The Bitter Pill

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Injuries and Death Reported in Patients Implanted With Bard Kugel Mesh Patch

Evelyn Pringle October 29, 2006

On January 13, 2006, CR Bard, Inc announced a Class I recall of the Bard Composix Kugel Mesh X-Large Patch after receiving 24 reports that the device’s plastic coil ring may not withstand the increased stress associated with certain surgical placement techniques.

Davol, Inc, a subsidiary of CR Bard, notified US customers of the recall by letter on December 27, 2005, sent by Federal Express. According to Bard, at that time, the company had sold approximately 32,000 units worldwide since 2002, and the three product codes involved generated sales of approximately $11 million in 2005.

The Kugel Mesh Patch is used to repair ventral hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision and then held open by a “memory recoil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.

The FDA reports that the reason for the recall is that the memory recoil ring can break and lead to bowel perforations and chronic intestinal fistulae, causing abnormal connections or passageways between the intestines and other organs.

The Bard Composix Kugel Mesh X-Large Patch recalls include the following lot numbers:

* 41XMXXXX – M = 2002
* 41XNXXXX – N = 2003
* 43XMXXXX – M = 2002
* 43XNXXXX – N = 2003
* 43XOXXXX – O = 2004
* 43XPXXXX – P = 2005

On March 2006, Davol, Bard and FDA notified healthcare professionals of an expanded recall to include Oval, Large Oval and Large Circle Kugel mesh patches and also issued letters to hospitals and health care professionals providing updated Instructions for Use, clarifying the proper insertion technique and patient management information.

In a March 24, 2006 letter to Hospital Administrators, marked “Urgent,” Bard said, Davol, is “expanding the Class I Recall of the Extra Large sizes of its Bard� Composix� Kugel Patch to include certain lots of Bard� Composix� Kugel Large Oval and Large Circle Products and all lots of the Oval product, intended for ventral hernia repair.”

In a letter to distributors of the device, Bard noted that the updated recall includes lots manufactured prior to and including December of 2003, and warned that there “is a risk that the welds could break under the stress placed on the large sized products during placement, which could lead to potential patient complications such as abdominal pain, bowel perforation or chronic enteric fistulas.”

In a March 24, 2006 letter to surgeons, Bard stated: “Immediately discontinue use of the specific product codes and lot numbers listed below.”

“Additionally,” the letter said, “please immediately distribute copies of this Important Patient Management Information to clinicians who may have implanted, or who may be managing patients already implanted with one of these products under voluntary recall.”

Through March 10, 2006, at the time of the latest recall, the company said a total of 31 ring breaks were reported and 20 involved patient injury, including 11 cases where the broken ring migrated into or through the patient’s abdominal wall, with infection in 2 cases; 1 case where the ring migrated into the vagina; 7 cases of bowel perforation; 1 case of bowel obstruction; and 1 death where the patient developed septic shock, consumptive coagulopathy and acute myocardial infarction after surgery to repair small and large bowel fistulas caused by perforation from the broken ring.

According to the company’s August 2006 SEC filing, following the recall, the FDA also conducted a follow-up inspection and issued the company an FDA Form-483 identifying certain observations.

“The company,” the filing states, “is in the process of addressing these observations and cannot give any assurances that the FDA will be satisfied with the company’s response.”

For patients implanted with the potentially harmful devices, the FDA recommends seeking immediate medical attention if they “experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.”

Filed under: 2006, Kugel patch, medical devices

Medical Devices – April 2007 Litigation Update (Part II)

Evelyn Pringle April 9, 2007

By the fall of 2006, sitings of a whole new batch of litigants were looming on the horizon for both Boston and Johnson & Johnson. October 23, 2006, the Boston Globe, reported, “as more evidence emerges that suggests drug-coated stents have caused higher rates of blood clots than the older generation of bare-metal stents, doctors at many hospitals have recently begun shifting toward the older, bare-metal stents they replaced.”

Stents are used to keep arteries open after they are unclogged with angioplasty. Boston and J&J are the only two companies that sell drug eluding stents (DES) in the US, and true to form, as soon as they were FDA approved, many surgeons stopped using the bare-metal stents even though the DES were only approved to treat certain types of patients with uncomplicated heart conditions.

According to the FDA, over 60% of DES are being implanted off-label in patients with more complex heart problems than the conditions for which the devices were approved.

Legal experts are now predicting that the off-label use of DES will result in an avalanche of lawsuits because some 2 to 3 million Americans have already been implanted with one of the devices, according to FDA estimates, at a rate of more than 900,000 patients a year. “It was a modern record for any medical device,” the December 4, 2006 Boston Globe noted.

But now, like with the other devices above, the DES are proving to be no better than the bare metal stents, and in fact worse, because they come with more serious adverse events, specifically the development of late thrombosis or blood clots which is a life-threatening condition because a clot inside a stent can cut off the blood supply to the heart.

In December 2006, the FDA’s Circulatory System Devices Advisory Committee held a hearing to review data on DES outcomes when they are used according to their label and the outcomes when they are implanted off-label.

In the briefing provided before the hearing, the FDA informed the panel that studies had found a small but significant increase in the rates of death or myocardial infarction, and non-cardiac mortality, in DES patients when compared to patients who received the older bare metal stents they were intended to replace.

A major problem with stents is that if adverse reactions do occur, removal is not an option because the tissue in the artery grows over the stent. Medical experts are warning that because the devices have only been on the market for less than four years, many more problems are bound to show up in the years to come.

Due to the increased risk of blood clots, DES patients are now being told that they have to take the blood-thinning drug Plavix together with aspirin every day for life, which translates into a financial hay-day for Sanofi-Aventis and Bristol-Myers Squibb, the co-marketers of Plavix.

According to an August 17, 2006, press release, since its approval on November 17, 1997, Plavix has been prescribed to more than 52 million patients worldwide. So with the average cost for the drug being $1,400 a year, the news that DES patients would have to take Plavix for life instantly guaranteed billions of dollars a year in profits for the drug makers for many years to come.

However, it is not even clear that long-term use of Plavix will prevent blood clots. A presentation at the Transcatheter Cardiovascular Therapeutics meeting, in October 2006, by Dr Alaide Chieffo, reported that among 3,021 DES patients, 16 had developed late thrombosis, even though 9 of the 16 patients were already taking Plavix.

Two more recent meta-analyses have suggested that rates of death and myocardial infarction are higher in patients who have received DES when compared to bare metal stents. A safety analysis was conducted on patient-level data from four randomized trials comparing sirolimus-eluting stents and bare-metal stents, during a follow-up period of 4 years for 1748 patients, and the results were reported in the March 2, 2007, New England Journal of Medicine.

The researchers reported the survival rate to be 93.3% in patients in the DES group, and 94.6% in the bare metal group.

In a group of 428 patients with diabetes, a significant difference in the survival rate was found in favor of the bare metal stents by a margin of 95.6% to 87.8%.

The authors of the study said that because the use of DES had increased so rapidly, with current rates of up to 80% of all procedures in some countries, the “consequences of even a slight increase in the rates of death and myocardial infarction would be dramatic, considering the current high rate of use of drug-eluting stents.”

Another study in the same issue of the NEJM, reviewed trials involving 878 patients treated with sirolimus-eluting stents, 1,400 treated with paclitaxel-eluting stents, and 2267 treated with bare-metal stents and pooled 4 years of follow-up data.

The cumulative incidence of stent thrombosis was found to be 1.2% in the sirolimus-stent group versus 0.6% in the bare metal group, and 1.3% in the paclitaxel-stent group versus 0.8% in the bare metal group.

Legal analysts are predicting that in the end, many lawsuits will also be filed against doctors and hospitals for their part in the overuse of DES, including implanting stents in patients who did not need them at all.

For example, on March 7, 2007, the Daily Times reported that at least 25 patients in Maryland received unnecessary stent procedures performed by Dr John McLean, at the Peninsula Regional Medical Center in 2006.

There was much to be gained all the way around by rushing to implant these new devices in as many patients as possible because a bare-mental stent only costs about $700, and the DES runs about $2300. On February 25, 2007, the New York Times reported that since the DES came on the market, the cost of stent surgery is now comparable to the cost of open-heart surgery for patients with multiple blockages, at about $30,000, quoting the American College of Cardiology.

And for the device makers, the total sales of the two types of DES earned J&J and Boston Scientific $3 billion last year alone.

But judging from media reports, neither company may end up banking any profits. On October 23, 2006, Bloomberg reported that 2.9% of DES patients could develop clots within three years and said, “More than 4 million people have received such stents since 2001, which means clotting related to drug-coated devices may have caused as many as 20,000 heart attacks and 10,000 deaths worldwide.”

On a final note, there may soon be major trouble in paradise for J&J, because on February 12, 2007, the company announced that some of its foreign units may have made improper payments related to the sale of medical devices in unspecified countries, leading to the immediate retirement of Michael Dormer, J&J’s worldwide chairman of the Medical Devices & Diagnostic unit.

On February 13, 2007, Reuters reported that Morgan Stanley analyst Glenn Reicin said the company’s admission was likely an attempt at damage control, since a company found guilty of a felony for violating the Foreign Corrupt Practices Act, could be barred from participating in the Medicare program.

For obvious reasons, a ban against the payment for a company’s products by Medicare is probably the harshest sanction available to issue against a pharmaceutical company.

In late 2005, C R Bard Inc, sent out a recall, on the hernia repair device known as the Kugel patch, warning doctors to stop using some versions of the device because a plastic component could break and cut through a patient’s internal organs. If a patient starts having abdominal pain or develops a fever, it could indicate that the device has cut tissue or is causing a peritonitis-like infection.

Since the recall, the FDA has received reports of more than 80 injuries and other problems thought to be related to the patch, including several death reports.

Under FDA regulations, device makers are required to have systems in place to accept and analyze all complaints received from doctors and hospitals and they are required to send any report that indicates that a product failure may have contributed to the injury or death of a patient to the FDA.

Bard subsidiary, Davol, based in Rhode Island, makes the Kugel patch in various sizes and according to FDA records it was shortly after the largest patch was introduced in 2002, that the company began to receive complaints about broken rings in the devices.

Some of the complaints, FDA records indicate, suggested that serious injuries similar to the one experienced by Cynthia Wilson were occurring.

In mid-2005, Davol received 10 complaints about ring breaks over a 3 month period, but the company said that because 6 of the reports came from Germany, and half of those came from the same doctor it concluded that doctors were implanting the device incorrectly.

According to Bard, as a result of the reports, Davol stopped producing the largest patches in August 2005, and the company began training doctors in Germany and started revising its instructions on how to implant the device.

However, the Times reports that in the interim, the company kept distributing the patch and doctors kept implanting it which allowed the problem to continue and in the end, Davol’s assessment proved wrong.

In early December 2005, the Times says, tests run by the company on a failed patch “suggested for the first time that the source of the ring break was caused by a failure at the ring weld,” according to Bard.

Shortly after the initial recall, FDA officials went to Davol in early 2006 to do an inspection and the agency’s report indicates a range of problems, including flaws in the complaint tracking system.

FDA inspectors also reported that the company had understated the potential severity of injuries, to the FDA, including 3 reports involving injuries and one involving a possible patch-related death.

On January 10, 2007 Davol, announced it was expanding the earlier recalls of the devices based on reports of further memory ring breakage. The patch recalls began in December, 2005, and continued into January and March, 2006, and applies to patches made between January 1, 2004 and September 30, 2005.

On February 1, 2007, the FDA classified Kugel as class 1 recall, and warned that breakage of the ring portion of the device could lead to “bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).”

A Milwaukee woman, Cynthia Wilson, has filed a lawsuit against Bard alleging that she had to undergo emergency bowel surgery in 2004 to repair a hole caused by a dislocated patch. “I went to the hospital for two weeks and my friends were praying for me,” she told the New York Times on March 16, 2007.

Similar injuries are beginning to show up in Kugel patients all over the US, but Bard refuses to say how many lawsuits involving the device have been filed or whether the company had settled any cases, according to the Times.

The FDA has now instructed surgeons and hospitals to discontinue use of the recalled patches and return any unused devices to the company.

The next new wave of lawsuits could involve the illegal marking of another type of stenting device. A spotlight was shined on the off-label marketing of bile-duct stents at an FDA meeting in March 2007, because the devices are being marketed for use in blood vessels.

Biliary stents are metal or plastic tubes used to prop open obstructed bile ducts in patients with pancreatic cancer to help drain the biliary tract and relieve pain.

According to the March 15, 2007, Wall Street Journal, the device makers are selling about 90% of these stents to catheterization labs for use in arteries rather than bile ducts.

During the FDA meeting, the Journal said, the agency pointed out the oddity that several companies had advertised bile-duct stents at a recent meeting of cardiologists, but did not at a meeting of gastroenterologists, the doctors who actually use the stents in bile-duct procedures.

“FDA has become aware that metal biliary stents are being promoted and used to open arteries in the vascular system — something they have not been tested to do, or approved for by the agency,” according to Karen Riley, a spokeswoman for the FDA in the March 16, Pioneer Press.

That’s troubling, she said, because heart stents must undergo a more extensive pre-market approval process than biliary stents.

The FDA also is concerned about the increasing reports of adverse events in patients who received biliary stents off-label, Ms Riley added.

This statement by Ms Riley might turn out to be a hot tip when it comes to guessing at which device makers will enter the legal arena this year.

Filed under: 2007, Kugel patch, medical devices, Plavix, stents

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