A Lawsuit Over Healthcare IT Whistleblowing and Wrongful Discharge: Malin v. Siemens Healthcare

"Any sufficiently advanced incompetence is indistinguishable from malice." - Grey's law

At an Aug. 2009 post "Why Siemens Healthcare Fails" I described medical informatics talent management issues that were apparent in a job posting at Siemens Medical Solutions, a company that a decade ago seemed to value medical informatics expertise. (They in fact wanted to hire me then, an offer former employees tell me I was fortunate to have rejected due to a better offer from pharma).

I now note a July 2007 healthcare IT-related lawsuit against the same company (and its summary dismissal) of which I was unaware when I wrote the above post.

A physician, Murray Malin, MD [note: I do not know this person and have never had contact with him - ed.], working for Siemen's medical IT subsidiary filed a July 2007 lawsuit for wrongful termination after raising safety issues with Siemens HIT designed for critical care.

The action initially began in late 2005 as a complaint against Siemens Health Services USA and Siemens Medical USA (which I shall refer to in this post as "Siemens Medical" for the sake of simplicity) to the Occupational Safety and Health Administration (OSHA) of the Department of Labor. This was done under the whistleblower protection provisions of Title VIII of the Sarbanes-Oxley Act of 2002 (SOX).

The OSHA complaint was followed by a pro se lawsuit in federal court. The lawsuit's specifics are covered in the following four court documents (PDF). The events described could quite possibly serve as a true poster example of all that's wrong in the too-often perverse world of health IT.

Sen. Grassley, take note.

Here are the court documents:

1. The Complaint: Complaint_Malin_vs_siemens_medical.pdf (3.3 Mb PDF)

2. Siemens Answer to Complaint: Complaint_answer_Malin_vs_siemens_medical.pdf (148 Kb PDF)

3. Memorandum Opinion: Memorandum_opinion_Malin_vs_siemens_medical.pdf (22 Kb PDF)

4. Judge Messitte opinion, US District Court Maryland: MalinvSiemensMedicalOpinion&Order07cv1896.pdf (97 Kb PDF)

(I have written about health IT problems extensively on this blog and at my academic website on HIT failure. These include but are not limited to: medical informatics specialists ignored by nonclinician IT personnel [the link is to another case involving critical care]; inverted and paradoxical organizational structures where IT facilitators become HIT project leaders and clinical leaders become HIT project facilitators; ill-conceived and poorly implemented mission hostile health IT; perverse and in fact clinically cavalier IT "politics"; failure to obtain patient informed consent as if health IT is an elite world not subject to the same ethical obligations as medicine; probable violations of Joint Commission safety standards and hospital executive fiduciary obligations, and numerous others.)

Here is a synopsis of why I think this 2007 lawsuit against Siemens Medical may be a sentinel case with regard to dysfunction in the healthcare IT industry, based upon the information in the court documents (read them yourself at the links above):

• Siemens Medical's physician internal consultants (skilled anesthesiologists/informatics specialists), apparently in writing and including a remediation plan, opined that an IT system developed for critical care had numerous severe flaws, of sufficient seriousness that in their opinion the systems could harm or even kill patients if deployed;

• These were warnings of defects and flaws in IT in the worst possible medical environment, critical care with the sickest and most vulnerable of patients, not some ambulatory clinic or primary care office;
  

• Allegations were raised that the warnings were ignored, with at least one of the physicians, Dr. Malin, who was strongly concerned and vocal about the risks then being told his position was being eliminated. [It is not a surprise to note this rings alarm bells about the possibility of wrongful discharge based on retaliation and/or "greasing the skids" to eliminate potential whistleblowers or "non-team players" who could delay release of the software and affect revenue - ed.];
  

• The company possibly ignored the remediation plans of their own clinician/informatics experts;

• There were allegations of company misrepresentations about the new system to the FDA;

• There were allegations of decision making on these issues by non-clinician IT managers lacking healthcare or healthcare informatics expertise.

• A wrongful discharge complaint and then lawsuit were filed by Dr. Malin on the basis of violation of the whistleblower protection provisions of the Sarbanes-Oxley Act of 2002 (SOX), 18 U.S.C. § 1514A ("Civil action to protect against retaliation in fraud cases - Whistleblower Protection for Employees of Publicly Traded Companies");
  

• The suit was dismissed on the apparent technicality that Siemens Medical in the U.S. is not subject to the provision in the SOX Act as is the publicly-traded corporate parent, Siemens AG; from document #4, pg 15:
  

... Health Services is a wholly-owned subsidiary of Siemens Med ... Siemens Med is a wholly-owned subsidiary of Siemens Corporation, which is indirectly owned, through two intervening layers, by Siemens AG, a German company that is publicly traded as defined by § 1514A of SOX ... Of these entities, only Siemens AG is a publicly-traded company. While both Health Services and Siemens Med are incorporated in Delaware and located in Malvern, Pennsylvania, they are separately incorporated entities.

• Siemens Medical in their response to the suit denied the most severe allegations regarding the IT defects, but this issue was not followed up upon due to the lawsuit's dismissal on SOX issues despite the obvious potential public hazards the allegations of IT defects could represent;

• In fact a US District Judge in the case, Peter J. Messitte, in the period after allowing Malin to prove the validity of SOX towards his case, opined that "No other discovery will be permitted, including but not limited to the alleged safety problems of Defendants’ product", document 4 above, Judge Messitte opinion, US District Court Maryland, pg. 25. [While perhaps understandable from a legal perspective, injured or dead patients don't really care about what legal precedents got them into the injured or dead state - ed.]
  

• Siemens Medical admitted in their responses to the suit that some of the software in question, actually put in use in hospitals, was in fact "beta" software, i.e., experimental (per Item 38 in 'Siemens Answer to Complaint' document).

This latter admission also raises numerous questions. The answering of these questions seems imperative on the grounds of public interest in a rigorous and safe healthcare IT industry, an industry that, in effect practicing medicine by machine proxy, should respect patient rights and the Hippocratic Oath:

• Were patients asked to give informed consent for the beta software's usage in their critical care?

• Were clinicians informed of the fact that the software was experimental?

• Were "hold harmless" clauses demanded from the customers?

• Did hospital executives violate their fiduciary and Joint Commission safety standards obligations by purchasing this beta software, either willfully, or inadvertently due to Siemens' possible concealment of the defects their own specialists wrote up?

• Would the use of beta-version software in critical care areas with possible known defects represent a human rights violation?
  

What is not clear in these court documents is whether any patient harm was attributed to these HIT systems. This is not the important issue, however. The issue is risk and risk mitigation through rigor. One should not depend on good fortune to avoid predictable patient harm, especially when those predictions are from internal experts and are explicit.

I therefore believe that the potential HIT safety issues raised in this case and the vendor's responses to internal warnings merit further investigation, especially regarding the specialist's concerns about the harmful defects in the software.

These medical concerns and whether they were improperly dismissed were apparently never investigated impartially, due to the lawsuit's rejection by the court on technical grounds of SOX inapplicability. See the attached court documents.

It is my personal opinion upon reading these court documents, and knowing this industry, that Dr. Malin was shafted. What is legal is not always just.

One can only wonder how many other cases like this exist v. Siemens or other healthcare IT vendors. Perhaps the investigation being conducted by Sen. Grassley will shed more light on this.

Finally, I note with sad irony, if these allegations are true, the doppelganger of a German-named company dismissing the concerns of an apparently Jewish physician about medical experiments possibly killing people.

-- SS

A Lawsuit Over Healthcare IT Whistleblowing and Wrongful Discharge: Malin v. Siemens Healthcare

"Any sufficiently advanced incompetence is indistinguishable from malice." - Grey's law

At an Aug. 2009 post "Why Siemens Healthcare Fails" I described medical informatics talent management issues that were apparent in a job posting at Siemens Medical Solutions, a company that a decade ago seemed to value medical informatics expertise. (They in fact wanted to hire me then, an offer former employees tell me I was fortunate to have rejected due to a better offer from pharma).

I now note a July 2007 healthcare IT-related lawsuit against the same company (and its summary dismissal) of which I was unaware when I wrote the above post.

A physician, Murray Malin, MD [note: I do not know this person and have never had contact with him - ed.], working for Siemen's medical IT subsidiary filed a July 2007 lawsuit for wrongful termination after raising safety issues with Siemens HIT designed for critical care.

The action initially began in late 2005 as a complaint against Siemens Health Services USA and Siemens Medical USA (which I shall refer to in this post as "Siemens Medical" for the sake of simplicity) to the Occupational Safety and Health Administration (OSHA) of the Department of Labor. This was done under the whistleblower protection provisions of Title VIII of the Sarbanes-Oxley Act of 2002 (SOX).

The OSHA complaint was followed by a pro se lawsuit in federal court. The lawsuit's specifics are covered in the following four court documents (PDF). The events described could quite possibly serve as a true poster example of all that's wrong in the too-often perverse world of health IT.

Sen. Grassley, take note.

Here are the court documents:

1. The Complaint: Complaint_Malin_vs_siemens_medical.pdf (3.3 Mb PDF)

2. Siemens Answer to Complaint: Complaint_answer_Malin_vs_siemens_medical.pdf (148 Kb PDF)

3. Memorandum Opinion: Memorandum_opinion_Malin_vs_siemens_medical.pdf (22 Kb PDF)

4. Judge Messitte opinion, US District Court Maryland: MalinvSiemensMedicalOpinion&Order07cv1896.pdf (97 Kb PDF)

(I have written about health IT problems extensively on this blog and at my academic website on HIT failure. These include but are not limited to: medical informatics specialists ignored by nonclinician IT personnel [the link is to another case involving critical care]; inverted and paradoxical organizational structures where IT facilitators become HIT project leaders and clinical leaders become HIT project facilitators; ill-conceived and poorly implemented mission hostile health IT; perverse and in fact clinically cavalier IT "politics"; failure to obtain patient informed consent as if health IT is an elite world not subject to the same ethical obligations as medicine; probable violations of Joint Commission safety standards and hospital executive fiduciary obligations, and numerous others.)

Here is a synopsis of why I think this 2007 lawsuit against Siemens Medical may be a sentinel case with regard to dysfunction in the healthcare IT industry, based upon the information in the court documents (read them yourself at the links above):

• Siemens Medical's physician internal consultants (skilled anesthesiologists/informatics specialists), apparently in writing and including a remediation plan, opined that an IT system developed for critical care had numerous severe flaws, of sufficient seriousness that in their opinion the systems could harm or even kill patients if deployed;

• These were warnings of defects and flaws in IT in the worst possible medical environment, critical care with the sickest and most vulnerable of patients, not some ambulatory clinic or primary care office;
  

• Allegations were raised that the warnings were ignored, with at least one of the physicians, Dr. Malin, who was strongly concerned and vocal about the risks then being told his position was being eliminated. [It is not a surprise to note this rings alarm bells about the possibility of wrongful discharge based on retaliation and/or "greasing the skids" to eliminate potential whistleblowers or "non-team players" who could delay release of the software and affect revenue - ed.];
  

• The company possibly ignored the remediation plans of their own clinician/informatics experts;

• There were allegations of company misrepresentations about the new system to the FDA;

• There were allegations of decision making on these issues by non-clinician IT managers lacking healthcare or healthcare informatics expertise.

• A wrongful discharge complaint and then lawsuit were filed by Dr. Malin on the basis of violation of the whistleblower protection provisions of the Sarbanes-Oxley Act of 2002 (SOX), 18 U.S.C. § 1514A ("Civil action to protect against retaliation in fraud cases - Whistleblower Protection for Employees of Publicly Traded Companies");
  

• The suit was dismissed on the apparent technicality that Siemens Medical in the U.S. is not subject to the provision in the SOX Act as is the publicly-traded corporate parent, Siemens AG; from document #4, pg 15:
  

... Health Services is a wholly-owned subsidiary of Siemens Med ... Siemens Med is a wholly-owned subsidiary of Siemens Corporation, which is indirectly owned, through two intervening layers, by Siemens AG, a German company that is publicly traded as defined by § 1514A of SOX ... Of these entities, only Siemens AG is a publicly-traded company. While both Health Services and Siemens Med are incorporated in Delaware and located in Malvern, Pennsylvania, they are separately incorporated entities.

• Siemens Medical in their response to the suit denied the most severe allegations regarding the IT defects, but this issue was not followed up upon due to the lawsuit's dismissal on SOX issues despite the obvious potential public hazards the allegations of IT defects could represent;

• In fact a US District Judge in the case, Peter J. Messitte, in the period after allowing Malin to prove the validity of SOX towards his case, opined that "No other discovery will be permitted, including but not limited to the alleged safety problems of Defendants’ product", document 4 above, Judge Messitte opinion, US District Court Maryland, pg. 25. [While perhaps understandable from a legal perspective, injured or dead patients don't really care about what legal precedents got them into the injured or dead state - ed.]
  

• Siemens Medical admitted in their responses to the suit that some of the software in question, actually put in use in hospitals, was in fact "beta" software, i.e., experimental (per Item 38 in 'Siemens Answer to Complaint' document).

This latter admission also raises numerous questions. The answering of these questions seems imperative on the grounds of public interest in a rigorous and safe healthcare IT industry, an industry that, in effect practicing medicine by machine proxy, should respect patient rights and the Hippocratic Oath:

• Were patients asked to give informed consent for the beta software's usage in their critical care?

• Were clinicians informed of the fact that the software was experimental?

• Were "hold harmless" clauses demanded from the customers?

• Did hospital executives violate their fiduciary and Joint Commission safety standards obligations by purchasing this beta software, either willfully, or inadvertently due to Siemens' possible concealment of the defects their own specialists wrote up?

• Would the use of beta-version software in critical care areas with possible known defects represent a human rights violation?
  

What is not clear in these court documents is whether any patient harm was attributed to these HIT systems. This is not the important issue, however. The issue is risk and risk mitigation through rigor. One should not depend on good fortune to avoid predictable patient harm, especially when those predictions are from internal experts and are explicit.

I therefore believe that the potential HIT safety issues raised in this case and the vendor's responses to internal warnings merit further investigation, especially regarding the specialist's concerns about the harmful defects in the software.

These medical concerns and whether they were improperly dismissed were apparently never investigated impartially, due to the lawsuit's rejection by the court on technical grounds of SOX inapplicability. See the attached court documents.

It is my personal opinion upon reading these court documents, and knowing this industry, that Dr. Malin was shafted. What is legal is not always just.

One can only wonder how many other cases like this exist v. Siemens or other healthcare IT vendors. Perhaps the investigation being conducted by Sen. Grassley will shed more light on this.

Finally, I note with sad irony, if these allegations are true, the doppelganger of a German-named company dismissing the concerns of an apparently Jewish physician about medical experiments possibly killing people.

-- SS

Why Siemens Healthcare Fails

I have written numerous times on this blog about the blind-man ignorance displayed by many healthcare IT and biomedical companies regarding Medical Informatics expertise.

As a graduate and postdoctoral-level Medical Informatics educator with considerable applied expertise, as well as talent management experience, I teach students of a variety of healthcare backgrounds that the only way to overcome the sociotechnical complexities (i.e., issues at the intersection of people and their interaction with technology) of HIT is via education and considerable experience.

Once students become aware of the nuances and complexities of HIT in real-world clinical settings (if not already enmeshed in such environments), they find the lessons learned from substantial and rigorous immersion into a wide corpus of literature, overseen by someone with expertise, profoundly important towards advising their own organizations in avoiding pitfalls and achieving success.

I note that I used to admire German engineering rigor, but after seeing ill conceived, misguided position ads like the following from Siemens Healthcare, I am having sincere doubts about that country's current prowess in that domain.

I refer to a recent ad (here at the moment) for a Physician Consultant:

Job Description

Siemens Medical Solutions is the industry leader in Healthcare IT technology and Clinical workflow solutions. We are seeking to hire an experienced Physician for our Professional Consulting Services Organization. In this highly visibly position, you will support the implementation of Siemens products (such as Soarian ) in hospitals nationwide. To be considered for this position, qualified candidates must have the following credentials and experience:

• U.S. based Medical degree with at least five years of post-residency experience in large multi-specialty practice or hospital-based facility in the United States.
• Currently practicing medicine, or must have practiced at least 1 week per month within the last 3 years
• Leadership experience with at least one CPOE implementation in a large, multi-facility health system, Integrated Delivery Network (IDN) setting
• Extensive public-speaking and executive presentation experience
• Medical informatics credentials or advanced degree preferred, but not required [Medical Informatics not required? - ed.]
• Prefer some experience in public-health related projects

Here are the obvious major problems:

One CPOE implementation or even several does not by any means qualify a person to counsel other medical organizations and clinicians as a representative of a company citing itself as "the industry leader in Healthcare IT technology."

Further, the criteria "Medical informatics credentials or advanced degree preferred, but not required" suggests the crafters knows little about Medical Informatics, or hold it at a low level of esteem, considering it an optional "gift" that might add slight extra value to the incumbent's ability to travel the country and give good advice and support in clinical IT implementation. What might substitute for such knowledge and expertise?

This J.D. might better be described as "glorified salesperson." It might be a good exit route for a "techie doc" (usually, someone who knows just enough about HIT to be destructive) who hates the current practice environment. It might also be good for managers who don't want knowledgeable experts pointing out their bad decisions and mismanagement, but I think a global company like Siemens should be setting its sights higher in such a crucial area as electronic medical records and clinical IT consultants.

I would not want such a physician advising or supporting complex HIT projects at my organization.

I spent time at Siemens Healthcare headquarters in Erlangen in 2000, and was offered gracious hospitality and a position overseeing the Soarian cardiology suite. The people I met in Erlangen then seemed extremely competent and informatics-savvy, but I turned the offer down through no fault of Siemens. I'd received a near-simultaneous offer (FAXed to my hotel in Erlangen, in fact) from pharma that involved a much stronger management role.

I understand through conversations over the past few years with current and ex-Siemens personnel that most of the Siemens personnel I'd met in Germany in 2000 are no longer with the company. I was told they'd performed suboptimally after the acquisition/merger with Shared Medical Systems (SMS) in Malvern, PA. (I do not find that credible, and would find it far easier to accept that the problems were on the American side, but that is a personal opinion.)

Questions raised by these observations:

• What manner of ideology about education and expertise does this job description represent?

• Is there nobody left in Germany with a realistic sense of the education and expertise required to advise on and support HIT implementations in a competent manner, I ask?

Allow me to answer question #1. It represents the IT designer-centric, data processing and tabulator punch card culture-based (and antithetical to medicine and science) view that with enough generalists and sufficient "process", any problem can be solved. By this logic, Bach and Beethoven would have had symphonies written for them by low level musicians in the name of "efficiency" and cost savings.

Wanted: consultants to write my Ninth Symphony, according to the Acme Symphony-Writing Process Manual. Musical experience not essential. Must be team players.

Shareholders, take note. I emailed this post to the Siemens Healthcare CEO Hermann Requardt, who I note (almost predictably) lacks a biomedical background other than having been a research assistant for aviation medicine once, and having worked on MRI:

Education

• Secondary school (baccalaureate)
• Studied physics at the Technical University of Darmstadt and University of Frankfurt (Dr. phil. nat., Dipl.-Phys.)

A lack of response is therefore not surprising.

-- SS