Hundreds of injured patients have already filed lawsuits against Atrium Medical, saying the company’s C-Qur family of hernia mesh products are defective.
- Potential side effects: device failure, infection, death.
- Federal lawsuits consolidated in New Hampshire.
Thousands of other hernia repair patients may have been harmed. Surgical mesh complications can be life-altering, if not life-threatening. Our lawyers want to help.
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Hundreds of patients say that a popular line of hernia repair products, manufactured by New Hampshire-based company Atrium, are defective. In a wave of product liability lawsuits, injured patients accuse Atrium of creating a hernia mesh patch that can induce severe immune system responses, leading to product failure and numerous debilitating complications.
C-Qur Lawsuits Say Mesh Causes Severe Side Effects
Nearly 300 patients have filed suit against Atrium, claiming the company’s C-Qur family of hernia mesh implants is defective. In all, the C-Qur product line encompasses seven separate products:
- C-Qur Mesh – indicated for use in hernia repair, chest wall reconstruction and for the closure of traumatic or surgical wounds
- C-Qur V-Patch – indicated for use in the repair of small hernia and other small abdominal wall openings
- C-Qur Tacshield – indicated for the repair of medium to large-size open ventral hernias
- C-Qur FX – indicated for certain open and laparoscopic hernia repairs
- C-Qur CentriFX – indicated for laparoscopic inguinal hernia repair
- C-Qur Mosaic – indicated for certain open and laparoscopic hernia repairs
- C-Qur Film – (not available in US) – indicated to assist in abdominal and pelvic surgeries to reduce the risk of postoperative adhesions
While the meshes vary in name and indication, each product shares a strikingly similar design. The mesh itself consists of a patch woven from fibers of polypropylene, a synthetic polymer used widely in consumer products. Surrounding this polypropylene patch is a coating of Omega 3 fatty acids, derived from fish oil and intended to act as a protective barrier against adhesions.
Polypropylene & Fish Oil
In their lawsuits, Plaintiffs point out two alleged problems with this design:
- polypropylene is biologically incompatible with human tissue, “promot[ing] an immune response in a large subset of the population”
- fish oils are commonly considered to be allergenic and immunogenic, intensifying allergic responses and immune system effects
In short, the materials from which C-Qur hernia mesh patches are made incite severe immune system responses in many patients, the plaintiffs write. In turn, they continue, these immune system responses increase the likelihood that a patch will break down prematurely inside the body, leading to a host of adverse health consequences. Atrium Medical had full knowledge of these risks, the patients say, but rather than inform the public, the company chose to lie about the product’s safety.
Dangers Of Hernia Mesh Highlighted In C-Qur Lawsuits
Physicians often use surgical mesh products to patch up traumatic wounds, close openings left by invasive operations or add support to muscles weakened by a hernia.
While common, the use of hernia mesh has come under fire in recent years, as thousands of patients have reported serious complications:
- severe pain
- adhesion (mesh becomes attached to internal organs, impairing organ infection and increasing the risk of fistula)
- fistula (the creation of an abnormal passageway between internal organs)
- internal bleeding
- organ perforation
Alongside these risks stands the substantial danger of a total device failure, the US Food & Drug Administration reports. Mesh products can migrate inside the body, threatening the integrity of surrounding organs. In many cases, surgeons have discovered fragments of hernia mesh that literally disintegrated, making total removal nearly impossible. Some mesh products have even been found to increase the likelihood of hernia recurrence, forcing patients back into the operating room for an invasive revision procedure.
Patients Claim Mesh Patches Led To Horrific Injuries
The injuries reported in C-Qur lawsuits, however, may be even more terrific. Many plaintiffs claim to have undergone repeated hernia repair procedures involving Atrium’s family of hernia mesh products – suffering repeated injuries and complications as a result.
Man Says Repeat Mesh Implants Intensified Complications
In a case filed on March 16, 2017, a man from Wyoming tells the devastating story of his own efforts to have two abdominal hernias repaired. Suffering from epigastric and umbilical hernias, the man underwent his first procedure in March of 2013, receiving two C-Qur Mesh patches in the process.
Less than five months after his surgery, Plaintiff returned to his surgeon with a hernia recurrence, the complaint states. The doctor found a “palpable bulge” directly above one of the patient’s implanted C-Qur meshes, but decided against performing a revision procedure immediately.
Severe Mesh Infection & Emergency Surgery
An emergency procedure, however, would become necessary two months later, when the man again presented to his surgeon, this time suffering from excruciating pain. One of the patient’s hernias had become incarcerated, the doctor found, as portions of an internal organ forced their way through his weakened abdominal wall. The man was rushed into surgery, court documents report, where physicians discovered pieces of his bowel had entered the hernia, leading to widespread inflammation and blood vessel rupture. After repairing the problem, the man’s surgeon closed the abdominal wall with yet another Atrium-made C-Qur Mesh hernia patch.
Only twelve days after the revision procedure, the man’s doctor received a frantic phone call from his patient’s wife. Instead of improving, Plaintiff’s condition was deteriorating quickly. He had begun to vomit, his wife said, and been unable to defecate for several days. His abdomen was swollen and tight. The doctor instructed the couple to seek immediate medical attention at an emergency room.
Colostomy Performed For Bowel Obstruction
At the hospital, doctors quickly found that the patient’s white blood cell count was elevated – indicating an infection. An emergency surgery was performed, in which physicians drained a “large amount of pus” from an abscess in the man’s abdomen. The doctors also discovered the source of infection, according to court documents. The man’s C-Qur Mesh patches had been colonized by infectious pathogens. While the ER physicians attempted to remove the patient’s hernia mesh, they noted significant difficulties in their report, writing:
“We took out at least 2 pieces of mesh. There might have been 3 pieces, it was hard to tell if [the mesh] was coming out piecemeal or intact[. The mesh] had not been incorporated into the tissues adequately.”
The patient’s ordeal wasn’t over, though. During the same emergency room procedure, doctors found that the man’s colon had become obstructed and swollen. The physicians immediately performed a resection and colostomy, the complaint says. The patient remained in the hospital for another eleven days. Over the next year, Plaintiff underwent two more procedures, one of which was intended to close the large wound left when the ER doctors removed his C-Qur hernia mesh.
Four C-Qur Patches, Six Revision Surgeries
On March 24, 2014, the man again visited his surgeon, complaining of pain and a strange tearing sensation at the site of one of his hernia. Noting a palpable hernia, the doctor scheduled yet another procedure for the following Wednesday. During the operation, the surgeon found more “dense adhesions,” court documents related. To repair the patient’s hernia, his doctor used another Atrium mesh product. Like previous devices, Plaintiff claims that this new mesh failed, leading to significant abdominal distension. While he considered additional revision procedures with his doctor, they decided to hold off.
The next year, the man presented to his surgeon’s office with multiple ventral hernias. His physician used a C-Qur Mosaic mesh to reinforce the patient’s abdominal walls, after lysing extensive organ adhesions. Only twelve days later, he returned to the doctor. This time, a large seroma had begun to form around the man’s hernia sac, allowing fluid to build up under his skin.
Hernia Patch Claims Consolidated In New Hampshire
C-Qur hernia mesh lawsuits have been consolidated in the US District Court of New Hampshire, forming a Multi-District Litigation titled In Re: Atrium Medical Corp. C-Qur Mesh Products Liability Litigation. As of March 17, 2017, nearly 300 hernia mesh lawsuits filed against Atrium have been gathered in the New Hampshire Court, located in the State’s capital of Concord.
In oral arguments held before the Judicial Panel on Multi-District Litigation, plaintiffs unanimously supported the US District Court of New Hampshire as their preferred venue for consolidation. Likewise, Atrium Medical felt New Hampshire an appropriate venue. The company is headquartered in Merrimack, a town 30 minutes south of Concord.
How MDL Will Impact C-Qur Lawsuits
Multi-District Litigation (MDL) is a common legal mechanism that allows a number of similar legal claims to be gathered together in a single federal court. The Honorable Landya B. McCafferty, nominated to the New Hampshire court by President Obama in 2013, has been selected to guide the consolidated litigation. Judge McCafferty is already familiar with the case against Atrium; she was assigned to preside over the first C-Qur lawsuit to appear in a US federal court.
After being transferred to a central jurisdiction, the lawsuits move through pre-trial proceedings as a group, allowing for a more efficient and cost-effective legal process. Most judges who preside over an MDL will appoint a select roster of plaintiffs’ attorneys to guide the litigation at a global level.
This Plaintiffs’ Executive Committee will develop legal arguments and direct the gathering of evidence, promoting the best interests of every plaintiff equally. On March 13, 2017, Judge McCafferty announced a leadership structure for the consolidated C-Qur lawsuits, naming attorney Jonathan D. Orent as Plaintiffs’ Lead Counsel. In addition to Mr. Orent, four other lawyers have been appointed to the Plaintiffs’ Executive Committee, while Russel Hilliard, an advocate from Portsmouth, New Hampshire has been selected to handle administrative matters for plaintiffs. Individual attorneys will remain active in the litigation, focusing on developing the facts particular to their own clients.
Will Consolidation Help Or Hurt Plaintiffs?
Though consolidation can provide certain benefits to defendants, most legal observers believe that Multi-District Litigation provides a strategic advantage for plaintiffs.
This is especially true when hundreds of injured individuals, who may have limited means, are going up against a large corporation. Coordinating the lawsuits allows plaintiffs to share common expenses, while increasing their leverage in settlement negotiations. Crucially, the formation of an MDL almost always speeds up the progress of litigation. Many corporate defendants attempt to delay court proceedings indefinitely, in hopes of exhausting a plaintiff’s financial resources. Consolidation can take this defense strategy off the table.
As a matter of judicial economy, MDL is unrivaled in its efficiency. Instead of being scattered across numerous federal courts, hundreds or thousands of lawsuits are assembled under the guidance of a single federal judge. Many of the MDL judge’s decisions will hold for each consolidated lawsuit, eliminating the potential for conflicting judgments in multiple jurisdictions.
Judge McCafferty has shown every sign of hoping to reach a swift resolution for the C-Qur hernia mesh lawsuits. In fact, the Court has already approved direct filing, allowing any lawsuit that would be eligible for transfer to the MDL to be filed in the New Hampshire District Court straightaway, no matter the plaintiff’s state of residence or the location of their hernia mesh procedure.
Atrium Hit By FDA Over C-Qur Manufacturing Problems
Atrium Medical is now a wholly-owned subsidiary of Maquet, a German multinational focused on manufacturing surgical equipment. Maquet itself is owned by a Swedish corporation, the Getinge Group. All three companies have been named as defendants in the C-Qur litigation.
Atrium Medical has been sanctioned over problems with the C-Qur mesh before. In 2015, the manufacturer entered a federal consent decree with the US Food & Drug Administration, after government regulators found “major violations” of federal law at three of the company’s manufacturing facilities. Over four years of audits, FDA investigators discovered evidence that Maquet had failed to establish appropriate product quality procedures, while hiding serious medical device injury reports from federal scrutiny.
Hernia Mesh Production Frozen Over Quality Concerns
The FDA filed suit against Maquet in the US District Court of New Hampshire, hoping to stop the company from producing medical devices and equipment that violated the law. Maquet, however, was not prepared to see the lawsuit enter a court of law. As the Justice Department notes, the medical device manufacturer decided to short-circuit the litigation before it began, agreeing to enter a consent decree on February 3, 2015, the same day that the FDA’s lawsuit was filed.
Pursuant to the consent decree, Maquet agreed to reform its manufacturing practices, bringing production in line with the US Food, Drug & Cosmetic Act. Moreover, the company was compelled to discontinue manufacturing, with minor exceptions, at its Hudson, New Hampshire facility. Production of C-Qur hernia meshes was stopped indefinitely, until independent safety experts could confirm that Maquet had improved its safety protocols.
A “Corporate Culture Of Non-Compliance”
After the government’s consent decree was announced, executives at Maquet maintained an apologetic tone. “We have learned from this experience,” said John Malmquist, the CEO of parent company Getinge Group, “this agreement with the FDA provides us with a clear path forward.”
Subsequent federal lawsuits, however, say the reality at Maquet is very different.
In a whistleblower lawsuit filed on December 9, 2016, a former Maquet employee accuses the company of firing compliance officers who called executives out for failing to follow FDA rules and regulations, along with federal law, Law360 reports. Maquet “maintains and perpetuates a corporate culture of non-compliance” with FDA guidelines, the whistleblower says. Her lawsuit was filed in a New Jersey state court, joined by a second complaint, brought by another former compliance offer who makes similar allegations.