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Military Earplug Hearing Loss Lawsuit Possible Consolidation

Former military service members continue to come forward to hold 3M accountable for military earplug hearing loss. Consequently, a request for centralization of the federal litigation for pretrial proceedings before one District Judge is now pending.

Currently, there are at least eight product liability lawsuits over permanent earplug hearing loss. The lawsuits against 3M Company and its Aearo Technologies unit are pending all across the county. The plaintiffs all cite similar allegations that the companies knowingly supplied the military with defective earplugs between 2003 and late 2015. As a result, many of these service members have suffered permanent hearing loss following military service.

Aearo originally introduced the Combat Arms Earplugs, Version 2 (CAEv2). 3M Company would later go on to acquire the company along with its defective product lines. The manufacturer designed the dual ended, or reversible, earplugs to work as traditional earplugs one way. The other end filtered and reduced noise to block loud battlefield noises so that the wearer could still hear spoken commands.

According to complaints currently pending in several different District Courts, the manufacturers knew and concealed the earplugs' dangerous defects. Specifically, the earplugs were too short to properly fit in the ear. Consequently, the earplugs failed to seal the ear canal, leaving military service members without adequate hearing protection.

Earplug Hearing Loss Lawsuit Motion to Transfer

Plaintiff John Ciaccio filed the motion to transfer with the Judicial Panel on Multidistrict Litigation (JPML) on January 25. Ciaccio is asking for the JPML to consolidate all the cases currently pending in the federal court system in the District of Minnesota. The multidistrict litigation (MDL) would coordinate pretrial proceedings to avoid conflicting pretrial rulings and duplicative discovery that can further delay the dissemination of justice in these complex litigations.

“Based on Movant’s Counsel’s research and given that the U.S. military purchased enough Combat Arms earplugs to provide one pair to all military personnel deployed each year in major foreign engagements from 2003 through 2015, Movant reasonably anticipates that thousands of other actions with similar allegations are likely to follow,” the motion states.

Centralizing federal lawsuits for pretrial proceedings in a complex product liability litigation is fairly common. This is especially true when a large number of individuals with similar injuries from the same product have cases pending throughout the federal court system. But, if parties are not able to reach settlement agreements during the MDL discovery process or after a series of early “bellwether” trials, the court may remand the claims back to their original district courts for separate trial dates.

“The individual complaints in the Related Actions involve overlapping causes of action that give rise to questions of fact about the same product defect and Defendants’ knowledge thereof, that are not merely common, but virtually identical,” the motion further states. “Centralizing the Related Actions will thus allow for coordinated discovery efforts aimed at the product defect and Defendants’ knowledge thereof, as well as coordinated motion practice related to any defenses Defendants may raise that will largely be generally applicable to all cases.”

Earplug Hearing Loss Settlement

In July 2018, 3M reached a $9.1 million settlement agreement with the Department of Justice over Combat Arms earplug hearing loss problems. The settlement resolved claims that 3M knowingly defrauded the government by consciously selling patently defective earplugs. Consequently, the government had to address the subsequent hearing loss of soldiers from the earplugs.

By Emily Cox

Johnson & Johnson and its DePuy Orthopaedics unit are fighting a $245 million metal hip judgement over dangerously defective hip implants, telling a Texas federal judge Wednesday that the injured plaintiffs failed to prove portions of their claims.

J&J and DePuy filed three separate motions Wednesday, asking District Judge Ed Kinkeade to overturn the jury’s findings in favor of the New York plaintiffs who claimed the companies deliberately failed to warn about the metal-on-metal hip implants’ substantial defects.

J&J argued that New York law dictates that “no reasonable jury” could have found it liable in a case built “almost entirely on the fact that it is the ultimate parent company of DePuy Orthopaedics, Inc.” According to J&J, the plaintiffs needed to show that J&J “manufactured or distributed the Pinnacle Ultamet” to succeed on these claims under New York law.

Furthermore, J&J claimed that all findings that the company failed to warn about the product’s dangerous nature also cannot stand, as none of the plaintiffs “proffered any expert testimony that the warnings accompanying the Pinnacle hip implant were inadequate.”

In its third motion, J&J asserted that the court must overturn the verdict on jurisdictional grounds because none of the cases had any connection to Texas.

“Notably, plaintiffs never contended that their claims had any relevant connection to Texas, and the court likewise did not hold that any such connection was established in rejecting defendants’ personal jurisdiction objections prior to trial,” J&J wrote. “Instead, the court concluded that defendants waived objections to personal jurisdiction by virtue of their agreement to waive venue in connection with the first two bellwether trials.”

Metal Hip Judgement

In August, Judge Kinkeade entered a metal hip judgement of more than $245 million for the plaintiffs from a November 2017 bellwether trial against J&J and DePuy that found the companies liable for the defective hip implants. The judgement covers past and future medical expense and punitive damages, as well as pain and suffering. The case was the fourth bellwether trial in the multidistrict litigation (MDL) that encompasses more than 9,000 cases alleging substantial design defects.

The plaintiffs counsel says that J&J’s motions are simply a “rehash” of arguments the court has already rejected.

This past November, Texas federal jury hit the companies with a combined $247 million metal hip judgement, levying the third consecutive nine-figure verdict in the ongoing MDL.

The jury unanimously found J&J and DePuy liable for a series of deign and manufacturing defects, fraud, and deceptive business practices, ruling that the companies had acted in a wanton, reckless, and malicious manner.

During the trial, jurors heard that J&J rushed the hip implants into production without clinical trials and used cheap and unsafe materials to shore up its bottom line.

In 2016, Texas juries ruled in favor of two groups of plaintiffs from Texas and California, returning with $504 million and more than $1 billion in verdicts, respectively. However, the court later reduced these awards to $150 million and $543 million. In the first bellwether trial over dangerous Pinnacle Ultamet defects, the jury sided with the manufacturers against a sole Montana plaintiff.

 

 

Zostavax lawsuits continue to flood the nation’s court systems as more individuals discover that the manufacturer continued marketing and selling the defective shingles vaccine despite knowing that it could cause serious injuries.

Marian and Richard Pearson filed the lawsuit earlier this month in the Western District of Louisiana.

According to the complaint, Marian Pearson received the Zostavax vaccine July 19, 2014, as part of her routine health maintenance to prevent shingles. However, the patently defective and dangerous vaccine caused painful injuries and damages that necessitated extensive medical care and treatment.

“The vaccine did not prevent shingles, but rather caused plaintiff Marian Pearson to contract a persistent strain of herpes zoster,” the lawsuit states. “Shortly after receiving defendants’ Zostavax vaccine, plaintiff Marian Pearson suffered from a severe right facial nerve axonopathy and was diagnosed with Bell’s palsy.”

The Zostavax vaccine received FDA approval in 2006. However, Pearson alleges that Merck knew that the vaccine was dangerous but failed to notify federal regulators, patients, and the medical community.

“Merck failed to exercise due care in the labeling of Zostavax and failed to issue to consumers and/or their health care providers adequate warnings as to the risk of serious bodily injury, including viral infection, resulting from its use,” the lawsuit states.

The Pearsons’ complaint joins a rapidly growing number of similar Zostavax lawsuits from individuals nationwide who never received any warning about the defective and dangerous nature of the shingles vaccine.

Zostavax Lawsuits Background

According to the Pearson’s lawsuit, as of July 2012, the patient information sheet, label, and prescribing information for the Zostavax vaccine contained no clear reference to the substantial risks for viral infections. Furthermore, Merck continued to manufacture and market the product despite knowing that the vaccine posed a serious risk of bodily harm to recipients.

"Merck downplayed the serious and dangerous side effects of its product to encourage sales of the product; consequently, Merck placed its profits above its customers’ safety,” the lawsuit states. “Although Merck knew…of the defective nature of its Zostavax vaccine, it continued to design, manufacture, market, and sell its product without providing adequate warnings and instructions concerning the use of its product so as to maximize sales and profits at the expense of the public health and safety, in knowing, conscious, and deliberate disregard of the foreseeable harm caused by its Zostavax vaccine.”

The label and prescribing information, as well as the patient information sheet for Zostavax failed to address the viral infection risks.

“All that was addressed is the concern that a rash and itching might develop at the injection site,” the Pearsons stated. “This is despite the fact that shingles was a noted occurrence during clinical trials of the vaccine.”

In addition to Marian Pearson’s injuries, the couple said they have incurred and will continue to incur medical expenses and other substantial economic harm as a direct result of using Zostavax.

The plaintiffs are seeking compensatory damages for past, present, and future damages. These include pain and suffering for severe and permanent personal injuries; health and medical care costs; and lost wages with interest and costs.

A new valsartan lawsuit is seeking class action status over recalled pills from numerous manufacturers who sold and distributed generic versions of the hypertension drug that were contaminated with carcinogenic impurities.

James Jones filed the complaint in the Eastern District of Missouri on September 11. According to the valsartan lawsuit, putative class members paid full price for valsartan pills that were worthless due to contamination with the dangerous and carcinogenic N-nitrosodimethylamine (NDMA) and are now facing incidental medical expenses.

The lawsuit names Zhejiang Huahai Pharmaceutical Co., Prinston Pharmaceutical, Inc., Solco Healthcare U.S. LLC, and Huahai US, Inc. as defendants. Jones is requesting class action status for all individuals who purchased the contaminated valsartan drugs and received advisement to discontinue using them due to impurities.

Valsartan Lawsuit Background

The European Health Products Regulatory Authority (HPRA) issued the first valsartan recalls July 5, after batches of the active ingredient from Zhejiang Huahai Pharmaceuticals in China tested positive for NDMA, which can increase the risk of numerous types of cancer. This initial recall affected about 2,300 batches of valsartan and valstartan HCTV throughout Europe and Canada. The same drug company was responsible for the Torrent Pharmaceutical pills recall.

The FDA followed close behind with its own recall July 13, announcing that the regulatory agency had launched its own investigation to determine the contamination’s scope and the risk to consumers.

According to Jones, he and other plaintiffs bought the drugs on the pretense that they were safe and now must undergo regular cancer monitoring because of the contamination.

“Plaintiff and the putative class members were injured by the full purchase price of their valsartan-containing medications and incidental medical expenses,” Jones indicated. “These medications are worthless, as they are contaminated with carcinogenic and harmful N-nitrosodimethylamine and are not fit for human consumption.”

Jones is presenting claims of failure to warn, unjust enrichment, strict product liability, fraudulent concealment, negligence, breach of contract, breach of implied warranty of merchantability, and gross negligence.

The FDA has allocated a group of pharmacists and nurses to answer consumers’ questions regarding the recalls. Since the initial recalls, the agency has received more than 6,000 such inquiries from doctors, nurses, patients, pharmacists, and academics. For more information, interested parties can call (855) 543-3784 or email druginfo@fda.hhs.gov.

The valsartan lawsuit request for class action status comes amidst a quickly escalating number of individual valsartan cancer lawsuits being pursued by individuals nationwide. These include claims for kidney cancer, liver cancer, and other digestive tract cancers.

In the wake of recent FDA warnings about the risk of flesh-eating infections from Invokana and similar diabetes drugs, a man is coming forward to take manufacturers to task for an Invokamet genital infection that ended in partial scrotum amputation.

Lee Letourneau filed the complaint in the District of New Jersey earlier this month. He developed Fournier’s gangrene after starting treating with Invokamet. The medication combines Invokana with the older diabetes drug metformin.

Letourneau began treatment with Invokamet in February 2017 and continued taking the diabetes medication throughout the rest of the year. After beginning treatment with the drug, he developed a life-threatening genital infection. Ultimately, the infection became so severe that it necessitated the removal of approximately 60 percent of his scrotum.

The Invokamet lawsuit indicates that Johnson & Johnson and its Janssen Pharmaceuticals unit deliberately withheld essential information pertaining to drug’s significant risks of developing Fournier’s gangrene and other serious infections. Consequently, Letourneau was completely unaware that the medication caused his infection until federal regulators issued a drug safety communication this past month.

FDA Invokamet Genital Infection Warning

The FDA issued a drug safety communication August 29, warning that Invokana, Invokamet, and other similar diabetes drugs were connected to reports of rare, but serious, genital infections. Fournier’s gangrene, also referred to as necrotizing fasciitis of the perineum, can be fatal and eat through flesh. Federal regulates indicated that, while diabetes can increase infection risks, the problems are still uncommon among diabetic patients not taking Invokana and similar medications.

According to the lawsuit, it is likely that the number of Invokana and Invokamet genital infections will continue to increase as awareness of the connection continues to spread.

“Defendants’ label for Invokamet does not contain a warning for Fournier’s gangrene. The label states only that gangrene may be a complication associated with lower limb amputations,” the lawsuit states. “It also states that animal studies were not conducted for Invokamet, but that in animal studies of canagliflozin and metformin individually, there were incidents of testicular tumors. Nowhere does the label state that a male patient might suffer Fournier’s gangrene, or lose part of his scrotum.”

Due to significant safety concerns, the FDA is now requiring new warnings to be included to all drugs that belong to the diabetes drug class. This includes Invokana, Invokamet, Invokamet XR, Xigduo XR, Farxiga, Jardiance, Qtern, Glyxambi, Segluromet, Steglatro, Synjardy, Synjardy XR, and Steglujan. While Steglatro is the only drug with no reports of flesh-eating genital infections, the agency is still requiring it to carry a warning label as a precaution.

The FDA indicates that the infections developed within months of starting treatment with one of the drugs. All 12 patients underwent hospitalization and surgery as a result of the severity of their infections. According to regulators, at least one patient died, and others suffered numerous disfiguring surgeries and other serious complications.

The flesh-eating genital infection alert is only the latest significant adverse health risk added to the diabetes drug class since they first emerged on the market. Previous warnings include kidney failure, diabetic ketoacidosis, and amputations.

Other Invokana and Invokamet Health Concerns

Invokana (canagliflozin) was the first SGLT2 inhibitor to hit the market. The drug received FDA approval in March 2013 and quickly became a blockbuster treatment. SGLT2 inhibitors work in a unique to eliminate excess glucose from the body through urination by impacting some normal kidney functions.

In December 2015, the FDA mandated new diabetic ketoacidosis warnings for Invokana and other drugs in its class. The agency indicated that the medications increase the risk of this serious condition which usually requires emergency treatment to avoid life-threatening injuries. Prior to the label update, the warnings failed to note the importance of seeking immediate medical attention for symptoms such as nausea, fatigue, respiratory problems, abdominal pain, or vomiting.

In June 2016, federal regulators required additional warnings about the association between kidney risks and the drug class, indicating that these medications can increase the risk of acute kidney injury and other significant health problems.

In May 2017, the FDA mandated further warning updates regarding Invokana amputation risks, indicating that the drug carries an increase risk for leg, foot, and toe amputations. Regulators are only requiring Invokana to carry these warnings. Manufacturers of other SGLT-2 inhibitors maintain that leg and foot amputation risks are unique to Invokana, indicating that these same risks have not emerged among users of their medications.

J&J and Janssen currently face several thousand Invokana lawsuits, alleging that they concealed the drug’s dangers from patients and the medical community. While most SGLT-2 inhibitor lawsuits are against Invokana manufacturers, there are similar lawsuits pending against other drugs in the class.

According to the FDA, 1.7 million prescriptions for SGLT2 inhibitors were dispensed in 2017 alone. The agency requests that anyone who suffers side effects after taking one of these drugs to filed a report with the FDA MedWatch adverse event reporting system.

A new lawsuit against Johnson & Johnson and its DePuy Orthopaedics subsidiary over their proprietary knee implants causing permanently debilitating injuries alleges that the Attune knee manufacturers actively conspired to conceal the device’s significant safety issues and defects.

David Love filed the complaint against the Attune knee manufacturers earlier this month in the Western District of Missouri.

According to Love’s allegations, J&J and DePuy “obviously” knew about the radically high number of Attune failures among recipients, necessitating additional and considerably risky surgical interventions. However, the Attune knee manufacturers deliberately failed to warn surgeons and patients, allowing unsuspecting surgeons to continue implanting the original, defective design. It wasn’t until December 2016 that DePuy began openly admitting to the high rates of Attune device failure in its MAUDE failure reports.

Unfortunately, these admissions came far too late for patients like Love. Furthermore, the companies never extended these admissions to surgeons and patients. Consequently, thousands of patients continued receiving the dangerous knee implant with its incumbent health risks, while J&J and DePuy reaped the rewards.

Love is presenting clams for strict liability, negligence, fraud, breach of warranty, and violations of consumer protection laws due to significant problems with the DePuy Attune Knee System.

Attune Knee Manufacturers Conspired to Hide Defects

Love received the DePuy knee in December 2015 during total right-side knee replacement surgery. Following implantation of the device, he began suffering severe and unceasing chronic pain, discomfort, instability, and reduced mobility, as well as popping and clicking of the implant. His physician determined that the blame for Love’s significant injuries fell squarely on “the loosening, the lack of long-term fixation, debonding, and migration of the defective tibial baseplate and ATTUNE device components.”

Consequently, Love underwent revision surgery in December 2017. His surgeon diagnosed him with a “failed tibial component” and went on the describe the tibial component as being “grossly loose” in a surgery operative note.

Love asserts that the Attune Knee manufacturers knew the “device could fail early in patients and could cause debonding, fractures, infection, soft tissue injury and permanent damage to bones and nerves surrounding the knee joint and, therefore, give rise to physical injury, pain and suffering, debilitation, and the need for revision surgery to replace the device with the attendant risks of complication and death from such further surgery.”

According to the complaint, the companies were “communicating, conspiring and concealing the safety issues and unacceptable safety defects with the original ATTUNE as early as 2013 or before.”

DePuy Knee Manufacturers Concealed High Failure Rates

The DePuy Synthes Attune Knee received FDA approval in 2010. Surgeons nationwide started widely adopting the device in early 2013. Due to the companies’ signature aggressive marketing strategies, about 400,000 patients worldwide have received the dangerously defective implant.

Despite the fact that most DePuy Attune knee replacements were only implanted in the past few years, high failure rates are already a hallmark of post-marketing adverse event reports.

By June 2017, the FDA had already been flooded with 1,400 reports of Attune knee failure. This includes at least 633 cases where individuals had already had to undergo revision surgery to address significant problems.

Love’s allegations are strikingly similar to those in other knee replacement lawsuits from individuals experiencing harrowing problems from DePuy Attune knees in recent years.

Surgeons often attribute mechanical loosening as the primary reason for failure in these cases. The failure of the tibial baseplate to correctly bond with the implant-cement surface causes this. These patients assert that when this loosening occurs, the knee device can detach from the existing bone and cause early failure.

When the knee implant loosens and fails, it can cause severe pain and even wear away the bone. Consequently, this can lead to restricted movement and even worse pain. These symptoms continue until the pain becomes unbearable, or the device ultimately fails, causing knee function loss.

Experts indicate that the DePuy Attune knee failure rate may very well increase dramatically as time goes on, as the devices are in place longer.

 

Bayer Healthcare recently updated investors on the status of the rapidly escalating litigation over its permanent birth control device causing debilitating and often irreparable injuries, indicating that there are now nearly 17,000 Essure lawsuits pending in the nation’s court system and the flood isn’t expected to slow anytime soon.

Essure is a permanent form of birth control that Bayer touts as a superior, nonsurgical alternative to tubal ligation. The outpatient procedure involves the placement of coils into the fallopian tubes that cause scar tissue to develop, preventing pregnancy. However, thousands of women allege that the device does not meet adequate performance expectations and causes serious damage.

Countless women have experienced painful and debilitating injuries when the coils moved out of position, perforating nearby reproductive organs – sometimes becoming lost entirely. The FDA has also received tens of thousands of reports of ectopic pregnancies, alopecia, allergic reactions, insufferable menstrual cycles, tooth loss, debilitating chronic pain, heavy bleeding, and even death. Furthermore, most injuries require the surgical removal of reproductive organs to even address.

The FDA received nearly 12,000 Essure injury reports in 2017 alone.  The Essure lawsuits allege that Bayer and Conceptus actively concealed considerable risks by failing to report thousands of additional adverse events from the device to the FDA.

In July, Bayer announced it will remove Essure from the U.S. market after December 31. The healthcare behemoth claims that a decline in Essure sales has made continuing to market the product line unsustainable. Bayer said it still stands behind the product’s safety and efficacy despite tens of thousands of women raising continual alarms about debilitating and often permanent injuries from the defective female sterilization implant. The company stopped Essure sales outside of the U.S. this past year, citing similar financial reasoning rather than worldwide outcry over the dangerous medical device.

Essure Lawsuits Report

In its 2018 interim second quarter financial report, Bayer indicates that Essure lawsuits continue to mount in the U.S. with at least 17,000 plaintiffs with claims pending so far and does not anticipate the deluge of lawsuits to slow down anytime soon. The company also reported that at least two Essure class action lawsuits are now pending in Canada.

essure lawsuits

“Plaintiffs allege personal injuries from the use of Essure, including hysterectomy, perforation, pain, bleeding, weight gain, nickel sensitivity, depression and unwanted pregnancy, and seek compensatory and punitive damages,” Bayer told investors. “Additional lawsuits are anticipated.”

Following a series of controversial regulatory hearings that featured testimony from larger numbers of women and medical experts, the FDA decided not to recall Essure in the U.S. However, the agency did mandate that Essure carry black box warnings pertaining to its high-risk profile. These warnings are the strongest that the FDA can require a medical device to include.

In the face of continuing adverse event reports detailing gruesome injuries, the FDA made significant changes to Essure’s premarket approval, requiring both doctors and patients to sign off on an Essure checklist of potential complications.

Approximately 750,000 women worldwide have received the dangerously defective device. Analysts estimate that approximately 70 percent of Essure patients are American women.

In 2017, Bayer spent about $413 million on defending the blooming Essure litigation and could face staggering liabilities if it chooses to face off against the thousands of injured women in court rather than reaching an Essure settlement to resolve the litigation.

A new lawsuit against Johnson & Johnson and its DePuy Synthes subsidiary indicates that the companies hid substantial Attune knee defects to maximize profits at the cost of patient health.

Derrick Pearson filed the complaint August 8 in the Northern District of Texas. He alleges that the companies knew that the DePuy Attune knee was defective and prone to failure but concealed these defects and continued to aggressively market the knee implant to increase sales, leaving patients like him to suffer severe consequences and additional surgeries when the knee replacement ultimately failed.

According to Pearson, he received the Attune knee implant during right-side total knee replacement surgery in March 2016. However, he began suffering from significant complications almost immediately from the faulty implant including severe chronic pain and difficulty walking.

By October 2016, his condition had deteriorated to the point that his surgeon took radiographs, finding loosening and debonding of the tibial tray. His surgeon even noted that the catastrophic failure was strikingly similar to issues he was seeing in other Attune knee systems.

In May 2017, Pearson underwent risky revision surgery due to Attune knee failure. His surgeon found that the tibial tray was completely loose and even removed it by hand without any instrumentation. He further noted that there was a complete separation of the cement in the tibial tray, as he is continually seeing in an ongoing series of other revisions involving the same J&J components.

Furthermore, J&J and DePuy knew that outcomes like Pearson’s and countless others were likely, given the defective nature of the implant. However, the companies continue to downplay the risks to push sales ever higher for the defective device.

Attune Knee Replacement Litigation

The FDA approved the DePuy Synthes Attune Knee system in 2010. Due to the manufacturers aggressive marketing, the medical community quickly adopted the Attune knee, pushing the implant’s sales to roughly 400,000 thousand devices worldwide.

Even though most DePuy knee systems have only been implanted in the past few years, a high failure rate has already surfaced in post-marketing adverse event reports.

As of June 2017, the FDA had received around 1,400 reports of DePuy Attune knee failures. At least 633 of these cases required revision surgery to treat.

Pearson’s lawsuit raises similar allegations as those in other Attune knee replacement lawsuits from individuals who have experienced substantial problems from the defective implant. The primary reason for Attune knee early failure is mechanical loosening due to the failure of the tibial baseplate to properly bond with the implant-cement surface. These lawsuits indicate that this loosening causes the artificial joint to detach from the bone, resulting in early failure.

Knee replacement loosening and failure causes severe pain and can wear away the bone, leading to restricted physical movement and pain escalation which will continue until the pain becomes unbearable or the device fails, taking knee function along with it. At this time, most patients elect to undergo revision surgery to remove the implant.

Given the popularity of the DePuy Attune knee implant coupled with the high failure rate, experts indicate that the litigation to grow by leaps and bounds as knees continue to fail and individuals discover that J&J could have prevented their severe injuries.

New research indicates that opioid use before joint replacement surgery puts patients at substantially higher risks for excruciating injuries, hospital readmittance, and joint implant failure, necessitating additional surgeries.

The Journal of Bone and Joint Surgery published the revelatory study this past month. Researchers from the University of Chicago found that more than half the patients in the national database study had at least one opioid prescription before undergoing total hip or knee replacement surgery. Consequently, researchers are alerting orthopedic surgeons to consider this factor during the screening process for artificial joint replacement candidates.

“Opioid use should be considered yet another risk factor for surgeons and patients to consider prior to elective primary joint arthroplasty,” wrote researcher Dr. Hue H. Luu.

The study followed approximately 324,000 total patients. All the patients had at least one year of follow-up data, following joint replacement surgery between 2003 and 2014. However, approximately 160,000 patients had three years of follow-up information, as well. 233,000 of the patients underwent total knee arthroplasty (TKA), and 91,000 were total hip arthroplasty (TKA) patients.

Researchers pulled the patients from a national database including patients with private insurance, as well as those on Medicare. Based on the data, researchers determined that preoperative opioid use to be a substantial risk factor for two serious adverse outcomes – rehospitalization within 30 days of joint replacement surgery and revision surgery due to artificial joint failure within one to three years of implantation.

The one-year follow-up group consisted of 51 percent ]TKA patients and 56 percent THA patients with one or more opioid prescriptions that were filled within six months before the procedure. Patients with continual preoperative use of more than 60 days represented 16 percent of TKA patients and 19 percent of THA patients.

Chronic Opioid Use Causes Joint Replacement Surgery Risks Spike

joint replacement

flickr/Lena

Researchers discovered that long-term opioid use of more than 60 days caused a significantly increase in risk of both possible adverse outcomes. In TKA patients, the hospital readmission rate was 4.82 percent among those with no preoperative opioid use. Patients with more than 60 days of opioid use exhibited a 6.17 percent readmission rate. THA patients experienced rates of 3.71 and 5.85 percent respectively.

In the one-year follow-up group, the revision rate for TKA patients doubled due to preoperative opioid use with 1.07 percent for patients with no opioid use and 2.14 percent for those with long-term chronic opioid use. In THA patients, the revision rate differences were even higher with .38 percent versus 1.1 percent.

The researchers also noticed significant risk increases in the three-year follow-up group associated with preoperative opioid use. In both groups, the risk increases directly related to opioid use remained significant after adjusting for age, sex, and the “comorbidity index” for other medical conditions. However, the researchers did concede some study limitations, including little data on the reasons for readmission or revision surgeries.

Joint Replacement Preoperative Opioid Use Implications

As the opioid crisis continues to escalate at a fever pitch, previous studies have also found preoperative opioid use to be detrimental to clinical outcomes for a diverse range of surgeries. Total knee and hip arthroplasty are two of the most common surgical procedures in the United States with more than a million procedures performed each year. Consequently, these findings add to the rapidly growing body of evidence that chronic opioid use poses a significant threat to sprawling patient populations, causing higher rates of complications, implant failure, and even death.

“Previous studies have highlighted factors associated with poor outcomes in total joint arthroplasty, such as diabetes, chronic kidney disease, obesity, and smoking,” Dr. Luu and coauthors wrote. “Our data suggest that preoperative opioid use may be another risk factor to take into consideration.”

Furthermore, researchers also found that more than half of patients engaged in opioid use prior to TKA or THA, often for extended periods of time.

“Although it may not be possible for certain conditions, diminishing or eliminating opioid use preoperatively would be beneficial when planning a total joint arthroplasty,” the researchers wrote.

“Both readmissions and additional revision surgeries add to the cost of healthcare and are often physically and emotionally challenging for our patients,” Dr. Luu noted. “As physicians, we can help our patients and the healthcare system by reducing or eliminating preoperative opioid use in hip and knee replacement patients.”

 

 

A new Zimmer hip implant lawsuit indicates that the popular hip system, consisting of the M/L Taper Hip and Versys femoral head, severely corroded due to the metal-on-metal design, causing heavy metal poisoning and premature failure, necessitating invasive and dangerous revision surgery.

Richard P. Torres and his wife, Pollyanna, filed the complaint July 24 in the Western District of Michigan. The couple names Zimmer Biomet Holdings as a defendant.

According to his lawsuit, Torres underwent total right hip replacement surgery in February 2014, receiving a Zimmer VerSys Hip Stem Femoral Head with an M/L Taper femoral stem and a Trilogy Acetabular Shell and Liner.

Zimmer Hip Implant Failure and Metal Poisoning Due to Corrosion

In late 2017, Torres began suffering from rapidly escalating pain and instability in his right hip. Consequently, he consulted with an orthopedic surgeon who tested his blood for ion levels and prescribed medication to help manage his pain. The blood tests showed high levels of chromium and cobalt, which is a known carcinogen, indicating that the Zimmer hip implant was shedding toxic metallic debris into his body. Meanwhile, his considerable pain and instability only continued to increase. Eventually, Torres required crutches or a walker to walk.

In March 2018, Torres consulted with another orthopedic surgeon who diagnosed him with mechanically-assisted crevice corrosion. He underwent revision surgery in May 2018. During the surgery, his surgeon noted significant corrosion around the femoral head-neck junction of the Zimmer hip implant. Furthermore, Torres also developed a left side inguinal hernia during the revision surgery and had to undergo additional surgery in June 2018 for hernia repair.

“In designing the Zimmer Hip System, Zimmer knew that the use of dissimilar metal alloys as well as taper size and geometry, trunnion surface finish, and flexural rigidity contribute to causing fretting and corrosion at the femoral head-femoral stem taper interface,” the lawsuit states. “Mechanically assisted crevice corrosion (‘MACC’) has been identified as a cause for symptomatic implant failure in metal-on-polyethylene hip devices. MACC produces cobalt and chromium ions, fretting byproducts and corrosive debris that can lead to adverse local tissue reaction.”

Zimmer Hip Implant Lawsuits

Torres joins a growing number of individuals stepping forward to take Zimmer to task over significant complications from its M/L Taper and Versys components due to their metal-on-metal design. Metal-on-metal hip designs have enjoyed increasing popularity in recent years. However, the virtual tidal wave of lawsuits flooding the nations courts against numerous manufacturers over high rates of failure and life-altering problems indicate that these designs are patently and even dangerously defective.

And, Zimmer’s hips are no exception. More than 100,000 Americans have received Zimmer hip implant systems. Given the high rate of failure of these devices, experts project that the litigation will quickly grow by leaps and bounds as more people discover that Zimmer concealed the high potential for significant problems from the public and medical community. Consistently, plaintiffs assert that the company knew that Zimmer hip implant components are prone to fretting and corrosion, shedding toxic metal debris into patients’ bodies to wreak havoc and resulting in necessary removal of the defective implants.

This past month, a group of plaintiffs filed a motion to consolidate all federal Zimmer hip implant lawsuits over the VerSys, M/L Taper, and M/L Taper with Kinectiv Technology, requesting for the Judicial Panel on Multidistrict Litigation (JPML) to transfer cases pending throughout the federal court system to District Judge Donovan Frank in Minnesota for pretrial proceedings.

Zimmer hip implant complaints are just the latest in a long line of metal hip litigations that have emerged recently over defective metal-on-metal hip replacement systems. Previously, the JPML has decided to centralize a number of these litigations in their own federal MDLs, including Biomet Magnum, DePuy ASR, DePuy Pinnacle, Stryker LFit v40, Stryker Rejuvenate, and Wright Conserve among other systems.

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