History of US Pharmaceutical Lawsuits

pile of empty orange pill bottles

Pharmaceutical lawsuits have resulted in many million- and even billion-dollar settlements throughout US legal history. Filing a lawsuit isn’t a get-rich-quick scheme; for one thing, the process is rarely quick. In some cases, filing a lawsuit may be the only way to hold manufacturers accountable for the harmful effects of their medications and to obtain the financial resources to care for conditions that have been caused by their negligence.

Many times, lawsuits are filed when manufacturers fail to warn doctors and patients about the long-term or dangerous side effects of a drug or medical device. When manufacturers withhold this information, doctors cannot communicate with their patients about the benefits and risks of the product. As a result, patients will be prescribed the product and could eventually experience serious health problems.

Here is some of the history of why pharmaceutical lawsuits occur and recent cases of pharmaceutical negligence.

Direct-to-Consumer Drug Advertising in the US

The US is one of the few countries that allows direct-to-consumer pharmaceutical advertising (DTCPA) for pharmaceutical drugs. Direct-to-consumer advertising for medications began in the early twentieth century, when there were only a few types of drugs on the market.

In 1905, the Council on Pharmacy and Chemistry, appointed by the American Medical Association, discouraged DTCPA by labeling drugs marketed to the general public as “non-ethical,” supporting only those that were marketed directly to medical professionals. However, DTCPA was never made illegal.

In 1906, the passing of the Pure Food and Drug Act created federal standards for educating patients on the effects of drugs, disclosing ingredients and including proper labeling, and not misrepresenting the drug’s effects. Then, additional regulations in 1938 and 1951 placed medications under additional federal restrictions in order to regulate their advertising, distribution, and use to protect consumers.

Although most manufacturer advertisements were initially aimed at physicians, direct-to-consumer advertisements have increased dramatically. Today, these advertisements add up to about 40 percent of the amount pharmaceutical companies spend on promotions. And although federal guidelines are designed to keep drugs safe for consumers, they aren’t always enough to stop harmful drugs from getting through to the public.

Due to the increased use of mass media to advertise prescription drugs that treat diabetes, cholesterol, erectile dysfunction, depression, pain, and a host of other conditions, consumers often engage in self-diagnosis. This leads to many consumers purchasing prescription drugs that they don’t need.

Fortunately, the US healthcare system has made even more important reforms over the last three decades to secure patients’ rights to information about treatment options and purchasing decisions.

The combination of direct-to-consumer pharmaceutical advertising and the high volume of medications used in the US every year leaves manufacturers and pharmaceuticals susceptible to lawsuits when drugs are misrepresented or their harmful effects are not fully disclosed, perhaps more so than in any other country.

Largest Recent Pharmaceutical Lawsuits

In the nearly three decades from 1991 to 2017, pharmaceutical manufacturers settled 412 cases with federal and state governments, paying a total of $38.6 billion for everything from false advertising to withholding knowledge of proven side effects.

Two of the largest pharmaceutical settlements in the US involved the companies GlaxoSmithKline and Takeda Pharmaceuticals.

GlaxoSmithKline: $3 billion

In 2012, GlaxoSmithKline (GSK) settled the biggest healthcare lawsuit in the US with a $3 billion payment.

GSK was charged for illegally promoting some of their prescription drugs, including Avandia, Paxil, and Wellbutrin. The company had failed to report some of the safety data to the FDA and also gave false drug prices in order to underpay discounts under the Medicaid Drug Rebate Program.

Additionally, the company misbranded their antidepressant drugs (Paxil and Wellbutrin) and also rewarded healthcare providers for recommending them to their patients for off-label uses.

Moreover, the company failed to produce safety data for Avandia, which was intended to treat diabetes, which left many patients concerned about the drugs’ cardiovascular safety.

Takeda Pharmaceuticals: $2.4 billion

In 2015, a pharmaceutical lawsuit was filed against Takeda Pharmaceuticals. The company was found guilty for concealing bladder cancer risks related to their oral diabetes drug, Actos. The company settled the over 8,000 federal and state lawsuits by paying $2.4 billion.

Actos was the company’s top-selling drug after it was approved in 1999 by the FDA. It became more popular after GlaxoSmithKline’s diabetic drug (Avandia) was restricted due to its cardiovascular safety concerns.

After the restriction of Avandia, Takeda advertised their top-selling drug claiming that it could lower blood sugar without increasing the risk of stroke or heart attack. However, the company was sued for misleading the public about the claimed benefits of the drug, which overlooked the harsh side effects.

Current Pharmaceutical Lawsuits

Pharmaceutical litigation attorneys at Napoli Shkolnik PLLC are currently involved in several lawsuits involving the misrepresentation and resulting harmful effects of pharmaceuticals. 

Opioid Lawsuits

The US opioid epidemic that has developed over the past several decades is now resulting in severe negative consequences for individuals and communities. Currently, opioid-related lawsuits are in progress against pharma companies, dispensaries, and retail pharmacies.

Napoli Shkolnik’s Opioid Trial Team was part of the landmark Ohio bellwether $320 million settlement in fall 2019. The firm is also leading the next round of opioid trials, which were scheduled in New York for March 2020 before being postponed due to COVID-19. 

Opioids are a group of pain-relieving drugs that interact with the opioid receptors in your cells. When used as recommended by a doctor and in small doses, these medications can help control acute pain. However, their addictive nature has been severely underrepresented for years, resulting in overprescription, addiction, and devastating numbers of overdose deaths.

Opioid lawsuits are all aimed at holding opioid producers and their distributors accountable for the opioid epidemic that has ravaged the United States.

Elmiron Lawsuits

Janssen Pharmaceuticals has been accused of failing to inform consumers about the potential vision loss caused by the drug Elmiron.

According to recent studies, the drug, which is used to treat interstitial cystitis and resulting bladder pain, can cause irreversible vision damage due to its ocular toxicity. Research presented at the American Academy of Ophthalmology in 2019 revealed that patients taking the drug showed signs of toxicity.

If you have taken Elmiron and suffered from vision loss, you may be entitled to compensation. Consumers have the right to make informed decisions about their health, and the Elmiron lawsuit holds Janssen Pharmaceuticals responsible for denying patients that information and right.

If you are experiencing severe health effects after taking a drug that was defectively manufactured or without being informed of its effects, you can help hold the pharmaceutical companies accountable by raising your voice.