Although safety and quality standards for the pharmaceutical industry have been strengthened in the past decade, contaminated and defective products still enter the market and injure or kill innocent patients throughout the U.S. and Florida.
In this blog post, we’ll look at two pharmaceutical products that have done irreparable and even fatal harm to unsuspecting patients. In the first case, the pharmaceutical manufacturer and distributor are presently being sued for negligence. In the second case, the pharmaceutical manufacturer was sued and had to pay millions of dollars in damages to hundreds of patients for producing a defective product that caused serious injuries and death.
Contaminated Stem Cell Therapy
According to a recent Washington Post report, at least 17 people, including 5 from Florida, have been hospitalized in the past year after receiving injections of umbilical cord blood products. The patients’ injection-induced symptoms range from swollen spinal discs and abscesses in their backs to infected blood, bones and joints. Several of the patients have had to be hospitalized for a month or more and are still in pain months later.
The Centers for Disease Control and Prevention’s initial 2018 investigation into adverse health events following injections of umbilical cord blood found E.cloacae, C.freundii, E.coli, and E.faecalis in vials of products processed by Genetech, Inc. and distributed by Liveyon, LLC. It appeared that the bacterial contamination happened prior to distribution at Genetech’s facilities, not at health clinics, as originally thought.
After the U.S. Food & Drug Administration and other health officials started investigating reports of infection from its stem cell product, ReGen, Liveyon recalled all of its potentially contaminated vials and stopped selling products processed by Genetech. However, this action came too late to prevent damage to the patients already injected with the contaminated product and suffering from serious septic conditions caused by bacterial contamination.
Thus far, four of the victims have filed suit against their healthcare providers, Liveyon and Genetch, claiming the contaminated “stem cell” product was negligently injected, negligently manufactured, negligently marketed, and negligently distributed. The plaintiffs are requesting compensation for their physical pain, mental anguish, medical and care expenses incurred as a result of the negligent treatment, and damages resulting from not being able to perform tasks and services that they would otherwise have been able to perform.
Contaminated Heparin from Baxter Healthcare Corporation
In 2008, the U.S. Food and Drug Administration (FDA) ordered a recall of heparin produced by Baxter Healthcare, after noting that many patients and doctors had reported severe reactions to the blood thinner drug. The adverse reactions included vomiting, decreased blood pressure, excessive sweating, and difficulty breathing. In some severe cases, it had even caused death.
A Centers for Disease Control and Prevention investigation of 152 negative reactions associated with heparin administered to 113 patients in 13 states, found that heparin manufactured by Baxter Healthcare was the cause. The Baxter product was contaminated by oversulfated chondroitin sulfate (OSCS), a compound consisting of animal cartilage. The compound supplied by Changzhou SPL, a Chinese firm, had been introduced into crude heparin as a cost-saving measure.
According to reports following the CDC investigation, the contaminated product injured over 700 people and killed more than 80. By showing that Baxter manufactured, marketed, and distributed a product they knew or should have known was defective, these victims and their families have won millions of dollars in numerous product liability and wrongful death lawsuits.
Help from Experienced Product Liability Attorneys
Unfortunately, those injured by contaminated heparin and contaminated umbilical cord blood are not alone. Each year, hundreds of patients seeking health care are seriously injured due to defective pharmaceutical products. CDC and FDA investigations and recalls are important to prevent additional injuries, but they don’t help those who have already suffered the effects of contaminated or defective pharmaceuticals.
For help when you or a family member has been seriously injured by a defective product, contact experienced Miami defective product attorneys. The premier attorneys of Boyers Law Group have successfully litigated numerous product liability lawsuits throughout Florida and have achieved substantial verdict and settlements on behalf of our clients.
Blossom, D.B., Kallen, A.J, Patel, P.R., et al. (2008, Dec. 3). Outbreak of adverse reactions associated with contaminated Heparin. New England Journal of Medicine.
Dmyterko, K. (2011, June 10). Baxter pays $625K in first heparin contamination suit. Cardiovascular Business. https://www.cardiovascularbusiness.com
Dinning v. Liveyon. Dist. Ct. Harris Cnty. Tex. 2018. Unofficial Copy of Dist. Clerk.
Perkins, K.M., Spoto, S., Rankin D.A., et al. (2018, Dec. 21). Notes from the field: Infections after receipt of bacterially contaminated umbilical cord blood-derived stem cell products for other than hematopoietic or immunologic reconstitution – United States, 2018. https://www.cdc.gov
Wan, W. (2019, Feb. 27). ‘Miraculous’ stem cell therapy has sickened people in five states. The Washington Post. https://www.washingtonpost.com/