Lawsuits against Smith & Nephew over the recalled Birmingham Hip Resurfacing, or BHR, hip implant system have passed the 200 mark, as the legal team at Jones Ward PLC continues to fight for injured people in dozens of states from California to New York and Florida to Alaska.
BHR lawsuits from more than 40 states are now part of a consolidated proceeding called MDL 2775 in Maryland federal court before Judge Catherine Blake. MDL stands for Multidistrict Litigation, and is a common way to litigate claims on behalf of hundreds or even thousands of people injured by the same medical device or drug. Jones Ward successfully argued in favor of creating the MDL in March 2017, telling a panel of federal judges that it would be more efficient to transfer the lawsuits before a single judge because so many people have been injured by the BHR.
The BHR and the Fight Against Preemption
A central issue before Judge Blake in Maryland is the extent to which the BHR system is subject to legal preemption. Due to the manner in which Smith & Nephew gained FDA approval to market the Birmingham system in 2006, known as Premarket Approval (PMA), lawyers for S&N argue that the company is immune from claims in federal court. Jones Ward and its partner law firms disagree, and they filed a 50-page brief with the court in November spelling out why. Here are just a few of the problems with the BHR:
- Smith & Nephew promised the FDA it would launch a clinical trial for the BHR to prove its safety, but the trial was delayed and hampered by allegations of criminal misconduct by Smith & Nephew, culminating in a Deferred Prosecution Agreement with the U.S. Attorney’s Office for the District of New Jersey on Sept. 27, 2007. Smith & Nephew later told the FDA that the Deferred Prosecution Agreement caused “significant time delays” in its efforts to implement the clinical study, due to additional contractual requirements for hiring surgeons to monitor patients.
- The inventor and designer of the BHR system, Dr. Derek McMinn, who was paid tens of millions of dollars to promote the hip device, presented biased and misleading data to U.S. regulators about the safety of the BHR.
- Female patients are particularly at risk of premature failure. The BHR has a 26 percent failure rate in women after ten years, but Smith & Nephew failed to communicate this risk properly to the medical community and to patients. The industry benchmark failure rate for a hip device is no more than 5.0 percent at ten years.
Next Steps in the BHR Legal Fight
Judge Blake is expected to make an initial legal ruling on the preemption issue in early 2018. In the meantime, Jones Ward continues to file lawsuits over the BHR device, which Smith & Nephew finally recalled in September 2015 after receiving hundreds of reports about failure due to metallosis and other injuries caused by toxic metal ions from the metal-on-metal device system. Plaintiffs from more than 40 states now have claims pending in the MDL proceeding. Jones Ward, which acts as co-lead counsel in the MDL, is pushing forward with requests for hundreds of thousands of pages of information from Smith & Nephew related to marketing, manufacturing defects, and the company’s post-approval studies and adverse event reporting.
How do I preserve my rights?
If you do not file a lawsuit within a certain amount of time, you may lose your right to compensation due to the Statute of Limitation. This deadline is different in each state, and it varies depending on the claims you are making in the lawsuit. In Kentucky, for example, the deadline for a product liability claim is one year. However, the same claim in Indiana is two years, and in Florida it is four years. For a free evaluation of your potential Smith & Nephew BHR hip recall claim, contact Attorneys Jasper D. Ward or Alex C. Davis.