The number of pharmaceutical lawsuits filed in the United States grows by the day. Pharma companies, which are responsible for creating lifesaving drugs and medical devices to ensure patients’ well-being, are making errors that could rewrite the destiny of patients. Don’t think these pharmaceutical titans were just recently sued. If we flip through the pages of American history, we can see many big pharma lawsuits and their settlements.
In 2021, America spent approximately $576.9 billion on prescription drugs, and a four to six percent increase is expected in prescription drug sales in 2022. According to the United States Department of Commerce, the United States earns approximately $148 billion in medical equipment sales alone, accounting for nearly half of the world’s share of the pharmaceutical market. When pharma product sales increase by leaps and bounds, on the one hand, the increasing number of pharma lawsuits on the other has become a serious matter of concern.
Through this blog, I am leading you all to the root causes of the rise of pharma lawsuits and the different drug & device lawsuits faced by the pharmaceutical behemoths. You can also see the biggest pharmaceutical lawsuit settlements in the history of the U.S.
Table of Contents
Types of drugs and device defects
A product can become defective at any three stages: design, manufacturing, or marketing. Any error or negligence during these stages could potentially put an end card to the life of the user. Let’s see what type of errors can occur in each stage.
- Design defects occur when pharmaceutical companies compromise the safety of a drug’s or medical device’s components. The following factors are most likely to cause defects in a medical drug or device.
- Inadequate testing to ensure safety
- Failure to anticipate potential interactions with food products and other medicines
- Failure to communicate side effects of the drug with the FDA during the approval procedure
- Failure to ensure the dosage of the ingredients to be used in the drugs
- Failure to identify potential side effects of the drug that could be discovered
- Improper design in the size and shape of the medical device could be harmful to the user.
- Manufacturing defects occur when the design instructions are not followed during production. The flaws that could occur during manufacturing are:
- Failure to include one or more of the ingredients specified in the design or inclusion of one or more ingredients that were not specified in the design
- The strength of the drug is affected when the dosage is reduced or increased.
- Unsanitary or contaminated conditions that could pollute one or more batches of medication
- Incorrect drug labeling
- Even minor defects in the size, shape, or speed of the device differing from the projected design could endanger the consumer.
- Marketing defects occur when the manufacturers do the following things such as:
- Failure to provide adequate or accurate warnings on the dangerous side effects in the labels
- Deliberately concealing the dangers in the labeling
- Failing to provide usage instructions
- Improper container design resembling food products
- Marketing the product for curing conditions other than those approved by the FDA
- Illegal marketing of the drug/device
On seeing the name, pharma lawsuits, if you think they are only drug-related lawsuits, you are wrong. Not only drugs but even medical devices can also give rise to a possible pharmaceutical lawsuit when they are defective and harm the patients or consumers. Here we are delving into the details of some of the most prominent drug and device lawsuits in the United States of America.
Prescription Drug and OTC Pharma Lawsuits
The United States has seen a train of prescription drug lawsuits in recent decades. Most of you might be unaware of many of these pharma lawsuits. Knowing them will prevent you from being one of the victims. Many of these have played their role in causing the opioid crisis in America. Let’s see some of them.
Elmiron is a prescription medication used to treat interstitial cystitis (IC), also referred to as painful bladder syndrome (PDS), an illness that causes painful pain and swelling of the bladder/pelvis as well as ulcers and bleeding. This pharma lawsuit claims that using the drug can cause maculopathy, an eye disorder affecting the macula, a part of the retina that can cause vision loss and blindness. It also claims that even though the manufacturer, Janssen was aware of the risk, they failed to warn patients of the risk of eye damage. There have been no settlements to date, and the first MDL trial is scheduled for January 2023.
Jardiance is a drug that helps people with type-2 diabetes manage their blood sugar levels. When taken with Farixga, this prescription drug can raise the risk of developing Fournier’s Gangrene. When compared to patients receiving other type-2 diabetes drugs, people taking these two medications had twice the risk of lower-limb amputations, according to one study. These pharma lawsuits allege that the drugmaker failed to notify patients about this risk. On the one hand, they were being researched for potential dangers, while on the other hand, they were still being prescribed to patients who were oblivious of the situation. Contact a lawyer to know if there are chances to get Jardiance lawsuit settlements.
Pradaxa is a blood thinner that prevents strokes by treating blood clots. Sad to say, this prescription drug has been linked to a large number of catastrophic bleeding cases, including several fatalities. The drug manufacturer Boehringer Ingelheim, a German pharmaceutical company, faced many wrongful death lawsuits as a result of Pradaxa. Claimants claim that PRADAXA’s manufacturer, Boehringer Ingelheim made false claims about the drug’s effectiveness, safety, and benefits. They agreed to pay $650 million to settle an estimated 4,000 Pradaxa pharma lawsuits in May 2014.
Proton Pump Inhibitors Lawsuits
Medications including Nexium, Protonix, Prilosec, and Prevacid belong to the proton pump inhibitors group of medications. They’re used to treat stomach ulcers and acid reflux, as well as disorders like gastroesophageal reflux disease and other esophageal-related problems. In PPI lawsuits, the drugs are blamed for causing kidney disease, renal damage and failure, and acute interstitial nephritis, or AIN. In cases against Nexium, Prilosec, Prevacid, Protonix, and other PPI products, AstraZeneca, Takeda, and Pfizer are accused of failing to warn about the dangers of proton pump inhibitors. PPI injury investigations are still ongoing, and no settlements have yet been reached.
As per the Prilosec lawsuit update 2022, the judge set the first Nexium bellwether trial for October 2022 despite the Nexium/Prilosec Proton Pump Inhibitor MDL having over 13,000 cases still pending. Between October and March of the following year, three PPI bellwether instances will follow.
Tenofovir is a prescription medicine for the treatment of HIV and hepatitis B infections. In some patients, this drug caused kidney problems and bone damage. The maker, Gilead Sciences, was aware of the risk yet did not remove it off the market. According to the lawsuits, the Foster City company developed a less toxic version of the medicine in 2000, but instead of continuing to develop the safer alternative, the company chose to conceal tenofovir’s risks while earning billions of dollars as it became one of the world’s most prescribed HIV medicines.
Valsartan is a prescription drug that is used to treat high blood pressure. The new case says that N-nitrosodimethylamine was found in many batches of valsartan, causing cancer in the liver, kidney, and stomach. Valsartan-containing drugs have also been recalled. A little more than 40 new Valsartan cancer lawsuits were added to the MDL as of April 2022. As of June 15th, there were 1,110 active cases in the MDL after about six cases were voluntarily dismissed during the same time period. If the settlement effort fails, the Valsartan bellwether trials will proceed to the first round.
Irritable bowel syndrome (IBS) medicine Viberzi is used to treat diarrhea and abdominal pain (IBS). The lawsuit began when the manufacturers failed to notify patients and doctors that persons who have lost their gallbladder are at risk of developing pancreatitis. Over 100 reports of people developing pancreatitis as a result of Viberzi were sent to the FDA. Between May 2015 and February 2017, 76 people were admitted to hospitals, and two of them died.
Zantac is a heartburn treatment and prevention drug. It may also be used to treat stomach ulcers and gastroesophageal reflux disease (GERD). NDMA, which causes cancer in the bladder, stomach, esophagus, liver, and pancreas, has been found in Zantac. Doctors who diagnosed folks with cancer after they started taking Zantac also diagnosed them with PPH and Crohn’s disease. Sanofi and Boehringer Ingelheim, according to the lawsuit, should have been aware of the cancer-causing chemical. In October 2022, the first Zantac bellwether lawsuit will go to trial.
Zostavax is a shingles prevention vaccination. Merck, a pharmaceutical company, is being sued for failing to warn doctors and patients that this vaccine can cause shingles. The FDA requested a change in the label from Merck to warn Zostavax users that the vaccination could cause necrotizing retinitis, a very deadly eye illness. In these vaccine lawsuits, Zostavax is accused of causing damage ranging from vision loss, hearing loss, and even death.
Medical Device Lawsuits
The medical field has provided and continuously provides a lot of new medical devices for efficient patient care. When pharma companies rush to market their products before testing them for efficiency and safety, it endangers the lives of the patients and consumers. When people start facing issues after using them, it will ensue in individual, MDL, or class action pharma lawsuits. Let’s have a glance through some of the well-known medical device lawsuits in America.
Transvaginal Mesh Lawsuit
Transvaginal mesh has been accused of causing pain, infection, bleeding, organ collapse, and autoimmune disorders in around 109,000 claims. For 20,000 cases, one of the largest transvaginal mesh settlements to date was $830 million. Boston Scientific paid $188.7 million to 47 states and the District of Columbia in March 2021 to settle charges that it misled consumers about its surgical mesh implants. The firm also promised to provide more detailed information to consumers on the safety and hazards of mesh use.
IVC Filter Lawsuits
IVC filters were created for individuals who have problems adhering to anticoagulant medication due to concurrent bleeding or a high risk of bleeding. These filters are implanted in the inferior vena cava to prevent blood clot fragments from moving to the pulmonary arteries, allowing uninterrupted blood flow. Death, caval thrombosis, caval perforation, filter embolization, filter migration, pulmonary embolism (PE), and filter fracture are all possible outcomes of IVC filter failure. In the first bellwether trial in the Philadelphia IVC filter mass tort action, a Philadelphia jury awarded $33.7 million against Rex Medical and Argon Medical Devices for defectively constructing the Option IVC filter device.
Hernia Mesh Lawsuits
Hernia mesh is a medical device that is used after surgery to support the healing tissues around the removed hernia site. The lawsuits claim that the implant devices were built incorrectly and that the manufacturers neglected to notify patients about dangers and side effects such as inflammation, excessive scar tissue, nerve damage, and mesh shrinkage. In one of the largest mass tort suits in New Hampshire courts, Merrimack-based Atrium Medical Corp. paid for more than $66 million over its hernia mesh implants. Johnson & Johnson and Ethicon had settled 42,000 hernia mesh lawsuits by paying $120 million in September 2021. In the MDL class action, there are over 3,617 pending J&J hernia mesh pharma lawsuits.
Breast Implant Lawsuits
Breast implants are used to improve the size and form of the breasts during reconstructive surgery. When those implants fail, they could result in dangerous health problems, such as cancer that was discovered in the case of Allergan breast implants. Medical Device Reports (MDRs) reported an increase in cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and BIA-ALCL-related deaths associated with these devices, prompting the FDA to order Allergan to recall all BIO CELL textured breast implants and tissue expanders in the United States. FDA had registered 620 Allergan implant failure instances as of August 20, 2020, and Allergan is facing various class-action pharma lawsuits for its product.
Pharma Lawsuit Settlements
The biggest pharmaceutical lawsuit settlements ever seen in the United States are listed below for your scrutiny. This will show how many people have been affected by the pharmaceutical companies negligence, and the lump sum settlements will show how serious the consequences were.
Because of the changing lifestyles and ever-evolving diseases, the pharmaceutical industry has become omnipotent and omnipresent in people’s lives. They are making a lucrative income by selling lifesaving drugs and medical devices. Even a minor shortfall on their part can have far-reaching repercussions. Whatever lawsuits we have gone through in this blog are only the tip of the iceberg. Most of the largest pharmaceutical company lawsuit settlements to date have focused on how companies misrepresented drugs and their uses to physicians. Many of these lawsuits were filed because drug manufacturers promoted their products for uses that were not approved by the FDA.
We will meet again with the updates on pharma lawsuit settlements 2022 to see if we can tether the pharma giants from making errors. Let us know your comments…