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For a case involving injuries resulting from a slip and fall on ice, a special settlement demand letter is warranted. Here is a sample for you to use in your own case.

Dear Insurance Adjuster:

Enclosed is wage los

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

s documentation and the complete medical specials for Nira Thomas. Ms. Thomas was severely injured on January 9, 2001 in a fall down accident for which you have accepted full liability.

Nira Thomas fell flat on her

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

Examples of combination products may in

back after sliding on the ice on your insured’s property. She immediately made an appointment with Dr. Jess P. Jones and was seen by him later that day. Ms. Thomas received chiropractic treatments from Dr. Jones on

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

January 9, 11, 17, 29 and February 5, 2001. Because the pain was not abating after these treatments, Ms. Thomas requested a referral to an orthopaedist. The pain actually got worse during the first six weeks after

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

the accident. The injury was exacerbated in the first two months by the physical and emotional stress of Ms. Thomas’s work responsibilities, which as detailed below, she was unable to substantially curtail.

Dr. Lero

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

Combination pro

Hamm examined Nira Thomas on February 12, and March 14, 2001. Dr. Hamm’s reports document that Ms. Thomas had been having some lower back pain just prior to this accident. The accident of January 9, 2001 exacerbate

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

her lower back pain, causing it to radiate to her right buttock. Dr. Hamm diagnosed Ms. Thomas as having suffered a lumbo sacral strain. He prescribed medication and a lower back physical therapy program. My clie

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

nt took medication for several months in conjunction with physical therapy, reducing the medication as tolerable.

Ms. Thomas began receiving physical therapy on February 15, 2001 at Nova Care. She treated consisten

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

ly through May 18, 2001. Ms. Thomas received additional treatment at Physical Therapy Now from May 21, 2001 to December 4, 2001. It was only this physical therapy which provided significant relief to my client.

Ms

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

Thomas was examined by her internist, Dr. William Schetzy in the Fall of 2001. The report he prepared for the U.S. Department of Labor is enclosed.

Note that Nira Thomas continues to this day to suffer considerabl

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

back pain and has significant limitation in her activities of daily living as the result of this accident. She takes pain medication typically on an intermittent basis, and on a daily basis when the pain is exacerb

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

Following aspects would a

ated. She does exercises at home and receives massages from her husband, Robert.

The marital strain on both of my clients, sexual, emotional and physical from the time of this accident, has been great. In addition

dd to the challenges in developing combination products:

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

to the daily marital and personal and work stresses Ms. Thomas has been under, the delay in pursuing her biological reproductive objectives greatly impacted and continues to impact my clients to this day. Financially

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

emotionally, physically and spiritually, it has been devastating.

Following the accident, Ms. Thomas’s supervisor would not permit her to substantially reduce her total weekly hours or work responsibilities for man

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

y weeks, until she was determined to be qualified under FMLA. In extreme pain in January-March, 2001, Ms. Thomas alternated standing and sitting at her desk, attempting to work on the computer. She was unable to si

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

for more than 10-15 minutes at a time. It was only after the FMLA qualification was submitted to the Human Resources department, that her supervisor was obligated to reduced Ms. Thomas’s hours and shift some of her

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

Professional from academic institutions, pharmaceutical industries, health care indust

work load to another employee. Until then, Ms. Thomas simply worked through the pain.

Another work consequence of the injury was that this supervisor did not allow Ms. Thomas to pursue professional development trai

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

ning programs in the Spring of 2001. My client had previously signed up for these programs but could not attend them because of her decreased hours. This loss of professional development for Ms. Thomas has impacted

.

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

her earning horizons. Ms. Thomas loss in productivity after the accident was a major reason that she did not get a raise or cost of living increase during her annual review in July, 2001.

In view of the clear liabi

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

Companies that provide selfless information through particip

ity and severity of the damages sustained, settlement demand is hereby made in the amount of $85,000.00 for Nira Thomas and $10,000.00 for Robert Thomas. Please contact me after your review of this claim is complete

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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