[Federal Register Volume 82, Number 191 (Wednesday, October 4, 2017)]
[Notices]
[Pages 46238-46241]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21291]


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FEDERAL TRADE COMMISSION

[File No. 171 0084]


Integra LifeSciences Holdings Corporation and Johnson & Johnson; 
Analysis To Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreement.

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SUMMARY: The consent agreement in this matter settles alleged 
violations of federal law prohibiting unfair methods of competition. 
The attached Analysis to Aid Public Comment describes both the 
allegations in the complaint and the terms of the consent orders--
embodied in the consent agreement--that would settle these allegations.

DATES: Comments must be received on or before October 27, 2017.

ADDRESSES: Interested parties may file a comment online or on paper, by 
following the instructions in the Request for Comment part of the 
SUPPLEMENTARY INFORMATION section below. Write: ``Integra LifeSciences 
et al.; FTC File No. 1710084'' on your comment, and file your comment 
online at https://ftcpublic.commentworks.com/ftc/integradivest by 
following the instructions on the web-based form. If you prefer to file 
your comment on paper, write ``Integra LifeSciences et al.; FTC File 
No. 1710084'' on your comment and on the envelope, and mail your 
comment to the following address: Federal Trade Commission, Office of 
the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), 
Washington, DC 20580, or deliver your comment to the following address: 
Federal Trade Commission, Office of the Secretary, Constitution Center, 
400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 
20024.

FOR FURTHER INFORMATION CONTACT: Aylin M. Skroejer, (202-326-2459), 
Bureau of Competition, 600 Pennsylvania Avenue NW., Washington, DC 
20580.

SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal 
Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, 
notice is hereby given that the above-captioned consent agreement 
containing a consent order to cease and desist, having been filed with 
and accepted, subject to final approval, by the Commission, has been 
placed on the public record for a period of thirty (30) days. The 
following Analysis to Aid Public Comment describes the terms of the 
consent agreement, and the allegations in the complaint. An electronic 
copy of the full text of the consent agreement package can be obtained 
from the FTC Home Page (for September 27, 2017), on the World Wide Web, 
at https://www.ftc.gov/news-events/commission-actions.
    You can file a comment online or on paper. For the Commission to 
consider your comment, we must receive it on or before October 27, 
2017. Write ``Integra LifeSciences et al.; FTC File No. 1710084'' on 
your comment. Your comment--including your name and your state--will be 
placed on the public record of this proceeding, including, to the 
extent practicable, on the public Commission Web site, at https://www.ftc.gov/policy/public-comments.
    Postal mail addressed to the Commission is subject to delay due to 
heightened security screening. As a result, we encourage you to submit 
your comments online. To make sure that the Commission considers your 
online comment, you must file it at https://ftcpublic.commentworks.com/ftc/integradivest by following the instructions on the web-based form. 
If this Notice appears at http://www.regulations.gov/#!home, you also 
may file a comment through that Web site.
    If you prefer to file your comment on paper, write ``Integra 
LifeSciences et al.; FTC File No. 1710084'' on your comment and on the 
envelope, and mail your comment to the following address: Federal Trade 
Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite 
CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the 
following address: Federal Trade Commission, Office of the Secretary, 
Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex 
D), Washington, DC 20024. If possible, submit your paper comment to the 
Commission by courier or overnight service.
    Because your comment will be placed on the publicly accessible FTC 
Web site at https://www.ftc.gov, you are solely responsible for making 
sure that your comment does not include any sensitive or confidential 
information. In particular, your comment should not include any 
sensitive personal information, such as your or anyone else's Social 
Security number; date of

[[Page 46239]]

birth; driver's license number or other state identification number, or 
foreign country equivalent; passport number; financial account number; 
or credit or debit card number. You are also solely responsible for 
making sure that your comment does not include any sensitive health 
information, such as medical records or other individually identifiable 
health information. In addition, your comment should not include any 
``trade secret or any commercial or financial information which . . . 
is privileged or confidential''--as provided by Section 6(f) of the FTC 
Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)--
including in particular competitively sensitive information such as 
costs, sales statistics, inventories, formulas, patterns, devices, 
manufacturing processes, or customer names.
    Comments containing material for which confidential treatment is 
requested must be filed in paper form, must be clearly labeled 
``Confidential,'' and must comply with FTC Rule 4.9(c). In particular, 
the written request for confidential treatment that accompanies the 
comment must include the factual and legal basis for the request, and 
must identify the specific portions of the comment to be withheld from 
the public record. See FTC Rule 4.9(c). Your comment will be kept 
confidential only if the General Counsel grants your request in 
accordance with the law and the public interest. Once your comment has 
been posted on the public FTC Web site--as legally required by FTC Rule 
4.9(b)--we cannot redact or remove your comment from the FTC Web site, 
unless you submit a confidentiality request that meets the requirements 
for such treatment under FTC Rule 4.9(c), and the General Counsel 
grants that request.
    Visit the FTC Web site at http://www.ftc.gov to read this Notice 
and the news release describing it. The FTC Act and other laws that the 
Commission administers permit the collection of public comments to 
consider and use in this proceeding, as appropriate. The Commission 
will consider all timely and responsive public comments that it 
receives on or before October 27, 2017. For information on the 
Commission's privacy policy, including routine uses permitted by the 
Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

Analysis of Agreement Containing Consent Orders To Aid Public Comment

Introduction

    The Federal Trade Commission (``Commission'') has accepted, subject 
to final approval, an Agreement Containing Consent Orders (``Consent 
Agreement'') from Integra LifeSciences Holdings Corporation 
(``Integra'') and Johnson & Johnson designed to remedy the 
anticompetitive effects resulting from Integra's proposed purchase of 
certain assets of Johnson & Johnson's Codman Neuro (``Codman'') 
division. The proposed Decision and Order (``Order'') contained in the 
Consent Agreement requires the parties to divest all rights and assets 
to Natus Medical Incorporated (``Natus'') related to Integra's 
intracranial pressure monitoring systems and fixed pressure valve shunt 
systems, as well as Codman's cerebrospinal fluid collection systems, 
non-antimicrobial external ventricular drainage catheters, and dural 
grafts.
    The proposed Consent Agreement has been placed on the public record 
for thirty days for receipt of comments by interested persons. Comments 
received during this period will become part of the public record. 
After thirty days, the Commission will review the comments received and 
decide whether it should withdraw, modify, or make the Consent 
Agreement final.
    Under the terms of the Asset Purchase Agreement signed on February 
14, 2017, Integra will acquire Codman in a transaction valued at 
approximately $1.0 billion (the ``Acquisition''). The Commission's 
Complaint alleges that the proposed Acquisition, if consummated, would 
violate Section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and 
Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. 
45, by substantially lessening competition in the U.S. markets for 
intracranial pressure monitoring systems, cerebrospinal fluid 
collection systems, non-antimicrobial external ventricular drainage 
catheters, fixed pressure valve shunt systems, and dural grafts. The 
proposed Consent Agreement will remedy the alleged violations by 
preserving the competition that otherwise would be lost in these 
markets as a result of the proposed Acquisition.

The Parties

    Integra, headquartered in Plainsboro, New Jersey, is a medical 
device company with worldwide operations and one of the largest 
surgical instrument suppliers in the United States. The company has two 
U.S. business units: Specialty Surgical Solutions and Orthopedics and 
Tissue Technologies. The Specialty Surgical Solutions division offers 
instruments and systems for, among other specialties, neurosurgery and 
critical care.
    Codman, part of Johnson & Johnson's DePuy Synthes Inc. business 
unit, is a global medical device company that offers a diverse 
portfolio of neurosurgery, neurovascular, and drug delivery products, 
including instruments and systems for hydrocephalus management, 
neurointensive care, and cranial surgery, as well as implantable drug 
infusion systems. The proposed transaction excludes Codman's 
neurovascular and drug delivery businesses.

The Relevant Products and Structure of the Markets

I. Intracranial Pressure Monitoring Systems

    Intracranial pressure monitoring systems are used in intensive care 
units and operating rooms to measure pressure inside the skull, which 
can increase in the event of traumatic brain injury, hydrocephalus, 
intracranial tumors, and other medical conditions. An increase in 
intracranial pressure can severely damage the brain or spinal cord and 
is a common cause of death in neurosurgical patients, making quick 
detection of pressure buildup critical. Intracranial pressure 
monitoring systems use a pressure-sensitive probe inserted through the 
skull to send measurements via a transducer cable to a monitor at the 
patient's bedside. Customers would not switch to an alternative product 
in response to a small but significant increase in the price of 
intracranial pressure monitoring systems.
    Integra and Codman are the only significant suppliers in the U.S. 
market for intracranial pressure monitoring systems, accounting for 68% 
and 26% of 2016 sales, respectively. The remainder of the market is 
comprised of small, fringe competitors that have limited competitive 
significance.

II. Cerebrospinal Fluid Collection Systems

    Cerebrospinal fluid collection systems drain excess cerebrospinal 
fluid and monitor pressures within the fluid. They consist of a plastic 
drainage bag, tubing, and other accessories that connect to a patient 
through an external ventricular drainage catheter. There are no viable 
alternatives to cerebrospinal fluid collection systems.
    Integra, Codman, and Medtronic are the only competitively 
significant suppliers of cerebrospinal fluid collection systems in the 
United States. Integra is the leading supplier with 57%

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of the market. Medtronic accounts for an additional 27% of the market, 
and Codman has a share of 14%. The next closest competitor is 
M[ouml]ller Medical, which offers a more complex technology and only 
accounts for a nominal share of the market.

III. Non-Antimicrobial External Ventricular Drainage Catheters

    External ventricular drainage catheters funnel excess cerebrospinal 
fluid from the brain to cerebrospinal fluid collection systems to 
relieve intracranial pressure. External ventricular drainage catheters 
are either antimicrobial or non-antimicrobial, and the two types 
constitute distinct antitrust markets because of the substantial 
differences between them. Non-antimicrobial external ventricular 
drainage catheters lack an antibiotic coating and are suitable for less 
critical patients; they also may be used to avoid the risk of 
antibiotic interference when diagnosing infections. They are 
significantly less expensive than antimicrobial external ventricular 
drainage catheters. Customers would not switch from non-antimicrobial 
external ventricular drainage catheters to the antimicrobial versions 
or any other product in response to a 5% to 10% increase in the price 
of non-antimicrobial external ventricular drainage catheters, in part 
because even with such a price increase, antimicrobial external 
ventricular drainage catheters would still be considerably more 
expensive.
    Integra and Codman account for 29% and 17% of the relevant market 
in the United States. The only other competitively significant firm is 
Medtronic, with a 51% share.

IV. Fixed Pressure Valve Shunt Systems

    Shunts are the primary tool that neurosurgeons use to treat 
hydrocephalus, or excessive accumulation of cerebrospinal fluid. Shunt 
systems redirect excess cerebrospinal fluid from the brain or spinal 
cord to another area of the body, usually the abdomen, for 
reabsorption. Shunt systems consist of three components: A ventricular 
catheter inserted into the brain, a valve to regulate the flow of the 
fluid, and another catheter that is threaded to the location where the 
fluid is emptied. Once implanted, the one-way valve in the shunt system 
regulates the pressure in the brain by governing the amount and 
pressure of cerebrospinal fluid passing through the catheter.
    There are two main types of hydrocephalus shunts: Fixed pressure 
valve shunts and programmable valve shunts. Fixed pressure valve shunts 
allow cerebrospinal fluid to pass through the shunt only when the 
pressure has exceeded some predetermined setting, which medical 
providers cannot adjust once implanted without another surgery. The 
settings on a programmable valve shunt system, which is significantly 
more expensive, can be adjusted non-invasively using specially designed 
magnetic tools. An insufficient number of customers are likely to 
switch to programmable valve shunts to prevent a small but significant 
increase in the price of fixed pressure valve shunt systems.
    Integra, Codman, and Medtronic are the only significant suppliers 
of fixed pressure valve shunt systems. Medtronic accounts for 55% of 
U.S. sales, and Integra follows at 23% share and Codman at 15% share. 
Aesculap and Sophysa hold small, fringe positions in the market and 
their products are not close substitutes to those of Integra and 
Codman.

V. Dural Grafts

    Dural grafts are used to repair or replace a patient's dura mater, 
the thick membrane that surrounds the brain and spinal cord and keeps 
cerebrospinal fluid in place. Integra leads the U.S. market with 66% 
share of 2016 sales. In addition, Integra manufactures approximately 
77% of the dural grafts sold in the United States. Medtronic, Codman, 
and Stryker account for 11%, 9%, and 8% of sales, respectively. Other 
suppliers account for only a nominal share of the market.

The Relevant Geographic Market

    The United States is the relevant geographic market in which to 
analyze the effects of the proposed Acquisition. These products are 
medical devices regulated by the U.S. Food and Drug Administration 
(``FDA''). Medical devices sold outside of the United States, but not 
approved for sale in the United States, do not provide viable 
competitive alternatives for U.S. consumers.

Competitive Effects of the Acquisition

    The proposed Acquisition would cause substantial competitive harm 
in the relevant markets. The parties are the only significant suppliers 
of intracranial pressure monitoring systems in the U.S. market, and two 
of only three significant suppliers of cerebrospinal fluid collection 
systems, non-antimicrobial external ventricular drainage catheters, and 
fixed pressure valve shunt systems in the United States. In the dural 
grafts market, a combined Integra/Codman would control the vast 
majority of the U.S. market and eliminate the close competition that 
exists between the parties today. Eliminating the head-to-head 
competition between Integra and Codman in all of these highly 
concentrated markets would allow the combined firm to exercise market 
power unilaterally, resulting in higher prices and reduced choice for 
customers in these markets.

Entry Conditions

    Entry in the relevant markets would not be timely, likely, or 
sufficient in magnitude, character, and scope to deter or counteract 
the anticompetitive effects of the proposed Acquisition. New entry 
would require significant investment of time and money to design and 
develop an effective product, obtain FDA approval, and develop clinical 
history supporting the long-term efficacy of a product. A new entrant 
must also establish a sales and marketing infrastructure, have or 
develop a track record of service and support, and offer a robust line 
of neurosurgical products sufficient to convince potential customers of 
the viability of its new product offerings. Such development efforts 
are difficult, time-consuming, and expensive, and often fail to result 
in a competitive product reaching the market.

The Consent Agreement

    The proposed Consent Agreement and Order remedy the competitive 
concerns raised by the proposed Acquisition by requiring the parties to 
divest to Natus all assets and rights to research, develop, 
manufacture, market, and sell Integra's intracranial pressure 
monitoring systems and fixed pressure valve shunt systems, as well as 
Codman's cerebrospinal fluid collection systems, non-antimicrobial 
external ventricular drainage catheters, and dural grafts. Integra is 
also required to divest its San Diego, California facility that 
manufactures a key component of its intracranial pressure monitoring 
systems. Additionally, to further ensure the divestitures are 
successful, the proposed Order requires the parties to supply Natus 
with cranial access kits for a limited time until Natus is able to 
secure supply of that product independently. The kit, which is often 
sold with the divestiture assets, includes items such as a hand drill, 
forceps, and sutures used during cranial surgery. The provisions of the 
Consent Agreement ensure that Natus becomes an independent, viable, and 
effective competitor in the respective U.S. markets in order to 
maintain the competition that currently exists.

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    Based in Pleasanton, California, Natus is a global healthcare 
company that provides screening, diagnostic, and monitoring solutions 
for its three business units: Neurology, newborn care, and hearing and 
balance care. Its neurology business includes systems that are highly 
complementary to the divestiture assets and test for a variety of 
medical conditions, including epilepsy, head injury, tumors, 
Parkinson's, and sleep apnea. Natus is well positioned to restore the 
competition that otherwise would have been lost pursuant to the 
proposed Acquisition.
    The parties must accomplish the divestitures and relinquish their 
rights to Natus no later than ten days after consummating the proposed 
Acquisition. If the Commission determines that Natus is not an 
acceptable acquirer, or that the manner of the divestitures is not 
acceptable, the proposed Order requires the parties to unwind the sale 
of rights to Natus and then divest the products to a Commission-
approved acquirer(s) within six months of the date the Order becomes 
final.
    To ensure compliance with the Order, the Commission has agreed to 
appoint a Monitor to ensure that Integra and Johnson & Johnson comply 
with all of their obligations pursuant to the Consent Agreement and to 
keep the Commission informed about the status of the transfer of the 
rights and assets to Natus. The proposed Order further allows the 
Commission to appoint a trustee in the event the parties fail to divest 
the products as required.
    The purpose of this analysis is to facilitate public comment on the 
Consent Agreement, and it is not intended to constitute an official 
interpretation of the proposed Order or to modify its terms in any way.

    By direction of the Commission.

Donald S. Clark,
Secretary.
[FR Doc. 2017-21291 Filed 10-3-17; 8:45 am]
 BILLING CODE 6750-01-P