While quashing FIR against four staff members of a diagnostic centre for issuing an allegedly false positive Hepatitis B report to a woman before her hernia surgery, the Telangana High Court said that not criminal law cannot be invoked to punish every instance of professional negligence.

In doing so the court held that mere inadvertence, an error of judgment, or a lapse in the exercise of due care cannot, by themselves, constitute an offence under Section 336 (Act endangering life or personal safety of others) IPC.

Justice N. Tukaramji held that even if there was a lapse in issuing the initial reactive HBsAg screening report without awaiting confirmatory testing, it could at the highest give rise to civil or consumer proceedings for deficiency in medical services. Criminal liability requires negligence of such a gross and reckless degree that it endangers human life.

The Court observed:

“Even assuming that there was some lapse in issuing the initial screening report without awaiting confirmatory testing, such omission, at its highest, may furnish a cause of action in civil law or under the consumer protection jurisdiction for alleged deficiency in medical services. However, such conduct falls far short of satisfying the stringent threshold required for constituting an offence punishable under Section 336 IPC. Criminal law cannot be invoked to punish every instance of professional negligence. Penal liability arises only where the negligence is so gross and reckless as to endanger human life within the meaning of the Penal Code. Mere inadvertence, an error of judgment, or a lapse in the exercise of due care cannot, by themselves, constitute an offence under Section 336 IPC"

The criminal case arose after the complainant, who had been advised to undergo a major surgical profile before hernia surgery, visited Vijaya Diagnostic Centre on June 10, 2022. Her blood sample was tested for HBsAg through a rapid screening test and was reported as “Reactive”.

According to the prosecution, the report caused her severe mental trauma, depression and suicidal thoughts. It also allegedly increased the anticipated cost of her proposed surgery.

On the advice of doctors at Yashoda Hospital, the complainant underwent another HBsAg test, which returned a “Non-Reactive” result. She subsequently approached the diagnostic centre and questioned its staff about the conflicting reports.

The retained blood sample was thereafter tested using the Chemiluminescent Microparticle Immunoassay (CMIA) method. This test also returned a “Non-Reactive” result.

During the investigation, the accused explained that the first test was only a rapid screening test conducted as part of the surgical profile. They said that such tests were susceptible to occasional false-positive results and that the complainant had declined to provide a fresh blood sample for further testing.

The Investigating Officer obtained an opinion from the Superintendent of Gandhi Hospital. The opinion stated that where an HBsAg rapid test gives a reactive result, it should be confirmed through another method such as CMIA, CLIA or ELISA, preferably using a repeat blood sample, before a final report is issued.

Relying on this opinion, the police concluded that the accused had negligently issued the reactive report without conducting a confirmatory test. A charge sheet was consequently filed against them for an act endangering the life or personal safety of others under Section 336 of the IPC.

The petitioners approached the High Court seeking quashing of the proceedings. They argued that, even accepting the charge sheet in its entirety, the allegations did not satisfy the ingredients of Section 336 IPC.

They further contended that the report itself carried a disclaimer stating that the rapid screening test should not be treated as the sole criterion for diagnosis and that confirmatory testing was required. They relied on scientific literature to contend that rapid HBsAg tests can produce false-positive results.

The State opposed the plea. It argued that issuing a report showing the complainant as HBsAg reactive had created unnecessary panic and caused her severe mental and financial trauma. It further contended that the individual roles of the petitioners and whether they were negligent were factual questions which should be decided at trial.

The High Court noted that Section 336 IPC does not criminalise every negligent act. Criminal negligence, it said, is “qualitatively different” from civil negligence and must be gross, culpable or of such a high degree as to exhibit utter disregard for the life and safety of others.

Examining the expert opinion relied upon by the prosecution itself, the Court found that it did not state that a reactive result from a rapid screening test was necessarily erroneous. Nor did it say that issuing such a report without prior confirmation would, by itself, amount to gross or criminal negligence.

Rather, the opinion reflected the accepted laboratory protocol that a reactive screening result should ordinarily be followed by confirmatory testing before reaching a definitive diagnosis.

The Court said:

“The subsequent CMIA report yielding a non-reactive result merely establishes a discrepancy between the screening test and the confirmatory test. Such discrepancy, by itself, cannot automatically lead to an inference of criminal negligence.”

The Court further noted that the diagnostic centre's report itself stated that the screening test was not intended to be the sole basis for diagnosis and required clinical correlation and confirmatory testing.

It also found that the petitioners' explanation that rapid HBsAg screening tests can occasionally yield false-positive results had not been effectively controverted through an independent expert medical opinion meeting the parameters laid down in Jacob Mathew.

The Court separately found that the charge sheet failed to attribute any specific act to the four petitioners. Petitioner Nos. 2 to 4 were the Associate Director (Microbiology), General Manager (Operations) and Cluster Manager (Operations), respectively, while petitioner No. 1 was a Consultant Microbiologist.

Holding that criminal liability is personal unless a statute specifically creates vicarious liability, the Court said a person cannot be prosecuted merely because they hold a managerial or supervisory position.

“Their implication appears to be founded primarily upon the official positions held by them within the Diagnostic Centre,” the Court noted. It found no specific allegations establishing each petitioner's individual involvement, knowledge or culpable conduct.

The Court ultimately held that the dispute essentially concerned an alleged deficiency in professional services arising from discrepant laboratory reports. The material fell short of establishing the gross rashness or criminal negligence required under Section 336 IPC.

Accordingly, it quashed the proceedings in C.C. No. 8530 of 2022 against all four petitioners.

Case Title: Manisha Singh & Ors. v. State of Telangana & Anr.

Case No.: Criminal Petition No. 1226 of 2023

Appearance: Raja Sripathi, Senior Counsel, appearing for B. Dileep Kumar, for the petitioners; Syed Yasar Mamoon, Additional Public Prosecutor, for the State.

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