Coffee With Q News Reporter Rene Perras sits down with trial attorney Joe Osborne to discuss the devastating impact of defective hip implants and how patients can protect themselves
Introduction
In a comprehensive two-part interview, Coffee With Q News Reporter Rene Perras spoke with Joe Osborne, a seasoned trial attorney with over 35 years of experience representing victims of defective medical devices. Osborne, a partner at Osborne & Francis, has successfully handled thousands of cases involving medical device failures, with a particular focus on hip implant litigation including the notorious Stryker LFIT V40 cases.
Starting from humble beginnings working off a card table in a small office, Osborne has built a law firm dedicated to leveling the playing field for ordinary people facing catastrophic injuries from medical device failures. His insights shed light on critical issues that impact patients, healthcare providers, and the broader medical device industry.
When Medical Devices Fail: The First Steps
Rene Perras: Joe, what are the initial steps that must be taken to help people who are living with a failing medical device, such as those who experience issues with Stryker hip implants?
Joe Osborne: Thanks for having me, Rene. There are several crucial steps that patients should take when they suspect their medical device is failing. First and foremost, if they believe the device is causing problems through symptoms or other complaints, they should return to the doctor who implanted the device. It’s critical that the doctor is made aware of these complaints and documents any problems in the medical records that are specifically related to the device.
If the physician or surgeon recommends that the device needs to be removed through surgery because it’s causing more harm than good, patients need to have it removed, even though nobody wants additional surgery, especially after recently having a device implanted with expectations of improvement.
Most importantly, if removal surgery is performed, it’s essential that the hospital preserve the device. Typically, when hospitals remove devices from patients, they discard them since they have no use for them. However, these devices can become crucial pieces of evidence in litigation. There are specific steps that need to be taken with both the hospital and the doctor to ensure that the device, which you believe failed, is preserved and can be used as evidence.
Understanding Mass Torts: Organization and Efficiency
Rene Perras: We hear a lot about mass torts. What is a mass tort in layman’s terms, and how has your extensive experience helped shape your strategy?
Joe Osborne: Mass torts are essentially the organization and collection of individual injury cases that all involve very similar issues. In the LFIT V40 Stryker cases, for example, all cases involve the failure of the same medical device – specifically Stryker’s V40 heads in hip implants.
These cases get consolidated, meaning they’re collectively organized in front of one judge for several important reasons:
Efficiency: Rather than having hundreds or thousands of cases prosecuted against the same defendant across the United States with different judges and different rulings, consolidation brings uniformity to the process.
Cost-effectiveness: When discovery and depositions occur, key witnesses like the Stryker engineer who designed the implant can be deposed once, and that deposition can be used in all cases. Individual plaintiffs don’t have to spend the money and attorney time to duplicate this work.
Shared benefits: Everyone gets the same work product and shares in the successes of the litigation as cases move forward.
Settlement Strategy: Individual Attention in Mass Cases
Rene Perras: Are there challenges when negotiating settlements in these cases, and how do you ensure settlements serve your clients’ particular interests?
Joe Osborne: When negotiating settlements in mass tort cases, experience is crucial because there are many pitfalls that lawyers can encounter, both in approach and ethically. Having done this for over 20 years and negotiated many settlement deals, we make sure to get individual authority from our clients.
Each client’s case is different. Even though cases are consolidated for discovery purposes and on the liability side, each client has their own causation and damages story – how long they had the implant, how it failed, and how it affected their lives.
It’s important to get individual authority and ensure each client is treated individually when it’s time to resolve their case. In every settlement we’ve done, we’ve performed this analysis for each client and secured individual numbers, so we can do the best job possible to address what they’ve been through and bring a satisfactory result.
The Critical Role of Scientific Evidence and Expert Collaboration
Rene Perras: How important is scientific and medical evidence in building cases against medical device manufacturers, and how do you collaborate with experts?
Joe Osborne: Scientific evidence and experts are everything in products cases and mass tort cases. We often get tipped off about problems with medical devices from the literature. For instance, a doctor who has implanted 200 Stryker products might start seeing an unusual failure rate – instead of patients having great success for 15-20 years, they’re returning within two or three years with problems.
Normal failure rates should be about 1-2% for a good, well-studied, safe, and effective implant. When failure rates reach 10%, 15%, or 20%, the literature captures this through case reports, and the scientific community gets alerted to specific problems.
Our experts – whether they’re biomechanical engineers, FDA experts, or orthopedic surgeons – use this scientific literature to formulate their opinions. When analyzing individual cases, they rely on the literature to determine whether failure was due to the device rather than other causes. The literature really forms the foundation for these expert opinions.
Bellwether Cases: Testing the Waters
Rene Perras: Can you explain what a bellwether case is and how they influence settlement discussions?
Joe Osborne: Bellwether cases are extremely important to the settlement process. When hundreds of cases are filed, it would be virtually impossible to try them all. Both sides work with the judge to find representative cases – not outliers in either direction, but something in the middle that’s representative of the overall case population.
These representative cases provide guideposts. If we try a case and win with a jury assigning a specific value, it helps indicate what the overall litigation might be worth. If we lose and get a zero verdict, it might make us rethink our case values.
Often, many bellwether cases are tried because you’re accumulating wins on both sides, ultimately providing insight into not only what you think cases are worth, but what the community and juries think they’re worth – and jury opinion becomes most important.
Supporting Clients Through Trauma and Recovery
Rene Perras: What forms of support are available for clients dealing with emotional trauma and physical injuries when devices fail?
Joe Osborne: It’s important that law firms handling these cases have the experience and relationships necessary to help. My firm has been involved in hip litigation for over a decade, so we have relationships with surgeons across the United States who can perform revision surgery.
We can help direct patients to physicians familiar with the process and skilled at removing failed implants. If a client tells me they had an implant in Texas but now live in California and don’t know where to go, we can coordinate access to great quality care without jeopardizing their case.
After surgery, there are needs for therapies and emotional support, plus economic impacts. Through our relationships, we can provide guidance regarding inpatient or outpatient therapy. When we bring a case, we consider the emotional impact of undergoing another surgery, pain and suffering, and economic impacts like lost work or business income.
The Complex Issue of Doctor Accountability
Rene Perras: What accountability can be assigned to doctors who performed these defective hip implant surgeries?
Joe Osborne: Unfortunately, medical device companies often create two victims: the patient and the doctors who implant these devices. Doctors are often victims themselves.
No doctor enters surgery intending to harm patients. They’re relying on science and information provided by companies like Stryker or Johnson & Johnson. These companies design the implants, bring engineers together, compile the science, and create the product. They essentially sell doctors on the idea that this is state-of-the-art technology with specific benefits.
Doctors attend medical school to care for patients, not to learn medical device creation. When devices fail and materials aren’t what they were claimed to be, physicians often become angry because they feel the medical device company let both them and their patients down.
Physicians will tell us: “If we had only known the truth, we never would have used this product in any of our patients.”
One of our major claims is called a “failure to warn” claim. The warning obligation runs to the doctor – it’s the medical device company’s responsibility to tell doctors the true risks and benefits so doctors can decide if the product is right for their patients. If real risks aren’t disclosed, and instead of a 1% chance of problems there’s actually a 15% chance, that makes what should be a safe device unsafe. The implanting physician often becomes one of our most important witnesses because of this failure to warn claim.
The Dangerous 510(k) Pathway: Patients as Guinea Pigs
Rene Perras: What are the broader implications of cases like Stryker hip implant litigation on medical device regulation and patient safety?
Joe Osborne: Unfortunately, we have something called the 510(k) process in the United States. This pathway allows companies to get FDA approval under “substantial equivalence” – a process that gets products to market quicker, cheaper, and in a less safe way. Patients receiving these products are essentially guinea pigs.
This is very different from what people think the FDA does – requiring studies and clinical information at major institutions. Even though cases like hip implant litigation exist, the 510(k) process hasn’t disappeared. It continues to rubber-stamp bad products that reach the U.S. market.
The 510(k) process does not require companies to do clinical studies before products go to market. Many doctors don’t even know this. There’s an alternative called PMA (post-market approval) that requires clinical studies, but it takes longer and costs companies more money from a regulatory standpoint, though it’s probably safer for patients.
Every medical device case I’ve been involved in has involved a 510(k) product. As long as this pathway exists, we’ll continue seeing more bad and failed products.
Rene Perras: Can consumers know whether a medical device went through 510(k) or PMA approval?
Joe Osborne: Absolutely. It’s all public record. When meeting with your doctor about needing a hip implant or knee replacement, ask: “What type of product am I getting? Who is the manufacturer and what’s the name of the product?”
You can go home and Google that product to see whether it’s 510(k) or PMA approved. You want it to be a PMA product.
Critical Advice for Patients
Rene Perras: What advice would you give to patients who suspect they might be experiencing complications related to a medical device?
Joe Osborne: It’s crucial that any complaints or problems a patient believes are device-related be reported to the doctor who implanted it. Make those complaints known and get them documented by that physician.
That physician, having implanted not only that individual product but probably hundreds of others, will be in the best position to correlate potential device failure patterns. Make sure everything is documented and your physician is aware of the problem.
If your physician believes your problems relate to the device, it should be reported to the FDA. The FDA accumulates complaints about specific products, and recalls often come from complaint accumulation. While no product is 100% guaranteed safe, if they expect to see 100 complaints but see 25,000, that raises red flags.
Most importantly: If your doctor recommends product removal, and it’s surgically taken out, ensure the hospital preserves it. The device becomes crucial evidence because our experts and engineers can examine it to identify exactly where it failed.
The Reality of Medical Device Litigation Timeline
Rene Perras: How do you balance securing timely resolution with ensuring fair compensation in medical device failure cases?
Joe Osborne: These companies – Johnson & Johnson, Stryker, Biomet, Boston Scientific – have millions invested in products and processes. Just because we file cases doesn’t mean they surrender. They defend their integrity, scientific approach, and reputation.
These cases take time because it takes time to make them uncomfortable. They start with strong convictions about their reputation and work quality. We challenge the heart of the company, and we make them uncomfortable by digging into their files and exposing problems or issues that were ignored during design or regulatory processes.
When we create enough risk – meaning outside people like juries won’t see them as pristine companies but as entities that hid issues, ignored problems, rushed products to market, or put profits over patient safety – that’s typically when settlements are reached.
Companies monitor the FDA complaint database and know relatively quickly when problems arise. We often see situations where companies had 25,000 complaints but continued marketing and selling products without informing doctors about these complaints.
A Landmark Victory: The $26 Million Boston Scientific Verdict
Rene Perras: Can you share a bellwether case that was important to your overall success?
Joe Osborne: The case I always think about was one I tried in 2014 in Miami Federal Court against Boston Scientific for their pelvic organ prolapse mesh product. Thousands of cases had been filed, and it was hard-fought litigation. I was lead trial lawyer, and it was on Court TV because Boston Scientific was really dug in – they didn’t think anything had gone wrong with their product and weren’t paying a dime.
We tried the case over two weeks, and the jury awarded $26 million. Our client was an amazing lady who had been severely harmed and lived in daily pain, having undergone many gynecological surgeries with her life destroyed.
We were proud of the result because of how hard the company was dug in about never paying. That case ultimately “loosened the screw” and the litigation resolved. I believe that case had real impact on the overall litigation and was the catalyst that started the company thinking about resolving cases.
Key Takeaways for Patients
Based on this comprehensive discussion, here are crucial points for anyone considering implant surgery:
Before Surgery:
- Research your implant thoroughly
- Find out if it went through proper clinical trials (PMA vs. 510k)
- Check the FDA complaint database for your specific device
- Ask your doctor: “What product am I getting? Who made it? What’s its approval pathway?”
After Surgery:
- Document any problems or complaints with your implanting physician
- Ensure problems are officially recorded in medical records
- If removal is recommended, insist the hospital preserve the device
- Report issues to the FDA
If Problems Arise:
- Return to your implanting physician immediately
- Get everything documented
- Preserve the device if removed
- Consider consulting with experienced medical device litigation attorneys
Conclusion
Attorney Joe Osborne’s three decades of experience reveal a troubling pattern in medical device regulation and corporate accountability. While medical advances have improved countless lives, the current regulatory system – particularly the 510(k) pathway – continues to put patients at risk by allowing inadequately tested devices to market.
The goal of this litigation isn’t just compensation – it’s holding medical device companies accountable so they fulfill their responsibility to consumers first and shareholders second, honoring the fundamental principle of “do no harm.”
For patients facing the nightmare of defective medical devices, knowledge is power. Understanding the regulatory landscape, knowing what questions to ask, and recognizing warning signs can mean the difference between successful treatment and catastrophic injury.
For more information about Joe Osborne and Osborne & Francis, visit www.realtoughlawyers.com or call 561-301-3292.
This interview was conducted by Coffee With Q News, a platform dedicated to shedding light on crucial legal matters through discussions with subject matter experts. For more legal news stories that impact our society, contact Legal News Reporter Rene Perras at rp@coffeewithQ.org