According to his complaint, Mosby took Pradaxa for his blood thinning needs, and later experienced a serious injury that put him in the hospital.

Pradaxa gastrointestinal bleed lawsuit

Mosby claims that in January 2011, he started taking Pradaxa to help reduce the risk of suffering a potentially harmful blood clot. A few months later, he experienced a severe gastrointestinal bleed. He went to the medical center in Shreveport, and later was hospitalized in Nacogdoches, Texas.

Mosby states that he was unaware of the risk of developing life-threatening Pradaxa side effects. He states that had he known about the dangers, and had manufacturer Boehringer Ingelheim provided adequate warnings on the product label concerning the lack of a reversal agent for excessive bleeding, he never would have taken Pradaxa. Instead, he states that as a result of using the drug, he suffered severe personal injuries, physical pain and mental anguish.

Boehringer Ingelheim overpromoted Pradaxa

The FDA approved Pradaxa in October 2010 to help reduce the risk of blood clots and stroke in patients with non-valvular atrial fibrillation. The agency allowed two doses—75 mg and 150 mg, to be taken twice daily.

When Pradaxa was first launched on the market, it was hailed as a more convenient, hassle-free alternative to warfarin, which was the main anticoagulant for decades. Patients on Pradaxa did not have to undergo regular blood monitoring to check the dose, as did those on warfarin. Neither did Pradaxa patients have to restrict their diets.

Mosby claims that Boehringer Ingelheim overpromoted Pradaxa, particularly during 2011, when they reportedly undertook 1.5 million Pradaxa “detailing sessions” with U.S. primary care physicians, internists, group practitioners, cardiologists, and practice nurses. They also widely disseminated direct-to-consumer advertising campaigns to influence patients to ask their doctors about Pradaxa.

Pradaxa side effects have no antidote

This Pradaxa gastrointestinal bleed lawsuit goes on to claim that in these marketing campaigns, the defendants overstated the efficacy of Pradaxa and failed to disclose that the medication had no reversal agent. Since there is no antidote to Pradaxa side effects like excessive bleeding, these side effects can be particularly serious and even deadly.

According to Mosby, Boehringer Ingelheim also failed to warn emergency room doctors, surgeons and other critical care medical professionals about the lack of a reversal agent, leaving them “no effective means to treat and stabilize patients who experience uncontrolled bleeding while taking Pradaxa.”

Between October 2010 and March 2011, the FDA received 932 Pradaxa-associated adverse event reports, including at least 120 deaths and over 500 reports of severe, life-threatening bleeding. From April 1 to June 2011, there were an additional 856 reports, including 117 deaths and over 510 cases of severe, life-threatening bleeding.

Plaintiff seeks damages for Pradaxa side effects

Mosby brings counts of failure to warn, design defect, negligence, negligent misrepresentation and/or fraud, breach of warranties, fraudulent concealment, and deceptive trade practices. Through his Pradaxa gastrointestinal bleed lawsuit, he seeks compensatory, economic, and punitive damages.

Resources Resources

The Bessemer clinic was larger than average, with 36 dialysis stations, and Alabama state health inspectors reported last year that deficiencies in infection control procedures at the center “had the potential to affect all patients served by the facility.” A total of seven deficiencies were reported, including failures to wash hands, change gloves, disinfect surfaces, and take other necessary precautions to prevent the spread of dangerous pathogens. These departures from the standard of care were not limited to Bessemer, and state health reports indicate that eleven other Fresenius clinics in Alabama also received citations about insufficient care in a two year period. Fresenius officials say their clinics have come into compliance with state health regulations since the violations were reported.

NaturaLyte and GranuFlo also cause Fresenius dialysis injury

Fresenius Medical Care has already come under fire because two of its dialysis products, NaturaLyte and GranuFlo, have been linked to serious injuries and deaths. NaturaLyte and GranuFlo are used in kidney dialysis which differ from traditional dialysis products in that they tend to increase the concentration of bicarbonate in the patient’s blood stream, potentially to dangerous levels. Doctors who use NaturaLyte or GranuFlo must adjust the level of bicarbonate used in dialysis to accommodate the Fresenius products.

However, according to over one hundred NaturaLyte and GranuFlo lawsuits, Fresenius failed to properly instruct doctors about the dosage and prescription information necessary to safely administer the chemicals. As a result, many Fresenius patients suffered injuries including metabolic alkalosis (a form of pH imbalance) and hypokalemia (low blood potassium), which caused some patients organ failure, heart attack, stroke, or even death. Citing these risks, the FDA issued a Class I recall of NaturaLyte and GranufFlo on March 29th 2012 in order to warn doctors of the serious health consequences these medications could cause.

Fresenius dialysis injury lawsuits

NaturaLyte and GranuFlo lawsuits accuse Fresenius of failing to provide doctors with adequate instructions on the safe use of the products. According to a leaked internal document, Fresenius notified doctors at its own clinics about the safety concerns surrounding these drugs after a study found a significantly increased incidence of heart attack in patients being cared for in Fresenius facilities.

However, Fresenius did not notify other doctors, or the public, about its findings and did not issue any product warnings or cautions until the FDA stepped in after receiving a copy of the Fresenius memo from an anonymous whistleblower. Over a hundred lawsuits citing this malfeasance have been filed against Fresenius in U.S. federal courts and been consolidated in Massachusettes for multidistrict litigation, or MDL, in order to move the large number of cases forward efficiently.

Resources Resources

Another Zoloft heart defects lawsuit has joined multidistrict litigation (MDL) No. 2342, which is currently proceeding in the U.S. District Court for the Eastern District of Pennsylvania under Judge Cynthia M. Rufe. The MDL was created to centralize federal complaints against Pfizer regarding the defendant’s SSRI antidepressant Zoloft.

Multidistrict litigation allows for shared pretrial proceedings for large numbers of plaintiffs, while preserving their rights to individual trials. This particular complaint was filed on May 28, 2013 on behalf of a mother from South Dakota and her minor child. The plaintiff alleges significant birth defects as a result of the antidepressant, and is seeking compensatory damages in excess of $75,000.

Plaintiff’s child required multiple surgeries

Zoloft is an antidepressant categorized as a selective serotonin reuptake inhibitor (SSRI) that works by balancing levels of serotonin in the brain to restore a stable emotional state. However, patients and doctors have been increasingly questioning the safety of the use of Zoloft during pregnancy and the alleged failure of the defendants to disclose the potential risks.

The plaintiff took Zoloft for an unspecified period of time prior to her pregnancy, and continued to take it throughout her pregnancy. According to the complaint, the plaintiff took the medication as directed. On August 21, 2009, she gave birth to her child, who was diagnosed with numerous birth defects that affected her heart health. She suffers from atrial septal defect, a non-Ebsteinoid valve abnormality, and patent ductus arteriosus. The latter condition refers to the failure of the ductus arteriosus, a blood vessel, to close. Normally, this blood vessel closes shortly after birth.

The child also displays abnormal development of the facial and cranial areas, as well as esotropia, which refers to a crossing condition of the eyes. As a result of her alleged Zoloft related birth defects, the minor child has had to undergo more than five surgeries, and continues to experience adverse effects and emotional trauma. Additionally, the plaintiff has incurred significant expenses for the hospitalizations, surgeries, and other medical expenses.

Zoloft birth defects lawsuit alleges inadequate testing, failure to warn

The Zoloft birth defects lawyer who filed the case alleges that Pfizer either “knew or should have known” that Zoloft and other SSRI drugs have the potential to result in congenital heart defects. The complaint points out that a similar SSRI, Paxil, had an additional warning added to the label in 2005 that cautioned consumers against using the drug during pregnancy because of the risk of birth defects such as cardiac malformations and PPHN.

Additionally, the preclinical animal trials conducted before the defendants received initial approval demonstrated “significant harm to fetuses,” such as heart defects. However, the defendants failed to test the safety of Zoloft when used by pregnant women, nor did they warn patients and doctors against the use of the drug during pregnancy. The lawyer charges that Pfizer’s marketing efforts promoted its use by pregnant women.

Since the initial approval of Zoloft, numerous studies have been published that demonstrate a link between SSRIs and heart birth defects, including atrial septal defects. Despite this, the defendants have still failed to update the warning label to include these risks.

Resources Resources

Numerous people have made similar allegations against Stryker Orthopaedics regarding the Rejuvenate hip replacement. Due to the results from post-marketing studies and the large number of complaints submitted to the FDA, a Stryker hip replacement recall was issued. To date, at least 150 Stryker hip lawsuits are pending in federal courts.

Side effects linked to Stryker Rejuvenate system

Stryker Orthopaedics received FDA clearance to sell and distribute the Rejuvenate Modular Primary Hip System on June 3, 2008. Stryker claimed that the hip replacement system was comprised of a chrome cobalt neck and titanium femoral stem that was resistant to corrosion and fretting. Since the femoral stem and neck components of the device were interchangeable, it allowed surgeons to create a hip implant that was custom-fitted for the anatomy of each individual patient. The Rejuvenate System was also designed to provide more flexibility, stability, and greater range of motion than other hip replacement devices in the market.

After the Rejuvenate System was released in 2009, post-market studies revealed that the device was susceptible to the effects of corrosion and fretting. Small metal particles fell off of the device and were absorbed into the bloodstream and soft tissues of the patients. Some of the side effects associated with the Rejuvenate System include loosening of the device, metallic poisoning, chronic pain, tissue damage, bone loss, pseudotumor formation, and early failure rates.

Stryker hip replacement recall

In June 2012, Stryker Orthopaedics issued a voluntary recall of the Rejuvenate and ABG II Modular Systems based on data that indicated the medical devices potentially posed serious safety hazards to patients. The manufacturer announced that fretting and corrosion of the components put patients at risk of developing inflammation, adverse soft tissue reaction, and pain. Physicians were advised to perform clinical examinations and diagnostic tests on patients who received the hip implants. Stryker stated that it would also reimburse patients for medical treatment, tests, revision surgery, and other costs related to the voluntary recall.

Negligence alleged in Stryker Rejuvenate lawsuit

The plaintiff received a Rejuvenate hip replacement on November 4, 2011. He started to experience serious pain in the hip area where the implant was placed. Blood tests revealed that he suffered from heavy metal contamination. In December 2012, the plaintiff underwent revision surgery to replace the hip implant. The Stryker Rejuvenate lawsuit alleges the hip implant was the proximate cause of the plaintiff’s injuries. The plaintiff is requesting compensation for medical expenses, lost wages, and other damages.

The court documents state that Stryker Orthopaedics was negligent and failed to use reasonable care while designing and manufacturing the medical device. The manufacturer allegedly didn’t perform sufficient clinical tests to ensure the medical device was safe for patients. The lawsuit also claims that healthcare professionals and patients weren’t adequately warned about the health risks and side effects associated with the Rejuvenate System.

Stryker Rejuvenate multidistrict litigation

Recently, the U.S. Judicial Panel decided to consolidate the federal cases involving Stryker’s Rejuvenate System and ABG II modular-neck stems. The Judicial Panel concluded that it will be more efficient to form a multidistrict litigation and transfer all of the cases to one federal court since the complaints involve similar legal issues, circumstances, and statement of facts. The lawsuits will be handled in the U.S. District Court for the District of Minnesota and Judge Donovan W. Frank will preside over the legal proceedings.

Resources Resources

The couple’s Actos lawyer filed the claim on June 4, 2013 in the U.S. District Court, Western District of Louisiana, home of the current products liability litigation involving the controversial drug. Takeda is being charged with failing to warn consumers and the medical community that Actos can cause bladder cancer and heart damage. Louis Woodall was diagnosed with bladder cancer on May 23, 2012 after ingesting Actos for less than two years under the supervision of his physician.

Utah plaintiff seeks Actos cancer compensation

The claimants are requesting damages for Louis’ injuries, blaming Takeda Pharmaceuticals for his bladder cancer diagnosis.

The couple is requesting compensation for:

• Past, present and future medical care
• Ascertainable economic losses
• Pain and suffering
• Attorney fees and court costs
• Loss of spousal consortium
• Punitive damages to punish and deter Takeda from the same or similar conduct 

Louis Woodall began taking Actos in 2010 under the assumption that the medication was safe and effective. However, prior studies had pointed to an increased risk of life-threatening side effects with Actos exposure over prolonged periods of time. Potential side effects of Actos included congestive heart failure, bone fractures, and bladder cancer.

The strong correlation between Actos and bladder cancer prompted both Germany and France to pull the diabetes drug from the market. And despite two FDA safety communications regarding bladder cancer risks and Actos, Takeda continued to promote the medication as safe. By 2008, Actos was the tenth top-selling prescription drug in the United States.

According to court documents, Takeda has yet to adequately warn consumers and the prescribing medical community about the significant risks of bladder cancer associated with Actos use.  And lacking this crucial information about the drug’s adverse side effects, the plaintiff and his physician were not able to accurately assess the true risks of the medicine.

Louis Woodall alleges to be permanently injured and will require ongoing medical care to treat his bladder cancer, which may include surgical removal of the organ if malignancies progress.

Nine counts brought against Takeda

The plaintiffs’ Actos lawyer adopts the following counts in the complaint:

• Products liability: manufacturing defect
• Failure to warn
• Breach of express warranty
• Breach of implied warranty of merchantability and fitness
• Negligence
• Loss of consortium
• Common law fraud
• Constructive fraud
• Negligent misrepresentation

The defendant’s wrongful conduct and negligent misrepresentations about the safety of Actos have caused the plaintiff to incur debilitating bodily injury, mental and physical pain, and economic loss, according to the plaintiffs’ Actos lawyer.  Woodall joins more than 3,000 other plaintiffs who are demanding Actos cancer compensation from Takeda.

Federal Actos lawsuits centralized as MDL

Owing to the large number of claims against Takeda, multidistrict litigation was established on December 29, 2011. The docket is being overseen by Judge Rebecca F. Doherty in the U.S. District Court for the Western District of Louisiana (MDL No. 2299). The Woodall case is one of the latest lawsuits to join the MDL proceedings, which will help expedite the pre-trial process.

Resources Resources

The deceased woman, from Harvey, Louisiana, was prescribed Pradaxa in October 2011. Shortly after, she suffered weakness in her right leg, causing her to sustain several falls and rendering her immobile without the aid of a walker. A physician who examined her in February 2012 diagnosed internal bleeding around the joint of her right knee. She underwent an arthrocentesis (also known as joint aspiration), a procedure whereby fluid is drained from the joints using a syringe.

The woman suffered a stroke in March 2012, prompting her family to bring a Pradaxa bleeding lawsuit against Boehringer Ingelheim. According to the complaint, the company knew or should have known of the risk of severe internal bleeding caused by Pradaxa. The company is also accused of failing to provide a ‘black box warning’ indicating a risk of serious bleeding events.

Pradaxa bleeding risk may be five times greater than alternative treatment

In October 2010, the FDA approved sale of Pradaxa in two dosages: 75mg and 150mg. Prior to that date, the only commonly-prescribed anticoagulant for cases of atrial fibrillation was warfarin, which has been used for more than half a century. During the marketing campaign for Pradaxa, Boehringer Ingelheim promoted the medication as a more convenient alternative to warfarin, which requires patients to follow strict dietary restrictions and have their blood closely monitored.

However, a recent report submitted to the FDA indicated that Pradaxa is five times riskier than warfarin, partly owing to the lack of antidote for the former. The review, conducted in 2012 by the Institute for Safe Medication Practices, found that Pradaxa was responsible for 178 deaths compared to warfarin’s 14 deaths.

The report also cited a study from New Zealand, which claimed patients with kidney disorders were at greater risk. It concluded that the marketing campaign for Pradaxa focused on the benefits while ignoring the potentially lethal side effects.

Pradaxa linked to more than 500 deaths

Pradaxa has generated more than a billion dollars in its two years on the market. Within the first year of going on sale, 2,367 ‘adverse event reports’ were filed with the FDA. It has been linked to more than 500 deaths in the United States, prompting consumers to demand a black box Pradaxa FDA warning be added to the labeling.

Pradaxa bleeding lawsuit figures expected to rise

The number of Pradaxa bleeding lawsuits currently exceeds 200, with more expected in the coming weeks and months. In all cases, Boehringer Ingelheim is accused of failing to warn the public, the FDA, and the medical community of the risk of uncontrollable bleeding with Pradaxa.

Multidistrict litigation (MDL) has been established to consolidate federal cases. Set to be heard in August 2014, District Judge David R. Herndon will oversee proceedings. He has ordered all parties to meet on a monthly basis between now and the first hearing, with a view to reaching out of court settlements.

Resources Resources

Zimmer knee implant lawsuit

Howard filed a complaint in the Northern District of Ohio back in 2002, alleging that defects in his Zimmer knee implant caused it to fail from lack of proper bonding with his natural bone, thereby causing pain and injury. Howard believed that Sulzer failed to remove machine oil residue, in violation of the “Good Manufacturing Practices” imposed by the FDCA. Due to the wealth of similar lawsuits pending, his case was remanded to the Northern District of Oklahoma in 2010 as part of MDL No. 1401. Initially, the Ohio district court refused to dismiss the negligence claim.

The case background

Sulzer designs, manufactures, and distributes knee and hip implants. Typically, the company machines the metal parts and then applies a porous coating to assist the bonding between the device and the patient’s bone. However, they began switching the steps — applying the coating prior to machining the parts. Unbeknownst to the manufacturer, this left oily residue on the implants, despite the fact that Sulzer used an FDA-approved cleaning process. When the error was discovered, Sulzer voluntarily recalled 40,000 implants. This new manufacturing process was used in the Inter-Op shell hip implants and the Natural Knee II Tibial Baseplate knee implants. They initiated a secondary recall for the knee implants and thousands of patients underwent revision surgery to replace the defective parts. Litigation soon followed.

The counter-argument by Sulzer

However, Sulzer filed a summary judgment motion based upon the determination that Howard’s knee replacement was not in the oil-contaminated lot. They believed this fact was obvious grounds for dismissal. The company presented evidence that the device met all the standards of the Pre-Market Approval (PMA) application. The court agreed with the manufacturer and threw the Zimmer knee implant lawsuit out.

Zimmer knee lawyer provides a persuasive appeal

In turn, Howard filed an appeal and his Zimmer knee lawyer was able to prove that he had a right to file a “negligence per se” claim. Under a “negligence per se” claim, an act is considered negligent because it violates a law and causes harm to another person. The attorney argued that there was negligence based on a violation of the Medical Device Amendments, which identifies safety controls, performance standards and premarket approval processes.

Though Sulzer interpreted the law as merely requiring them to have a process for oil residue removal in place, Howard’s lawyer argued that the law also requires them to ensure that the implants are free from oil residue. He added that Howard’s Zimmer knee implant lawsuit was a “parallel claim” to the others in the MDL and, even though this particular device may not have been in the contaminated lot, chemical tests did show that there was mineral oil residue on his implant. Furthermore, there were grounds for litigation based on violation of the Good Manufacturing Practices law, rather than the Pre-Market Approval law.

Judgment is reversed and Zimmer knee implant lawsuit moves toward trial

The 10^th Circuit reversed the summary judgment awarded to Zimmer, following the Oklahoma Supreme Court’s decision that there is a valid “negligence per se” claim based on a violation of the Medical Device Amendments.  The court published a three-page opinion on May 29^th, contending that: “Oklahoma law allows private individuals to maintain a parallel claim for negligence per se based on violation of a federal regulation whose enforcement lies with a government entity.” They added that the claim “should be allowed to proceed.”

Resources Resources

Joint inflammation can warn of Zimmer hip complications

According to a study recently published in the Journal of Bone & Joint Surgery, if a type of joint inflammation called synovitis shows up on the MRI, it could be a signal that two or more metal components are rubbing against each other in the artificial joint and releasing toxic debris that is harming the surrounding tissue. If this metallosis is allowed to progress, it can cause severe and debilitating side effects including bone loss, soft tissue damage, and permanent pain and disability. The use of magnetic resonance imaging could help doctors diagnose failing implants when the patient is experiencing unexplained pain, or even screen for failing implants before patients experience any symptoms.

MRI screening could be especially helpful for patients who have hip implants that have been recalled, such as the Zimmer Durom Acetabular Component, or Durom Cup. The Durom Cup was subject to an FDA recall in 2008 amid growing concerns that metal-on-metal hip implants were unreasonably dangerous when compared with traditional metal-on-plastic or ceramic hip devices. Patients with recalled hip replacements may be advised to undergo regular screening so doctors can try to diagnose failing implants early and minimize the damage these devices can do. The most common diagnostic procedure now used is a serum ion level test, which measures the presence of toxic metallic particles in the bloodstream, but the author of the MRI study points out that serum ion levels do not indicate the extent of the damage the metallic particles are actually doing, which may differ significantly from patient to patient.

Failing implants spark wave of Zimmer hip lawsuits

The MRI study found that almost 75% of hip implants examined had some level of adverse local tissue reaction, as indicated by the presence of synovitis joint inflammation near the implant. In total, 27% of the hip implants examined showed signs of mechanical failure, including implant loosening or dislocation, bone fracture, or faulty positioning, and 43% of the implants were causing unexplained pain in and around the hip joint. These high levels of hip implant failure have been the driving force behind a wave of litigation alleging product defects in Zimmer hip implants as well as negligence and fraud on the part of Zimmer Corporation itself.

In addition to the production of toxic metallic debris, many Zimmer hip lawsuits allege that the Durom Cup is prone to loosening and detachment because of a flaw in its design. The Durom Cup is supposed to be implanted without adhesive in a way that allows the bone to grow into the device’s special porous surface, but in practice, bone growth often pushes the Durom Cup out of place. The resulting loosening can worsen metal-on-metal wear and make the implant more prone to dislocation, which causes debilitating pain and requires surgical repair. Over 200 Zimmer hip replacement claims are now pending in state and federal court as a result of these alleged defects in the Durom Cup.

Resources Resources

All federal lawsuits involving alleged injuries from the birth control pills, including Yaz blood clots and related complications like pulmonary embolism, were consolidated as multidistrict litigation in the Southern District of Illinois in October 2009, for more efficient pre-trial processes. Since that time, manufacturer Bayer has negotiated settlements in about 4,800 lawsuits, totaling more than $1 billion.

Plaintiffs suffer from Yaz blood clots and deep vein thrombosis

In this Yaz deep vein thrombosis lawsuit, all five plaintiffs allege injuries stemming from blood clots:

1. Michigan resident Kelly Stone started using Yaz/Yasmin in 2010 and continued using it through 2011. She suffered severe pain and blood clots in her legs, and was later diagnosed with deep vein thrombosis, a condition in which blood clots may form in the deep veins of the body, typically in the legs. She went through numerous surgeries and medical procedures to try to correct the problem, and remains on blood thinning medications to this day.
2. Mississippi resident Lashaunda McDaniel started using Yaz/Yasmin in 2008 and continued to take it through 2009. She also suffered severe pain and developed deep vein thrombosis. She has gone through numerous surgeries and medical procedures in an effort to get better.
3. Illinois resident Amilyn Gabbard started taking Yaz/Yasmin in 2010 and used it through 2011. She developed deep vein thrombosis.
4. Kansas resident Courtney Tihonen started using Yaz/Yasmin in 2006, and continued through 2007. She suffers deep vein thrombosis.
5. Wisconsin resident Bethany Aquino started taking Yaz/Yasmin in 2004 and continued using it through 2005. She was later diagnosed with deep vein thrombosis.

Plaintiffs bring claims against Bayer

The FDA approved Yasmin in 2001 and Yaz in 2006 for use as birth control options. Both pills contain the fourth generation progestin “drospirenone,” which was later linked with an increased risk of blood clots and related complications like pulmonary embolism, stroke, and heart attack.

Because drospirenone causes an increase in potassium levels in the blood, it can lead to a condition known as “hyperkalemia,” where potassium levels become too high. This can cause heart rhythm disturbances, which if not treated, can cause heart attack.

The plaintiffs in this Yaz deep vein thrombosis lawsuit claim that Bayer knew or should have known about the risks associated with Yaz/Yasmin, and should have done more to warn patients and physicians.

Studies and reports indicate serious Yaz blood clots

In April 2002, the British Medical Journal reported that the Dutch College of General practitioners recommended older birth control pills be prescribed as a result of 40 cases of  blood clot-related injuries among women taking Yasmin and Yaz. Between 2004 and 2008, over 50 reports of deaths among users of Yasmin and Yaz were filed with the FDA, with some deaths occurring in women as young as 17 years old.

In April 2012, the FDA issued a public safety communication warning that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. “The revised drug labels will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins….” the agency stated.

The plaintiffs in this lawsuit bring claims of defective manufacturing, defect in design or formulation, inadequate warning, failure to adequately test, negligence, breach of warranties, and negligent misrepresentation and/or fraud.

Resources Resources

The case was the first ASR hip trial to go before a jury and was presided over by Honorable Judge J. Stephen Czuleger. Following the jury’s decision, lawyers for DePuy petitioned the judge to vacate the verdict, arguing that the plaintiff provided insufficient evidence to support his charges. Judge Czuleger announced that the verdict will stand, and that DePuy was found guilty for breaching its duty to warn consumers about the risks they were facing.

The plaintiff, a retired prison guard who resides in Montana, alleged in his complaint that the now-recalled ASR hip implant caused him significant suffering and permanent injuries. The metal-on-metal design has been blamed for most of the implant’s problems, which occurred when the metal cup made contact with the metal ball, shedding debris into the body. These metallic ions led to a chain reaction of problems including inflammation, tissue necrosis, and in some cases, damage to the bone.

Since the DePuy ASR recall was issued in 2010, thousands of injured recipients have come forward seeking compensation for the harm they’ve sustained – and Kransky’s jury verdict gives hope to many.

More than 10,000 DePuy ASR lawsuits pending

The A.S.R. stands for Articular Surface Replacement – a type of hip replacement that is seldom used by orthopedic surgeons due to potential for fretting and corrosion of the metal components.  A key piece of evidence in the California DePuy ASR trial was an internal memo, in which Johnson & Johnson acknowledged that nearly 40 percent of all people who were implanted with the ASR would need revision surgery within five years.  This is a stark contrast to the 15 to 20-year lifespan of a normal hip replacement. The jurors ultimately decided that DePuy had breached its legal duty to warn consumers about the defective nature of its artificial hips.

Another ASR case that was heard in an Illinois state court rendered a verdict for DePuy; however, thousands of cases are still pending. The majority have been consolidated on a federal level for more streamlined pretrial proceedings. The DePuy ASR multidistrict litigation (MDL) is located in the Northern District of Ohio, and being overseen by U.S. District Judge David Katz.

Settlement offers rejected by ASR hip recall plaintiffs

While DePuy has reportedly settled a handful of DePuy ASR lawsuits with some claimants, others have rejected these offers. Insiders report that Johnson & Johnson has earmarked an estimated $2 billion for future DePuy hip settlements. The MDL bellwether trials are slated to begin over the coming months, which will be another prime indicator of how jurors respond to evidence and testimony presented by both sides. 

The DePuy ASR recall affected 93,000 defective implants, and patients who received the devices complain of persistent pain in the hip and groin area, loosening of the implant, inflammation, complications from metal poisoning and early hip failure.

Resources Resources