Monthly Archives: June 2013

Mutual Pharmaceutical v. Bartlett Lawsuit

Mutual Pharmaceutical v. Bartlett Lawsuit
This week, in a far-reaching decision, the U.S. Supreme Court demonstrated once again that pro-business decisions are defining the Roberts court.
In a case involving Philadelphia’s Mutual Pharmaceutical Co., the court split 5-4 along the traditional conservative-liberal line to award a victory for the drug industry and, indirectly, the U.S. Food and Drug Administration. The court ruled that federal law related to pharmaceutical regulations preempts a person’s ability to sue in state courts and allege that a generic drug is designed badly.
The generic drug industry, which accounts for almost 80 percent of the U.S. market, now has a blanket exemption from liability. The ruling means that consumers who take name-brand drugs can sue for damages, but consumers who take a generic version of the same drug can’t sue
This ruling came from the case of Mutual Pharmaceutical Company v. Bartlett. Karen Bartlett suffered a rare, severe skin reaction three weeks after starting therapy with a generic version of the pain reliever Clinoril. She is now legally blind. She claimed not only that Mutual didn’t adequately warn of its drug’s dangers, but also that the product was defective and shouldn’t have been sold. A jury awarded her $21 million for her injuries. Mutual Pharmaceuticals argued that the product and its label were FDA-approved and that those approvals preempt Bartlett’s state-court claims.
The conservative majority wrote that Bartlett’s situation was “tragic and evokes deep sympathy,” but said the law requires that the judgment of the lower court be reversed.
Business decisions by the Supreme Court are almost always overshadowed by cases on controversial social issues. But the business docket reflects something truly distinctive about the court led by Justice John G. Roberts Jr. Studies have shown the current court over all is only slightly more conservative than the courts led by Justices Warren E. Burger and William Rehnquist. Business decisions have been far friendlier to business than any court since at least World War II.
Since the Bartlett decision, Senate Judiciary Committee Chairman Pat Chairman Patrick Leahy (D-Vt.) and five other lawmakers wrote to FDA Commissioner Margaret Hamburg and asked her to rewrite regulations so people can sue generic drug manufacturers for injuries.
“A consumer should not have her rights foreclosed simply because she takes the generic version of a prescription drug,” Leahy said.
While the FDA has indicated they will review the court decision, given the language of the federal statute, it is unlikely they will be able to change the regulations. Past rulings by the agency have been unusually favorable to generic drug manufacturers.
But what remains most troubling in the Bartlett ruling is that the court has stripped consumers of their 7th Amendment rights to access the court and allowed a multi-billion dollar industry to operate without impunity over the consumers they serve.

Hip Replacement Implant Lawsuit News

Hip Replacement Implant Lawsuit News
From our main website:
Read more about defective hip implant devices here: or click here to contact us today.
The massive failure of metal-and-metal hip implants is one of the biggest medical device failures in history. It is a cautionary tale of our time — of what happens when the safety of patients succumbs to lax oversight, outright negligence and the drive for corporate profits.
It is, in the simplest of terms, about greed.
When metal-on-metal hips were introduced they were designed to last longer and allow for high-impact activity, such as running and jumping.
But within a few years, problems began appearing. Patients complained of acute pain and becoming immobilized by joint dislocations, infections and bone fractures. Metal-on-metal hip implants were found to be problematic because, according to the Food and Drug Administration, their components were shown to grind together and shed metallic debris. This metallic debris can damage tissue and bone and metal ions can enter the bloodstream.
DePuy Orthopedics, a division of Johnson & Johnson, was the largest maker of metal-on-metal hips and over 93,000 of the company’s A.S.R replacement joint were implanted worldwide. Even before the company began marketing the A.S.R in the United States in 2005, they had been receiving complaints for years from doctors in Europe. Consulting surgeons to DePuy in Europe stopped using the device because of its poor record.
In 2007, DePuy conducted internal tests on the A.S.R and the joint failed, and reported, “The current results for A.S.R. do not meet the set acceptance criteria for this test.”
The company considered a redesign but in 2009 the Food and Drug Administration rejected an application to sell a resurfaced version of the A.S.R. in the United States. In 2010 the company was forced to issue a recall of the defective implants. Documents have since shown that DePuy executives then started calculating when the company should stop selling the A.S.R., based on the time it would take to convert surgeons to another company implant.
But DePuy was only the largest maker of metal-on-metal hip replacements. Other companies making metal-on-metal hip implants began receiving eerily similar complaints. Dislocations, infections, and pain were common in recipients.
Stryker, maker of the Rejuvenate and ABGII, recalled both hip replacement systems in July 2012. Worldwide, 30,000 of the Stryker hip systems were installed; 20,000 of them in U.S. patients. Both implants were found to be prone to corrosion, joint dislocation, and the release of metal ions which can cause metallosis, tissue inflammation, necrosis and death.
Other smaller manufacturers have also recalled their metal-on-metal hip joints such as the Smith & Nephew R3 and the Zimmer Durom Cup. However, even in spite of the dangerous health threats metal-on-metal joints are proven to pose, several products remain on the market. The Biomet Magnum, the Encore and the Wright Profemur Converse, Dynasty and Lineage, remain available, but are all failing at unacceptably high rates.
Unlike new drugs, the metal hip replacements didn’t have to undergo clinical trials before receiving approval from the FDA, the government agency with the role of protecting consumers from dangerous products.
Without rigorous independent testing that would have uncovered the dangers of metal-on-metal joints, the responsibility fell on the companies that manufactured them to insure their safety. In almost every case they failed miserably and decisions were made based on profits rather than the health and safety of the patients they served.
By 2008, DePuy was well aware of the design flaws in the A.S.R. but continued to actively market it to surgeons in the United States, who then implanted it into tens of thousands of patients. Knowing full well they had a defective product, a top sales official in the company wrote to a colleague that, “We will ultimately need a cup redesign, but the short-term action is to manage perceptions”
For the Stryker Rejuvenate and ABGII hip replacement systems, some doctors have predicted the failure rate might go as high as 70 percent. That would mean over 20,000 patients with the implant will have to undergo painful revisions on top of the painful complications they’ve already endured.
According to a filing with the Securities and Exchange Commission, since the A.S.R. was recalled more than 10,000 lawsuits have been filed against Johnson & Johnson.. In March, a California jury awarded $8.3 million to a retired prison guard who sued the company over health complications caused by his A.S.R. implant. Analysts predict total damages for the company could eventually reach a billion dollars or more.
The failure of the Stryker Rejuvenate and ABGII has so far led to over 100 lawsuits being filed in Bergen, N.J., where the company’s headquarters are located. With over 20,000 of the defective implants in U.S. patients, analysts expect the number of lawsuits against the company to grow dramatically.
There are many reasons patients elect to have hip-replacements, but in every case, regardless of the medical cause, patients all expect to have a better quality of life. In tens of thousands of patients, the failure of metal-on-metal joints in patients who elected to have them implanted has damaged their health and quality of life in ways that may be irreversible. Revised artificial hips often perform worse than a first prosthetic because of issues with bone loss and fit, and in addition to the pain and suffering, they are likely to never recover the same quality of life they expected.
More oversight and corporate governance that placed patient welfare above the bottom line could have prevented these patients’ suffering. But as the lawsuits continue to mount, it is clear what was at the root of this health disaster – greed.

Stryker Rejuvenate and ABG II Hip Implant Lawsuits Go to Minnesota Judge

Stryker Rejuvenate and ABG II Hip Implant Lawsuits Go to Minnesota Judge
A June 12, 2013 Court Order assigned lawsuits involving the Stryker modular neck hip implant recall to United States District Judge Donovan W. Frank in Minneapolis, Minnesota. The National Judicial Panel for the federal courts had been considering attorneys petitions to centralize all of the lawsuits involving the recalled Stryker Rejuvenate and ABG II hip implants before a single judge.
This procedure is called multidistrict litigation under the federal court rules. It is not a class action. It merely coordinates all of the individual lawsuits before a single judge to avoid conflicting rulings on the same issues. It also helps to coordinate the progress of all of the cases together in the discovery process. Multidistrict litigation is very common in medical product or drug recall cases where there are many lawsuits over a defect or recall in a single product. The legal issues about the safety of the product and what the manufacturer knew and when they knew it are common issues to all of the cases. Each person who was injured by the product may have somewhat different injuries and financial losses but the legal liability of the Company is likely to be the same in all of the cases.
The federal multidistrict judge will set up a schedule to move the cases forward towards trial and also supervise and encourage the parties efforts to settle the lawsuits.
The Stryker Rejuvenate and ABG II hip implants were recalled in July of 2012 after being on the market for less than three years. These products are designed with a modular neck between the stem in the femur and the ball that goes into a cup that is set in the pelvis. This modular neck was designed to allow the surgeon to pick different lengths and angles for the modular neck to try to get the best alignment and leg length for the artificial hip. Prior implant designs merely had a stem in the femur and a ball that could be placed on the end of the femur stem.
Our lawsuits against Stryker allege that the modular neck design was defective and negligent because the multiple joints involved can move slightly causing damage to the metal, corrosion and leaching of cobalt and chromium into the patients hip tissue and blood stream. This metal poisoning is called metallosis. When the hip tissues become damaged by the metallosis the hip must be removed in an operation call a hip revision and a new hip implanted.
A new article in the Journal of Bone and Joint Surgery confirms the same theory that we are alleging in our lawsuits. The 2013 article is titled Adverse Local Tissue Reaction Arising from Corrosion at the Femoral Neck-Body Junction in a Dual-Taper Stem with a Cobalt-Chromium Modular Neck. The article was written by H. John Cooper, MD, Robert M. Urban, PhD, Richard L. Wixson, MD, R. Michael Meneghini, MD, and Joshua J. Jacobs, MD.
The peer reviewed scientific article was based upon a case study of 12 hip implants involving the Stryker Rejuvenate and ABG II hip implants that had failed. There are a number of earlier medical studies that had suggested this risk years before that should have put Stryker on notice that a modular neck design would have these problems but Stryker marketed the product anyway. This is one of the key reasons why we believe Stryker should be held liable in the lawsuits.
Read more about the Stryker Rejuvenate at Stryker Hip lawsuit Website