Citation Nr: 0617465	
Decision Date: 06/15/06    Archive Date: 06/27/06

DOCKET NO.  04-26 023	)	DATE
	)
	)

On appeal from the
Department of Veterans Affairs (VA) Regional Office (RO) 
in New York, New York



THE ISSUES

1.  Entitlement to compensation under the provisions of 
38 U.S.C.A. § 1151 for skin cancer based on medications 
prescribed by treating VA physicians.  

2.  Entitlement to compensation under the provisions of 
38 U.S.C.A. § 1151 for muscle damage diagnosed as myopathy 
based on medications prescribed by treating VA physicians.   



REPRESENTATION

Appellant represented by:	New York State Division of 
Veterans' Affairs




ATTORNEY FOR THE BOARD

Thomas H. O'Shay, Counsel



INTRODUCTION

The veteran had active military service from October 1959 to 
October 1963.  

This matter comes before the Board of Veterans' Appeals 
(Board) on appeal of a February 2003 rating decision by the 
RO.  

The issue of compensation under the provisions of 38 U.S.C.A. 
§ 1151 for muscle damage diagnosed as myopathy based on 
medications prescribed by treating VA physicians is addressed 
in the REMAND portion of this document and is being remanded 
to the RO via the Appeals Management Center (AMC), in 
Washington, DC.  



FINDINGS OF FACT

1.  The veteran underwent a heart transplant at a private 
facility in 1991, following which he required permanent 
immunosuppressive therapy which included the use of 
cyclosporine.  

2.  The treating VA physicians have prescribed his 
cyclosporine for the veteran since at least 1998.  

3.  The veteran developed recurring skin cancers beginning in 
1999, secondary to the use of cyclosporine prescribed by VA 
physicians.  

4.  The recurring skin cancers caused by the use of 
cyclosporine prescribed by VA physicians was an event not 
reasonably foreseeable.  



CONCLUSION OF LAW

The criteria for the grant of compensation under the 
provisions of 38 U.S.C.A. § 1151 for skin cancer have been 
met.  38 U.S.C.A. §§ 1151, 5107 (West 2002); 38 C.F.R. §§ 
3.102, 3.361 (2005).  



REASONS AND BASES FOR FINDINGS AND CONCLUSION

The Veterans Claims Assistance Act of 2000 redefined VA's 
duty to assist a claimant in the development of a claim.  
However, given the favorable action taken hereinbelow, 
further discussion explaining how VA complied with this Act 
is unnecessary.  


Factual background

The veteran contends that medication prescribed by VA led to 
the development of his recurring skin cancers.  

VA treatment records for 1997 to November 2004 note that the 
veteran underwent a heart transplant in July 1991 at a 
private facility, and show that his permanent course of 
treatment included immunosuppressive therapy with 
cyclosporine.  The records show that he received 
prescriptions of cyclosporine through VA at least since 1998.  

In 1999, he was evaluated for chest lesions shown on biopsy 
to represent squamous cell carcinoma.  Subsequent treatment 
records document recurring cancerous skin lesions affecting 
primarily the upper extremities, trunk, face, and head.  
Biopsies of the lesions variously revealed squamous cell 
carcinoma, basal cell carcinoma and Bowen's disease.  His 
treating physicians presumed the lesions were related to the 
immunosuppressive therapy.

The veteran attended a VA examination in January 2003.  The 
examiner noted that the veteran had multiple basal cell and 
squamous cell carcinomas of the skin through a large area of 
the body, including the face, upper extremities, trunk, and 
thighs.  

The examiner concluded that the cyclosporine used by the 
veteran was more than likely responsible for the "totally 
unprecedented" amount of skin cancers.  

The veteran attended a second VA examination in December 
2003.  The examiner noted scars and active lesions of a 
keratotic nature scattered over the veteran's body.  

The examiner concluded that the veteran had multiple skin 
cancers as likely as not caused or exacerbated by the 
immunosuppressive drugs, and cyclosporine in particular.  

In a May 2004 addendum, the December 2003 physician noted 
that the association of the immunosuppressive medications 
with skin cancer was in the range of possibility, given the 
expected alteration of the immune defenses, but that he could 
not state definitely that such an association was present in 
the veteran's case.  He clarified that many of the veteran's 
skin lesions were not malignant, but rather were benign 
keratoses with the potential to transform into malignancies.  

In response to the RO's request for an opinion as to whether 
the skin cancers were a "reasonably foreseen/necessary 
consequence" of the medications, the December 2003 examiner 
essentially indicated that if the immunosuppressive 
medications did cause the skin cancer, then that consequence 
was properly described as unexpected.  He explained that he 
found no evidence of fault on VA's part with respect to the 
development of the skin cancers.  


Analysis

Title 38, United States Code § 1151 provides that, where a 
veteran suffers an injury or an aggravation of an injury 
resulting in additional disability by reason of VA  
hospitalization, or medical or surgical treatment, and the 
proximate cause of the additional disability was 
carelessness, negligence, lack of proper skill, error in  
judgment, or similar instance of fault on VA's part in  
furnishing the medical or surgical treatment, or the 
proximate cause of additional disability was an event which 
was not reasonably foreseeable, compensation shall be awarded 
in the same manner as if such disability were service 
connected.  

The requirement to show that the proximate cause of the 
additional disability was fault on VA's part or an event 
which was not reasonably foreseeable was added by amendments  
to 38 U.S.C.A. § 1151 made by Public Law 104-204 and applies 
to claims for compensation under 38 U.S.C.A. § 1151 which, as 
in this case, were filed on or after October 1, 1997.  
VAOPGCPREC 40-97.  

Effective on September 2, 2004, VA promulgated a final 
regulation establishing the criteria for adjudicating claims 
under the provisions of 38 U.S.C.A. § 1151 filed on or after 
October 1, 1997.  See 69 Fed. Reg. 46426, 46433-34 (codified 
at 38 C.F.R. § 3.361) (2004).  

The Board finds that compensation for skin cancer under the 
provisions of 38 U.S.C.A. § 1151 is warranted in this case.  

The records show that the veteran has received cyclosporine 
and other immunosuppressive medications through VA for a 
number of years.  His treating physicians operate under the 
assumption that his immunosuppressive medications, and 
cyclosporine in particular, caused the documented skin 
cancers to develop.  

The January 2003 VA examiner concluded that the cyclosporine 
used by the veteran caused the skin cancers.  The December 
2003 examiner concluded that the immunosuppressive 
medications, especially cyclosporine, as likely as not caused 
or exacerbated the skin cancers.  

Based on the above, the Board finds that the evidence as a 
whole shows that the veteran's recurring skin cancers were 
caused by his use of immunosuppressive medications, 
especially cyclosporine.  

The December 2003 examiner determined that there was no 
evidence suggesting fault on VA's part in the development of 
skin cancer in this case.  

He did, however, describe the development of skin cancer from 
the immunosuppressive medications as an unexpected 
consequence.  

The January 2003 examiner described the amount of skin 
cancers developed by the veteran in connection with 
cyclosporine use as "totally unprecedented."  

The Board finds that the opinions of the January 2003 and 
December 2003 examiners together can reasonably be read to 
conclude that the skin cancers resulting from the use of 
cyclosporine in this case were not a reasonably foreseeable 
consequence of VA's prescribing the drug to the veteran in 
connection with his treatment.  
 
Therefore, as the evidence is in relative equipoise in this 
case in showing that the veteran's skin cancer as likely as 
not was an event flowing from the use of immunosuppressive 
medication prescribed by VA which was not reasonably 
foreseeable.  

By extending the benefit of the doubt to the veteran, 
disability compensation is payable.  





ORDER

Compensation benefits under the provisions of 38 U.S.C.A. 
§ 1151 for skin cancer based on medications prescribed by 
treating VA physicians is granted.  



REMAND

The veteran contends that medication prescribed by VA led to 
the development or aggravation of his myopathy.  

The private medical records show that in 1977, he developed 
severe and diffuse muscle pains.  A muscle biopsy confirmed 
myositis, and he was diagnosed with polymyositis.  He was 
prescribed prednisone, which effectively controlled the 
polymyositis.  

As noted in the previous section, the veteran underwent a 
heart transplant in July 1991, following which he has 
continuously received immunosuppressive therapy, including 
the use of cyclosporine.  He has received prescriptions of 
cyclosporine and prednisone through his VA physicians for a 
number of years.  

VA medical records on file show that in June 1999, he was 
prescribed pravastatin (pravachol).  

The VA medical records show that around early 2000, the 
veteran reported experiencing progressive muscle weakness.  
His medications at the time included pravastatin, 
cyclosporine, and prednisone.  After evaluation, the veteran 
was determined to have myopathy.  

The records show that the prednisone and pravastatin were 
initially considered the precipitants of the myopathy.  Both 
medications were discontinued, and the veteran did experience 
some return of strength with the cessation of pravastatin in 
particular.  He nevertheless continued to experience 
significant myopathy.  His treating physicians at one point 
considered the possibility that the prior polymyositis might 
have played a role in the current myopathy.  

More recently, his treating physicians have concluded that 
the myopathy was medication-induced.  Specifically, they 
believe the myopathy was induced by pravastatin with 
potentiation of the toxicity by cyclosporine.  

The veteran attended a VA examination in January 2003.  The 
examiner concluded that the muscle weakness was secondary to 
myopathy, but that it was unlikely that the myopathy was 
caused by pravachol.  He did state that it was at least as 
likely as not that the myopathy resulted from the use of 
cyclosporine.  

The veteran was again examined by VA in December 2003.  The 
examiner noted that treatment with immunosuppressive 
medications can result in hypercholesterolemia, and that the 
veteran was therefore placed on simvastatin, a drug known to 
produce myalgia and myopathy.  

The examiner noted that prednisone and cyclosporine could 
also contribute to the development of such disorders.  

The examiner noted that the myopathy appeared to be a 
consequence of the veteran's use of simvastatin and 
cyclosporine, and possibly prednisone as well.  He concluded 
that the medications prescribed to the veteran were 
appropriate, and that there was no evidence suggesting 
carelessness, negligence, lack of judgment, or deficits in 
skill or training.  

The examiner also concluded that the development of myopathy 
and neuropathy from the medications was well-described in the 
literature and foreseeable.

In a May 2004 addendum, the physician explained that the 
complication of myopathy from the medications at issue was a 
known side effect, and was not unexpected.  

He explained that what was unexpected was the failure of the 
myopathy to resolve once one of the major culprits for the 
side effect (simvastatin), was removed.  He concluded, 
however, that VA was not at fault in the occurrence of that 
event.  

The Board points out that, effective on September 2, 2004, VA 
promulgated a final regulation establishing the criteria for 
adjudicating claims under the provisions of 38 U.S.C.A. 
§ 1151 filed on or after October 1, 1997.  See 69 Fed. Reg. 
46426, 46433-34 (codified at 38 C.F.R. § 3.361) (2004).  

The RO never informed the veteran of the referenced 
regulation, nor adjudicated his claim under that regulation.  
Instead, the RO provided him with the text of 38 C.F.R. 
§ 3.358, pertaining to claims based on 38 U.S.C.A. § 1151 
filed prior to October 1, 1997.  

The Board also notes that the December 2003 examiner based 
his opinion on the understanding that the veteran was 
prescribed simvastatin.  In point of fact, the drug at issue 
is pravastatin, and not simvastatin.  Under the 
circumstances, the Board is of the opinion that further VA 
examination of the veteran is warranted.  

In addition, the Board points out that an April 1999 entry in 
the VA treatment records suggests the veteran was in receipt 
of disability benefits from the Social Security 
Administration (SSA).  Records from that agency have not been 
obtained.  

The Board lastly notes that the veteran, in August 2002, 
informed VA that his muscle biopsy at VA was taken to 
Cleveland for a symposium, and that the participants to this 
symposium concluded that "Provostat ate [his] muscles."  

A June 2004 entry by the Albany VA Medical Center's Chief of 
Neurology Services indicates that the veteran recently called 
him to learn what the muscle biopsy showed.  The physician 
noted that he explained that the biopsy was shown to a group 
of muscle pathologists, who agreed that the biopsy 
demonstrated myopathy.  

Although the above June 2004 entry appears to relate to the 
"symposium" referenced by the veteran, his representative 
has strenuously asserted that VA has failed to assist the 
veteran in obtaining any records associated with the 
"symposium."  

Accordingly, the case is REMANDED to the RO for the following 
actions:

1.  The RO should provide the veteran and 
his representative with a corrective VCAA 
notice under 38 U.S.C.A. § 5103(a) and 38 
C.F.R. § 3.159(b), that includes an 
explanation as to the information or 
evidence needed to establish a disability 
rating and an effective date for muscle 
damage diagnosed as myopathy, as outlined 
by the Court in Dingess/Hartman v. 
Nicholson, 19 Vet. App. 473 (2006).

2.  The RO should take appropriate steps 
to contact the veteran and request that 
he identify the names, addresses and 
approximate dates of treatment for all 
health care providers, VA and private, to 
specifically include the "symposium" 
referred to in his August 2002 statement, 
who may possess additional records 
pertinent to the remaining claim on 
appeal.  With any necessary authorization 
from the veteran, the RO should attempt 
to obtain and associate with the claims 
file any medical records identified by 
the veteran, to include from the above 
"symposium," which have not been 
secured previously.  

3.  After completion of the foregoing, 
the RO should schedule the veteran for a 
VA examination by a physician with 
appropriate expertise.  All indicated 
studies should be performed, and all 
findings should be reported in detail.

The physician must render an opinion as 
to whether it is at least as likely as 
not that the veteran's myopathy was 
caused by carelessness, negligence, lack 
of proper skill, error in judgment or 
similar instance of fault on the part of 
VA in prescribing cyclosporine, 
pravastatin, and/or prednisone to the 
veteran, or that the myopathy was due to 
a not reasonably foreseeable event.

A complete rationale must be provided for 
all opinions expressed.  The claims 
folder, including a copy of this remand, 
must be made available to and reviewed by 
the examiner.  The examination report is 
to reflect whether such a review of the 
claims file was made.  

4.  Thereafter, the RO must review the 
claims folder and ensure that the 
foregoing development actions, as well as 
any other development that may be in 
order, has been conducted and completed 
in full.  The RO should review the 
examination report to ensure that it is 
in complete compliance with the 
directives of this REMAND.  If the report 
is deficient in any manner, the RO must 
implement corrective procedures at once.   

5.  The RO must then readjudicate the 
issue remaining on appeal.  If any 
benefit sought on appeal is not granted 
to the veteran's satisfaction, the RO 
must issue the veteran and his 
representative a Supplemental Statement 
of the Case (SSOC), which should include 
citation to the newly added 38 C.F.R. 
§ 3.361.  See 69 Fed. Reg. 46426, 46433-
34 (2004).  The veteran should be given 
an opportunity to respond to the 
supplemental statement of the case as set 
forth in 38 U.S.C.A. § 5103(b) (West 
2002).  

Thereafter, if indicated, the case should be returned to the 
Board for the purpose of appellate disposition.  

By this remand, the Board intimates no opinion as to any 
final outcome warranted.  No action is required of the 
veteran until he is notified by the RO.  

The veteran has the right to submit additional evidence and 
argument on the matter the Board has remanded to the RO.  
Kutscherousky v. West, 12 Vet. App. 369 (1999).  

This case must be afforded expeditious treatment.  The law 
requires that all claims that are remanded by the Board of 
Veterans' Appeals or by the United States Court of Appeals 
for Veterans Claims for additional development or other 
appropriate action must be handled in an expeditious manner.  
See 38 U.S.C.A. §§ 5109B, 7112 (West Supp. 2005).  



______________________________________________
STEPHEN L. WILKINS
Veterans Law Judge, 
Board of Veterans' Appeals


 Department of Veterans Affairs