By: Martin Healy, Jr. & Dennis M. Lynch
In the past few years we have seen the risks resulting from the import of drugs from foreign countries. Although the Food and Drug Administration (FDA) has the right to inspect foreign manufacturing plants, budget cuts, limited manpower and unfamiliarity with the foreign territories and their procedures have lead to serious problems.
This past year saw a massive recall of one of the oldest pharmaceutical drugs still on the market: Heparin. Following 4 deaths and over 350 other adverse reactions, the FDA ordered a recall of Heparin. Today, the death toll exceeds 80 people. The Heparin case highlights the problems with importing pharmaceuticals from overseas.
Heparin is a widely used anti-clotting medication. It is principally used following cardiac surgeries to prevent blood clots, which can embolize and cause stroke or death if not prevented. It is sold by Baxter International, which has its headquarters in Deerfield, Illinois. Although there have always been side effects associated with Heparin, early last year the FDA began receiving increasingly high reports of adverse reactions to Heparin, culminating in a report of the deaths of four children in Missouri undergoing dialysis. The Heparin was found to be contaminated and was tracked back to a manufacturing plant in China.
Closer scrutiny revealed that the manufacturing plant had not been inspected by the FDA. Because of a paperwork error, the FDA believed the plant had been inspected, but in fact it was another plant with a similar name that had been inspected. Additionally, the Chinese equivalent of the FDA never inspected the plant, because it was not certified as a manufacturer of pharmaceuticals. According to a New York Times report, over 500 manufacturing plants in China export drugs to the United States, but only 13 were inspected by the FDA last year. U.S. Senator Richard Durbin was critical of the FDA’s role in this incident, and other incidents involving products made in China, characterizing the FDA’s measures as “entirely inadequate and indicates not nearly enough is being done to inspect these imports.”
Following the incident, U.S. inspectors were sent to the Chinese plant to conduct an investigation. Although they had traced the problem back to the plant, the source of the problem itself was, at first, unknown. An initial report highlighted several problems with plant, including a lack of specific procedures for removal of impurities, no documentation of the suppliers’ source of the raw materials, and improperly cleaned and maintained equipment.
Further investigation revealed the contaminant was oversulfated chondroitin sulfate, a sugar compound that is molecularly similar to Heparin itself. Because of the similarities, the contaminant was missed during traditional screening methods. Many have alleged the similarity between the two substances suggests the contaminant may have intentionally been placed in the Heparin in an effort to cut costs.
Fortunately, although Chinese plants seem to be the origins of the problem, an injured party will not have to travel to China to seek relief. Under Illinois law, any corporation who sells a pharmaceutical drug in a defective condition is strictly liable for injuries that occur because of the defect. This is true even if the seller was unaware of the defect at the time of the sale and even if there is no negligence on the part of the seller. Strict products liability exists to make sure that the sellers and manufactures of defective products, which reap the financial benefits of their sales, also bear responsibility for the consequences of defective products.
As such, Illinois-based Baxter International, as a seller, will have to answer for the defective Heparin. Indeed, following the FDA recall, several lawsuits have been filed in Cook County Circuit Court against Baxter International. Because Baxter International is headquartered in Illinois, even individuals injured in other states may pursue their claims in Illinois.
In addition to strict products liability claims against Baxter, many are accusing Baxter of having insufficient quality control in place to detect problems from its manufacturing plants. Baxter turns to Chinese manufacturing plants to try and keep production costs low. However, Baxter should keep in mind that allowing its drugs to be manufactured overseas means it loses control over the manufacture, and may allow the devastating results like we have seen with Heparin.
Notably, despite actions by the FDA and Baxter, contaminated Heparin may still be in circulation. As recently as last month, the FDA took the rare step of seizing contaminated Heparin from a small Cincinnati, Ohio manufacturer. The FDA alleged that the manufacturer was not taking necessary steps to detect and remove contaminated Heparin or to warn patients who may have been exposed to the Heparin.
As you read this article, a new federal administration is either preparing to take office or has recently taken office. One of the many tasks ahead of them is to fund and staff the FDA and to give the FDA a mandate to toughen inspections on foreign manufacturers and foreign or local pharmaceutical sellers. In the meantime, we all must ensure that sellers and manufacturers are held responsible when injuries occur because of defective products.
Healy Scanlon Law Firm has in the past represented injured victims in cases involving Heparin and other defective drugs. If there are any questions, feel free to call the firm.