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Just Answers - A Philadelphia Eye Injury Attorney Talks About Eye Injury Claims
Eye injury claims often require expert testimony from a vision specialist. The vision specialist will meet with the injured person, review the medical reports and create an expert report discussing the psychosocial aspects of vision impairment, the effect of a visual impairment on daily life and treatment and support for people with visual impairments. Here is an example of such a report:
MEDICAL HISTORY
Mrs. M.’s most recent opthamologist visit documented a change of vision in her right eye from 20/200 to “light perception.” This is a significan
MEDICAL HISTORY
Mrs. M.’s most recent opthamologist visit documented a change of vision in her right eye from 20/200 to “light perception.” This is a significan
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
t decrease in usable vision, as was noted by Dr. Elliot.
In an office setting Mrs. M. appeared tense. Her right eye shows some disfigurement around the eye, and the sclera appears red. Mrs. M. squinted frequently under fluorescent office lighting.
Since the incident, Mrs. M. has developed a marked degree of blepharospasm involving both eyes. Blepharospasm is a neurological disorder characterized by involuntary muscle contractions, which causes “uncontrollable blinking and lid squeezing”. It “involves both eyes and may result in temporary inabilit
In an office setting Mrs. M. appeared tense. Her right eye shows some disfigurement around the eye, and the sclera appears red. Mrs. M. squinted frequently under fluorescent office lighting.
Since the incident, Mrs. M. has developed a marked degree of blepharospasm involving both eyes. Blepharospasm is a neurological disorder characterized by involuntary muscle contractions, which causes “uncontrollable blinking and lid squeezing”. It “involves both eyes and may result in temporary inabilit
; 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
to see” during spasms. Dictionary of Eye Terminology, 3d Ed., Barbara Cassin, Sheila A. B. Solomon, Triad Publishing Co. Gainesville, FL, 1997. In addition to the functional vision loss this causes, it is very cosmetically displeasing, causing the eyes to squint and blink. During spasms the eyelids almost completely closed causing functional loss of vision.
Mrs. M. describes the vision loss in her right eye as having gotten worse, and indicates that she is only able to see using her left eye. She complains of pain in the orbital area of the eye,
Mrs. M. describes the vision loss in her right eye as having gotten worse, and indicates that she is only able to see using her left eye. She complains of pain in the orbital area of the eye,
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
nd in the tissue around the eye as far back as her ear. Mrs. M. describes hearing loss concurrent with the vision loss. This is undocumented in other medical findings. The discomfort is worse in cold weather.
With only light perception in her right eye, Mrs. M. functions with monocular vision. Monocular vision leaves her without depth perception. The lack of depth perception has an impact on all activities that require binocular vision. These extend across settings in activities of daily life, mobility, work and recreation.
Some activities that
With only light perception in her right eye, Mrs. M. functions with monocular vision. Monocular vision leaves her without depth perception. The lack of depth perception has an impact on all activities that require binocular vision. These extend across settings in activities of daily life, mobility, work and recreation.
Some activities that
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
rs. M. has identified as difficult include: Reaching for items on a grocery store shelf, measuring ingredients, pouring liquids, laundry, walking up and down steps, accessing public transportation, childcare, and playing recreational Mah-jong, and cards.
Mrs. M. indicates that she used to read for pleasure. She does not read since the incident, due to discomfort from the combined visual issues. She has also reduced her frequency of writing to family members. She uses the telephone in place of the letters she used to write to children and family in
Mrs. M. indicates that she used to read for pleasure. She does not read since the incident, due to discomfort from the combined visual issues. She has also reduced her frequency of writing to family members. She uses the telephone in place of the letters she used to write to children and family in
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
the Philippines and Italy.
Mrs. M.’s mobility patterns are typical for an individual with vision loss who has not received vision rehabilitation or orientation and mobility training.
She must protect her left eye by exercising caution in her activities, and by wearing protective eye wear, to retain her remaining vision. Monocular vision, and the depth perception problems it creates, make it harder for individuals to judge distance, and increase the occurrence of small and more serious accidents.
I fabricated two sets of goggles to simulate Mrs. M.
Mrs. M.’s mobility patterns are typical for an individual with vision loss who has not received vision rehabilitation or orientation and mobility training.
She must protect her left eye by exercising caution in her activities, and by wearing protective eye wear, to retain her remaining vision. Monocular vision, and the depth perception problems it creates, make it harder for individuals to judge distance, and increase the occurrence of small and more serious accidents.
I fabricated two sets of goggles to simulate Mrs. M.
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
s acuity deficit. The first set simulates 20/200 vision, which was Mrs. M.’s vision as of her March 16, 2004 visit with her doctor. The second set of goggles simulates Mrs. M.’s vision as of her April 21, 2005 visit with Dr. Werner, which was light perception with no projection. These devices do not simulate blepharospasm.
MOBILITY ISSUES
In the area of mobility, Mrs. M. was observed walking, in an unfamiliar office setting, on steps and in an open parking lot. Mrs. M. uses an adapted trailing technique. Using her left hand she trails/feels al
MOBILITY ISSUES
In the area of mobility, Mrs. M. was observed walking, in an unfamiliar office setting, on steps and in an open parking lot. Mrs. M. uses an adapted trailing technique. Using her left hand she trails/feels al
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
ng a wall until she reaches an open space. Mrs. M. negotiates open space with a tentative semi-shuffling gate. When walking through a doorway she grasps it with her left hand to guide herself through it.
Steps are negotiated with a non-alternating descent pattern, left foot first, then right foot joining on the same step. (The typical adult pattern is alternating feet on alternating steps.) Mrs. M. used her right hand on the handrail after first standing at the left side as if she would prefer to use her left hand and descend on the left side. Asc
Steps are negotiated with a non-alternating descent pattern, left foot first, then right foot joining on the same step. (The typical adult pattern is alternating feet on alternating steps.) Mrs. M. used her right hand on the handrail after first standing at the left side as if she would prefer to use her left hand and descend on the left side. Asc
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
nt was similar.
In the sunny parking lot, Mrs. M. indicated discomfort from glare. She again traversed open space with a tentative gait. There was no evidence of protective posture at this time. She walked more comfortably when she was able to use her hand to trail a car, wall or other object.
Vision loss is a cause of mobility problems. Before the incident, Mrs. M. rode public transportation to work, as she was in the process of doing at the time of this incident. She is now unable to travel unassisted.
She uses her left eye but does not scan
In the sunny parking lot, Mrs. M. indicated discomfort from glare. She again traversed open space with a tentative gait. There was no evidence of protective posture at this time. She walked more comfortably when she was able to use her hand to trail a car, wall or other object.
Vision loss is a cause of mobility problems. Before the incident, Mrs. M. rode public transportation to work, as she was in the process of doing at the time of this incident. She is now unable to travel unassisted.
She uses her left eye but does not scan
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
with it. She needs training to learn the habit of scanning when she walks. She would benefit from a long cane.
Mrs. M.’s son reports that she has fallen several times since the incident. Outside, she encounters undetected curbs and bumps. Inside, she has bumped into tables and chairs. Her family is concerned about her safety when traveling, and in activities inside the home. A sister or friend accompanies her when she travels by bus. She has greatly reduced her travel for pleasure and for activities of daily life because of this.
OTHER FUNCTIO
Mrs. M.’s son reports that she has fallen several times since the incident. Outside, she encounters undetected curbs and bumps. Inside, she has bumped into tables and chairs. Her family is concerned about her safety when traveling, and in activities inside the home. A sister or friend accompanies her when she travels by bus. She has greatly reduced her travel for pleasure and for activities of daily life because of this.
OTHER FUNCTIO
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
AL LIMITATIONS
Before the incident, Mrs. M. reported participating independently in a wide range of activities. In community life she went on day trips, to church and social gatherings, babysat her grandchildren, played Mah-jong and cards with friends. She took public transportation to the grocery store, shopping and to babysitting jobs. At home, she cleaned her house, cooked, and took care of the laundry. She enjoyed reading, and also liked to put on makeup and get dressed up to attend social events. She led a very active, independent life and
Before the incident, Mrs. M. reported participating independently in a wide range of activities. In community life she went on day trips, to church and social gatherings, babysat her grandchildren, played Mah-jong and cards with friends. She took public transportation to the grocery store, shopping and to babysitting jobs. At home, she cleaned her house, cooked, and took care of the laundry. She enjoyed reading, and also liked to put on makeup and get dressed up to attend social events. She led a very active, independent life and
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
was active in the Filipino community.
Because of her vision loss, and her resulting mobility and perceptual problems, and other injuries, she requires assistance to shop. She has difficulty picking items off the shelf, as she “misses” what she reaches for at the grocery store. Because of her lack of depth perception, she sometimes misses the cup when she pours liquid from a pitcher. She is afraid to cut food for fear of injuring herself. She does not cook on the stove or with the microwave, after having some accidents and “making messes.” Overall
Because of her vision loss, and her resulting mobility and perceptual problems, and other injuries, she requires assistance to shop. She has difficulty picking items off the shelf, as she “misses” what she reaches for at the grocery store. Because of her lack of depth perception, she sometimes misses the cup when she pours liquid from a pitcher. She is afraid to cut food for fear of injuring herself. She does not cook on the stove or with the microwave, after having some accidents and “making messes.” Overall
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
she and her family feel that cooking is too dangerous.
She does not read due to visual discomfort. She no longer plays Mah-jong. She has curtailed much of her social activity, and does not put on makeup anymore. Whether this is due to physical discomfort, social discomfort, or depression, I was not able to ascertain in the 45-minute interview.
Mrs. M. seemed distraught over her situation, and it was hard for her to talk about how her life has changed. She seemed to have enthusiasm for the things she used to do. When asked how she spends her time
She does not read due to visual discomfort. She no longer plays Mah-jong. She has curtailed much of her social activity, and does not put on makeup anymore. Whether this is due to physical discomfort, social discomfort, or depression, I was not able to ascertain in the 45-minute interview.
Mrs. M. seemed distraught over her situation, and it was hard for her to talk about how her life has changed. She seemed to have enthusiasm for the things she used to do. When asked how she spends her time
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
currently, she stated that she sits in her bedroom and plays solitaire all day. (She indicates that she has to hold the cards close to her face to read them.) Her husband now does all of the house cleaning, cooking and laundry. He also works 4-6 hours per day. Her son indicates that the husband is not accustomed to doing these chores, and that there is friction in the family due to the change in roles. The couple fights and argues more frequently due to this conflict.
Mrs. M. maintains her personal hygiene, such as showering, brushing her teeth,
Mrs. M. maintains her personal hygiene, such as showering, brushing her teeth,
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
aking care of her hair and dressing.
She is less active with her grandchildren, and no longer baby-sits. Her five year old grandchild asks her what’s wrong with her face.
RECOMMENDATIONS
Mrs. M. would benefit from a full assessment by a vision rehabilitation therapist or low vision therapist. I strongly recommend intensive rehabilitation training so that she can learn techniques to care for herself and to engage in activities of her choosing. She would benefit from a mobility evaluation by an orientation and mobility instructor, and orientation
She is less active with her grandchildren, and no longer baby-sits. Her five year old grandchild asks her what’s wrong with her face.
RECOMMENDATIONS
Mrs. M. would benefit from a full assessment by a vision rehabilitation therapist or low vision therapist. I strongly recommend intensive rehabilitation training so that she can learn techniques to care for herself and to engage in activities of her choosing. She would benefit from a mobility evaluation by an orientation and mobility instructor, and orientation
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
nd mobility training for safe, independent indoor and outdoor travel.
The assessing professionals will determine a course of treatment. My conservative estimate for initial rehabilitation and follow up would be for 2 hour sessions of private rehabilitation training on a weekly basis for at least 4 months. This will cost approximately $90.00 an hour. Similarly in orientation and mobility, 2 hour sessions of orientation mobility training on a weekly basis for at least 4 months. This will also cost approximately $90.00 an hour. When that is complete
The assessing professionals will determine a course of treatment. My conservative estimate for initial rehabilitation and follow up would be for 2 hour sessions of private rehabilitation training on a weekly basis for at least 4 months. This will cost approximately $90.00 an hour. Similarly in orientation and mobility, 2 hour sessions of orientation mobility training on a weekly basis for at least 4 months. This will also cost approximately $90.00 an hour. When that is complete
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
, the professionals she works with will set up a schedule for follow-up and maintenance of skills. Again, my estimate is of monthly follow-up for 6 to 12 months of 2-hour sessions at $90.00 an hour.
Mrs. M. needs audiology testing for her hearing loss. Her hearing loss aggravates the functional problems and safety issues brought on by her vision loss, and increases communication problems.
A person with monocular vision has a substantially greater risk of becoming visually impaired in the good eye than a fully sighted person has of suffering damage
Mrs. M. needs audiology testing for her hearing loss. Her hearing loss aggravates the functional problems and safety issues brought on by her vision loss, and increases communication problems.
A person with monocular vision has a substantially greater risk of becoming visually impaired in the good eye than a fully sighted person has of suffering damage
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
in either eye. I recommend that Mrs. M. wear protective glasses, and exercise caution in activities.
I am sending her catalogues with various adaptive items for household tasks, such as telephones with large numbers, playing cards with large markings, stove and microwave controls for the visually impaired, etc. The cost of equipping her home with some of the items she needs is approximately $500.00. There may be other costs incurred for materials associated with her rehabilitation. These materials will help her to be more independent and to acti
I am sending her catalogues with various adaptive items for household tasks, such as telephones with large numbers, playing cards with large markings, stove and microwave controls for the visually impaired, etc. The cost of equipping her home with some of the items she needs is approximately $500.00. There may be other costs incurred for materials associated with her rehabilitation. These materials will help her to be more independent and to acti
.
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
ely engage in activities in her home and community.
Mrs. M. is going through a period of grieving and loss associated with vision loss. I recommend that doctors and family members be aware of this, and monitor her for signs of depression. I recommend that she attend a support group for individuals with vision loss.
CONCLUSIONS
A person in her 60’s can work, play an active role in her grandchildren’s’ lives, run errands, do housework and lead a fulfilling life. Since the incident, instead of being a caregiver, Mrs. M. is now a care consumer. Mrs
Mrs. M. is going through a period of grieving and loss associated with vision loss. I recommend that doctors and family members be aware of this, and monitor her for signs of depression. I recommend that she attend a support group for individuals with vision loss.
CONCLUSIONS
A person in her 60’s can work, play an active role in her grandchildren’s’ lives, run errands, do housework and lead a fulfilling life. Since the incident, instead of being a caregiver, Mrs. M. is now a care consumer. Mrs
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
M. has suffered a life-changing event. She has lost a great deal of confidence in her ability to function in daily life. Although she may never recover the function she had before the incident, rehabilitation training and orientation and mobility training will help her to be more independent with her residual vision.
All of the conditions and functional ramifications mentioned herein are a direct result of the visual impairment caused by Mrs. M.’s injury. All of my opinions are stated to a reasonable degree of professional and scientific certainty
All of the conditions and functional ramifications mentioned herein are a direct result of the visual impairment caused by Mrs. M.’s injury. All of my opinions are stated to a reasonable degree of professional and scientific certainty
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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