When “My Pikin” Became a Killer: The Barewa Pharmaceuticals Case and the Role of Laboratory Analysis in Public Health Law

In November 2008, a tragedy unfolded in Nigeria that would forever change the landscape of public health regulation and enforcement. Parents began rushing their children to hospitals across the country, all reporting a terrifying and identical set of symptoms: acute kidney failure and the inability to pass urine. Within weeks, dozens of children succumbed to this mysterious illness. It did not take long for healthcare professionals to connect the dots. The children had one thing in common—they had all been administered a teething syrup branded “My Pikin,” manufactured by Barewa Pharmaceuticals.

What followed was not just a national public health emergency but a legal saga that would underscore the critical role of laboratory analysis in enforcing food and drug regulations. As NAFDAC (the National Agency for Food and Drug Administration and Control) scrambled to mitigate the crisis, they discovered that “My Pikin” contained diethylene glycol, a toxic chemical commonly found in antifreeze. This was no ordinary case of negligence; it was a textbook example of systemic failure in the pharmaceutical industry. The legal battle that ensued raised critical questions about quality control, regulatory compliance, and the role of scientific evidence in securing convictions.

This article explores the facts of the case, the legal issues raised, and the decisions of the Court of Appeal. More importantly, it discusses how this case highlights the indispensable role of laboratory analysis in prosecuting violations of food and drug regulations and protecting public health in Nigeria.

A Spoonful of Poison: The Facts of the Case

The crisis began when the Chief Pharmacist at Ahmadu Bello University Teaching Hospital (ABUTH) in Zaria reported an alarming pattern of child deaths to NAFDAC. The deaths were linked to a teething syrup, “My Pikin,” which NAFDAC officials discovered was contaminated with diethylene glycol. This toxic substance is typically used as an industrial solvent and antifreeze, and its ingestion can cause renal failure and death. Preliminary investigations revealed that the contaminated batch of the syrup, identified as Batch 02008, was manufactured at Barewa Pharmaceuticals’ facility under deeply flawed conditions.

NAFDAC acted swiftly, conducting a nationwide recall of “My Pikin” and sealing off Barewa Pharmaceuticals’ production facility. Investigators uncovered a series of egregious failures. The chemical diethylene glycol had been purchased by a school certificate holder employed by the company, who mistook it for propylene glycol, a harmless ingredient commonly used in pharmaceuticals. The company’s Quality Control Officer failed to test the raw material properly before its use. The Production Manager compounded the issue by authorizing production based on verbal assurances, without written approval or documented tests. The resulting contamination of the syrup caused the deaths of numerous children and exposed significant lapses in the company’s quality control processes.

The company, along with its Quality Control Officer and Production Manager, was charged with manufacturing and distributing adulterated drugs, as well as conspiracy to sell dangerous products. These charges were brought under the Counterfeit and Fake Drugs and Unwholesome Processed Foods Act and the Miscellaneous Offences Act. The prosecution relied heavily on laboratory analysis conducted by NAFDAC, which conclusively demonstrated the presence of diethylene glycol in Batch 02008.

The Courtroom Drama: Trial and Convictions

Barewa Pharmaceuticals and its managers faced trial in a Federal High Court, which turned into a legal battle pitting regulatory enforcement against corporate defence strategies. The prosecution presented evidence, including laboratory test results, testimonies from NAFDAC officials, and documents obtained from Barewa’s factory. Seven prosecution witnesses, including pharmacists and police investigators, testified, detailing the failures in quality control and the toxic contamination of “My Pikin.”

The trial court convicted Barewa Pharmaceuticals on charges of selling adulterated drugs. The company was ordered to wind up, and its assets were forfeited to the federal government. The court also sentenced the Quality Control Officer and the Production Manager to seven years in prison each. Dissatisfied with the judgment, Barewa Pharmaceuticals and its managers appealed the decision, raising several legal issues that challenged the validity of the convictions and the handling of evidence.

The Seven Legal Battles at the Court of Appeal: A Fierce Fight for Justice

The courtroom was a battlefield, and Barewa Pharmaceuticals came armed with a barrage of arguments, determined to overturn their conviction. The stakes were monumental—not just for the accused but for the integrity of public health enforcement in Nigeria. As the Court of Appeal dissected the issues one by one, the case evolved into a high-stakes legal drama.

1. Was There Sufficient Scientific Evidence?

The lawyers for Barewa Pharmaceuticals vehemently argued that the prosecution, NAFDAC, had failed to meet the gold standard of scientific evidence required to establish their guilt. They claimed that laboratory analysis, no matter how rigorous, was insufficient to definitively prove that “My Pikin” was dangerous. In their view, the prosecution’s reliance on test results lacked the robustness needed for a criminal conviction. Barewa's lawyers pressed further, asserting that the burden of proof lay squarely on the prosecution to eliminate every shadow of doubt.

But the Court of Appeal was unimpressed by these claims. In a decisive ruling, the court upheld the integrity of the laboratory tests conducted by NAFDAC, which revealed the presence of diethylene glycol—a substance universally recognized as toxic. The court declared that the certificates issued under Section 55 of the Evidence Act were conclusive evidence of the contamination. These certificates carried a presumption of regularity, meaning they were presumed accurate unless disproved by Barewa Pharmaceuticals. The burden, therefore, shifted to Barewa Pharmaceuticals to refute the findings. Barewa Pharmaceuticals failed to do so, leaving the court with no reason to doubt the scientific evidence. The ruling was clear: NAFDAC’s laboratory analysis provided a solid foundation for the conviction.

2. Was the Chain of Custody Compromised?

Barewa Pharmaceuticals' lawyers next turned their attention to the chain of custody, arguing that a 44-day delay between the collection of samples and laboratory testing had fatally undermined the integrity of the evidence. They questioned whether the samples tested in the laboratory were the same as those retrieved from their factory. This, they claimed, created reasonable doubt about the prosecution’s case.

The court, however, found this argument unconvincing. It meticulously reviewed the evidence and determined that the chain of custody was intact. The samples had been sealed in the presence of the accused, who had signed off on the process. Detailed documentation recorded every step of the evidence’s journey, from collection to testing. The court emphasized that there was no suggestion of tampering or substitution during the delay. While the 44-day gap might have raised eyebrows, it did not compromise the integrity of the samples. Thus, as long as the chain of custody is well-documented and secure, procedural delays do not necessarily invalidate evidence.

3. Did Witness Discrepancies Undermine the Case?

In a bid to discredit the prosecution’s case, Barewa Pharmaceuticals highlighted discrepancies in the testimonies of NAFDAC officials and other witnesses. Some referred to the product as “My Pikin Baby Teething Mixture,” while others described it as “My Pikin Paracetamol Syrup.” They argued that these inconsistencies created uncertainty about the identity of the product tested and undermined the credibility of the NAFDAC’s evidence.

The court, however, was quick to dismiss this line of defence as a red herring. It ruled that such discrepancies were minor and immaterial. What mattered, the court emphasized, were the consistent identifying details: the batch number, the brand name, and the manufacturing records, all of which pointed unambiguously to Barewa Pharmaceuticals. The court concluded that the evidence overwhelmingly established the identity of the product and left no room for doubt. It was a reminder that minor inconsistencies in witness testimony cannot derail a case when the core evidence remains unshaken.

4. Was the Laboratory Analysis Valid Without the Analyst’s Testimony?

Barewa's lawyers launched yet another attack, this time on the admissibility of the laboratory reports. They argued that since the analyst who conducted the tests did not testify in court, the reports should be deemed hearsay and inadmissible. This argument was aimed at striking a fatal blow to the prosecution’s case, which relied heavily on the test results.

The court was unyielding in its rejection of this argument. Citing the Evidence Act of Nigeria, the judges ruled that supervisors or heads of laboratories are authorized to testify on behalf of their teams. In this case, the laboratory reports were signed by senior officials who oversaw the testing process. Their testimony was sufficient to validate the findings. The court underscored the importance of practicality in legal proceedings, noting that requiring every individual involved in the testing process to testify would place an unreasonable burden on the prosecution. This reaffirmed the reliability of laboratory reports as key evidence in regulatory cases.

5. Was There Evidence of Conspiracy?

One of the most contentious issues was the charge of conspiracy. Barewa Pharmaceuticals argued that their actions, while negligent, did not amount to a deliberate plan to sell dangerous products. They insisted that the contamination was a tragic mistake, not the result of a criminal agreement.

The Court of Appeal agreed with the appellants on this point, overturning the conspiracy conviction. The judges found no evidence of a “meeting of minds” or a deliberate intent to conspire. Instead, the contamination was traced to gross negligence in the procurement and quality control processes at Barewa Pharmaceuticals. The court’s decision on this issue highlighted the distinction between negligence and conspiracy, reminding prosecutors that criminal intent must be clearly established for a conspiracy conviction.

6. Was the Order to Forfeit Assets Justified?

The lawyers also took issue with the trial court’s order to wind up Barewa Pharmaceuticals and forfeit its assets to the federal government. They argued that the punishment was disproportionate and unsupported by the relevant laws.

The appellate court found partial merit in this argument. While it upheld the forfeiture of the adulterated drugs, it ruled that the law did not authorize the forfeiture of the company’s entire assets. Instead, the court substituted the order with a fine of ?1,000,000, which it deemed a more proportionate penalty. As a general rule in criminal proceedings, it is important to align judicial orders with statutory provisions to ensure fairness in sentencing.

7. Did Procedural Lapses Justify Conviction?

Finally, the Barewa's lawyers contended that the lapses in their quality control processes—such as failing to test raw materials—did not amount to criminal behaviour. They argued that procedural failures, while regrettable, were insufficient to warrant a conviction for selling dangerous drugs.

The court firmly disagreed. It held that these procedural lapses directly led to the contamination of “My Pikin” and, by extension, the deaths of innocent children. The judges emphasized that adherence to regulatory standards is not optional; it is a legal obligation. Failure to comply, particularly in the pharmaceutical industry, constitutes a violation with potentially deadly consequences. The court’s ruling reinforced the principle that negligence in quality control is not just a procedural error—it is a criminal offence when it endangers public health.

Why Laboratory Analysis Matters

The Barewa Pharmaceuticals case demonstrates the indispensable role of laboratory analysis in prosecuting violations of food and drug regulations. It serves as a cornerstone of public health enforcement, providing scientific evidence that is objective, reliable, and admissible in court.

NAFDAC’s laboratory analysis was pivotal in identifying diethylene glycol as the contaminant in Batch 02008. This finding not only established the product’s danger but also linked the contamination to Barewa Pharmaceuticals’ production process. The analysis provided the factual basis for NAFDAC’s nationwide recall of “My Pikin” and its subsequent prosecution of the company.

Laboratory analysis also played a critical role in overcoming the challenges posed by the defence. It provided consistent and verifiable evidence that countered the appellants’ claims about discrepancies, chain of custody, and witness credibility. By adhering to established scientific protocols, NAFDAC was able to maintain the integrity of its findings, which were upheld by the Court of Appeal.

The Bigger Picture: Lessons for NAFDAC

The Barewa Pharmaceuticals case exposed significant gaps in regulatory enforcement and highlighted the need for systemic improvements.

NAFDAC’s inspection team must prioritize regular audits of manufacturing facilities, ensuring that companies comply with quality control standards. Training programs should be introduced to equip inspectors with the skills needed to identify risks, such as mislabeled chemicals or inadequate laboratory facilities.

The enforcement team must streamline its evidence-handling processes, ensuring that samples are promptly transferred to laboratories and stored under proper conditions. Rapid response protocols should be developed to effectively contain public health risks.

The prosecution team must adopt a more comprehensive approach to case preparation. This includes anticipating potential defences, using expert witnesses to explain laboratory findings, and ensuring that charges align with the evidence presented.

A Landmark Case for Public Health

The Barewa Pharmaceuticals case is a landmark moment in Nigeria’s regulatory history. It underscored the devastating consequences of lapses in quality control and highlighted the need for rigorous enforcement of food and drug laws. More importantly, it showcased how science and law can work together to protect public health and hold violators accountable.

The Court of Appeal’s rulings were a blend of affirmation and correction. While it upheld key convictions, it also ensured that the punishment fit the crime, striking a balance between accountability and fairness. For Barewa Pharmaceuticals, the rulings were a sobering reminder of the catastrophic consequences of negligence. For the legal and regulatory communities, the case was a watershed moment, showcasing the power of laboratory analysis in securing justice and protecting public health.

Finally, this case serves as a cautionary tale for the pharmaceutical industry and a call to action for regulatory agencies. By strengthening their processes and leveraging laboratory analysis, agencies like NAFDAC can ensure that tragedies like “My Pikin” never happen again. Ultimately, the case is a powerful reminder of the importance of protecting public health, one laboratory test at a time.

The full report of the case can be read here: Barewa Pharmaceuticals v. F.R.N (2016) 17 NWLR (Pt. 1540) 63 and Barewa Pharm. Ltd. v. F.R.N (2019) 9 NWLR (Pt. 1677) 331