The United States Food and Drug Administration (FDA) is taking a deeper dive into the investigation of AstraZeneca Plc’s COVID-19 vaccine study and will now look at data from previous trials of similar vaccines developed by the same researchers at Oxford University. Despite taking a closer look, they don’t believe there are any safety issues associated with these vaccines. “It just shows that the FDA is being thorough,” explains a source.
AstraZeneca’s trial in the U.S. has been on hold since September 6th, when a participant in Britain fell ill with transverse myelitis, a rare spinal inflammatory disorder. Regulators in the United Kingdom, Brazil, India, and South Africa have already resumed studying the efficacy of the vaccine.
Given the increased FDA investigation, further delays are likely for what was one of the most advanced COVID-19 vaccine studies in the U.S. The additional data requested by the FDA was expected to be delivered in early October and will require time to review.
An effective vaccine is essential for efforts to end the global COVID-19 pandemic that has already killed over one million people. President Donald Trump (who announced that he tested positive for COVID-19 on October 2nd) and his administration have pledged 1.2 billion dollars to support the development of AstraZeneca’s vaccine and to secure 300 million doses for American citizens. Pfizer Inc, Moderna Inc, and Johnson & Johnson are also in the U.S. vaccine race.
The FDA declined to comment, and Oxford University did not respond to requests. In a statement, AstraZeneca said: “We are continuing to work with the FDA to facilitate review of the information needed to make a decision regarding resumption of the U.S. trial.”
The C-Qur hernia mesh product line (pronounced “secure”) was introduced by Atrium Medical Corporation in March 2006 with the promise that its combination of standard synthetic polypropylene mesh and Omega 3 Fatty Acid Fish Oil (“O3FA”) would be superior to other contemporary mesh products. The C-Qur line was, for its time, a novel approach by a relatively small medical device firm founded in 1981. Indeed, the C-Qur product family would help push Atrium out of obscurity and triple its revenues to $200 million between 2004-2011, while making it a lucrative acquisition target by larger device manufacturing firms.
Regrettably, the promise of Atrium’s C-Qur product line was soon riddled with adverse event reports to the U.S. Food and Drug Administration (FDA) claiming high rates of infection and other problems associated with the device. The issues associated with C-Qur elevated the FDA’s enforcement attention to the point that Atrium recalled the C-Qur line in 2013. Later in 2015 Atrium was compelled by the FDA to cease the manufacturing of the C-Qur line at its facility in Hudson, New Hampshire, for sanitary conditions and quality assurance issues. Today, nearly 2,200 cases are pending in a multidistrict litigation (MDL) pending in a New Hampshire federal court with patients alleging that the C-Qur meshes implanted in them were not only defective and caused harm, but that C-Qur knew of the issues and attempted to cover them up.
Background of the C-Qur Product Line
Compared with other medical device manufacturing firms, Atrium was a relatively obscure start-up founded in 1981 that specialized in the manufacture of chest drainage machinery and related vascular products. In 1993, the firm branched out with its first hernia mesh devices: the ProLite Mesh and later the ProLite Ultra Mesh. The market for mesh devices quickly became a key revenue channel for Atrium and led to the introduction of its more prolific C-Qur family of mesh products starting in 2006:
C-Qur Mesh
C-Qur Tac Shield
C-Qur V-Patch
C-Qur Edge
C-Qur Lite Mesh V-Patch
C-Qur Edge Mesg V-Patch
C-Qur V-Patch Mesh
C-Qur OVT Mesh
C-Qur RPM Mesh
C-Qur Mosaic
C-Qur FX
C-Qur CentriFX
The C-Qur line was approved for the U.S. market pursuant to the fast-track 510(k) clearance process which allowed Atrium to skip over the ordinary research concerning safety and effectiveness for other devices requiring pre-market approval. In its filings with the FDA, Atrium claimed that 510(k) clearance was warranted because C-Qur mesh was “substantially equivalent” to earlier mesh designs even though it incorporated O3FA fatty fish oils into the design – the first ever to do so; and despite knowledge by both physicians and researchers alike that O3FA carries with it the potential for life-threatening allergic reactions.
Acquisition by the Getinge Group
By 2011, Atrium had swollen to become a company with revenues in excess of $200 million annually, more than 700 employees, a sales force throughout North America, Europe, Asia, and Australia/New Zealand, and 106 distributors across 102 countries. In that moment, Getinge Group, a multi-billion dollar Swedish device manufacturer moved-in and orchestrated the acquisition of Atrium for $680 million through a German subsidiary, Maquet.
Advertised Uses for C-Qur Mesh
Initially, C-Qur was intended as a mesh for surgical use with ventral and inguinal hernia conditions. C-Qur was advertised as a novel approach to implantation and a way to ameliorate past issues with polypropylene mesh organ adhesion by virtue of its coating with O3FA, a pharmaceutical-grade fatty-fish acid coating.
Issues and Complications Associated with C-Qur Mesh
It is well-established that certain proteins in oily bio-product derived from fish are bound to cause allergic reactions. Common human responses to fish proteins such as those contained in fatty fish oil can range from increased sensitivity and rashes – all the way up to death. Concerns about the possibility of allergenic contamination were allayed by assurances that the O3FA coating utilized by Atrium would be screened, tested, and inspected to ensure that no non-soluble proteins would be present in the coating.
Almost immediately following the introduction of the C-Qur line and for years following afterward, physicians and surgeons reported disturbing levels of infection and other conditions following implantation with the C-Qur line. One “adverse event” report to the FDA involved a woman implanted with C-Qur mesh who began suffering intense pain and a “constant burning sensation” within 6 hours following her hernia repair procedure. She was immediately taken back for a second operation wherein the surgeon noted that the woman’s abdomen and the pelvic area looked like “a bomb went off” and “like a third-degree burn” due to the intense infection and inflammation.
Other similar adverse event reports have C-Qur mesh implantees complaining of “purulent discharge” and swelling from abdomen wounds. A patient in 2012 required mesh removal, drainage of his abdomen, treatment with intravenous antibiotics, surgery for obstruction, and five days in the hospital less than a week after a hernia procedure involving C-Qur mesh.
FDA Warning Letter and Class II Recall of C-Qur
The FDA expressed serious concerns to Atrium in a letter dated October 11, 2012, wherein the agency believed that Atrium was not adequately addressing the issues corresponding to numerous adverse events involving C-Qur mesh. Most of these complaints involved infections and other reactions to the C-Qur mesh that pointed directly at either insufficient or deficient sterility and sanitary procedures at the point of manufacture.
In August 2013, the FDA announced a Class II recall of the C-Qur Edge Mesh due to manufacturing and sterilization issues that caused the device to adhere to its packaging after exposure to conditions of high humidity. Although the recall impacted over 1,500 meshes, Atrium did not pull any products from shelves and merely warned physicians to inspect meshes prior to implantation.
FDA Lawsuit and Consent Decree of Permanent Injunction
The issues with Atrium and C-Qur became so pronounced that the U.S. Department of Justice, on behalf of the FDA, filed a lawsuit in federal court in February 2015, to stop Atrium from the production of meshes at its production line in Hudson, New Hampshire. The lawsuit was followed by a permanent injunction and “consent decree” which accused Atrium of violating the Federal Food, Drug and Cosmetic Act (FFDCA) by putting mesh devices on the market which were illegally “adulterated” and mis-branded; and which were not manufactured utilizing “current good manufacturing processes”.
C-Qur Mesh Lawsuits
There, at present, over 2,200 lawsuits naming Atrium and its C-Qur mesh line seeking damages for injuries, suffering, and medical expenses. Lawsuits involving C-Qur mesh accumulated to the point that in 2016, they were consolidated into a single multidistrict litigation taking place in federal court in New Hampshire. The first “bellwether” trial in this MDL (MDL-2753) is expected in late 2020.
The 3M Company and Aearo Technologies designed and manufactured specialized combat earplugs for U.S. servicemen and women which were supplied throughout combat zones in Iraq and Afghanistan between 2003 and 2015. Ostensibly, these devices were supposed to protect the hearing of our troops while offering them two fitting options for different types of encounters. In particular, one end of the 3M Combat Arms earplugs was supposed to protect against harmful battlefield noise levels while allowing troops to hear commands as well as the footsteps and other sounds from enemy combatants. Unfortunately, a design defect, one that both Aearo and 3M likely knew about in advance, allowed dangerous levels of noise to enter the ear and cause permanent hearing loss and tinnitus in many returning veterans.
Background and History
Aearo Technologies became the exclusive supplier of dual-ended combat arms earplugs for the entire U.S. military under an “Indefinite Quantity Contract” (IQC) awarded in 2003. Partially in response to the success of Aearo in securing such a lucrative contract, the defense contractor was acquired by 3M in 2008 and continued to supply earplugs through at least 2012.
The dual-ended combat arms earplugs manufactured by 3M and Aearo are known as “non-linear” or “selective attenuation” earplugs. This design was intended to permit soldiers to protect their hearing while choosing from either a “blocked” or “unblocked” fitting position in the ear. In the blocked position, the earplugs were supposed to perform as traditional earplugs and block as much potentially harmful noise as possible. In the “unblocked” position, the earplugs were intended to minimize loud impulse sounds (i.e. battlefield explosions, rockets, and artillery fire) while allowing quiet noises such as commands or footsteps to pass through.
Design Defect
However, as injured soldiers claim in multiple lawsuits, the earplugs did not perform as advertised. They believe that the combat earplugs’ instruction manual, in combination with an inherent design defect, involving the third-flange of the non-inserted end, prevented the plugs from fitting snugly in the ear canal. When the flange of the non-inserted end pressed against the ear, it folded and loosened the seal. Troops who believed their ears were being adequately shielded from battlefield noise were allegedly exposed to much higher-than-safe levels of decibels. It is believed that, at a minimum, thousands if not millions of soldiers have suffered significant hearing loss as a consequence.
3M and Aearo Knowledge of the Defect
At the dawn of the program in January 2000, testing of the combat arms earplugs began at Aearo’s own laboratories, rather than at an outside and independent laboratory. Aearo employees closely monitored the results of testing, which suggested that the noise reduction factor offered by the devices was far below what was considered adequate. Aearo determined that the positioning and fitting of the flanges in the design were the cause of the deficiency in the earplugs’ performance.
Aearo employees and engineers concluded that a snug fit on the “closed” end of the earplugs required the user the fold back the flanges on the “open” end in what was termed as a “modified” fitting procedure. Testing resumed in February 2000 using the modified fitting technique and the results of these tests were the basis for Aearo’s and eventually 3M’s claims about the noise reduction ratings for the combat arms earplugs.
Instructions for Proper Use
Despite allegedly knowing that their product contained a serious design defect that could render its claims of noise protection virtually meaningless, Aearo and 3M went ahead and sold the dual-ended combat arms earplugs to the U.S. military for several years. And potentially more damning, given what they knew about the defect and their own testing, they failed to include the “modified” fitting procedure in the standard “instructions for proper use” issued with the device.
Whistleblower Settlement
In 2016, a competing firm of Aearo/3M filed a federal whistleblower complaint claiming that 3M violated the False Claims Act concerning statements and representations it made to the U.S. Government concerning the safety record of the dual-ended combat arms earplugs. Specifically, Moldex’ claimed that 3M employees were well-aware that the earplugs did not perform as claimed to go all the way back to 2000. In July 2018, 3M agreed to settle the claims in the whistleblower complaint for $9.1 million without a direct admission as to any liability on the part of 3M.
Tinnitus and Hearing Loss
Tinnitus is described as a general ringing in the ears. According to the U.S. Department of Veterans Affairs, tinnitus is one of the most commonly reported disabilities among servicemen and women. It is widely understood that our nation’s fighting men and women are especially vulnerable to tinnitus and hearing loss due to excessive noise exposure from gunfire, explosions, and helicopter rotors.
These loud noises can permanently damage the cells within the inner ear causing much discomfort and loss of enjoyment of life. Veterans with tinnitus can hear a ringing, hissing, or buzzing that prevents concentration or sleep. On the other hand, hearing loss can make it difficult for someone to maintain relationships with loved ones and friends leading to depression or even cognitive decline.
Is there a Dual-End 3M Combat Arms Earplugs Lawsuit?
In 2019, veterans from across the United States began filing lawsuits naming 3M which claim that the company sold defective earplugs and then intentionally made false representations to the U.S. Government concerning the safety and effectiveness of the combat arms earplugs. These lawsuits have now been aggregated into a multidistrict litigation taking place in a federal court in Florida (MDL-2885). The first bellwether trials in the MDL began in April 2021. Some of the lead plaintiffs include:
Andrew Bridges
Bridges is a veteran of the United States Marine Corps who joined in 2006 at the age of 18 and was deployed to Iraq in 2009. He was supplied with dual-end 3M Combat Arms earplugs during his service and wore them during tank firing, training exercises, live-fire training, vehicle maintenance, and combat exercises. According to his complaint, Bridges was never instructed to fold back the flanges on the earplugs and in 2010 was first diagnosed with hearing issues, including sensorineural hearing loss and tinnitus.
John Ciaccio
Also a veteran of the United States Marine Corps, Ciaccio joined the Marines in 1991 and served until 2017, during which he was deployed to Iraq (twice) and Afghanistan. He worked extensively in maintenance, demolition, and as a convoy team member. Like Bridges, he was supplied dual-end 3M Combat Arms earplugs and wore them throughout the remainder of his service. Like Bridges, Ciaccio was never instructed on how to bend back the third flange on the opposite side of the earplug. In 2009, he was diagnosed with tinnitus and hearing loss which requires him to wear hearing aids.
Trial Progress Update
The first three trials involving 3M’s Combat Arms earplugs under the consolidated multidistrict litigation taking place in Pensacola resulted in at least two jury verdicts in favor of injured veterans with damages totaling $8.8 million. One of the three resulted in a jury verdict in favor of 3M.
Fourth Trial – Brandon Adkins
On October 1, 2021, a jury in a Pensacola federal court found 3M liable for hearing damages suffered by U.S. Army veteran Brandon Adkins. Adkins served in the Army from 2004 to 2009 and did two tours in Afghanistan. The jury ruled that a design defect in the 3M Combat Arms Earplugs caused Adkins’ to suffer tinnitus and permanent hearing loss and that the company failed to warn of the defect. It then awarded Adkins $8.2 million in damages.
Additional Bellwether Trials Authorized
On October 8, 2021, the federal judge overseeing all of the consolidated lawsuits involving 3M Combat Arms Earplugs authorized an additional four “bellwether trials” used by the parties to gauge the range of damages and define settlement options.
What Do I Need to File a Dual-End 3M Combat Arms Earplug Lawsuit?
Veterans who served in the U.S. military between 2003 and 2015 may consider filing a lawsuit to recover compensation for injuries and loss of quality of life. The first step is to contact an experienced 3M Combat Arms earplugs case attorney for an initial consultation. These visits are an excellent opportunity to learn more about the ongoing litigation and what it means for you. Furthermore, they are always free-of-charge to you.
Some things to have organized for your initial consult with an attorney include:
Service records detailing your time in the military, deployments, and work fields/occupations while in service.
Any paperwork, records, or notes you have recalling when you were issued the 3M Combat Arms earplugs and when you wore them.
Reports and records from the Veterans Administration detailing hearing tests and results (these can also be supplied by the V.A. upon request).
Disability Benefits and Filing a Lawsuit
Veterans who receive disability benefits should not be concerned that any award resulting from filing a lawsuit for their injuries will adversely impact those benefits. According to attorneys familiar with this process, disability benefits are given on the basis of injury and are not based upon income or financial need. Bearing this in mind, any benefits received which are needs-based or income-based could be affected. It is important to consult with an attorney knowledgeable about these matters when starting the claims process.
6) “The impact of hearing impairment and noise-induced hearing injury on quality of life in the active-duty military population: challenges to the study of this issue” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4830069/
Since 2019, hundreds of patients have come forward to file claims in court alleging that the popular heartburn medication, Zantac (ranitidine) was contaminated with harmful carcinogenic compounds and that the contaminated medication caused them to develop a variety of dangerous cancers. Several of those cases have now been consolidated into multidistrict litigation now taking place in a federal court in Florida.
Background and History
Zantac (named generically as ranitidine) belongs to a class of medications known as H2-receptor antagonists (“H2 Blockers”) which act to lower the level of acid produced in the stomach. H2 Blockers are frequently used to treat gastric ulcers, heartburn, acid indigestion, and other related gastrointestinal conditions. It was developed in 1976 by researcher John Bradshaw and submitted by Glaxo Holdings (now GlaxoSmithKline) for approval by the U.S. Food and Drug Administration (FDA) in 1983.
Beginning in the 1980s, Zantac was sold and distributed in prescription format accompanied by one of the industry’s (then) most ambitious marketing programs. Zantac did not disappoint and Glaxo reached $1 billion in sales by December 1986 making the drug one of the most successful runaway hits in the industry. Zantac became available over-the-counter (OTC) in 1996 and soon thereafter was made available as a generic. Although brand name sales of Zantac declined once generics came on the market, the drug itself continued to propel strong sales. In 2018, Zantac ranked as one of the top-10 antacid tablets in the United States.
Valisure and Detection of NDMA in Ranitidine
The story about NDMA contamination in Zantac/ranitidine batches might not have come to light but for the efforts of a small, start-up pharmacy laboratory in New Haven, Connecticut. Known as Valisure, the company traces its genesis to founders Adam Clark-Joseph and David Light reconnecting after Clark-Joseph suffered from a contaminated batch of medication. The unfortunate incident served as an inspiration for the two scientists and entrepreneurs to bring together a team of professionals focused on preventing low-quality medications from entering the market.
Beginning in March 2019, Valisure began testing Zantac for carcinogens on a whim after Clark-Joseph’s infant daughter began taking it for acid-reflux. Immediately the testing revealed abnormal spikes evidencing the presence of NDMA – a potent carcinogen. After more testing, Valisure alerted the FDA in June 2019, and in September 2019, both the FDA and European regulators announced their own investigations into the safety of ranitidine. Soon thereafter, some drug makers announced unilateral halts in the production of generic Zantac while Canada intervened to stop distribution.
As a final blow to generic ranitidine, the FDA notified all manufacturers of Zantac to conduct testing for NMDA in October 2019. This order was followed by a recall of all Zantac products from the market on April 1, 2020.
What is NDMA?
Also known as “N-Nitrosodimethylamine”, NDMA is an organic chemical that is part of a family of compounds known as N-Nitrosamines. This group has been recognized as potent carcinogens with substantial dangers to human health and life. The United States Environmental Protection Agency (EPA) and the International Agency for Research on Cancer (IARC) both classify NDMA as a probable human carcinogen. The World Health Organization’s (WHO) own testing indicates that NDMA exposure is associated with gastric and/or colorectal cancer. NDMA is generally never intentionally produced in the United States unless it is going to be used to induce tumor growth in lab experiments.
How Did NDMA Get in Zantac?
The presence of NDMA in Zantac is not generally believed to be caused by a defect in the manufacturing process itself. Rather, it is alleged that NDMA is inherently a structure present in the molecular structure of ranitidine. Specifically, claims allege that when anyone takes ranitidine, the active ingredient in the medication produces NDMA, exposing every user to the carcinogen.
Is There a Zantac Lawsuit?
Beginning in 2019, cancer sufferers, believing that they developed their illnesses after taking Zantac, began filing lawsuits against the manufacturers of ranitidine in several courts across the United States. The manufacturers named in many of these lawsuits are:
Boehringer Ingelheim Pharmaceuticals, Inc.
Sanofi Aventis, S.A./Sanofi-U.S. Services, Inc.
Chattem, Inc.
Pfizer, Inc.
GlaxoSmithKline, Inc.
Specific Cases:
Joseph John Balisteri
Mr. Balisteri began using OTC Zantac in 2000 and continued using the 150mg variety 2-3 times a week until 2019. In November 2018, he was diagnosed with bladder cancer, a condition associated with NDMA contamination. After learning about the recall and his cancer diagnosis, he filed suit in California in November 2019.
Walter H. Hansen
Walter Hansen, a resident of Solano County, California, began taking OTC Zantac in 2010 and used the 150mg dosage at least once a day through 2019. In 2017, he was diagnosed with colorectal cancer, which later spread into his liver and lungs. These are all cancer vectors associated with NDMA contamination. He filed suit in California in October 2019.
Cases similar to those filed by Mr. Hansen and Mr. Balisteri have now been filed all over the United States and in 2020 were consolidated into a single multidistrict litigation (MDL) taking place in federal court in Florida (MDL-2924). Judge Robin L. Rosenberg of the Southern District of Florida (West Palm Beach) is presiding over the MDL and new cases are being added at this time.
Joining a Zantac Lawsuit
If you believe that your cancer diagnosis – in particular: liver, bladder, stomach, intestinal, colorectal or esophageal; was the result of taking Zantac or generic ranitidine, and are interested in participating in a lawsuit seeking damages, you and your lawyer will need to establish a few preliminary facts as part of a claim. Specifically:
That You Took Zantac or Generic Ranitidine.
While this may not sound difficult, in reality, it can be an issue depending upon which type of Zantac you ingested. If you took a prescription Zantac, then those records may be simple to obtain. However, if you took OTC Zantac or ranitidine, you may have to produce receipts and doctor’s notes or similar evidence to establish your identity as a consumer.
You Have a Cancer Diagnosis.
Although Zantac consumers may suffer from any of a wide variety of cancers, a certain few are generally associated with NDMA contamination, such as liver, bladder, stomach, intestinal, colorectal, or esophageal cancers.
A Linkage Between Cancer Diagnosis and Use of Zantac or Generic Ranitidine.
If you took Zantac daily for 20 years, it may be easier to establish a linkage between your cancer diagnosis and the medication, than if you only took Zantac periodically for a very short period of time (less than a year).
Regardless of whether you feel you have answers to all of these threshold questions, if you feel you have been harmed then you should take the opportunity to consult with an attorney to learn more about your rights and possible entitlement to compensation for injuries. Consultations with law offices in these types of matters are free-of-charge and do not oblige you to any further action unless you wish to proceed.
Formed through the 2014 merger of two modern medical device manufacturers, Zimmer Biomet is a leading player in the market for musculoskeletal healthcare. The combined entity designs and manufactures: orthopedic reconstructive products; sports medicine, biologics, extremities, and trauma products; spine, craniomaxillofacial and thoracic products; and dental implants; as well as related surgical products. Zimmer Biomet is one of the fastest-growing medical device manufacturers in the orthopedic prosthesis market with an anticipated market share in excess of 20% by 2024 (second only to Johnson & Johnson’s DePuy Synthes).
These days, however, Zimmer isn’t only attracting attention for its explosive growth and market presence. It is also the subject of lawsuits consolidated into multidistrict litigation (MDL) in Indiana concerning its metal-on-metal (MoM) hip implant technology system, the Zimmer M/L Taper with Kinectiv Technology. Claimants in these lawsuits allege that Zimmer Biomet either knew or should have known that the Zimmer M/L Taper with Kinectiv Technology had a dangerous design defect allowing corrosion of the metal alloys in critical junctures which causes tissue damage, dislocation, and metallosis.
History and Background of Zimmer Biomet
Zimmer Biomet was established by its founder Justin Zimmer in Warsaw, Indiana, in 1927, to manufacture aluminum splints. Zimmer’s take on the medical devices grew in popularity and by 1942, the company’s annual sales reached $1 million. In 1950, Zimmer introduced the company’s first hip prosthesis in association with Dr. Palmer Eicher, and in 1972 the company was acquired by pharmaceutical and medical device behemoth, Bristol Myers Squibb. In 2001, Zimmer was spun off by Bristol Myers Squibb as a free-standing public company and in 2014, Zimmer paid $13.4 billion to acquire Biomet, Inc., in the process forming today’s Zimmer Biomet.
Among the range of products Zimmer Biomet manufactures and markets across its divisions, its total hip replacement systems are some of the most prominently featured. Zimmer Biomet’s hip replacement systems include the following brands:
Taperloc Hip System
Zimmer M/L Taper Hip Prosthesis
Arcos Modular Hip System
Continuum Acetabular System
G7 Acetabular System
Issues with Zimmer Biomet Hip Implant Technologies and Implant Lines
Zimmer Biomet pushed the M/L Taper line with Kinectiv Technology through the 510(k) Clearance process which does not require that the device go through the rigors of a clinical study to gain approval by the U.S. Food and Drug Administration (FDA). The M/L Taper Line with Kinectiv Technology made it onto the market in March 2015 and remained there briefly, until April 2015 when it was removed. In May 2018, Zimmer Biomet sent an “Urgent Medical Device Recall Letter” to hospitals, physicians, and distributors and in June 2018, the U.S. Food and Drug Administration issued a Class I recall of the M/L Taper with Kinectiv Technology for 64 lots (752 devices in total) due to higher than allowed cytotoxicity levels found within the product. In 2018, the FDA issued a subsequent Class II recall notice concerning packaging issues involving telltale “black residue” emerging within the polyethylene bags containing implant devices.
Several lawsuits have been filed over the Zimmer Biomet M/L Taper Line with Kinectiv Technology and these have been consolidated into a single MDL before a federal court in Indiana. Claimants in these suits allege, among other things, that the modular neck-stem design creates threading and several junctures where the metal head is more likely to produce wear and debris in a process known as “fretting”. In turn, the corrosion and wear from the fretting are believed to have caused severe tissue damage and even metallosis in implantees. These conditions require patients to undergo painful and expensive revision surgeries that do not always completely resolve either the complications of the original underlying condition.
The Stryker Corporation is a well-established and well-known manufacturer of a range of medical devices on the market in the United States today. Over recent decades, the company has positioned itself to be a prominent player in the hip and knee-joint replacement category with several popular joint replacement products. Some have gone on to be huge successes for Stryker, while others, such as the Rejuvenate, ABG II, and LFIT 40 lines became the objects of controversy and later – lawsuits; due to high rates of revision surgery and metal contamination.
History and Background of Stryker
Stryker is a specialty medical equipment manufacturer that designs, develops and manufactures surgical and health care products. From its headquarters in Kalamazoo, Michigan, it has grown to become one of the world’s largest medical technology companies with product lines spanning:
Orthopaedic Implants
Orthopaedic Trauma Systems
Endoscopic Systems
Patient Care Technologies
Stryker was established in 1941 by Dr. Homer Stryker, an orthopaedic surgeon from Kalamazoo who was dissatisfied with the medical products he encountered in those days. Immediately, he and his company set out to design newer and improved devices to replace the ones that he deemed were ineffective or inefficient. His first successful device was the “Stryker Frame” – a mobile hospital bed which pivoted easily. A common sight in hospitals even today, Stryker beds allow doctors to shift injured patients while keeping them immobilized.
Under the tenure and watch of Dr. Stryker and his son, Lee, Stryker grew steadily through the 1950s and 1960s. However, it wasn’t until the 1970s and the arrival of Stryker’s new CEO, John Brown (formerly of Bristol Myers Squibb) that the company launched down the path of explosive growth that characterizes Stryker to this very day. Over the 32-year span of John Brown’s career at Stryker, he took the company public (1979) and turned Stryker into a perennial favorite of the Fortune 500.
Today, Stryker sells its products in over 100 countries, owns nearly 5,000 patents globally, and has 33,000 employees worldwide. In 2015 it boasted 36 years of straight sales growth and $9.9 billion in sales revenue. Hip implants from its Howmedica Osteonics division, which it purchased from Pfizer Inc., in 1998 for $1.9 billion in cash, accounted for 13% of sales in 2015 alone. Orthopedic implants account for 43% of Stryker’s sales and it maintains a position within the top three manufacturers globally for knee and hip implants – a 22% market share for these devices.
Issues with Stryker Hip Implant Technologies and Product Lines
Accolade, ABG II and Rejuvenate Systems
The Accolade, ABG II and Rejuvenate hip joint systems were all designed and manufactured by Stryker’s Howmedica Osteonics business unit to utilize a proprietary alloy known as “TMZF” (Titanium/Molybdenum/Zirconium/Iron) which, it was believed, would better approximate the elastic properties of bone, while allowing for increased flexibility and strength.
The Accolade system was presented and marketed as a total hip femoral stem for coupling with Stryker’s other proprietary femoral head technologies. Alternatively, the Rejuvenate and ABG II were marketed as femoral stem “modular” component systems with varying sizes of stems (right and left) as well as modular necks. Both sets of device lines utilized TMZF in the stem while ABG II also incorporated a cobalt-chromium alloy into the neck.
The U.S. Food and Drug Administration (FDA) approved the Rejuvenate and ABG II lines for sale in the United States in 2008 and 2009 respectively. Both devices were reviewed under the FDA’s 510(k) clearance process without requiring any extensive studies, clinical trials or pre-market testing prior to implantation in patients. Almost immediately, surgeons and patients started noticing issues with the devices associated with corrosion and fretting at the modular neck-joint. Neck failure and corrosion frequently necessitated expensive and painful revision surgeries and were accompanied by: metallosis; bone necrosis; pseudotumors and acute metal toxicity in the blood.
Both the Rejuvenate and ABG II product lines were recalled in July 2012. Subsequently, Stryker completely eliminated the TMZF alloy from its entire product lineup.
LFIT V40 Femoral Heads
The LFIT V40 femoral head is the “ball” component which was configured more broadly into the overall Stryker TMZF “stem” product line beginning in the early 2000s. Specifically, the femoral head fits neatly into the bone socket of the pelvis and allows freedom of rotation. These devices were marketed ostensibly as a way of minimizing dislocation issues for patients.
In 2016, an investigative report issued by a prominent medical journal concerning issues involving metallic debris and damage to soft tissue stemming from corrosion and wear on the LFIT V40. Not long afterward, Stryker released an urgent “medical device notification” to the surgical community, then recalled nearly 42,000 units of the LFIT V40 due to concerns over the potential for hip dislocation and metallosis.
Tritanium Acetabular Shell
In 2008, Stryker introduced a porous 3D-printed acetabular cup made from Tritanium alloy marked under its “Trident” line. It later introduced its “next-generation” version of the Trident II cup in 2018. The design of the Trident line allows for large femoral head size options and a greater range of motion. According to Stryker, the Trident promises greater joint stability and lower risk of dislocation, while the porous surface is intended to mimic the characteristics of pelvic cancellous bone.
Stryker itself funded a 2013 follow-up study which reviewed the Total Hip Arthroplasties (THA) of 252 patients who received the Tritanium cup. The study, which was conducted, in part, by authors who were receiving royalties from Stryker or had preexisting financial relationships with Stryker, triumphantly reported that 100% of the implants were still successful 25-56 months following surgery.
However, independent studies published between 2017 and late 2018 have uncovered concerns about the safety and effectiveness of the primary Tritanium acetabular cups. Indeed, a study conducted at the NYU Langone Hospital, which was published in 2018, reported that five revision patients who were implanted with the primary Tritanium acetabular cup had failed to achieve “bone-in growth” following THA procedures between 2011 and 2016. At least two other contemporary studies have uncovered similar findings.
What these studies implicate in the primary Tritanium acetabular cup is a “loosening” because of its failure to encourage bone growth following implantation. This bone growth is essential to keeping the cup in place following THA. Consequently, patients loosening may experience pain and swelling; or worse yet – instability (“hip-locking”) or even dislocation.
17) “Comparison of a highly porous titanium cup (Tritanium) and a conventional hydroxyapatite-coated porous titanium cup: A retrospective analysis of clinical and radiological outcomes in hip arthroplasty among Japanese patients” https://pubmed.ncbi.nlm.nih.gov/30055877/
Over the past few decades, hip replacement surgery, or Total Hip Arthroplasty, to repair hip-joints, often damaged by osteoarthritis, rheumatoid arthritis, and traumatic arthritis, has become a commonplace procedure within hospitals and ambulatory surgical centers across the United States. Going forward, it is expected that the market for hip-joint replacement will dramatically expand. Due to a combination of the aging population trend and an explosion in robotically-assisted surgery, experts anticipate that the market for hip replacement devices will leap to $10.51 billion annually by 2026. Numbers like this are not lost on device manufacturers. Companies like DePuy (a Johnson & Johnson business unit), Stryker, Smith & Nephew, and Zimmer devote considerable resources and capitalization toward rapid development of newer hip-joint products in order to ensure that they capture a significant share of this highly profitable market.
With that in mind, the ability of these companies to rapidly develop and deploy new hip-joints rests squarely on navigating the U.S. Food and Drug Administration (FDA)pre-market approval process, and in particular its 510(k) Clearance process. If a new medical device product can be proven to be “substantially equivalent” to another previously-approved product line, then the 510(k) process allows that manufacturer to bypass the ordinary safety and effectiveness testing rigors involved with standard pre-market approval.
Starting in the early 2000s, several manufacturers aggressively marketed hip-joints through the 510(k) process featuring a “Metal-on-Metal” (MoM) coupling feature between the ball and socket of the joint. In MoM joints, the metal ball and metal cup slide against each other during walking or running. This friction between the ball and socket can cause the release of metal particles that will wear off of the device and embed in surrounding tissue as well as metal ions of cobalt and chromium entering the bloodstream. Over time, this leaching of metal from the joint into surrounding tissue causes “Adverse Local Tissue Reaction” (ALTR) and/or “Adverse Reaction to Metal Debris” (ARMD). The bottom line for patients implanted with MoM joints, however, is that they suffer damage and pain, device failure, loosening, and the need for revision surgery. Furthermore, patients implanted with MoM hip joints can also suffer from a condition known as “metallosis” – a potentially fatal complication arising from metallic erosion in the joint which induces pain around the joint, pseudotumors, and a noticeable rash.
By 2010, the issues with MoM were becoming apparent to both the manufacturers and the FDA alike. The first MoM joint recall involved the DePuy ASR followed by market withdrawals of the Biomet Magnum M2A and others. Lawsuits soon followed and between 2013 and the present, billions of dollars in verdicts and settlements were racked-up over these devices. Currently, there are six active multidistrict litigation (MDL) cases involving hip-joint devices and their manufacturers, taking place in federal courthouses across the country with nearly 11,800 claimants in various stages of progress – and a possible seventh on the way. Some of these cases have resulted in verdicts and settlements in the hundreds of millions or even billions of dollars.
Historic Hip Joint Lawsuits, Recalls, Verdicts, and Settlements:
DePuy ASR XL Acetabular System and ASR Hip Resurfacing Resurfacing Platform (MDL-2197)
DePuy manufactured the ASR Hip Implant Device line and is a business unit of the global device giant, Johnson & Johnson. The ASR XL Acetabular System was made up of three components:
The metal femoral stem inserted inside of the femur.
The metal femoral head (or ball) connected to the stem; and
The metal acetabular cup (socket).
Similarly, the ASR Hip Resurfacing Platform involves a metal cap placed over the natural femoral head and replacing the acetabulum with a metal cup.
Beginning in 2008, the FDA started receiving approximately 400 complaints from patients in the United States who were implanted with the devices. These patients complained of pain, swelling, inflammation, and damage to the bone and tissue – as well as a lack of mobility. Many of these patients required expensive and painful revision surgeries.
In 2010, DePuy issued a voluntary recall of ASR Hip Implant Devices and the first lawsuits naming DePuy soon followed thereafter. The cases were consolidated into an MDL and between 2013 and 2017, DePuy paid nearly $4.8 billion to settle approximately 7,500 cases.
It has been over ten years since the original ASR recall. And although this MDL is technically still open, settlement protocols have a stipulated deadline for potential litigants requiring a revision surgery to have been performed no later than July 2017.
DePuy Pinnacle Hip Replacement System with TrueGlide Technology (MDL-2244)
The DePuy Pinnacle Acetabular Cup System was launched in 2001 and offered the option of either a polyethylene or metal insert for use with a titanium cup to replace the natural hip socket. This was followed by the launch of the Pinnacle system coupled with TrueGlide technology in 2007.
Although the Pinnacle system was not subject to recall, patients still reported many of the same issues as those suffering with the DePuy ASR devices. Issues with loose implants, inflammation, swelling and damage to surrounding tissue coupled with the spread of metal debris and contamination throughout the body were not infrequent. Many patients implanted with Pinnacle devices suffered loss of mobility and went through painful and expensive revision surgeries in an attempt to correct issues.
Lawsuits involving the Pinnacle Hip Replacement System were aggregated into an MDL in a federal courtroom in Texas. In 2016, the second bellwether case in the MDL yielded a verdict in favor of the claimants to the tune of $502 million (later reduced under Texas law limiting punitive damages). A third bellwether case resulted in a $1 billion verdict in favor of claimants (reduced to $543 million on appeal) and a fourth bellwether case wound up with a $247 million verdict in favor of claimants.
In June 2019, DePuy announced that it would settle up to 6,000 of the Pinnacle lawsuits for $1 billion. DePuy is settling each case individually and as a consequence, this MDL remains open with up to 9,155 cases still pending.
Stryker Rejuvenate and ABG II Hip Replacements (MDL-2441)
Howmedica Osteonics Corporation, under the market name, Stryker, designed, developed, and marketed the Rejuvenate and ABG II MoM hip replacement devices. In 2012, Stryker recalled the Rejuvenate system due to issues with fretting and corrosion at the modular-neck junction. Following the recall, patients came forward with lawsuits, and these were consolidated into an MDL in Minnesota.
Between 2014 and 2016, Stryker settled the bulk of these cases for an estimated $1.4 billion. Despite the settlement, the MDL remained open well into 2020 with over 360 cases still pending.
Stryker LFIT V40 Femoral Head (MDL-2768)
Starting in 2000, Stryker marketed its MoM Accolade hip replacement system to hospitals and surgeons which involves two crucial components: the TMZF Hip Stem and LFIT Anatomic V40 Femoral Head. It is called a “monoblock” or single-piece artificial hip replacement device that utilizes a proprietary titanium alloy consisting of titanium, molybdenum, zinc, and iron.
Following a 2016 investigative report in the Journal of Bone and Joint Surgery, which reported on issues involving corrosion in the V40 head as well as metallic debris and damage to the soft tissue, Stryker issued a recall of LFIT V40 heads. Lawsuits from implant patients suffering from metallosis and other issues associated with the LFIT V40 were then aggregated into an MDL in Massachusetts. In 2018, a confidential settlement was announced and individual cases are still being settled. Accordingly, this MDL remains open in 2020 with over 500 cases still pending.
Current Hip Joint Lawsuits
Smith & Nephew, Inc. Birmingham Hip Resurfacing System (MDL-2775)
In 2006, United Kingdom-based Smith & Nephew introduced the MoM Birmingham Resurfacing (BHR) system. A prosthesis, the BHR is comprised of two components:
The Birmingham Resurfacing Femoral Head; and
The Birmingham Resurfacing Acetabular Cup.
The FDA order allowing Smith & Nephew to market the BHR in the United States required the company to comply with several post-market survey and reporting practices relaying knowledge of adverse reactions, injuries or issues with the device, back to the FDA. Claimants in litigation pending before a Maryland federal court allege that Smith & Nephew in fact knew about a multitude of common MoM issues and adverse reports involving the BHR but either delayed reporting them to the FDA, underreported them or did not report them properly at all.
This MDL is still active and in its early stages. The first bellwether trials have been scheduled to commence in May 2021 and July 2021.
Zimmer M/L Taper Hip Prosthesis and Versys Femoral Head (MDL-2859)
Indiana-based Zimmer Biomet Holdings, Inc. developed and marketed the Zimmer M/L Taper hip implant with its proprietary Kinectiv Technology. This model of the M/L Taper with the Kinectiv technology utilized a modular MoM design that featured a cobalt-chromium coupling. In court documents, claimants allege that the Zimmer hip joint suffers from corrosion which introduces metal fragments into surrounding tissue as well as elevated levels of metals into the bloodstream causing pain, swelling, tissue necrosis, and other ailments.
This MDL is currently in its early stages and new cases are being added.
Bearing Scrutiny:
Stryker Tritanium Acetabular Shell
Stryker received clearance from the FDA to market its Tritanium Acetabular Cup in 2008 and later in 2011, received further clearance for a Tritanium Acetabular Shell with “Peri-Apatite” coatings on the bone-implant interface. Specifically, this coating added a “Particle Sintered Foam” (PFS) coating overlaid with Peri-Apatite.
In 2017, the journal Arthroplasty Today published an article on behalf of the American Association of Hip and Knee Surgeons which delved into the cases of five patients who underwent revision surgeries for loosening issues with Stryker’s tritanium acetabular cups resulting in groin and hip pain. A 2018 article in Orthopaedic Proceedings which evaluated 121 revision surgeries involving Stryker tritanium devices made similar findings of premature deterioration in the hip joint.
New legal complaints naming Stryker and alleging design defects in the Tritanium Acetabular Shell line were filed in state court in New Jersey in 2019 and are currently pending further action.
“Bill Gates used to think of the U.S. Food and Drug Administration as the world’s premier public-health authority. Not anymore.”
“And he doesn’t trust the Centers for Disease Control and Protection either. Both, in his view, are casualties of a presidency that has downplayed or dismissed science and medicine in the pursuit of political gain. One recent example came when FDA Commissioner Stephen Hahn, speaking at one of President Donald Trump’s news conferences, exaggerated the benefit of blood plasma as a treatment for Covid-19, then backtracked the following day.
“We saw with the completely bungled plasma statements that when you start pressuring people to say optimistic things, they go completely off the rails. The FDA lost a lot of credibility there,” Gates, the billionaire philanthropist, said in an interview on Bloomberg Television.
“Historically, just like the CDC was viewed as the best in the world, the FDA had that same reputation as a top-notch regulator,” Gates said. “But there’s been some cracks with some of the things they’ve said at the commissioner level.”
At stake is nothing less than public confidence in the vaccine that could end the coronavirus pandemic, and which the FDA would have to approve. Polls conducted in the past two months show a majority of Americans worry the development of the vaccine is being rushed and a third wouldn’t get inoculated.”
AstraZeneca vaccine trials continue in the United Kingdom, but U.S. regulators are continuing to investigate.
“The Food and Drug Administration is weighing whether to follow British regulators in resuming a coronavirus vaccine trial that was halted when a participant suffered spinal cord damage, even as the National Institutes of Health has launched an investigation of the case.
“The highest levels of NIH are very concerned,” said Dr. Avindra Nath, intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke, an NIH division. “Everyone’s hopes are on a vaccine, and if you have a major complication the whole thing could get derailed.”
For sufferers of the side-effects of dangerous drugs and medical devices, the journey to justice and seeking compensation for injuries is not always a straightforward one. Unfortunately, some claims for injury can be thwarted at the very outset due to a complex legal policy enshrined in Article VI of the U.S. Constitution – the “Supremacy Clause”. Known as the “Preemption Doctrine” it shields some manufacturers of approved drugs and devices from liability arising from the claims of victims.
“Preemption” describes the legal basis for dismissal of a claim under state law where the courts hold that federal law reigns supreme and invalidates state law. In essence, where state laws run contrary to or otherwise interfere with federal law, the federal will preempt the state law thereby excluding those claims.
How Does Preemption Apply to Drug and Device Manufacturers?
Prescription Drugs and Medical Devices are regulated under a federal law known as the Food, Drug and Cosmetic Act (FDCA). The U.S. Food and Drug Administration (FDA) is charged with primary enforcement responsibility and to regulate drug and device manufacturers under the FDCA. To that end, the FDA has created an elaborate “pre-market approval” process designed to examine the safety and effectiveness of drugs and medical technology covered by the law. Over the past two decades, the existence of the FDCA has been used by drug and device manufacturers to argue that they cannot be sued on claims arising under state law.
When Does Preemption Become a Factor?
Preemption usually crops up as a defense by drug and device manufacturers against claims for injury made under state law. Manufacturers will point to the state law claims and say that because their products are regulated by the FDA and have gone through the federal “pre-market approval” process, they should be shielded from state law claims. And sometimes this strategy works – preemption does prevent some sufferers from mounting an effective case in court. But as the U.S. Supreme Court has ruled over the past two decades, preemption can’t stop every drug and device case and that is an important distinction for sufferers of side effects from dangerous drugs and devices.
Medical Device Lawsuits and Preemption
The FDCA sets down a detailed set of rules and standards which are designed to ensure that approved medical devices are safe and effective (the pre-market approval process). Part of the pre-market approval process involves certification and testing to make certain each submitted device meets minimum requirements before it is marketed to consumers and the healthcare industry in the United States. It goes without saying that the medical device pre-market approval process is rigorous, detailed and lengthy. Furthermore, the FDCA creates an explicit preemption rule for medical devices which have done through pre-market approval.
However, not every medical device is subjected to this rigorous process. Many medical devices on the market today and which have been implanted in patients throughout the United States can bypass the more detailed pre-market process and opt instead for the “Pre-Market Notification” or Section 510(k) Process. Essentially, these devices can avoid layers of FDA scrutiny and go straight into use.
With this in mind, the U.S. Supreme Court has made at least two critical rulings about the preemption defense and its use:
510(k) Approval Does Not Shield the Manufacturer – Medtronic v. Lohr:
In 1990, Lora Lohr’s Medtronic pacemaker failed, allegedly according to a defect. Lohr and her spouse filed a Florida state-court suit, alleging both negligence and strict-liability claims. The device at the center of Lohr’s claims made it to market through the markedly less rigorous 510(k) process. The state court dismissed Lohr’s claims ruling they were preempted. However, on appeal in 1996, the U.S. Supreme Court reversed the lower court and established that medical devices that go through the 510(k) process, instead of the more rigorous pre-market process, cannot hide behind a preemption defense.
Premarket Approval Preempts – Riegel v. Medtronic:
During Charles Riegel’s angioplasty, his surgeon used an Evergreen Balloon Catheter to dilate his coronary artery. The catheter burst, causing extreme complications. Riegel sued the manufacturer, Medtronic, for negligence in the design, manufacture, and labeling of the device. Lower courts agreed with Medtronic that the corporation was shielded from Riegel’s state claims because the device in question was subjected to the more rigorous pre-market approval process and therefore enjoyed an explicit preemption defense under the federal law. The U.S. Supreme Court later affirmed this ruling.
Pharmaceutical Drugs and Preemption
Under the FDCA and subsequent amendments to the law, drug manufacturers have to file a New Drug Application (NDA) with the FDA before marketing a new drug. This NDA must contain detailed information about the drug’s composition, safety and effectiveness. The FDA will not approve a new drug if it finds that the drug is unsafe or ineffective – for use under the conditions prescribed, recommended or suggested on the label. Once approved, drug manufacturers must continue to monitor and report anything about the drug’s use which would compromise its safety, effectiveness or labeling.
Under the FDCA and subsequent amendments to the law, drug manufacturers have to file a New Drug Application (NDA) with the FDA before marketing a new drug. This NDA must contain detailed information about the drug’s composition, safety and effectiveness. The FDA will not approve a new drug if it finds that the drug is unsafe or ineffective – for use under the conditions prescribed, recommended or suggested on the label. Once approved, drug manufacturers must continue to monitor and report anything about the drug’s use which would compromise its safety, effectiveness or labeling.
Unlike medical devices, however, drugs do not enjoy an explicit presumption of preemption under the FDCA. And this has led to a range of divergent court opinions over the years.
Approved Drug Label Does Not Shield the Manufacturer – Wyeth v. Levine
Diane Levine had Phenergan, a drug made by Wyeth and used to prevent allergies and motion sickness, intravenously injected into her arm, and complications arising from the injection eventually led to the amputation of her arm. Ms. Levine sued Wyeth asserting that the company failed to include a warning label describing the possible arterial injuries that could occur from negligent injection of the drug. Wyeth argued that because their warning label had been deemed acceptable by the FDA, a federal agency, any Vermont state regulations making the label insufficient were preempted by the federal approval. The U.S. Supreme Court agreed with Ms. Levine asserting that the Wyeth bore ultimate responsibility for the content of its labels – at all times. The Court also rejected Wyeth’s preemption argument and reasoned that Congress did not intend to preempt state-law in failure to warn actions when it created the FDCA.
Generic Drugs Distinguished from Brand-Name Drugs – PLIVA v. Mensing
Gladys Mensing took the drug metoclopramide for four years to help fight diabetic gastroparesis. She filed a lawsuit against the generic drug’s manufacturers and distributors, contending that the drug gave her a severe neurological movement disorder, tardive dyskinesia, but none of the generic drug’s manufacturers and distributors made any effort to include warnings on the label. The manufacturers of this generic labeled drug claimed that Ms. Mensing’s claims were preempted under federal law. A lower court and the U.S. Supreme Court agreed with the drug manufacturers on the basis that generic drugs are manufactured under a label submitted by another manufacturer. To require generic drug manufacturers to change that label would result in a violation of federal law. A subsequent case: Mutual Pharmaceutical v. Bartlett extended this preemption shield on generic drugs further by also preempting claims other than “Failure to Warn”.
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