Heparin Class Action
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Heparin Lawsuits
The biggest story of damaging medical products this year has been the ongoing drama involving the heparin recall. Heparin is a widely used anticoagulant that is given to patients during heart surgery and other procedures including non-surgical treatments such as kidney dialysis.
Baxter Healthcare Corporation produces about half the heparin used in the United States. In February of this year the company instituted two recalls of its heparin products, the second expanding upon the first to include many more dosages and heparin devices. The FDA has issued multiple public advisories and warnings to medical facilities about the dangers of using contaminated heparin, which initially identified Baxter as the source producer.
The FDA has confirmed reports of over 160 deaths that involved heparin use. Baxter, for its part, has identified the problem as being contaminated product being delivered to them by their Chinese manufacturing facility. The FDA, while intending to inspect the Chinese plant, never got there.
The FDA and Baxter are suggesting that the contaminated heparin may have been made intentionally, with a change in the manufacturing process resulting in significant cost savings for the Chinese manufacturer. While fingers are pointing in all directions, the recall has spread to ten other countries and fatalities have been reported in Germany.
There have been perhaps twenty lawsuits filed in the United States as of early May. Some have been for fatalities resulting from use of the contaminated heparin, some for severe allergic reactions generated by the drug. There is no shortage of reports about damage done by this contaminated drug. New legal action is occurring on a weekly basis.
At some point a heparin class action suit is probably inevitable. Baxter seems unconcerned, their CEO maintaining that they see no major impact on the firm because heparin is a small part of their business. Other analysts point out that the Supreme Court has ruled that individuals cannot seek damages from drug companies in state courts if the medical device that has done them harm has been approved by the FDA.
The whole imbroglio shows a serious breach in the ability of the FDA to protect consumers from more and more foreign products as outsourcing continues to flow overseas. At the same time, the high court may be inclined to consider pharmaceutical products with federal approval exempt from damages. With that scenario and with a contaminated product of this magnitude slipping through the inspection net, a heparin class action suit may be what it takes to force renewed attempts to protect the American public from shoddy offshore production.
