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The U.S. District Court for the District of Columbia reached an instructive decision regarding conflicting expert testimony in prescription medication injury cases where causation is at issue.

In the case, Patteson v. Maloney, Dist. Court, Dist. Col. (2013), the plaintiff was suing her prior psychiatrist for prescribing her Seroquel, which was an antipsychotic drug, in order to treat her insomnia.

After taking the medication, the plaintiff developed tardive dyskinesia, a movement disorder characterized by repetitive, involuntary movements and uncontrollable muscular tics. Her lawsuit thus claimed that the condition was caused by the Seroquel, on the basis of expert testimony. The defendant psychiatrist motioned to exclude all testimony linking Seroquel to tardive dyskinesia.

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The U.S. District Court for the District of South Carolina recently handed ruled on a motion to dismiss, filed by Walgreens in a negligence lawsuit regarding improperly dispensed fertility medication.

In the case,

Caesar v. Walgreen Co., Dist. Court, D. South Carolina (2013), the plaintiffs allege that Walgreens improperly filled her prescription at three times the proper dosage. The couple was in the process of attempting to conceive a child through the process of in vitro fertilization (“IVF”). Following some testing regarding her levels of thyroid stimulating hormone (“TSH”), she was prescribed 50 mcg of levothyroxine in order to lower her TSH levels to an optimum number for conception.

However, instead of being given the 50 mcg, Walgreens provided her with a dosage of 150 mcg, which caused her TSH levels to drop dramatically to 0.006, far below the optimal levels of 1 and 2 for conception and implantation. She had filled her initial prescription and subsequent refills at the same Walgreens for a period of three months.

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In 2009, the United States Supreme Court handed down a seminal decision regarding the liability of drug manufacturers for failure to adequately warn of the risks associated with using a particular drug. The Court examined the argument of a drug manufacturer that it could not be held liable for a failure to warn, eventhough it would have been possible to issue a more updated warning label, because the FDA had already approved the drug, and its manner of uses, as safe.

The case, Wyeth v. Levine, 129 S. Ct. 1187 (2009), arose out of an incident whereby the injection of a drug caused a woman to suffer gangrene from a known side effect, which ultimately resulted in the amputation of her arm.

The drug at issue, Phenergan, is an antihistamine used to treat nausea. The injectible form of the drug can be administered two different ways. One way is through a traditional IV, and the other is more akin to a shot. If the drug accidentally enters an artery, it causes immediate and irrevercible gangrene. When the patient was given the drug, she was given it in the shot manner, and it somehow entered an artery, causing gangrene, which ultimately resulted in the amputation of her forearm.

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The Massachusetts Senate voted late last month unanimously to increase regulatory oversight within the state of drug compounding pharmacies, in order to help protect patient safety.

The potential issues regarding the largely unregulated compounding pharmacies such as the one in Massachusetts, which was believed to be the source of a deadly fungal meningitis outbreak, have been discussed at length on this blog.

Following the contamination of compound medications affecting hundreds of patients, which was eventually traced back to a Massachusetts lab, one of the most important regulations of the bill is that it establishes sterile compounding and complex non-sterile compounding specialty licenses, which will be issued by the Board of Registration of Pharmacy.

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Federal investigators and prosecutors in Indiana believe that four doctors at various medical center locations may be responsible for having caused as many as 27 deaths.

The individuals who died were all patients at a group of clinics in the area. Two of the doctors accused of causing the deaths are also the co-owners of the locations. The charges include various drug and conspiracy charges. A federal Drug Enforcement Agency investigation filed some 95 felony charges against nine employees, which included the two doctor owners.

According to an affidavit, the clinic was known as a go to place for individuals seeking access to prescription medications. According to some individuals, it was sometimes referred to as “the candy shop.”

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An Alabama jury recently awarded a widow $850,000 after her husband was allegedly administered triple the normal dosage of medication for a pre-existing condition, and died as a result on Christmas Day.

The jury reportedly spent hours deliberating before delivering the verdict against the man’s doctor, for having purportedly caused the 62 year old’s death. The man was initially hospitalized for pneumonia, and had spent 11 days there for treatment. According to reports, he was given three times the amount of lithium that he actually needed in order to treat his bipolar disorder.

The man’s wife has already made a $1 million settlement with the hospital where the man was undergoing treatment at the time of the accidental overdose. The man had apparently been transferred to a different hospital for treatment, where blood tests showed elevated lithium levels, and he was then moved to another location for dialysis where he died.

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The family of a young girl recently filed a $750,000 federal lawsuit against her local pharmacy, alleging that the business wrote the incorrect directions on her prescription for a seizure medication, causing the girl to take five times the proper dosage of the drug.

According to the lawsuit, the little girl was given a prescription when she was four years old for two milliliters of an anti-seizure medication, to be taken twice a day. However, when the prescription was filled, the instructions stated that the girl should be given two teaspoonfuls twice a day. One teaspoon is the equivalent of almost five milliliters. The pharmacist in the case stated that she repeated the dosage back to the doctor at the time it was filled, and it was confirmed as written.

The young girl’s mother stated that immediately after giving her daughter the incorrect dosage, the girl suffered a serious seizure requiring immediate hospitalization and treatment at a local hospital. According to the lawsuit, the girl became catatonic, and the girl was later transferred to a Children’s Hospital where she remained unconscious for some time. Once she regained consciousness, the girl was unable to walk, and had to be fed baby food, resulting in a 17-18 pound weight loss. She reportedly still suffers side effects from the incorrect drug dosage, and is afraid of taking medicine.

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A doctor/medication safety specialist recently wrote an article about a common abbreviation that could lead to severely adverse consequences in patients. The article, which appears in the web version of the Pharmacy Times, discusses one common abbreviation for acetaminophen, APAP, which is based upon the chemical composition of the drug, that could lead to a deadly overdose when patients take other medications not knowing that they contain the same drug.

For example, in one case following surgery, a 56 year old man was prescribed a hydrocodone/acetaminophen combination drug, but on the label it was abbreviated Hydrocodone/APAP. The instructions said to, “take one tablet by mouth every 4 to 6 hours as needed for pain.” The patient took the medication as instructed, but had insufficient pain relief, so he began taking additional over the counter acetaminophen, and followed those instructions, taking two caplets every 4 to 6 hours as needed.

Following some four days of this combination, the patient returned to the doctor for his post-op appointment, he complained of a lack of appetite, nausea, vomiting, and abdominal pain. The doctor was able to determine that the man was taking over 8 g of acetaminophen per day. The patient told the doctor that the pharmacist did not counsel him on the daily limit of acetaminophen, and that he was unaware that his prescription also contained acetaminophen. The patient was subsequently admitted to the hospital and treated for acute hepatotoxicity, and he luckily made a full recovery.

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In probably one of the most egregious incidents that have occurred in pharmacy error news lately, a young woman was intentionally given the incorrect prescription medication in order to induce a miscarriage.

The 27 year old Florida woman was apparently deceived by her boyfriend who colluded with a local pharmacy employee, and she is now suing the pharmacy that provided the medication.

According to the woman’s lawsuit, she reportedly thought that she was receiving amoxicillin, which had allegedly been prescribed by her boyfriend’s father, an obstetrician who’d confirmed her pregnancy. Instead, however, she was given misoprostol, a stomach ulcer medicine that can cause abortion and birth defects. According to her recently filed negligence lawsuit, just a few days later, the woman had a miscarriage.

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As previously discussed on this blog, one of the most common errors made by prescribing doctors, or in those who input values, is accidentally increasing the dosage, such as in the entering of “10.0 mg,” when the person should have input “1.0 mg.” Even though the error is only a matter of a decimal, it could kill or severely injure a patient.

Medication errors such as these occur frequently, at an estimated one million incidents each year, contributing to 7,000 deaths.

According to recent research, the best known way for hospitals to protect patients from errors is by adopting technology called computerized physician order entry (CPOE). The way these systems work, is that when the person who is entering the prescription into the system enters the values, they are checked against the patient’s records, allergies, etc. This information is then cross referenced for safety and other measures before being sent to the pharmacy. In the opening hypothetical, a properly performing system would alert the physician to the misplaced decimal in the order. Some of the best systems may have actually prevented the order from being written in the first place.

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