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:

  1. Separation from service;
  2. Disability;
  3. Death;
  4. At a date or under a schedule specified at the time of deferral;
  5. Change in control of the corporation; or
  6. 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:

  1. Review all NQDCP documents and any other arrangements providing for deferred compensation (including employment agreements) that may be affected by the new rules.
  2. 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.
  3. Inform participants and any other employees who could be affected by any required changes.
  4. Coordinate with any outside parties such as plan administrators.
  5. 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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What's Inside



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Is Negligent Credentialing A Risk For Physician Practices?

 



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Marketing Your Patent: A Legal Perspective



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New Legal Requirements For Nonqualified Deferred Compensation Plans
 






       










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