On August 29, 2016, Stryker issued a voluntary recall of certain lots of Stryker LFit Anatomic Cobalt Chromium V40 femoral heads, a prosthetic hip replacement device, manufactured before March 2011. This recall included over 40,000 defective hips. Stryker cited to “higher than expected” complaints about the failure of the femoral head to fully lock onto the stem at the stem-head taper junction, also referred to as “taper lock failure.” Additionally, patients have experienced issues with fretting and corrosion where the femoral head connects to the femoral stem, which has led to the systematic release of metal particles into surrounding tissue and bone. The systematic release of these metal particles has placed patients at risk for certain medical conditions and has required some patients to undergo revision surgery. The issues may not only be due to the femoral head design, but also due to its intersection with the Stryker Accolade, Meridian and Citation titanium alloy femoral stems.
Due to the defects in the Stryker devices, multiple federal and state courts lawsuits arose all over the country against Stryker Orthopaedics and its New-Jersey-based subsidiary, Howmedica Osteonics Corporation (“HOC”). In the last year, plaintiffs with lawsuits in both federal and state courts have requested to consolidate their cases into multi-district litigation (“MDL”) and multi-county litigation (“MCL”), respectively.
Why Would Plaintiffs Want to Consolidate Their Stryker LFit Cases?
There are many strategic explanations for why plaintiffs may decide to consolidate their cases. The “centralization” of multiple actions promotes just and efficient conduct of the actions, serves the convenience of all parties and witnesses, promotes the interest of justices and conserves judicial resources. The plaintiffs can pool their resources and coordinate legal strategies while reducing costs, avoiding potentially inconsistent rulings by the courts and eliminating unnecessary duplicative discovery. Cases consolidated into multi-district or county litigation get a lot of attention; the more plaintiffs involved in the litigation, the higher the cost to the defendant, which the plaintiffs can use as leverage during settlement negotiations. And, for HOC, the MDL and MCL litigation will attract extra negative attention.
Consolidation of Federal and State Court Lawsuits
In April of 2017, the U.S. Judicial Panel on Multidistrict Litigation (also known as “JPML” or “Judicial Panel”) considered a request by plaintiffs to consolidate federal court lawsuits against HOC over the femoral heads in Massachusetts federal court. Defendant HOC opposed centralization but, as an alternative, suggested the selection of the District of New Jersey or Southern District of New York as the transferee district. But, all responding plaintiffs supported centralization in the District of Massachusetts. After considering all arguments, the Judicial Panel signed off on the plaintiffs’ request to centralize the lawsuits. The Judicial Panel decided that the actions in this litigation involved common questions of fact. Centralization in the District of Massachusetts would serve the convenience of the parties and witnesses and would promote the just and efficient conduct of the litigation.
While it was decided that the federal cases would be transferred to the District of Massachusetts, plaintiffs with pending cases across the state of New Jersey patiently awaited a decision from the New Jersey Supreme Court on whether their statewide cases would be consolidated under a multi-county litigation. In seeking MCL status, the plaintiffs argued that the litigation involved recurrent legal issues of design defect, failure to warn, breach of warranty, and possibly manufacturing defect. Defendants argued that the designation was unnecessary because the pending lawsuits were already assigned to Judge Harz and steps had been taken to effectively coordinate the matters. Defendants argued that if the Supreme Court did grant the plaintiffs’ request for MCL, the MCL should be limited to only those devices that were specifically recalled. Plaintiffs disagreed, arguing that such a limit would preclude the numerous device failures of non-recalled femoral heads from being included in the MCL.
On May 16, 2017, the New Jersey Supreme Court approved the bid from plaintiffs to consolidate the state court lawsuits, therefore designating all pending and future actions against HOC, in connection with the Stryker LFit V40 femoral heads, as multicounty litigation. The MCL was assigned to Bergen County for centralized case management by Superior Court Judge Rachelle L. Harz. And, the Supreme Court chose not to limit the MCL to specifically recalled lot numbers of the Stryker devices, again finding in favor of the plaintiffs.
This designation came rather quickly—not even a year has passed since Stryker issued the previously discussed recall of certain lots of the Stryker LFit V40 femoral head devices. Just 7 days after the Supreme Court’s Order designating the MCL, Judge Harz issued the first comprehensive Case Management Order, which discussed both proper procedure and the Court’s expectations of the parties throughout litigation in the MCL. Judge Harz has already scheduled a Case Management Conference for June 21, 2017.
Lawsuits have been filed against Stryker since 2013 alleging that its line of TMZF hip replacement stems are a danger when combined with metal femoral heads. However, patients who have received this potentially dangerous combination of products are just now being notified. Oddly enough, Stryker is not the one doing the notifying. Despite recalling approximately 44,000 metal heads in 2016, Stryker has left it up to surgeons to notify patients. Some doctors have now taken it upon themselves to write to their patients explaining their concern over the product’s safety.
To compound the danger, Stryker’s instruction in its recall is for patients to “continue to follow up with their doctor at their normal scheduled appointment.” Most patients are released from the doctor’s care after one year of follow-up. So, if a patient’s implant has been in for a few years, then they are not scheduled for any follow-up appointments.
Dangerous Situation for TMZF Stem Hip Recipients with Metal Heads
These devices fail in much the same way tens of thousands of metal implants have failed over the past 10 years. At the connection between the TMZF titanium stem and the chrome/cobalt metal head motion leads to corrosion. This, in turn, leads to material loss. The process leads to toxic metal debris getting into the patient’s tissue and bloodstream. The metal debris can result in the death of both muscle and bone, as well as an inflammatory response leading to large fluid collections. Not all patients who suffer from this problem feel symptoms. Left untreated, the process can cause muscle and bone loss substantial enough to leave the patient with serious disabilities even after the bad device is removed and replaced.
Letter Sent from Local Surgeon
Read the letter here. Click on the image.
The latest letter that has come to my attention is from a surgeon at Holy Cross Hospital in Fort Lauderdale, Florida. The letter was sent to one of my existing clients who has already undergone revision surgery because of the above problems. He forwarded the letter to me.
Potentially thousands of these devices were implanted in Florida because of its large retirement population. Any patient implanted with a Stryker hip after 2006 should contact their surgeon and ask for their specific implant model. If the patient has any combination of a TMZF stem (Accolade, Meridian or Citation) and a metal head, they should insist on having a baseline blood chromium and cobalt study even if they are not having problems. Obviously, if the patient is having problems, he or she should consult with their surgeon as soon as possible. Finally, if the blood study shows elevated cobalt or chromium in their blood, they should insist on having a MARS protocol MRI scan of the affected hip.
One last comment about the recall. Stryker is only recalling a small subset of the metal heads it manufactured from 2002 – 2011. I have personally seen numerous failures in patients who received metal heads that are not on the recall list either because of their size or because they were manufactured after 2011. If it were me, I would not be satisfied if my surgeon told me I had nothing to worry about just because the metal head I have is not on the recall list.
The U.S. Judicial Panel on Multidistrict Litigation (“JPML” or “The Panel”) is a body of seven federal district judges who manage multidistrict litigation, meeting on a bimonthly basis to consider requests to establish MDLs. The Panel has the authority to determine whether civil actions pending in two or more federal judicial districts should be transferred to a single federal district court for pretrial proceedings.
The Panel is holding its next MDL hearing on Thursday, May 25, 2017, at the John H. Wood, Jr. United States Courthouse in San Antonio, Texas.
One noteworthy argument to be heard is in regards to MDL No. 2782, a set of products liability claims involving the Physiomesh Flexible Composite (hereinafter “Physiomesh”), a synthetic mesh hernia repair device designed, manufactured and sold by Ethicon, Inc. and Johnson & Johnson. Plaintiffs are moving to transfer 18 product liability actions pending in 9 federal district courts to the Middle District of Florida, or in the alternative, to the Southern District of Illinois, for coordinated and/or consolidated pretrial proceedings.
The argument favoring the “centralization” of multiple actions maintains that such action will promote just and efficient conduct of these actions, serve the convenience of all parties and witnesses, promote the interest of justice, conserve judicial resources, reduce litigation costs, avoid potentially inconsistent pretrial scheduling orders and substantive rulings, and will eliminate unnecessary duplicative discovery.
Physiomesh Litigation Overview
Yet another 510(k) approval under recall.
Each of these 18 actions allege that the defendants Ethicon, Inc. and Johnson & Johnson defectively designed and manufactured the Physiomesh products, and failed to provide appropriate warnings and instructions with these devices. The Physiomesh has a unique design, which has never been used in any other hernia repair product. The product was represented and promoted by the Defendants to prevent or minimize adhesion and inflammation and to facilitate incorporation and fixation of the mesh into the abdomen. However, the Plaintiffs allege that the design prevented adequate incorporation of the mesh and caused or contributed to a variety of serious complications. Plaintiffs additionally claim that the Physiomesh was insufficient to withstand normal abdominal forces. This often resulted in herniation through the mesh itself, recurrent hernia formation and/or rupture and deformation of the mesh.
The Plaintiffs people who received implants of the Physiomesh product for hernia repair, and where applicable, their spouses. All of the plaintiffs suffered serious and often permanent physical injuries from the implantation of the Physiomesh. They often required additional surgeries, additional medical expenses, and unresolved medical complications. Where applicable, plaintiffs’ spouses have alleged loss of consortium.
Defendants Withdraw Product from Market
The defendants ultimately withdrew the Physiomesh device from the market in May 2016, when Ethicon, Inc. issued an Urgent Field Safety Notice. Unpublished data from two large independent hernia repair registries indicated that recurrence and reoperation rates after laparoscopic ventral hernia repair using Ethicon Physiomesh were noticeably higher than the average rates of hernia mesh issues among other products in the market. Plaintiffs intend to establish that Ethicon’s decision to withdraw Physiomesh from the market was a direct consequence of the frequency and severity of the complications experienced with this product worldwide.
There were more than 330,000 Physiomesh devices sold worldwide and it is believed that 50% of those products were sold in the U.S. It is anticipated that hundreds of additional Physiomesh lawsuits will be initiated in the near future.
In April of 2016, the Judicial Panel on Multidistrict Litigation determined that coordination of federal court lawsuits involving men who developed melanoma after taking Viagra was appropriate. MDL No. 2691, styled In Re: Viagra (Sildenafil Citrate) Products Liability Litigation Viagra, was then established before Judge Seeborg, a federal court judge, in the Northern District of California, San Francisco Division. Nearly a year later, more than 100 individual personal injury and wrongful death lawsuits have been filed by patients alleging that Viagra, manufactured by Pfizer, was defectively designed, inadequately tested, and improperly marketed as patients and prescribing physicians were not properly informed that Viagra use can cause or promote the growth of melanoma cancer cells. Recently, the MDL judge expanded the Viagra melanoma litigation efforts to also include claims against Eli Lilly & Company for patients who ingested Cialis (or both drugs) and developed melanoma.
Viagra Melanoma Is One Of Deadliest Cancers
According to the American Cancer Society, melanoma accounts for only about 1% of skin cancers, but, sadly, is one of the most deadly cancers. It is estimated that 87,110 new cases of melanoma skin cancer will be diagnosed in the United States in 2017, with men being diagnosed more frequently than women. Nearly 10,000 patients are projected to die from melanoma in 2017. The rates for melanoma have been rising for the last 30 years, with melanoma cancer rates being much higher in Caucasians and in patients who are over age 60.
Viagra Has Been On The Market Since 1998
Viagra was first approved for sale in the United States in March of 1998 by the Food & Drug Administration. The drug entered the market with quite a lot of fanfare in 1998, and has been aggressively promoted by Pfizer ever since for the treatment of erectile dysfunction. It was one of the first drugs introduced to treat erectile dysfunction, a condition that affects an estimated 30 million men in the United States. Erectile dysfunction (which is often referred to as “ED”) can be caused by a number of common medical conditions: diabetes, high blood pressure, heart disease, smoking, alcoholism, obesity, prostate problems, low testosterone, and as a side effect of other medications. In just 2013, Pfizer enjoyed approximately $1.8 billion in sales of Viagra worldwide.
Cialis (also known as tadalafil) is another erectile dysfunction drug that is very similar to Viagra. It is currently sold by Eli Lilly and Company, an international pharmaceutical company based in Indianapolis, and was initially developed through a partnership between Glaxo Wellcome (now GlaxoSmithKline) and ICOS. Cialis was first approved by the FDA in 2003, and was the third drug approved for sale in the PDE5 inhibitor drug class (with Viagra being the first and Levitra (also known as vardenafil) being the second). Cialis has a longer half-life than Viagra, which means that the drug is able to continue working in the body for a longer period of time. This longer half-life may also be part of the liability case against the drug manufacturer in the pending lawsuits, as it is theorized that this longer half-life may also make Cialis more likely than Viagra to promote the growth of cancer cells. Hopefully, ongoing scientific studies and internal documents (once they are produced in the consolidated litigation efforts) will shed some light on this critical issue.
Both Viagra and Cialis treat erectile dysfunction by inhibiting the secretion of phosphodiesterase type 5 (“PDE5”), an enzyme responsible for the degradation of cyclic guanosine monophosphate (“cGMP”). When the cGMP is not degraded by the PDE5, smooth muscles in the corpus cavernosum relax; this, in turn, permits an inflow of blood to the corpus cavernosum, creating an erection. Some recent studies published by independent scientists have shown that this same mechanism of blocking the production of PDE5 can lead to the creation of melanoma cells and promote melanoma cell invasion. This potential link to cancer was not included in the warning labels or advertising materials for the drugs, and is a key focus of the pending lawsuits.
Progress in Viagra Melanoma Lawsuits
Over the past 12 months, Judge Seeborg has held regular hearings to obtain reports on the progress of the litigation. The attorneys who represent the injured patients are seeking the production of millions of pages of documents from the drug companies involved in the development and marketing of Viagra and Cialis to help prove the plaintiffs’ claims that the manufacturers should have known of the link to cancer many years ago and provided proper warnings to the patients and their doctors (if the drugs should have ever been approved at all by the FDA). It is estimated that it will likely take another 6 to 12 months to complete the production of documents from the drug companies, which are anticipated to be tens of millions of pages of documents that were produced by employees in the United States as well as overseas. Once the document production is complete, dozens of depositions will need to be taken of drug company employees who played critical roles in the development of the drug, interaction with the FDA and other drug safety regulatory agencies, marketing of the medication to doctors and directly to consumers, conducting and monitoring scientific studies, and surveillance of adverse event reports to determine whether there were potential signals of safety issues associated with the ED medications.
Cialis Claims Added
Since the Cialis claims were added to the litigation effort just recently, it is likely that the first cases that will be ready for jury trials in the coordinated proceedings will involve ingestion of Viagra. Judge Seeborg has not yet scheduled for first trials for the litigation, but will likely do so in the coming months. Once the judge selects individual cases to be included in the MDL bellwether trial process, those plaintiffs, their family members, and their treating doctors will provide sworn testimony in depositions. Experts hired by both the plaintiffs and the defendants will be required to file detailed reports with regard to scientific and medical issues and provide sworn deposition testimony as well. The plaintiffs are hopeful that the first Viagra and perhaps Cialis cases will be tried in 2018 or 2019. Prior to any jury trials, Judge Seeborg will also be required to rule upon a number of legal issues, including admissibility of scientific testimony and evidence.
The drug and medical device lawyers at Searcy Denney have represented patients who developed melanoma after ingesting Viagra and/or Cialis and are still accepting new cases in the pharmaceutical litigation. Sadly, since both drugs have not been recalled and many patients remain unaware of the potential link to cancer, it is likely that the litigation could persist for years as new patients are diagnosed with melanoma.
Miami Beach was the place to be for mass tort lawyers last week, with two drug and medical device conferences as well as a critical hearing before the Judicial Panel on Multidistrict Litigation (also known as the “JPML”). The Judicial Panel, a group of federal judges that meets every two months to consider requests to establish MDLs for pharmaceutical, medical device, environmental, consumer fraud, securities and other mass tort cases, held a hearing on Thursday, January 26, 2017, at the federal courthouse in Miami which included discussion on a potential Eliquis MDL.
One of the most significant arguments heard by the JPML Panel last week was for the establishment of a new MDL No. 2754 for product liability claims stemming from Eliquis. Eliquis is a popular blood thinner drug prescribed to patients who suffer from atrial fibrillation, deep vein thrombosis, or pulmonary emboli. This drug, also known as apixaban, is part of the same class of newer anti-coagulants, which includes Pradaxa and Xarelto. Eliquis is manufactured and sold by Bristol-Myers Squibb and Pfizer.
The manufacturers of Pradaxa and Xarelto have been mired in thousands of lawsuits filed by patients who suffered serious personal injuries or died as a result of taking these drugs. The individual lawsuits focus on the manufacturers’ failure to properly test the medications prior to marketing, irregularities in the conduct of the clinical trials that were completed, failure to properly report adverse events, and inadequate warnings. The lack of a reversal agent and questionable data demonstrating effectiveness of Pradaxa and Xarelto over Coumadin (which has an antidote) are also key contentions in the liability cases against the manufacturers. Similar allegations are now being made as well against the manufacturers of Eliquis.
Eliquis Still on the Market
Eliquis, like Pradaxa and Xarelto, remains on the market, even in the face of the troubling safety issues. Many of the Pradaxa cases were settled a few years ago, while the Xarelto manufacturers will face the first jury trials in the coordinated litigation in 2017. Bristol-Myers Squibb and Pfizer have urged the JPML Panel to establish an Eliquis MDL for the Eliquis cases in the federal court for the Southern District of New York. It is anticipated that hundreds of additional Eliquis lawsuits will be filed in the coming months if an Eliquis MDL is granted.
The dedicated Mass Tort Unit of Searcy Denney Scarola Barnhart & Shipley represents plaintiffs who have been injured by defective drugs and medical devices. The firm filed one of the first lawsuits in the national Pradaxa litigation and has played an active role in litigating Pradaxa and Xarelto blood thinner lawsuits on behalf of a number of injured patients.
Currently, the orthopedic and scientific community is trying to grasp the scope and danger associated with corrosion and fretting failures at the femoral head and stem interface or trunnion. Every manufacturer has thousands if not hundreds of thousands of titanium stems with metal femoral heads implanted in patients so this is a huge issue.
Why the sudden uptick in failures? I believe two factors are relevant. First, over the past ten years manufacturers have designed and released larger and larger metal heads. They have done so under the guise of providing surgeons with an option that will lessen the risk of dislocation. Since the true risk of dislocation in competent hands is less than 2%, this is another example of industry creating a solution to a problem that does not exist. It only provides yet another marketing advantage. At the same time, trunnions and neck profiles have gotten smaller and smaller under the guise of lessening the risk of impingement. Again, a risk that is extremely low in competent hands. Skilled surgeons tell me that if an implant is placed in correct, anatomic alignment the hip will not dislocate or impinge.
Second, since most of these devices are not “recalled” many surgeons have simply failed to make the appropriate diagnosis leading to under reporting of adverse events. Metal wear disease is a relatively new concept in orthopedics. As such, non-recalled devices don’t raise eyebrows when patients return complaining of pain and limited mobility. I’ve seen surgeons follow such patients for years giving repeated steroid injections, aspirating the hip, suspecting infection and sending patients back to rehab without ever making the correct diagnosis. So, simple lack of recognition has led to under-reporting. But, more recently the medical literature has started to address this situation. Stryker recently recalled thousands of metal heads. The issue is becoming more prominent leading to quicker, more accurate diagnosis. The issue has simply risen to the top.
When Trunnions Get Smaller and Heads Get Larger
What is the result of smaller trunnions, lower profile necks and larger heads? Well, if you were to pose that question to Sir John Charnley over 50 years ago he would say that larger heads increase the rotational forces on the head (torque) which is directly transferred to the head/neck interface (trunnion). As trunnions get smaller, the larger forces created by larger heads are borne by smaller surface contact. The result is more motion at the interface between head and stem. Motion = fretting or wearing away of the metal (actually the passive layer of oxides that form on the metal) and corrosion occurs. The additional factor of smaller neck profiles exaggerates the motion and simply makes matters worse. The laws of physics did not change over the past 50 years! Why ignore the sage wisdom of your forefathers?
When a titanium stem and metal head (most frequently a chromium/cobalt alloy) move upon one another and corrosion occurs there is actual material loss from both the chrome/cobalt head and the titanium stem. It’s typically microscopic and almost undetectable to the eye. But, the amount of chromium and cobalt that are given off during the corrosion process is substantial and biologically devastating to tissue and bone. Surgeons have taken to calling this failure, “metallosis.”
What Is Metallosis?
Metallosis is simply toxicity to tissue and bone when exposed to chromium and cobalt. Tissue, muscle and bone die. Frequently abnormal masses of tissue grow and these are referred to as pseudotumors. Large collections consisting of milky, purulent appearing fluid can also occur and are often mistaken for infection. If allowed to progress, metallosis can destroy very important muscles as well as bone.
The surgical “fix” for metal wear failure is to remove the offending device and replace it. But, there is substantial debate among surgeons as to what should be removed. Many doctors are simply removing the metal head and replacing it with a ceramic head, leaving the well ingrown femoral stem in place. That would include the potentially worn trunnion upon which the new head is placed. Others are removing both the stem and head out of concern that an “eyeball test” of the trunnion is sufficient.
Surgeons are very hesitant to remove a well ingrown stem. The procedure is time consuming and frequently requires cutting a large window in the femur followed by placing several cables to hold the bone together. Rehabilitation time is greatly increased. Complications are not uncommon. So, if you can get away with leaving the stem, the temptation is to do so. But, at what cost?
I actually attended an American Society for Testing Materials (ASTM) subcommittee on Medical and Surgical Materials meeting devoted entirely to this topic. At that meeting there was substantial disagreement over whether an intraoperative “eyeball test” of a used trunnion was sufficient to insure integrity. I have also spoken with numerous surgeons who have expressed great concern over this issue. They have no idea what the long-term consequence is when a new head is impacted on a worn, used trunnion. It scares them.
L-Fit V40 Head Revisions
Finally, this week I had the opportunity to review a revising surgeon’s pre-operative office note. The surgeon is well-known and was revising a failed Stryker Accolade TMZF stem that had been implanted with Stryker’s L-Fit V40 (Low Friction Ion Treatment) chrome/cobalt head. This surgeon has been a Stryker consultant in the past and has worked on design teams creating new Stryker products. The head was one Stryker has recently recalled (36mm +5). All of the appropriate pre-revision work-up indicated the devices had failed due to metal wear. Even before he performed the surgery, this Stryker consultant planned to remove the stem. In the final pre-operative office note he said, “I would not sleeve this and convert it over to ceramic. There is too much damage to the trunnion.This is a small trunnion and I do not think sleeving these is reasonable.” He made the comment about too much trunnion damage before surgery, well before he even saw it.
This is the first time I have seen a surgeon commit to writing the thought process I have heard so many voice and what some advocated at the ASTM conference. It confirms my suspicion that thought processes are changing and more surgeons are going to be unwilling to leave a worn trunnion/stem in place. Of course, the risks of leaving a worn trunnion behind will not be known until well down the road when and if they fail.