Case 2:22-cv-05324-KS Document 1 Filed 07/31/22 Page 1 of 17 Page ID #:1
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`LAW OFFICE OF BRIAN NOMI
`Brian Nomi, Esq. (CBN: 203059)
`Local Counsel
`215 E Daily Dr, Ste 28
`Camarillo, CA 93010
`Phone: 805-444-5960
`Fax: 805-357-5333
`Email: briannomi@yahoo.com
`
`AYALA LAW, P.A.
`Eduardo A. Maura, Esq. (FBN: 91303)
`Pro Hac Vice Counsel [pending]
`2490 Coral Way, Ste 401
`Miami, FL 33145
`Phone: 305-570-2208
`Fax: 305-503-7206
`Email: eduardo@ayalalawpa.com
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`Attorneys for Plaintiff Genolab, Inc.
`
`
`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
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`
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`
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`
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`Case No. 22-cv-
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`COMPLAINT
`
`Plaintiff,
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`Genolab, Inc.,
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`
`
`v.
`
`[ermo Fisher Scientific, Inc., and
`[ermo Fisher Financial Services, Inc.
`
`
`
`
`Defendants.
`
`Plaintiff Genolab, Inc., by and through its attorneys, for its Complaint against
`
`Defendants [ermo Fisher Scientific, Inc. and [ermo Fisher Financial Services,
`
`Inc., alleges, on knowledge as to its own actions, and otherwise upon information
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`LAW OFFICE OF BRIAN NOMI
`Brian Nomi, Esq. (CBN: 203059)
`Local Counsel
`215 E Daily Dr, Ste 28
`Camarillo, CA 93010
`Phone: 805-444-5960
`Fax: 805-357-5333
`Email: briannomi@yahoo.com
`
`AYALA LAW, P.A.
`Eduardo A. Maura, Esq. (FBN: 91303)
`Pro Hac Vice Counsel [pending]
`2490 Coral Way, Ste 401
`Miami, FL 33145
`Phone: 305-570-2208
`Fax: 305-503-7206
`Email: eduardo@ayalalawpa.com
`
`Attorneys for Plaintiff Genolab, Inc.
`
`
`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`
`
`
`
`
`
`
`
`
`Case No. 22-cv-
`
`COMPLAINT
`
`Plaintiff,
`
`Genolab, Inc.,
`
`
`
`v.
`
`[ermo Fisher Scientific, Inc., and
`[ermo Fisher Financial Services, Inc.
`
`
`
`
`Defendants.
`
`Plaintiff Genolab, Inc., by and through its attorneys, for its Complaint against
`
`Defendants [ermo Fisher Scientific, Inc. and [ermo Fisher Financial Services,
`
`Inc., alleges, on knowledge as to its own actions, and otherwise upon information
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`Case 2:22-cv-05324-KS Document 1 Filed 07/31/22 Page 2 of 17 Page ID #:2
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`
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`and belief, as follows:
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`PARTIES
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`1.
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`Genolab, Inc. is a corporation that is incorporated in California, with its
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`principal place of business in Los Angeles, CA.
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`2. [ermo Fisher Scientific, Inc. (“[ermo Fisher”) is a corporation that is
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`incorporated in Delaware, with its principal place of business in Waltham, MA.
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`3. [ermo Fisher Financial Services, Inc. (“TFFS”) is a corporation that
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`is incorporated in Delaware, with its principal place of business in Waltham, MA.
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`Upon information and belief, TFFS is owned in its entirety by [ermo Fisher.
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`JURISDICTION AND VENUE
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`4. [is Court has subject matter jurisdiction over this action pursuant to
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`28 U.S.C. § 1332(a)(1), in that this is an action between citizens of different States,
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`and the amount in controversy exceeds $75,000.00, exclusive of interest and costs.
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`5.
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`Venue is proper in this district under 28 U.S.C. § 1391(b)(2), in that a
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`substantial part of the events giving rise to the claims occurred in this district.
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`FACTS
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`6.
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`Genolab is a California-based organization that performs cutting-edge,
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`industry-leading molecular and genetic testing. Genolab is CLIA-certified by the
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`Centers for Medicare and Medicaid Services (CMS).
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`7.
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`Using state-of-the-art technology, Genolab performs different types of
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`Case 2:22-cv-05324-KS Document 1 Filed 07/31/22 Page 3 of 17 Page ID #:3
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`molecular testing for doctors, hospitals, and research institutions.
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`8.
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`Doctors and hospitals routinely use and rely on Genolab’s test results
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`to make diagnoses and formulate patient treatment protocols.
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`9.
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`In December 2020, Genolab was in the market to acquire one or more
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`gene sequencing instruments, which it uses to perform certain steps in its testing.
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`10. Gene sequencing instruments dramatically speed up the identification
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`process of pathogenic genetic variants, primarily because they evaluate large data
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`sets exponentially faster than human scientists.
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`11. For multiple years, [ermo Fisher has manufactured, marketed, sold,
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`and leased—whether directly or through subsidiaries—gene sequencing instruments
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`and software.
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`!e Ion Torrent Genexus Integrated Sequencer (“Genexus Instrument”)
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`12. [ermo Fisher describes the Genexus Instrument as “the first turnkey
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`next-generation sequencing (NGS) solution that automates the specimen-to-report
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`workflow and can deliver results in a single day.”1
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`13.
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`Intrigued at the prospect of streamlining and improving its sequencing
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`operations, Genolab began discussions and negotiations with [ermo Fisher for the
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`lease of a Genexus Instrument.
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`1 https://www.thermofisher.com/order/catalog/product/A45727.
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`Case 2:22-cv-05324-KS Document 1 Filed 07/31/22 Page 4 of 17 Page ID #:4
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`14. [ermo Fisher represented to Genolab that the Genexus Instrument was
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`fully capable of both reliably sequencing data and interpreting the data it produces.
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`15. On December 24, 2020, based on the representations about the quality,
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`characteristics, and performance of the Genexus Instrument, Genolab entered into a
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`lease agreement with TFFS, Lease No. x-6407 (the “Genexus Lease”), under which
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`Genolab agreed to lease a Genexus Instrument for 36 months at a rate of $7,181.10
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`per month. Genolab also made a down payment of $30,000.00.
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`16. As part of the Genexus Lease, Genolab purchased IQ/OQ/IPV2 services
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`for the Genexus Instrument to verify the instrument’s ability to meet manufacturer
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`design specifications for performance.
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`17. On May 3, 2021, the parties signed an addendum to the Genexus Lease,
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`which reduced the monthly rate after the first month to $6,273.49.
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`18. During instrument installation, the IQ/OQ was not completed, and the
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`result was catastrophic. See Image 1, below.
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`Image 1
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`2 IQ = Installation Qualification; OQ = Operational Qualification; IPV = Instrument
`Performance Verification.
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`Case 2:22-cv-05324-KS Document 1 Filed 07/31/22 Page 5 of 17 Page ID #:5
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`19.
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`Image 1 shows the results from the first run of the Genexus Instrument
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`on June 2, 2021.
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`20. [e amount of reads on this run was unacceptable according to [ermo
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`Fisher’s manufacturer instructions and did not pass quality control.
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`21. [e Genexus Instrument also displayed an unknown and unidentified
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`camera and/or sensor issue, where it would request reagents be put in/taken out in a
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`random order—as opposed to systematically—and also would misidentify reagents
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`as used and/or expired when they were not.
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`22. A field service engineer (“FSE”) began troubleshooting, and a control
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`run was completed on June 3, 2021. See Image 2, below.
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`Image 2
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`23. However, once the control run was completed, it was determined that
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`the Genexus Instrument needed parts for the sensor.
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`24. On June 10, 2021, a [ermo Fisher FSE returned to Genolab after the
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`parts were received, and a test run was commenced. [is test run failed, resulting in
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`the Genexus Instrument aborting it. See id.
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`25. A few hours later, another control run was commenced and completed.
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`26. On June 15, 2021, [ermo Fisher emailed Genolab, stating: “We still
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`Case 2:22-cv-05324-KS Document 1 Filed 07/31/22 Page 6 of 17 Page ID #:6
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`don’t know the reason your first run with the cardio panel had so few reads.”
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`27.
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`In its email, [ermo Fisher did identify an issue with the default settings
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`of the Genexus Instrument, stating:
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`Before we ran that first lane, we had intended to change the denature
`temperature from the default 99C to 98C, although we didn’t think this
`would have a large effect on your run because your panel requires so
`few reads, anyway I know you remember we were not able to make that
`change. Today I was finally able to change it successfully, the new
`assay name is Hereditary Cardiac Panel v2, it should be the only option
`for running your custom assay. If you ever need to create a new Assay,
`please let us know so we can ensure it’s also set for 98C denature.
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`28. Additionally, Genolab was told the IQ/OQ was not completed correctly
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`and had to be redone after the test run failure of June 10, 2021.
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`29. Since the problem with the Genexus Instrument was still unidentified,
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`Genolab requested that a [ermo Fisher employee be present during the next run.
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`30. [e next run was done on June 21, 2021. See Image 2. [is control run
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`failed, resulting in the Genexus Instrument aborting it.
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`31. At this point, the Genexus Instrument was still not in working condition
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`and the quality control tests were still not passed.
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`32. On June 22, 2021, another test run was done. [e Genexus Instrument
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`displayed an error, requesting reagents be placed in a nonsequential order. Genolab
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`was instructed to ignore this, and this was the first run successfully completed.
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`33. [e agreement with Defendants was that the Genexus Lease would not
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`commence until the IQ/OQ and training had been completed.
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`Case 2:22-cv-05324-KS Document 1 Filed 07/31/22 Page 7 of 17 Page ID #:7
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`34. Defendants broke this agreement by charging Genolab for two months
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`of the Genexus Lease prior to IQ/OQ completion and successful training.
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`35. Despite being in breach of the agreement, Genolab paid $7,181.10 on
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`May 5, 2021, and $6,723.49 on June 17, 2021.
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`36. Subsequently, the Genexus Instrument continued to display sensor and
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`camera problems but produced three complete runs between June 24 and September
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`2, 2021. See Image 3, below.
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`Image 3
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`37. On September 7, 2021, the Genexus Instrument suffered a catastrophic
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`failure, which included the loading deck being flooded and the pipettor getting stuck
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`in the downward position, and the run was aborted. See id.
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`38. After contacting [ermo Fisher, Genolab was told that it thought “the
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`problem is with the pipettors at this point, but the FSE need to look.”
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`39. [ermo Fisher did not share with Genolab what problems its FSE found
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`in the Genexus Instrument. However, it was evidently deemed irreparable, since the
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`Genexus Instrument’s mainboard was replaced along with other key parts.
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`40. On September 16, 2021, the Genexus Instrument completed a test run
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`successfully. However, the next run resulted in an unacceptably low amount of reads
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`Case 2:22-cv-05324-KS Document 1 Filed 07/31/22 Page 8 of 17 Page ID #:8
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`by [ermo Fisher standards, similar to the first run where the cause was considered
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`undetermined. See Image 4, below.
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`Image 4
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`41. [ereafter, the issue with the sensor and camera remained. Genolab was
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`instructed to force clean the Genexus Instrument and restart it.
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`42. Genolab was also forced to request replacement reagents since all were
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`used in the troubleshooting and by [ermo Fisher staff.
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`43. Genolab did not receive the reagents it requested from [ermo Fisher
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`until October 5, 2021.
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`44. Genolab had to wait for [ermo Fisher in order to run the force clean
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`that it was instructed to perform, pushing the next run to October 21, 2021.
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`45. While the Genexus Instrument did complete three more successful runs,
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`each one displayed the same issues with the sensor and camera. Each time, Genolab
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`was instructed by [ermo Fisher to restart the machine until the problem could be
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`fixed. [e issue remains until today.
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`Case 2:22-cv-05324-KS Document 1 Filed 07/31/22 Page 9 of 17 Page ID #:9
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`46.
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`In attempting to use the Genexus Instrument in its unworkable form,
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`Genolab has wasted several thousand dollars on reagents and support services.
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`47. Moreover, the problems with the Genexus Instrument have decreased
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`Genolab’s workflow capacity, resulting in considerable lost revenue and profits.
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`!e QuantStudio 12K Flex Accufill System (“QS Instrument”)
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`48. [e QS Instrument is described by [ermo Fisher as “a highly flexible,
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`comprehensive real-time PCR platform.”3
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`49. On April 1, 2021, Genolab entered into a lease agreement with TFFS,
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`Lease No. x-6520 (the “QS Lease”), to lease a QS Instrument for 36 months at a rate
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`of $2,980.63 per month, plus a down payment of $55,298.87.
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`50. As part of the QS Lease, Genolab also paid for IQ/OQ services for the
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`QS Instrument.
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`51. Upon delivery, the original QS Instrument was not working, and it was
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`replaced with a new machine.
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`52.
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`In early 2022, Genolab reached out to [ermo Fisher to add more tests
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`to the QS Instrument’s menu, and to perform calibration services on the equipment.
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`53. [ermo Fisher did not reply to Genolab’s request and failed to provide
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`calibration services for the QS Instrument.
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`3 https://www.thermofisher.com/order/catalog/product/4471021.
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`Case 2:22-cv-05324-KS Document 1 Filed 07/31/22 Page 10 of 17 Page ID #:10
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`54. Upon information and belief, [ermo Fisher’s failure to service the QS
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`Instrument was in retaliation for Genolab’s complaints regarding its issues with the
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`Genexus Instrument described above.
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`55. As a result of Defendants’ actions, Genolab has suffered and continues
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`to suffer damages, including but not limited to having to hire the undersigned counsel
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`to investigate and litigate this matter.
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`COUNT I – BREACH OF CONTRACT (GENEXUS LEASE)
`(Against all Defendants)
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`56. Genolab repeats and realleges paragraphs 1 through 47 above, as if fully
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`set forth herein.
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`57. On December 24, 2020, Genolab entered into the Genexus Lease, under
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`which Genolab agreed to lease a Genexus Instrument from [ermo Fisher.
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`58. [e Genexus Lease was signed by TFFS, [ermo Fisher’s alter ego.
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`59. As part of the Genexus Lease, Genolab purchased IQ/OQ/IPV services
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`for the Genexus Instrument.
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`60. Defendants and Genolab agreed that payments for the Genexus Lease
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`would not commence until the IQ/OQ and training had been completed.
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`61. Defendants broke this agreement by charging Genolab for two months
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`of the Genexus Lease prior to IQ/OQ completion and successful training.
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`62. Defendants also breached their obligations under the Genexus Lease by
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`providing a product that was defective and failed to function as intended, advertised,
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`Case 2:22-cv-05324-KS Document 1 Filed 07/31/22 Page 11 of 17 Page ID #:11
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`and represented to Genolab.
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`63. As a result of Defendants’ breach of the Genexus Lease, Genolab has
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`suffered and continues to suffer damages that flow directly from and are the natural
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`and probable consequences of Defendants’ breach or were foreseeable and within
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`the contemplation of the parties before or at the time the contract was made.
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`WHEREFORE, Genolab demands judgment against Defendants for damages,
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`in an amount to be determined at trial, costs, interest, and all other relief the Court
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`deems just and proper.
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`COUNT II – BREACH OF CONTRACT (QS LEASE)
`(Against all Defendants)
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`64. Genolab repeats and realleges paragraphs 1 through 11 and 48 through
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`55 above, as if fully set forth herein.
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`65. On April 1, 2021, Genolab entered into the QS Lease, under which
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`Genolab agreed to lease a QS Instrument from [ermo Fisher.
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`66. [e QS Lease was signed by TFFS, [ermo Fisher’s alter ego.
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`67. As part of the Genexus Lease, Genolab purchased IQ/OQ services for
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`the QS Instrument.
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`68.
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`In early 2022, Genolab reached out to [ermo Fisher to add more tests
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`to the QS Instrument’s menu, and to perform calibration services on the equipment.
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`69. [ermo Fisher did not reply to Genolab’s request and failed to provide
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`calibration services for the QS Instrument, in breach of the QS Lease.
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`Case 2:22-cv-05324-KS Document 1 Filed 07/31/22 Page 12 of 17 Page ID #:12
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`70. As a result of Defendants’ breach of the QS Lease, Genolab has suffered
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`and continues to suffer damages that flow directly from and are the natural and
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`probable consequences of Defendants’ breach or were foreseeable and within the
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`contemplation of the parties before or at the time the contract was made.
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`WHEREFORE, Genolab demands judgment against Defendants for damages,
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`in an amount to be determined at trial, costs, interest, and all other relief the Court
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`deems just and proper.
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`COUNT III – BREACH OF EXPRESS WARRANTY
`(Against <ermo Fisher)
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`71. Genolab repeats and realleges paragraphs 1 through 47 above, as if fully
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`set forth herein.
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`72. At all times material hereto, [ermo Fisher was a manufacturer, seller,
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`and/or supplier of gene sequencing instruments, including the Genexus Instrument.
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`73. To induce Genolab to purchase the Genexus Instrument, [ermo Fisher
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`made representations or promises before, during, and after delivery of the Genexus
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`Instrument regarding its quality and performance. [ese representations constituted
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`express warranties by affirmation, promise, description, or sample.
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`74.
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`In its Terms and Conditions of Sale, [ermo Fisher warranted that its
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`“instruments will be free of defects in materials and workmanship, when subjected
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`to normal, proper, and intended usage by properly trained personnel.”
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`75. [ermo Fisher also warranted that “spare parts you purchase from us
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`Case 2:22-cv-05324-KS Document 1 Filed 07/31/22 Page 13 of 17 Page ID #:13
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`and that we install or are installed by a company we have certified as an authorized
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`installer, will be free of defects in materials and workmanship.”
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`76. At all times material hereto, Genolab used [ermo Fisher’s products in
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`a manner that [ermo Fisher reasonably could have foreseen, and Genolab adhered
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`to the workflow required and explicitly described in the provided written materials,
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`personnel, representatives, and agents.
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`77. Nevertheless, [ermo Fisher violated its express warranties, in that the
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`Genexus Instrument failed to meet its specifications and function as represented in
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`the Terms and Conditions of Sale.
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`78. As a direct and proximate result of [ermo Fisher’s breach of express
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`warranties, Genolab was injured and is entitled to damages.
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`WHEREFORE, Genolab demands judgment against [ermo Fisher for
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`damages, in an amount to be determined at trial, costs, interest, and all other relief
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`the Court deems just and proper.
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`COUNT IV – BREACH OF IMPLIED WARRANTY OF
`MERCHANTABILITY
`(Against <ermo Fisher)
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`79. Genolab repeats and realleges paragraphs 1 through 47 above, as if fully
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`set forth herein.
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`80. [ermo Fisher is a “merchant,” as defined in the California Commercial
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`Code (the “Code”). See Cal. Com. Code § 2104(1).
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`Case 2:22-cv-05324-KS Document 1 Filed 07/31/22 Page 14 of 17 Page ID #:14
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`81. [e Genexus Instrument is a “good,” as defined in the Code. See Cal.
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`Com. Code § 2105(1).
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`82. [ermo Fisher was in privity with Genolab because Genolab was the
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`foreseeable and intended beneficiary of implied warranties relating to the Genexus
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`Instrument.
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`83. [ermo Fisher impliedly warranted that the Genexus Instrument was
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`merchantable. See Cal. Com. Code § 2314.
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`84. Specifically, [ermo Fisher warranted that the Genexus Instrument
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`would pass without objection in the trade; was of fair average quality; was fit for the
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`ordinary purposes for which it was to be used; would run as other machines similar
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`in kind, price, and quality; was adequately contained, packaged, and labeled; and
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`would conform to all affirmations of fact made regarding quality and performance
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`of the Genexus Instrument.
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`85. [e Genexus Instrument, when manufactured and sold by [ermo
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`Fisher, was defective and not merchantable.
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`86. [ermo Fisher breached its implied warranty of merchantability by
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`failing to properly design, manufacture, test, and inspect the Genexus Instrument
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`and by delivering a machine that was unfit for its ordinary use.
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`87. As a direct and proximate result of the breach of said warranty, Genolab
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`was injured and is entitled to damages.
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`Case 2:22-cv-05324-KS Document 1 Filed 07/31/22 Page 15 of 17 Page ID #:15
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`
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`WHEREFORE, Genolab demands judgment against [ermo Fisher for
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`damages, in an amount to be determined at trial, costs, interest, and all other relief
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`the Court deems just and proper.
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`COUNT V – BREACH OF IMPLIED WARRANTY OF FITNESS FOR
`PARTICULAR PURPOSE
`(Against <ermo Fisher)
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`88. Genolab repeats and realleges paragraphs 1 through 47 above, as if fully
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`set forth herein.
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`89. [ermo Fisher is a “merchant,” as defined in the California Commercial
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`Code (the “Code”). See Cal. Com. Code § 2104(1).
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`90. [e Genexus Instrument is a “good,” as defined in the Code. See Cal.
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`Com. Code § 2105(1).
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`91. [ermo Fisher was in privity with Genolab because Genolab was the
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`foreseeable and intended beneficiary of implied warranties relating to the Genexus
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`Instrument.
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`92. At the time Genolab leased the Genexus Instrument, [ermo Fisher
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`knew or should have known that the Genexus Instrument was being leased for a
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`particular purpose, including, but not limited to, use as a DNA sequencing system
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`and it would be necessary to operate it without malfunctioning.
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`93. At the time Genolab leased the Genexus Instrument, [ermo Fisher
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`knew or should have known Genolab was relying on its skill and judgment to select,
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`Case 2:22-cv-05324-KS Document 1 Filed 07/31/22 Page 16 of 17 Page ID #:16
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`furnish and provide a machine that was fit to be used for a particular purpose,
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`including, but not limited to, use as a DNA sequencing system and that it would be
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`necessary to operate the Genexus Instrument without it malfunctioning.
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`94. [ermo Fisher impliedly warranted that the Genexus Instrument was
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`reasonably fit for the intended use of Genolab. See Cal. Com. Code § 2315.
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`95. Genolab relied on the representations, skill, and judgment of [ermo
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`Fisher to furnish a product fit for its intended use.
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`96. At the time Genolab leased the Genexus Instrument, defects existed in
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`the Genexus Instrument that were not discoverable by simple observation at the time
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`of delivery. As a result of the defects, the Genexus Instrument was not fit for its
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`intended purpose.
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`97. [ermo Fisher breached the implied warranty of fitness for a particular
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`purpose by selecting, furnishing, and providing a Genexus Instrument that was not
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`fit for its intended purpose and was otherwise unfit.
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`98. As a direct and proximate result of the breach of said warranty, Genolab
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`was injured and is entitled to damages.
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`WHEREFORE, Genolab demands judgment against [ermo Fisher for
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`damages, in an amount to be determined at trial, costs, interest, and all other relief
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`the Court deems just and proper.
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`Case 2:22-cv-05324-KS Document 1 Filed 07/31/22 Page 17 of 17 Page ID #:17
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`JURY TRIAL DEMANDED
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`Plaintiff demands trial by jury of all issues so triable.
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`Dated: July 25, 2022
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`Respectfully submitted,
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`By: /s/Eduardo A. Maura
`Eduardo A. Maura, Esq.
`Fla. Bar No. 91303
`Ayala Law, P.A.
`2490 Coral Way, Ste 401
`Miami, FL 33145
`Phone: 305-570-2208
`Fax: 305-503-7206
`Email: eduardo@ayalalawpa.com
`Attorney for Plaintiffs
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