The U.S. Food and Drug Administration defines "off-label use" as "use for indication, dosage form, dose regimen, population or other use parameter not mentioned in the approved labelling." Translated, the FDA is saying that "off-label" means using a drug or medical device for something other than what it was specifically made for.
Intergel was a gel-like substance that was literally "poured" into a woman's pelvis followed gynaecological surgery. The stuff consisted of "an amber coloured, viscous solution of sodium hyaluronate ... ionically crosslinked with ferric ions" in the words of Lifecore, the Chaska, Minnesota company that made Intergel. The gel was designed to aid the healing process by preventing internal, post-operative scars (also called "adhesions") from developing in female patients.
Intergel was rolled out in the European market in the late 1990s. Approval took longer in the United States, with the FDA initially turning the drug down. The FDA eventually relented and re-examined the drug, and approved it for sale in the U.S. in 2002. Doubts remained about the product, however. The FDA ordered that the drug be packaged with a warning indicating it was only considered "reasonably safe" in the government's eyes.
Intergel was sold through the Gynecare division of Ethicon, itself a branch of pharmaceutical giant Johnson & Johnson. It was only supposed to be used in patients undergoing open "conservative" gynaecological surgery.
Problem was, doctors used the gel for off-label purposes, "in laparoscopy and non-conservative surgical procedures (such as hysterectomy)," according to a letter Gynecare sent to physicians on March 28, 2003.
Off-label use led to "adverse events" such as "late-onset, post-operative pain and repeat surgeries following the onset of pain, non-infectious foreign body reactions and tissue adherence," continued the Gynecare letter. "In some patients, a residual matter was observed during the surgery. The post-operative pain could be suggestive of other, serious complications and physicians should be aware of this in managing patients in the post-operative period."
READ MORE LEGAL NEWSThe letter explained that Gynecare had contacted the FDA, indicating they wanted to withdraw the drug from the market. Doctors were urged to stop using the gel. The FDA, for its part, said it received over 100 reports of problems associated with Intergel, including three deaths.
"Gynecare Worldwide, a division of Ethicon Inc., of Somerville, New Jersey, notified the FDA that they are voluntarily withdrawing Gynecare Intergel adhesion prevention solution from the global market and are urging customers to immediately stop using this device," stated an FDA "MedWatch" bulletin from April 16, 2003.
Gynecare and Lifecore are still in business, but Intergel isn't. Intended to ease the post-surgical complications for women, the drug became a magnet for litigation instead, in large part thanks to off-label use.