Big Pharma and Medical Device Manufacturers: Lawsuits, Recalls & Corporate Negligence
Big Pharma and other medical device manufacturers’ products and corporate negligence have led to recalls. People have also filed lawsuits claiming these manufacturers’ drugs and devices caused serious harm. If you’ve been injured by a medical product, talk to an attorney about filing a claim.
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The largest and most profitable pharmaceutical manufacturers, known as Big Pharma, include companies like Pfizer, Johnson & Johnson, AbbVie, Merck and Roche. In 2025, the top Big Pharma manufacturers in the U.S. earned roughly $234 billion in revenue.
While many Big Pharma companies produce helpful and necessary medical products, they sometimes face injury lawsuits. Plaintiffs claim that manufacturers failed to warn about health risks, made defective or inadequately tested products and misled consumers about product safety.
If you were harmed by dangerous drugs or devices, you may be able to file a product liability lawsuit to receive compensation for damages.
Why Are Big Pharma Companies and Other Medical Device Manufacturers Facing Lawsuits?
Lawsuits claim that Big Pharma companies and other medical device manufacturers prioritized profits over safety, resulting in serious health concerns like cancer, infections, revision surgeries and even death.
- Failure to Warn About Side Effects: Companies must warn doctors and patients about health risks linked to their products. Consumers may file a lawsuit when a product causes severe side effects that the manufacturer didn't list on the drug's label or prescribing information.
- Misleading Marketing: Some companies might make inaccurate statements about their products' effectiveness or safety to ensure sales. A manufacturer can be held liable for harm caused by misleading claims.
- Defective Design or Manufacturing: Defective design claims arise from faulty plans for a product before it's manufactured. These can include toxic ingredients, inadequate safety guards and more.
- FDA Recalls and Regulatory Actions: When a high volume of side effects is reported for a product, the FDA may ask the manufacturer to recall it. Common reasons for a recall include sterility issues and failure to comply with good manufacturing practices. Alternatively, the FDA may request that manufacturers add a black box warning, the agency’s strongest packaging alert.
These allegations can lower the public’s trust and result in negative feelings toward pharmaceutical companies. According to a Gallup Poll, only around 18% of Americans viewed the pharmaceutical industry positively in 2023.
Big Pharma Companies and Other Medical Device Manufacturers Linked to Major Lawsuits and Recalls
Big Pharma companies, like Bayer and Pfizer, and other pharmaceutical manufacturers, including Bard and CooperSurgical, have been linked to major recalls and faced lawsuits.
Some injuries claimed in lawsuits include cancer, organ damage and the need for additional surgeries.
| Manufacturer | Key Products Under Litigation | Lawsuit Injuries |
|---|---|---|
| 3M / DuPont | AFFF Foam, PFAS chemicals | Cancer |
| Abbott / Mead Johnson | Similac, Enfamil | NEC in premature infants |
| Bard (BD) | Hernia mesh | Adhesions, fluid buildup, infection, pain or hernia recurrence |
| Bard | IVC filters | Embolization, hematoma, infection, internal bleeding or respiratory distress |
| Bard | PowerPort | Hematoma, hemorrhage, infections, perforations or sepsis |
| Bayer / Monsanto | Roundup | Non-Hodgkin lymphoma |
| CooperSurgical / Teva Pharmaceuticals | Paragard IUD | Infertility, injuries from broken IUD pieces embedding in organs, pain or removal surgery |
| Ethicon (J&J) | Transvaginal mesh, surgical mesh | Bleeding, infection, pain, perforation and the movement of mesh through tissue |
| Exactech | Hip, knee, ankle implants | Bone loss, instability, pain, revision surgery or swelling |
| GlaxoSmithKline | Zantac | Cancer |
| Johnson & Johnson | Hip Implants | Allergic reaction, implant failure, metal poisoning, revision surgery, severe pain or tissue damage |
| Johnson & Johnson | Talcum powder | Mesothelioma or ovarian cancer |
| Novo Nordisk / Eli Lilly | Ozempic, Wegovy, Mounjaro | Deep vein thrombosis, intestinal obstruction and stomach paralysis |
| Pfizer | Depo-Provera | Tumors in the brain (meningioma) |
| Philips | CPAP Machines | Cancer |
Drugwatch includes regular updates for most of these active lawsuits. Check back often for the latest litigation information.
Biggest Legal Settlements Involving Big Pharma and Other Medical Device Manufacturers
Several pharmaceutical companies, like Johnson & Johnson, Bayer and GlaxoSmithKline, have paid billions to resolve injury claims related to defective drugs and devices.
These high-profile settlements show how widespread some injuries were and how legal action can hold companies accountable.
| Company | Product(s) | Settlement Amount | Year(s) |
|---|---|---|---|
| 3M | Combat Arms Earplugs (military case) | $6.01 billion | 2023 to presen |
| Bard / CR Bard | Hernia mesh | $1+ billion (estimated) | 2024 |
| Bayer / Monsanto | Roundup weed killer | $10+ billion | 2020 |
| Boston Scientific | Transvaginal mesh | $8 billion+ (ongoing) | 2014 to present |
| GlaxoSmithKline | Zantac | $2.2 billion | 2024 |
| Johnson & Johnson | Talcum powder | $8 billion offered, still awaiting approval | 2023 to present |
| J&J and three wholesalers | Opioids | $26 billion (multi-manufacturer global deal) for drug treatment programs | 2022 |
| Takeda | Actos (bladder cancer) | $2.4 billion | 2015 |
These settlements reflect past results and do not guarantee future compensation. Even after a settlement is reached, lawyers may still accept cases.
How Big Pharma Companies and Other Medical Device Manufacturers Harm Consumers
Lawsuits claim Big Pharma and other medical device manufacturers harm consumers by concealing adverse events, cutting corners during product testing, manipulating scientific data, using misleading marketing and pushing drugs for unapproved uses.
Unethical practices and corporate negligence adversely impact consumers physically, financially and emotionally.
Concealing Health Risks
Product liability lawsuits are full of claims that pharmaceutical companies actively concealed their product’s health risks and failed to warn the public of potential dangers.
For example, talcum powder lawsuits against J&J allege that the health care giant hid the fact that its talc powder was contaminated with asbestos and could lead to ovarian cancer.
In 1971, a mineralogist hired by J&J found talc and asbestos in ovarian cancer tissue. The manufacturer convinced him not to publish the findings.
Cutting Corners in Testing
Some companies have been accused of cutting corners or falsifying test results. For example, 3M Combat Arms Earplug lawsuits detail how inappropriate testing skewed the noise reduction results, making the earplugs seem more effective than they were.
These earplugs led to hearing loss, tinnitus and other injuries. In 2018, 3M paid $9.1 million to the DOJ to settle claims that it sold the earplugs to the military without disclosing defects.
The company also agreed to pay $6 billion to resolve lawsuits for hearing loss and other injuries.
Manipulating Scientific Studies
Roundup lawsuits claimed that Monsanto, now Bayer, ghostwrote several studies and retracted journal articles to downplay glyphosate’s link to cancer. Scientists in Research Policy confirmed this by studying legal documents.
“It is now generally recognized that Monsanto engaged in research misconduct to distort the scientific record with the goal of preventing proper regulatory oversight by the US Environmental Protection Agency (EPA),” according to an article published in Research Policy.
Misleading Marketing
According to talcum powder lawsuits, J&J’s marketing for its baby powder is misleading. Messages included statements like “use anytime you want skin to feel soft, fresh and comfortable” and suggested using it on infants “after every bath and diaper change.”
However, lawsuits claim Johnson’s Baby Powder is not safe because it’s linked to ovarian cancer.
“Defendants do not tell consumers about the dangers associated with the talc-based Johnson’s® Baby Powder,” according to Mona Estrada’s class action complaint. “Instead, Defendants continue to expressly and impliedly represent that the product is safe and intended for women to use the Baby Powder in the very manner most likely to result in an increased risk of ovarian cancer.”
Pushing Drugs Off-Label
Prescribing a drug for unapproved use, known as off-label drug use, isn’t illegal. However, drugmakers are banned from encouraging it.
According to the Department of Justice, J&J pleaded guilty to criminal charges in 2013 and settled civil allegations for promoting its antipsychotic drug Risperdal to health care providers for off-label uses.
While Risperdal was approved to treat schizophrenia, sales representatives from Janssen Pharmaceuticals Inc., a J&J subsidiary, promoted the drug to treat anxiety, agitation, confusion, depression and hostility. The manufacturer paid $2.2 billion.
Off-label use of the drug led to breast growth in thousands of men. J&J settled those cases for an undisclosed amount, but the company disclosed that it recorded $800 million in expenses related to the agreement.
What To Do if You’ve Been Harmed by a Manufacturer’s Drug Or Device
If you’ve been harmed by a pharmaceutical company’s drug or device and want to file a lawsuit, you should identify the manufacturer, understand your legal rights and get advice from a product liability lawyer.
Identify the Manufacturer
You can identify the manufacturer of the drug, device or product by reviewing your medical records or prescription receipts.
Looking at the receipt from the business where you purchased the product can help. If it’s difficult to identify the manufacturer, a lawyer can advise you on how to proceed.
Understand Your Legal Rights
Product liability laws allow injured people to file a lawsuit for compensation. Drugwatch can connect you to an attorney for a free drug, device or product lawsuit consultation.
Some lawsuits are consolidated into multidistrict litigation (MDL). An MDL groups several similar cases together to expedite the litigation process. However, these types of complex cases often take years to resolve.
Contact a Lawyer Experienced in Product Liability
Contact a lawyer with experience in product liability law, specifically pharmaceutical or medical device litigation. This type of attorney will help you through the legal process best.
It’s also wise to talk to a lawyer immediately because there are time limits to file your case, called the statute of limitations. These can vary by state.
Where To Learn More About Drug & Device Manufacturers
You can learn more about drug and device manufacturers through the FDA’s resources.
- FDA Medical Product Safety Educational Resources: An overview of how to report problems to the FDA.
- FDA Product Safety Information: Shares safety information for drugs, animal health, biologics, medical devices and cosmetics.
- Recalls, Market Withdrawals, & Safety Alerts:Contains information from press releases and other notices from the FDA. You can also sign up for FDA alerts.
Drugwatch also has several Big Pharma and other medical device manufacturer pages, news posts and litigation updates to help you stay current on safety, recalls and lawsuits.
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