Big Pharma: The Cost of Non-Compliance

From opioids to off-label marketing, Big Pharma’s most notorious legal settlements offer a cautionary tale on the limits of unchecked commercial ambition. 

In six of the largest cases on record – spanning brand-name giants and generic manufacturers alike – governments have levied over $44 billion in fines, corporate restructuring mandates, and long-term compliance overhauls.

“These settlements show what happens when the ethical voice inside the business is drowned out by commercial urgency,” explains Allan Murphy-Bruun, Life Sciences Compliance Expert at SimplerQMS, a cloud-based quality management solution provider for life sciences companies. “Regulators can step in, but by then, the harm is already done.”

Here, Murphy-Bruun examines six of the most consequential pharmaceutical settlements in history; what triggered them, what they cost, and the role a Quality Management System (QMS) could have played in preventing them. 

The 6 Largest Big Pharma Settlements

1. National Opioid Settlement – Johnson & Johnson + McKesson, AmerisourceBergen, Cardinal Health (2021) – US$ 26 B

Violation: Failure to monitor suspicious orders, deceptive opioid marketing.

Consequences: States earmark 85% of proceeds for opioid treatment. Share prices absorb the hit within months, but reputational damage lingers.

How QMS could have prevented it: A shared, real-time tracking system, similar to what quality standards like ISO 13485 require, could have helped the distributors spot unusual orders and stop suspicious opioid shipments before they broke DEA regulations.

“When distributors and a household‑name manufacturer let sales volume steer healthcare, the courts stepped in to remind industry that patient safety, not profit metrics, holds the final word,” says Murphy-Bruun.

2. Purdue Pharma / Sackler Family (2025) – US$ $7.4 B

Violation: OxyContin misbranding, downplaying of addictive potential, aggressive promotion via incentives to healthcare providers.

Consequences: Court‑appointed monitor, public disclosure of over 30 million documents, ongoing bankruptcy reorganization.

How QMS could have prevented it: A high-level CAPA (Corrective and Preventive Action) system, connected to drug safety monitoring data, could have brought early warning signs of addiction to light.

3. Teva Pharmaceuticals (2023) – US$ 3.34 B + In‑kind Narcan®

Violation: Oversupply of opioid products, including fentanyl and oxycodone generics, aggressive marketing without sufficient safeguards against misuse and diversion.

Consequences: 13‑year staggered payments, strict marketing limitations, enhanced compliance monitoring.

How QMS could have prevented it: By combining distribution data with structured change-control processes, Teva could have identified unusual ordering patterns and signs of opioid misuse during routine management reviews.

“Teva’s settlement demonstrates the importance of quality systems that actively monitor distribution and detect misuse. Without them, early warning signs of oversupply were buried beneath aggressive sales strategies,” says Murphy-Bruun. 

4. GlaxoSmithKline (2012) – US $3 B

Violation: Big Pharma’s unlawful promotion of prescription drugs, failure to report safety data, and paying kickbacks to physicians.

Consequences: A $1 billion criminal fine and $2 billion in civil penalties, a five-year Corporate Integrity Agreement (CIA) to implement substantial changes to its compliance programs, including altering its sales force compensation to remove incentives based on sales targets and allowing for the recoupment of bonuses from executives involved in misconduct.

How QMS could have prevented it: A company-wide system for managing documents that includes clear checks for label compliance and approvals from medical, legal, and regulatory teams could have stopped non-compliant marketing materials before they were ever circulated.

5. Takeda Pharmaceutical (2015) – US$ 2.4 B

Violation: Concealment of bladder‑cancer risks linked to diabetes drug, Actos.

Consequences: Largest single‑product settlement outside the U.S. opioid sphere, heavier post‑marketing study requirements in Japan and the EU.

How QMS could have prevented it: Implementing a vigorous post-market surveillance system, aligned with ISO 14971 Clause 10, could have made it harder for emerging safety signals to be overlooked or downplayed. By requiring systematic collection and review of global adverse event data, a well-designed QMS would have created greater internal accountability.

“When safety data is siloed or selectively ignored, the real failure becomes structural, and that’s exactly what a strong quality system is built to prevent,” says Murphy-Bruun.

6. Pfizer (2009) – US$ 2.3 B

Violation: Big Pharma’s off-label promotion of Bextra, Geodon, Zyvox, and Lyrica, and kickbacks paid to healthcare providers to encourage prescriptions of these and other drugs.

Consequences: $1.195 billion criminal fine, the most significant criminal fine ever imposed in the United States at that time, and a $1 billion civil settlement under the False Claims Act, five-year Corporate Integrity Agreement (CIA) requiring the company to implement and maintain a comprehensive compliance program.

How QMS could have prevented it: Embedding promotional review authority within the Quality department and maintaining automated training records could have ensured that all promotional materials underwent proper compliance checks. This approach would have helped prevent the dissemination of unapproved marketing content and ensured that sales teams were adequately trained on regulatory requirements. 

Allan Murphy-Bruun, Life Sciences Compliance Expert at SimplerQMS, commented:

“The financial penalties imposed in these cases may seem staggering, but they’re typically calculated with precision, based on illicit gains, the extent of public harm, and how the company responded once violations came to light. Criminal fines follow federal sentencing guidelines, while additional costs often stem from years-long compliance agreements, legal expenses, and lasting reputational damage.”

“What’s more revealing than the fines themselves is how unevenly they land. While some companies treat them as a temporary cost of doing business, only those that see these settlements as a turning point – and invest in robust, preventive quality systems – are truly positioned to restore trust and rebuild credibility.”