Archive for the ‘Product Liability’ Category

Surgical Mesh Complications

Wednesday, August 17th, 2011

Our injury lawyers have previously discussed recent FDA warnings against the use of transvaginal surgical mesh.  This article expands on complications from surgical mesh, as well as previous FDA warnings.

Surgical mesh is an implantable medical device, much like an artificial hip or heart valve. They are commonly used to treat pelvic organ prolapse, a rare but serious complication of difficult childbirths. The condition occurs when the muscles which support the pelvic organs become stretched or weakened, and fall or slip out of position.

The condition can vary in severity. With milder forms of prolapse, physical therapy or medication can be used to treat and even correct the problem. But if these treatments fail, surgery may be required. That is where surgical meshes have entered the picture.

The number of surgeries using surgical meshes gradually increased. By 2003, about 200,000 prolapse surgeries were being performed in the U.S. each year, and almost all involved the implantation of surgical mesh.

But as the use of surgical meshes has increased, so to has the number of women who have suffered from severe complications, including:

  • perforation of the bowel
  • perforation of the bladder
  • incontinence
  • inflammation
  • infection
  • fibroids
  • pain, especially during intercourse
  • vaginal shrinkage
  • erosion through the vaginal epithelium
  • vaginal scarring

Some victims who suffer these complications must endure additional treatments, blood transfusions, and even additional surgeries. These surgeries can correct the complications in some cases, but not all. And once the mesh is installed, it usually cannot be removed – the victim is stuck with the mesh, whatever follows.

Dating back to October of 2008, the FDA issued a warning that surgical meshes could pose a potential danger. This was only after the agency received over a thousand reports of complications from these products. And the agency has still not recalled or banned the products, however, and they continue to be used.

Left without help from the government, women injured by surgical mesh have turned to the courts. Since 2008, many women ave filed civil actions against mesh manufacturers (such as C.R. Bard, the industry leader). For federal cases, there is now a federal multi-district litigation  pending.

If you had surgery for pelvic prolapse, and had surgical mesh implanted, you may have believed that your problems were unique. This is simply not the case: you are far from alone. Talk to an experienced Chicago injury attorney at Passen Law Group about your complications – he or she can help you decide whether to take legal action to recover for your injuries and pain.   For a free consultation with one of our top-rated attorneys, call us at (312) 527-4500 or email info@passenlaw.com.

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Products Liability: A Primer

Thursday, August 11th, 2011

If someone is seriously injured or killed by a dangerous or defective product, there may be a viable action for product liability.

Broadly stated, a products liability claim is any legal claim which alleges that the victim was killed, injured, or otherwise suffered damages due to a product her or she purchased and used. Although every case is unique, generally speaking there are three types of products liability claims: defective manufacture, defective design, and failure to provide adequate warnings (or, in some cases, instructions).  Regardless of the type of products liability claim, the victim must demonstrate that the product was defective, that she suffered injury or damage, and that this defect caused her injuries or damages.

Defective Manufacture

This type of product liability action is well ingrained in the public consciousness. A claim for defective manufacture arises when there is some error or problem when the product is being made, leading to a flaw in a single product or a batch or batches of the product. But whatever the details, the product which injured the plaintiff is different from the products that are usually on the shelf.

Examples of defective manufacture include:

  • stroller with a crack in the frame, leading to collapse with a child inside
  • batch of pain killers (such as ibuprofen) tainted with a hazardous chemical
  • car or truck with missing brake pads
  • Plane crash due to negligently installed wing

In each case, not every customer who purchased the product or brand suffered any injury – only the customer who purchased the specific item with the defect.

Defective Design

The second type of products liability claim, a claim of defective design, is also well-recognized. In a defective design case, it is not one specific item which is defective, but the entire inventory. This is because defective design claims center on the design, composition, or plan for the product, which is then used to manufacture each one. In these claims, there is no problem in the manufacturing process – the product which caused the injury is made exactly as the manufacturer intends. Yet the product is still dangerous: something in the product is inherently dangerous.

Examples of defective design include:

  • model of vehicle which tends to roll over on sharp corners
  • brand of sunscreen that does not actually block UV rays
  • line of blenders that can electrocute the user when placed on a particular setting

Inadequate Warnings

The final broad category of product liability claims comes into play when a product is dangerous, usually in a way that is not immediately obvious, and the manufacturer fails to warn the customer about that danger. This can also be true if the danger can easily be avoided by taking a simple precaution, or using the product only in specified ways, and the manufacturer fails to provide this information to the customer.

Situations involving defective manufacture include:

  • electric tea kettle with a steam vent in an unusual location, with no warning on the package
  • Pharmaceutical drug with no warning label stating that it can be dangerous if taken in combination with certain allergy medications
  • cleaning product packaged without a warning that it can produce dangerous fumes if used in an enclosed space and not immediately rinsed

Practical Example

Any product could potentially give rise to any of these three types of claims. Take, for example, an outdoor playset. If the playset is designed so that children on the swings can swing backward and hit their head on the platform above and suffer a brain injury, a child injured in such an accident could have a defective design claim.

If, however, a particular playset was built using a rotted piece of wood on the platform, and that wood gives way under a child, causing him to fall and break his leg, then that child could have a defective manufacture claim.

Finally, if the playset comes with two slides, each with the same connector at the top, but if they are connected in the wrong places a child using the slide exits directly in the path of the swings, and the manufacturer provides no warning or instructions as to which slide goes where, then an injured child could have a claim for inadequate warnings (note that this could also give rise to a defective design claim).

Passen Law Group represents individuals and families in product liability actions in a variety of contexts, and with record results.  For a free consultation with an experienced Chicago products liability lawyer at Passen Law Group, call us at (312) 527-4500 or email info@passenlaw.com.

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FDA Warns Against Use of Transvaginal Mesh

Thursday, August 4th, 2011

Today, our medical malpractice lawyers discuss a recent FDA report concerning the safety of transvaginal surgical mesh.

Surgical mesh is a metallic or polymeric screen that can be implanted inside a person’s body to reinforce soft tissue or bone where weakness exists.  Surgical mesh has been used for several decades to repair abdominal hernias and, more recently, gynecologists began using surgical mesh products for transvaginal repair of pelvic organ prolapse (POP) and  for surgical treatment of stress urinary incontinence (SUI).

Since that time, thousands of women have suffered serious injuries or death as a result of transvaginal mesh placement.  Indeed, according to the FDA, there have been nearly 4,000 reported cases of injury, death and malfunction related to urogynecologic surgical mesh products, 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs.

The FDA recently issued a warning in a report titled, “Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse.”

The FDA essentially found that the health risks associated transvaginal placement of surgical mesh to treat POP far outweigh any benefit from the procedure.

Transvaginal Mesh Injury

The FDA identified several serious safety concerns associated with transvaginally placed surgical mesh for repair of pelvic organ prolapse (POP), including:

  • Approximately 10 percent of women who undergo transvaginal POP repair with mesh experience vaginal mesh erosion (also called exposure, extrusion or protrusion) within 12 months of surgery, often requiring two or three additional surgeries and continued sequelae (e.g., pain) even after mesh removal;.
  • Mesh contraction, causing vaginal shortening, tightening, and/or vaginal pain;
  • New onset SUI following repair with surgical mesh;
  • Infection;
  • Bleeding;
  • Pain during intercourse;
  • Organ perforation;
  • Urinary problems

No Benefit from Transvaginal Repair of POP with Surgical Mesh

According to the FDA, transvaginal apical or posterior repair with surgical mesh does not a provide any benefit compared to traditional surgery without mesh.  In other words, traditional POP repair carries far less risk to women, and provide every bit as much benefit, as compared to using transvaginally placed mesh in POP repair.

The medical malpractice attorneys at Passen Law Group have a vast amount of experience representing patients and their families in medical negligence actions, and consult with the top medical professionals in their respective fields of specialty to assist with proving each case.  To speak with an attorney about a case relating to an injury from transvaginal mesh, call us at 312-527-4500 or email info@passenlaw.com.

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