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American Medical Systems Archives - Carey Danis & Lowe

$2M Vaginal Mesh Verdict Tied Up in Appeals Court

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

transvaginalmeshlawsuitFast-tracking medical device approvals is tying up a $2 million jury verdict. The plaintiff in a transvaginal mesh lawsuit won a $2 million award, but now the award is under question in an appeals court.

Why?

The defendant in the case, transvaginal mesh manufacturer C.R. Bard, argues that the verdict needs to be voided. The company contends that evidence presented to the jury was incomplete.

During the trial, both parties didn’t mention how the transvaginal mesh device under question received its approval from the US Food and Drug Administration (FDA).

With most transvaginal mesh products, companies received approval via the 510(k) process.

What’s a 510(k)?

Think of the 510(k) as a template system. A medical device manufacturer submits their transvaginal mesh device to the FDA for approval. That device wins approval due to its rigorous testing, and it becomes the template for future products.

Future transvaginal mesh devices can apply for FDA approval using the 510(k) process, and can cite similarity to that first device that received FDA approval.

In the case of transvaginal mesh, citing similarity was enough to bring these defective products to consumers.

Too many modifications

However, there comes a point when medical devices have been modified so much, they can no longer be considered similar to the first device with FDA approval. This alone should require the manufacturer of the highly-modified device to conduct rigorous research to determine safety.

This wasn’t the case for most transvaginal mesh devices, and is the reason why women all over the world are stepping forward to hold manufacturers like C.R. Bard, Ethicon, American Medical Systems, and Boston Scientific accountable.

We can help you step forward.

Are you ready to share your transvaginal mesh story? We’re here to listen, and to help you.

Our experienced transvaginal mesh lawyers are available to discuss your case during a free consultation. We’ll guide you through your legal options, compensation eligibility, and whether filing a transvaginal mesh lawsuit is the right decision for you.

Contact Carey Danis & Lowe by phone at 800.721.2519, or by completing a confidential personal injury claim form.

We look forward to hearing from you soon.

American Medical Systems Settles Nearly 100 Vaginal Mesh Lawsuits

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

ams_american_medical_systems_transvaginal_mesh_lawsuitAmerican Medical Systems settled nearly 100 transvaginal mesh lawsuits. According to a court document recently filed in the American Medical Systems multidistrict litigation (MDL), Judge Joseph R. Goodwin granted a Joint Motion to Dismiss Without Prejudice 95 cases.

The reason for dismissal is that American Medical Systems settled the cases.

One of the settled cases involves a plaintiff and her spouse; the plaintiff received an implant of the American Medical Systems MiniArc Sling in 2009.

The plaintiff’s claim cites negligence, design and manufacturing defects, failure to warn, fraudulent concealment, and punitive damages among a number of other allegations. Also, the plaintiff’s spouse, who is named as a plaintiff in lawsuit, cited loss of consortium.

As of April 24, 2015, the couple’s lawsuit is settled.

The defective medical device lawyers at Carey Danis & Lowe are pleased that American Medical Systems is making considerable headway in settling vaginal mesh lawsuits. The women named in these lawsuits have been waiting years for closure, and now, some of them finally have it.

Were you injured by vaginal mesh or a bladder sling?

Carey Danis & Lowe represents women who have been injured by vaginal mesh and bladder slings manufactured by American Medical Systems, a unit of Endo. Our personal injury lawyers are currently investigating these types of cases; so if you have suffered physical and emotional injuries from vaginal mesh, we encourage you to contact us for a free legal consultation.

During our free legal consultations, one of our attorneys will guide you through your legal options and compensation eligibility; and if applicable, we will walk you through the process of filing a transvaginal mesh lawsuit.

Contact Carey Danis & Lowe

 

Transvaginal Mesh Settlement Urged by Judge

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

transvaginal_mesh_lawsuitsThe federal judge who is overseeing the pretrial proceedings in the 7 transvaginal mesh multidistrict litigations (MDLs) urged the defendants in each of the MDLs to settle the tens of thousands of vaginal mesh lawsuits that they face. U.S. District Judge Joseph R. Goodwin expressed his belief that without a transvaginal mesh settlement, decades would pass before finally resolving these cases.

According to a Reuters report, Judge Goodwin pointed to the American Medical Systems settlement as a praiseworthy example of what should be done.

Though Judge Goodwin has been pushing for settlement, a few of the vaginal mesh makers, among them C.R. Bard, Ethicon, and Boston Scientific, have been averse to the judge’s recommendation, as they continue to adhere to the belief that their vaginal mesh products are not defective. Still, the increasing amount of pressure that these vaginal mesh makers face may play a major role in ultimately influencing the manufacturers to work out a settlement.

Carey Danis & Lowe Represents Mesh Victims

The dedicated team of defective medical device lawyers at Carey Danis & Lowe represent women who have been injured by transvaginal mesh products manufactured by C.R. Bard, Ethicon, Boston Scientific, American Medical Systems, Coloplast, and Cook Medical.

If you have been injured by a transvaginal mesh product manufactured by one of the makers named above, you may be entitled to receive compensation. One of our attorneys can discuss your compensation eligibility during a free, no obligation case evaluation.

Contact Carey Danis & Lowe by phone at 800.721.2519, or by completing a confidential personal injury claim form.

Stay up-to-date on the latest transvaginal mesh lawsuit updates by reading the Carey Danis & Lowe law blog. Find out about Johnson & Johnson’s allegation of fraud, or about Obtape vaginal mesh lawsuits being settled in Georgia.

American Medical Systems Begins Vaginal Mesh Study

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

ams_transvaginal_mesh_lawsuit_settlementsAs mandated by the U.S. Food and Drug Administration (FDA), American Medical Systems (AMS) has started its transvaginal mesh study by enrolling its first participant. The transvaginal mesh manufacturer announced the enrollment in a press release published by the Wall Street Journal.

According to the press release, the AMS study will take place over a period of five years, with two years designated as an enrollment period, and the remaining three years allotted for tracking patient health. The study is to look at the AMS transvaginal mesh product, Elevate (TM) Anterior and Apical Prolapse Repair System.

Though news of the AMS transvaginal mesh study is a welcome announcement, such an in-depth examination of the health effects of transvaginal mesh for the treatment of pelvic organ prolapse (POP) would have best been conducted prior to releasing these types of products onto the market.

Carey Danis & Lowe Represents Victims

A law firm headquartered in St. Louis, Carey Danis & Lowe is dedicated to providing their expert legal assistance to victims of transvaginal mesh. Our team of defective medical device and personal injury lawyers understand the pain and suffering that individuals and families endure in the wake of injuries from a defective product. If you or someone you love has been injured by transvaginal mesh, work with a team of lawyers that are committed to your case.

Explore your legal options and compensation eligibility with a Carey Danis & Lowe lawyer today. Our initial consultations are free.

Transvaginal Mesh Lawsuits Move Forward against American Medical Systems, as Federal Court Issues Order for Third Round of Trials

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

Published May 19, 2014 by Digital Journal

Anterior-Vaginal-MeshThousands of transvaginal mesh lawsuits filed against American Medical Systems, Inc. continue to move forward in a consolidated litigation underway in U.S. District Court, Southern District of West Virginia. On May 16, 2014, the Court approved a new Docket Control Order pertaining to the litigation’s third round of bellwether trials. Among other things, the Order stipulates that all discovery, including depositions of all company witnesses and third parties, will be completed by July 14, 2014. Dates for pretrial and settlement conferences, as well as the start date for the trial itself, will be determined by the Court at a future Status Conference. (In Re American Medical Systems, Inc. – MDL No. 2325)

Vaginal Mesh Lawsuits

According to court documents, tens of thousands of vaginal mesh lawsuits have been filed against American Medical Systems in courts around the country. The vast majority of claims are pending in the Southern District of West Virginia, where Jeffrey S. Grand is serving on the Plaintiffs’ Steering Committee.

On April 30, 2014, Endo International PLC, the parent company of American Medical Systems, announced a settlement agreement that could potentially resolve some 20,000 transvaginal mesh lawsuits pending against the company. Among other things, Endo indicated that it has set aside $830 million to cover the settlement agreement, which is expected to be implemented over the next year. Endo did not admit liability or fault for any plaintiffs’ alleged vaginal mesh complications in agreeing to the settlement plan.*

According to court filings, American Medical Systems is just one of several companies named in vaginal mesh lawsuits in the Southern District of West Virginia. In addition to his work on that litigation, Mr. Grand is also serving on the Plaintiffs’ Steering Committees in several proceedings established in that jurisdiction that involve Boston Scientific Corp., (MDL 2326), C.R. Bard, Inc. (MDL 2325) and Ethicon, Inc. (MDL No. 2327).

Mr. Grand is also serving as Co-Liaison Counsel in two consolidated proceedings established for C.R. Bard and Ethicon mesh lawsuits in New Jersey’s Atlantic Superior Court. He was also a member of the plaintiff’s trial team for the first Ethicon trial, which ended in March with an $11 million verdict for the Plaintiff. (In re: Pelvic Mesh/Gynecare Litigation, No. 6341-10; In re: Pelvic Mesh Litigation/Bard, No. L-6339-10).

Alleged victims of serious vaginal mesh complications may be entitled to compensation for their injury-related damages. To learn more about filing a transvaginal mesh lawsuit, please visit Carey Danis & Lowe’s website https://www.careydanis.com. To obtain a free, confidential and no-obligation case review, please call 1.800.721.2519.

 

Federal Judge Overseeing Ethicon Transvaginal Mesh Lawsuits Levies Sanctions Against Defense Counsel

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

Published May 16, 2014 by Digital Journal

Boston Scientific Ordered to Release Defective Transvaginal Mesh DocumentsBoston Scientific Ordered to Release Defective Transvaginal Mesh DocumentsThe federal judge overseeing thousands of transvaginal mesh lawsuits filed against Johnson & Johnson’s Ethicon, Inc. unit has sanctioned the companies’ attorneys for removing certain cases to federal court, despite numerous rulings that the lawsuits belong in a Pennsylvania litigation. According to court documents, the lawsuits in question named Pennsylvania-based Secant Medical Inc. as a defendant, and were originally filed in the Philadelphia Court of Common Pleas. In an Order issued on May 13, 2014, U.S. District Judge Joseph R. Goodwin of the Southern District of West Virginia wrote that the defense attempts to move the cases, despite repeated rulings that Secant had not been fraudulently joined, were calculated “to keep these cases out of state court for as long as possible and to waste the court’s time and the plaintiff’s resources.” (In re: Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation – MDL No. 2327)

Ethicon Transvaginal Mesh Lawsuits

Court documents indicate that more than 18,000 transvaginal mesh lawsuits have been filed in the Southern District of West Virginia on behalf of women who were allegedly injured by Ethicon devices used in the treatment of pelvic organ prolapse and stress urinary incontinence. Bernstein Liebhard LLP partner, Jeffrey S. Grand, is serving on the Plaintiffs’ Steering Committee in that proceeding. All of the complaints allege that the use of these devices caused thousands of women to suffer mesh erosion, chronic pain, organ damage and other serious, and sometimes permanent, vaginal mesh complications.

Mr. Grand is also serving as Co-Liaison Counsel in two multicounty litigations underway in New Jersey Superior Court for transvaginal mesh lawsuits involving products marketed by C.R. Bard and Ethicon. He was also a member of the Plaintiff’s trial team on the first Ethicon trial in that proceeding, which ended in March with a jury awarding $11 million in compensatory and punitive damages to a woman who was harmed by the Ethicon Gynecare Prolift device. (In re: Pelvic Mesh/Gynecare Litigation, No. 6341-10; In re: Pelvic Mesh Litigation/Bard, No. L-6339-10)

According to court records, more than 55,000 transvaginal mesh lawsuits have been filed against a number of device manufacturers in litigations that are underway in the Southern District of West Virginia. Mr. Grand is also serving on the Plaintiffs’ Steering Committees in proceedings involving : American Medical Systems, Inc. (MDL No. 2325); Boston Scientific Corp., (MDL No. 2326); and C.R. Bard, Inc., (MDL No. 2187).

<p”>Alleged victims of vaginal mesh complications may be entitled to file their own transvaginal mesh lawsuit. To learn more about the litigation involving these devices, please visit https://www.careydanis.com. To obtain a free, confidential and no-obligation case review, please call 1.800.721.2519.

As 50,000 Vaginal Mesh Lawsuits Await Litigation; FDA Moves to Reclassify Transvaginal Mesh as High-Risk Medical Devices

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

Published May 13, 2014 by Digital Journal
Anterior-Vaginal-MeshCarey Danis & Lowe, an experienced law firm representing women in vaginal mesh lawsuits, is pleased to report that the U.S. Food & Drug Administration (FDA) has proposed new regulations to mitigate the risks associated with surgical mesh used in the transvaginal repair of pelvic organ prolapse. According to a press release issued by the agency on April 29, 2014, the FDA has proposed reclassifying vaginal mesh as “high-risk.” The new rule would subject the products to greater regulatory scrutiny, and require manufacturers to submit a premarket approval application to the agency to evaluate safety and effectiveness.
[http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm395192.htm]

According to the FDA, transvaginal mesh products intended to treat pelvic organ prolapse are currently classified as “moderate risk” devices. As such, they are eligible for the agency’s 510(k) clearance process, which doesn’t require a manufacturer to conduct human clinical trials of a product before it is launched on the market. As high-risk devices, surgical mesh used to transvaginally repair prolapse would no longer be eligible for this process. The proposed regulations would also require manufacturers of devices already on the market to conduct safety studies of their products if they intend to continue selling them.
[http://www.federalregister.gov/articles/2014/05/01/2014-09909/effective-date-of-requirement-for-premarket-approval-for-surgical-mesh-for-transvaginal-pelvic-organ]

The FDA’s actions follow warnings issued by the agency in October 2008 and July 2011 regarding the risk of serious vaginal mesh complications associated with transvaginal mesh products used to treat pelvic organ prolapse and stress urinary incontinence. In announcing the proposed regulations earlier this week, the FDA said it had since “identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse.”

According to court documents, more than 50,000 transvaginal mesh lawsuits have been filed in the U.S. District Court, Southern District of West Virginia by women who were allegedly injured by these products. The litigations include:

  • In re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation (MDL No. 2325)
  • (In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation – MDL No. 2327)
  • In re: Boston Scientific Corp., Pelvic Repair System Products Liability Litigation (MDL No. 2326);
  • In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2187)
  • In Re: Coloplast Corp. Pelvic Support System Products Liability Litigation (MDL No. 2387)
  • In Re Cook Medical, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2440)

Carey Danis & Lowe is representing alleged victims of transvaginal mesh complications in numerous claims that have been filed in the Southern District of West Virginia, and continues to offer free vaginal mesh lawsuit reviews to women who may have been injured by these devices. Learn more by visiting www.careydanis.com or by calling 1.800.721.2519.

FDA Inspects American Medical Systems Headquarters

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

ams_transvaginal_mesh_lawsuit_settlementsThe parent company of American Medical Systems, the medical device manufacturer whose transvaginal mesh products are currently the subject of thousands of lawsuits in West Virginia, received a warning letter from the U.S. Food and Drug Administration (FDA) in February. Endo was dealt the warning letter following an inspection of an American Medical Systems headquarters located in Minnesota.

According to an article recently published in the Wall Street Journal, American Medical Systems has made efforts to improve their business practices according to the contents drawn up in the warning letter, which primarily concerned safety procedures.

As American Medical Systems works on corrective measures at their headquarters, the transvaginal mesh lawsuits targeted at them and their mesh products continue to pile up in a federal court in West Virginia. To date, there are currently well over 17,000 lawsuits filed in the American Medical Systems multidistrict litigation (MDL).

The next two American Medical Systems MDL status conferences have been canceled, according to the court’s website. However, the MDL will soon start the bellwether trial process, as the court is scheduled to hear two bellwether cases, with the first to begin on June 2, 2014 and the second on July 7, 2014.

Carey Danis & Lowe Investigating Mesh Cases

The defective medical device lawyers at Carey Danis & Lowe continue to hear from women who have been severely injured by defective transvaginal mesh products. Carey Danis & Lowe is a committed advocate of victims of defective medical devices. We offer free initial case evaluations, and encourage you to contact our law firm if you have been injured by defective transvaginal mesh.

Share your story with Carey Danis & Lowe today by calling 800.721.2519, or complete one of our confidential personal injury claim forms.

American Medical Systems MDL News: Cases Rescheduled

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

ams_american_medical_systems_transvaginal_mesh_lawsuitIn March, the judge presiding over the American Medical Systems multidistrict litigation (MDL) in West Virginia rescheduled two of the bellwether cases. The lawsuits were originally in line to be tried in April and May, but according to a court document, they have been rescheduled for June 2 and July 7, 2014.

The two bellwether cases that were rescheduled are Serrano v. AMS, Inc., et al. and Jilovec v. AMS, Inc. If the status of either of these cases changes between now and the scheduled trial dates, the next two bellwether cases in line for trial are Weiler v. AMS, Inc. and Fontes, et al. v. AMS, Inc.

The outcome of each of these bellwether cases has the potential to strongly impact the resolution of the thousands of cases pending in the West Virginia MDL. As so many women and their families have been negatively impacted by transvaginal mesh products manufactured by American Medical Systems, defective medical device lawyers at Carey Danis & Lowe believe that it is of the utmost importance to closely follow these bellwether cases as they move through the trial process.

As of mid-April, there are over 17,000 vaginal mesh lawsuits consolidated into the American Medical Systems MDL. The number of cases in the MDL have seen a significant increase since almost a year ago, when the court recorded approximately 5,000 transvaginal mesh lawsuits targeted at American Medical Systems.

Carey Danis & Lowe Can Help

Carey Danis & Lowe is a national law firm specializing in pharmaceutical product liability litigation. Our defective medical device lawyers represent victims who have sustained life-altering injuries after using certain medical products, including transvaginal mesh.

Our law firm offers free case evaluations. Share your transvaginal mesh story with Carey Danis & Lowe today by calling 800.721.2519, or by completing one of our confidential personal injury claim forms.

New Court Document Filed in Consolidated West Virginia Transvaginal Mesh Lawsuits

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

transvaginal_mesh_lawsuit_settlements_mdl_multidistrict_litigation_class_action_lawsuit_vaginal_mesh_fda_lawsuitsA new pretrial order document has been filed in two of the six transvaginal mesh multidistrict litigations (MDLs) in a federal court in West Virginia. Filed in the Ethicon MDL and the American Medical Systems MDL, the court document pertains to severing claims. According to the court document, written by Judge Joseph R. Goodwin, there are two transvaginal mesh lawsuits consolidated into the Ethicon MDL, and three lawsuits consolidated into the American Medical Systems MDL, that wrongly combine more than one plaintiff into a single case.

Judge Goodwin ruled to dismiss the co-plaintiffs from these five lawsuits due to the inappropriate merging of plaintiffs into one lawsuit. However, these individuals have been granted the opportunity to resubmit their claims to the West Virginia federal court.

Lawsuits that name spouses as a co-plaintiff will not be dismissed and do not require separate filings, as the claims demonstrate relation.

Carey Danis & Lowe represents victims of defective medical devices, including those who have used transvaginal mesh products manufactured by Ethicon and American Medical Systems. We frequently hear from women who believe that their injuries, pain, and suffering are the result of having been implanted with a defective transvaginal mesh device.

If you have injuries that you believe originated from defective transvaginal mesh, you may have a case worthy of compensation. Contact the St. Louis class action attorneys at Carey Danis & Lowe for a free case evaluation.

Furthermore, if you would like to learn more about how transvaginal mesh can impact your health, speak with one of our on-staff nurses, who can tell you more about transvaginal mesh erosion and mesh contraction.

Share your story about how a defective medical device has impacted your life with Carey Danis & Lowe today by calling 800.721.2519, or by completing a confidential personal injury claim form.

Also, learn more about these West Virginia MDLs by reading about settlement discussions and about a recent jury verdict in Cisson v C. R. Bard. Check the Carey Danis & Lowe personal injury litigation blog frequently for updates on transvaginal mesh lawsuits and more.