ParaGard IUD Lawsuit

What Is a ParaGard IUD?

A ParaGard intrauterine device (IUD) is a medical product that can provide birth control to women for up to 10 years after being inserted. Intrauterine devices are often referred to as a non-hormonal IUD option. The ParaGard device is comprised of a T-shaped plastic frame with copper wire coiled around it. The device is then inserted into the uterus and the copper wire creates an inflammatory reaction that is toxic to the sperm and eggs (ova)—preventing pregnancy.

Although the ParaGard IUD is intended to be easily removable and allow for women to conceive after the device has been removed, there can be painful complications if the device fractures or breaks. Now dozens of lawsuits are being filed by women who claim that the ParaGard broke during the removal procedure.

Injuries from ParaGard IUDs

Since 2010, the Food and Drug Administration (FDA) has received more than 1,600 reports of ParaGard breakage, with more than 700 reports classified as ‘serious.’ A study published by the American Journal of Obstetrics & Gynecology found that ParaGard users may experience higher expulsion rates and unwanted pregnancies compared to other IUDs.

Other injuries from ParaGard IUDs include:

  • ParaGard device becomes embedded in the uterus
  • ParaGard device becoming “stuck” in the uterus
  • Perforation of the uterine wall
  • Movement or migration of the device which can lead to organ damage
  • Device breakage during surgery
  • Inflammation and other injuries from the copper left in the body
  • Scarring inside of the uterus
  • Possible hysterectomy or uterus removal required
  • Infections
  • Ectopic pregnancy
  • Pelvic pain
  • Expulsion

State Court Cases in Pennsylvania

Currently 21 ParaGard lawsuits have been filed in Philadelphia in the Court of Common Pleas. The lawsuits are currently overseen by Judge Daniel Anders.

ParaGard IUDs were originally manufactured by Teva Women’s Health Inc. before the company sold the product to Cooper Pharma.

Petition to Consolidate ParaGard IUD Lawsuits Into MDL

A group of plaintiff attorneys filed a petition with the Judicial Panel for Multidistrict Litigation (JPML) on September 24, 2020 to transfer the ParaGard IUD lawsuits to the United States District Court for the Central District of California for pretrial consolidation and coordination.

The petition notes that there are currently 55 lawsuits pending in 29 different judicial districts across the United States and that a multidistrict litigation (MDL) is relevant due to how similar the cases are. The lawsuits are claiming that the IUD devices were defectively designed and manufactured, and that the manufacturer Teva Pharmaceuticals failed to warn that the device could break during removal and failed to warn of the device’s potential negative side effects. The petition states that “in this instance, transfer, coordination and consolidation is appropriate because many common questions of fact and law exist, including but not limited to the following: whether ParaGard was defectively designed; whether the ParaGard lots at issue contained manufacturing defects; whether ParaGard was marketed with an adequate label; whether Defendants conducted adequate pharmacovigilance of ParaGard; and whether Defendants engaged in negligent conduct resulting in Plaintiffs’ injuries.” The JPML will consider an argument from parties involved during a hearing session scheduled for December 3, 2020 in San Antonio, Texas.

GoldenbergLaw Can Help

The Minnesota Defective Medical Device Attorneys at GoldenbergLaw have over thirty years of experience representing victims who have been harmed by a defective medical device. Contact us today and leave the sleepless nights to us.

J&J Discontinues Sales of Talc-Based Baby Powder

Johnson & Johnson announced today it was discontinuing sales of its talc-based baby powder products in the United States and Canada amid a firestorm of lawsuits claiming its signature product contains asbestos. The announcement comes just weeks after US District Judge Freda Wolfson ruled to allow testimony from plaintiffs’ experts in the New Jersey-based Multidistrict Litigation. Thousands of claimants have argued that regular exposure to the baby powder has caused them to develop ovarian cancer and mesothelioma.

Was Decision To Pull Talcum Powder Related To 2019 Recall?

In October 2019, J&J issued its first ever recall of talc-based baby powder after FDA testing found trace amounts of asbestos in the product. The company claims that this is a “commercial decision” due to a 60% decline in sales since 2017 as consumer habits change due in large part to lawsuits filed over the safety of the product.

As to the timing of discontinuing the talc-based Baby Powder, Professor of Marketing at Georgetown, Christie Nordhielm, claims that it appears Johnson & Johnson decided to withdraw from the market while consumers are concerned with the COVID-19 pandemic: “It’s a nice time to quietly do it, it will eliminate reputational hit.”

Thousands of lawsuits from consumers and survivors claim that Johnson & Johnson’s talcum powder products caused cancer due to contamination with asbestos—a known carcinogen to humans. Internal company records and trial evidence demonstrate that from at least 1971 to the early 2000s, J&J’s raw talc and finished powders sometimes tested positive for small amounts of asbestos.

Johnson & Johnson has also been the target of a federal criminal investigation into their lack of forthrightness about their talc products’ safety. 41 states have investigated Johnson & Johnson’s Baby Powder in addition to an investigation being launched by a Congressional subcommittee about the health of asbestos in talc-containing consumer products.

The pharmaceutical giant will continue to sell its cornstarch-based powder.

Ruling Clears Plaintiffs For Bellwether Trials

Judge Wolfson ruled on April 27, 2020 that five plaintiffs’ experts in the Talcum Powder litigation against Johnson & Johnson could appear before juries.

This is the first ruling by a federal judge on the reliability of plaintiffs’ experts testifying about whether or not talcum baby powder causes ovarian cancer. Of the five plaintiff experts that Judge Wolfson allowed to testify before juries in talcum powder litigation, two of those experts have testified before Congress on talcum powder safety.

Based on epidemiological studies, the plaintiffs’ experts will be able to testify that J&J’’s talc-based products can contribute to the development of ovarian cancer cancer due to contamination with asbestos and heavy metals. J&J wanted to prevent the plaintiffs’ experts from testifying in order to effectively eliminate all of the cases overseen by Judge Wolfson.

A handful of the more than 16,000 talcum powder lawsuits that have been consolidated under the MDL overseen by Judge Wolfson will now be selected for early “bellwether” trials which can help determine the strength of each side’s case and aid in a potential settlement process.

The decision opens the path for bellwether trials to begin in the MDL sometime in 2021.

Let Us Help

GoldenbergLaw is currently litigating cases where individuals have been diagnosed with ovarian cancer or mesothelioma after long term talcum powder exposure.  To get in touch with us regarding any potential talcum powder cases we may investigate on your behalf, please contact our Senior Partner Stuart Goldenberg at slgoldenberg@goldenberglaw.com or by phone at 612-335-9960, or our Partner Noah Lauricella at nlauricella@goldenberglaw.com or by phone at 612-335-9977.

Contact us today, and let us deliver the Gold standard advocacy you deserve.

How Safe is Hernia Mesh?

Concerns over the lack of clinical evidence and medical device testing of hernia mesh products has led to an outcry in the United Kingdom.

New data shows that there are more than 100 different types of surgical hernia mesh that were purchased by the National Health Service (NHS) Trusts from 2012-2018 in England and Scotland to perform the approximately 100,000 hernia operations every year; however, there are concerns about the safety of these products. In the United Kingdom, hernia mesh devices can be approved if they are ‘similar’ to older products—older products which may not have been required to undergo any rigorous testing or clinical trials to determine their safety.

International guidelines estimate that one in 10 patients will experience “significant chronic pain” following mesh repair. Professor Carl Heneghan, a medical device expert at the University of Oxford, explained that the complications may be due to a lack of testing before the hernia mesh products enter the market.

He explained that some devices have only been required to be tested on animals such as rabbits for a short period of time, with the implanted mesh only left inside the animal for a few days. He reported that “if there’s no remaining immune reaction, you pass the test” and the product goes to the market. Professor Heneghan stresses the inadequacy of these tests due to their limited nature and the fact that they cannot test for pain, which is the most common complication of surgeries involving hernia mesh.

Professor Heneghan asserted that there was “no chance” that the more than 100 types of hernia mesh devices used by the NHS were all individually tested because there have not been 100 trials in this area of medical device testing. He calls for the NHS to “immediately” stop using those devices that have “no clinical evidence attached to them whatsoever.”

Exposed Hernia Mesh Manufacturer Video

The UK’s news agency, the BBC, recently viewed a leaked promotional video intended for the medical community that was funded by Ethicon—one of the world’s largest mesh manufacturers.

The video, which is over a decade old, shows a surgeon discussing how some older types of mesh can become “hard as stone” after only one year inside of a patient and can cause damage to the body, including chronic pain. However, the product mentioned in the video is still being sold by Ethicon and used by the NHS in England and Scotland.

How has the UK Government Responded to these Findings and Concerns?

Director of Devices at the Medicines and Healthcare Products Regulatory Agency (MHRA) Graeme Tunbridge said that “the benefits and risks of using mesh for hernia repair have been considered in detail by clinicians and the professional bodies who represent them. We continue to monitor and review evidence as it becomes available and will take any appropriate action on that basis.”

Mr. Tunbridge acknowledged that the medical device testing system “does need strengthening” and said that new legislation on medical device testing, which would include strengthening requirements on manufacturers to ensure that sufficient clinical evidence is in place for their products, would take effect in May 2020.

A spokeswoman for the Department of Health and Social Care said that “on the rare occasion where a patient has suffered as a result of a mesh procedure, we are taking steps to improve patient safety- including improving how we listen to patients and how the system learns when concerns are raised.”

How has the U.S. Responded to Hernia Mesh Complications?

The U.S. Food and Drug Administration (FDA) considers the mesh used for hernia mesh repair surgeries to be safe, but acknowledges that ‘in rare cases’ complications may occur and that the most severe of these complications may be deadly. The FDA also recognizes that complications with the mesh may result in, at the very least, severe pain and require revision surgery.

However, the FDA claims that many of the more severe complications associated with hernia mesh repair pertain to recalled mesh products that are no longer on the U.S. medical device market.

A 2016 study analyzing the long-term recurrence and complications associated with elective incisional hernia repair reported that the number of complications after hernia surgeries increased over a five year span. Out of the 3242 participants in the study, 1050 participants required another abdominal surgery.

What is a Hernia?

A hernia occurs when an organ, intestine, or fatty tissue squeezes through a hole or weak spot in the surrounding muscle or connective tissue. Most commonly, hernias occur at the abdominal wall and sometimes may be visible as an external bulge particularly when straining or bearing down.

Types of Hernias

  • Inguinal hernias occur in the inner groin
  • Femoral hernias occur in the upper thigh or outer groin
  • Incisional hernias occur through an incision or scar in the abdomen
  • Ventral hernias occur in the general abdominal or ventral wall
  • Umbilical hernias occur near the belly button
  • Hiatal hernias occur inside the abdomen, along the upper stomach

How Common are Hernia Repairs?

Hernia repairs are extremely common; more than one million hernia repairs are performed each year in the U.S. Since the 1980s, there has been an increase in mesh-based hernia repairs. Surgical mesh is supposed to strengthen the hernia repair and reduce the rate of recurrence. Currently, more than 90% of the one million plus hernia surgeries performed each year in the U.S. use hernia mesh to perform the repairs.

Surgeons cutting hernia meshWhat is Surgical Hernia Mesh?

Surgical hernia mesh is a medical device used to provide additional support to tissue that has been weakened or damaged by a hernia. Hernia mesh is a surgical implant which often made of a synthetic plastic called polypropylene or animal tissue that reinforces torn or damaged tissue around hernias and strengthens it as it heals.

Synthetic materials can be absorbable, non-absorbable or a combination of both types of materials. Animal-derived mesh is made of animal tissue that has been processed and disinfected to be suitable for use in an implanted device; animal-tissue based mesh is absorbable. Non-absorbable mesh will stay in the body forever and is considered a permanent implant intended to provide permanent reinforcement to the repaired hernia. However, absorbable mesh will degrade over time and is not intended to provide permanent reinforcement. As the material disintegrates, new tissue grows and ideally provides strength to the repair.

What are Hernia Mesh Complications?

The most serious complications of hernia mesh are also some of the most common:

  • Adhesion- Scar-like tissue that sticks together and leads to bowel obstructions.
  • Bowel obstruction – Occurs if the mesh adheres to the intestines and cuts off blood flow.
  • Bowel perforation – Occurs when the hernia mesh punctures or erodes into the bowel.
  • Infection – Chronic infection symptoms may not occur until years after hernia mesh surgery.
  • Rejection – Materials within the hernia mesh may trigger the body’s immune system and cause the body to reject the mesh.
  • Migration – If the hernia mesh detaches after surgery, it can migrate through the abdomen and lead to adhesions, fistulas, abscesses, and bowel obstruction or perforation.
  • Recurrence – A common complication of hernia surgery is that hernias may return.
  • Chronic pain

Nearly one-third of people who have hernia surgeries experience some type of complication—excessive pain is the most frequent complication. These complications may appear shortly after surgery or years later.

How GoldenbergLaw Can Help You

GoldenbergLaw is currently investigating hernia mesh failure cases where an individual required a revision surgery. If you need a hernia mesh lawyer, we have the expertise and experience to help bring you justice. Contact us today for a free consultation, and let us deliver the Gold Standard you deserve.