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healthlaw reference
- December 2004 -
Is Negligent Credentialing A
Risk For Physician Practices?
By
Michael A. Cassidy,
Esq.
A recent Pennsylvania Superior Court case decision, Sutherland v.
Monongahela Valley Hospital, 2004 PA Super 245 (July 12, 2004),
holds that the doctrine of negligent credentialing in Pennsylvania does
not apply to physician practices, but the conclusion may provide a false
sense of security.
Negligent credentialing is a relatively recent tort doctrine holding
healthcare institutions liable to patients for the malpractice of
physicians practicing on the medical staff of the institution. Although
the hospital or healthcare institution may or may not be liable under a
theory of agency, the negligent credentialing doctrine of liability is a
separate doctrine and makes the hospital independently liable for the
credentialing decision. There have been cases decided in various
jurisdictions on this issue. The leading case in Pennsylvania is
Thompson v. Nason Hospital, 527 PA 330 (Pa. 1991), which held that a
hospital has the following duties:
- A duty to use reasonable care in the maintenance of safe and
adequate facilities and equipment;
- A duty to select and retain only competent physicians;
- A duty to oversee all persons who practice medicine within its
walls as to patient care; and
- A duty to formulate, adopt and enforce adequate roles and polices
to ensure quality care for the patients.
Sutherland declines to extend that theory of liability through
physician practices, stating:
"In Thompson, the Supreme Court recognized that ‘the corporate
hospital of today has assumed the role of the comprehensive health
center with responsibility for arranging and coordinating the total
healthcare of its patients.’ The same cannot be said for a physician’s
practice group. Accordingly, we decline Dr. Alioto’s invitation to
extend the negligence principles contemplated by Thompson to
the case sub judice".
Sutherland may provide only cold comfort to physicians. Under
Pennsylvania law, physicians are liable for their own malpractice under
several legal principles:
- Physicians are always liable for their own acts of malpractice,
including the supervision of non-physician providers;
- Physicians will be vicariously liable for the malpractice of other
physicians in medical practices organized as partner- ships or sole
proprietorships, even if the physician himself was not involved in the
case, under various theories of agency and vicarious liability, but
physicians will not be liable for the malpractice of others if they
practice in professional corporations or restricted professional
companies (RPCs), which are the limited liability company version of a
professional practice; and
- Professional corporations and RPCs as entities will be vicariously
liable for the malpractice of their agents, i.e., the physicians and
other healthcare practitioners practicing under the auspices of the
practice.
Negligent credentialing is a distinct theory of liability, because
the negligent credentialing act itself, i.e. the act of allowing a
physician to practice or the granting of clinical privileges when the
entity knows or should have known that the physician was not competent
to perform the permitted procedures, creates the liability of the
practice entity, not the agency relationship. Prior to the establishment
of the theory of negligent credentialing, hospitals were routinely
absolved from liability for the physicians practicing at the hospitals,
because the physicians were deemed to be independent contractors,
thereby negating the agency connection between the hospital and the
physician.
The Sutherland decision does not absolve professional
corporations and other practice entities from liability for the
physician’s malpractice under any theory of agency or vicarious
liability. The practice entity will remain liable under those theories.
The Sutherland decision simply states that the Superior Court of
Pennsylvania did not extend the theory of negligent credentialing to
professional corporations.
We caution physicians not to use this decision as the basis for
neglecting their duties to assure that physicians practicing within
their practice are competent. We doubt that the Sutherland case
would be decided similarly or affirmed under facts in which other
physicians in the practice were aware of a particular physician’s
professional problems and shortcomings, but permitted the physician to
remain within their practice regardless. The basis of the distinction
between hospitals and physician practices in the Sutherland case
is the theory of corporate liability and the hospital’s assumption of
the responsibility for arranging and coordinating care. It is doubtful
that this distinction would "hold water" in any large or multi-specialty
medical practice and, once that distinction is breached, there will be
no basis for treating large physician practices differently from small
physician practices. It will not take much for a court, faced with
genuine personal damages and actual knowledge by physicians of a problem
which they failed to address, to dispatch the Norman Rockwell idea of
physician practices and conclude that the theory of corporate liability
should apply to them as well as hospitals.
Healthcare practices in Pennsylvania should not maintain from
misguided reliance that the Sutherland case will insulate them
from the malpractice of their colleagues.
Michael Cassidy
is a shareholder in the firm’s Business and Finance Department and Chair
of the Health Care Practice Group. If you
have any questions about how this case might affect your practice,
please contact Mike at 412.594.5515 or via e-mail at
mcassidy@tuckerlaw.com.
Marketing Your Patent: A
Legal Perspective
Ralph F. Manning,
Esq.
Patent protection for your invention is the first step in
seeking monetary rewards and recoupment of your research and development
costs. This article will provide patent holders key issues to consider
in capitalizing on their patent.
To properly market a patent, the patent holder should commercialize a
product or process in commercial quantities to meet the applicable
market demands in a timely manner at profitable and competitive pricing,
either on its own or through strategic partnerships or carefully
developed licensing to third parties.
Commercialization and Marketing Issues to
Consider
You can market your product by manufacturing the product or
installing the process in-house or by licensing or assigning, in whole
or in part, the patent rights to third parties. The steps in determining
how to market your patent depend upon the answers to the following
questions:
1.) Who are the main players in the industry related to the patent?
Have all appropriate applications and industries for your patented
product or process been identified and evaluated? What is your worldwide
market and market potential for the patented process, product or method?
Who are the competitors? What market share will you reasonably be able
to obtain and at what costs, revenues and profits? How, where and with
whom will your product or process be marketed and sold? You must develop
a foolproof marketing plan and budget which is
achievable in a timely manner.
2.) It is critical that the patented product, process or method
results in products or services of the highest quality which are able to
be produced on a commercial scale and in commercial quantities to meet
customer demand as needed. What are the roadblocks in costs to achieve
this goal? Product or process quality problems may arise in the
transition from pilot scale production to commercial production and must
be anticipated, identified and resolved prior to contracting with
prospective customers, prospective licensees and other third parties.
3.) Do you intend to sell, develop and commercialize the product,
process or method disclosed in the patent yourself? Is this technology a
ground breaking innovation or does it supplement intellectual property
held by another party? Can you put all the pieces together and create a
new entity? Is it feasible to obtain sufficient capital funding to
construct, own or lease a facility to manufacture the patented product
or to install the patent process or method? Are such funding and actions
profitable and supported by an appropriate business plan?
4.) The funding and sources of capital are critical elements in
marketing your patent. Funding can come from a variety of sources
including internal reserves, debt financing, equity financing
(additional investors, venture capitalists, angel investors), federal,
state and local governmental grants and loans, strategic partners and
financial partners. Do you have competent and experienced financial
consultants who can assist you in this process? If you do not have
financial contacts or sources of funding, your marketing goals and plans
will likely fail, no matter how unique and beneficial your patented
product and/or process. Obtaining money from third parties can be a very
frustrating and highly competitive process, and is the most common
reason why a patented product or process fails to be marketed
successfully.
5.) If you choose to license this technology, in whole or in part, to
third parties, will you do so on an exclusive or a non-exclusive basis
or a combination? Be very careful if you use exclusive licenses - keep
such licenses narrow in scope and include quotes. What is the best
available royalty arrangement for this license, e.g. lump sum and/or
percent of sales?
The answers to these questions will help to determine the best
approach in the marketplace for the license, sale and/or other
commercialization of your patent rights.
How Much Should You Disclose?
Whether you are seeking a strategic relationship with a competitor or
are intending to give up, sell and/or license all or part of your patent
rights, deciding how much information to disclose and at what point in
the negotiations to disclose such information are delicate issues.
Generally, if you are a patent owner, all of the information in the
patent is already public knowledge. The issue then becomes how much
development, proprietary information and improvements have been achieved
subsequent to obtaining the patent. In any event, you should always
enter into a mutual nondisclosure agreement and always involve
competent, experienced and ethical marketing professionals and attorneys
in the patent marketing process.
Case Study Summary
A holder of a patent issued in March 2000 for a disposal and portable
urinary capturing device knows that the device will help long-term and
acute-care customers, including 50 percent of nursing home residents and
many persons with disabilities, including those confined to homecare or
wheelchairs.
The patent holder determined it was unable to manufacture the product
in commercial quantities with its own resources. Major U.S. companies
manufacturing diapers and specialty diapers were unwilling to license or
partner with the patent holder without requiring unreasonable
concessions. The patent holder’s main competitor was in the process of
manufacturing plastic bottles with a low unit cost and a low sales
price. In contrast, the patent holder’s product has a compact and simple
design, and is disposable, sanitary and very affordable. The patent
holder eventually secured manufacturing costs which are highly
competitive with the plastic bottle concept of the competitor.
With the assistance of the Pittsburgh Life Sciences Greenhouse
executives and other consultants, the patent holder is pursuing
manufacturing the product in China, where manufacturing and machinery
costs are 10 percent of U.S. costs. The patent holder is pursuing
contracts with home health product agents and dealers and with national
pharmacy firms in order to achieve the minimum commitment required by
the Chinese manufacturers.
The product has no significant regulatory requirements, but is not
covered by direct reimbursement from a healthcare viewpoint. The product
is not normally appealable to venture capitalists since it is a one shot
type product. However, the patent holder has determined that it should
be able to capture 10 percent of the market of nursing home residents
(approximately $43.8 million annually) and 10 percent of the remaining
incontinent market (approximately $312 million annually).
The key to the patent holder’s success will be in obtaining binding
commitments from its potential customers in the areas of national and
regional pharmacies and home health supply companies. As yet, the patent
holder has still not manufactured its product on a commercial scale in
commercial quantities.
Obstacles often arise when it comes to manufacturing and marketing
your patented product or process. Prudent investment of your time
immediately upon issuance of your patent can save valuable resources
later on.
Tucker Arensberg has an experienced, business-oriented intellectual
property law team to assist you in protecting, developing and
commercializing your patent. If you have any questions or need
assistance with these matters, please contact Ralph Manning at
412.594.5540 or via e-mail at
rmanning@tuckerlaw.com.
New Legal Requirements For
Nonqualified Deferred Compensation Plans
By
Michelle L, Kopnski,
Esq.
The American Jobs Creation Act, signed into law by
President Bush on October 22, 2004, significantly alters the federal
income tax rules governing non-qualified deferred compensation plans
("NQDCPs"). Most employers will be required to amend their existing
NQDCPs and to operate those plans under the new rules in order to avoid
the immediate taxation of deferral amounts, in addition to the
imposition of interest and penalties.
The new rules broadly define a NQDCP as any plan or arrangement that
provides for the deferral of compensation other than certain qualified
employer plans. NQDCPs include elective salary deferral plans, bonus
deferral plans, supplemental executive retirement plans (SERPs), stock
appreciation rights (SARs) and severance pay plans. In fact, any
contract or agreement which provides for the deferral of compensation,
including individual employment agreements, change in control agreements
or termination agreements, may be considered a NQDCP for purposes of the
new rules. The new rules apply to NQDCPs which cover employees, as well
as NQDCPs which cover directors, independent contractors and
consultants.
In the event that a NQDCP fails to meet the requirements of the new
rules, all compensation deferred under that plan in that taxable year,
and all compensation deferred under that plan in all preceding taxable
years, will be included in the gross income of the participant. In
addition, the amount that must be included in gross income is subject to
(1) a penalty equal to 20 percent of such amount and (2) interest
calculated at the IRS underpayment rate plus one percent.
In general, the new rules involve three areas: the timing of the
distribution of deferred compensation, the timing of an election to
defer compensation, and the funding of deferred compensation.
Under the new rules, distribution of deferred compensation may be
made only in the following circumstances:
- Separation from service;
- Disability;
- Death;
- At a date or under a schedule specified at the time of deferral;
- Change in control of the corporation; or
- The occurrence of an unforeseeable emergency.
It is no longer permissible to accelerate the distribution of
deferred compensation. For example, NQDCPs may no longer permit
participants to receive immediate payment of deferred compensation in
exchange for the forfeiture of a certain percentage of the benefit
(i.e., a "haircut" provision).
Generally, the new rules require that deferral elections must be made
no later than the close of the taxable year preceding the taxable year
in which the deferred compensation is earned. For the initial year of
eligibility, deferral elections must be made within 30 days of the
initial eligibility date. For "performance based" compensation (such as
bonuses), deferral elections must be made no later than six months
before the end of a 12 month performance period. The new rules also
place substantial restrictions on re-deferral elections and any change
in form of payment.
Although the essence of a NQDCP is the fact that it is "unfunded,"
and therefore, any assets set aside to make distributions remain subject
to the claims of general creditors, some employers nevertheless devised
methods to create funding arrangements to safeguard such assets. Under
the new rules, any funds set aside in a trust (such as a rabbi trust) or
any other funding vehicle held outside of the United States, are
immediately taxable to the participant. Employers also often created
funding arrangements pursuant to which assets were restricted to payment
of deferred compensation upon a change in the financial health of the
employer. Again, under the new rules, such funds are immediately taxable
to the participant.
The new rules apply to amounts deferred on or after January 1, 2005.
Amounts deferred in taxable years prior to that date will be subject to
the new rules if the plan under which the deferral is made is materially
modified after October 3, 2004. Amounts deferred prior to January 1,
2005, under a plan that is not materially modified after October 3,
2004, will not be subject to the new rules.
It is important for employers to take steps immediately to make
certain that their NQDCPs have and retain the desired tax consequences.
The following actions should be taken:
- Review all NQDCP documents and any other arrangements providing
for deferred compensation (including employment agreements) that may
be affected by the new rules.
- Identify and amend any provisions of such NQDCPs and arrangements
that must be modified to ensure compliance with the new rules, or
consider the adoption of new NQDCPs that comply with the new rules.
- Inform participants and any other employees who could be affected
by any required changes.
- Coordinate with any outside parties such as plan administrators.
- Review the employer’s overall compensation policies to determine
if any changes would be beneficial.
Michelle Kopnski is an attorney in the firm’s Health Care Practice
Group. For more information, please contact Michelle at 412-594-5522 or
mkopnski@tuckerlaw.com.
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