Side Effects & Recall Lawsuit
- Category: Recall Lawsuit
Stryker Rejuvenate Hip Replacement Implant Recall Lawsuit
Stryker Rejuvenate Hip Implant Lawsuits
On January 25, a Stryker Rejuvenate class action lawsuit was filed in a south Florida federal court seeking free treatment and medical monitoring for people implanted with the recalled metal hip replacement devices. Michigan-based Stryker Orthopedics recalled its metal Rejuvenate Modular hip implants in June 2012 following widespread reports of metal poisoning, local tissue reactions, pain, premature device failure, and early modular-neck junction corrosion attributed to its design defects. The FDA received as many as 60 complaints on the hip implant failure, metallosis, infection, and bone necrosis in the four months preceding the recall.
An estimate released by Stryker Orthopedics in January 2013 puts the total costs the manufacture has to pay for personal injury lawsuits filed following the hip system recall at $390 million. The number of Stryker Rejuvenate hip lawsuits is expected to rise in the months ahead as more patients are coming forward seeking compensation for injury, pain, side effects, suffering caused by the device and reimbursement for medical and implant costs. In January 2013, the Supreme Court of New Jersey ordered for consolidated proceeding of all Stryker hip product liabilities filed in the state courts.
Stryker Rejuvenate Hip Implant: The System and Drawbacks
Stryker Rejuvenate hip implants were introduced in the United States in February 2010 following authorization through the FDA’s controversial 510(k) approval process. The procedure, which is being subject to strong criticism, permits introduction of new drugs or medical devices “substantially equivalent” to similar products already approved by the FDA for marketing and consumer use. Stryker introduced the Rejuvenate hip implants claiming that the system was similar to Profemur hip implants produced by Wright Medical Technology in design and offered superior intraoperative efficiency and flexibility.
The Stryker Rejuvenate hip implant system consists of the following three components
- A chromium-cobalt stem
- A non-metallic ball
- A titanium neck
The design of Stryker Rejuvenate hip implant system has been found defective and causes rubbing of metal components of the system against each other that discharges metal particles into the blood stream, putting users at the increased risk of metal poisoning. Many patients using these metal artificial hips have been diagnosed with high blood chromium and blood cobalt levels. Continuous and unusual fretting disables the metal parts early, and the devices last less than a quarter of the 15-year life span claimed by the manufacturer. Metal particles released from the artificial hip implants also cause infection, bone necrosis, and scar tissue and pseudotumor formation in and around the hip area.
The Wring Profemur hip implants with which Stryker Rejuvenate systems share design similarity have been subject to many lawsuits for their early failure, loosening of implants, consistent hip pain, and problem in walking or standing.
Stryker Rejuvenate Hip Implant: Major Side Effects
- Metallosis and toxicity
- Thyroid disorders
- Cardiovascular problems
- Hip area inflammation
- Metal poisoning leading to nervous system, gastrointestinal, cognitive disorders, vision and hearing problems, skin rashes, myocardiopathy, hypothyroidism, and death
- Sharp rise in cobalt and chromium ions in blood
- Peripheral soft tissue damage
- Nerve palsy and other side effects impacting normal nervous system functioning
- Device dislocation and chronic pain
- Premature device failure leading to secondary or revision surgery
- Bone necrosis and fractures
Stryker Rejuvenate Hip Implant Warnings
More than 17,000 complaints have been made through the FDA adverse reporting system, highlighting side effects and failure of metal hip implants in the last one decade. In May 2011, the FDA asked all metal artificial hip implant manufacturers, including Stryker, to conduct comprehensive safety assessment of its products fully reflecting safety concerns of consumers raised through complaints to the regulator.
- Category: Recall Lawsuit
GranuFlo Lawsuit and NaturaLyte Lawsuit
GranuFlo and NaturaLyte Lawsuits
On January 25, 2013, a 38-year-old Louisiana man filed a product liability lawsuit against Fresenius Medical Care, claiming he had suffered from life-threatening dialysis injuries. According to the GranuFlo and NaturaLyte lawsuit filed at the Louisiana east district court, Ronnie Glasper suffered from heart stroke, heart attack, and severe pain following hemodialysis treatment at Fresenius clinic in Ferriday. He was administered with two dialysates NaturaLyte and GranuFlo, manufactured by Fresenius, which have been linked to the substantial risk of cardiovascular problems, metabolic imbalance, and wrongful death.
The hemodialysis lawsuit is one of the three dozen similar litigation cases filed against Fresenius in various federal courts across the United States. The number of lawsuits is expected to grow into hundreds, and the motion for MDL consolidation has already been filed. Internal memos leaked in March 2012 revealed that Fresenius was aware of hundreds of deaths caused by improper doses of NaturaLyte and GranuFlo at its clinics in 2010, but continued to treat patients with these hemodialysis solutions without any warning or disclosure of safety concerns.
- Category: Recall Lawsuit
Subaru Recall Lawsuit
Subaru Recalls 634,000 Vehicles Citing Potential Fire Hazard
On January 3, 2013, Japanese car maker Subaru announced recall of 634,000 vehicles, including sedans, crossovers, and wagons, sold in the United States, citing potential fire hazard caused by an electrical problem. The National Highway Traffic Safety Administration has confirmed to have received at least 10 reports of smoke and melting caused by short-circuit in the wiring and connectors of the puddle lamp located under doors of Subaru vehicles when exposed to electrolytic moisture. The Subaru car fire hazard recall covers all 2010 and 2011 Legacy and Outback models, some Tribeca SUVs made from 2006 to 2012, and selected Forester crossovers manufactured between 2009 and 2012.
- Category: Recall Lawsuit
Nap Nanny Recall Lawsuit
Nap Nanny Recliner Recall Following Deaths and Injuries
On December 27, 2012, four retailers announced recall of 150,000 Baby Matters Nap Nanny recliners following an appeal by the U.S. Consumer Product Safety Commission (CPSC). The market withdrawal was expected following an administrative complaint filed by the CPSC on December 5 seeking the product recall on the ground that defective design and lack of adequate warning on them increase the risk of infant injury and death. In the last 28 months, the CPSC has received 72 reports of infant injuries caused by fall from these recliners. The manufacturer continues to stand by its product and is yet to issue a recall on its own.
There were reports of at least five deaths and 92 injuries caused by infants falling out of first and second generation Nap Nanny recliners and Nap Nanny Chill baby recliners prior to the recall issued by Buy Buy Baby, Babies R Us, Diapers.com, and Amazon.com. The present Baby Matters Nap Nanny recliner recall was second in the last two years after about 30,000 recliners were recalled in July 2010 following similar infant injury and death complaints.
CPSC Warning and Administrative Complaint
According to the CPSC, three Nap Nanny recliner models - Generation One, Generation Two, and Chill - have defects in their design, label warnings, and instruction manuals, which put infants at the risk of grievous injury and death. Its earlier recall in 2010 following infant injuries and death forced Baby Matters to introduce a second-generation version of these inclined foam beds fitted with fabric cover. However, indentation on which the babies are placed continues to remain defective and harness belts have failed to protect infants. The incidents of death and injury have gone up manifold, forcing the federal regulator to determine that warnings and instructions are insufficient to protect babies.
On December 5, 2012, the CPSC filed an administrative complaint asking for suspension of sale and a nationwide recall of purchased Nap Nanny and Nap Nanny Chill recliners. It claims that dangerous design defects were behind deaths and injuries caused by infants falling out of these foam beds and seeks an order for the manufacturer to notify all distributors and consumers about the serious risks posed by the product. If the complaint is accepted, Baby Matters will be required to recall products and refund the full value of purchased recliners to consumers.
The administrative complaint by the CPSC is rare and the fourth in the last 11 years. Two of the previous instances include recall of two child-linked products, Zen Magnet and Buckyball desk toys, in August.
- Category: Recall Lawsuit
Steroid Injection Meningitis Lawsuit Attorney Tainted Steroid Spinal Injections.
Rare fungal meningitis caused by contaminated steroid injections has left 47 people sick and five dead in seven states. Preliminary investigations by the Centers for Disease Control and Prevention indicate that the outbreak is linked to steroid injections custom-made by New England Compounding Center, a Massachusetts-based specialty pharmacy. These epidural steroid shots used to alleviate back pain are suspected to have aspergillus fungus, a common mold considered the reason for the meningitis outbreak. FDA officials have discovered fungal infection in at least one sealed steroid vial at the production facility of the pharmacy in Framingham.
About 75 clinics in 23 states received 17,700 vials supplied by the pharmacy between July and September. A Nashville-based clinic is said to have received the largest consignment of steroid vials suspected to have been infected. The highest number of meningitis cases, 18 hospitalized and three deaths, has been reported from Tennessee. The Tennessee Department of Health confirmed the first meningitis case on September 21, 2012, following discovery of deadly brain infection in a patient, who had received methylprednisolone acetate spinal injection to alleviate back pain at an ambulatory surgery center. The CDC discovered another Tennessee man with a similar infection within a week. The list went up, with the increase in the number of meningitis cases reported in Tennessee, Michigan, Florida, North Carolina, Indiana, Virginia, and Maryland.
Federal and state health officials are also looking for other possible reasons leading to the present fungal meningitis outbreak, such as the solution and the anesthetic used during administration of these steroid injections.
Recall of Suspected Steroid Vials
On September 26, 2012, the compounding pharmacy issued a recall of three lots of possible contaminated methylprednisolone steroid injections while investigations over suspected contamination and pharmacy error were continuing. It expanded the recall on October 4 to include all its injectable drugs and vials of methylprednisolone acetate products supplied since July. The New England Compounding Center at Framingham, MA, is a specialty pharmacy authorized to create custom-made steroid injections. It mixes medications and drugs taking into consideration patient conditions, dosing requirements, specific allergies, and need to change medication. The FDA has advised consumers and healthcare professionals against using New England Compounding Center products until the investigation is over.
Methylprednisolone acetate is a corticosteroid used to deal with inflammation that causes back and spinal pain. The steroid is injected into the spine directly to contain inflammation and ease pain. Hundreds of people in the United States use these injections everyday to get relief from lower back pain caused by a herniated disk. According to a report by the Department of Health and Human Services' inspector general published in 2010, about one-third of 433 injections audited as samples failed to meet Medicare standards.
Steroid Injection Meningitis Symptoms
Tainted steroid causes fungal meningitis that leads to infection of the brain and spinal fluid. The infection starts with the spinal cord inflammation and gradually contaminates protective membranes surrounding the brain. Aspergillus-induced fungal meningitis is rare, and this condition can be fatal for those with weakened immune systems.
Meningitis signs, such as headache, neck stiffness, vomiting, fever, light sensitivity, and confusion, start within three to seven days of the infection and proceed to coma and death. The transmission occurs only through direct fluid contact. In case of contaminated steroids, it develops fast because of direct delivery to spinal canal. The treatment for fungal meningitis requires prolonged hospitalization from weeks to months.
Hospital Infection and Pharmacy Error Lawsuits
According to a report by the Institute of Medicine of the National Academies, about 1.5 million U.S. residents die or face serious life threats due to medication or pharmacy error every year.
In June 2012, eight former patients sued the cardiac catheterization clinic of Exeter Hospital’s at New Hampshire for Hepatitis C exposure. The patients were diagnosed with Hepatitis C following their treatment at the hospital between October 2010 and May 2012. According to state health officials, 19 patients were infected with the disease after a hepatitis C infected employee of the hospital gave shots to patients with self-used needles. In February 2010, a Las Vega Endoscopy Center paid more than $3 million to settle 85 hospital infection lawsuits filed following similar outbreak of Hepatitis C in January 2008. In March 2012, reports of fungal eye infections led to recall of Brilliant Blue G dye used in eye surgery.
In March 2011, Birmingham-based compounding pharmacy Med IV recalled its Total Parenteral Nutrition products after investigating officials linked them to an outbreak of infection in six Alabama hospitals. The TPN was contaminated by Serratia marcescens bacteria that resulted in nine deaths. A number of wrongful death lawsuits have been filed against the compounding pharmacy by family members of deceased patients.
In August 2007, a Florida court awarded $33.3 million to family of a breast cancer patient, who died after being accidentally given a blood thinner dosage by technician at Walgreens Pharmacy. A superior court rejected Walgreens’ appeal challenging the judgment in the pharmacy error lawsuit and upheld the compensation awarded in March 2010.
In February 2009, Walmart Pharmacy paid an undisclosed sum to settle a wrongful death lawsuit filed by family of a Maryland man, who died in 2007. The pharmacy error lawsuit filed in a Baltimore court claimed that the 66-year-old died after he was given drugs prescribed for someone else. A similar case filed against Walmart in a Texas court in May 2010 is awaiting trial.
A pharmacy error lawsuit has also been filed against Detroit-based Rite-Aid Pharmacy following death of a man caused by wrong medication in 2007. According to the lawsuit filed in Michigan’s Wayne County Circuit Court in December 2009, 54-year-old John Sheridan died because of Temodar overdose. The technician at the pharmacy gave the cancer treatment drug that was 10 times more potent than the prescribed dose.