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News: The patient, a 37-year-old woman, was prescribed the oral contraceptive pill Yasmin by her physician in an attempt to control irregular bleeding. Thirteen days after she began taking the medication, she suffered a stroke that resulted in serious brain damage. The patient was left partially paralyzed on her left side and suffers from speech problems, among other permanent injuries. The patient brought suit and claimed that the physician knew or should have known that she had an increased risk of stroke due to pre-existing risk factors for birth control pill blood clots. The physician denied any wrongdoing. The jury found the physician liable and awarded the patient $14 million in damages.
Background: The patient was a woman who consulted her physician about irregular bleeding she was having. The physician prescribed the oral contraceptive pill Yasmin (drospirenone and ethinyl estradiol), manufactured by Bayer HealthCare Pharmaceuticals. Yasmin contains drospirenone, a synthetic form of the naturally occurring female hormone progesterone, and it is one of the most popular oral birth control products, along with a newer version sold under the brand name Yaz. Yasmin and Yaz have been the subject of controversy and lawsuits over the past few years. Medical professionals allege that the medications have severe adverse side effects, including heart attacks, strokes, pulmonary embolism (PE), and deep vein thrombosis (DVT). Last year, the Food and Drug Administration (FDA) issued a safety review update for Yasmin and other birth control drugs containing drospirenone, including Ocella, a generic version of Yasmin. Medications with drospirenone have been found to triple the risk of blood clots in patients. The FDA review specifically recommends that "[h]ealthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs." For more information, see http://www.fda.gov/drugs/drugsafety/ucm299305.htm.
Thirteen days after beginning to take the medication, the patient suffered a stroke, which resulted in serious brain damage. She was left partially paralyzed on her left side and must use a wheelchair, along with suffering from speech problems. The patient now requires round-the-clock care, which her husband has been providing since the accident and is thus unable to work himself. The patient brought suit against the physician and medical center that referred her to the physician, and she alleged that the physician knew or should have known that the patient had an increased risk of suffering a stroke on Yasmin due to pre-existing risk factors for birth control pill blood clots. The patient also claimed that the physician did not tell her about the risks associated with Yasmin.
Prior to the case going to trial, the medical center settled for $2.5 million. The physician denied any negligence, and he claimed that he did not have actual knowledge about the patient’s underlying risk factors contributing to the blood clot. A two-week trial resulted in a verdict for the plaintiffs, with the jury awarding $14 million to the injured patient and her husband caretaker.
What this means to you: The primary issue in this case was whether the physician fell below the standard of care in prescribing the patient this particular medication. A physician can be found negligent if reasonable physicians, given the same or similar circumstances, would not have prescribed the medication for several reasons. The most important reason in this case was the particular patient’s pre-existing risk factors, which pose potentially deadly consequences when combined with the known side effects of the medication. For physicians, this means that there are two important concerns that are shown in this case: Physicians must be aware of a patient’s particular medical and family histories and pre-existing risk factors, and physicians must be informed about medications they are prescribing and the potential side effects.
Knowledge of a patient’s medical and family histories is extremely important in many aspects of a physician’s work. On an individual level, a particular patient might have had past occurrences that have future consequences on the patient’s overall health, such as increasing the chances that an otherwise rare event might happen. Blood clots are one such event, and they occur more frequently in patients with particular characteristics: smoking, obesity, diabetes, elevated cholesterol, etc. This situation is especially relevant to blood clots caused by hormonal birth control, which is a known side effect of hormonal birth control. Beyond the individual patient, however, physicians should inquire into the patient’s family history. Family history might reveal further information that is highly important to diagnosis, prescriptions, or treatment. There are numerous genetic disorders that are passed down in a family history but might not display any signs or symptoms, thus a patient might be unaware that the patient has the condition. When posed with these decisions, physicians should have the patients inquire about their own personal family history in addition to running tests that can determine such latent conditions.
For another illustration of the importance of medical and family histories, consider that there are a number of genetic blood clotting disorders. One is factor V Leiden, the most common genetic condition that can lead to blood clots. According to Children’s Hospital of Los Angeles a person with factor V Leiden has 10 times an increased chance of developing a blood clot. Moreover, a person on hormonal birth control has about three times an increased chance of developing a blood clot. The combination of factor V Leiden and hormonal birth control thus increases the risk of getting a blood clot by 30-40 times that of an average, healthy individual. Thus, a 16 year-old girl who has factor V Leiden, if put on the hormonal birth control pill, has a risk of roughly 1 out of 1,600 for developing a blood clot whereas a healthy teenager not on the birth control pill enjoys only what is roughly a 1 out of 50,000 chance. A patient’s specific family history is an invaluable tool here since factor V Leiden is passed down from a child’s parents. It is more common among families with ancestry in the Middle East, but it also occurs in families with ancestry in Europe.
Along these lines, physicians can add an extra layer of protection by having patients sign a statement of patient responsibilities’ along with patient rights, and included in this statement is the patient’s responsibility to provide the complete medical and family history as requested. Because patients might omit critical information purposefully to obtain certain medications or treatments, this statement can aid a physician in protecting oneself. A physician who does not inquire about the patient’s family history, or run appropriate tests to determine these potential risk factors, might be negligent if reasonable physicians in the same position would inquire. These kinds of questions are simple to ask patients and have potentially huge consequences if left unanswered.
Physicians must be informed about the medications they are prescribing, especially side effects, which might have serious detrimental results. The pharmaceutical industry is a booming giant, with innumerable medications already in existence and new medications consistently being introduced. The Food and Drug Administration (FDA) is responsible for approval of prescription drugs, and it is an invaluable source of information for any physician. The FDA’s website (www.fda.gov) has an overwhelming amount of information, including drug safety information and recall information. FDA still might approve medications that can have serious, dangerous side effects. A physician can be responsible for prescribing an FDA-approved medication when it is given in the wrong circumstance, such as when a patient has other risk factors which, along with the side effects, might cause harmful consequences to the patient. Yasmin has had a black box warning, the FDA’s strongest warning, since 2003. These warnings must be reviewed, and recommendations for safe prescribing must be followed. Physicians also can seek information from the drug manufacturer, and many manufacturers take a proactive approach by using sales representatives to seek out physicians to inform and persuade them to prescribe their drugs to patients. Because this field is a competitive, billion-dollar industry, pharmaceutical companies might take this offensive approach to informing physicians, but physicians should be cautious in relying solely on a pharmaceutical company’s representations. The company has an obvious interest in promoting its medications.
When prescribing a patient medication, physicians should inform the patient about the side effects to fully inform the patient before they choose which to take. There might be a number of different medications that have the same positive effect but have lesser or varying side effects, and physicians should consult with the patient before choosing any single medication. Patients might have concerns of their own or want to stay away from specific side effects for their own reasons. If the patient is not specifically told about a medication’s side effects, the patient might simply assume that there are none. Furthermore, informing patients of the side effects will allow them to recognize potentially dangerous symptoms to ensure that if something does happen, the patient can identify this symptom and seek treatment immediately. Physicians who fail to inform patients before the patient makes an important medical decision might be liable for negligence, if reasonable physicians under the same or similar circumstances would fully discuss and inform patients about their options and the effects of their choices.