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Answers - Investigating Medical Negligence Cases
How do you know if you, a family member, or friends have been the victim of medical negligence? What information is important? What are the issues? What are the types of damages that can be recovered? How long do you have to take legal action? These are all impo
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
rtant questions and this article will attempt to provide you with useful answers. What Information is Important? Our analysis of your potential case begins with a thorough investigation and examination into your medical history. Any previous hos
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
pitalizations regardless of the reason may be important. We need to review your medical records from your family or primary care doctor for several years prior to the date of the treatment which you believe was negligent. We will need to review all records surro
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
unding the treatment which you believe to have been improper. Finally, we need to understand all medications which have been ordered for you during the last several years. No doctor or hospital can refuse to provide you with a copy of your records – it’s the law
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
! They may charge you a fee for copying the records but must provide the records within 15 days of your request. You do not have to inform the health care provider that you are requesting the records for review in a potential legal matter.
What Is Medic
What Is Medic
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
al Negligence? In Virginia, and most other states, a doctor, nurse, dentist, or other medical professional is guilty of medical negligence if their care of a patient is below what a reasonably trained and experienced medical professional would have done
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
for the patient under similar circumstances. This negligence may be the result of actions or inactions by the medical professional. For example, if a reasonable and competent Emergency Room doctor would order a chest x-ray and cardiac studies for a patient with
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
complaints of chest pain and shortness of breath - then it would be negligent for that doctor to fail to order these tests to determine the patient’s cardiac status. Also, if a reasonable and prudent nurse would not give 100 mg of Demerol (narcotic pain medicati
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
on) to a post-operative patient who had already received post-operative pain medication in the recovery room, then it would be negligent for the nurse to give the patient the additional dosage of pain medication.
What is Causation? Proving that
What is Causation? Proving that
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
the doctor, dentist, or nurse was negligent is not enough to prove your case. You must also be able to establish the negligence of the health care professional directly caused injury or death. The easiest way to understand this principle is to discuss a situati
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
on where causation is not proven. Let’s assume that you are cleaning the gutters from a ladder at your house and fall and injure your arm. A family member takes you to the doctor who orders x-rays, and after reviewing the films, tells you that you have just brui
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
sed your arm and sends you home. Upon returning home, and for the next 24 hours, the pain in your arm becomes unbearable. You head to the local hospital emergency room and additional x-rays are taken which clearly establish that you broke your arm as a result of
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
the fall from the ladder. Yes, the first doctor was most likely negligent in failing to diagnose your broken arm but what damages were caused by the negligence? You would have had a cast placed on your arm 24 hours earlier but would still have endured a fair am
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ount of pain. In other words, you cannot prove that the first doctor’s negligence caused you to suffer additional injury requiring additional medical treatment.
What Damages May be Recovered? Assuming you can establish that your doctor or nurse
What Damages May be Recovered? Assuming you can establish that your doctor or nurse
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
was negligent and that such negligence caused you further harm there are several different types of damages which the law entitles you to recover. First, you may recovery for additional medical costs/charges if the negligence required you to remain in the hospit
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
al for a longer period of time or receive medical care from other doctors to fix the medical problem. Second, you may recover any wages or income lost as a result of your inability to work – even if you will be unable to work for the remainder of your life. Thir
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
d, you may recover for the added “pain and suffering” which results from your doctor’s negligence. Finally, you may recover damages for the loss or reduction in the enjoyment of everyday life if your injuries are permanent in nature and prevent you from doing th
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
e things you have always done (i.e. golf, hiking, etc.).
How Long Do I Have to Make a Claim? The general rule in Virginia is that you have two years from the date of the negligence to file a civil claim for damages. This time may be shorter or
How Long Do I Have to Make a Claim? The general rule in Virginia is that you have two years from the date of the negligence to file a civil claim for damages. This time may be shorter or
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
longer depending on the facts of your case. The rule is different for children who have suffered from acts of medical negligence and there are different restrictions if the defendant is a division or agency of the Commonwealth (i.e. UVa. Medical Center, etc.) Al
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
l claims, regardless of their merit, are barred if filed after the expiration of these cutoffs or periods of limitation. The best practice is to consult with an attorney as soon as you have questions about the medial care provided to you, your family, or friends
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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