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Defective Medical Devices
Allograft Implants
Guidant Defibrillators
Medtronic Marquis® Defibrillators
Medtronic Sigma™ Pacemakers
Ortho Evra® Patch
Sulzer Hip

Allograft Implants
Allograft implants are used in numerous types of reconstructive surgeries that require extra bone, skin, cartilage, tendons and connective tissue. The implants, which are harvested from donors (usually cadavers at time of death), allow surgeries to be performed without extracting tissue from the patient.

In recent years, it has been uncovered that the top U.S. tissue transplant companies have been more focused on profit than on safety or ethics. Cryolife, the leading provider of transplanted human tissue, was cited by the FDA for regulatory violations due to negligence that could have caused allograft contamination. In 2002, Cryolife was ordered by the FDA to recall and destroy all of its human tissue products. Although the company’s ability to distribute allograft products has since been reinstated, contaminated tissue was linked to several deaths and many medical complications.

In the fall of 2005, Biomedical Tissue Services (BTS) was required to recall its allograft products due to its involvement in the theft and distribution of bone and tissue products. The company not only stole the allografts from non-donor cadavers, but it also failed to screen the illegally harvested bone and tissue for disease, subjecting unknowing recipients to infections and other serious health problems.

If you feel that you or a loved one might have received contaminated allograft implants, call our Law Firm we can help.


Guidant Defibrillators
Like Medtronic defibrillators, Guidant’s implantable cardioverter defibrillators (ICD) are supposed to help prevent cardiac deaths; however, product flaws have caused many of the ICDs to malfunction. These defective defibrillators have failed at least 45 times and have been linked to at least two wrongful deaths. Guidant recalled about 50,000 ICDs due to a short-circuiting malfunction, and the company announced that another 45,000 devices may have faulty switches.
An independent research panel appointed by Guidant found that the engineers at the company were making medical decisions without consulting doctors. It was also discovered that Guidant did not alert physicians of possible risks associated with the defibrillators.

If you have been injured by a defective Guidant defibrillator, call our Law Firm we can help.


Medtronic Marquis® Family of Defibrillators
Implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) are implanted in patients who are at high risk for sudden cardiac death. The devices monitor the heart for irregular heartbeat or arrhythmias. When an irregularity occurs, the defibrillators deliver an appropriate shock to prevent a heart attack. The Medtronic Marquis® family of ICD and CRT-D devices with batteries manufactured prior to December 2003 may be prone to rapid battery depletion due to a specific internal battery short mechanism. If the defibrillator’s battery fails, the results could be deadly.

In February 2005, Medtronic issued a statement that 87,000 units were sold with the defective batteries. The defective defibrillators include Marquis® VR (model 7230) and DR (model 7274), Maximo® VR (model 7278), InSync I /II /III Marquis™, and InSync III Project™ (models 7277, 7289).

If you or a loved one has been adversely affected by any of the defective Medtronic defibrillators, call our Law Firm we can help.


Medtronic Sigma™ Series Pacemakers

The Medtronic Sigma™ series pacemakers are surgically implanted and attached to the heart by wires. These small, battery-powered devices are designed to monitor the electrical impulses of the heart and ensure that a normal heart rate is maintained. However, it has been discovered that some of the Medtronic Sigma™ series pacemakers have a faulty connection, allowing for a separation of the wiring from the hybrid circuit. Such a disconnection of the wires will cause the pacemaker to fail and may put patients’ lives in danger. The surgery to replace these devices also creates unnecessary health risks since the likelihood of post-surgical infection is higher for patients with weakened immune systems. If an infection does occur, then all of the hardware has to be removed in a potentially dangerous procedure.

If you have a pacemaker from the Medtronic Sigma™ series, call our Law Firm we can help.


Ortho Evra® Patch
The Ortho Evra® patch, manufactured by Ortho-McNeil Pharmaceutical, Inc., is a birth control patch that was approved by the FDA in November 2001. The adhesive patch has become the most popular form of prescribed birth control in the United States, used by over five million women. Marketed to doctors and their patients as safe and “effective as the pill but even simpler,” the Ortho Evra® patch works in the same way as oral birth control pills: they both release a constant supply of hormones in order to prevent ovulation and therefore pregnancy. However, the Ortho Evra® patch releases 60 percent more estrogen into a woman’s bloodstream than does the average birth control pill.

The patch has become associated with serious side effects including blood clots, stroke, heart attack, coma, and death. The FDA reports that at least 17 women between the ages of 17 and 30 have suffered serious and fatal side effects since 2002. Ortho-McNeil began warning the public about the high dose of estrogen and related health risks in November 2005.

The Ortho Evra® patch is currently the focus of lawsuits filed on the behalf of victims who have experienced serious injury or death after using it. If you or someone you love has suffered serious side effects while using the Ortho Evra® patch, call our Law Firm we can help.


Sulzer Hip
The Sulzer Inter-Op™ Acetabular Shell is an orthopedic implant used in hip replacement surgeries. Unlike traditional implants that must be screwed or cemented into place, the Inter-Op™ shell was designed to allow the bone to bond naturally with the device. During the manufacturing of the Sulzer hip joint replacement, lubricant residue was left on the device. This residue hindered the shell from properly fusing with the bone, causing many patients to suffer from extreme groin pain and the inability to bear weight on their leg.

In December of 2000, Sulzer voluntarily recalled approximately 40,000 units of its Inter-Op™ Acetabular Shell, of which about 26,000 had already been implanted in patients. In May 2002, a U.S. district court approved a class action settlement against Sulzer regarding the defective products.

If a defective Inter-Op™ shell was used as part of your hip replacement surgery, call our Law Firm we can help.

We are committed to our clients. If you or a family member has suffered a loss - call us day or night at 1-888-513-6198 or locally at 210-922-2200

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