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The Medical Device Safety Act of 2009 was introduced in the U.S. House and U.S. Senate to reverse a decision by the U.S. Supreme Court last year in Riegel v. Medtronic, which held that product liability lawsuits challenging the safety or effectiveness of medical devices are pre-empted by federal law if they are approved by the FDA.

Corporations which manufacture defective medical devices and dangerous drugs have been arguing for years that they should be insulated from liability for injuries caused by their products so long as the FDA approved the products. However, in reality, the FDA is not equipped to be the last line of defense for product safety, and their regulations should be viewed as the floor, not the ceiling.

Ultimately, responsibility for the safety of medical devices and prescription drugs should fall to the manufacturer, and a consumer should be entitled to compensation when a corporation fails to ensure that their product is safe and effective.

Earlier this month, in the case of Wyeth v. Levine, the U.S. Supreme Court came down on the side of the consumer, finding that makers of pharmaceutical drugs are not insulated from liability for faulty warning labels, regardless of whether the FDA approved the label.

However, the Riegel decision is continuing to present substantial hurdles for individuals injured by defective medical devices, such as the Medtronic Sprint Fidelis defibrillator lead that was recalled in 2007.

Although Medtronic was aware that the small wires they were selling to connect cardiac defibrillators to the heart were prone to fracture or break, they continued to allow the products to be implanted for months.

In January 2009, U.S. District Judge Richard H. Kyle in Minneapolis cited the Riegel decision as the basis of his dismissal of over 1,400 Medtronic lawsuits that had been filed on behalf of patients who were injured by the defective Medtronic defibrillator leads.

The legislation introduced by Sentator Edward Kennedy (MA-D), Rep. Frank Pallone (NJ-D) and House Energy and Commerce Chairman Henry Waxman (CA-D) could restore these lawsuits and protect other consumers injured by medical devices, by ensuring that they are able to hold the manufacturer responsible for a negligent design that results in a dangerous and defective medical device.

ACT NOW TO SUPPORT THE MEDICAL DEVICE SAFETY ACT

To preserve your right to pursue a product liability lawsuit for injuries caused by a bad medical device, it is important that you contact your Senators and Representative to make sure they understand the importance of supporting the Medical Device Safety Act.

The civil justice system and state court juries are an important safeguard to hold companies accountable for decisions which put profits ahead of consumer safety. Let your voice be heard.

>>Read More from American Association for Justice.

The hernia mesh lawyers at Saiontz & Kirk, P.A. have been investigating potential cases against Bard and their subsidiary Davol, Inc. involving problems with the design of several of their hernia repair products.

Design defects have caused a number of people to suffer severe complications after hernia repair surgery, such as:

• Intestinal Pain
• Bowel Perforation
• Intestinal Fistula
• Additional Hernia Surgery
• Death

Between October 2005 and January 2007, Bard issued three separate Kugel Hernia Patch recalls involving different sizes of their mesh. However, the company has been widely criticized for failing to adequately investigate complaints received and for delaying the recalls even after they received numerous reports of problems.

The Kugel hernia mesh contains a memory recoil ring which has been found to break in some cases, resulting in small, sharp pieces of plastic cutting up the intestines. Hundreds of thousands of Kugel patches were implanted in patients throughout the United States, even though C.R. Bard and their subsidiary Davol knew about the defective ring.

Problems have also been associated with other types of hernia repair mesh made by Davol and Bard which they have not recalled. Hernia repair patches that utilize a dual-mesh technology, combining palypropylene mesh with an expanded polytetrafluorothyleen (ePTFE) layer, both with and without a memory recoil ring, have been included in the federal Kugel Hernia Patch litigation that is pending in the U.S. District Court for the District of Rhode Island.

During FDA inspections at C.R. Bard’s plant in Puerto Rico where many of these products are made, the FDA has identified a number of violations of the Good Manufacturing Practices of the Quality System regulation under the Food, Drug and Cosmetic (FD&C) Act. Bard was found to not follow up on quality control problems, mislabeled and mixed up products and even sold some Kugel patches that were labeled with the wrong size information.

BARD HERNIA MESH LAWYERS

Most patients who receive a hernia surgery mesh are unaware of the type of patch that was used. However, our product liability lawyers provide free consultations and claim evaluations for any individuals who have had a hernia repair and experienced unusual complaints or problems following surgery.

Cases are investigated and reviewed to determine if the hernia surgery complications may be related to the defects in Bard hernia mesh products. If you, a friend or family member think you may have a case, request a free consultation and claim evaluation.

The hospitals’ negligence was disclosed after a local television station, WVAY, ran a report about a woman who discovered through her own medical records that the patch used by her surgeon had been recalled. Judith Coyne had a hernia repair surgery performed last June at Sentara Virginia Beach General Hospital, where her surgeon implanted a Kugel Mesh Patch. Following her hernia surgery, she began to develop excruciating pain. “At times it feels like knives and at times it feels like burning,” she described to the Virginia news reporter.

Although Sentara initially denied that a recalled hernia patch had been used, they have since acknowledged the hospital’s mistake and also disclosed that six other patients received the mesh after it had been recalled. According to hospital administrators, four patients at Sentara Virginia Beach General Hospital and three at Sentara Leigh Hospital received a Kugel Mesh Hernia Patch after the recall.

Since October 2005, Davol, Inc. has issued several different Kugel Mesh Hernia Patch recalls after receiving reports of serious injury and death linked to design defects which could cause a plastic memory ring around the perimiter to break. This could cause severe abdominal pain, tenderness at the site where the patch was inserted, itestinal fistula, bowel perforation or other severe intestinal injuries

KUGEL MESH HERNIA PATCH LAWSUITS

The Kugel lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who had a hernia repair where a defective Kugel Mesh Hernia Patch was used. Although the Sentara Hospital problems were clearly caused by the hospitals’ negligence, thousands of people received the hernia mesh prior to the recall. Those who experience hernia repair problems due to the defective mesh patches, may be entitled to compensation from the manufacturer.

If you, a friend or family member have been diagnosed with an intestinal injury, bowel perforation or other severe injury which could be related to the mesh used during a hernia repair, request a free consultation and claim evaluation.

>>INFORMATION: Kugel Hernia Mesh Lawsuits

The annual report, which was filed with the SEC as a Form 10-K filing, indicates that 580 federal and 280 state Composix Kugel lawsuits have been filed on behalf of approximately 2,135 plaintiffs as of February 25, 2008. In addition, nine putative Kugel hernia mesh class action suits have been filed against C.R. Bard, Inc., though none of them have yet been certified.

According to Bard, the putative Kugel mesh class action suits seek (a) medical monitoring for individuals who received one of the hernia patches, (b) compensatory damages for injuries caused by the defective mesh, (c ) punitive damages, (d) a judicial finding of defect and causation and/or (e) attorney fees.

The majority of the lawsuits filed are individual claims on behalf of people who have suffered personal injuries following a hernia repair as a result of defective surgical mesh manufactured by Davol, Inc., a subsidiary of Bard. The lawyers at Saiontz & Kirk, P.A. represent people who are pursuing individual Kugel lawsuits to obtain compensation for medical bills, lost wages and the pain and suffering caused by the defective hernia patches.

All of the federal Kugel Mesh cases have been transferred to the United States District Court for the District of Rhode Island for pre-trial proceedings, as part of a Multidistrict Litigation (”MDL”). Of the state Kugel lawsuits, 245 have been filed in the Superior Court of the State of Rhode Island, where the hernia patch manufacturer is based, with approximately 35 others in various jurisdictions throughout the United States.

C.R. Bard, Inc. disclosed these figures as part of their annual report required by the United States Security and Exchange Commission (SEC). The Form 10-K, which was recently filed for the company’s fiscal year ended December 31, 2007, provides a comprehensive overview of publicly traded companies’ business and financial conditions.

>>SEC LINK: Bard Annual Report
(search for “2,135″ to locate discussion
about Composix Kugel Mesh lawsuits)

Bard reported, “We believe that many settlements and judgments relating to the Composix Claims may be covered in whole or in part under our product liability insurance policies. ”

COMPOSIX KUGEL HERNIA MESH ATTORNEYS

The Kugel hernia mesh lawyers at Saiontz & Kirk, P.A. are continuing to review potential lawsuits on behalf of individuals who have experienced problems following a hernia surgery. Many people who contact our law firm for a free claim evaluation are unaware of the type of hernia mesh patch used during their surgery. Following a free consultation, our legal team can help determine whether problems may be related to defective surgical hernia mesh manufactured by Davol / Bard.

If you, a friend or family member believe you may qualify for a Kugel hernia mesh lawsuit, request a free consultation and claim evaluation.

>>INFORMATION: Hernia Patch Lawsuits

Since October 2005, there have been three separate recalls involving different sizes of Davol Bard Composix Kugel Hernia Mesh, which contain a memory recoil ring. Defects in the design of the hernia repair patches caused some of the plastic rings to break, resulting in serious injuries such as bowel perforation, chronic intestinal fistula and death.

However, there have been reports of problems after hernia repair surgery involving other patches which were not part of these recalls. Hernia patches which utilize a dual-mesh technology, combining palypropylene mesh with an expanded polytetrafluorothyleene (ePTFE) layer, both with and without a memory recoil ring, have been associated with defects which could be responsible for serious injuries.

Hernia patch lawsuits filed in Federal courts throughout the United States have been consolidated for pretrial proceedings as part of a multi-district Hernia Patch litigation (also known as an MDL). The MDL, which is similar to a Hernia patch class action, combines individual lawsuits involving “common questions of facts” for discovery and pre-trial motions.

Last month, the U.S. District Judge who is overseeing Davol hernia patch lawsuits issued an order requiring the manufacturer to preserve additional documents relating to other hernia repair products that include dual-mesh, regardless of whether they also include a ring.

The consolidated hernia patch litigation now includes the following products made by Davol (also known as Bard and Surgical Sense):

• Composix Kugel Hernia Patch
• Kugel Hernia Patch
• Ventralex Hernia Patch
• CK Parastomal Hernia Patch
• Modified Kugel Patch
• Composix E/X Hernia Mesh
• Composix Mesh
• Composix L/P Mesh
• CruraSoft Patch

HERNIA PATCH LAWSUIT EVALUATION

The product liability lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits for any individuals who have had a hernia repair surgery since 2000 and subsequently experienced problems which could be related to the hernia patch. Symptoms could include pain, discomfort, bowel perforation, intestinal problems or death.

It is not necessary that individuals have a product subject to a prior hernia patch recall to qualify for a claim, and most individuals are unaware of the specific type of hernia repair mesh used. Following a free consultation, our hernia mesh lawyers will review the medical records to help determine if problems may be related to a defective Davol hernia patch. Request a free consultation and hernia patch lawsuit evaluation.

>>INFORMATION: Hernia mesh recall

The unique element of the Kugel hernia patch is a hard plastic memory recoil ring which allows the surgical mesh to be folded and put in place through a small incision.  The memory ring is designed to cause the mesh to spring open and lay flat once it is in place.  This results in a less invasive hernia repair surgery, and the patient is able to make a much quicker recovery. 

Over the past year there have been three separate recalls announced for different models of the Composix Kugel patch, manufactured by C.R. Bard, Inc., and their subsidiary, Davol, Inc.  To date, the recalls have involved certain large and extra large models of the patch.  However, there are other models which have a similar memory recoil ring and some question whether there will be additional hernia mesh recalls in the future.

The manufacturer failed to perform sufficient pre-market tests to evaluate the pressures which are placed on the plastic ring during insertion.  When the makers announced the recall, they indicated that the surgical stresses which are exerted on the plastic ring are accountable for the device failure.  There is no excuse for their failure to account for these stresses, especially since they are the ones who often train the physicians on how to insert the surgical mesh.  As a result, the makers face thousands of lawsuits from individuals who suffered serious complications after hernia repair surgery.

>>INFORMATION: Hernia mesh lawsuits

The manufacturers have also failed to conduct appropriate testing to determine the strength of the ring when placed under the normal stresses encountered over the life of the patient.  It is not well understood whether the plastics and forming techniques which lead to the weaknesses in the ring could also cause future failure or deterioration.  Therefore, some believe that it is possible that some of these devices will fail in the future, even if the ring did not break immediately during insertion.

HERNIA MESH RECALL LAWYERS

The lawyers at Saiontz & Kirk, P.A. represent individuals who have suffered complications after hernia surgery which are caused by the defective Kugel hernia repair mesh.  If you, a friend or family have experienced bowel perforation or intestinal problems after a hernia repair since 2002, request a free claim evaluation to determine if you may be eligible for a claim.

>>REQUEST A FREE HERNIA MESH CLAIM EVALUATION<<

>>INFORMATION: Hernia surgical mesh recall lawsuits

In December 2005, March 2006 and January 2007, C.R. Bard, Inc., and their subsidiary, Davol, Inc., issued recalls for certain models and lots of their Composix Kugel Hernia Patch.  The surgical mesh contains a plastic memory recoil ring which could break under the stress of surgery, leading to bowel perforation, chronic intestinal fistula or death.  The hernia mesh recall applies to the Oval, Large Oval, Extra Large Oval and Large Circle models.

>>INFORMATION: Composix Kugel Hernia Mesh Recall

At the time of hernia surgery, most individuals are unaware of the brand name or type of mesh which is used, much less the exact model or lot number necessary to determine if their mesh has been recalled.  In addition, when hernia repair problems are encountered after surgery, many individuals do not fully understand what caused the complications, but rather simply know that they required another hernia surgery. 

SURGICAL MESH RECALL LAWYERS

While some patients have received recall notices, many individuals are unaware that they have the defective and recalled hernia mesh.  The hernia mesh lawyers at Saiontz & Kirk, P.A. are investigating lawsuits against the manufacturer for failing to properly test their product before placing it on the market. 

Symptoms or signs of problems with the surgical mesh could include:

• Fever
• Abdominal tenderness or pain
• Nausea
• Diarrhea
• Abnormal bowel movements
• Distended abdomen

If any hernia patients experience unusual or unexplained symptoms after repair surgery, they should immediately consult with their physician.  Possible tests which could be done to determine if problems after hernia repair surgery are caused by failure of the Kugel hernia mesh include:

• Lower plate xray
• Barium swallow or enema
• Reverse imaging CT scan

If hernia repair problems have been experienced, our legal team can review the circumstances surrounding the injury and evaluate whether a recalled surgical mesh could have caused the complications .  If you, a friend or family member have experienced complications after a hernia repair surgery, you can speak with one of our attorneys to explore your legal rights and determine if you may be entitled to compensation.  Request a free consultation.

>>INFORMATION: Kugel Hernia Mesh Problems

In 2002 Davol, Inc., a subsidiary of C.R. Bard, Inc., introduced larger versions of their Composix Kugel hernia repair mesh which are designed so that they can be folded during placement and then spring open once in place to lay flat under the hernia.  It was not long after they were introduced that the makers began to receive reports of an unusually high number of reports that the plastic memory recoil ring in the larger hernia patches was breaking, which could cause injury to internal organs and tissue.

As a result of the manufacturers failure to properly assess the hernia patch problems, they continued to manufacture the mesh and distributed it for placement inside of patients.  In December 2005, the largest of these devices, known as the Kugel Extra-Large Oval, were recalled.  However, they did not recall other potentially defective large patches.

The New York Times reports that after the initial hernia patch recall, the FDA inspected Davol and found there were inconsistencies and discrepancies in how Davol monitored hernia mesh problems and reported injuries.  According to inspection reports, Davol did not accurately report the number of problems as well as the extent of the problems with the hernia mesh.  This has led to two subsequent recalls of the Composix Kugel Large Oval and Large Circle. 

>>INFORMATION: List of Recalled Composix Kugel Hernia Patch Products

The defective hernia repair patches are used to repair ventrical hernias which may develop at the site of prior surgical incisions in the abdomen.  The patch problems could result in failure of the memory recoil ring, leading to possible bowel perforation, intestinal fistula or death.

KUGEL HERNIA PATCH RECALL LAWSUITS

The Kugel hernia patch problems are so severe that the FDA classified the recall as Class I in January 2007, since the defect has a reasonable probability of causing serious adverse health consequences, including death.  Individuals who have had a hernia repair surgery and suffer severe abdominal pain, high fever, tenderness at the site of the hernia repair or other unusual and unexplained symptoms, should consult with their doctors immediately.

The Kugal hernia patch recall lawyers at Saiontz & Kirk, P.A. provide free consultations  to help determine if you may be eligible for compensation.  Request a free claim evaluation.

The Kugel Hernia Mesh Patches are used to repair ventrical hernias, also known as incisional hernias.  The product is designed so that it can be folded during insertion and then spring open once in place to lay flat under the hernia.  As a result of a design defect, the memory recoil ring may break, causing bowel perforation, intestinal problems or death.

The Kugel Hernia Patch recall is classified by the FDA as a Class I recall, since it has a reasonable probability of causing serious adverse health consequences.

>>INFORMATION: Kugel hernia mesh problems

If you, a friend or family member have had surgery to repair a hernia and believe you may have a recalled Kugal Patch, request a free consultation to speak with one of our product liability lawyers.  Compensation may be available.  Request a free claim evaluation.