Wiliam Sepulvado - Trivent Legal



07/23/YYYY

Viagra Case Review – XXXXXX

|Parameter |Findings |Bates Ref |

|First Name |XXXXXX |V - 4 |

|Initial |M |V - 4 |

|Last Name |XXXXXX |V -4 |

|DOB |12/22/YYYY |V -4 |

|Medication Taken |Viagra, Levitra, and Cialis |V -474, 250, 246,|

| | |277 |

|Viagra Start Date |04/03/YYYY (Per medical records) |V -474, 439 |

| | | |

| |*Reviewer’s comments: In the available medical and pharmacy records, first use of Viagra was noted on | |

| |04/03/YYYY and first refill on 04/04/YYYY. However exact start date of Viagra is unknown. | |

|Dosage |Viagra 50 mg, 100 mg; Levitra 10 mg; Cialis 20 mg |V -474, 439, 447,|

| | |277, 250, 246 |

|Total Exposure |2600 mg (Calculated from available pharmacy records) |V -439, 447 |

|Viagra Discontinued Date |Unknown |V -250 |

| | | |

| |*Reviewer’s comments: In the available records last use of Cialis is noted on 04/30/YYYY however further | |

| |medical records are not available to know if Viagra/Cialis was discontinued. | |

|Viagra Adverse Events |Yes |V -57-58 |

|(Whether diagnosed with Melanoma, other | | |

|skin cancer or any other events) | | |

|Other Cancer Prior To Viagra |Not available | |

|Date of Diagnosis of Melanoma |03/16/YYYY: Pathology report revealed lentigo malignant melanoma in abdominal wall |V -57-58 |

|Staging of Melanoma |03/16/YYYY: Clark’s level II |V -57-58 |

|Management of Adverse events |03/22/YYYY: Underwent wide excision of melanoma of the abdomen |V -41 |

|Smoking history |Never smoker |V -242 |

|Predisposing factors (Fair skin, Blonde |As on 12/05/YYYY: History of sunburn, blistering, some freckles in the sun. The patient is a Fitzpatrick |V -507-511 |

|hair, Moles, exposure to sun, radiation |skin type III. Lifetime ultraviolet exposure. | |

|exposure) | | |

|Prior Medical History |Past medical history: Atrial fibrillation, colonic polyps, coronary artery disease, hyperlipidemia, |V -242, 118 |

| |hypertension, recurrent prostatitis | |

| | | |

| |Past surgical history: Tonsillectomy, vasectomy, stent right and left coronary arteries, right shoulder | |

| |rotator cuff 08/2010 | |

| | | |

| |Family History: Father – liver disease, mother- Cancer, Brother – Heart disease | |

| | | |

| |Social history: Never smoker, occasional alcohol use | |

| | | |

| |Allergies: No known drug allergies | |

|Condition of The Patient Per Last |12/05/YYYY: History of melanoma excised on right abdomen - No recurrence - Has benign nevi of back, chest, |V -507-511 |

|Available Record |abdomen, and extremities - Lesion on left lateral thigh stable in measurement; Actinic keratosis of head | |

| |and ears, right cheek, face – Liquid nitrogen given on right cheek – Recommended use of sunscreen, shave | |

| |biopsy of lesion on right anterior arm. | |

| | | |

| |*Reviewer’s comments: Further medical records after 12/05/YYYY are not available for review. | |

Pharmacy Log:

|Date |

Missing Medical Record:

|What Records are |Hospital/Medical |Date/Time Period |Why we need the records? |Is Record Missing |Hint/Clue that records are missing |

|Needed |Provider | | |Confirmatory or Probable? | |

Medical Chronology of Hospitalization Events

(Including Operative Procedure, Reason for Surgery, Complications, Pathology, Findings)

|DATE |PROVIDER |OCCURRENCE/TREATMENT |BATES REF |

|01/04/YYYY-01/16/Y|Multiple Providers |Multiple visits for hypertension, and depression, left nasal al lesion, leukoplakia, and pharmacy records: |V- 467, 469, 474, |

|YYY | | |273, 439, 447 |

| | |01/04/XXXXX: Denies any change in sexual frequency. Though admittedly, it is not as frequent as it was 20 years | |

| | |ago. | |

| | | | |

| | |02/20/yyyy: Has superficial lesion on left nasal ala which scabs over when he picks at it – On examination, there | |

| | |is a very superficial hemangioma left nasal ala for which no treatment is offered though suggested to watch for it| |

| | |in future. | |

| | | | |

| | |09/13/yyyy: Seen for tiny lesion on left ala of the nose which has been present for several months – Under | |

| | |Xylocaine anesthesia a superficial biopsy of 2 mm lesion is performed. Base is cauterized with silver nitrate. | |

| | |Lesion is frozen for 1 minute with the cryosurgical unit – Specimen submitted to pathology | |

| | | | |

| | |04/03/YYYY: Viagra 50 mg | |

| | | | |

| | |04/04/YYYY-03/02/YYYY: Viagra 50 mg refilled (Pharmacy refill) | |

| | | | |

| | |01/16/YYYY: Concerned of a spot on his lower lip – On examination of lower lip reveals a small area of leukoplakia| |

| | |about 4 mm in diameter on the mid portion of lower lip – Diagnosis: Hopefully this is premalignant actinic | |

| | |keratosis - Referred to Dr. XXXXX for biopsy. | |

| | | | |

| | |*Reviewer’s comments: Above visits are combined and only significant details pertaining to Viagra case review have| |

| | |been elaborated. | |

|*Reviewer’s comments: Interim medical records from 01/16/YYYY-02/24/YYYY pertaining to Viagra case review are not available for review. |

|02/24/YYYY |XXXXX, M.D. |Visit to check mole: |V- 478 |

| | | | |

| | |Examination reveals a 5 mm darkly pigmented skin nodule on the right abdomen. It is roughly circular in shape with| |

| | |irregular outline. Pigmentation is uniform. However, it is significantly darker than any other mole on his trunk. | |

| | | | |

| | |Assessment: Rule out early melanoma | |

| | | | |

| | |Plan: Will return for punch biopsy of the lesion. | |

|03/11/YYYY |XXXXX, M.D. |Follow-up visit for shave biopsy: |V - 275 |

| | | | |

| | |Patient comes in to have a biopsy of a suspicious mole done. | |

| | | | |

| | |Physical examination: 4 mm punch biopsy is submitted to pathology | |

| | | | |

| | |Plan: Daily antibiotic ointment and band aid; Follow-up by phone in 1 week | |

|03/16/YYYY |XXXXX Medical |Pathology report: |V - 57-58 |

| |Foundation | | |

| | |Diagnosis: | |

| |XXXXX, M.D. |Skin biopsy, abdominal wall: Lentigo malignant melanoma. | |

| | | | |

| | |Clark’s Level II - Thickness: 0.31 mm | |

| | |Resection margins: Incompletely excised | |

| | | | |

| | |Prognostic indicators: | |

| | |Mitotic Rate: Low | |

| | |Ulceration: Absent | |

| | |Regression: Indeterminate | |

| | |Lymphocytic response: Moderate | |

| | |Angiolymphatic invasion: Absent | |

|03/16/YYYY | |Telephone note:(Illegible notes) |V- 275 |

| | | | |

| | |Diagnosed with lentigo malignant melanoma – Appointment with Dr. XXXXX on 03/18/YYYY | |

|03/19/YYYY |XXXXX, M.D. |Correspondence to Dr. XXXXX, M.D. regarding abnormal mole: |V -295 |

| | | | |

| | |Patient presents with an abnormal mole. He describes this as being dark black with a red border. This had changed.| |

| | |It had increased in size. He has recently undergone a punch biopsy of this and this demonstrated a melanoma. This | |

| | |was a fairly thin, Clark’s II melanoma and additionally was only 0.31 mm in thickness. | |

| | | | |

| | |Physical examination: Abdomen is soft. There is a well healing incision noted in the right lower quadrant. There | |

| | |are no lymph nodes which I can note in either the right axillary or the right groin area. | |

| | | | |

| | |Plan: I have discussed with him wide excision. This will be done under a Local Anesthetic on 03/22/YYYY. | |

|03/22/YYYY |XXXXX Surgery Center |Operative report of wide excision of melanoma of the abdomen: |V- 41 |

| | | | |

| |XXXXX, M.D. |Pre and postoperative diagnosis: Melanoma of the abdomen | |

| | | | |

| | |Anesthesia: Local with intravenous sedation | |

| | | | |

| | |Procedure performed: Wide excision of melanoma of the abdomen | |

| | | | |

| | |Operative procedure: An elliptical skin incision was made which completely excised this previous excision site | |

| | |with 1-cm margins. This was carried down through the subcutaneous tissues and into the subcutaneous fat. This was | |

| | |excised sharply. Bleeding was controlled using electrocautery. This required undermining in all four sides. The | |

| | |two ends were then brought into apposition using 3-0 Vicryl in the subcutaneous tissues followed by Steri-Strips | |

| | |for the skin. This was tolerated well. The blood loss was less than 50 cc. | |

|03/22/YYYY |XXXXX Surgery Center |Records related to hospitalization: Anesthesia record, assessment, orders |V - 40, 44, 43 |

|03/22/YYYY |XXXXX Surgery Center |Discharge instructions: (Illegible notes) |V - 42 |

| | | | |

| | |Medications: Darvocet N prescribed for pain | |

| | | | |

| | |Dressing/wound care: May remove dressing after _______reapply___ | |

| | | | |

| | |Other instructions: Leave Steri-Strips in place - Will fall off | |

| | | | |

| | |Follow-up: In 2 weeks | |

| | | | |

| | |*Reviewer’s comments: Discharge summary is not available for review. | |

|03/24/YYYY |XXXXX Medical |Pathology report: |V - 59 |

| |Foundation | | |

| | |Diagnosis: Skin, abdomen: | |

| |XXXXX, M.D. |No evidence of residual malignant melanoma. | |

| | |Reactive changes consistent with history of previous surgical excision. | |

|04/02/YYYY |XXXXX, M.D. |Correspondence to XXXXX, M.D. regarding follow-up on melanoma: |V - 301 |

| | | | |

| | |Patient underwent a wide excision of his melanoma site. The pathology from this reveals all cancer removed. His | |

| | |wound is healing well today. | |

|05/03/YYYY |XXXXX of Central States|Pathology report: |V - 360 |

| | | | |

| |XXXXX, M.D. |Date of biopsy: 04/28/YYYY | |

| | | | |

| | |Clinical data: Melanoma versus seborrheic keratosis | |

| | | | |

| | |Diagnosis: Irritated seborrheic keratosis, right shoulder, anterior | |

| | | | |

| | |*Reviewer’s comments: Records corresponding to biopsy of the right shoulder and reason for biopsy are not | |

| | |available for review. | |

|*Reviewer’s comments: Interim medical records from 05/03/YYYY-02/07/YYYY are reviewed and noted no significant details hence combined at the end of chronology and not |

|elaborated. |

|02/07/YYYY |XXXXX, M.D. |Visit for chronic itching of feet and sexual dysfunction: |V - 277 |

| | | | |

| | |Patient is having some sexual difficulties and request help with this problem. We have discussed erectile | |

| | |dysfunction in the past. | |

| | | | |

| | |Assessment: Sexual dysfunction | |

| | | | |

| | |Plan: Samples of Levitra 10 mg given | |

|11/04/YYYY |Memorial Hospital of |Hospitalization for unstable angina: |V - 117-119 |

| |XXXXX | | |

| | |Past surgical history: Removal of malignant melanoma, considered completely cured | |

| |XXXXX, M.D. | | |

| | |Impression: History of malignant melanoma, cured | |

| | | | |

| | |*Reviewer’s comments: Only significant details elaborated from above hospitalization records. | |

|*Reviewer’s comments: Interim medical records from 11/04/YYYY-12/04/YYYY are reviewed and noted no significant details hence combined at the end of chronology and not |

|elaborated. |

|12/04/YYYY |XXXXX of Central States|Pathology report: |V - 375 |

| | | | |

| |XXXXX, M.D. |Date of biopsy: 11/30/YYYY | |

| | | | |

| | |Clinical data: Rule out atypical nevus – Chest, left | |

| | | | |

| | |Diagnosis: Junctional melanocytic nevus | |

| | | | |

| | |*Reviewer’s comments: Records corresponding to biopsy of the chest and reason for biopsy are not available for | |

| | |review. | |

|*Reviewer’s comments: Interim medical records from 12/04/YYYY-07/17/YYYY are reviewed and noted no significant details hence combined at the end of chronology and not |

|elaborated. |

|07/17/YYYY-04/30/Y|Multiple Providers |Multiple visits for gout, hypertension, atrial fibrillation, dyslipidemia: |V - 193-198, |

|YYY | | |242-251 |

| | |07/17/YYYY: Medication list: Viagra 100 mg (Sildenafil citrate) | |

| | | | |

| | |04/09/YYYY-04/30/YYYY: Medication list: Cialis 20 mg (Tadalafil) | |

| | | | |

| | |*Reviewer’s comments: Above visits are combined and only significant details pertaining to Viagra case review have| |

| | |been elaborated. | |

|*Reviewer’s comments: Interim medical records from 04/30/YYYY-12/05/YYYY are reviewed and noted no significant details hence combined at the end of chronology and not |

|elaborated. |

|12/05/YYYY |XXXXXX, M.D. |Follow-up visit status post biopsy left chest junctional melanocytic nevus: |V - 507-511 |

| | | | |

| | |Personal history of skin cancer, melanoma, actinic keratosis, sunburn, blistering | |

| | | | |

| | |Problem 1: Seborrheic keratosis on back and right arm: The lesion has been present for several months before | |

| | |09/YYYY. It is described as becoming larger, some itching. Symptoms are not present. | |

| | | | |

| | |09/YYYY: Though present stable with history as above | |

| | |12/YYYY: Patient states has noticed a new spot on the left chest | |

| | | | |

| | |Problem 2: Actinic keratosis of the ears evaluation: The lesion has been present for several months before | |

| | |05/YYYY. It is described as changing- Rough & scaly. Symptoms are pain. | |

| | | | |

| | |11/YYYY: States new lesion on lip, scabs | |

| | |03/YYYY: Doing well some still present | |

| | |06/YYYY: Stable | |

| | |09/YYYY: Has noticed rough areas on ears | |

| | |08/2011: States unaware of any new or changing lesions since last dos. | |

| | |04/YYYY: States has noticed a red spot on the right forearm that itches | |

| | |06/YYYY: States has noticed a few new spots on the face, lesion right forehead is somewhat tender and similar in | |

| | |texture to similar spots | |

| | |12/YYYY: States roughness present on the right cheek – Liquid nitrogen (LN2) to similar lesions. | |

| | | | |

| | |Problem 3: Skin cancer screening exam: There are no other new or changing lesions. No moles have been removed. | |

| | |There is a history of sunburns, some freckle in the sun. The patient is a Fitzpatrick skin type III. Lifetime | |

| | |ultraviolet exposure is significant after reviewing social history with patient. He did have melanoma biopsied and| |

| | |removed within the last two months on the right abdomen. He states Clark level 2 is what he thinks it is depth | |

| | |wise. | |

| | | | |

| | |Physical examination: Waxy tan plaques of back and upper extremities, face. Brown and tan macules of back, chest, | |

| | |abdomen, and extremities with even pigmentation and smooth, distinct borders - Number is more than 50; | |

| | |Erythematous keratotic plaques with scale on face | |

| | | | |

| | |Left lateral thigh 20x 15 mm brown plaque sharp border; Face and nose examined with actinic damage noted | |

| | |External ears: Erythematous keratotic plaques of face, ears | |

| | | | |

| | |Abdomen: Right abdomen with linear scar with no recurrence | |

| | | | |

| | |Assessment: Skin cancer screen | |

| | |Benign nevi of back, chest, abdomen, and extremities: 06/YYYY lesion on left lateral thigh stable in measurement | |

| | |History of melanoma excised on right abdomen: No recurrence | |

| | |Actinic keratosis of head and ears, right cheek, face: LN2 on right cheek | |

| | | | |

| | |Discussion and medical decision making: Need for sunscreen including Titanium dioxide, Zinc oxide and Parsol 1789 | |

| | |daily use recommended. Shave biopsy of lesion on right anterior arm. | |

| | | | |

| | |Prescriptions: Hydrocortisone, Protopic ointment and Nystatin topical ointment | |

| | | | |

| | |*Reviewer’s comments: Further medical records after 12/05/YYYY are not available for review. | |

|07/18/YYYY-04/23/Y|Multiple Providers |Records not relevant to Viagra Case Review: |

|YYY | | |

| | |Blank pages, consent, correspondence, cover pages, labs, medical bills, pathology report, procedure report, telephone conversation, |

| | |rhythm strips, ultrasound, pharmacy dispensing/medication refill, consultation report |

| | | |

| | |Bates ref: V - 514, 520-521, 328-330, 515, 512, 517, 519, 522, 523, 516, 87-88, 111, 513, 518, 524, 449-450, 113, 361, 6, 466, 468, |

| | |470, 471, 47, 48, 257, 49, 259, 335-336, 260, 52, 261, 262, 262, 263, 472, 264, 265, 266, 270, 338-341, 94-95, 473, 258, 475, 342-343,|

| | |98-99, 298, 267, 268, 100-101, 476, 102-104, 105-107, 108-110, 271, 53, 272, 354, 274, 286, 3, 55, 4, 477, 356, 362-363, 364, 278, |

| | |365-366, 279, 479, 480-482, 483-500, 7-8, 9, 120-123, 430, 139, 501-503, 280, 66, 303-304, 67, 281, 68-71, 282, 141, 504, 72-73, 10, |

| | |144-145, 124-125, 114, 11, 146, 505, 149-150, 151-152, 506, 464, 142, 147-148, 154, 74, 75-77, 78, 79, 156, 80, 432, 309, 12, 81-82, |

| | |159, 312-313, 83-86, 389-392, 207-209, 218-220, 283, 457-458, 310, 284-285, 210-212, 165-167, 20-21, 22-24, 14-16, 17-19, 396-401, 32,|

| | |25, 213, 34-37, 236-237, 168-171, 214-216, 172, 305-307, 173, 241, 126-128, 129-130, 131-132, 174-178, 133, 179-184, 221-222, 223-224,|

| | |321-322, 185-192, 217, 134-137, 199-201, 238, 239, 323-324, 202-205, 420-423, 325-327, 253-255, 459-462, 451-456, 448, 440-446, 276 |

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