How An Experienced Medical Device Lawyer Can Help
Fighting a case against a major corporation is notoriously difficult, as such internationally-successful companies can often afford to hire top defense lawyers to plead their case. Furthermore, medical device litigation can be particularly complex and requires many years of relevant experience to navigate, as the victim’s lawyer must convincingly demonstrate to the judge and jury that the plaintiff’s injuries were plausibly caused by the device in question.
To make this argument, it helps for the personal injury lawyer to be:
- highly familiar with legislation surrounding drugs and medical devices
- experienced at succinctly explaining relevant medical research to those without a healthcare background
- well-versed in common defense tactics so that he or she can anticipate any possible objections from the defendant’s’ lawyers.
It’s easy to see why having a seasoned attorney with extensive experience in product liability / medical device litigation can help a hip replacement failure victim move much more efficiently and with less stress / worry through the necessary legal processes.
“Faulty” Design Leads To Early Failure, Plaintiffs Say
According to a wave of recent lawsuits, Stryker’s LFIT V40 Cobalt-Chromium Femoral heads, a line of components commonly used in total hip replacement surgery, are prone to premature wear and even breakage due to a complication called “taper-lock failure.”
As described by scientists from the Rothman Institute at Thomas Jefferson University Hospital in Pennsylvania and other leading orthopedic researchers, the main design issues may stem from:
- The manufacturer’s choice to use cobalt and titanium in the implicated hip implants, as such electrochemically dissimilar metals can cause increased wear and release of potentially-toxic metal ions through a process called “galvanic corrosion,” and
- The geometry of Stryker’s femoral heads; in particular, the design of the connecting piece between the femoral heads themselves and the hip stem, which is the part that’s attached to the patient’s femur.
But one might wonder, how did these alleged design “flaws” make it past the FDA in the first place?
510(k) Clearance: Is FDA Weak On Medical Devices?
First of all, Stryker was able to avoid the FDA’s rigorous approval process by submitting its application for the device through 510(k) Clearance, in which a Class II medical device (moderate risk requiring “special controls”) is accepted for market release without the need for the usual strict standard for safety testing and clinical trial data. Instead, the application is judged only on the new device’s similarity to a device that’s already on the market. 510(k) Clearance is designed to help expedite the development and introduction of new medical devices, but many critics feel that it can put public health at risk through the hasty release of potentially dangerous, untested products.
Also, some orthopedics researchers and other medical professionals believe that metal hip implants are not placed in the right regulatory class and should actually be considered a “high risk” Class III device, a class that is always required to obtain FDA approval before being marketed.
Stryker Accused of Violating FDA Regulations
Though taking advantage of 510(k) Clearance may seem questionable considering the potential dangers of hip implants, it’s currently a legal and commonly-accepted way for device manufacturers to speed up their product releases. But hip replacement plaintiffs say they believe that Stryker kept the “dangerous” device on the market by neglecting or willfully failing to adhere to key FDA requirements for Class II devices, such as informing the FDA of:
- Any adverse event reports involving the product
- Recorded product failures
- Unanticipated side effects emerging after product is on the market
- Any increase in incidence of adverse effects / events
- Product corrections / improvements
Also, according to the plaintiffs, Stryker failed to conduct “design validation”–testing or other research performed to confirm that the product in question is meeting patient needs for its intended use(s).
Legal Theories Used Against Stryker
Stryker hip attorneys have generally supported allegations against Stryker and other orthopedic companies accused of releasing “faulty” hip replacement systems with the following legal theories:
As an influential part of the healthcare community, medical device manufacturers are responsible for upholding patient safety, and are thus obligated to exercise a standard level of care in conducting all of the tasks required to design, build / manufacture, test, distribute, and market their products.
If these companies fail to perform their duties with a reasonable level of diligence and attention (judged according to how the average person with experience and education comparable to that of the defendant(s) would behave), then they may be accused of being negligent.
Strict Products Liability
Under this legal theory, manufacturers are liable for any injuries caused by their products when employed for their intended use, regardless of intent or conduct of the manufacturer. That is, even if the manufacturer did everything possible to prevent patients from being injured by a product, as long as the plaintiff’s lawyer is able to demonstrate that the product was plausibly the cause for the plaintiff’s injuries, the manufacturer will be held liable. Though this theory doesn’t necessarily apply to drugs and devices that are judged “unreasonably dangerous” to begin with, hip implants, currently classified as only moderate risk devices, would not likely be thought of as dangerous enough that users should expect such severe adverse effects as loss of mobility, intense pain, heart attack / stroke, or surgical complications from early revision.
Failure to Warn
If a healthcare company becomes aware of potential hazards associated with a new or existing product, it’s typically obligated to inform the public, the FDA and the medical community of these risks as soon as possible.
Stryker hip attorneys claim in recent lawsuits that Stryker should have known that its choice to use a trunnion-interface design and dissimilar metals–cobalt and chromium–in its LFIT V40 Femoral Heads carried risks of high wear rates and release of metal debris due to the effect of galvanic and fretting corrosion.
Yet before releasing its “voluntary recall” of the device, Stryker issued no warnings whatsoever about the possibility of taper lock failure or other related complications, even though the company admitted in the recall that it had been receiving high numbers of patient complaints. Furthermore, readily-available orthopedic research studies had been already discussing concerns over potential design flaws in modular hip implants for years before the Stryker recalls.
Loss Of Consortium
The pain, suffering, and loss experienced by patients who fall victim to severe medical device complications not only affects them personally but naturally often also impacts the quality of life of their spouse / life partner. When someone files a hip implant lawsuit on behalf of their spouse (or files jointly with their spouse), they may be able to invoke loss of consortium, where defendants are held liable for causing the plaintiff to miss out on the expected benefits of partnership, such as companionship and emotional and financial support.
Witt Vs. Stryker Lawsuit
One of the more recent examples of a Stryker hip replacement lawsuit was filed in district court of Alaska on January 12, 2017, by couple Patton and Annie Witt. The Witts filed their case against Howmedica Osteonics Corporation, the subsidiary of Stryker that manufactures the LFIT V40 Cobalt-Chromium Femoral Head.
Patton Witt’s Hip Device Complications
According to the lawsuit, Patton underwent total hip replacement of his left hip in March 2008 to help alleviate effects of arthritis (the arthritis in his right hip was judged too severe for hip replacement surgery). The hip system he received included both Stryker’s LFIT (low friction ion treatment) V40 Cobalt-Chromium Femoral Head and its Accolade TMZF (titanium-molybdenum-zinc-iron) femoral stem.
Sometime after the surgery, Patton suffered from unexplained severe pain in the hip area. He went back to his surgeon for diagnostic tests. His doctor found that he had higher-than-normal cobalt serum levels (3.9 ng/mL) and ordered an MRI, which revealed a “large soft tissue mass.” Judging from these results, the surgeon suspected that Patton was suffering from “adverse local tissue reactions” from corrosion in the junction between the Stryker hip stem and the femoral head, and advised Patton to undergo revision surgery.
The revision, performed in January 2015, caused Patton even more pain and suffering, as well as extensive medical costs from the surgery itself, the post-surgical rehabilitation, and continued pharmaceutical needs.
Reportedly, after the allegedly failed hip implant was removed from Patton, the operating surgeon took it apart and closely inspected it, reporting that the he could “clearly see extensive corrosion” in the connector piece between hip stem and femoral head.
Financial Relief For The Witts
Patton was forced to have revision surgery within only 7 years after his initial hip replacement–much earlier than suggested by the standard 10-15 years that hip devices are supposed to last.
The Witts claim that due to the “defective design” and “manufacturing defects” in the Stryker femoral head, as well as Stryker’s alleged negligence and failure to warn, Patton developed complications and sustained injuries that he would not have otherwise suffered, if the product was safely designed and manufactured. Also, if Stryker had only properly warned doctors and the general public about the potential risks, Patton says, he would never had chosen that particular hip implant. Because of these alleged wrongdoings, the Witts hold Stryker accountable for their hardships, asking for more than $75,000 in compensation for their pain, suffering, reduced quality of life, and financial difficulties due to past, current, and future medical expenses.
Will Plaintiffs Receive Much-Needed Compensation?
Growing numbers of hip replacement patients are now filing legal claims similar to the Witts’ lawsuit. But does it look like plaintiffs have a hope of winning compensation to help them recover from their injuries, suffering, and loss? Judging by fairly recent litigation involving previous Stryker hip device product lines, one might say yes.
In 2014, Stryker settled thousands of legal complaints from patients who needed early revision surgery after implantation with Stryker’s Rejuvenate and ABG II Hip systems. This settlement was among the largest in hip litigation history–Stryker offered a base amount of $300,000 per hip, which could be augmented with “enhancements” according to the number of additional injuries suffered by the claimant. And though this initial settlement was limited to patients who had undergone revision surgery prior to November 3, 2014, Stryker recently extended the settlement agreement to include plaintiffs who received revision before December 19, 2016.
This settlement, along with hip litigation trial developments and settlements issues by other hip device manufacturers, suggests a promising legal environment is emerging for hip replacement plaintiffs hoping to secure compensation for unnecessary hardships and injuries.
Related Stryker Hip Implant Pages