Litigation surrounding hip surgeries and implants
If you are having a hip replacement procedure, then you know that new hardware is involved. Technically, you’re going to become a little bionic. Part of your body will be removed by a surgeon and a foreign object will be implanted in its place.
Obviously, this might lead to some trepidation on your part. Is the device safe? Has it been market tested? What about the surgeon? Has anything ever gone wrong on his watch? Are there any hip replacement lawsuits against the manufacturer or surgeon?
Most of the time, everything goes according to plan. The damaged bone is removed, the implant replaces it, and you’re sewn up without issues. The implant lasts its usual lifetime of 15-ish years and then you go through the process again.
What if things go wrong?
Hip replacement lawsuits - background
A hip replacement is a procedure that removes damaged bone and replaces it with a metal, ceramic or plastic ball-in-socket joint. Bones that have been damaged by fractures, aging, arthritis and more can make normal activities difficult – dressing, walking, sitting and even sleeping.
When medications or changes to lifestyle fail (such as a cane, walker, exercise regimens, NSAIDs or other non-surgical methods), a hip replacement may be suggested by your medical professional.
Your surgeon will acquire an implant from a device manufacturer. Medical device companies are held to a higher standard, so a defective device lawsuit will not have to focus on the manufacturer’s intent – just whether there was an injury.
Manufacturers are responsible for creating a product that works in a safe way. They must warn end users about potential harms and provide accurate instructions. If they don’t, consumers can sue for everything from lost wages to the cost of additional surgeries. Sometimes products make it to market without having gone through appropriate FDA testing. This is called the 510(K) Premarket Notification Process. If a company has submitted a product to the FDA and has received approval to sell it, they can sell another substantially similar product that hasn’t been vetted yet. This is one major way that defects can go unnoticed by the public until it’s too late.
Sometimes, to preclude a wave of lawsuits, manufacturers will figure that out themselves and start a preemptive recall of defective devices.
Why do people go to court over hip implants?
It’s one thing to have a surgery for a painful condition and still experience pain afterward, despite the fixed condition.
That’s not what hip surgery lawsuits are about.
The most common reasons for these surgeons and medical device manufacturers to get sued are complications, problems and after-effects caused by:
- Device loosening
- Metallosis (buildup of metal particles shedding from the device)
- Implant failed earlier than anticipated
- The device was marketed as safe when it was not
- Patient required additional surgeries that could have been avoided
- Device was not accompanied by adequate safety/implanting instructions
- Failure to warn
Defective products cases after hip surgery
There are many lawsuits for hip surgeries gone wrong. If you Google “hip replacement class action,” you’ll receive 352,000 results. What it comes down to is that hip replacement manufacturers have paid out $7.5 billion to injured patients since 2000. As of late 2017, there are approximately 13,000 hip surgery court cases pending across the United States.
There are many class action suits for this type of case.
Multidistrict litigation, or MDL, is a process that joins together at least two manufacturers and allows hundreds or even thousands of similar plaintiffs from different federal districts to move quickly through the courts. When there are so many plaintiffs whose complaints seem almost interchangeable, this keeps judges from having to hear and re-hear the same case over and over again. These are still in the early stages.
The FDA regulates the medical devices industry. It notifies medical professionals and the public at large when it becomes known that a hip replacement model should be avoided. Following is a list of manufacturers and their hip replacement device models which have been the subject of lawsuits or device failures that we know of:
- Wright Medical Technology
- Conserve Plus
- Profemur Z
- Metal Transcend
- Stryker Orthopedics
- ABG II
- Sulzer Inter-Op
- Trident Hemispherical SH
- Smith & Nephew
- Metal liner of R3
- IVS Tunneler
- Modular SMF
- Modular Redapt Femoral System
- TriGen Hip Nail
Metal-on-metal hip implants are the implant type that fail most often, and those have been the subject of many lawsuits against manufacturers.
The following companies have cases pending against them or paid out large awards for hip replacement settlements or lawsuits:
- Depuy’s Pinnacle lawsuit: A jury awarded $502 million to five plaintiffs in January 2016; another jury awarded $1 billion to six plaintiffs in December 2016; and a third jury awarded $247 million to six plaintiffs.
- Stryker’s LFIT V40 lawsuit: A federal panel combined six lawsuits in 2017 over Stryker’s femoral head into an MDL in Massachusetts federal court. This MDL contains more than 160 lawsuits. In New Jersey, the state Supreme Court combined all state court LFIT 40 lawsuits, which has 83 cases pending.
- Smith & Nephew’s BHR and R3 hip implant lawsuit: Maryland’s district court reported that there are 127 lawsuits pending in its MDL.
What qualifies as medical malpractice?
Let’s say your implant broke down. Okay. What do you need to do in order to start a case for damages?
You might immediately think this is medical malpractice, though a dual examination must be performed in this instance. Medical malpractice occurs when a licensed medical professional strays from what is considered to be the accepted standard of care in the field. But what about the device itself? (We’ll get there. Stay with us.)
If your surgeon, nurse, doctor, anesthesiologist or other health professional committed one of the acts listed below, you might have legal options:
- Conducted unneeded surgery
- Performed poor follow-up care
- Offered an incorrect diagnosis
- Discharged you early
- Misread or disregarded a critical lab result
- Failed to diagnose a condition
- Gave the wrong medication or dosage
If you think you might have a medical malpractice case, the first thing you need to do is prove negligence on the part of your health care provider. Also, remember that “health care provider” is a loose definition that can range from a doctor to a nurse to an anesthesiologist to a pharmaceutical company to an entire hospital.
In a hip replacement scenario, anyone from your surgeon to a discharge nurse could make a mistake. Was the surgery performed correctly? Did the implant break apart? Were too many pins put in, or not enough? Did the surgeon break your femur when shoving it back into the socket?
What is negligence?
Negligence is what victims must prove if they want to receive damages. There are four foundational elements that have to be established.
Let’s say you went to the doctor for hip replacement surgery, and the metal pieces that were implanted end up breaking and migrating within your body. There is a potential defective products case here, because the metal was faulty, did not stay where it was supposed to and did not do its job. If the surgeon had any idea that the implant was faulty or inserted it incorrectly, he might be liable for a medical malpractice case. That is why a dual examination should be performed – is this a medical malpractice case or a products defect case? Could it be both?
In terms of the medical malpractice case, you would need to show the following:
- Duty: Once the doctor/patient relationship was established, the surgeon owed you a duty of care. This duty required your surgeon to act like any other surgeon would in that situation, meaning he was required to follow accepted medical practices that are standard in the field.In this instance, you went to your surgeon, submitted personal information so that you could be admitted, and received a surgical implant. This created the relationship and duty of care. The surgeon should act like any other doctor would in that situation.
- Breach: Once the duty of care is established, your surgeon must exercise reasonable care and follow common procedures.Here, the duty was breached when the surgeon implanted a faulty device that ended up migrating.
- Injury: You must suffer an injury because of the surgeon’s actions.Here, you definitely became injured. To win a medical malpractice suit, your attorney must prove that your surgeon directly caused your injuries. So was it the surgeon, or was it the device?
- Damages: Your lawyer must prove that you suffered economic and non-economic damages from the injury.In this instance, you accumulated significant medical bills that would not have been there without the implant’s breakdown. You have further costs from missing work, traveling and lodging. You need additional surgeries to fix the implant. You have significant non-tangible costs, such as pain and suffering, emotional distress, and loss of consortium.
For the medical professional to be found negligent, your attorney must show that his or her conduct fell below the “accepted standard” of medical care, so having experts testify will help as well.
In terms of the defective products lawsuit, it could fall into one of three categories:
- Failure to warn: These are also called “marketing defects” and focus on the supply chain. The product was properly designed, but it was not accompanied by the correct instructions or warnings. This lack of warnings made the product unreasonably dangerous to its intended consumers.
- Design defects: Even if it was made flawlessly, it can still endanger the end user. A product can be considered unreasonably dangerous if it does not perform as safely as reasonably expected when a consumer uses it in its intended manner.
- Manufacturing defect: Even if the product were designed to be safe, the end result was not in harmony with that design. If that end product then causes an injury to its intended user, the manufacturer can be held responsible.
As long as the victim can prove the product was indeed defective, the manufacturer’s intent doesn’t matter. All that matters is whether someone can prove the product did not work as intended. Many hip implants were approved by the FDA only to later find that they were manufactured incorrectly or endangered the end user.
Starting a medical malpractice case or a defective products case for your hip surgery
Each state has its own local laws when it comes to medical malpractice and products liability. If your hip replacement broke down or was implanted incorrectly, you very likely have such a case.
Make sure to find out the relevant statute of limitations for your state. This is how much time you have to file a case. If you don’t file within that timeframe, you lose the ability to file.
For medical malpractice, there are often pre-filing requirements, such as sending notice to the doctor in question and providing a letter from a certified medical professional that details how you were injured. If you don’t fulfil these requirements, you could also be barred from filing the actual lawsuit.
Finding the right attorney for your case
It is very important to do a lot of research and choose an attorney with experience. These types of law are specialized and require a seasoned lawyer. This is because there is overlap between complicated medical and legal matters. There also are unique procedural issues that come up.
Consider checking out the Enjuris law firm directory to find the right lawyer for you.
- Hip Replacement Surgery
- DePuy Orthopaedics Hip Replacement Devices
- Hip Replacement Complications
- Hip Replacement Lawsuits
- Hip Replacement Surgery Overview
- Metallosis from Hip Replacement Devices
- OMNIlife Hip Replacement Lawsuits
- Recalls for Hip Replacement Devices
- Smith & Nephew Hip Replacement Devices
- Stryker Orthopedics Hip Replacement Recalls and Lawsuits
- Wright Medical Hip Replacement Devices
- Zimmer Biomet Hip Replacement Recalls and Lawsuits