Articles Posted in Product Liability

There is a new warning from the U.K. health officials, that states patients who received combination DePuy MITCH and Stryker Accolade metal-on-metal hip replacement components are experiencing a high failure rate.

The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) issued a medical device alert (pdf) on April 2, stating that there is an increased rate of revision surgery among patients who had a DePuy MITCH acetabular cup/modular head used in combination with uncemented Stryker Accolade femoral stems.

The MHRA is advising orthopedic surgeons not to use the components together and to follow up on all patients implanted with the combination of DePuy and Stryker components as part of a metal-on-metal total hip replacement.

In December of 2011, The U.S. Food and Drug Administration (FDA) issued a safety announcement, that it was “evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate).

Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.”

Pradaxa Side Effects

Federal drug regulators are expanding the warnings over the potential heart risks of Celexa, with new dosing instructions for the elderly and people with liver problems.

The FDA issued a new Celexa drug safety communication on March 28, limiting the maximum dose as 20 mg for patients over the age of 60. The limit is also recommended for patients with liver problems, who are taking the anti-ulcer medication Tagamet, or who are poor CYP2C19 metabolizers or are taking a CYP2C19 inhibitor.

Celexa (citalopram hydrobromide) belongs to a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs), and is approved for the treatment of major depression. Celexa is often used off-label to treat other psychological disorders. Celexa is available in brand name form or as a generic in 10 mg, 20 mg and 40 mg tablets, as well as a 10 mg/5 mL oral solution.

According to federal drug regulators, Merck failed to conduct requested testing on their popular diabetes drugs Januvia and Janumet, which was designed to assess the risk of pancreatis from Januvia and Janumet.

The FDA issued a warning letter to Merck on February 17, and the FDA indicated that Merck failed to comply with proper testing for Januvia and Janumet, and therefore the drugs are now considered misbranded.

Merck promised to conduct the three-month pancreatic safety study when the FDA expanded approvals for Januvia and Janumet.

According to new medical research, Byetta and Januvia may cause increased risk of pancreatitis and pancreatic cancer.

A medical study in 2011 found that users of Januvia and Byetta may be six times more likely to be diagnosed with pancreatitis and three times more likely to develop pancreatic cancer.

Byetta (exenatide) is used to control blood sugar levels and is part of a class of medications known as incretin mimetics, which imitate natural hormones that lower blood glucose levels. In recent years, FDA adverse event reports have raised concerns about a link between Byetta and pancreatitis, including severe cases of necrotizing pancreatitis and hemorrhagic pancreatitis, which have resulted in several deaths.

An initial conference has been set for April in the federal multidistrict litigation (MDL) involving all lawsuits over Wright Medical metal-on-metal hip replacements.

In February, the U.S. Judicial Panel on Multidistrict Litigation centralized the Wright Medical hip replacement lawsuits in the U.S. District Court for the Northern District of Georgia.

According to a Pretrial Order issued March 19, the Court is expected to review issues surrounding the organization of the MDL, a deadline for discovery and pretrial motions, as well as a target date for the conclusion of the MDL.

As reported in the New York Times, Johnson & Johnson executives in 2009 phased out their ASR hip implant and sold off their inventory just weeks after the Food and Drug Administration asked the company for added safety data about the implant.

At the same time, the federal regulators told the company that blood tests of some patients who got the all-metal hip showed a “high concentration of metal ions” that it found “concerning.” These concerns were highlighted in the F.D.A. letter, obtained by The New York Times under the Freedom of Information Act.

Officials expressed concern that reports showed that the ASR was performing “somewhat more poorly” than data submitted by the company’s DePuy Orthopaedics unit indicated. By mid-2009, data from the UK and Australia showed that the device was failing at high rates just a few years after implantation, rather than lasting 15 years as expected.

According to a report by Bloomberg News, Johnson & Johnson sold their Gynecare Prolift mesh for several years before obtaining FDA approval. Johnson & Johnson has been subjected to product liability lawsuits brought by women who suffered complications allegedly caused by design defects with the vaginal surgical mesh.

Johnson & Johnson’s Ethicon unit began selling the Prolift mesh in March 2005, but it was not approved by the FDA until May 2008.

Johnson & Johnson sold the Gynecare Prolift mesh without approval, and claimed that it was substantially similar to the Gynecare Gynemesh, which was already on the market.

Canadian health regulators have added new label warnings to Pradaxa, the new blood thinner. In Canada it is known as Pradax. The regulators are warning that the risk of bleeding events may be increased among patients with kidney problems.

The Pradaxa warnings were announced on March 16, and recommend that all patients should have their renal function assessed before starting Pradaxa, and that doctors should assess any changes in renal function while on the treatment, especially among patients over 75 years old.

Health Canada indicated that use of Pradaxa was not recommended for patients with rheumatic valvular heart disease, especially mitral stenosis, or patients with prosthetic heart valves, as the safety and efficacy of Pradaxa has not been studied among those patients.

New medical research suggest that the popular diabetes drugs Byetta and Januvia could increase the risk of pancreatitis and pancreatic cancer.

In a study published this summer in the medical journal Gastroenterology, researchers from the University of California, Los Angeles (UCLA) found a nearly threefold increase in reported cases of pancreatic cancer and a sixfold increase in reported cases of pancreatitis among Byetta and Januvia users.

Researchers also found an increase in thyroid cancer among Byetta users.