Actual - Legal

Medical negligence is much more than a doctor making a mistake. To prove that the doctor was medically negligent,

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

your solicitor must also show that in making that mistake the doctor or dentist provided a standard of care that

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

was unacceptable by the standards of the profession. Negligence can include an act or a failure to carry out an

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ct (an omission). This might include, for example, a doctor performing surgery incompetently or failing to refer

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

a patient for specialist advice where this is indicated.

Your solicitor will also need to prove a link between t

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

e alleged act of negligence and the damage or injury suffered. This link is called causation and is often the mos

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

t difficult part of evidence in a medical negligence claim.. For example, if a General Practitioner failed to ref

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

r a patient to hospital who was suffering from bowel pain and eventually the patient is seen at hospital and is d

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

iagnosed a suffering from cancer. Your specialist medical negligence solicitor would have to prove that any negli

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

ent delay in the referral to the specialist caused a deterioration of the cancer or that had the referral been ma

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

de initially a full recovery might have taken place. Your solicitor will need to obtain expert medical advice to

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

assist with these questions.

The legal tests of negligence and causation are difficult to establish and it is im

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ortant that you seek early and urgent legal advice only from a specialist solicitor.

You should ensure that your

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

solicitor has a Legal Services Commission franchise in medical negligence. Only firms with this franchise can of

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

er public funding (Legal Aid) to pursue medical negligence claims. The firms are assessed for expertise and inter

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

nal management standards before being awarded a franchise and their performance is measured against quality stand

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

rds in an annual audit.

Specialist solicitors are usually members of the AVMA (Action for Victims of Medical Acc

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

idents) panel or the Law Society Medical Negligence panel. These bodies ensure that any solicitor on their panel

.

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 experience and expertise in dealing with a range of medical negligence claims from outset to trial, if this pr

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

oves necessary.

AVMA or the Legal Services Commission can give you details of specialist solicitors in your area

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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