She had undergone several surgeries including colon-rectal surgery and a colostomy reversal and every time she was sewn up and sent home, her condition deteriorated. He got her medical records and referred her to a medical malpractice law firm. (He has a small litigation law firm and doesn't practice med mal.)
But the law firm told him there wasn't a case. The lawyer was about to write a non-engagement letter to his client when suddenly, the light bulb flashed -- he realized this was a products case and not medical malpractice -- whatever was going into this woman's body was not OK! Through the surgical notes, he discovered that doctors had identified the foreign body and it was clear that Panacryl sutures, made by Ethicon Inc., had been used and had to be surgically removed from her abdomen not once but numerous times.Back in 2003, there was little information about Panacryl sutures. However, another product made by Ethicon Inc. -- Vicryl sutures -- had an unfortunate history. In 1994 the same company did a massive recall of Vicryl sutures and since then, there have been complaints brought against the company (specifically,1996, 1998, 2001, 2002, 2003 and 2004) regarding the unexplained infections linked to the product line. Ethicon Inc., a Johnson & Johnson company based in Somerville, New Jersey recalled 3.5 million packages of its Vicryl brand of sutures in 1994, under pressure from federal regulators.
Meanwhile, the lawyer's client was still having problems, two years post-surgery. He filed a suit against Ethicon and J&J and in the course of discovery, the lawyer met with his client's physician. At first the physician was reluctant to talk, but once he realized there was genuine concern for this woman and potentially other patients that had suffered due to Panacryl sutures, the doctor disclosed that he alone had 13 near-disastrous results, all within a several month period! As the doctor was taking Panacryl out of one of his patients, he realized how bad this product was. Needless to say, this particular doctor stopped using Panacryl sutures.
The lawyer ended up with about a dozen cases and an amended lawsuit was drafted on behalf of these people. The amended lawsuit was sent to the Ethicon attorneys stating that the lawsuit would be filed in two weeks, thereby blowing the whistle on their whole operation. Within a week, the Ethicon attorneys got a call back -- Ethicon wanted to sit down and talk.
In February and March of 2006, 11 Panacryl cases were settled in Missouri, but this is just the tip of the iceberg. At that time, it looked like the Panacryl case was over, but life doesn't always work that way. The law firm started to get calls from all over the US, from victims of Panacryl sutures, people who didn't even know about the settlement.
Strangely enough, Panacryl was recalled in March 2006, four years after the company stopped selling it as a general purpose suture. The lawyer believes that Ethicon knows a lot more than they are telling the public -- and the FDA.
About Panacryl -- the Product
The following information is based on interviews with three doctors and their patients.
Panacryl sutures have an unusually high incidence of adverse tissue reaction when used in lower abdominal surgeries. It appears to have something to do with the chemical compound of the suture or the fact that it is a woven strand rather than a monofilament. Or a combination of the two -- nobody is sure yet. But what is known is that it sets up a negative reaction and the body won't absorb the suture; it sits there and gets infected and the doctors have to remove it.
To compound the problem: the doctors don't necessarily know where all the suture product is so they can only go back in and remove it when it becomes infected -- this is the only way to find them. Each time a suture becomes infected, the patient requires major surgery -- what a mess.
There are a lot of injured people out there due to Panacryl sutures -- some are in recovery but they went through hell to get well. Panacryl sutures may have been a contributing cause to one or more deaths: cancer patients have had to go off chemotherapy due to infected sutures.
All Panacryl sutures were voluntarily recalled by Ethicon on March 28, 2006. The company's reason for the recall was that "The unique absorption profile of Panacryl in the suture could act as a foreign body so that surgeons should consider its use in specific situations." According to Ethicon, the recall includes 1,061,712 sutures which were distributed nationwide and internationally.