The discovery of quality lapses at major drug companies around the nation proves that careless practices and contamination are not confined to inadequately regulated compounding pharmacies. Several major drug factories were found to have unacceptable quality issues, including weevil and spider infestations, mold in production areas, morphine cartridges with twice the labeled dose, and even a barrel of urine.
A Congressional report presents an even graver scenario – close to one-third of the industry’s production capacity is outside of regular protocol. Our defective drug lawyers at Pintas & Mullins Law Firm are concerned about the serious risks that patients face from serious quality breaches.
In the short span of three years, the FDA warned six major injectable drug makers that they were seriously infringing manufacturing rules. Most either considerably slowed down the pace of their production or shut down their factories in order to resolve the issues. This led to a deficit of essential drugs, which made compounding pharmacies an attractive alternative for medical professionals.
Compounding pharmacies may not be reliable. This became obvious after the continuing meningitis outbreak which resulted from injection with a tainted steroid that was produced by a Massachusetts compounding pharmacy. Two generic manufacturers (Sandoz and Teva) of the steroid in question – methylprednisolone acetate – stopped manufacturing it, leading to a shortage of the drug.
Though the majority of sterile injectable drugs marketed in the United States are superior grade, a number of former plant employees and industry observers said that the current quality shortcomings were disturbing. Drug makers were hesitant to resolve the issues because halting production is very expensive in an industry where the degree of profit depends on volume.
The production process attracted greater attention three years back ago when a new FDA commissioner stepped in and vowed to crack down on plant inspections. That same year, Teva was cited for various violations at its Irvine, California-based injectable drug plant.
Other manufacturing companies found to have quality issues include Hospira, Ben Venue (a branch of Boehringer Ingelheim), A.P.P. Pharmaceuticals, Luitpold Pharmaceuticals and Sandoz.
Hospira officials are accused of failing to maintain equipment and firing seasoned employees associated with Project Fuel. At Ben Venue, FDA agency inspectors found urine, mold and rusty tools. At A.P.P., there were complaints of fungal growth and human hair in vials. A previous plant supervisor said that his managers were hesitant to halt production, so they demanded shortcuts that put quality at risk.
Despite this series of overlooked plant violations, plenty of manufacturers spent millions of dollars to fix the quality problems. Ben Venue, for example, spent more than $300 million to improve its Ohio factory. The company also intends to start a new plant to produce cancer drugs.
While more deadly meningitis cases continue to be reported around the nation, one state is seeking broader access to the medical records of hospital patients. An assistant state attorney general in New Hampshire recently requested that a judge order Exeter Hospital to deliver more medical information on all individuals suffering from meningitis.
Reports indicate that more than 30 of the hospital’s patients have already
tested positive for the same hepatitis C strain as a former contract worker
at the hospital. The worker allegedly passed on the virus to these patients
by injecting himself with an anesthetic, then re-using the infected syringes
Federal law regulates the access of hospital patient information. In an effort to protect the privacy of patients, states are only allowed minimal access to hospital records. At a minimum, requests must be limited to a specific time period and to specific patient names.
If you contracted meningitis from a contaminated injection, you deserve to be compensated. Our rare meningitis lawyers at Pintas & Mullins Law Firm are currently evaluating meningitis claims.