Shandra Eisenga Human Cell and Tissue Product Safety Act

Floor Speech

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Mrs. DINGELL. Mr. Speaker, I rise today to share my strong support of H.R. 1082, the Shandra Eisenga Human Cell and Tissue Product Safety Act.

I am very proud to lead this bill with my good friend and colleague from Michigan, Representative John Moolenaar. Both of us have been very personally involved with the family and learning where there are serious deficiencies within our government.

In the summer of 2023, I was contacted by the medical director of the Washtenaw County Tuberculosis Clinic and head of public health who was treating Shandra for a severe postsurgical tuberculosis infection. She was Representative Moolenaar's constituent but was being treated at a medical facility in my district. After a month battling a severe TB infection in the intensive care unit, Shandra unfortunately died.

Since Shandra's passing, it has been discovered that her death was, indeed, linked to contaminated bone graft material. She was 1 of 36 patients who received material from the contaminated lot, and this latest outbreak is linked to the deaths of two patients, including Shandra.

It had been preceded 2 years before by an outbreak, again, linked to contaminated bone allografts, which resulted in multiple deaths. The outbreak then infected 113 patients across 18 States, and it led to at least 3 confirmed TB-related deaths with some sources citing a total of 8 deaths.

This has to stop. Too many people get bone grafts and have no idea, including the doctor that did a bone graft on me, that they even needed to worry about this.

This bill requires the Department of Health and Human Services to conduct research and education campaigns to prevent TB outbreaks caused by contaminated human cell and tissue product donations.

Through the markup process, we have also included an important provision to allow the Federal Government to pursue civil penalties from providers who caused an outbreak of the infectious disease. Patients deserve to know the risks associated with tissue donations and companies that make and distribute contaminated products must be held accountable for their actions.

Mr. Speaker, I thank the Energy and Commerce Committee Chair Guthrie, my dear friend Mr. Bilirakis, and Ranking Member Pallone for fighting for this important piece of legislation.

Again, I thank Representative Moolenaar for being such a great bipartisan partner. We owe it to Shandra, her family, and every other patient who has been affected by contaminated bone grafts to ensure we are doing everything we can to prevent these unnecessary tragedies from ever happening again.

Mr. Speaker, I urge my colleagues to vote ``yes'' on this important bill.

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