Interview with Tampa Wrongful Death Attorney Mitchell Feldman
Interviewer: Hello Attorney Mitchell Feldman. Today we are going to be discussing the dangerous drugs known as ESAs. Let’s start with the basics: What is an ESA and what are the dangers of ESAs such as Procrit?
Attorney Feldman: ESAs, or Erythropoiesis-Stimulating Agents, are a class of drug that physicians use to increase red blood cells when there has been a large loss of blood. It has been considered an alternative to blood transfusions. In the past, there has been lesser risk of developing complications and death associated with ESA usage verses having blood transfusions. However, the FDA recently issued a new Black Box Warning due to concerns that the drug’s use can lead to Deep Vein Thrombosis (DVT), blood clotting and ultimately death.
When we began handling cases involving ESAs, such as Procrit, we discovered that these drugs are lethal. We’ve discovered that physicians are uneducated about the risks and side effects or the needed protocols to follow in order to avoid patient death.
“The FDA is requiring all drugs called Erythropoiesis-Stimulating Agents (ESAs) to be prescribed and used under a risk management program, known as a risk evaluation and mitigation strategy (REMS), to ensure the safe use of these drugs.”
These are dangerous drugs and many physicians are administering them without fully understanding the FDA guidelines. Patients are not being warned or given informed consent to make the decision, and it is leading to ESA patient death.
Interviewer: Attorney Feldman, can you please tell us about your current Procrit case?
Attorney Feldman: Feldman Legal Group. is now representing the surviving spouse of a 53-year-old gentleman. He died after developing Deep Vein Thrombosis, blood clots, and a pulmonary embolism after an orthopedic shoulder surgery in the hospital. On the morning after the surgery, the doctor gave him an injection of Procrit, an ESA, because of a concern over blood loss. However, the physician failed to monitor the blood levels thereafter and institute the necessary use of Anticoagulation Therapy. This led to the development of blood clots and ultimately his death. The sole cause of death was the Procrit.
Interviewer: What have you found out about overall doctor awareness regarding the dangers associated with prescribing Procrit?
Attorney Mitch Feldman: From our own case, we have discovered that the physician who prescribed the Procrit was uneducated as to the recent FDA Black Box Warning changes, and had no clue about the causal relationship of the drug to blood clots and death. These findings lead us to conclude that there are many more physicians out there who are unaware of the FDA Black Box Warning.
This is not an isolated incident. What we are very likely to find is that physicians aren’t handing the patient the medication guides and that they still look at ESAs as a viable, safe option when someone has lost blood. Procrit is used as an alternative to a blood transfusion, and these physicians are giving out this dangerous drug leading to blood clotting without being familiar with the necessary follow-up and protocols for Anticoagulation Therapy.
Interviewer: What is the statute of limitations associated with ESA products liability?
Attorney Mitch Feldman: In death cases involving dangerous drugs such as ESAs (Epogen, Procrit and Aranesp), generally you have two years in most states to pursue a wrongful death claim. If you have a loved one who has died following a hospital stay or accident with a loss of blood, then you have a two-year period of time to start looking at causes of that person’s death.
However, in instances such as Procrit, where the FDA came out with Black Box Warning changes in February of 2010, arguably you have two years from the date of the FDA Black Box Warning changes. In the case of an ESA-related death, the FDA changes were in February 2010, so you would have until February 2012. Therefore, if you have a loved one who has died in the last several years up through today’s date, now is the time to call for action, and to call a firm like Feldman Legal Group. that can investigate the death and determine whether a dangerous ESA was the cause of your loved one’s death.
Interviewer: Can you tell us a bit more about the Black Box Warning for ESA drugs?
Attorney Mitch Feldman: In February of 2010, the FDA changed the warnings on the class of drugs called ESAs which are Procrit, Epogen, and Aranesp, three different brand names of the same drugs. Epoetin alfa, marketed as Procrit, is manufactured by Janssen, while Amgen manufacturers Aranesp (darbepoetin alfa) and Epogen (epoetin alfa).
ESAs are drugs that physicians might use in situations where someone has lost blood in order to raise their red blood cell levels. It’s an alternative to giving blood transfusions that was thought to have a lesser risk of harm occurring to the patient.
Well, in February of 2010, the FDA changed the Black Box Warning, which is the warning that the manufacturers are required to place on the product guide that a physician would see. The Black Box Warning is also part of the medication guides that a physician would be required to hand out to the patient if he or she is given this drug. These Black Box Warnings include everything that every physician needs to know, that every hospital needs to know, before dosing this medication. They include the dangerous side effects and give guidelines for the use of these drugs, the protocols, the follow-ups, and in the case of ESAs, the FDA has determined there is a causal relationship between blood clotting occurring very quickly after dosing. Black Box Warnings now require the physician to follow up and review for Anticoagulation Therapy, the use of blood thinners, and to immediately warn the patient of the risks of developing the Deep Vein Thrombosis and blood clotting. These are now mandated in the product guide and the medication guide, and must be discussed between the patient and the physician at the time of dosing.
The first thing to know is that the Food and Drug Administration (FDA) has made it a requirement that the physician prescribing Procrit or another ESA hand their patient the Medication Guide. Why? Because Procrit is a dangerous drug. A drug with a risk of death, and the FDA mandated in these types of circumstances that the patient be fully informed of the risks involved in order to make an informed decision about whether or not to take the drug.
A physician prescribing an ESA has the duty — has the obligation — to discuss the risks of harm and the side effects with the patient prior to giving the patient the medication. These risks include developing blood clots, developing Deep Vein Thrombosis and ultimately death. The physician has the duty to discuss this so that the patient can make an informed decision on whether he or she wishes to choose this medication. Absent the physician discussing the side effects and the warnings with the patient, he or she will never have an opportunity to make an informed decision in this context.
Interviewer: What does Feldman Legal Group. do in regard to a wrongful death case?
Attorney Mitch Feldman: When Feldman Legal Group. is referred a wrongful death case, when there’s concern over an unexpected death, the first thing we do is obtain the medical records and look to see if there’s an autopsy report. Then, we’re going to look to see what the course of treatment was in the hospital and post-discharge from the hospital to see if that person was given the right care and treatment.
Often we find that dangerous medications were delivered and dosed to the patient without the proper warnings, without the proper follow-up and monitoring, and that leads to complications including death. So we are going to look at what drugs were involved, the Black Box Warnings that are associated with those drugs, the FDA warnings, and we look for drug interactions and for a cause of death. We will investigate and review all the literature. And we will consult with experts in medical science.
So if you have a loved one who has died in the last several years, now is the time to call for action, to call a firm like Feldman Legal Group. We will investigate the medical records and determine whether a dangerous ESA was the cause of your loved one’s death.
Interviewer: Thank you, attorney Feldman, for providing an insight into wrongful death associated with the drugs known as ESAs. How can you be contacted for further information?
Attorney Mitch Feldman: You can call the offices of Feldman Legal Group. at 877-946-8293 or use our online contact form.