Pharmaceutical Profits & Side Effects…

Big Pharma Profits, Lawsuits, Side Effects, and Deaths

Overview of Big Pharma Profits

The pharmaceutical industry, often referred to as Big Pharma, has been consistently profitable, with profit margins ranging from 10% to 42% in 2013, averaging around 18% This profitability is attributed to several factors, including the ability to set high drug prices, the protection of patents, and the use of research and development (R&D) tax credits. For instance, drug patents last for 20 years, ensuring high prices by reducing competition. Pharmaceutical companies also employ tactics such as evergreening and thicketing to extend drug exclusivity

Major Lawsuits Against Big Pharma

Big Pharma has faced numerous lawsuits over the years, often stemming from allegations of off-label marketing, fraudulent practices, and the concealment of harmful side effects. Here are some of the most significant lawsuits:

1. Purdue Pharma and the Opioid Crisis

• Settlement: $26 billion, with $23.9 billion allocated to combat the opioid crisis
• Allegations: Purdue Pharma was accused of aggressively marketing OxyContin, leading to widespread addiction and overdose deaths. The company and the Sackler family, its owners, were criticized for their role in the opioid epidemic

1. Johnson & Johnson and Risperdal

• Settlement: $2.2 billion, with $1.72 billion for civil settlements and $419 million for criminal fines
• Allegations: Johnson & Johnson was found guilty of misbranding the antipsychotic drug Risperdal and providing kickbacks to doctors and pharmacists

1. GlaxoSmithKline (GSK)

• Settlement: $3 billion, the largest healthcare fraud settlement in U.S. history
• Allegations: GSK was found guilty of unlawfully promoting drugs such as Paxil, Wellbutrin, and Avandia, failing to report safety data to the FDA, and reporting false drug prices to underpay rebates under the Medicaid Drug Rebate Program

1. Pfizer and Pharmacia & Upjohn

• Settlement: $2.3 billion
• Allegations: Pfizer was accused of illegal promotion of drugs including Bextra, Geodon, Zyvox, and Lyrica, and submitting false claims to government healthcare programs

1. Takeda and Actos

• Settlement: $2.4 billion to settle approximately 8,000 lawsuits over the oral diabetes drug Actos

Side Effects and Deaths

The side effects of pharmaceutical drugs have led to numerous deaths and serious health issues. Some notable examples include:

1. Opioids

• Impact: The opioid crisis has resulted in over 400,000 overdose deaths in the U.S. since 1999 Counties with the highest distribution of opioid pills experienced death rates three times the national average

1. Xarelto

• Impact: Patients using Xarelto have reported internal bleeding, stroke, and death. The drug’s manufacturers, Janssen Pharmaceuticals and Bayer, were accused of downplaying the risks and marketing the drug as a safer alternative to warfarin

1. Singulair

• Impact: Merck’s asthma drug Singulair has been linked to suicides and psychiatric problems. Despite thousands of reported adverse events, the FDA delayed adding a black box warning to the drug’s label

1. Risperdal

• Impact: Johnson & Johnson’s antipsychotic drug Risperdal was linked to severe side effects, including gynecomastia (breast growth in boys and men), which led to numerous lawsuits

Preemption and Legal Defenses

Pharmaceutical companies often use legal defenses such as preemption to shield themselves from liability. Preemption relies on the notion that state laws are unnecessary when federal regulations already protect citizens. For example, in the case of Singulair, Merck and its spinoff Organon have used preemption to stymie lawsuits, arguing that the FDA’s approval and labeling decisions preempt state law claims

Public Perception and Trust

Public trust in the pharmaceutical industry has been significantly eroded due to these lawsuits and the perceived prioritization of profits over patient safety. According to a Gallup Poll, only around 18% of Americans viewed the pharmaceutical industry positively in 2023 The industry’s reputation has been further damaged by allegations of fraudulent practices, misleading marketing, and the suppression of harmful side effects.

Summary Table

Company	Drug	Settlement Amount	Allegations	Impact
Purdue Pharma	OxyContin	$26 billion	Aggressive marketing, addiction, overdose deaths	Over 400,000 overdose deaths since 1999
Johnson & Johnson	Risperdal	$2.2 billion	Misbranding, kickbacks	Severe side effects, including gynecomastia
GlaxoSmithKline (GSK)	Paxil, Wellbutrin, Avandia	$3 billion	Unlawful promotion, safety data concealment	Widespread health issues and financial fraud
Pfizer	Bextra, Geodon, Zyvox, Lyrica	$2.3 billion	Illegal promotion, false claims	Serious side effects and financial fraud
Takeda	Actos	$2.4 billion	Adverse health effects	Numerous lawsuits and health issues

This table summarizes the most significant lawsuits, the drugs involved, the settlement amounts, the primary allegations, and the broader impacts on public health and trust.

Recent developments and studies regarding lawsuits over COVID-19 vaccine side effects highlight ongoing legal challenges and the complexities of seeking compensation.

Here are some key points:

• AstraZeneca Admits Rare Side Effect: AstraZeneca has formally admitted in court documents that its COVID-19 vaccine can cause a rare side effect known as Thrombosis with Thrombocytopenia Syndrome (TTS) in very rare cases. This admission could lead to potential payouts in specific legal cases where the vaccine is linked to serious illness or death.
• Lawsuit Against CICP: A group of COVID-19 vaccine recipients has filed a lawsuit against the federal government, alleging that the limited ability to seek financial compensation for vaccine injuries through the Countermeasures Injury Compensation Program (CICP) deprives them of their constitutional rights. The lawsuit aims to move COVID-19 vaccine injuries from the CICP to the National Vaccine Injury Compensation Program (VICP), which is seen as more transparent and better equipped to handle such claims.
• CICP Criticisms: The CICP has been criticized for its lack of transparency, slow processing times, and limited due process protections. As of December 1, 2024, 13,555 people had filed compensation claims in the CICP for severe injuries caused by the COVID-19 vaccine, but only 20 have been awarded compensation, with an average payout of approximately $4,000 each. The program lacks basic legal protections such as the right to review evidence, obtain discovery, present expert witnesses, and appeal adverse decisions.
• Legal Protections for Vaccine Manufacturers: In the United States, vaccine manufacturers like Pfizer and Moderna are protected from legal liability under the Public Readiness and Emergency Preparedness (PREP) Act. This protection was intended to encourage rapid vaccine development and distribution but has made it difficult for individuals to seek compensation for severe side effects through traditional legal means.
• National Vaccine Injury Compensation Program (VICP): The VICP is a no-fault alternative to the traditional legal system for resolving vaccine injury petitions. It provides financial compensation to individuals who file a petition and are found to have been injured by a VICP-covered vaccine. However, as of now, the COVID-19 vaccine is not included in the VICP, and efforts are underway to change this…

These developments underscore the ongoing debate and legal challenges surrounding the compensation for vaccine-related injuries, highlighting the need for a more robust and accessible system for those affected.

Below is a table summarizing some of the most significant financial settlements and legal cases involving pharmaceutical companies, including the greatest financial penalties.

Each entry includes the company, the drug or issue involved, the settlement amount, the primary allegations, and the references.

Significant Financial Settlements and Legal Cases in Big Pharma

Company	Drug/Issue	Settlement Amount	Primary Allegations	References
Purdue Pharma	OxyContin (Opioid Crisis)	$26 billion	Aggressive marketing, addiction, overdose deaths	[2], [11]
Johnson & Johnson	Risperdal	$2.2 billion	Misbranding, kickbacks, severe side effects (gynecomastia)	[2], [12]
GlaxoSmithKline (GSK)	Paxil, Wellbutrin, Avandia	$3 billion	Unlawful promotion, safety data concealment, false drug prices	[4], [5]
Pfizer	Bextra, Geodon, Zyvox, Lyrica	$2.3 billion	Illegal promotion, false claims	[5]
Takeda Pharmaceutical Company	Actos (Diabetes Drug)	$2.4 billion	Adverse health effects (bladder cancer)	[4]
Merck	Vioxx	$4.85 billion	Concealment of cardiovascular risks, wrongful deaths	[1], [3]
Eli Lilly	Zyprexa	$1.42 billion	Off-label marketing, kickbacks	[6]
Abbott Laboratories	Depakote	$1.5 billion	Unlawful promotion, kickbacks	[2], [4]
Teva Pharmaceutical Industries	Opioids	$2.1 billion	Role in the opioid crisis, improper marketing	[7]
Johnson & Johnson	Surgical Mesh	$9.9 million	Failure to warn about risks, product liability	[4]

References

1. Merck Vioxx Settlement: Merck Settles Vioxx Lawsuits for $4.85 Billion
2. Johnson & Johnson Risperdal and Opioid Settlements: Johnson & Johnson to Pay $2.2 Billion in Risperdal Settlement, Purdue Pharma to Pay $26 Billion in Opioid Settlement
3. Drug Distributors Price-Fixing: Pharma Companies Lose Venue Battle in Price-Fixing Lawsuits
4. Takeda Actos, Johnson & Johnson Surgical Mesh: Takeda to Pay $2.4 Billion in Actos Bladder Cancer Settlement, Johnson & Johnson to Pay $9.9 Million in Surgical Mesh Settlement
5. Pfizer and GSK Settlements: Pfizer to Pay $2.3 Billion to Settle Criminal and Civil Liability Allegations, GSK to Pay $3 Billion in Healthcare Fraud Settlement
6. Eli Lilly Zyprexa: [Eli Lilly to Pay $1.42 Billion in Zyprexa Settlement](https://www.reuters.com/article/us-eli-lilly-zypre