If you have an implanted medical device that failed, have already had revision surgery, or have learned that something inside your body was recalled, you may have a defective medical device lawsuit available to you.

Many patients in this situation assumed for years that a device on the market with FDA involvement must have been proven safe. That assumption is understandable. Unfortunately, it is often the wrong assumption. Some of the largest medical device mass tort cases in American history involve devices that were never required to prove safety to the FDA before reaching an operating room.

This article explains the two FDA pathways most patients have never heard of, the legal doctrine that determines whether a patient can sue the manufacturer, and the four device categories where litigation has produced multi-billion-dollar outcomes.

FDA Clearance Is Not the Same as FDA Approval

The FDA reviews medical devices through different pathways depending on risk level. Most patients are surprised by how little testing many implanted devices underwent before they were cleared for use.

Class I devices are low-risk products like bandages and tongue depressors. Most are exempt from formal premarket testing.

Class II devices are moderate-risk devices, including most surgical mesh, most inferior vena cava filters, and most orthopedic implants. They reach the market through the 510(k) clearance pathway, under which the manufacturer is required only to show that the device is “substantially equivalent” to a predicate device already on the market. The FDA is careful with its own language here as it states that Class II devices are cleared, not approved, and the FDA expressly prohibits manufacturers from marketing them as “FDA approved.”

Class III devices are high-risk, life-sustaining products such as pacemakers and certain heart valves. They generally reach the market through the Premarket Approval (PMA) pathway, which requires clinical trials and a manufacturer demonstration of “reasonable assurance of safety and effectiveness.”

The practical difference is substantial. A 2021 study in JAMA (Journal of the American Medical Association) Internal Medicine examining device recalls from 2008 through 2017 found that approximately 97% of recalled devices had reached the market through 510(k) clearance, not PMA. This path of least resistance to the U.S. market produces most of the recalls.

Why the 510(k)/PMA Distinction Determines Whether You Can Sue

This distinction matters more to a patient with a failed device than almost any single regulation. It comes from two Supreme Court decisions handed down twelve years apart.

In Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the Court held that 510(k) clearance does not preempt state-law product liability claims. Because the substantial-equivalence review is a comparative process rather than a device-specific safety determination, it does not produce the kind of federal requirements that block state-law lawsuits.

In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the Court reached the opposite conclusion for PMA devices. In an 8-1 decision written by Justice Scalia, the Court held that the express preemption provision of the Medical Device Amendments of 1976 bars most state-law tort claims against Class III devices that received full premarket approval. In plain terms, if a device went through PMA, the manufacturer is largely shielded from state product liability lawsuits.

The result is that the largest medical device mass tort cases in U.S. history, including the DePuy ASR hip implant litigation, the transvaginal mesh litigation, the IVC filter litigation, and the hernia mesh litigation, all involve 510(k) devices. Manufacturers in those cases cannot use the Riegel preemption shield, and patients may pursue the full range of state-law product liability claims: design defect, manufacturing defect, and failure to warn. A narrow exception called the “parallel claims” doctrine may allow some PMA-device claims to proceed when a state-law claim mirrors a specific federal requirement, but that pathway is substantially more limited.

What Manufacturers Are Required to Disclose

A device reaching the market does not end a manufacturer’s obligations. Under the FDA’s Medical Device Reporting requirements, manufacturers must report device-related deaths, serious injuries, and certain malfunctions to the FDA on defined timelines. State product liability law separately imposes a continuing duty to warn physicians and patients of known risks, particularly when the manufacturer learns of a failure mode after the device is already in use.

When internal documents show that a manufacturer knew about a defect and kept selling the device anyway, that concealment can give rise to punitive damages on top of compensatory damages. Court records from the DePuy ASR hip implant litigation revealed an internal analysis projecting that the ASR system could fail in approximately 37% of patients within 4.6 years of implantation. NBC News reported in 2015 that C.R. Bard executives had been aware of risks associated with the company’s IVC filters for years before any public disclosure. In cases like these, punitive damages may be available because the conduct goes well beyond a design failure to a knowing decision to keep selling.

Four Device Categories Where Accountability Has Produced Real Outcomes

Transvaginal Mesh – Seven Federal MDLs, More Than $8 Billion in Settlements

Transvaginal mesh is a synthetic woven fabric used to treat stress urinary incontinence and pelvic organ prolapse. Most products reached the market through 510(k) clearance, often predicated on older, discontinued devices.

Federal cases were consolidated into seven MDLs before U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia. More than 100,000 cases were filed against manufacturers including Johnson & Johnson’s Ethicon subsidiary, Boston Scientific, C.R. Bard, American Medical Systems, and Coloplast. All seven federal MDLs have closed, with industry-wide settlements estimated at more than $8 billion as of 2026. State court claims within the applicable statute of limitations may still be available.

Notable outcomes include: Endo International paying approximately $830 million in 2014; Johnson & Johnson Ethicon paying a $117 million multistate settlement in 2019 for deceptive marketing; Boston Scientific paying $188.6 million to 47 states and the District of Columbia in 2021; C.R. Bard paying $60 million in a 2020 multistate settlement; and the California Superior Court entering a $344 million judgment against Johnson & Johnson in January 2020.

On the regulatory side, the FDA reclassified transvaginal mesh for pelvic organ prolapse as Class III in 2016. In April 2019, the FDA ordered the remaining manufacturers to immediately stop selling all transvaginal mesh products for POP repair. That order applies only to mesh used for transvaginal POP repair. It does not apply to midurethral slings for stress urinary incontinence or to mesh placed abdominally for sacrocolpopexy.

Metal-on-Metal Hip Implants – DePuy ASR, Stryker Rejuvenate, and the End of an Era

Metal-on-metal hip implants were marketed in the early 2000s as more durable for younger, more active patients. All reached the market through 510(k) clearance. In practice, contact between the metal femoral head and the acetabular cup generated microscopic debris that damaged surrounding tissue and, in some patients, elevated cobalt and chromium levels in the bloodstream, a condition called metallosis.

The DePuy ASR hip system was recalled worldwide in August 2010 after registry data showed unacceptably high failure rates. Federal litigation consolidated in the Northern District of Ohio before U.S. District Judge David A. Katz. Johnson & Johnson settled approximately 8,000 ASR revision cases for roughly $4 billion in November 2013, with an additional $420 million resolving about 1,800 more cases in March 2015. The related DePuy Pinnacle hip litigation produced a $502 million bellwether verdict in 2016, later reduced to $151 million on appeal, and in May 2019 Johnson & Johnson agreed to a $1 billion settlement covering approximately 6,000 Pinnacle cases.

Stryker issued a worldwide market withdrawal in 2012 of its Rejuvenate and ABG II hip stems. A 2014 settlement was valued at approximately $1.43 billion, with subsequent payouts bringing the cumulative Stryker resolution to roughly $2.2 billion.

No metal-on-metal hip replacement systems remain FDA-cleared today.

Inferior Vena Cava (IVC) Filters – Active Litigation Continues

IVC filters are small cage-like devices implanted in the large vein returning blood from the lower body to the heart, intended to capture blood clots before they can reach the lungs. Most reached the market through 510(k) clearance. IVC filter lawsuits typically allege that the device was designed in a way that made it prone to fracture, migration, tilting, vena cava perforation, or embolization of fragments to the heart or lungs, and that the manufacturer failed to warn physicians and patients.

C.R. Bard was the defendant in MDL 2641 in the District of Arizona, which has closed after confidential settlements with thousands of plaintiffs. Cook Medical remains the defendant in MDL 2570 in the Southern District of Indiana before Senior U.S. District Judge Richard L. Young, with approximately 6,750 cases pending as of early 2026 and settlement discussions actively underway.

Notable verdicts include a $3.3 million Wisconsin federal jury verdict against C.R. Bard, upheld by the Seventh Circuit in August 2023, and a $386,250 Dallas jury verdict in 2021 in a fractured-filter case. The FDA has recommended that retrievable IVC filters be removed within 29 to 54 days of implantation once the pulmonary embolism risk has passed, but studies show only approximately 8.5% of retrievable filters are actually removed within that window.

Hernia Mesh – Four Federal MDLs, More Than 86,000 Adverse Event Reports

Hernia mesh is a synthetic or biologic patch used to repair abdominal and inguinal hernias. Most products reached the market through 510(k) clearance. The FDA has received more than 86,000 adverse event reports related to hernia mesh since 2019, with the most commonly reported complications including chronic pain, infection, mesh migration, adhesions, bowel obstruction, and organ perforation, often requiring revision surgery.

Four federal MDLs have consolidated thousands of cases. C.R. Bard/Davol in MDL 2846 in the Southern District of Ohio: Becton, Dickinson and Company, Bard’s parent, announced a settlement in October 2024 to resolve approximately 38,000 cases, with Bloomberg and Reuters reporting the total payout will exceed $1 billion. Covidien in MDL 3029 in the District of Massachusetts before Chief U.S. District Judge Patti B. Saris. Atrium Medical in MDL 2753 in the District of New Hampshire, with most cases having reached confidential settlements. Ethicon Physiomesh in MDL 2782 in the Northern District of Georgia, with nearly all cases settled.

Notable hernia mesh verdicts include a $4.55 million Rhode Island state court verdict in Trevino v. C.R. Bard, Inc. (August 2022, as reduced on post-trial motions) and a series of federal bellwether verdicts in the Bard MDL ranging from $250,000 to $500,000.

Exactech Joint Implants – A 2021 Recall, an Active MDL, and a 2024 Bankruptcy

The Exactech matter is the most current of the major device mass tort cases. Exactech issued a recall in August 2021 of certain knee and ankle implants with polyethylene components after discovering that defective vacuum packaging had allowed oxygen to degrade the polyethylene before implantation. The degraded polyethylene could produce accelerated wear, debris, bone loss, and component fracture, in some cases requiring revision surgery. The recall expanded in 2022 to include certain Exactech hip implants.

Federal cases were consolidated in October 2022 as MDL 3044 in the Eastern District of New York before U.S. District Judge Nicholas G. Garaufis. Exactech filed for Chapter 11 bankruptcy in October 2024. Most cases in the MDL and in parallel state court matters are currently stayed by the bankruptcy automatic stay. Patients who have not yet filed are encouraged to speak with counsel as soon as possible to preserve their position in the bankruptcy proceedings.

Who May Have a Claim

A patient may have a viable claim when all of the following apply: the device has been recalled, has been the subject of an FDA safety communication, or is involved in active multidistrict litigation; the patient experienced complications consistent with the device’s known failure modes; the patient required revision surgery, device removal, or other corrective intervention; and the complication occurred within the applicable state statute of limitations, which varies and may run from the date of injury, the date the patient connected the device to the injury, or the date of revision surgery.

Patients who are uncertain whether their device is recalled or involved in active litigation can identify it by its Unique Device Identifier (UDI), which the FDA has required on most implants since 2013. The implanting physician or the hospital’s medical records department can usually provide the UDI on request.

We Are Here to Hear Your Story

If you were implanted with a medical device that failed or caused serious complications, you may have a claim against the manufacturer. Constant Legal Group handles medical device mass tort cases nationally. We offer free, confidential consultations with no obligation and no upfront cost. We only get paid if we recover compensation for you.

Deadlines vary by state and device, and some active MDLs are approaching settlement cut-off dates. The time to start a confidential conversation is now, even if you are not certain you want to file.
Call us at 855-906-2561

This article is for informational purposes only and does not constitute legal advice. Contact Constant Legal Group for a confidential evaluation specific to your circumstances. Case outcomes vary significantly based on the specific facts of each case, jurisdiction, and applicable law.