SEC Company Response from ANGEION — Aug 12, 2005
ANGEION CORP/MN (CIK 0000815093)
Date: Aug. 12, 2005 · CIK: 0000815093 · Accession: 0001104659-05-039120
AI Filing Summary & Sentiment
Referenced dates: September 2, 2003
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CORRESP
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August 12, 2005
VIA EDGAR
Attn:
Brian Cascio, Accounting Branch Chief
Mail Stop 0306
Division of Corporation Finance
Securities and Exchange Commission
450 Fifth Street, NW
Washington, DC 20549-0306
Re: Angeion
Corporation
Form 10-KSB for the fiscal year ended October 31, 2004
Dear Mr. Cascio:
This
letter will memorialize the June 13, 2005 conversation with Dale H. Johnson,
Angeion Corporation CFO, Kristin Lochhead, SEC Staff, and Andrew D. LaFrence
and Leslie Coolidge of KPMG. The purpose
of the conference call was to provide the Company and its auditors an
opportunity to understand any open issues regarding the SEC’s May 11, 2005
comment letter that would affect Angeion’s financial statements. This follow-up letter responds to the
comments raised by the staff with the response numbered to correspond with the
staff comment contained in its May 11, 2005 comment letter.
Form 10-KSB
for the year ended October 31, 2004
(13)
Discontinued Operations — Page 43
Comment 1
We note your response to comment 9. It remains unclear to us why it is
appropriate to record the contingent gain for amounts recoverable from product
liability insurance for the ELA Medical litigation. Question 5 of SAB Topic 5Y states that “The
staff believes there is a rebuttable presumption that no asset should be
recognized for a claim for recovery from a party that is asserting that it is
not liable to indemnify the registrant.”
Registrants that overcome that presumption should disclose the amount of
recorded recoveries that are being contested and discuss the reasons for
concluding that the amounts are probable of recovery. Tell us why you believe that the recovery is
probable and you can confirm the acquisition of an asset from the insurance
company when the outcome is dependent on a decision by the court or a
compromise among the parties in a settlement agreement. Additionally, tell us whether the entire
balance of assets of discontinued operations relates to the contingent gain at
October 31, 2004 and how you determined a reasonable estimate of the amount to
be recovered.
SEC
Response No. 1
Angeion
Corporation’s May 25, 2005 response letter indicated that the Company would
disclose several developments in the lawsuit in its Form 10-QSB for the quarter
ended April 30, 2005, which was filed on June 14, 2005. In addition, the Company indicated that it
would expand the disclosures in its Form 10-QSB filing for the quarter ended
April 30, 2005 to disclose the amount of recorded recoveries that are being
contested and discuss the reasons for concluding that the amounts are probable
of recovery.
Supplementally, the points
discussed during the June 13, 2005 conference call were to i) clarify that the
Company acknowledges it is responsible for assessing the probability that a
recovery will occur against the insurer, ii) explain the reasons for the
differing dates associated with ICDs remaining implanted in patients, and iii)
confirm that the cost of future explantations was not included in the current
accrual.
The Company agreed to revise
its disclosure as to how management determined the probability of
recovery. We agreed to make it clear
that the Company decided on the merits of its analysis that it is probable that
a recovery will occur against the insurer.
The Company’s outside counsel also came to the same conclusion as a
result of its independent analysis.
In the Company’s draft of
Note 9, the number of ICDs remaining implanted in patients was disclosed as of
different dates for domestic and international patients. The timing difference emanates from the fact
that the patients are controlled by different regulatory bodies, the Food and
Drug Administration in the United States and other regulatory bodies in
countries outside of the United States.
We explained that the information disclosed was the most recent
information available.
The
staff inquired as to whether the cost of future explantations was included in
the Company’s current liabilities of discontinued operations. We explained that future explantations cannot
be predicted and are not considered probable. As a result, the cost of future explantations
was not included in the Company’s current liabilities of discontinued
operations. The Company modified its
language in Note 9 to clarify those facts.
The following paragraphs
represent Note 9, “Discontinued Operations and Litigation,” in Notes to
Consolidated Financial Statements in the Form 10-QSB for the quarter ended
April 30, 2005, which was filed on June 14, 2005. We believe that we have addressed all the SEC
comments from the May 11, 2005 letter and the June 13, 2005 conference call in
this footnote which follows:
9. Discontinued Operations and
Litigation
During
the period from October 1990 through March 2000, the Company was
engaged in the development, design, manufacture and sale of implantable
cardioverter defibrillator (“ICD”) systems.
ICDs are electronic devices that are implanted within the body and are
connected to the heart with defibrillator leads. They are designed to treat abnormally rapid heartbeats
or tachycardia in the ventricular (or lower) chambers of the
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heart by monitoring the
patient’s heartbeat and, in the event of tachycardia, delivering an electrical
shock to return the heartbeat to normal rhythm.
During
March 2000, the Company announced its decision to discontinue the development,
manufacture and distribution of ICDs.
Accordingly, the Company accounts for the ICD business as a discontinued
operation and amounts in the financial statements and related notes for all
periods shown reflect discontinued operations accounting.
In
June 2002, ELA Medical, a former partner of Angeion in a joint venture that
manufactured and distributed ICDs, advised Angeion that some of the ICDs
formerly manufactured by Angeion were experiencing premature battery depletion
and that 14 had been explanted. In
accordance with FDA procedures, Angeion instituted a field corrective action
and recall on certain of the ICDs.
In
June 2003, ELA Medical sought reimbursement from Angeion for the cost of
explanting and replacing the ICDs.
Angeion advised its insurance carrier of the ELA Medical claim and
sought coverage of the claim.
On September 13, 2004, the basic insurer, Medmarc
Casualty Insurance Company, advised Angeion that Medmarc was denying insurance
coverage to Angeion for the claim by ELA Medical. In addition, on September 13, 2004, Medmarc
commenced a declaratory judgment action against Angeion and ELA Medical in United
States District Court for the District of Minnesota seeking a declaratory
judgment that Medmarc’s interpretation of the policy is correct. In the lawsuit, ELA Medical filed a
cross-claim against Angeion for the costs and expenses it incurred in
connection with the recall in the equivalent amount of $1,665,068.
Angeion
has denied liability to ELA Medical and has counterclaimed against Medmarc and
is seeking a declaratory judgment that Medmarc is liable (i) to Angeion for any
amount that it is required to pay to ELA Medical, and (ii) for any fees and
expenses that Angeion has incurred in connection with defense of the
cross-claim by ELA Medical and the declaratory action by Medmarc. Angeion vigorously intends to pursue its
available defenses against ELA Medical and it asserts that Medmarc is required
to provide Angeion insurance coverage with respect to these matters.
The
lawsuit is currently in the discovery stage.
A summary judgment argument motion has been scheduled for June 24, 2005
on cross motions by the Company and Medmarc over whether or not Medmarc has a “duty
to defend” the Company in the claim brought by ELA Medical. The Company expects a decision within 90 days
after the oral argument. The Company
expects that any trial in this matter will not occur until the spring of 2006.
The Company believes that although it may have some liability to ELA
Medical, for several reasons, it is not liable to ELA Medical for the entire
amount alleged. ELA Medical has provided detailed information
in support of the claimed amount associated with explantations that have taken
place through March 31, 2004. The
Company has received sufficient information to reasonably estimate a range of
expected loss based on the fact that (i) ELA Medical may not be able
to substantiate the entire amount of the claim, (ii) a portion of the claimed
amount is for explantations that appear to have been outside of the guidelines
provided by the Company and approved by the FDA, (iii) the
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amounts
for the explantations vary widely and some of the claimed amounts may not
ultimately be determined as reasonable, and (iv) some ICDs remain implanted in
patients. As a result of these factors,
the Company determined a range of possible losses associated with the claim and
recorded the minimum amount of the range.
The current liability of discontinued operations is $989,000 at April
30, 2005. This amount includes the
minimum amount of the claim as discussed above together with other related
expenses, including legal fees.
The Company evaluated its claim for potential
recovery from product liability insurance separately from its evaluation of the
liability for possible losses associated with the claim. As a result of that evaluation, the Company
has recorded a receivable for an estimated amount recoverable from product
liability insurance, including insurance coverage for recalls that the Company
carried for the ICD products.
The
Company considered a number of relevant facts in determining that it had a
valid claim for an insurance recovery and that realization of that claim for
recovery was probable. The following
facts were analyzed and considered in this evaluation of the claim for
recovery:
1. In a letter
dated September 2, 2003, Medmarc Insurance Company initially advised Angeion
that there was coverage, at least in part, and ultimately established a reserve
for that coverage.
2. The Company
received written claims loss reports from Medmarc stating that the insurer had
established a total reserve of $425,000 as of September 30, 2003 and that
Medmarc had increased the reserve to $1,025,000 as of March 31, 2004.
3. When the
insurance policy was originally purchased and in response to Angeion’s specific
request for product recall expense coverage, Medmarc amended its standard
insurance policy by adding unique endorsements that were drafted by Medmarc to
provide “Coverage for Product Recall-Related Medical Expenses.” This was done primarily through two
endorsements that together greatly expanded the ordinary definition of “bodily
injury” to include, among other things, “the cost of reasonable and necessary medical expenses attributable to the withdrawal of the ICDs,
including any physical examinations and surgical expenses.”
4. Most of Medmarc’s
arguments simply ignore the recall-related expense coverage endorsements that
were drafted by Medmarc.
As
stated above, in September 2004, over one year after being served notice with
the claim, Medmarc advised the Company that it was denying coverage and
commenced a court action against the Company seeking a declaratory judgment
that Medmarc’s interpretation of the policy was correct. Subsequent to this action, the Company worked
closely with outside legal counsel to determine the probability and estimated
amount of recoverability of insurance from Medmarc now that the recovery was
subject to litigation. This included
consultation with attorneys that practice in the areas of insurance contractual
matters and related litigation. Based on
these consultations and the analysis described above, the Company and its
outside counsel continue to believe that it is probable that a recovery will
occur against the insurer.
The
Company determined the amount to recognize as recoverable by analyzing the
range of probable recoveries that included (i) the claim, (ii) the self-insured
retention obligation under the policy and (iii) legal fees. The Company considered each element
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separately and based on the
information provided by outside counsel, determined and recorded the minimum
amount of the range for each element. As
of April 30, 2005, the entire $700,000 balance of current assets of
discontinued operations represents elements related to the claim for recovery
from product liability insurance.
During
the second quarter of 2005, the Company determined that there were no changes
in facts or circumstances that would require adjustment of the current assets
of discontinued operations or current liabilities of discontinued operations as
of April 30, 2005.
The
ultimate amount of both the liability due to ELA Medical and the amount
recoverable from insurance carriers are subject to future development and
additional information. The amounts
currently estimated for the claim and associated expenses as well as the
probable insurance recovery are based on data provided by ELA Medical for
explantations that occurred through March 31, 2004 and other information
related to the cause of the battery depletion.
As of March 29, 2005, 35 of the original 122 ICDs remained implanted in
patients in the United States. As of
August 31, 2004, the most recent date for which data is available, 110 of the
original 261 ICDs remained implanted in patients outside of the United States. Since some devices remain implanted in
patients, the Company is not able to estimate the ultimate amount of the claim
and has not included the cost of future explantations in its liability for
possible losses associated with the claim.
While it is not possible to predict the ultimate amount of the claim or
the associated expenses, the Company believes that if the amount of the claim
increases, the amount recoverable from the insurance company would also
increase. In addition, the Company’s
liability insurance coverage for claims associated with its ICD products
expires on July 11, 2005.
The Company may incur additional expenses, which
could be substantial, in connection with any purchase of insurance coverage
beyond July 11, 2005.
If
the Company does not prevail in its case against Medmarc Insurance Company, it
would immediately seek to negotiate a settlement with ELA Medical. The Company believes that it could negotiate
a settlement and structure a payment schedule acceptable to both parties. Moreover, the Company also believes that additional
insurance coverage beyond July 11, 2005 can be purchased and financed with
existing cash.
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The Company hereby acknowledges
that:
• it is responsible for the adequacy and
accuracy of the disclosure in the Company’s filings;
• staff comments or changes to disclosure
in response to staff comments in the filings reviewed by the staff do not
foreclose the Commission from taking any action with respect to the filing; and
• the Company may not assert staff comments
as a defense in any proceeding initiated by the Commission or any person under
the federal securities laws of the United States.
Please contact the undersigned at (651) 766-3492 if you have any
questions or need additional information.
Very
truly yours,
Angeion
Corporation
/s/
Dale H. Johnson
Dale
H. Johnson
cc:
Thomas G. Lovett, IV, Lindquist & Vennum
John C. Penn, Audit Committee Chair
Andrew LaFrence and Leslie Coolidge, KPMG LLP
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