Case 1:17-cv-00598-BKS-CFH Document 189 Filed 05/05/21 Page 1 of 105
`
`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF NEW YORK
`
`
`ANGIODYNAMICS, INC.,
`
`
`
`
`
`1:17-cv-00598 (BKS/CFH)
`
`Plaintiff,
`
`Defendants.
`
`
`v.
`
`C.R. BARD, INC. and BARD ACCESS SYSTEMS, INC.,
`
`
`
`
`Appearances:
`
`For Plaintiff:
`Philip J. Iovieno
`Nicholas A. Gravante, Jr.
`Mark A. Singer
`Cadwalader, Wickersham & Taft LLP
`200 Liberty Street
`New York, NY 10281
`
`Adam R. Shaw
`Anne M. Nardacci
`Boies Schiller Flexner LLP
`30 South Pearl Street, 11th Floor
`Albany, NY 12207
`
`For Defendants:
`Andrew J. Frackman
`Edward N. Moss
`O’Melveny & Myers LLP
`7 Times Square
`New York, NY 10036
`James P. Nonkes
`Philip G. Spellane
`Harris Beach PLLC
`99 Garnsey Road
`Pittsford, NY 14534
`
`

`

`Case 1:17-cv-00598-BKS-CFH Document 189 Filed 05/05/21 Page 2 of 105
`
`Hon. Brenda K. Sannes, United States District Judge:
`
`MEMORANDUM-DECISION AND ORDER
`
`I.
`
`INTRODUCTION
`
`Plaintiff AngioDynamics, Inc. (“AngioDynamics”) brings this antitrust action against
`
`Defendants C.R. Bard, Inc. and Bard Access Systems, Inc. (collectively, “Bard”), asserting a
`
`claim of illegal tying in violation of section 1 of the Sherman Act (codified at 15 U.S.C. § 1)
`
`under “per se” and “rule of reason” theories of liability. (Dkt. No. 1). AngioDynamics seeks
`
`treble damages, a permanent injunction, and declaratory relief. (Id. at 29). Presently before the
`
`Court are: (1) AngioDynamics’ motion for partial summary judgment on liability and antitrust
`
`injury, (Dkt. No. 134); (2) Bard’s motion for summary judgment seeking dismissal of the
`
`complaint, (Dkt. No. 133); and (3) Bard’s motion in limine to preclude the trial testimony of
`
`AngioDynamics’ causation and damages expert, Dr. Alan Frankel, (Dkt. No. 132). The Court
`
`heard oral argument on the motions on April 6, 2021. For the reasons below, both parties’
`
`motions for summary judgment are denied, and Bard’s motion in limine is granted.
`
`II.
`
`FACTS1
`
`This case centers on AngioDynamics’ claim that Bard’s policy of only selling the
`
`proprietary stylet for its Tip Location System (“TLS”) preloaded into its own peripherally
`
`inserted central catheters (“PICCs”), and refusing to sell its TLS stylet separately for use with its
`
`competitors’ PICCs, constitutes an illegal tie in violation of the Sherman Act. The facts and
`
`evidence relevant to the Court’s resolution of the pending motions are summarized below.
`
`
`1 The following facts are drawn from the parties’ statements of undisputed material facts and responses pursuant to
`Local Rule 56.1 (formerly Local Rule 7.1(a)(3)), (Dkt. Nos. 133-2, 134-2, 144-1, 146), to the extent those facts are
`well-supported by pinpoint citations to the record, as well as the exhibits attached thereto and cited therein to the
`extent they could “be presented in a form that would be admissible in evidence” at trial. Fed. R. Civ. P. 56(c)(2). In
`considering the parties’ cross-motions for summary judgment, the Court “in each case constru[es] the evidence in the
`light most favorable to the non-moving party.” Krauss v. Oxford Health Plans, Inc., 517 F.3d 614, 621-22 (2d Cir.
`2008).
`
`2
`
`

`

`Case 1:17-cv-00598-BKS-CFH Document 189 Filed 05/05/21 Page 3 of 105
`
`A.
`
`Background on PICCs and TLSs
`
`1.
`
`PICC and TLS Technology
`
`Bard and AngioDynamics compete to develop, manufacture, market, and sell vascular
`
`access medical devices, including PICCs, to hospitals and other medical care providers. (Dkt.
`
`No. 133-2, ¶¶ 1-2; Dkt. No. 134-2, ¶ 1; Dkt. No. 144-1, ¶¶ 1-2; Dkt. No. 146, ¶ 1). PICCs are
`
`long, thin, soft, flexible catheters inserted into the body through a vein, most commonly the
`
`basilica vein in the upper arm, and navigated to the distal superior vena cava, the large vein
`
`leading to the right atrium of the heart. (Dkt. No. 133-2, ¶¶ 3-4; Dkt. No. 134-2, ¶ 2; Dkt. No.
`
`144-1, ¶¶ 3-4; Dkt. No. 146, ¶ 2). Clinicians use PICCs to deliver medications, fluids, and
`
`nutrients into a patient’s body, sample blood, and power-inject contrast media. (Dkt. No. 133-2, ¶
`
`3; Dkt. No. 134-2, ¶ 3; Dkt. No. 144-1, ¶ 3; Dkt. No. 146, ¶ 3). PICCs are generally suited for
`
`patients requiring long-term intravenous medical treatment. (Dkt. No. 134-2, ¶ 3; Dkt. No. 146, ¶
`
`3). PICCs can be placed either at a patient’s bedside by a nurse or in an interventional radiology
`
`(“IR”) suite, usually by a physician. (Dkt. No. 134-2, ¶ 14; Dkt. No. 146, ¶ 14).
`
`During placement of a PICC, clinicians often use a guidewire (also known as a “stylet”)
`
`inside the PICC to stiffen it so that it can be threaded through the patient’s veins. (Dkt. No. 133-
`
`2, ¶ 5; Dkt. No. 144-1, ¶ 5). After completing the PICC placement procedure, the clinician will
`
`remove the stylet from the PICC and discard it. (Dkt. No. 133-2, ¶ 5; Dkt. No. 144-1, ¶ 5).
`
`Because there are several places where a patient’s veins branch before reaching the superior vena
`
`cava, clinicians sometimes route PICCs incorrectly. (Dkt. No. 133-2, ¶ 6; Dkt. No. 144-1, ¶ 6). In
`
`addition, sometimes clinicians get the final placement incorrect. (Dkt. No. 133-2, ¶ 7; Dkt. No.
`
`144-1, ¶ 7). Historically, clinicians used a chest x-ray or fluoroscopy (a medical imaging
`
`technique that uses x-rays) to confirm that a PICCs’ final placement was correct. (Dkt. No. 133-
`
`2, ¶¶ 7, 12; Dkt. No. 134-2, ¶ 10; Dkt. No. 144-1, ¶¶ 7, 12; Dkt. No. 146, ¶ 10).
`
`3
`
`

`

`Case 1:17-cv-00598-BKS-CFH Document 189 Filed 05/05/21 Page 4 of 105
`
`To assist with the PICC navigation process and minimize the complications associated
`
`with incorrect PICC placement, certain companies developed TLSs. (Dkt. No. 133-2, ¶ 8; Dkt.
`
`No. 144-1, ¶ 8). TLSs can offer two key functions: pinpointing the location of the stylet as it
`
`moves through the body (“navigation”) and confirming the PICC’s location once it has been
`
`placed (“confirmation”). (Dkt. No. 133-2, ¶ 8; Dkt. No. 144-1, ¶ 8). A TLS may feature
`
`navigation functionality, confirmation functionality, or both. (Dkt. No. 133-2, ¶ 9; Dkt. No. 144-
`
`1, ¶ 9). Navigation technology uses magnetic tracking or Doppler technology to provide
`
`information regarding directionality of the PICC as it moves through the patient’s veins, assisting
`
`clinicians in threading the PICC. (Dkt. No. 133-2, ¶ 10; Dkt. No. 134-2, ¶ 13; Dkt. No. 144-1, ¶
`
`10; Dkt. No. 146, ¶ 13). Confirmation technology enables a clinician to confirm the final location
`
`of the PICC within the superior vena cava using a patient’s electrocardiographic (“ECG”)
`
`waveform. (Dkt. No. 133-2, ¶ 11; Dkt. No. 134-2, ¶ 11; Dkt. No. 144-1, ¶ 11; Dkt. No. 146, ¶
`
`11).
`
`While many clinicians now use TLSs to place PICCs because doing so is less expensive,
`
`less time consuming, and more accurate than placing PICCs without TLSs, not all clinicians use
`
`TLSs. (Dkt. No. 133-2, ¶ 12; Dkt. No. 134-2, ¶ 10; Dkt. No. 144-1, ¶ 12; Dkt. No. 146, ¶ 10).
`
`For example, physicians placing PICCs in an IR suite still typically use fluoroscopy, rather than
`
`a TLS, to confirm PICC placement. (Dkt. No. 133-2, ¶ 12; Dkt. No. 134-2, ¶ 16; Dkt. No. 144-1,
`
`¶ 12; Dkt. No. 146, ¶ 16). There are also some hospitals in which nurses continue to place PICCs
`
`without navigation assistance or use chest x-rays rather than TLSs for confirmation. (Dkt. No.
`
`133-2, ¶ 12; Dkt. No. 134-2, ¶ 17; Dkt. No. 144-1, ¶ 12; Dkt. No. 146, ¶ 17). However, a
`
`majority of PICCs placed by nurses at a patient’s bedside use TLSs with navigation capabilities.
`
`(Dkt. No. 133-2, ¶ 12; Dkt. No. 134-2, ¶ 17; Dkt. No. 144-1, ¶ 12; Dkt. No. 146, ¶ 17).
`
`4
`
`

`

`Case 1:17-cv-00598-BKS-CFH Document 189 Filed 05/05/21 Page 5 of 105
`
`2.
`
`PICC Purchasing Decisions
`
`PICCs differ from each other in a variety of ways, including with respect to the material
`
`they are made from, the number of lumens (tubes or channels), the outside diameter, whether the
`
`PICC is valved (which can help prevent the backflow of blood into the PICC) or non-valved, and
`
`whether the PICC is preloaded with a TLS stylet. (Dkt. No. 133-2, ¶ 13; Dkt. No. 144-1, ¶ 13).
`
`Manufacturers typically sell PICCs in a kit that also contains various accessories, which vary
`
`depending on, among other things, whether the PICC will be placed by a nurse at the patient’s
`
`bedside or by a physician in an IR suite. (Dkt. No. 133-2, ¶¶ 14-15; Dkt. No. 144-1, ¶¶ 14-15).
`
`The process by which hospitals decide whether to purchase a particular manufacturer’s
`
`PICC is “complex,” “not monolithic” and “varies by hospital.” (Dkt. No. 133-2, ¶¶ 15-17; Dkt.
`
`No. 144-1, ¶¶ 15-17). Depending on the hospital, various constituencies may be involved in the
`
`purchasing decision, including doctors, nurses and representatives from the supply chain, risk
`
`management and infection control departments. (Dkt. No. 133-2, ¶ 15). In some cases, hospitals
`
`have “value analysis committees,” or “VACs,” which play a role in the procurement process and
`
`consist of representatives from various hospital departments. (Id.). Some hospitals are part of
`
`Group Purchasing Organizations (“GPOs”) or Integrated Delivery Networks (“IDNs”), which
`
`negotiate pricing for their member hospitals and have played an increasingly larger role in
`
`influencing the purchasing decisions of their member hospitals. (Dkt. No. 133-2, ¶ 16).
`
`Hospitals consider a variety of factors when deciding whether to purchase PICCs, or
`
`particular types of PICCs, from a given supplier, including, among other things, price, quality of
`
`the PICCs, clinical outcomes, safety, PICC functionality and features (including whether they are
`
`preloaded with a TLS stylet or not, whether they are valved or not, and whether they have a
`
`flare-tip or small diameter, among other factors), the components of the kit in which the PICCs
`
`come (or the potential kit options), the breadth of a manufacturer’s product portfolio, the benefits
`
`5
`
`

`

`Case 1:17-cv-00598-BKS-CFH Document 189 Filed 05/05/21 Page 6 of 105
`
`of dealing with a single vendor for multiple products, the manufacturer’s clinical team and
`
`training and customer support, and the requirements of GPO and IDN contracts. (Dkt. No. 133-2,
`
`¶ 17). Different hospitals may weigh and prioritize these factors differently, depending on their
`
`particular needs and concerns. (Dkt. No. 144-1, ¶¶ 15-17).
`
`B.
`
`Relevant Competitors and their Key Products
`
`Several companies compete in the sale of PICCs. The three largest competitors, in terms
`
`of market share, are Bard, AngioDynamics, and Teleflex Incorporated (“Teleflex”). (Dkt. No.
`
`133-2, ¶ 21; Dkt. No. 144-1, ¶ 21). These competitors’ products that are most relevant to this
`
`litigation are described below.
`
`1.
`
`AngioDynamics’ BioFlo PICCs
`
`In 2012, AngioDynamics began selling PICCs known as BioFlo PICCs after acquiring
`
`the technology from another company. (Dkt. No. 133-2, ¶ 33; Dkt. No. 144-1, ¶ 33). BioFlo
`
`PICCs are the first PICCs in the market to use Endexo Technology, a technology designed to
`
`reduce thrombus accumulation (blood clots). (Dkt. No. 134-2, ¶ 4; Dkt. No. 146, ¶ 6). Thrombus
`
`accumulation is a common problem associated with PICC placement that can lead to serious
`
`complications such as deep vein thrombosis (“DVT”) and pulmonary embolism (“PE”). (Dkt.
`
`No. 134-2, ¶¶ 5-6; Dkt. No. 146, ¶¶ 5-6). The parties dispute whether the clinical evidence and
`
`published literature establishes that BioFlo is actually effective at reducing thrombus
`
`accumulation and its resulting complications, with both parties citing record evidence in support
`
`of their respective positions. (Dkt. No. 133-2, ¶¶ 34-36; Dkt. No. 134-2, ¶¶ 4, 7; Dkt. No. 144-1,
`
`¶¶ 34-36; Dkt. No. 146, ¶¶ 4, 7).
`
`Bard has spent significant time, money and energy working to develop a PICC with an
`
`anti-thrombus coating, including with Endexo Technology, but has been unsuccessful. (Dkt. No.
`
`134-2, ¶ 8; Dkt. No. 146, ¶ 8). Bard claims, however, that its FT PICC, which has a taper with a
`
`6
`
`

`

`Case 1:17-cv-00598-BKS-CFH Document 189 Filed 05/05/21 Page 7 of 105
`
`smaller diameter at the axillary arch in the arm vein where the majority of DVTs occur, has
`
`proven effective at reducing DVT rates. (Dkt. No. 146, ¶ 8).
`
`2.
`
`Bard’s TLS
`
`Bard sells PICCs under several brand names, has been selling PICCs for decades, and
`
`sells the majority of PICCs in the U.S. (Dkt. No. 133-2, ¶ 22; Dkt. No. 144-1, ¶ 22). In 2006,
`
`Bard became the first company to develop a TLS with navigation technology, which it called the
`
`Sherlock tip navigation system. (Dkt. No. 133-2, ¶ 24; Dkt. No. 144-1, ¶ 24). In 2011, Bard
`
`received FDA approval for a tip confirmation system called Sapiens. (Dkt. No. 133-2, ¶ 24; Dkt.
`
`No. 144-1, ¶ 24). Then, in 2012, Bard launched the Sherlock 3CG TLS, which included both
`
`navigation and confirmation capabilities. (Dkt. No. 133-2, ¶ 24; Dkt. No. 144-1, ¶ 24). Bard’s
`
`Sherlock 3CG system, which only works with Bard’s special, patented proprietary stylet, is the
`
`first and only TLS to combine three technologies: (i) ultrasound technology to identify a suitable
`
`vein for inserting the PICC;2 (ii) magnetic tracking navigation technology to monitor and guide
`
`the PICC through the venous system; and (iii) ECG technology to confirm the final location of
`
`the PICC’s tip in the superior vena cava. (Dkt. No. 133-2, ¶¶ 25-26; Dkt. No. 134-2, ¶ 21; Dkt.
`
`No. 144-1, ¶¶ 25-26; Dkt. No. 146, ¶ 21).
`
`Bard only sells its proprietary stylet pre-loaded into its PICCs; it does not sell the stylet
`
`“single sterile,” i.e. as a standalone product that can be loaded into a different company’s PICCs
`
`by a nurse or other medical professional at the patient’s bedside. (Dkt. No. 133-2, ¶¶ 26-27, 30;
`
`Dkt. No. 134-2, ¶¶ 22-23; Dkt. No. 144-1, ¶¶ 26-27, 30; Dkt. No. 146, ¶¶ 22-23). As a result, a
`
`customer who wishes to use Bard’s TLS can only do so by purchasing the stylet preloaded into a
`
`
`2 While Bard’s TLS system combines ultrasound with navigation and confirmation technology, “ultrasound is
`universally available,” “there are many [ultrasound systems] in the market,” and a hospital can use any ultrasound
`system, including Bard’s or another company’s, in conjunction with Bard’s TLS. (Dkt. No. 146, ¶ 21).
`
`7
`
`

`

`Case 1:17-cv-00598-BKS-CFH Document 189 Filed 05/05/21 Page 8 of 105
`
`Bard PICC; there is no option to purchase a Bard TLS separately and combine it with a
`
`competitor’s PICC. (Dkt. No. 133-2, ¶ 30; Dkt. No. 134-2, ¶ 22; Dkt. No. 144-1, ¶ 30; Dkt. No.
`
`146, ¶ 22). To date, Bard has only made a single exception to its TLS policy: sales of a
`
`standalone stylet for a limited time to Cleveland Clinic, the circumstances of which are discussed
`
`further below in Section II.E.5.a infra. (Dkt. No. 133-2, ¶ 30; Dkt. No. 134-2, ¶ 23; Dkt. No.
`
`144-1, ¶ 30; Dkt. No. 146, ¶ 23). While Bard does not sell its TLS stylets separately from its
`
`PICCs, it does sell its PICCs separately from its stylets and acknowledges that certain customers
`
`combine its PICCs with other companies’ TLSs, though it does not expressly “condone the use
`
`of an alternative stylet with [its PICCs].” (Dkt. No. 134-2, ¶ 24; Dkt. No. 146, ¶ 24).
`
`Bard executives’ stated justification for its TLS policy is that loading Bard’s TLS stylet
`
`into a PICC at a patient’s bedside increases the risk of stylet breakage, serious patient injury,
`
`contamination of the sterile field and resulting patient infection. (Dkt. No. 133-2, ¶ 28).
`
`However, AngioDynamics challenges this justification, citing to analyses by several of its
`
`experts disputing that there is a clinical benefit to preloading a TLS stylet or an increased risk
`
`from loading the stylet bedside. (Dkt. No. 144-1, ¶ 28). Bard also claims that it designed its TLS
`
`stylet to be preloaded into its PICCs by trained operators in its manufacturing facilities and not
`
`by nurses at a patient’s bedside, but AngioDynamics disputes this, noting that Bard has FDA
`
`approval to sell its TLS stylet single-sterile for bedside insertion, which it obtained in connection
`
`with its decision to sell Cleveland Clinic a single-sterile stylet. (Dkt. No. 133-2, ¶ 29; Dkt. No.
`
`144-1, ¶ 29).
`
`According to AngioDynamics, aside from Bard’s sales of a single-sterile stylet to
`
`Cleveland Clinic, Bard “took steps to hide the fact that it had FDA approval to sell its stylet
`
`single sterile and attempted to block customers from ordering the stylet single sterile”; Bard
`
`8
`
`

`

`Case 1:17-cv-00598-BKS-CFH Document 189 Filed 05/05/21 Page 9 of 105
`
`disagrees with this characterization, and justifies its actions by claiming that Bard “did not want
`
`to release false information to the market by suggesting that the product was available to the
`
`market broadly when in fact it was not.” (Dkt. No. 133-2, ¶ 39; Dkt. No. 146, ¶ 39).
`
`AngioDynamics cites to the following record evidence:
`
`• A Bard executive wrote to team members, “Fucking A. Keep on down low!” when
`referring to Bard’s application to the FDA to sell its TLS stylet as a standalone product.
`(Dkt. No. 138-12, at 2).
`
`• A Bard vice president told others at Bard that Bard’s decision to make the standalone
`stylet available to Cleveland Clinic was “top secret[.]” (Dkt. No. 138-13, at 2).
`
`• A Bard product manager instructed Bard employees to keep any product information
`about the standalone TLS stylet “private as much as possible,” explaining that “[w]e
`don’t want to publicize that we offer a standalone Sherlock 3CG option to the masses.”
`(Dkt. No. 138-14, at 3).
`
`• When Bard’s corporate representative was asked why Bard did not want to publicize the
`standalone option to the masses, he testified that Bard “would not have wanted to create
`demand for it.” (Dkt. No. 138-15, at 8). He also testified that Bard did not want to
`publicize the “one-off experiment with the Cleveland Clinic” because “the only reason it
`worked for Cleveland was because we fully understood that risk and we had a complete
`connectivity with the clinical management in a hospital that satisfied us we could on-
`board this safely,” and that Bard did not want to “promot[e] something when it was a
`limited market release.” (Dkt. No. 147-16, at 22-23).
`
`• The ordering information for Bard’s standalone TLS stylet was not available on Bard’s
`computer ordering system. (Dkt. No. 138-2, at 4).
`
`• A Bard PICC Product Manager instructed that the product code for Bard’s standalone
`TLS stylet “should remain ‘invisible’ to all of our customers” except for Cleveland
`Clinic and “should not be published in any pricing catalogs, online, etc.” (Dkt. No. 138-
`18, at 2).
`
`3.
`
`AngioDynamics’ Attempts to Acquire a TLS
`
`
`
`Since at least 2011, AngioDynamics has attempted to develop or acquire a TLS. (Dkt.
`
`No. 133-2, ¶ 48; Dkt. No. 134-2, ¶ 52; Dkt. No. 144-1, ¶ 48; Dkt. No. 146, ¶ 52). Since then,
`
`there have been times during which AngioDynamics offered a TLS. (Dkt. No. 133-2, ¶¶ 49-50;
`
`Dkt. No. 144-1, ¶¶ 49-50). For example, from 2013 through 2016, pursuant to a license from
`
`9
`
`

`

`Case 1:17-cv-00598-BKS-CFH Document 189 Filed 05/05/21 Page 10 of 105
`
`another company, AngioDynamics sold a confirmation-only TLS called Celerity, for which it
`
`attempted to develop a navigation component. (Dkt. No. 133-2, ¶ 51; Dkt. No. 134-2, ¶ 53; Dkt.
`
`No. 144-1, ¶ 51; Dkt. No. 146, ¶ 53). However, in January 2016, when the Celerity technology
`
`was up for sale, Teleflex outbid AngioDynamics and acquired the technology, at which point
`
`AngioDynamics ceased its efforts to obtain FDA approval for navigation-enabled Celerity and
`
`discontinued selling Celerity aside from a small number of units from its remaining inventory.
`
`(Dkt. No. 133-2, ¶ 52; Dkt. No. 134-2, ¶ 54; Dkt. No. 144-1, ¶ 52; Dkt. No. 146, ¶ 54).3 In
`
`addition to Celerity, AngioDynamics has offered other TLSs at times in the past, but it has never
`
`offered a TLS with both navigation and confirmation capabilities. (Dkt. No. 133-2, ¶¶ 49-50;
`
`Dkt. No. 144-1, ¶¶ 49-50). In late 2019, AngioDynamics acquired a TLS called C3 Wave, which
`
`has confirmation, but not navigation, capabilities. (Dkt. No. 133-2, ¶ 56; Dkt. No. 144-1, ¶ 56).
`
`Several AngioDynamics executives have publicly stated their belief that C3 Wave will help
`
`AngioDynamics compete in the PICC market, though deposition testimony from
`
`AngioDynamics’ General Manager of Vascular Access clarified that these statements refer to the
`
`more limited market for PICCs that use confirmation-only TLS technology, not the much larger
`
`market for PICCs that use navigation-enabled TLSs like Bard’s. (Dkt. No. 133-2, ¶¶ 58-59; Dkt.
`
`No. 144-1, ¶¶ 58-59).
`
`4.
`
`Teleflex’s PICC and TLS Technology
`
`Like Bard and AngioDynamics, Teleflex markets and sells PICCs. (Dkt. No. 133-2, ¶ 63;
`
`Dkt. No. 144-1, ¶ 63). Like Bard, but unlike AngioDynamics, it also markets and sells TLSs that
`
`
`3 In January 2017, Teleflex received FDA approval for a TLS that was based off the same technology that
`AngioDynamics would have used to develop Celerity with navigation. (Dkt. No. 144-1, ¶ 52). Several AngioDynamics
`executives have testified as to their frustration and disappointment that Teleflex outbid AngioDynamics for the
`Celerity technology, and their belief that navigation-enabled Celerity would have helped AngioDynamics compete in
`the PICC market. (Dkt. No. 133-2, ¶¶ 53-54; Dkt. No. 144-1, ¶¶ 53-54).
`
`10
`
`

`

`Case 1:17-cv-00598-BKS-CFH Document 189 Filed 05/05/21 Page 11 of 105
`
`provide both navigation and confirmation capabilities. (Dkt. No. 133-2, ¶ 63; Dkt. No. 144-1, ¶
`
`63). Unlike Bard, Teleflex historically has sold, and continues to sell, its TLSs both preloaded
`
`into its PICCs and as separate, standalone products that are compatible with third-party PICCs.
`
`(Dkt. No. 133-2, ¶ 64; Dkt. No. 134-2, ¶ 42; Dkt. No. 144-1, ¶ 64; Dkt. No. 146, ¶ 42).
`
`Therefore, hospitals that want to pair AngioDynamics’ BioFlo PICCs with a navigation-enabled
`
`TLS are able to do so with Teleflex’s TLSs. (Dkt. No. 133-2, ¶ 65; Dkt. No. 144-1, ¶ 65).
`
`AngioDynamics has, at times, marketed the option of pairing BioFlo with Teleflex’s TLS
`
`technology to its customers, and some hospitals do utilize this option. (Dkt. No. 133-2, ¶¶ 66-67;
`
`Dkt. No. 144-1, ¶¶ 66-67).
`
`C.
`
`Relevant Markets and the Competitors’ Market Shares
`
`The parties dispute the relevant product market for purposes of the Court’s antitrust
`
`analysis. The parties appear to agree that PICCs constitute a distinct market from other types of
`
`vascular access devices; that all PICCs compete in the same market, regardless of the various
`
`distinctions between particular PICCs; and that the relevant geographic market is the United
`
`States. (Dkt. No. 144-1, ¶ 13; Dkt. No. 136-9, at 26-27, 36-37; Dkt. No. 147-13, at 13-14, 16).
`
`However, Bard contends that the only relevant product market is the market for “differentiated
`
`PICCs”—i.e. PICCs that differ from each other on a number of characteristics such as size,
`
`material, and others—and that Bard’s preloaded TLS stylet is merely one way in which Bard’s
`
`PICCs are differentiated, rather than a distinct product with its own market. (Dkt. No. 145, at 7-
`
`15, 17-19). AngioDynamics contends that PICCs and TLSs comprise two separate, distinct
`
`product markets. (Dkt. No. 134-1, at 14-19; Dkt. No. 152, at 7-9, 10-11).
`
`Bard has historically captured the majority of the PICC market, with AngioDynamics and
`
`Teleflex capturing significantly smaller market shares. (Dkt. No. 133-2, ¶ 21; Dkt. No. 144-1, ¶
`
`21; Dkt. No. 138-78, at 2-3).
`
`
`
`11
`
`

`

`Case 1:17-cv-00598-BKS-CFH Document 189 Filed 05/05/21 Page 12 of 105
`
`
`
`
`
`(Dkt. No. 133-2, ¶ 21; Dkt. No. 144-1, ¶ 21).
`
`PICCs used with TLSs constitute by far the largest segment of the PICC market. (Dkt.
`
`No. 133-2, ¶ 57; Dkt. No. 146, ¶ 57). The evidence cited by AngioDynamics suggests that,
`
`between 2013 and 2018, Bard sold the overwhelming majority of TLSs on the market—more
`
`than
`
` percent—and Bard has not offered evidence contesting that assertion. (Dkt. No. 134-2, ¶
`
`47; Dkt. No. 146, ¶ 47). Teleflex, the only other seller of navigation-enabled TLS stylets, sold a
`
`much smaller percentage of TLSs—only
`
` percent—over the same period. (Dkt. No. 134-2, ¶
`
`49; Dkt. No. 146, ¶ 49). Other TLSs sold today do not include navigation components and make
`
`up a negligible percentage of TLS sales. (Dkt. No. 138-20, at 25 n.107). Because Bard, which
`
`sells the majority of the TLSs, does not sell its TLS stylets single-sterile as a matter of policy,
`
`only a small percentage of all TLS stylets on the market are sold single-sterile. (Dkt. No. 146, ¶
`
`43). However, the percentage of stylets sold single-sterile by Teleflex, Bard’s only meaningful
`
`competitor in the TLS space, is significant: between 2013 and 2018,
`
` of Teleflex’s
`
`TLS stylets were sold separately from its PICCs. (Dkt. No. 134-2, ¶ 43; Dkt. No. 146, ¶ 43).
`
`The parties dispute whether, assuming TLS stylets comprise a separate market from the
`
`PICC market, there are high barriers to entry in the TLS market that enable Bard to sustain such
`
`a high market share. AngioDynamics cites “high development costs, the requirement for FDA
`
`clearance of medical devices, and Bard’s ownership of patented TLS technology” as such
`
`barriers to entry. (Dkt. No. 134-2, ¶ 50). The evidence cited by the parties on each of these issues
`
`may be summarized as follows:
`
`• High Development Costs: The parties agree that both AngioDynamics and Bard have
`spent significant time, effort and money developing navigation-based TLSs (Bard
`
`12
`
`

`

`Case 1:17-cv-00598-BKS-CFH Document 189 Filed 05/05/21 Page 13 of 105
`
`
`
`successfully, and AngioDynamics unsuccessfully). (Dkt. No. 134-2, ¶¶ 51-52; Dkt. No.
`146, ¶¶ 51-52). Bard nonetheless contests AngioDynamics’ assertion that high
`development costs pose a significant barrier to entry, noting that AngioDynamics’ own
`expert has identified seven different competing TLS products that have been developed
`by Bard’s rivals in the past. (Dkt. No.146, ¶ 50).
`
`• FDA Approval: AngioDynamics cites the need for FDA approval of medical products
`as a barrier to entry for developing a TLS with navigation. (Dkt. No. 134-2, ¶ 50). Bard
`points out, however, that AngioDynamics’ own expert economist opined in his
`deposition that FDA clearance is “not [an] insurmountable” barrier, and that “[i]f you
`have a successful technology . . . simply getting the FDA approval shouldn’t be that
`difficult.” (Dkt. No. 146, ¶ 50).
`
`• Patents: The parties agree that Bard has multiple patents on its TLS stylets. (Dkt. No.
`134-2, ¶ 55; Dkt. No. 146, ¶ 55). AngioDynamics’ liability expert, Professor George
`Alan Hay, opined that entry into the alleged TLS market is “complicated by the fact that
`both Teleflex’s and Bard’s navigation systems are patented,” as this patent protection
`requires an entrant into the TLS market to “invent around” these companies’ existing
`intellectual property, and “entry with a similar technology could lead to costly patent
`litigation, even if there is no infringement.” (Dkt. No. 134-2, ¶ 56; Dkt. No. 146, ¶ 56).
`During his deposition, however, Dr. Hay admitted that he “ha[s] not studied the patents,”
`does not know “which patents Bard has on tip location,” and could only make general
`assumptions about “which specific technological features of the Bard tip location system
`are covered by patents.” (Dkt. No. 146, ¶¶ 50, 56). As noted above, Dr. Hay also
`identified seven different TLS products developed by Bard’s competitors,
`notwithstanding Bard’s patent protection. (Dkt. No. 146, ¶ 56). Bard’s corporate
`representative testified that “[a competitor] could easily have reverse engineered [Bard’s
`3CG] stylet, and they would have to change an approach to creating a magnetic field to
`avoid our intellectual property. But they could do that and . . . that has been done.” (Dkt.
`No. 138-26, at 4).
`
`D.
`
`General Explanations for AngioDynamics’ Alleged Lost Sales
`
`Citing record evidence, Bard contends that AngioDynamics has lost existing PICC
`
`business or been unable to win new PICC business because of a variety of factors other than
`
`Bard’s TLS policy, including “price, contracts, quality issues, product recalls, competing
`
`technologies, incomplete product lines, lack of data, customer relationships, and product
`
`backorders.” (Dkt. No. 133-2, ¶ 38). AngioDynamics does not appear to meaningfully dispute
`
`that these factors have impacted its PICC business, but it contends that Bard’s TLS policy is at
`
`least one materially contributing factor to its loss of PICC sales to Bard and/or its failure to win
`
`13
`
`

`

`Case 1:17-cv-00598-BKS-CFH Document 189 Filed 05/05/21 Page 14 of 105
`
`PICC business from Bard. (Dkt. No. 144-1, ¶ 38). Some of the most significant factors Bard
`
`discusses with respect to the pending motions are discussed below.
`
`1.
`
`Pricing
`
`AngioDynamics’ BioFlo PICCs are sometimes priced at a premium to other PICCs in the
`
`market at the point of sale. (Dkt. No. 133-2, ¶ 39; Dkt. No. 144-1, ¶ 39). According to Tom
`
`Aldrich, a former sales executive at AngioDynamics, AngioDynamics’ former CEO believed
`
`that “customers should pay more for BioFlo than the other PICCs on the market.” (Dkt. No. 133-
`
`2, ¶ 40; Dkt. No. 144-1, ¶ 40). AngioDynamics also believes that any price premium on BioFlo
`
`PICCs is justified by evidence that BioFlo PICCs’ thrombus-accumulation-reducing properties
`
`result in long-term cost savings to the hospitals using them. (Dkt. No. 144-1, ¶¶ 39, 41-42).
`
`Nonetheless, AngioDynamics concedes that some hospitals are unwilling to pay a premium for
`
`BioFlo PICCs. (Dkt. No. 133-2, ¶ 43; Dkt. No. 144-1, ¶ 43).
`
`AngioDynamics does not dispute that, as a result of this price premium, the combination
`
`of BioFlo PICCs with Teleflex’s TLS stylets is “sometimes” more expensive than Bard’s PICCs
`
`preloaded with its stylets. (Dkt. No. 133-2, ¶ 41; Dkt. No. 144-1, ¶ 41). However,
`
`AngioDynamics asserts that because AngioDynamics competes with Bard and other competitors
`
`on price, its pricing of BioFlo is specific to each customer, and that therefore, its pricing of
`
`BioFlo is sometimes higher and sometimes lower than Bard’s pricing of its PICCs. (Dkt. No.
`
`144-1, ¶ 41; see also Dkt. No. 138-61, at 2).
`
`2.
`
`Quality/Reputational Issues
`
`AngioDynamics has suffered from “multiple quality issues across multiple product lines
`
`and areas.” (Dkt. No. 133-2, ¶ 45; Dkt. No. 144-1, ¶ 45). As relevant to its PICC business, in
`
`2015, AngioDynamics recalled its entire line of Morpheus PICCs due to quality issues. (Dkt. No.
`
`133-2, ¶ 46; Dkt. No. 144-1, ¶ 46). There is evidence in the record suggesting that the Morpheus
`
`14
`
`

`

`Case 1:17-cv-00598-BKS-CFH Document 189 Filed 05/05/21 Page 15 of 105
`
`recall damaged AngioDynamics’ relationship with at least some of its customers, and that these
`
`issues negatively impacted AngioDynamics’ PICC sales. (Dkt. No. 133-2, ¶¶ 46-47). In internal
`
`correspondence, General Manager of Vascular Access Chad Campbell referred to a “Morpheus
`
`hangover”; Campbell testified that this merely referred to the fact that AngioDynamics had some
`
`“slow orders as [it] converted [its customers] to [its] other products,” though he acknowledged
`
`that AngioDynamics also lost business entirely as a result of the Morpheus recall. (Dkt. No. 133-
`
`2, ¶ 46; Dkt. No. 144-1, ¶ 46; Dkt. No. 144-47, at 4). Unlike AngioDynamics, Bard has never
`
`recalled an entire line of its PICCs. (Dkt. No. 133-2, ¶ 23; Dkt. No. 144-1, ¶ 23).
`
`3.
`
`AngioDynamics’ Lack of a TLS
`
`Because some customers value the convenience of preloaded PICCs and dealing with a
`
`single vendor, and thus prefer to purchase PICCs and TLSs from the same supplier even if they
`
`have the option to purchase them separately, (Dkt. No. 146, ¶¶ 65-66), Bard cites the fact that
`
`AngioDynamics does not offer its own TLS with both navigation and confirmation capabilities
`
`as a factor negatively impacting its PICC sales, independent of Bard’s TLS policy. (Dkt. No.
`
`133-2, ¶¶ 61-62). Bard cites to AngioDynamics’ thus-far unsuccessful efforts to develop its own
`
`navigation-enabled TLS, as well as AngioDynamics’ internal documents reflecting that it
`
`believes its lack of navigation-enabled TLS to be a reason for its loss of PICC market share and
`
`its difficulties competing with Bard’s PICCs. (Dkt. No. 133-2, ¶¶ 48-62).
`
`4.
`
`FDA Approval
`
`Bard also cites regulatory issues as a factor impacting AngioDynamics’ ability to win
`
`sales of PICCs against Bar