The Legal Fallout from Exactech and Bard PowerPort Lawsuits

The relationship between a patient and their medical device is one of implicit trust: trust in the manufacturer’s design, testing, and integrity.

When that trust is betrayed by a defective product, the consequences can be catastrophic, leading to immense pain, financial hardship, and the need for complex corrective surgery.

This article examines the rising tide of product liability litigation in the medical device industry, focusing on two prominent examples: the widespread failure of Exactech’s Optetrak knee and ankle systems due to packaging defects and the design flaws alleged in the Bard PowerPort catheter.

These cases not only highlight critical failures in manufacturing and quality control but also expose the profound legal and financial complexities that arise when multibillion-dollar corporations face mass torts.

Product Liability and the Three Defects

The legal claims against companies like Exactech and Bard are rooted in product liability law, which holds manufacturers, distributors, and sellers responsible for placing a defective product into the stream of commerce. 

For a closer look at how defective medical device claims are handled at the state level, see our guide to Defective Medical Device Lawsuits in California

A plaintiff typically bases their case on one or more of three primary legal theories, which are central to every mass tort:

1. Manufacturing Defect: A flaw in the product that occurred during the production phase, meaning the final product deviates from its intended design.
2. • Relevance to Exactech: This theory is paramount in the Exactech lawsuits, where the core defect was faulty vacuum-sealed packaging. The polyethylene inserts themselves may have been designed correctly, but the non-conforming packaging allowed oxygen to compromise the components before implantation, leading to premature oxidation and accelerated wear.
3. Design Defect: The product is inherently dangerous because the design itself is flawed, even if manufactured perfectly. The plaintiff must often show that a safer, economically feasible alternative design existed.
   • Relevance to Bard PowerPort: The Bard PowerPort litigation heavily involves this theory, as plaintiffs allege the Chronoflex polyurethane tubing material is prone to degradation and fracturing when exposed to the body's environment, making the overall design unreasonably dangerous.
4. Failure to Warn (Marketing Defect): The manufacturer failed to provide adequate warnings or instructions about a known or knowable non-obvious danger associated with the product’s use.
   • Relevance to Both: Both litigations involve allegations that the companies knew or should have known about the issues—premature wear (Exactech) or catheter fracture/migration (Bard)—and failed to promptly and transparently warn the medical community and patients, thereby causing further injury.

Case Study 1: The Exactech Recall and the Fallout from Faulty Packaging

The Exactech crisis began with an insidious flaw: a simple, yet critical, failure in packaging. The recall primarily involved the Optetrak, Optetrak Logic, and Truliant knee systems, as well as the Vantage ankle systems.

• The Root Cause: Exactech used a non-vacuum-sealed, out-of-specification polyethylene bag and a secondary box containing an oxygen-degradable stabilizer layer for its components. This faulty primary packaging allowed excessive oxygen exposure to the polyethylene inserts.
• The Consequence: Polyethylene is highly susceptible to oxidation. The premature exposure led to the degradation of the plastic components before they were ever implanted. Once in the body, this degraded material suffered from accelerated wear, osteolysis (bone loss), loosening, and component fracture, causing severe pain and failure in a fraction of the device’s expected 15-20 year lifespan.
• Timeline: The company initiated its first major recall in August 2021, expanding it significantly in February and April 2022 to cover nearly 150,000 devices implanted in the U.S. since 2004. The sheer time frame—nearly two decades of allegedly defective packaging—underscored the gravity of the quality control failure.

The Legal Response and the TPG/Bankruptcy Factor

Thousands of injured patients filed lawsuits, leading to a massive Multi-District Litigation (MDL) in federal court.

However, the litigation took a dramatic turn when Exactech, facing "unsustainable liabilities," filed for Chapter 11 bankruptcy in late 2024.

• The Bankruptcy Strategy: Exactech’s filing was a strategic move to centralize liability and limit compensation. Original proposals sought to shield its private equity owner, TPG Capital, from liability by establishing a patient compensation trust with a minimal contribution from TPG.
• The Private Equity Question: This move introduced the controversial issue of private equity liability in product defect cases. Claimants’ committees argued that TPG, which acquired Exactech in 2018, exercised sufficient operational control or profited from the company's cost-cutting decisions (allegedly including packaging choices) that contributed to the crisis. While a U.S. District Judge had previously dismissed TPG from direct personal injury claims by ruling the firm lacked the "requisite control," the creditors' committee continued to press the issue within the bankruptcy court, arguing that TPG was attempting to "bury" the patient claims to protect itself.
• Current Status: The focus shifted to an exit plan where the company's assets would be transferred to its top lenders, with a revised plan to establish a claimant trust for victims. The outcomes of these bankruptcy proceedings, including the final size of the patient fund and the success of claims against TPG, remain critical for determining the final compensation for thousands of patients.

Case Study 2: The Bard PowerPort Catheter Defect and MDL

Bard PowerPort is a popular model of implantable port catheter, often used to deliver chemotherapy, fluids, or medications directly into a patient’s bloodstream over long-term treatment.

Lawsuits against the manufacturer, C.R. Bard (now owned by Becton, Dickinson and Company), allege significant and life-threatening design defects.

• The Core Defect: The central allegation is that the catheter's unique material, Chronoflex polyurethane mixed with barium sulfate, is inherently flawed. The addition of barium sulfate, used to make the catheter visible on X-rays—allegedly compromises the structural integrity of the polyurethane, making it susceptible to brittleness and degradation within the body.
• The Injuries: As the catheter degrades, it can lead to two major categories of injury:
  1. Catheter Fracture & Embolism: Fragments of the brittle tube break off (a fracture) and travel through the bloodstream (catheter embolism). These shards can puncture blood vessels, vital tissues, or even the heart, leading to cardiac perforation, organ damage, and in some cases, death.
  2. Infection/Sepsis & Thrombosis: Fractures and rough surfaces on the compromised catheter create sites for bacteria to accumulate, leading to severe bloodstream infections and sepsis (a life-threatening whole-body inflammatory response). The presence of the damaged catheter material also significantly increases the risk of Deep Vein Thrombosis (DVT), or blood clots.

The Legal Strategy and Path to Settlement

Bard PowerPort lawsuits have been consolidated into an MDL in the District of Arizona under Judge David G. Campbell, with nearly 2,000 cases pending as of late 2025.

• Failure to Warn Claims: Central to the case is the accusation that Bard had received numerous Adverse Event Reports (AERs) detailing catheter fractures and other complications but failed to change the design or provide adequate warnings to doctors and patients, a clear failure to warn.
• Bellwether Trials: As the litigation is still in its discovery phase, no global settlement has been reached. Instead, the court and the parties are preparing for a series of Bellwether Trials—initial, representative test cases—scheduled to begin in March 2026 and continue through the end of the year. The outcome of these trials is critical, as they will test the legal theories, evidence, and jury reactions to key injury types (e.g., fracture, infection, thrombosis), ultimately setting a precedent for the negotiation of a global settlement for all other plaintiffs.
• Potential Damages: Estimated settlement values are expected to vary significantly based on the severity of the injury, ranging from tens of thousands of dollars for port removal to six figures or more for life-threatening complications like organ damage, sepsis, or wrongful death.

The Broader Implications of Mass Torts

The mass tort litigation against Exactech and Bard is more than a legal battle for compensation; it is a critical check on corporate accountability within the highly regulated medical device sector.

These cases underscore that defective devices lead to a re-injury cycle—the original ailment, followed by an injury from the device, and finally, the trauma of revision surgery.

The legal system must grapple with complex issues: the role of sophisticated engineering materials, the adequacy of FDA clearance processes, and the ethical obligations of manufacturers.

Furthermore, the Exactech case introduces the contentious issue of private equity's role in healthcare, challenging the notion that financial entities can claim immunity while leveraging control over manufacturing and safety decisions.

As the Bard PowerPort MDL progresses toward its bellwether trials and Exactech's bankruptcy concludes, the resolution of these mass torts will send a powerful message.

It will either affirm the patient's right to expect a safe product and receive fair compensation for devastating injuries, or it will create a new legal shield for corporations willing to risk public safety for profit.

For the thousands of patients who trusted these devices, the outcome will define whether justice is ultimately served.

The Role of Bellwether Trials in Mass Tort Resolution

When thousands of patients are hurt by the same product, the court system faces an impossible task: how do you fairly resolve all those claims without holding thousands of individual trials?

That’s where bellwether trials come in.

These “test cases” act like trial runs, giving both sides and the judge a sense of how juries might respond to the evidence and injuries at the heart of the litigation.

Federal Judicial Center (FJC) has even published a guide for judges on how to run these trials, stressing that they’re one of the most useful tools for managing multidistrict litigation (MDL).

Why They Matter to Patients and Companies

• Testing the Issues: Bellwether cases put key questions like whether a design is inherently dangerous or whether warnings were adequate before a jury.

• Shaping Settlements: A win for patients in a bellwether trial can push companies toward higher settlements. A defense win, on the other hand, may lower expectations.

• Managing Chaos: Instead of drowning in thousands of trials, courts can use bellwethers to establish common rulings and streamline the process.

• Flexibility: As the FJC points out, there’s no one-size-fits-all formula. Each MDL is different, and bellwethers have to be tailored to fit.

What This Means for Exactech and Bard

For Bard’s PowerPort MDL, the first bellwether trials are set for 2026. These will likely focus on cases involving fractures, infections, and thrombosis. The outcomes could set the tone for thousands of other patients still waiting for resolution.

For Exactech, things are trickier. Because the company filed for bankruptcy, traditional bellwether trials may not play out in the same way. But test cases or even hypothetical “proof-of-concept” claims could help determine whether patient compensation funds are adequate before the bankruptcy plan is finalized.