See attached Indian Abroad article here at http www.indiaabroad-digital.  It is also publicly available (though in a rather cumbersome interface that makes viewing difficult) at:  http://www.indiaabroad-digital.com/indiaabroad/20111104?pg=10#pg10.

In the September 29, 2011 edition of the NEJM, Drs. Kesselheim and Rajkumar raise significant questions about the U.S. Supreme Court’s recent decision in Stanford University v. Roche Molecular Systems et al where a 7-2 majority ruled in favor of Roche, affirming the appellate finding that the Bayh-Dole Act does not create a presumption of institutional patent ownership on the basis of federal funding. Kesselheim et. al. highlight significant concerns and predict that the Roche decision will stifle innovation by: (i) increasing contractual jockeying between potential technology partners, (ii) increasing patent filing and prosecution by federal grantees, and (iii) ultimately threatening the ability of academic institutions to achieve reasonable returns while using federal dollars. Kesselheim et. al. conclude that an amendment to the Bayh-Dole Act is essential, and argue that “to make such an amendment more politically palatable, universities should reexamine and perhaps revamp their licensing practices to ensure that they are indeed acting as stewards of the public good, rather than simply seeking to maximize their own licensing revenues.”(1)

As a physician at an academic hospital, I salute the call for universities to be “stewards of the public good.” Having practiced corporate and intellectual property law in Silicon Valley since the late 1990’s, however, I am not sure that academic institutions should be treated differently as commercial entities. Universities and academic hospitals engage in commercial activities, as do their faculty. While such activities of course demand a necessary degree of regulation (e.g. monitoring conflicts to preserve academic integrity)(2) , the ability of these entities to participate in the marketplace relatively unfettered and relatively unaided might be critical to maintaining the most efficient and free marketplace.(3) It is at the very least a defensible position that neither universities (nor governments for that matter) should specially benefit from legislated presumptions of ownership that violate fundamental contract law, patent law, and/or freely negotiated agreements. The Supreme Court ruling in Stanford University v. Roche Molecular Systems et al might arguably be more likely to foster research and fruitful collaboration by protecting the ability of private entities including inventors, universities, and small companies to create and commercialize technology with the reasonable expectation that the benefits of novel inventorship will be preserved.(4)

Moreover, nothing in the Supreme Court’s ruling prevents academic institutions from revamping employment agreements, assignment agreements and employee policy manuals to ensure that academic and research institutions retain tighter control over employee activities and work product. Academic institutions will of course need to carefully weigh any such revamping against the need to attract faculty, researchers and staff who legitimately desire robust involvement in the private sector and in private commercial transactions. This kind of involvement has been the hallmark of innovative collaboration between the commercial sector and the academic sector.

Indeed, the Roche decision is not necessarily surprising given federal jurisprudence in analogous settings. Federal courts have shown repeated reluctance to insulate overtly noncommercial entities with special status when those entities engage in fundamentally commercial technology activities. In Farhang v. Indian Institute of Technology, a Silicon Valley technology company and California based entrepreneur filed claims in 2008 against an academic institution (that is also a governmental entity of the Republic of India) for alleged trade secret misappropriation, alleged breach of non-disclosure agreement, and alleged breach of joint venture. In 2010, the 9th Circuit declined to dismiss the defendant institution, noting that the academic and governmental entity had engaged in commercial activity and thereby fell under a well circumscribed sovereign immunity exception.(5)

For now it remains unclear whether the particular outcome in the Roche case was appropriate, noting that there were specific factual circumstances (and some admittedly counterintuitive legal principles on the technicalities of contractual assignment clauses) which make the Stanford position at least viscerally more appealing to this author. Regardless, from a transactional and litigation perspective, one critical lesson emerges from the Roche matter regardless of the nuts and bolts of the Supreme Court’s logic. Universities and private companies will need to do much more than tinker with language in existing boilerplate or freshly negotiated agreements, and the same is true for private companies entering joint ventures, engaging consultants, and the like. It is the often neglected step of actual investigation and diligence which plays out repeatedly with unexpected liabilities in litigation matters, acquisitions, and the private financing of technology companies. Contracting parties and potential joint venturers cannot merely rely on written representations but must roll up their sleeves and conduct actual diligence on the representations and/or reservations contained in typical intellectual property assignment agreements and outside consulting disclosures.

The language itself in an IP assignment clause or agreement, however iron clad it purports to be, is not enough. The third parties or employees executing such agreements may be private individuals or small entities with conflicting obligations and considerable unchecked intellectual property baggage. Such individuals or entities, bluntly speaking, often do not have the deep pockets or insurance to address any liability created by the third party technology that they often unknowingly bring to the table. Against this backdrop, it is essential to conduct diligence on any key consultant, potential joint venture partner, or recipient of confidential information, and to conduct far more rigorous diligence on third party engagements of faculty and staff.

The costs of such diligence will not be insignificant—but years of litigation and the costs of law and motion practice, pre-trial discovery, trial, and appeal are not either.

Disclosure: I am an attending physician in the Department of Medicine at Stanford University Hospital and Clinics. This article does not represent, embody or express the official views, perspectives, or opinion of Stanford University, its officers, or affiliates. As my readers know, I am principal and majority shareholder of SNS PLC (Sanjiv N. Singh, A Professional Law Corporation). SNS PLC is currently co-lead counsel in Farhang v. Indian Institute of Technology Kharagpur. This case is currently pending in U.S. District Court, Ninth Circuit. An order from the pending Farhang litigation is discussed above and cited below under Endnote 5.

References:

[1] Kesselheim, AS and Rajkumar, R.  N Engl J Med 2011; 365:1167-1169, September 29, 2011.

[2] Bok, D. Universities in The Marketplace:  The Commercialization of Higher Education. (Princeton University Press, 2003). See p. 145.

[3] The Statement of The BioTechnology Industry Organization On The Bayh Dole Act:  The Next Twenty Five Years.  Presented to The House Science And Technology SubCommittee On Technology And Innovation.  August 27, 2007.

[4] Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc., 563 U.S. No. 09-1159 (June 6, 2011).

[5] Farhang v. Indian Institute of Technology Kharagpur et al. ORDER denying Motion to Dismiss for Lack of Subject Matter Jurisdiction.  No. C-08-02658 RMW (January 26, 2010)

The internet has redefined persona.  And it certainly has redefined how we view professionals we trust with our lives, finances, and assets. Beginning as early as 1999, it was assumed that any legitimate professional should have some kind of internet footprint—and with that initial assumption, a community mandate emerged that any legitimate professional can be and should be reviewed and rated by the community of users searching the web.  The internet has transformed professional accountability into a real time, interactive dynamic.

For physicians, the internet has enabled online tracking of performance, satisfaction and allows multiple users to share information about the same provider.  Physicians and health providers are now fair game for a wide range of online rating scales.  The terrain is fairly uniform, most of the scales relying on some combination of objective and subjective criteria (wait times, bedside manner, communication, scheduling time, access) while also collating user (i.e. patient) reviews that are often highly specific, detail-rich, and quite subjective.  Board certification is disclosed, as is age, medical school and number of years since graduation.  Some of the most frequented and/or better known physician review websites include:  HealthGrades (suitably titled, considering that massive extinction level events like MCAT scores and grades in organic chemistry are the evolutionary bottlenecks that whittle down the population of pre-medical students so that only the allegedly “fittest” survive admission to medical school), Vitals (ironically titled since physicians rarely collect vitals on their own, have been known to fumble with blood pressure cuffs, and rely almost exclusively on nursing and triage staff to collect them), Angie’s List (not an escort service, and you should know it is more legitimate than Craigslist, includes fewer serial killers per region enrolled as users, and is widely used for vetting a vast array of services from rug cleaning to scoping your colon), and Yelp (the “barbaric yawp”, I mean “yelp”, of reviewing physicians by the masses), to name a few.

Conducting my own empiric study, using HealthGrades as the intervention of choice, I subjected a number of Stanford and UCSF internal medicine and medicine subspecialty providers to online review—the cohort was divided evenly between outstanding providers and average providers, based entirely on my own experience working with them in clinic or in the inpatient setting.  I also added a few “troubled” providers from both institutions, each of whom I had observed having less than ideal interactions with patients and/or their families (yes, they exist even at top centers of excellence like Stanford and UCSF).   The results, though clearly anecdotal, were illuminating to say the least:

-less than fifty percent of the providers I considered to be stellar (with whom I would trust my own family) were ranked highly on HealthGrades

-some of the “troubled” providers (who clearly should have pursued investment banking, and not medicine) received shockingly high scores

-older veteran providers (i.e. those who had been practicing for thirty or more years) often had no reviews and no scores

-the extremes seemed to be missed, with veteran providers having zero reviewers and very recent graduates also having zero reviewers

-inpatient providers were almost universally not reviewed unless they had an outpatient clinic

-the absolute number of reviews for each physician was shockingly low, ranging from three to five for the typical physician I searched

In summary, at least based on my own anecdotal, retrospective gloss, HealthGrades proved to be a not so sensitive litmus for detecting excellent physician performance, and seemed woefully underpowered, particularly given the complexity of the various criteria it tries to evaluate.  I conducted a similar experiment with Yelp.  Yelped physician reviews were often quite detailed (and indeed entertaining at times) and were often supported by far more reviews (better power).  That being said, the overall review framework still seemed disjointed and, like the typical Yelp experience with restaurants, very much hit-or-miss.   Physicians seem very much vulnerable to the local neighborhood bias (where it seems obvious that you sent an e-mail to local fans stating “Dear friends, neighbors and loved ones, please log on and rate me as extraordinary…”) or to the lone gunman bias (where the one patient who waited an hour to see you due to no fault of your own, has now used the internet to attribute all ills–their own and the world’s– to you and your office.)

Suffice it to say, the system is flawed and health researchers and health mavens have been pontificating since the mid 2000’s on the ills of the system.  One study out of Tufts concluded that most of the physician rating sites are far too kind, primed to collect information skewed towards positive performance, and also noted that there seemed to be less overall interest in reviewing physicians.  (J Gen Intern Med. 2010 Sep;25(9):942-6. Epub 2010 May 13. Lagu et. al. do a remarkable job of reviewing and analyzing the various physician review websites, providing useful data helping to characterize the portals themselves as well as the nature of their findings.  Lagu’s data suggest an even more extreme version of local neighborhood bias, where the physician herself writes an anonymous review replete with publication data, biographical data, and glowing accolades.)  Other commentators insist that the large majority of their colleagues within a given region are not being reviewed, leaving one to conclude that online doctor reviews perhaps only offer insight into the performance of the more tech savvy physicians or the performance of physicians caring for tech savvy patients.

No doubt, physician reactions have been varied.  On perhaps the more extreme and aggressive side, Medical Justice, a group seemingly devoted to protecting the reputation of physicians, proposes a number of unconventional and hyperlegal approaches by which the physician can combat lone gunman bias.  Most notably, among the various legal contraptions it sells to defamation-wary physicians, Medical Justice offers a template agreement which purportedly any physician can use to prevent a patient from posting comments online; reportedly, the patient agrees in advance, presumably as a precondition to receiving medical services, that they will not post comments on the internet about the medical service provided.  The enforceability of these clauses is highly questionable:  (i)  like similarly unenforceable anti competition clauses, the clauses seem improperly broad;  (ii) on first blush, the patient waivers appear to be potentially improper restraints on the exercise of first amendment rights;  (iii) the waivers are likely obtained under circumstances where patients will not understand the true nature of the restraints to which they are consenting; and (iv) contrary to the assertions of Medical Justice supporters, the restraint does not actually shift focus to the internet providers.  In fact, the waivers may pose far less danger to the review websites themselves, many of which may enjoy statutory protection from suit if they are merely acting as forums for information exchange and are not otherwise soliciting collection of improper information (see 47 U.S.C. § 230;  see also Nemet Chevrolet. Ltd. v. Consumeraffairs.com. Inc., 591 F.3d 250, 255 (4th Cir. 2009);  cf. Fair Housing Council v. Roommates.com, LLC, 521 F.3d 1157, 1174 (9th Cir.2008)).  In reality, Medical Justice’s waivers will likely acutely target individual patients, having the intuitively paradoxical result of holding an unsuspecting, lay patient liable while the website that published the review (and arguably multiplied any alleged damage to reputation) sits comfortably behind the protections of 47 U.S.C. § 230.

On the other end of the physician spectrum, the proposals are equally controversial though arguably several notches more credible.  In 2007, UCSF’s Bob Wachter, noted hospitalist (an understatement considering he is often credited with founding the hospitalist movement, assuming there was an actual “big bang” from which myriad highly skilled, white caped practitioners began roaming the wards, admitting patients, and improving the galaxy with quality control measures) proposed publishing physician board scores:

“Yes, you heard me right: I’d like the Board to tell me whether the doc was in 5th percentile on the certifying exam or the 87th. It doesn’t pass the smell test to say that we consider both these board certified docs to be undifferentiate-able. In this new era of transparency, if we physicians would want that information before choosing a doc for ourselves (and I sure would), then I believe that patients should have access to it as well.”

Click here for the full blog post.

I had coffee with Dr. Wachter (still can’t call him Bob…) a few months ago.  I have known him since attending medical school at UCSF (where he is Chief of Medical Services, Chief of the Hospitalist Service, and holds the Lynne and Marc Benioff Endowed Chair in Hospital Medicine). He mentored me on a first of its kind major policy commentary I published on Telemedicine that was published in the NEJM in 2008.  Suffice it to say, I have the utmost respect for him.  In person, over a cappuccino in the lovely UCSF café overlooking the park, he explained to me his rationale for the otherwise shocking board score proposal—that if physicians do not seize control of the review process, current online physician review sites will pervert the process and physician accountability will be driven by the random and sporadic nature of what is posted online by individual reviewers. The Tufts study and my own ad hoc, retrospective review of Stanford and UCSF providers seem to confirm Dr. Wachter’s concern, at the very least as a general principle.

I have no doubt that Dr. Wachter, as one of the fiercest, self-proclaimed iconoclasts of health reform, is acutely aware that his board score disclosure proposal poses a dangerous precedent.  As he is on the governing board of the ABIM, his views are certainly not to be underestimated or discounted. 

To that end, I offer my mentor and colleague a few thoughts in response.  First, board scores (as distinct from passing the boards) are not a reasonable metric for evaluating physician performance or patient satisfaction over the long term.  As with any highly trained profession, much of what is learned after licensing and board certification affects the quality of a practicing physician.  My own experience with my colleagues is that it is often the average board scoring physician that takes the extra step to question what they are doing, think about whether the prescribed steps in a clinical algorithm make sense for a particular patient, and really understand the patient’s overall clinical picture.  While of course there are physicians with high board scores who are excellent physicians, there are as many with lower but passing scores (keeping in mind the internal medicine boards are rigorous) who are excellent physicians as well.  The internal medicine boards is a multiple choice test;  medicine is not a multiple choice practice, and in fact when it is practiced in that manner, it often leads to unfortunate results. 

Harvard’s Bruce Landon observed (in a 2008 Archives editorial) that:  “Currently, there is little research relating performance on written cognitive examinations with actual clinical practice, so it is not clear to what extent performance on such examinations is reflective of individual physician practice. . .Nevertheless, the meaning of specific knowledge deficits on examinations is unclear, because, in practice, many physicians have available professional colleagues and consultants as well as additional information sources that they can use in real time to help them evaluate patients and formulate treatment plans. Therefore, knowledge deficits in the artificial setting of an examination do not imply that physicians will make mistakes in caring for patients.”  Landon’s full editorial was balanced and did not draw conclusions one way or the other;  it was written in response to the 2008 Holmboe et al. study published in the same issue.   

Second, and perhaps more importantly, disclosure of physician board scores would set a troubling precedent for physician empowerment and indeed seems to run directly contrary to the notion that board scores will somehow become the great leveler for physicians and avoid the irrational online forces of patient reviews and HealthGrades.  The reality is that physicians are arguably one of the most politically and economically disenfranchised groups in America.  The vast majority of physicians work an enormous number of hours and shoulder considerable personal and professional risk every hour of every day they work.  It is probably the best kept secret in the American, media-driven understanding of medicine (an understanding premised on Sanjay Gupta gallivanting the globe, House “bah humbugging” his way through the halls of a swank modern hospital,  and now The Doctors talk show…well…how do I say this politely…I’ll reserve comment) that modern day physicians are in truth in most instances meagerly compensated.  In fact, physicians are probably among the lower if not the lowest paid members of your skilled health provider team when objective criteria (length of training, nature of work performed and critical decisions made, hours worked, and risks assumed) are used to evaluate adequacy of compensation.  Disclosure of individual physician board scores would be yet another disenfranchising force in the ongoing physician struggle for a more unified and effective lobbying voice and more competitive compensation.  Physicians would suddenly be stratified into high board scorers and low board scorers, and inevitably insurance companies, hospitals, and other members of the health community would use this information (most likely improperly without real correlation to the performance of the actual physician) to make compensation decisions, administrative decisions, and potentially, reimbursement decisions. 

Specific board scores, as I view it, yield a noisy, unusable data set.  High board scores can be as distorting as local neighborhood bias, and the low board score as distorting as the lone gunman bias.  If board scores are to be used as any kind of equalizer for improving physician accountability, the task is to ensure that the vast majority of physicians employed have passed their respective boards and studied for it rigorously during residency, and to ensure that the board examination itself is a grueling and challenging exam.  The ABIM already is doing this, and creating an additional mandate to disclose individual board scores seems to be an inefficient allocation of resources and energy that could be better spent in tackling the more challenging issues of how to better empower and equip physicians in the age of accountability.

My life and career—none of it a master plan and much of it the product of good luck, happenstance, and the alignment of random events–is good fodder for my foray into blogdom. I have been practicing law for thirteen years, and am in my third year of practice as a physician. It is an absurdly frantic, pressure-cooker life at times, at least for now, and every day brims with truly remarkable people and events. Seven months from now, I’ll slow it down a bit and scale back the juggling to a more humane load. On July 1st, 2011, I return full time to SNS PLC, the practice I founded in 2002. After that, I will continue as a “nocturnist” (an emerging species of hospitalist), one night a week, at some busy hospital that needs me.

For now, the double life works more or less, with no small thanks to the revenue share and affiliate relationships my practice has nurtured over the years, and with the greatest thanks to a patient wife (who has twice my brain capacity and thus more free time from her busy life as a dermatology resident) who permits me to spend my weekends and nights, when I am not in the hospital, reviewing documents and drafting briefs on my client matters.

As of late, the legal cases are a veritable bounty of moral energy. Cases I was born to take, I tell myself, when I am awake over documents and it is burning midnight in the brightly lit corner of the front of our house. The cases are quintessential. They involve abuses of power, dishonesty, greed, misappropriation and protecting the rights of the aggrieved, whether it is the rights of the professional who was wronged or the very valuable rights of the little company that could. And all of these cases involve acts that, as I see it, were wrong, plain and simple.

It’s probably the “wrong” that drives me the most. I was always the little angry kid—no, not the big bully. The other one. No, not the pitiful, whiny one in the corner. The other one—the one who butted in and tried to help the victim. The indignant one, the…well, maybe now and then, the self-righteous one. That the “wrong” drives me is probably not surprising. It is also what drives me in medicine. Of course, the big bad defendant in medicine is a wily foe. If it’s not the terrible tumor, it’s the gnarly pneumonia. Any one of these malfeasants could breach your patient’s body without remorse, loot them of their life core, and sack a soul if given half the chance.

As a night doctor, you are the gatekeeper and to some degree, the protector for the night. You bring the patient into the hospital, stabilize them (hopefully), and make the family and loved ones believe there is a way out of the tight corner where their love one is slumped. You set the patient on a journey that will hopefully be smooth and finite, launching them on a small well made craft with the right medicine and a tincture of hope, strength and humor that gets them through to the AM and out of the hospital as soon as possible.

So why am I rambling about this somewhat comical dichotomized life in my first blog post? As a blogger, author, or speaker, you are given a gift. The gift is your audience, and it is yours to squander or enjoy. While this first post is of course a justification, a confession, and explanation–all of which you would expect–it is above all a thank you. A thank you that you actually took the time to click on the Google link that popped up and brought you unexpectedly to this blog site. A thank you with a promise to bring both perspectives to the table but to teach them some manners—the lawyer in me and the doctor in me, both disciplines that have seized control of at least a good half of my brain, both disciplines that have been criticized for their arrogance, bullheadedness and lack of foresight. And yet both disciplines that share the unique challenge of shepherding others through unfamiliar and sometimes terrifying territories.

Of course, in the spirit of full disclosure, the blog is a mutant of my law practice, born of the SNS PLC website and a business decision to revamp the original practice website, scraps of html that should have been cordoned off a few years ago to the “closed exhibit” section of the internet. But regardless of how the blog was born, I give you my word I will bring my whole life to bear on it.

One of my colleagues in medicine once said to me, “I could tell you are a lawyer. You just have this way…” And the comment gave me pause. Maybe I am the “wolf in a white coat” as I had been labeled once. On the other hand, I am fairly certain my desire to treat and my desire to claim for the wronged come from the same place. My legal life and medical life really are not all that different.

Or is that just a deluded rationalization for leading this double life?

In reading this blog, some of you might just diagnose me with that illness. Others will be the judge of that.