately tested. Another recent example: The subsidiary of one of the world’s largest drug makers pleaded guilty to distributing drugs that had been contaminated, mislabeled or were not the proper strength because of problems at the manufacturing plant (see video below).
U.S. attorney general Eric Holder announces a $520 million settlement with AstraZeneca for illegally marketing drugs for uses that had not been approved (video)
Defects in implanted heart defibrillators have led to product recalls and deaths, and the industry still faces problems with its products. In 2005 Guidant, one of the leading makers of implantable defibrillators, did not warn doctors about a potentially fatal flaw in its products. But despite the industry’s vows after that disclosure to be vigilant in protecting patient safety, more problems arose with a defibrillator component, the lead that connects the device to the heart that could short-circuit and provide unintended painful shocks.
A device that was intended to relieve pain has instead led to debilitating injuries. Shoulder pain pumps, meant to deliver local anesthetics to injuries, have been linked to chondrolysis, a rare ailment in which the shoulder cartilage dies and the patient is left with bone grinding on bone. Sometimes the condition can be resolved only with a joint replacement. The pumps were never approved for use in joints by the federal Food and Drug Administration.
Drug-coated stents seemed like a life-saving innovation when they were introduced, as they appeared to keep clogged arteries open and prevent heart attacks. But the devices haven’t been safe for everyone, as they increase the risk of blood clots forming where the stent damages the artery wall. And some patients getting stents for more complex uses that had not been tested have found themselves at a much higher risk of heart attack, blood clot or re-clogging of the artery.
The valves of your heart need to work properly to keep you alive. Unfortunately, sometimes artificial heart valves used to replace damages valves have stopped working without warning, leading to instant death. Hundreds of valves manufactured Shiley Inc., a division of pharmaceutical giant Pfizer, failed after they were implanted in patients. Consumer attorneys found company documents that detailed the dangers the company knew about, and Shiley removed the product from the market, but tens of thousands of people still had the potentially deadly device in their chest.
Hip replacements aren’t necessarily able to last for the life of the recipient, so in an attempt to increase the time the replacement hip would last—and reduce the number of later replacement surgeries—manufacturers developed an all-metal replacement. But with metal grinding against metal, small metal shavings can be released into the bloodstream and cause problems including heart failure. The federal Food and Drug Administration had allowed the hips to go on the market without any testing, as medical devices are not held to the same testing standard as prescription drugs. The hips have since been recalled, but tens of thousands of patients are still living with the problems.
An orthopedic surgeon explains the problem (video)
Knee replacements that are supposed to improve the mobility of hobbled patients sometimes have the opposite effect. One knee replacement manufacturer has been sued claiming it knew its device was defective and had the potential of breaking and leaving its patients facing the prospects of immobility and further surgery. Another company is facing hundreds of suits over its knee replacement, with allegations it knew about the defects and was misleading in its advertising of the product’s benefits. The defective implants can lead to persistent pain and swelling, difficulty standing or walking, and the need for corrective surgery.
Surgical sponges, clamps, scalpels, even scissors—all these items and more have been inadvertently left inside patients after surgical procedures. This falls under the category that medical experts refer to as “never events,” because it should never happen. Yet it is all too common: during the first four years the California Department of Public Health began requiring hospitals to report cases where items were left inside patients, starting in 2007, there were 850 such incidents. Nationally recent estimates indicate this may happen 2,000 times a year. And consequences for patients can be serious, including infections, longer hospital stays, additional surgeries and even death.
It would seem to be the most basic assumption a patient could make: the surgical procedure he or she entered the hospital to have would be the one that was done. But patients continually fall victim to an unspeakable error and have the wrong surgery. Sometimes it’s on the wrong side of the body (for instance, the left kidney is removed instead of the right one); sometimes it’s in the wrong part of the body altogether; and sometimes it’s actually a surgery that was scheduled for a different patient. California hospitals reported more than 160 incidents of these serious surgical errors over the most recent four-year period, and according to the Joint Commission Center for Transforming Healthcare it’s believed to happen 40 times a week nationally.
A Rhode Island hospital has had an epidemic of wrong-site surgery
Tips for patients on how to prevent wrong-site surgery
It seems obvious that a patient receiving a kidney transplant should receive a healthy kidney. But it’s not always the case. At the University of Pittsburgh Medical Center, doctors missed six chances to see that a kidney donor had hepatitis C before transplanting one of her kidneys into a man who did not have the disease. In San Diego, a man received a kidney that had a cancerous tumor, even though the surgeon knew about the tumor. And the USC University Hospital kidney transplant program had to be shut down after a kidney was transplanted into the wrong patient, an error that could have been fatal.
Man received kidney with cancerous tumor
The problem is serious: a weakening of a woman’s pelvic muscles that causes the bladder to drop into the vagina, leading to discomfort and incontinence. But the “cure” has often turned out to be worse. Many women have received implants of a synthetic mesh to hold the bladder and other pelvic organs in place. The mesh has been used successfully to treat hernias but was never tested for vaginal use. The unfortunate results of some vaginal mesh implants include the mesh cutting through the vaginal lining and organs, pain during intercourse, infection, bleeding and severe pelvic pain, with many patients requiring multiple surgeries to correct the problem. One mesh product was voluntarily taken off the market in 1999, but a similar product from Johnson & Johnson remained on the market and has been the subject of hundreds of reports of resulting injury and death.
3. Implantable defibrillator
4. Shoulder pain pumps
5. Drug coated stents
6. Artificial heart valve
7. Prosthetic hips
8. Prosthetic knees
9. Items left inside of patient
10. Wrong site surgical mistakes
12. Vaginal mesh