At my Aug. 7. 2012 post "Malpractice Attorney Puts ONC-Authorized Testing and Certification Bodies (ATCBs) at Risk of Litigation?" I wrote:
... I returned to the U.S. to find that the defense attorney for the hospital where my mother was severely injured, and then died as a result, is once again raising an absurd issue in objections to the medical malpractice Complaint that was refiled within the Statute of Limitations for technical reasons. The President Judge of the county where the case is filed had dismissed this complaint (among many others) some time ago:
(ii) Plaintiffs Software Design Defect Claims are Preempted by the Federal HITECH Act
... To the extent Plaintiff attempts to bring a common law product liability claim against [name redacted] Hospital for required use of EMR software [see addendum below - ed.], such a claim is barred due to Federal Preemption of this area with the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act. 42 U.S.C. 201, 300, et seq.
Specifically, the design, manufacture, specification, certification and sale of EMR in the United States is a highly regulated industry under the jurisdiction of the Department of Health and Human Services (HHS). The HHS draws its statutory authority to design and certify EMR as safe and effective under the HITECH act as amended. Id.
The Supremacy Clause of the United States Constitution, article VI, clause 2, preempts any state law that conflicts with the exercise of federal power. Fid. Fed. Say. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 102 S. Ct. 3014 (1982). “Pre-emption may be either express or implied, and ‘is compelled whether Congress’ command is explicitly stated in the statute’s language or implicitly contained in its structure and purpose.” Matter of Calun Elec. Power Co-op., Inc., 109 F.3d 248, 254 (5th Cir. 1997) citing Jones v. Rath Packing Co., 430 U.s. 519, 525 (1977).
In this case, to impose common law liability upon [name redacted] Hospital for using certified EHR technology, which was in compliance with federal law and regulations for Health Information Technology, would directly conflict with Congress’ statutory scheme for fostering and promoting the implementation and use of EHR
I really don't think Congress intended HIT to maim and kill patients with impunity. In any case, this assertion was thrown out in its entirety several months ago, but here it is again in a new set of objections. I find its reappearance remarkable. I also wonder if the industry is behind it.
What I didn't post is the reply to this nonsense that was presented to the court by Plaintiff (me), via Plaintiff's counsel after my analysis of this passage, in a Memorandum of Law to the court Dec. 5, 2011:
... HHS does not regulate the design, manufacture, specification, certification, and sale of EMRs or any other clinical information technology. The HITECH Act itself does not establish standards and certification criteria for health information technology, but instead establishes the HIT Standards Committee to implement such specifications and standards for certification. HITECH Act § 3003, 42 U.S.C. § 300jj-13.
The initial set of standards specifications and certification criteria were not published until July 28, 2010, approximately 2 months after Mrs. Silverstein entered [name redacted] Hospital. Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 75 Fed. Reg. 44589 (July 28, 2010). Therefore, it would have been impossible for [name redacted] Hospital’s EMR system “to be in compliance with federal law and regulations for Health Information Technology” during the time of Mrs. Silverstein’s admission.
These facts were filed with the Court and delivered to the defense on Dec. 5, 2011 regarding health IT certification. An Affidavit/Certificate of Service to the defendants was also filed with the Response and Memorandum of Law as is customary, and are noted on the Prothontary website. No "I didn't receive it" excuse is possible...
The facts about health IT "certification" are trivial to verify.
As the hospital admission where my mother was injured, and the injury itself, were in May 2010, "using certified EHR technology in compliance with federal law and regulations for Health Information Technology" was not possible at that time. (Not to mention the facilities' EHR's were not actually "certified" until December 2010 via the ONC database of certified systems.)
Thus, the defense attorney by re-issuing this claim in August 2012 (to the new judge overseeing the case re-filing) is now knowingly lying to the Court in sworn filings, in order to harass, cause unnecessary delays in litigation, and needlessly increase the cost of litigation while collecting hourly fees for production of frivolous and untrue assertions.
The attorney is also making a mockery of the court system in the locality where the case is being heard, and also insulting the judges' intelligence.
These are the lengths to which hospitals and defense attorneys seem to be willing to go in defense of health IT. I find this remarkable (but not surprising).
It will be interesting to see how the judge responds to an attorney knowingly trying to blow smoke up his behind.
Addendum: Also pointed out in earlier filings was the fact that use of EMR's is not "required." It seems the defense attorney, besides being a liar, has a thick skull.