Tainted Tissue Lawyers & Attorneys | Legal Information

Tainted Tissue Lawyers & Attorneys | Legal Information

Breaking News: April 18, 2007

Acting in the best interest of public safety, the Food and Drug Administration took possession of all implantable medical devices from Shelhigh, Inc. on April 18, 2007. Investigators from the FDA discovered serious problems with production processes such as improper sterilization and extension of expiration dates past their appropriate deadlines at Shelhigh's Union, New Jersey plant. Some of the devices affected by this FDA Preliminary Public Health Notification include:

• Shelhigh BioRing™ (annuloplasty ring)
• Shelhigh Gold™ perforated patches
• Shelhigh Internal Mammary Artery
• Shelhigh No-React® Dura Shield
• Shelhigh No-React® EnCuff Patch
• Shelhigh No-React® Pericardial Patch
• Shelhigh No-React® PneumoPledgets
• Shelhigh No-React® VascuPatch
• Shelhigh No-React® Stentless Valve Conduit
• Shelhigh No-React® Tissue Repair Patch/UroPatch™
• Shelhigh Pericardial Patch
• Shelhigh Pre Curved Aortic Patch (Open)
• Shelhigh Pulmonic Valve Conduit No-React® Treated
• Shelhigh BioConduit™ stentless valve
• Shelhigh BioMitral™ tricuspid valve
• Shelhigh Injectable Pulmonic Valve System
• Shelhigh MitroFast® Mitral Valve Repair System
• Shelhigh NR2000 SemiStented™ aortic tricuspid valve
• Shelhigh NR900A tricuspid valve

The FDA recommends that if you use any of these products that you consult your doctor immediately to determine what is the appropriate medical course of action.

Types of Infected Body Parts

There are thousands of occasions where people may need to replace a worn or injured body part.  Disease, accident, and injury can all cause grievous damage that requires an organ transplant, and most people take for granted that their new body parts will be safe and disease-free.  Unfortunately, a ring of illegal organ harvesting has tainted the entire organ donor business due to a number of serious infections that stemmed from ill-gotten tissues.  There is a very real fear that many of the patients run the risk of developing Hepatitis B, Hepatitis C, AIDS and syphilis because of the lack of safety protocols and testing to ensure that the tissues weren’t infected.

Bone Grafts

Bone grafts involve bone taken from a donor area for transplant into a recipient body.  Doctors make frequent use of bone grafts for a variety of situations, but by far the most common use is in dental implants. Bone grafts enable doctors to repair bone to ensure proper healing, but reports of bone illegally harvested from bodies potentially infected with Hepatitis and AIDS casts a long shadow over the transplant industry.

Skin Grafts

Skin grafts are used to transplant skin tissue to areas subjected to damage from trauma, burns, infection, or used in certain procedures that require new skin for proper healing.  Although many skin grafts use skin transplanted from the patient’s own body, some require more extensive grafts.  Recipients of these donated grafts could develop serious side effects if they are tainted with a contagion such as Hepatitis or AIDS.

Organ Transplants

Major organ transplants are perhaps the most dramatic of all transplant procedures.  Hearts, livers, lungs, bone marrow, and kidney transplants can mean the difference between life and death, but if they are contaminated with a disease they can destroy an otherwise healthy body.  These are precision procedures, and are complicated enough without adding the potential for disease or infection due to poorly screened tissues.

Dental implants

Dental implants are used to help people restore their mouths to proper health condition.  There are many reasons people need dental implants, but most frequently large segments of bone have been destroyed due to disease or infection. Dental implants need a great deal of bone in order to properly integrate into the surrounding structures, so bone grafts help provide support and where there is insufficient bone to provide a healing scaffolding.  If this bone is tainted or contaminated, recipients can develop potentially life-threatening complications.

Discovering that you are the recipient of a tainted tissue transplant is unsettling and disturbing.  If you or someone you love was injured due to a tainted tissue transplant, you may be entitled to take legal action against those responsible.  Let a dedicated and compassionate tainted tissue attorney help you through this difficult time and get you the financial compensation you deserve.  Contact one today.

Infected Body Part Story Timeline

The sordid story of the infected body parts timeline began when transplant recipients began to complain of severe infections of undetermined cause.  By the end of the debacle there were 13,000 tainted transplant pieces of which 8,000 were actually implanted into unwitting victims.

2001 – Former oral surgeon Michael Mastromarino and embalmer Joseph Nicelli begin a tissue harvesting company called Biomedical Tissue Services.

2002 – The pair first start harvesting tissues from unwitting victims and bodies.

2004 – The first complaints of contaminated tissue prompt a police investigation of a funeral home Nicelli sold.

October 7, 2005 – The media discovers the investigation of the funeral home

October 13, 2005 – The Food and Drug Administration recalls all tissues unused by BTS.

November 2005 – Medical giant Medtronic states that it of the 13,000 tainted tissues samples it received, 8,000 of them were implanted in victims.

February 3, 2006 – Due to mounting pressure from the media and healthcare professionals, the FDA shuts down Biomedical Tissue Services.

February 23, 2006 Mastromarino and Nicelli and two others are named in a 122-count indictment in Brooklyn, New York.

March 8, 2006 – Authorities in Brooklyn ready indictments against other funeral home employees.

April 23, 2006 – Patients nationwide are now developing infections of Aids, Hepatitis B and C, and syphilis. 100 people in Atlanta were informed they potentially received tainted tissues, organs, and body parts.

These criminals attempted to circumvent the normal tissue harvesting process in order to make a profit. Tissue harvesting is a billion dollar a year business, and by illegally harvesting tissue from corpses without proper screening they exposed thousands of people to potentially deadly diseases.

If you or someone you know was the victim of a tainted tissue transplant, you need to consult an attorney immediately. There are state laws that limit the amount of time you have to take action against those responsible, so you need to act quickly to ensure you do not lose out on the financial compensation you deserve.  Contact a lawyer today.

FDA Letter to Biomedical Tissue Services

On January 31, 2006, the Food and Drug Administration sent a letter to Biomedical Tissue Services, LTD that ordered the company to cease and desist the manufacturing and distribution of human cells, tissues, and cellular and tissue-based products (HCT/Ps) due to numerous violations of Public Health Service Acts and Federal Regulations.  These violations created a public health concern because many of the donors of the tissue in question did not meet the standards of safe tissue harvesting.   The FDA pointed out seven specific conditions in the procedures of Biomedical that caused these concerns to arise:

1. Failure to implement standard operating procedures (SOPs) for all steps in determining donor eligibility
2. Failure to implement the SOPs established for all steps to determine donor eligibility, regarding assessment of risk factors for, or clinical evidence of, relevant communicable disease agents and diseases
3. Failure to create and maintain accurate records of donor eligibility and viability
4. Failure to implement the SOPs established for donor eligibility determinations specifically for documenting and confirming the identity of the donors' next of kin
5. Failure to implement the SOPs established for donor eligibility determinations
6. Failure to recover HCT/Ps in a manner that does not cause contamination or cross-contamination during recovery
7. Failure to implement SOPs established for donor eligibility determinations, specifically to confirm whether an autopsy was performed.

The FDA then alerted the tissue distribution centers LifeCell Corporation of Branchburg, NJ, Lost Mountain Tissue Bank of Kennesaw, GA, Blood and Tissue Center of Central Texas in Austin, TX, Tutogen Medical, Inc., of Alachua, FL, and Regeneration Technologies, Inc., of Alachua, FL that the transplant material they received from BTS could potentially be contaminated with Hepatitis, AIDS, and/or syphilis. These firms recalled all remaining tissue samples to prevent further public health issues.
Experts still speculate on the long term consequences of the gruesome actions of Biomedical Tissue Services. Although the FDA now requires extensive testing of prospective tissue, the 8,000 people who received tainted tissue must now live in constant fear and anxiety because of the greed and avarice of disreputable businessmen. If you are the victim of tainted tissue, you must consult a lawyer immediately, for you may be entitled to financial compensation for your pain and suffering. Let a compassionate and dedicated attorney help you get the restitution you deserve today.

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