Kip Petroff 1 Comment

Smith & Nephew Hip Implant Litigation Website Launched Today

Today is the day I launch my new website. It is dedicated to highlighting the metal on metal hip implant products and related conduct of Smith & Nephew, a multibillion-dollar medical device company from the United Kingdom. I looked around for websites that discussed Smith & Nephew, and I couldn’t find any resources that were helpful. That’s one reason I’m dedicating my new website to this company’s metal hip implants and the ongoing litigation against them nationwide.

 

    • Why Smith & Nephew? I have spent most of the last three years working on personal injury cases involving Smith & Nephew hip implants, and that has given me the chance to get to know this company. What I’ve learned is shocking. This website will focus on some of the ways that Smith & Nephew has manipulated our regulatory and legal system in this country over the years. The new pages today provide only a rough outline of what is to come. I will add to this reference library regularly. My goal is to provide an online library of regulatory and legal information about this company and their metal-on-metal hip implants that have harmed and continue to harm many people nationwide on a regular basis.
    • What’s in the website? My new website has many features that will make it easy to understand why I’m so interested in tracking this company. I will preview some of my favorite features here.
    • Timeline. One of my favorite new features is a Smith & Nephew timeline that begins with the FDA’s first classification meeting over metal-on-metal hip implants in 2001 and ends with the FDA issuing its final order regulating metal-on-metal hips in 2016. In between is a detailed account of what Smith & Nephew did to get its metal-on-metal hip portfolio cleared in the U.S. and when it began pulling these disastrous devices from the market. It is color coded based on the topics covered. For example, purple is regulatory and orange is for tracking this company’s criminal activities involving their hip implants.  Make sure to expand the timeline to see it better. There is more information there than you may realize.
    • Court Documents and Filings. I will gather and comment on some of my favorite court documents in this section of the “Smith & Nephew Legal Page.” There are so many to choose from! I will add to this page regularly.
    • Criminal Proceedings. Smith & Nephew got in trouble for the way they sold their hip implants in the U.S. and internationally. They paid more than one hundred million dollars in fines and had to agree to several years of direct regulatory oversight to avoid more serious criminal punishment. Read about it in the “Criminal Proceedings” section of the “Smith & Nephew Legal Page.”
    • Regulatory Shenanigans. Smith & Nephew is a company that had difficulty convincing the FDA to clear their metal hip implant systems for sale in this country. The documents in the “Regulatory Violations” section of the “Smith & Nephew Legal Page” will focus on some of the company’s unsuccessful attempts to obtain clearance for their metal on metal hip implant systems. The company followed the same pattern of (1) filing an application for clearance, followed by (2) failure, then (3) asking for more time, and then (4) withdrawing the application rather than complying with FDA requirements. The company tried to obtain clearance in this manner for their metal on metal hip system three times over five-plus years but met failure each time. But that didn’t stop Smith & Nephew from selling their hip implants anyway. I will explain how they did that in future pages on this website.
  • Comments? Questions? I hope this new website is useful and informative. I welcome feedback, good or bad, about these pages. Use my online contact form to provide feedback, questions, or ideas for future Smith & Nephew topics to discuss here.
Kip Petroff 2 Comments

SMITH & NEPHEW LOSES ANOTHER FEDERAL COURT APPEAL INVOLVING METAL HIP IMPLANTS

Yesterday was a good day for people fighting Smith & Nephew over defective metal on metal hip implants. On March 1, 2018, the U. S. Circuit Court of Appeals in Philadelphia ruled in favor of the consumers in Walter and Vivian Shuker v. Smith & Nephew. Sickened by the implants he received in 2009, Mr. Shuker’s case landed in the Federal appeals court process, where I watched it for the past two + years. The good guys won yesterday, and it spells trouble for Smith & Nephew, an overseas company with a reputation for selling harmful, unapproved hip implants.

  • Unapproved Hip Parts.

Mr. Shuker’s metal on metal implant case was unusual for many reasons. For one, the Food and Drug Administration (FDA) officially weighed in on the legal arguments and actually filed a brief in Federal court. Secondly, it involved a combination of metal parts that received FDA clearances through two entirely different regulatory classification systems. The specific combination of Smith & Nephew parts in this case involved an “R3 Shell and Liner”, a femoral head, and a stem that connected the metal head to the thighbone. The metal liner was FDA approved as a “Class III device”, meaning it supposedly underwent a rigorous pre-market approval process. The other parts, however, all were cleared as Class II devices, involving a much more lenient process.

In the end, the Third Circuit ruled that the Shukers should have a chance to prove that Smith & Nephew is legally responsible for injuries caused by the unapproved device combo.  But it hasn’t been smooth sailing. Far from it! While Smith & Nephew must face the Shukers’ claims for negligently promoting this combination of parts for use together, the Court threw out claims for strict products liability, breach of warranty, and general negligence.  But after more than four years of waiting, this victory should be encouraging for all people with failing Smith & Nephew hip implants!

  • Trouble for Smith & Nephew.

The Shuker case is similar to another case against Smith & Nephew, Joe Mink v. Smith & Nephew, Inc. In 2017, I presented oral argument in the Mink case in the U. S. Circuit Court of Appeals in Miami. Mink and Shuker are unique in that, to date, they are the only two Federal Appeals Court metal on metal hip implant cases in the country decided against Smith & Nephew. It is doubtful they will remain alone! Smith & Nephew’s unapproved metal on metal hip implants used for hip replacements are failing at an alarming rate.  New cases are being filed against this company weekly and nationwide. There is an active and growing mass of Smith & Nephew cases in Baltimore Federal Court in MDL # 2775.

Smith & Nephew, Inc. is a Tennessee company whose parent company, Smith & Nephew, plc, is an international, multi-billion-dollar enterprise based in the United Kingdom. Smith & Nephew’s disdain for the FDA is apparent, leaving in its profitable wake failure after failure after failure. For three years, I’ve devoted myself practically full-time to seeking justice for those injured by this British company’s arrogance. For various reasons that I’ll explain in future blogs, Smith & Nephew has managed to largely avoid the costly nationwide litigation that ensnared its competitors in the metal hip implant industry. Yesterday’s win in Philadelphia is especially encouraging, signaling a new era of accountability.

  • No more FDA Shenanigans.

In 2016, the FDA finally changed regulatory requirements in this country for manufacturers of metal hip systems used for total hip replacements. (See “METAL HIP IMPLANT MAKERS STOP SELLING PRODUCTS RATHER THAN PROVE THEY ARE SAFE”, posted on March 8, 2016). The FDA had previously allowed metal hip implants to be sold in this country via a regulatory “fast track” loophole, but growing concern about their safety and effectiveness resulted in the FDA basically closing that loophole for good in May 2016. The FDA gave the companies more than three years advance notice and then issued an Order requiring them to quit selling the devices or prove they were safe by May of 2016. I predicted in early 2016 that none of the hip implant makers would try to prove their products were safe and effective, and I was right. The companies all chose to quietly discontinue selling their metal hip replacement systems as soon as the FDA required them to prove they were safe and effective.

Smith & Nephew, however, was able to avoid FDA scrutiny of their metal hips because the company never obtained approval to sell a metal on metal hip replacement system in the first place. The companies that legally sold FDA-cleared implants had to undergo the expense and embarrassment of publicly withdrawing their bad products. But in an ironic and twisted turn of events, Smith & Nephew was exempt from complying with the FDA’s orders because it had never obtained approval to sell metal on metal hip replacements in the first place. The one company that never obtained approval was also the only company that did not have to comply with the May 2016 deadline.

And so, while yesterday was a banner day, signaling a new era of accountability, it is still just the beginning. Other hip implant manufacturers have been paying significant settlement money for hip implant injuries for years, but Smith & Nephew has managed to benefit from its unique position of non-approval and non-regulation … until recently. I predict Smith & Nephew, a British mega-company that routinely engages in regulatory shenanigans in this country, will pay a hefty price for their smugness. And when it happens, I’ll be there to tell you I predicted it all.