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In obstetrics negligence cases, a frequent claim is that an obstetrician negligently delivered an infant ca

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

using brachial plexus injury or Erb’s Palsy. During a vaginal delivery after the infant’s head delivers, th

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

Examples of combination products may in

e anterior shoulder can get stuck behind the mother’s pelvic bone. This stuck shoulder syndrome is called s

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

oulder dystocia.

There are numerous maneuvers to free the shoulder; none of these maneuvers involve touchi

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

ng the baby’s head. When an obstetrician applies excessive force to the neck—Erb’s palsy usually occurs.

C

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

Combination pro

unsel may encounter the following defenses:
Even if the doctor applied undue force – this was after al

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

l – an emergency. Attempts at lateral traction are never acceptable for two reasons. 1--the procedure canno

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

t free the anterior shoulder and 2--lateral traction is the only known cause for Erb’s palsy.

The obstetri

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

ian didn’t know the baby weighed 8 pounds 14 oz or more. This is bad practice as there are numerous tools t

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

o determine the baby’s fetal weight.

Shoulder dystocia was not predicted because the infant was not about

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

verage weight. Should dystocia is still predictable if there’s disproportion between the size of the fetus

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

Following aspects would a

and size of the pelvis.

Delivery was normal and easy; Erb’s palsy must’ve happened in utero. Excessive lat

dd to the challenges in developing combination products:

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

eral traction is the only known cause for Erb’s palsy in a head first vaginal delivery.

The obstetrician a

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

plied gentle lateral traction. Once shoulder dystocia happens, no lateral traction should be administered.

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

By understanding the birth injury mechanisms, counsel can effectively respond to the defense’s contentions

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

and demonstrate that the injury was both predictable and preventable.

Source: Based on an article w

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

Professional from academic institutions, pharmaceutical industries, health care indust

ritten by Stephen H. Mackauf for the Association Trial Lawyers

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

of America, .

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

ractice-Witness-In-An-Erbs-Palsy-Case&id=564872">Cross-Examination Of An Expert Medical Malpractice Witness

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

Companies that provide selfless information through particip

In An Erbs Palsy Case, and The Problems With Shoulder Dystocia by Anapol Schwartz Philadelphia Lawyers

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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