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SMITH & NEPHEW HIP IMPLANT LAW SUITS: A MID-YEAR UPDATE

The year 2018 has been the most active year yet in litigation involving Smith & Nephew metal hip implant cases, and we’re only halfway! There have been a number of fascinating developments, and with the increased volume of cases, there is also an increase in misinformation. Many people, including lawyers, are still confused about which types of cases are the best ones and why. I can help clear up the confusion.

In my Blogs this summer, I will share my Smith & Nephew experiences and keep readers up to date with a convenient one-stop resource for everyone, including victims of the bad devices and fellow lawyers. Public and private comments are welcome, and I will try to answer every question.

Why should a hip implant victim listen to me? Because I know the time, consideration, and emotion involved in each step of the process, from having the surgery to recovery and physical therapy to the uncertainty that accompanies each discomfort afterward. I’m a former athlete with three implants myself – both knees and a full, ten piece lower back.

And I’m a Plaintiff’s lawyer (meaning a victims’ advocate) representing those with Smith & Nephew metal hip complaints – and I’m one of the few lawyers actively working to develop individual cases against this company. There are only a handful of lawyers who are actively litigating these cases on an individual basis, and currently, my experiences – in both state and federal court – are the most diverse and among the most successful. I understand this company’s methods and can make reasonable predictions about what is likely to happen next. A Federal Court of Appeals ruled in my favor last year in a Smith & Nephew case, and I successfully procured almost a dozen depositions of Smith & Nephew witnesses in three other cases. And in April, I argued a Motion in the “MDL Court” in Baltimore. I covered a lot of Smith & Nephew ground in the last couple years. I am 100% committed to the litigation and to seeing this company do what is right for its consumers.

SMITH & NEPHEW HIP CASES.

The first thing you need to know about any medical device case is the exact brand of your implant. The laws that apply to your case will be vastly different depending on the brand and the construction. For example, a plaintiff with a device that received full FDA premarket approval or clearance will have a tougher time in court than one whose product was never FDA approved at all.

Smith & Nephew has hundreds of cases filed against them involving their FDA approved hip resurfacing device, and there are dozens of cases involving two types of metal devices that did not have approval. It is easy to tell the difference, if you know what you are looking for, and it is crucial to understand this before you start investigating the possibility of a lawsuit. The product brand and its regulatory history are the most determinative factors in predicting success.

If you don’t know your product, I can help. Stop right here and contact me using my online contact form, as the remainder of my blogs are written under the assumption that readers or their clients have a Smith & Nephew metal hip implant.

My goal is to provide you with as much useful information as possible to help you understand your case and eventually resolve your complaint. Start by reading Chicago Bet the Company Seminar,  a paper I wrote for a speech I gave to a group of lawyers in Chicago in May. Take a look around my website for other information about Smith & Nephew, including historical company documents of interest and a comprehensive time line that will put your potential case in context.

And please stay tuned for my next few blogs, keeping clients and attorneys apprised of Smith & Nephew developments so far this year. I will provide updates as they occur, and will make predictions about this massive corporation’s next self-serving moves.

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Chicago “Bet the Company” MDL Seminar + What’s So Special About Smith & Nephew Metal Hip Implant Cases?

There is a new type of metal on metal hip implant case recently sent to the Smith & Nephew MDL that is among the strongest products liability cases being litigated today. It is a metal on metal hip implant construct involving Smith & Nephew metal parts that were never approved for use together. A similar Smith & Nephew part is likely to be included in this MDL any minute now, thereby making the Smith & Nephew MDL a relatively new MDL as hip implant MDLs go. These new cases highlight some of the factors that can make or break any products liability personal injury case. It is useful to consider this information even if you are not currently defending or prosecuting any Smith & Nephew hip implant cases.

The Smith & Nephew cases described here involve products that couldn’t gain FDA marketing clearance despite multiple attempts and submissions to the FDA over a four-year period. A meeting was held with FDA officials and the company hired outside experts on FDA matters, but the company still failed to convince the FDA. The company sold the devices anyway.

  • HOW TO SPOT A GOOD PRODUCTS LIABILITY CASE.

All products liability cases involve the age old, three-part question about the company’s
knowledge and product-related conduct:

  1. What did the company know?
  2. When did they know it?
  3. What did they do about it?

Seems like every discussion about products liability cases eventually turns to these three questions. I have used this exact trilogy of questions when it helps me at trial, and Zimmer, Inc. used it successfully against me in a hip implant trial last year. Whether you represent Plaintiffs or Defendants, the answers provide a good, common sense framework for assessing the facts and your likely success with any particular products liability case. The Judge, jury, and your opponent have likely already begun framing their own conclusions.

With the above three questions in mind, consider what Smith & Nephew executives at the highest levels of the company knew about their metal on metal hip implants and what they did about it when they learned it.

 

  • BACKGROUND OF SMITH & NEPHEW HIP IMPLANTS.

In the past several years, there have been many thousands of product liability lawsuits filed in U.S. courts claiming medical problems from allegedly defective metal on metal hip implants. The following brief history will demonstrate what most of us already know – metal on metal hip implant cases can make for a good trial story. Several MDLs have been established for metal on metal hip implant cases against Zimmer, DePuy, Stryker, Wright Medical, and Biomet. The organization of these MDLs occurred while the FDA was acquiring knowledge and voicing increased concern about the emerging medical problems associated with this class of implantable metal medical device. The FDA began a process in 2011 that resulted in a Final Order on February 18, 2016 that essentially banned metal on metal hip implants from the total hip replacement market in this country. Thousands of cases have settled as part of the MDL process and some have been resolved in other ways, but more than ten thousand metal on metal hip implant cases are still on file in Federal and state courts today. Many thousands of people have  suffered significant injuries because of metallosis and other serious health problems directly linked to this dubious class of metal medical device. Revision surgeries involving metal on metal hip implants continue to occur at an alarming rate.

A newcomer to the hip implant MDLs is Smith & Nephew, Inc. The Smith & Nephew MDL wasn’t even created until March of last year, and the cases discussed below were only added to MDL 2775 beginning in January of this year. Lawyers with experience in the other hip implant MDLs may find the significant differences between their cases and the Smith & Nephew cases intriguing. A quick review of the products involved in MDL 2775 will make it easier to recognize what makes the Smith & Nephew total hip arthroplasty cases different from the others.

MDL No. 2775 is formally known as the “Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, MDL 17-MD-2775.” It is pending in front of Senior Judge Catherine C. Blake in the U.S. District Court in Baltimore, Maryland. A detailed discussion of the background of the Smith & Nephew MDL can be found in Judge Blake’s March 26, 2018 written opinion concerning Smith & Nephew’s Motion to Dismiss. See Memorandum, In re: Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, CCB-17-2775, Document 608 (D. Md. Mar. 26, 2018). This MDL Memorandum Order is recommended reading for anyone with Smith & Nephew metal hip cases in the MDL or in state court.

MDL 2775 now involves two types of Smith & Nephew hip implant cases with another one soon to be included. The two new ones involve a combination of metal parts that the FDA never approved or cleared at all [The term, “approved” means the device reached the market through the premarket approval process in the Medical Device Amendments of 1976, 21 U.S.C. sec. 360c et seq and “cleared” means the FDA determined under 21 U.S.C. sec. 510(k) that the device was substantially equivalent to devices already on the market in 1976. See generally, Medtronic v. Lohr, 116 S. Ct. 2240 (1996); Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008)]. This alone makes MDL 2775 unusual, because other hip implant MDLs have primarily involved a company’s integrated product system that received FDA approval or clearance. The two devices already involved in MDL 2775 are as follows:

  • Birmingham Hip Resurfacing Device: Commonly referred to by its abbreviation “BHR,” this device is what is shown in the left hip in the illustration below. It is not considered a “traditional” total hip arthroplasty because it only resurfaces, or shaves down, the femoral head instead of replacing the entire femoral head and neck. It was FDA-approved under PMA number P040033 on May 9, 2006.
  • Modular Femoral (Hemi) Head and Modular Sleeve: These two metal parts mated together and were sold and marketed in Europe and Australia as the main components of the Birmingham Hip Modular Head System. The head and sleeve were never cleared or approved for total hip arthroplasties, but this device was used almost exclusively in the U.S. off-label for that surgery.

A third product, the Smith & Nephew R3 Acetabular System metal liner, is likely to be included in the MDL soon. The metal liner was approved on November 13, 2008 as PMA supplement S006 to the BHR. The metal liner was never approved in the U.S. for use in traditional total hip arthroplasties, but the vast majority of them were used for that surgery. The analysis below does not change whether the liner is or is not included in the MDL, because the “modular femoral (hemi) head” is the same with or without the liner.

The illustration below from a Smith & Nephew Power Point depicts the difference between the two surgeries. The one on the left is the BHR and the one on the right is the THA.

smith-and-nephew-hip-implant-illustration

 

The most notable difference is the large spike-like stem in the THA on the right.

For the first year of its existence, MDL 2775 was a single product affair, involving only the BHR hip resurfacing cases. The MDL Panel not only consolidated all the Birmingham Hip Resurfacing (BHR) cases into one MDL in early 2017, but the Panel also expressly declined to include S&N’s Total Hip Arthroplasty (“THA”) cases. This MDL remained a single product case until January 2018 when the MDL Panel began sending THA cases to Baltimore. It now involves the resurfacing and THA cases involving the BHR cup, and it will probably include the R3 Metal Liner cases before long. There are 318 cases currently in this MDL, according to the “Notice of Filing Updated Listings of Pending BHR Track and THA Track Cases” filed on May 21, 2018, with 264 described as “BHR” cases and 54 listed as “THA” cases. New cases are currently being filed in or transferred to this MDL almost every day.

 

  • REGULATORY SHENANIGANS.

The regulatory history of the Smith & Nephew metal hip devices is unique in metal-on-metal hip litigation for at least two reasons. Unlike other hip implant MDLs, there is no FDA cleared total hip replacement or resurfacing system involved. There is no name for the configuration of THA implants involved in this MDL because the company was unable to obtain clearance for a metal on metal total hip implant system. The parties and the MDL Court just call them “THA cases”, referring to the generic name for the surgery as opposed to an actual legally marketed product. The case is also unusual because the FDA expressly rejected the femoral part of the THA metal parts involved in this MDL. The company obviously knew this when it happened, but what they did about it is probably what got them into MDL 2775.

The FDA refused to allow Smith & Nephew to market their THA device three separate times from 2005 to 2010. Many of us have handled cases involving implantable devices that were FDA approved or FDA cleared, and some might have even handled cases involving hybrid devices that were part approved and part cleared. Issues of the prescribing doctor’s off label use of the drug or device frequently permeate many of our pharmaceutical cases. But the Smith & Nephew metal on metal total hip arthroplasty cases always involve a rare four-part combination in each surgery of the following: (1) parts approved by the FDA’s premarket approval process, (2) parts cleared by the FDA’s premarket 510(k) notification process, (3) surgeon use of the parts in unapproved ways, and (4) parts that the FDA specifically refused to allow for sale in this country – three separate times. Sparks are going to fly whenever a case involves all these conflicting elements, and the Smith & Nephew total hip replacement cases will be no exception. The next section of this paper will briefly explain how all these facts have resulted in a remarkably troublesome case for Smith & Nephew. The Smith & Nephew THA cases will undoubtedly present unique factual and legal questions as they work their way through our court systems. Numerous FDA “No Sell”

  1. Numerous FDA “No Sell” Letters.

It goes without saying that you cannot properly analyze a products liability case without first determining how the offending product got on the road, in the air, in your home, or on hospital shelves. This is usually easy to determine, especially if the product was expressly approved by the governing body. Of course, in a regulated society the product is usually on the market legally. In my experience, it is very rare to find a products liability case where the product itself was not even allowed on the market. But that’s what we seem to have in the Smith & Nephew THA cases.

Starting as early as 2005, Smith & Nephew began efforts to gain FDA clearance for a traditional THA system in the U.S. Its first 510(k) application for this involved a product called the “Birmingham Hip Modular Head System.” This application was filed on October 4, 2005. The FDA assigned it file number K052808. It was intended to be marketed both for primary (e.g. first) traditional hip arthroplasty procedures and as a revision option for failed BHRs. The FDA confirmed receipt of the premarket notification and included this written warning: “YOU MAY NOT PLACE THIS DEVICE INTO COMMERCIAL DISTRIBUTION UNTIL YOU RECEIVE A LETTER FROM FDA ALLOWING YOU TO DO SO.” Letter from FDA to Smith & Nephew, at 1 (Oct. 4, 2005), emphasis in original. I call this a “No Sell” letter. All manufacturers understand that they cannot sell a product involved in FDA premarket notification activities unless and until the FDA issues a written determination allowing it.

Two months later, the FDA concluded that it was unable to determine that the Birmingham Hip Modular Head System was substantially equivalent to the predicate devices in the 510(k) application. The FDA explained that there was a lack of clinical data supporting the device, noting that it disagreed with Smith & Nephew’s attempt to rely on BHR clinical data for its THA submission. The FDA further explained that “the clinical data for a resurfacing hip prosthesis cannot be used to predict the safety and effectiveness of a total hip prosthesis.” K052808. Letter from FDA to Smith & Nephew, at 1 (Dec. 12, 2005). The FDA basically rejected all the clinical data the company offered. The FDA even suggested that the application might be better suited as a supplement to the BHR. The FDA issued another No Sell letter. Smith & Nephew withdrew K052808 on March 1, 2006, and the FDA issued yet another No Sell letter.

Smith & Nephew had hit a THA dead-end with the FDA after failing to gain FDA clearance for the Birmingham Hip Modular Head System. It decided to approach the problem one component part at a time. On May 1, 2006, Smith & Nephew filed a 510(k) application for a “monoblock” femoral head. It was assigned 510(k) number K061243, and the FDA cleared the device on July 17, 2006, but only for use in hemi-arthroplasties. An application for the “Modular Femoral (Hemi) Head” was filed a month later, on August 17, 2006. (K062408) The FDA granted that application on September 12, 2006. These two applications for 510(k) premarket clearances were granted only for “hemiarthroplasty” procedures, where the metal femoral head articulates only against natural bone. Again, the metal femoral head used in the Smith & Nephew THA cases in MDL 2775 was never approved or cleared for THA procedures. A hemiarthroplasty can never be a metal on metal hip device, and none of the cases in the MDL should ever involve this procedure. This is important because every Smith & Nephew metal on metal THA case involves a femoral component that was only cleared for a hemiarthroplasty.

The illustration below 3 depicts the difference between a hemiarthroplasty and a total hip arthroplasty.

 

hip-replacement-illustration

Source: India Health Help, http://Russian.indiahealthhelp.com/procedure/hip-arthroplasty/ (last visited May 22, 2018).

The most notable difference in the above illustrations is that the hemiarthroplasty does not have any artificial acetabular component.

Around this same time, on July 28, 2006, Smith & Nephew filed a second 510(k) application for the Birmingham Hip Modular Head System (K062189). Soon thereafter, the FDA issued a ten page No Sell letter and advised Smith & Nephew that it still couldn’t determine whether the device was substantially equivalent to the predicate devices. The FDA’s concerns with the clinical data for this application were similar to its concerns with the first application; the long list of deficiencies included criticisms about the investigative site’s location and investigator, and noted that the study had no “clear patient inclusion/exclusion criteria.” Letter from FDA to Smith & Nephew re: FDA’s K062189, at 1 (Oct. 25, 2006). The FDA also found that there was a significant amount of missing data, id. at 2, and the FDA recommended that an application for this device for a THA should “be submitted as a PMA supplement” to the BHR. Id. at 9. Rather than curing the deficiencies in the No Sell letter, Smith & Nephew withdrew its 510(k) application on March 21, 2007, and the FDA issued yet another No Sell letter.

Smith & Nephew was not so quick to file its third 510(k) application for a THA system, waiting until after it launched its R3 Acetabular System and secured PMA approval for the R3 Metal Liner for use as part of the BHR. However, Smith & Nephew filed another 510(k) application for the Birmingham Hip Modular Head System on October 1, 2009 (K093095). Unsurprisingly, the FDA issued another lengthy No Sell letter and again told Smith & Nephew that it was unable to determine substantial equivalence. Like clockwork, Smith & Nephew withdrew its 510(k) application a few months later, on February 24, 2010. The FDA issued yet another No Sell letter.

There were about a dozen No Sell letters issued for Smith & Nephew’s THA metal on metal hip products eventually. Smith & Nephew stopped trying to obtain clearance for these components for use in total hip arthroplasties after their third failure. All of the No Sell letters involve the same femoral head that is in all the Smith & Nephew metal on metal THA cases. After years of trying and after collecting a dozen or so No Sell letters, Smith & Nephew abandoned its efforts to obtain FDA clearance or approval to sell the combination of metal parts used in its THA cases.

  1. Sell Despite No Sell Letters.

It is important to emphasize that use of these devices for unapproved THA surgeries was not rare or isolated. The most frequent use for the modular femoral head was off-label as part of metal-on-metal total hip arthroplasties, usually articulating against either the R3 Metal Liner or an unlined BHR acetabular cup. That is how they are almost always used if they are used in a metal-on-metal THA. The company knew their THA product was not approved and had been expressly rejected three times by early 2010, but the company still distributed the parts for these uses. .

  1. FDA Reclassification of Metal Hip Implants.

According to the FDA’s website [U.S. Food & Drug Administration, Metal-on-Metal Hip Implant Systems, (Dec. 28, 2017).], “as of Nov. 30, 2012, the FDA had cleared 190 submissions for metal-on-metal hip replacement systems.” The FDA could probably be criticized for allowing so many metal on metal hip systems to easily slip through its regulatory system, but no one can say they let Smith & Nephew slip by. The FDA did what they could to stop Smith & Nephew, but it wasn’t enough, and that’s why there’s a new “THA Track” for the Smith & Nephew MDL.

 

CONCLUSION

The metal liner that will probably soon be involved in the Smith & Nephew MDL was recalled from the U.S. market for safety reasons in 2012 and the modular femoral head already in the MDL was withdrawn for safety reasons in 2015. The FDA issued more than a dozen No Sell letters in response to Smith & Nephew’s repeated efforts over four + years to secure clearance to market a metal-on-metal THA hip product in this country. They probably thought they had stopped Smith & Nephew with all their No Sell letters over the years, but the existence of 50 + THA cases already on file in MDL 2775 suggests otherwise.

All of the documents referenced in this paper are available on this website at https://www.kippetroff.com/smith-and-nephew-hip-implant-legal-information/. You can also email me using the convenient online contact form here, or call me at (972) 294-7530 with any questions.

 

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. 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 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 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.
    • 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. 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, will pay a hefty price. And when it happens, I’ll be there to tell you I predicted it all.

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HOW TO SPOT THE RIGHT LAWYER FOR YOUR PERSONAL INJURY CASE

My friend was looking for a lawyer for a business dispute and was at a loss. She didn’t know who to hire or how to even get started looking, so she began by asking me. I pointed her in the right direction, but her quest made me realize that most people – those who don’t practice law – lack the resources to find good legal counsel.

So how does a non-lawyer determine who is a qualified candidate for their particular case? Of course, you can’t get all the information for your decision in this Blog, but I’ll try to help with some general questions and considerations that apply to most cases.

General Considerations. Does your case involve a fairly typical fact pattern, like an automobile intersection collision? Or does it involve some unusual legal issue? Is yours the type of case where you want a local lawyer or is there some strategic benefit to having a lawyer nearer where the lawsuit might be filed? Are you looking for a specialist? Do you want to pay by the hour or are you more comfortable with a contingent fee?

Network with people you trustYour friends and family are great resources, especially if you know someone who is a lawyer, a paralegal, or who works in the court system. This is a wonderful place to start, but it is only a start. After you get recommendations, you still need to make sure that person is right for your particular case and that they are qualified to represent you from start to finish (and hopefully to a good outcome!).

Know Your Lawyer. All lawyers are not created equal. There are both good and bad, and where one falls can be difficult to assess.

Use public information (like a Google search) to find lawyers who work in your field; focus on those who specialize in your area of need. There are online lawyer referral services that can help you find a lawyer, but I think you still need to follow these suggestions for “vetting” whoever you may find online.

Spend some time on candidates’ websites. If they don’t have websites, you should be concerned.

Research your state’s State Bar Association. There you may find some basic information including birth date, Bar admission date, law school attended, as well as address and contact information. You may also find information on legal problems such as public disciplinary proceedings.

Almost every courthouse has a way that one can search for lawsuits by or against your prospective lawyer. Most are online and can easily be searched by the lawyer’s name. Some counties may still have paper records, but I’ve never found a courthouse that doesn’t have easy access to an index of cases that can be searched by a party’s name. Check out the local courthouse database for your lawyer’s name and see what he or she has been doing besides filing cases for clients. I would hesitate to hire a lawyer who is involved in personal lawsuits, especially cases filed by former clients.

Experience with similar cases. You should try to find a lawyer or law firm that handles your type of situation. Chances are your case has a lot in common with others, which means your attorney will already have a solid foundation for his or her argument. Experience is an important key to success, and you should look for someone with a proven record successfully managing your type of case. The time, effort, and money invested in previous similar cases will also save you, the client, those same investments. This can be a huge benefit in the right case!

Many states have a process that lawyers can follow if they want to be recognized as “board certified.” That usually involves the lawyer proving that he or she has sufficient experience to seek certification from a “Board” that certifies the lawyer as a “specialist” in a particular field. Most states have specialties in areas ranging from labor and employment law to divorce and family law as well as personal injury, criminal, probate, real estate, appellate, and others. Many states require the lawyer to pass a difficult exam before they can call themselves, “Board Certified.” In general, I recommend hiring a certified specialist if possible.

Ask Questions/Research your lawyer. You have every right to interview prospective lawyers. This is also a great way to help you predict if you will like working with this person. Most lawyers are on their best behavior when trying to convince a prospective client to hire them, so if a question or two causes tension at your first meeting or during your first phone call, then imagine how the relationship could sour after they feel they have you hooked and stress sets in. Cases can go on for years. Be sure you connect with the person you hire in such a way that you can work together until the case is resolved.

CONCLUSION. Hopefully, you found some useful advice in this brief message. If you have asked around and still have questions, feel free to contact me via my firm’s Contact Form. I’ll see if I can help you locate the right lawyer for your case’s unique requirements.

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METAL ON METAL HIP IMPLANT PATIENTS NEED TO KNOW THIS!

A Dallas, Texas jury last week unanimously found that a subsidiary of Johnson & Johnson, the baby powder people, sold defectively designed metal on metal hip implants that significantly harmed five people. The jury awarded more than $400 million in punitive and compensatory damages against Johnson & Johnson and its subsidiary after a ten-week trial. I watched almost every day of that trial, and I came away with a good understanding of how bad these particular medical products are and how much harm they can cause. I also know that far too many people are unaware of the silent harm that these products can cause. This is because the manufacturers, the government, and far too many doctors don’t publicize when bad products, like metal on metal hip implants, are unleashed on the public.

Today’s blog is my humble effort to send a message to the hundreds of thousands of Americans who received one or more “metal on metal” hip implants in the past ten years or so. This message is intended primarily for those folks who do not have a lawyer, or who have not been back to their hip implant surgeon for a year or so. You should be getting this important from your doctor, but I know that many doctors simply don’t keep their patients updated when the products they put in them are recalled from the market. This information also should come from the manufacturers of the implants, but many of them claim that “privacy rules” prevent direct communication with patients. Some of this information actually comes from the Federal government, but it is not well-publicized, is hard to find, and even harder to understand.

I know from experience that many patients with metal on metal implants simply do not understand the risk they took and the problems they might encounter in the future. I also know that the government, the companies, and probably even your doctors are not reaching out to you to provide this message. So I’ll do it for them.

 

  • Bad Products.

My last blog explained that any metal on metal hip implants placed in your body a few years ago have probably already been removed from the U.S. market or will be very soon. Check out: “Metal Hip Implant Makers Stop Selling Products Rather than Prove they are Safe” (March 8, 2016). The Food and Drug Administration has given the metal hip implant companies a May 18, 2016 deadline to either prove their implants are safe or stop selling them altogether. This nationwide phenomenon should be grabbing headlines everywhere, but few people even seem to realize it is happening.

 

  • A Silent Injury.

It is important to understand that you might be having serious medical problems related to your metal on metal hip implants without even knowing it. You cannot assume you are doing fine just because you are not hurting or experiencing significant difficulties with your hip implant. Your implant could be shedding metal debris in your body and causing significant, permanent injuries without you even knowing it.

 

Message # 1Do some investigation.

The first thing you need to do if you are concerned is determine if you actually have a metal on metal (“MoM”) hip implant. You probably already did that if you are still reading this, but make sure you clearly understand what product you received. Today’s blog is directed only to people who have or had MoM hip implants. The FDA cleared dozens of hip implants containing metal parts during the past fifteen years, but this blog and most public announcements about hip implants only apply to hip implants where there is a metal part rubbing directly against another metal part.

 

Message # 2A medical checkup.

I am not a doctor and cannot make a medical recommendation, but the FDA recommends that you make an appointment with your orthopaedic surgeon promptly for further evaluation if it’s been over a year since your last visit or if you develop any symptoms that your device is not functioning properly. Aside from a physical exam of the hip, the orthopaedic surgeon may consider several tests to evaluate these symptoms including:

Using a needle to remove fluid from around the joint (joint aspiration).

Soft tissue imaging.

Blood tests, including checking levels of metal ions in the blood.

The FDA also recommends that patients who received MoM hip implants should pay close attention to changes in their general health including new or worsening symptoms outside their hip. If they are referred to a doctor to evaluate new conditions, they should let their physician know they have a MoM hip implant. There have been some case reports and articles in the medical literature that suggest patients with a MoM hip implant may have certain symptoms or illnesses elsewhere in the body (systemic reactions). These include:

  • General hypersensitivity reaction (skin rash).
  • Cardiomyopathy.
  • Neurological changes including sensory changes (auditory, or visual impairments).
  • Psychological status change (including depression or cognitive impairment).
  • Renal function impairment.
  • Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold).

Even if you are not experiencing any of the above problems, the FDA is recommending that patients with MoM hip implants continue to follow-up with their orthopaedic surgeon every 1 to 2 years to monitor for early signs of change in hip status.[1]

This means the FDA thinks it is a good idea to see your doctor about your hip implants if you haven’t done that for over a year. That is exactly what I recommend to every person I talk with if they haven’t seen their orthopedic doctor for over a year. You may as well accept the fact that metal implants shed metal particles as the metal surfaces rub against each other during normal activities of daily living. The metal particles, though much smaller than microscopic in size, can migrate throughout your body. Your body has been fighting your metal implants since you received them, deploying valuable biologic defense resources with every step you take. You don’t get clear warning signs when your body is losing the battle. Your blood can be measured for excessive metal with a simple and inexpensive metal ion test, but those are not completely reliable or determinative of a growing medical problem. A positive result does not mean there’s impending disaster and a negative result does not mean all is well, but these tests are better than nothing.  The test results can establish a baseline to compare against past or future tests and they can help your doctor assess your condition even if the tests do not give all the answers.

All doctors who implanted metal on metal implants know of the importance of obtaining these tests periodically on their metal on metal hip patients. It would be a good idea to ask your doctor if you should be concerned at this time. I would be very concerned if your doctor is not concerned for you. Give it a try and see what he or she says.

 

Message # 3Know Your Rights.

One of the wonderful things about living in America is that companies can sometimes be held financially accountable to the people they hurt. There is cause for concern if you received MoM hip implants, and many people in this position have legal rights that may entitle them to monetary compensation. There have been thousands of lawsuits filed nationwide and you might even have a right to participate in a financial settlement that already exists or is about to occur. There are deadlines and statutes of limitations that apply to any legal rights you might have. You should take the time to know your rights before it is too late. It all depends on knowing your product and when you received it, so go back to “Message # 1” above if you are still not sure. You have to know your medical product if you want to know your legal options.

 

Message # 4A Legal Check Up.

The MoM hip implant world is going through major medical and legal changes right now.  There are several reasons for the legal changes, including a huge jury verdict last week and numerous fast-approaching legal deadlines. Changes are occurring in the medical world as many thousands of people with MoM hip implants are requiring revision surgery every year in this country, and because patients are starting to ask their doctors additional questions about these bad products.

You should consider yourself one of the lucky ones if you already have a knowledgeable lawyer who is interested in your case and is responsive to your questions and concerns. But I know there are many folks who do not have a lawyer or who are unsure if they need one. Now is a good time to decide if you need a lawyer for your potential hip implant lawsuit or claim. Lawyers who rejected your case previously might be interested again in light of the recent developments discussed above. Some law firms who stopped taking new cases months or years ago have already reversed course and are once again eagerly accepting new cases. If you currently have or have ever had MoM implants in your body there are statutes of limitations that are running, so you cannot delay any longer if you think you will ever pursue a legal case or claim.

There is no time like the present to check out your legal options. Lawyers nationwide are showing a renewed interest in these cases. I would be happy to talk with you about your case if you have any questions, but I probably will not take your case unless it involves a Smith & Nephew hip device. Just complete the online Hip Implant Questionnaire or Contact Form at www.kippetroff.com, and I will promptly contact you and try to help.

 

[1] http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm

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METAL HIP IMPLANT MAKERS STOP SELLING PRODUCTS RATHER THAN PROVE THEY ARE SAFE

  1. A Failed Regulatory System.

I am a relative newcomer to metal on metal hip implant cases, but I am in my fourth decade of working on litigation involving bad medical devices, starting with breast implants and HIV-tainted blood products in the early nineties and continuing with vaginal mesh and metal hip medical devices more recently. I have seen many things change during the 30+ years I have been suing drug and device companies. The FDA has changed. The litigation environment and parts of the court system have even changed. Most of these changes, though not perfect, resulted in a net improvement for patient safety and regulation of drugs and devices. But not all change represents an improvement.

  1. The Metal on Metal Hip Implant Experience.

Metal hip implants have been in the news recently for many reasons, including ongoing trials over allegedly bad implants nationwide. Recent trials have resulted in mixed results for the implant patients, but that will change in coming months as the issues and company conduct become clearer through experience. I predict a steady flow of increasingly large verdicts against hip implant makers in coming months. I will discuss the trials and company defense strategies in more detail in future writings, but I’ll briefly describe here the circumstances that resulted in an American tragedy for hundreds of thousands of people with bad hips who ended up getting bad hip implants.

The FDA quietly issued a “Final Order” last month that finally gave all the manufacturers of artificial hips one last chance to apply for “premarket approval” of their metal on metal hip implants. The Final Order was issued on February 18, 2016, after more than three years of consideration and public comment, and it gave the companies ninety days to submit a plan for proving their metal hip implants are safe and effective. Companies choosing not to stand up for their products in front of the FDA by mid-May of this year have to remove their unproven implants from the market.  It looks like the majority of metal on metal hip implant makers will quietly remove most of their products from the market rather than try to prove they are safe.

Hundreds of thousands of American patients have suffered serious problems from these bad products without the companies ever having to prove or even address the safety or effectiveness of the new devices. This happened because of a regulatory loophole that permits “grandfathering” of new devices simply by showing the FDA that the new devices were substantially similar to the old ones. Every company that wanted to enter the U.S. metal on metal hip business could do so quite easily, and they all did just that.

The companies will probably continue to argue that they did the best they could. They will argue that medical progress and innovation requires some element of experimentation. They will claim there was a void in technology twenty years ago that made orthopedic surgeons literally beg for a new alternative device which resulted in this failed metal on metal experiment. The companies will also argue that their implants really were not that bad.

I will discuss this regulatory loophole in future blogs, but the main point here is that our system of medical device regulation has once again put the cart before the horse – ten years of bad hip implants sold to the American public since the mid-2000s and our regulators are just now catching up with them.

  1. What happens to the patients?

I have spent the last nine weeks in a Dallas courtroom watching almost every day of a trial involving five unfortunate patients-turned-Plaintiffs suing DePuy/Johnson & Johnson over bad implants they received from 2004 to 2010. The FDA “Final Order” requiring “premarket approval” came out in the middle of this trial. The companies involved will probably quietly remove their bad products rather than try to prove they are safe and effective, but the patients who received these implants can’t remove them so easily. They are stuck with them. Even removing the implants and replacing them with non-metal parts isn’t a sure cure, because many millions of metal debris particles are already in their systems.

Dozens of medical articles about bad metal implants have been published over the past decade and the journals are full of new articles in every issue. Companies are now finally funding studies about hip implant safety. These new studies are mainly aimed at defending hip implant products that are no longer on the market. Tens of thousands of people will have to undergo revision surgeries in the next decade to remove these bad products and clean up the toxic metal mess left behind. Many of these patients are much worse off now than when they received these products. I’ll be there watching and taking names and notes, and I’ll tell you all about it right here.

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Medical Device Makers should follow Frozen Treat Makers’ Recall Strategy

Two makers of ice cream and frozen yogurt products issued voluntary recalls of ALL their frozen treats this week amid fears of potential listeria contamination. This has provided a glimpse into the way two different frozen food companies have contemporaneously handled similar product safety crises. There will undoubtedly be some who will criticize the frozen treat companies for being too slow or not responsive enough to their respective crises, but even those critics would have to agree that medical device companies could learn from following the frozen treat companies’ recall strategies.

Blue Bell Creameries, the famous century old Texas ice cream maker, announced a voluntary recall of all its products on the market on Monday. This was after at least ten reported illnesses and three reported deaths associated with listeria contamination. Jeni’s Splendid Ice Creams issued a similar listeria-related recall of all its ice cream and frozen yogurt products and closed all of its retail stores on Thursday. Jeni’s did this even though the company says it is not aware of any reports of customer illness.

Amidst notorious vehicle recall scandals and pharmaceutical product failures and finger pointing, these frozen food companies have aggressively removed all their products from the marketplace. And if that wasn’t enough, they have also taken steps to keep the public fully informed. Blue Bell has pledged to continue the dairy product blackout until it could be “completely confident that our products are safe for customers.” Jeni’s has proclaimed that the company’s “top priority is guaranteeing the safety of all consumers” and says it will not reopen stores or restock shelves “until we are 100 percent confident every item we sell is safe.” These are reassuring, widely publicized statements from companies facing consumer confidence crises the likes of which neither of them have ever seen before. They are sending the message that they sincerely care about customer safety and will not sell their treats again until everything is completely okay.

I recently spoke with two people who received surgically implanted bilateral metal on metal hip implants roughly five years ago. Each has had one device fail, requiring painful removal and revision with a new device that isn’t working very well. They are both also having trouble with the original metal implant remaining in their bodies. Both received their metal on metal hips from the same doctor and he performed both of their revision surgeries, noting “mechanical failure” in their medical records. Neither was aware that the device had already been withdrawn from the market until they spoke with me three years later.

Strangely, the market withdrawal was very visibly listed on the FDA’s “RECALLS” page, drawing suspicion from consumer watchdogs and understandably causing confusion among concerned patients.

And here is some food for thought: All modern implanted medical devices are registered to the patient through a sophisticated serial number system that details information about the product and connects it to information about the patient and their surgeon. Ice cream obviously is not trackable like that. It is much easier and way more important to identify and contact those with medical devices than those who purchased frozen treats.

And there are other very important differences between ice cream and surgically implanted medical devices. Ice cream sits in the freezer, and if it is not eaten, a recall simply means walking to the freezer, perhaps taking a photo of the container before trashing it, and requesting a refund. Unless someone becomes sick, the trashcan is basically the end of the line for that tub of creamy goodness. But a device that has been surgically implanted cannot simply be tossed in the trash. Folks in this situation have a world of problems the ice cream eater doesn’t encounter.

For those device wearers who have had no ill effects, they are left with painful questions: Should I replace a device that is recalled but which is apparently giving me no obvious problems? What if I wait, and I begin experiencing problems in a few years, perhaps when I’m older, less healthy, and with different insurance? Should I go ahead and have surgery today as a precaution? Can I trust my original surgeon now that I know he or she didn’t tell me that my original device was removed from the market? How will my insurance handle all this? In addition, the revision surgery itself is very painful, and recovery is long and requires a great deal of rehabilitation and therapy. And devices that replace removed devices frequently have more complications than the original one.

And for those whose replacement devices are failing, revision surgery is imminent. And in these cases, removal might reveal that the device has caused additional internal damage. Often tiny bits of metal shavings (the result of the metal on metal failure) have worked their way loose and migrated away from the device, embedding themselves in what had previously been healthy tissue. Removal requires cutting open healthy tissue to forcibly dig out the failed device along with troublesome metal particles of all sizes. The device itself is sometimes cracked and broken during the removal surgery, which inevitably leaves additional metal debris behind.

All victims of failed medical devices wish it was as simple as tossing a carton of questionable Cookies ‘n Cream in the trash. How they wish it only involved a $5 refund coupon rather than tens of thousands of dollars in new medical bills, not to mention all the pain, missed work, unreimbursed deductibles, etc.

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REPORT IT IF YOU KNOW IT: MORE REASONS YOU SHOULD REPORT CONSUMER PRODUCT PROBLEMS

Posted 9-29-14

When trying to decide on the latest gadget or novelty, it is easy to become overwhelmed with the massive amounts of information (and misinformation) readily available at the click of a mouse. And while buying has become a type of instantaneous gratification, so has the disappointment of learning that your latest purchase may have also been your latest mistake! We are high tech, speed-driven, information-rich, go-getters with in-boxes full of very important distractions and very little time to allow ourselves to become distracted. So stopping everything to find your receipt and complete a complaint form is the last thing on your mind.

But I’m here to tell you that there is no time like the present to make your consumer product complaints known. American consumers have two strong allies in the Consumer Products Safety Commission (CPSC) and the Federal Trade Commission (FTC). Both the Chairman of the CPSC and the Chairwoman of the FTC are relatively new to their jobs. These fresh faces and their eager staffs can alter the course of consumer product safety in America, but it is up to you to point them in the right direction.

THESE AGENCIES ARE WORKING!

It is no secret that many governmental agencies seem to lack purpose or are terribly inefficient. I have spent most of my legal career dealing with Federal Agencies (FDA, OSHA, CDRH, CPSC, etc.) and have seen it all! I empathize with the public’s reluctance to cross bureaucratic lines, but as an attorney, I had no choice. Reporting, while a nuisance, always helped my clients and was always the right thing to do. That’s still the case, and recent experience suggests that the time is right for consumers to let these agencies know about bad products and false ads.

The CPSC.

The CPSC, according to its website, “is charged with protecting the public from unreasonable risks of injury or death associated with the use of thousands of types of consumer products . . . [that] cost the nation more than $1 trillion annually . . . [and] is committed to protecting consumers and families from products that pose a …. hazard.” The CPSC proudly boasts that its activities have “contributed to a decline in the rate of deaths and injuries associated with consumer products over the past 40 years.”

The CPSC online complaint report form takes less than ten minutes to complete and immediately generates an email with an incident report number. After filing reports recently on behalf of several clients, three different CPSC field investigators called. They asked insightful questions, requested a chance to see the reported products and interview the clients, and through their actions proved that they were serious about investigating the complaints.

What is the purpose of the field investigator? They compile data and look for patterns within the data. Is this complaint the result of an isolated incident, or does it appear to be part of a larger problem or a serious product defect? Each report becomes part of a searchable database. The data is about patterns, and yours may be the one missing dot that allows researchers to create the “big picture.” With time, and with enough information, changes can be implemented to improve safety. Your data, however small, could save a life.

Check out the CPSC at: www.CPSC.gov.

The FTC.

The FTC, according to its website and press statements “works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them.” “The FTC’s mission is to protect consumers and promote competition.” Like the CPSC website, the FTC’s website is full of useful information and resources for any consumer who thinks they have “spotted” a false advertisement or statement. There is an “Online Complaint Assistant” if you have questions about your report or how to file it. See: www.ftc.gov.

The FTC says they read all mail they receive, so your voice will be heard! Just last week, the agency began “Operation Full Disclosure,” warning top American advertisers about fine print in ads. And their enforcement strategies are encouraging! There are currently 2411 active cases displayed transparently on their website. They mean business, which is why every consumer should feel compelled to report. If an advertisement strikes you as false or misleading, there is a good chance that someone somewhere believes it. Reporting your suspicions might prevent a rich company from becoming wealthier by taking advantage of consumers less savvy than yourself.

START REPORTING NOW.

Tattletale used to sound so negative, but consumers in the crowded, noisy marketplace need watchdogs. There is a strong momentum toward safer products and stronger government enforcement of existing laws and regulations. The future is bright for American consumers, but we each must take the time to let the proper agencies know when products fail or ads deceive. The CPSC and the FTC are run and staffed by enthusiastic, safety-minded consumers themselves. They want to hear about bad products and false advertising, but it is up to consumers to start the process.

Report! For product defects, file your complaint at www.CPSC.gov. For false or misleading advertising, file your complaint at www.ftc.gov.

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Wonder if it’s worth complaining? How seven complaints in Fargo, North Dakota resulted in the largest and most expensive drug recall in American History.

My last blog urged consumers to speak up about defective products. Consumers are the ones with the most information, but when faced with the task of actually filing a report, some are understandably hesitant. It’s the same kind of reluctance that keeps many well-minded citizens from voting: “Why bother? My opinion will never make a difference anyway!” But the truth is you can make a difference.

The Fen-Phen Recall of 1997

“Fen-Phen” was a combination of two FDA-approved weight loss drugs that were highly sought after in the 1990’s. The massive popularity of Fen-Phen was eclipsed only by that of Redux, a drug that was supposed to be the once-a-day, new and improved version. Redux was approved for weight loss in 1996 amid massive media attention. Together, they were poised to become blockbuster obesity solutions.

American Home Products stood to profit from the sale of both these drugs. And profit they did! Hundreds of thousands of new prescriptions for Fen-Phen and Redux were written in the year after Redux was approved, bringing the total estimated users nationwide to six million. People across the US were shedding pounds effortlessly! It looked like the world would become a thinner, healthier place thanks to a new “magic pill.”

But there was a problem.

In early 1997 in North Dakota, a cardiac sonographer noticed a pattern. Several young women who had taken Fen-Phen were now having rare left-sided heart valve leakage. She mentioned this to the cardiologists in her group, and they contacted the Mayo Clinic who then contacted American Home Products and the Food and Drug Administration. By July of 1997, it became evident that the popular weight loss drug came at a dangerously steep price.

A press conference was held at the Mayo Clinic that summer, and American Home Products, under pressure from the FDA, “voluntarily” recalled the drugs and initiated a massive public safety and product recall.

It was originally estimated that as many as 2 million people might have been sickened – a true public health crisis. Tens of thousands of Fen-Phen users returned their unused prescriptions and rushed to their doctors for urgent care. Thousands of medical tests were run in the first month alone, while thousands more enrolled in medical studies. An astronomical number of lawsuits were filed, making Fen-Phen the largest pharmaceutical recall and mass tort litigation in the history of the United States.

Why should you report a faulty or defective product? The Fen-Phen recall was the direct result of one woman, a technician, following through on a suspicion many others might have ignored. Her actions almost certainly prevented hundreds, if not thousands, of additional heart problems and set in motion events that would compensate those already injured.

My partner and I tried the first Fen-Phen lawsuit, and we were able to prove that American Home Products, known by then as Wyeth, had been aware of health risks but had failed to inform the public. My firm would go on to try several additional Fen-Phen cases and would settle over 10,000 – a small fraction of those that existed nationwide. It was a major medical mistake that resulted in thousands of damaged hearts, hundreds of products liability trials, and more than $22 billion dollars in damages – a price today’s pharmaceutical consumers continue to pay.

The Fen-Phen Lesson

Fen-Phen litigation was my full-time job from 1997 to around 2005. My firm tried four individual cases to jury verdict, relying heavily on those initial Fargo sonogram reports. To this day, the experience stands as a shining example of how a tiny bit of data, when viewed with a watchful eye, can impact millions. Your formal complaint becomes one dot on a blank sheet of paper. Maybe it will be the only one, but maybe it will join others, and a pattern will begin to emerge, allowing a governmental field investigator to connect the dots and see a red flag before more people get hurt.

The “Consumer Corner” on my firm’s website makes reporting easy by providing a separate button for each of the most common consumer complaints. Each agency has a toll free number, and you can also contact my firm directly through the online Contact Form, if you still have questions. Gather your documentation, press the appropriate button in the Consumer Corner, and the complaint process will be over before you know it. You’ll be glad you did!