Monday, March 18, 2013

Spine Stimulator Lawyer: St. Jude Stimulators, Medtronic Stimulators, and Boston Scientific Stimulators May Malfunction Causing Pain and Requiring Removal by Spinal Stimulator Lawyer Jason S. Coomer

Spine Stimulator Lawyer: Implantable Neurostimulation Systems Including St. Jude Stimulators, Medtronic Stimulators, and Boston Scientific Stimulators May Malfunction Causing Pain and Requiring Removal by Spine Stimulator Lawyer Jason S. Coomer

Several Implanted Spine Stimulators have malfunctioned including locking on and failing to work causing significant pain and many situations additional surgeries to repair or remove the implanted stimulators. Persons with or thinking about receiving an implanted spine stimulator, should speak with their health care provider about the potential health risks of having a spine stimulator implanted in them as well as make sure that the device is being used for an FDA approved indication.

Persons that have experienced severe shocks, malfunctioning batteries, and other problems with an implanted spinal stimulator, should consult their health care provider and make sure that any adverse health events are reported to the FDA. For more information on spine stimulator lawsuits, please go to the following web page: Defective Spine Stimulator Lawsuit Information or please feel free to send an e-mail to Spine Stimulator Lawyer Jason Coomer.

Implantable Spinal-Devices Are a Multi-billion Dollar Industry and the Leaders In the Industry Are Medtronic, St. Jude Medical, and Boston Scientific

Implantable Neurostimulation Systems and other spinal-devices are a huge business for the medical implant device industry.  The global market for spinal-devices is currently over $ 3 billion per year and is expected to increase to over $5 billion per year by 2018.  Currently, the major manufacturers in the neurostimulator market are Medtronic, St. Jude Medical, and Boston Scientific.
Neurostimulators have been used for a variety of types of chronic back pain situations including heriniated disks, postlaminectomy paid, Complex Reginal Pay Syndrome, unsuccessful disk surgery, Degenerative Disk Disease, and Failed Back Syndrome. The Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) as an aid in the management of chronic, intractable pain of the trunk and/or limbs—including unilateral or bilateral pain associated with several different conditions.   Unfortunately, because of the profits to be made from implanting a spinal stimulator, many people have received spinal stimulators for off-label or non-approved indications.  

Medical professionals that are aware of significant off-label use of spinal stimulators are encouraged to properly report any Medicare fraud or Medicaid fraud that may be occurring.  Please feel free to go to the following web page for information on Qui Tam Whistleblower Reward Lawsuits and Reporting Medicare Fraud
FDA Action on Spine Stimulators

The U.S. Food and Drug Administration (“FDA”) issues warning letters when it finds certain problems that it wants a company to fix.  In a letter dated July 17, 2012, the FDA issued a warning letter related to Medtronic’s process for handling complaints and stated that regulatory action might ensue should the manufacturer fail to address the agency’s request to take action. The FDA also issued a warning letter to St. Jude Medical, resulting in the company’s announcement that there were weld failures present within the internal batteries of their units. Physicians and Patients who may have been implanted with defective stimulators are being notified individually by St. Jude Medical. Since the problem surfaced in 2011, over 300 heat-related complaints have been filed on behalf of carriers of defective units and several lawsuits have been filed. The failure of a stimulator to operate correctly has had many effects on our clients. At a minimum, defective devices expose clients to the very pain the devices are supposed to relieve. In addition to increased pain, other symptoms our clients have reported experiencing include:
  • Severe irritation and  burning at the battery site
  • An inability to control the stimulator (resulting in unwelcome jolts, pain, or temporary paralysis)
  • Severe burns while recharging the battery
  • Premature battery depletion
  • Bladder problems
  • Increased numbness
  • Lead migration and broken anchors
  • Partial paralysis
In most cases, when a stimulator is found to be defective it must be removed. This surgery can be both costly and cause its own complications. Not only is there always a risk of infection with every surgery, but because the removal of a stimulator requires navigating delicate nerves in the spine, it is possible that nerves can be nicked or otherwise damages during the procedure leading to symptoms such as weakness, pain, or numbness in the body. In some cases, removal of the simulator can result in a leakage of spinal fluid from the epidural space, leading to severe and long-lasting headaches or feelings of fatigue which may heal on its own or may require its own surgery to repair.

Spinal Stimulator Lawsuit Information

In reviewing potential failed back surgery implant lawsuits, it is important to obtain copies of your medical records and to determine if the implantable neurostimulation system was properly implanted by the spinal surgeon or if the spinal stimulator was defective.  If the spinal stimulator was defective and has/had to be removed, it is important that the defective device is kept as potential evidence.  For more information on this topic, please feel free to go to the following web page, Failed Back Surgery and Defective Implantable Neurostimulation System Lawsuits  or please feel free to send an e-mail to Defective Spinal Stimulator Lawyer Jason Coomer.

Thursday, March 14, 2013

Incretin Drug Cancer Risk: Diabetes Drugs in the Incretin Mimetic Class May Cause an Increased Risk of Pancreatic Cancer and Pancreatitis By Incretin Drug Pancreatic Cancer Lawyer Jason S. Coomer

Incretin Drug Cancer Risk: Diabetes Drugs in the Incretin Mimetic Class May Cause an Increased Risk of Pancreatic Cancer and Pancreatitis By Incretin Pancreatic Cancer Lawyer and Diabetes Incretin Drug Cancer Lawyer Jason S. Coomer

Diabetes drugs in the incretin mimetic class may cause an increased health risk of pancreatic cancer and pancreatitis.  These incretin diabetes drug include  exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. They are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

Many of these incretin diabetes drugs already include a black box warning regarding thyroid cancer risk, but evidence is growing that these drugs may also create an increased risk of pancreatic cancer. People that are taking incretin diabetes drugs including: Januvia, Janument, Victoza, Byetta, Onglyza, Tradjenta, Bydureon, Oseni, and other diabetes drugs should be aware of the cancer health risks. If you have been taking a diabetes drug and have been diagnosed with Pancreatic Cancer or you have lost a loved one that was taking a diabetes drug and the loved one was diagnosed with pancreatic cancer, please report the adverse action to the prescribing medical doctor and FDA as soon as possible.

FDA Drug Safety Communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes

The U.S. Food and Drug Administration (FDA) is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes. FDA has asked the researchers to provide the methodology used to collect and study these specimens and to provide the tissue samples so the Agency can further investigate potential pancreatic toxicity associated with the incretin mimetics.