Cytosol Laboratories, Inc. v. Federal Insurance

536 F. Supp. 2d 80, 2008 U.S. Dist. LEXIS 17023
CourtDistrict Court, D. Massachusetts
DecidedMarch 6, 2008
DocketCivil Action 06-12129-JLT
StatusPublished
Cited by3 cases

This text of 536 F. Supp. 2d 80 (Cytosol Laboratories, Inc. v. Federal Insurance) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Cytosol Laboratories, Inc. v. Federal Insurance, 536 F. Supp. 2d 80, 2008 U.S. Dist. LEXIS 17023 (D. Mass. 2008).

Opinion

MEMORANDUM

JOSEPH L. TAURO, District Judge.

Plaintiff Cytosol Laboratories, Inc. (“Cy-tosol”) seeks a declaratory judgment that certain claims made against it by Advance Medical Optics, Inc. (“AMO”), are covered under insurance policies issued by Defendant Federal Insurance Company (“Federal”). In turn, Federal seeks a declaratory judgment that the policies provide no coverage, and that Federal has no duty to indemnify or defend in this matter. Cyto-sol also seeks recovery under Massachusetts General Laws chapter 93A, alleging that Federal’s denial of coverage constituted an unfair or deceptive trade act. Presently at issue are the Parties’ cross-motions for summary judgment. 1 For the following reasons, Federal’s motion is ALLOWED except as to costs and attorneys fees, and Cytosol’s motion is DENIED.

Factual Background 2

A. Relevant Entities

Cytosol Laboratories is a life sciences pharmaceutical manufacturer registered in Massachusetts, with a principal place of business in Braintree, Massachusetts. 3 Cytosol Opthalmics, Inc. (“Cytosol Op-thalmics”) is a North Carolina corporation that sells medical products for use during opthalmic surgery, with a principal place *83 of business in Lenoir, North Carolina. 4 Advanced Medical Optics, Inc. (“AMO”) is a California corporation that sells and distributes ophthalmic products to the medical community, with a principal place of business in Santa Ana, California. 5

B. Cytosol’s Insurance Coverage

For purposes of summary judgment, during the relevant time period, Cytosol was covered under three main insurance policies from Federal. 6 Under the Custo-marq Series Life Sciences Insurance Program, Cytosol had coverage under two policies: (1) a claims-made Products/Completed Operations Liability Policy (“Products Policy”); 7 and (2) a General Liability Policy. 8 Cytosol also had a(3) Forefront Portfolio Directors & Officers Liability Policy (“D & 0 Policy”), which had a “Corporate Liability Coverage Section” with an aggregate cap of $1,000,000. 9 Lastly, as a supplement to the Products Policy and General Liability Policy, Cytosol purchased additional Products Withdrawal and Crisis Management Insurance. 10

C. Endosol

In June of 2004, AMO contracted with Cytosol Opthalmics to manufacture and supply AMO with Endosol Balanced Salt Solution, 11 a solution used to irrigate patients’ eyes, nose, and throat during a variety of procedures including cataract surgery. 12 Cytosol Opthalmics outsourced the manufacture of Endosol to Cytosol Laboratories. 13 Cytosol Laboratories manufactured, bottled, sealed and packaged the Endosol product in boxes with AMO’s label, and then shipped it to AMO. 14 AMO then sold the product as “AMO Endo-sol.” 15

On November 10, 2005, AMO issued a “Medical Device Safety Alert” (“Alert”) regarding “AMO Endosol Products” to all of its customers. 16 The Alert indicated:

AMO has received reports that some physicians using the AMO Endosol products have observed a Toxic Anterior Segment Syndrome (TASS) response in their patients following surgery. TASS results when a contaminant (noninfectious toxic agent) enters the anterior segment during surgery and causes an inflammatory reaction. 17

The Alert further stated, “[W]e believe it is in the best interest of physicians and patients to STOP THE USE OF ALL AMO ENDOSOL LOTS MANUFAC- *84 TUBED BY CYTOSOL LABORATORIES, INC. until further notice.” 18

On November 18, 2005, in an “Urgent Medical Device Recall,” AMO recalled all Endosol manufactured by Cytosol based on the same TASS and inflammation issue. 19

On December 18, 2005, Mark Broadley (“Broadley”), Cytosol’s Vice President and General Manager, wrote the Chubb Group of Insurance Companies (“Chubb”), Federal’s parent company, alerting Chubb of the recall. 20

Several days after Cytosol sent the letter, Jill Boon (“Boon”), a Senior Litigation Examiner for Federal, followed up with a phone call to Broadley (Cytosol). 21 Boon requested that Broadley “keep her posted” of any developments. 22

On February 10, 2006, the United States Food & Drug Administration (“FDA”) issued a “FDA Requested Recall” notice to Cytosol. 23 In part, the letter stated:

This letter is to request that you immediately initiate a recall of Balanced Salt Solution (BSS), in all size containers and labels, manufactured by your firm in Braintree, MA, including initiating a request to your distributors to conduct sub-recalls to the user level of physician and hospitals. A November-December 2005 FDA inspection revealed that the manufacturing and testing controls for your BSS products are inadequate to prevent elevated endotoxin levels. The presence of endotoxins in elevated levels in these products can represent a serious hazard to health. 24

On February 14, 2006, Cytosol initiated a voluntary recall for all lot numbers of the Balanced Salt Solution manufactured in its Braintree facility. 25

On February 15, 2006, Broadley (Cyto-sol) sent Chubb written notice of its voluntary recall, stating, “We are providing this notification pursuant to the terms of the above referenced [Chubb liability] policy for any potential claims that may arise from the recall.” 26

On April 26, 2006, Janet Richardson, Corporate Counsel for AMO, wrote a letter to John Serio of the law firm Brown Rudnick, counsel for Cytosol Opthalmics and Cytosol Laboratories. 27 In the letter, AMO stated that “[t]here can be no doubt that the Product supplied by Cytosol failed to conform to the warranties set forth in Agreement Section 7.

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Bluebook (online)
536 F. Supp. 2d 80, 2008 U.S. Dist. LEXIS 17023, Counsel Stack Legal Research, https://law.counselstack.com/opinion/cytosol-laboratories-inc-v-federal-insurance-mad-2008.