The woman had anemia for which she underwent a bone marrow biopsy on January 19, 2009. The results of the biopsy indicated slight changes in the woman’s bone marrow that may have been related to a vitamin deficiency or caused by some form of therapy that she had received. Nonetheless, the doctor advised the woman that she had myelodysplasia (which he called “pre-leukemia”), without conducting recommended additional testing, and advised her that she needed immediate treatment by him to save her life. In fact, the biopsy results ruled out leukemia and there was no elevation in blastocyte numbers.
What Is Myelodysplasia?
Myelodysplastic syndromes (MDS) are conditions that occur when the blood-forming cells in the bone marrow are damaged and leads to low numbers of one or more types of blood cells. MDS can turn into a fast-growing cancer of bone marrow cells called acute myeloid leukemia that occurs in about 1 out of 3 people with MDS. In the past, MDS was called pre-leukemia or smoldering leukemia. Since most MDS patients do not get leukemia, these terms are no longer used.
The woman’s doctor began treating her with Vidaza, which was approved by the FDA for injectable suspension on May 19, 2004 for use in patients with all subtypes of myelodysplastic syndromes. However, the doctor allegedly obtained a counterfeit drug at a deep discount from Turkey that was transported into the United States in unrefrigerated containers.
The doctor reportedly pleaded guilty to a federal charge of introducing misbranded and adulterated prescription medications into interstate commerce and was sentenced in May 2012 to two years of probation, 200 hours of community service, and a $250,000 fine, as well as paying more than $1 million to settle claims that he submitted false claims to Medicare and other federal health agencies. The doctor’s medical license was also suspended, according to news reports.
The medical malpractice plaintiff alleges that she received a letter from the defendant doctor dated January 6, 2012, in which he admitted that he gave her unapproved drugs.
The woman’s medical malpractice lawsuit alleges that the defendant doctor lied to her about the pre-leukemia diagnosis and treated her with unapproved drugs that caused her unnecessary emotional trauma. She further claims that she suffered renal damage, gastrointestinal problems, and fatigue due to the unapproved drugs and that she incurred unnecessary medical expenses.
The woman had initially filed her medical malpractice case against the doctor pro se (without a lawyer representing her) on December 28, 2012, which she voluntarily dismissed on May 3, 2013. The current medical malpractice lawsuit was filed on May 1, 2014, by the woman’s attorneys.
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