Scroll down for a current list of breast implant lawsuits. Mentor MemoryGel Silicone Breast Implant lawsuits started in October 2016 with Ebrahimi v. Mentor. A Mentor MemoryGel Silicone Breast Implant case, Gravitt et al v. Mentor, was able to in part pass preemption two times, first in January and then in June 2018. Lawsuits for ladies with BIA-ALCL commenced in 2018 and are continuing to be filed. In January 2019, two Canadian law firms have requested to file a potential class action lawsuit against three breast manufactures (Allergan, Mentor, and Ideal) of textured breast implants; and another Canadian law firm has commenced a potential class action against Mentor MemoryGel Silicone Breast Implants. In May 2019, a Canadian class action commenced against breast implant manufacturer Allergan. In July 2019, the FDA requested Allergan to recall its textured breast implants from the US market. Allergan responded with a global recall of silicone and saline textured breast implants and tissue expanders. This comes after more cases of BIA-ALCL have been reported. There are two US law firms investigating breast implant illness claims, Dampier Law Firm and CityWide Law Group. They are interested in filing cases against all manufacturers implanted after 2006, Allergan recalled breast implants, ruptures, cancers with breast implants, and BIA-ALCL In 2019, a bipartisan bill called the Medical Device Safety Act 2019 H.R. 2669 was introduced and is key to changing the current preemption laws that protect the manufacturers. If you are interested in following developments in any of these cases and in information in regard to breast implant lawsuits please leave a comment below.
Where to Start:
Gather all medical records from each of your medical providers, such as: implanting surgeon, primary doctor, specialists, dentist, etc. Regardless of a lawsuit, it is important to keep your own file of all pertaining medical records. How long medical offices are required to retain medical records varies with each state. See requesting medical records for more information.
1. Obtain every page of your plastic surgery records (all operative reports, follow-up visits, etc). Ask if you were part of a manufacturer breast implant study and check all your records for any notes made by the surgeon.
2. Write down all your symptoms and try to put them in chronological order. Note the year and the month if possible of when each one started. This is important to document.
3. Talk with your doctor; share the chronology of symptoms and provide scientific literature of foreign body reaction and silicone as an adjuvant. Explant is a medical necessity procedure for many of us. Discuss this with your health care provider and see if a Medical Necessity Letter can be written.
4. Heavy metal and chemical testing before explant can help to see if there is any measurable, quantitative toxicity, as well as any other lab work that is related to your health. There is a toxicology lab in Colorado called The Carlson Company that can do heavy metal and chemical testing of explanted capsule tissues.
5. When you explant make sure your implants and capsules are not destroyed and make arrangements to secure them. Ask your surgeon for pictures of the implants and capsules at the time of surgery. You can even try asking if they will video the surgery. Maintain a chain of custody for both, implants and capsules.
6. Research medical device product liability and parallel state law claims. There have been an increasing number of Class III medical device parallel claims pursued with relative success.
7. Research and put together a list of other medical device cases that have either won or are currently ongoing against your manufacturer or other medical device manufacturers (ex. transvaginal mesh, hip implants, Essure cases, etc).
8. Search for a product liability lawyer. Provide them with your research in an organized fashion: a chronology of your medical history, any doctor reports that support your allegations, the current breast implant cases below and the other current medical device cases you researched.
9. When researching and choosing a law firm, ask what their intentions are in the larger scheme – are individual cases being filed for the purpose of a MDL (multi district litigation) or is a collective class action being organized? Pay caution if a law firm is preparing for a breast implant class action lawsuit, those are what happened in the 90s and were ultimately in the best interest for the attorneys, not the women. Class actions in this type of litigation result in low ball settlements and high attorney fees.
10. Read over a retainer very carefully, make any adjustments, and sign with the law firm. Generally, product liability and personal injury cases are taken on contingency. This means the attorney shall advance litigation costs, travel expenses, copying fees, expert witnesses, etc. In a contingency case you should not have to upfront costs. If you win the case, a lawyer’s fees come out of the money awarded. Contingency fees can range from 25-40%, with average being 33% or one-third. If there is trial involved, contingency fees can be 40%.
In the 1990s, Dow’s scandal of falsified studies, circus of inadequacy in faulty manufacturing, and campaign of deceit and denial was exposed. Over 450,000 women came forward, litigation and bankruptcies ensued among various breast implant manufacturers, along with a moratorium that banned silicone breast implants for 14 years, from 1992-2006. The exception for their usage were certain reconstruction and revision cases that were supposed to be enrolled and followed in manufacturer ‘Adjunct Studies.’ The book ‘The Document Investigation and Review Committee (D.I.R.T.)‘ by Gail Hamilton provides excellent insight on the matter.
In the early 2000s, Allergan and Mentor were approved for premarket Investigational Device Exempt (IDE) studies where a limited number of plastic surgeons were allowed to use silicone breast implants, accordingly they were supposed to inform women of the study and follow up on them. In November 2006, Mentor and Allergan silicone breast implants were conditionally approved and six postmarket studies were to be conducted, see Mentor Approval Order and Allergan (formerly Inamed) Approval Order. The manufacturer premarket and postmarket studies have overall failed to follow up on women and provide real statistics on health problems that arise.
Presently, in 2019, there are over 90,000 women in breast implant illness Facebook support groups. Similar to the Dow times, the manufacturers have again pushed a campaign marketing the safety and inertness of implants rather than disclosing the truth of lack of real statistics and follow ups, the adjuvant immunologic effects of silicone, and the numerous heavy metals and chemicals used in manufacturing. As of 2019, the FDA has finally recognized breast implant illness as risk of breast implants. Awareness efforts have been increasing. However, there is still a public health crisis occurring as the medical community at large has failed to help women identify breast implants as playing a role in their symptoms and has led to many misdiagnoses, unnecessary medications and treatments, and body parts being removed (thyroid, gall bladder, uterus, etc.). History is repeating itself and the manufacturers need to be held accountable for the lack of informed consent and toxicity caused by saline and silicone breast implants.
Current Breast Implant Lawsuits:
- Weber v. Allergan (2012)
- Ebrahimi v. Mentor (2016)
- Mize v. Mentor | Nguyen v. Mentor (Spouse Plaintiff) (2017)
- Gravitt v. Mentor | Gravitt v. Mentor (Spouse Plaintiff) (2017)
- Skelton v. Allergan – BIA-ALCL (2018)
- Cashen v. Mentor | Cashen v. Mentor (Spouse Plaintiff) – BIA-ALCL (2018)
- Rea v. Allergan – BIA-ALCL (2018)
- Vieira et al v. Mentor Worldwide, LLC et al (2018)
- Sewell et al v. Mentor (2018)
- Jacob v. Mentor (2019)
- Gale et al v. Mentor Worldwide (2019)
- Billetts et al v. Mentor Worldside (2019)
- Graham v. Mentor Worldwide (2019)
- Tinkler v Mentor Worldwide (2019)
In December 2018, investors filed a class action lawsuit against leading breast implant manufacturer Allergan, alleging that the company concealed from them both the association between textured breast implants and a rare form of cancer and the threat this link posed to Allergan’s regulatory approvals. See Alleran Faces Fresh Woes as Investors Sue.
Lenze Lawyers, PLC in Manhattan Beach has been filing Mentor MemoryGel Silicone breast implant cases, mostly meeting the criteria of a rupture.
For BIA-ALCL cases, attorney Dena Young Lebovic with Ross Feller Casey and co-counsel have 50+ BIA-ALCL cases filed in the New Jersey Superior Court.
Dampier Law Firm & CityWide Law Group:
Dampier Law Firm is interested in filing various breast implant cases including:
- All manufacturers implanted after 2006
- Recalled Allergan textured saline and silicone breast implants
- Cancers developed with breast implants
In July 2019, there was a worldwide recall of Allergan textured saline and silicone breast implants: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants.
Regardless of whether one has explanted or not, the law firm may be contacted. They are planning on filing many breast implant cases of those implanted after 2006, but first are starting with women implanted after 2016. Contact Megan Marie at (850) 450-1837 or email [email protected]
Kantor & Kantor – Explants Denied by Insurance Claims:
Kantor & Kantor law firm in California was able to get an explant insurance denial overturned. See Coverage for Breast Explant Surgery Was Denied – Kantor & Kantor Stepped In and Got the Denial Overturned (June 2019).
They are now interested to speak to women who have had to pay out-of-pocket for explant and have had explant insurance denials from: BCBS California, BCBS of Illinois, BCBS of Montana, BCBS of New Mexico, BCBS of Oklahoma, or BCBS of Texas. Please contact attorney Cari Schwartz if you meet these case criteria and are interested in filing a lawsuit, her contact number is (818) 886-2525.
Canadian breast implant lawsuit legal firms:
1. On January 3rd, 2019, the law firm Rice Harbut Elliot in Vancouver, BC “has commenced proceedings in the Supreme Court of British Columbia against Mentor Worldwide LLC and Johnson & Johnson in a potential class action lawsuit on behalf of British Columbian women who have been affected by” Mentor MemoryGel Silicone Breast Implants.Click here to read more on Rice Harbut Elliott filing breast implant lawsuits.
“If you have information that may be helpful to the claim, including abnormal blood work results, diagnoses from doctors about breast implant autoimmune disease or anaplastic large-cell lymphoma (BIA-ALCL), pending scheduled or completed explants, or testing of explanted capsules, please leave a message with our office. Please keep in mind that due to the volume of feedback we have received from women all across Canada, a response may be delayed. Any inquiries about updates in this class action claim will not be answered. We will inform you by email if there are any major developments that may be important for your possible claim. Please keep in mind that litigation is a lengthy process, therefore, it is not unusual for months to go by without an update.
Please note: At present we have not commenced any proceedings for implants of the Mentor saline type or any other brand of implants including those sold and marketed by Allergan Inc., Inamed Corporation, or Ideal Implant Inc.
If you have implants of the Mentor saline type and are suffering from symptoms of Breast Implant Illness, you should seek other legal representation as we have no intention of starting proceedings relating to saline breast implants.
If you have implants sold and marketed by Allergan Inc., Inamed Corporation, or Ideal Implant Inc. we would be interested in hearing from you, in light of the recent recall in the European Union of those products, as found here.”
2. Two Canadian law firms based in Montreal, Quebec, LPC Lawyer Inc and Tiger Banon Inc, have requested to file a potential class action lawsuit against Allergan, Mentor, and Ideal for their textured breast implants. The two primary reasons are for the increased risks of cancer and of rupturing. See Case No. 500-06-000966-198. Read more on CTV News and Global News.
3. “On May 23, 2019, Thomson Rogers and Rochon Genova LLP issued a class action on behalf of Canadians who were implanted with breast implants manufactured and distributed by Allergan plc and several of its affiliates.” See Canadian Class Action against Breast Implant Manufacturer Allergan to read more.
For further information or to be included in the Allergan Implants class action, please contact Kate Cahill at 416-868-3120 or toll-free at 1-888-223-0448 or by email.
4. Gluckstein law firm in Toronto is filing cases nationwide against Mentor for smooth and textured breast implants. You do not have to be explanted to file a claim. Jordan Assaraf is the attorney handling these cases. Contact the law firm at 1 (416) 788-4851 and ask for Vafa.Click here to read more on information on lawsuits filed and to look at the law firms for each case.
Mentor Silicone Breast Implant Lawsuits:
Lawsuit Filed Against Mentor Worldwide Over Mentor MemoryGel Silicone Breast Implants
(September 28, 2016)
A Seattle woman, Sara Ebrahimi, has filed suit against Mentor Worldwide LLC and its parent company, Johnson & Johnson Services, Inc., alleging the defective manufacturing of Mentor MemoryGel™ Silicone Breast Implants. The lawsuit alleges that Mentor and its parent company, Johnson & Johnson, repeatedly failed to follow the requirements imposed by the Food and Drug Administration (“FDA”) in connection with the approval of Mentor’s premarket approval application. It is further alleged that the companies failed to warn the FDA and women receiving the implants of the devices’ known dangerous propensities. The lawsuit — Ebrahimi v. Mentor Worldwide LLC, et al. (case no. 2:16-cv-07316-DMG) — was filed in the Central District of California in Los Angeles, where Mentor is headquartered.
Mentor develops, manufactures, and markets products for surgical and non-surgical procedures, including Mentor MemoryGel™ Silicone Breast Implants. The lawsuit alleges that chemicals Mentor used in the manufacturing process bled through the implants, and into Ms. Ebrahimi’s body, causing her to suffer serious medical problems. It is alleged that Mentor and Johnson & Johnson knew that their devices were defective, yet allowed them to be surgically implanted in Ms. Ebrahimi and other unsuspecting women. It is further alleged that Mentor and Johnson & Johnson failed to warn the FDA of these risks by not providing adequate follow-through studies.
Mentor MemoryGel™ Silicone Breast Implants are regulated medical devices under the Food, Drug and Cosmetic Act that require FDA approval. As a condition of approval, the FDA required that Mentor conduct six post-approval studies to demonstrate, over time, that its silicone implants were safe and effective. The lawsuit alleges that Mentor failed to design effective studies and, as a result, failed to provide the FDA with the longitudinal studies that were required as a condition to the devices’ approval. It is alleged that:
It was Mentor’s obligation to design and execute a study where women were able to access internet forms that are easily understood and provide a working forum to report their experience with implants. Mentor intentionally and systematically failed to make this happen which is a violation of the FDA’s conditions for approval. Data collection was sparse and potential serious side effects and harmful complications were downplayed and under-reported due to inadequate sample size.
Ms. Ebrahimi is represented by the law firm of Cotchett, Pitre & McCarthy, LLP, which has decades of experience litigating complex cases involving defective products that harm consumers. They are currently not accepting any new clients for breast implant cases until they can get passed preemption.
This lawsuit influenced a new wave of breast implant litigation. Its research is being used as a template being replicated by the following lawsuits below.
Due to Federal Preemption laws, this case was dismissed and in January 2019 was moved to the US Court of Appeals Ninth Circuit. The same had previously happened with Weber v. Allergan.
Rexina Mize, et al. v. Mentor Worldwide LLC
(February 2nd, 2017)
The case is Mize v. Mentor Worldwide LLC, No. BC-649083, California Superior Court (Los Angeles). In March 2017, the case was transferred and reassigned to the federal judge handling Ebrahimi v. Mentor and the case number was changed to CV 17-1747 DMG (KSx). Some federal court documents are viewable for free on Court Listener. In August 2017, the case was remanded back to state court. To search the case see lacourt.org and enter BC649083 as the case number.
Her husband, Spouse Plaintiff Minh Nguyen, is also suing Mentor on loss of consortium.
From the article, Johnson & Johnson Unit Sued Over Leaking Breast Implants:
“We believe the problems with Mentor’s silicone implant are pervasive and may have harmed thousands of women,” Moss said. “This suit may be just the tip of the iceberg.”
“The suit filed yesterday contends Mentor officials failed to warn Mize, who says she’s suffering from pain, nausea, skin rashes and extreme fatigue, and her physician about “the risk of serious defects and life-altering complications” tied to the leaking implants.”
Catherine Gravitt, et al. v. Mentor Worldwide LLC
(July 25th, 2017)
The case is Gravitt et al v. Mentor Worldwide LLC, No. 1:2017cv05428, Illinois Northern District Court (Chicago). Catherine Gravitt and her husband Travis Gravitt are the plaintiffs who filed against Mentor, see Complaint. She was implanted with textured Mentor MemoryGel Silicone Breast Implants in 2010 and in 2016 she discovered a rupture. Health complications included abnormal thyroid levels, swollen lymph nodes, severe and random skin rashes, blackouts and periods of disorientation, extreme fatigue and weakness, muscle soreness, frequent flu like symptoms, anxiety, depression, and more. Additionally it is alleged she gave birth to a son and daughter who both developed defects related to the toxic materials leaking from her breast implants. See docket and the news article, “Couple’s lawsuit faults California breast implant maker.“
In January 2018, the case was in part able to pass federal preemption. See Memorandum Opinion and Order and news article, “Mentor Silicone Breast Implant Lawsuit Not Preempted, Cleared To Proceed: Judge.”
In June 2018, the case was again in part able to pass federal preemption. See Memorandum Opinion and Order. Unfortunately, a majority of the alleged claims were dismissed with prejudice (permanently) and only one was allowed through preemption:
“Remaining Claim … that Mentor had information suggesting that MemoryGel ruptures were more frequent than what it reported to the FDA, and thus that Mentor ‘concealed its knowledge of known safety risks,’ including the true risk of MemoryGel implants bleeding, ‘from the FDA and the public,’ in part by failing to update its product labeling.
… In sum, Plaintiffs’ allegation that Mentor underreported the frequency of MemoryGel ruptures is sufficient to support their negligence and product liability claims. … Were Plaintiffs to prove that Mentor concealed the true rate of rupture of MemoryGel implants, Mentor may have breached its state law duty to warn potential customers–and their physicians–of the product’s risks. …
Mentor’s motion to dismiss is granted in part and denied in part Plaintiffs may proceed with Catherine’s claim that Mentor violated its state tort law duties by concealing that the risk of gel bleed associated with MemoryGel was higher than the company publicly revealed, and with Travis’s associated consortium claim. The other claims are dismissed. … [T]he dismissal is with prejudice.” (pages 24 and 25).
Renee Cashen, et. al v. Mentor Worldwide LLC, Ethicon, and Johnson & Johnson
(April 27th, 2018)
The case is Cashen et al v. Mentor Worldwide LLC, filed in the Superior Court of New Jersey. Renee Cashen and her husband Richard Cashen are plaintiffs. In February 2008, she was implanted with textured Mentor MemoryGel Siltex Round Moderate Gel Breast Implants. After implantation, she was discharged from the post-market study she had been enrolled in. In 2016, she noticed a lump under her right armpit. A month later a biopsy was done and ALCL was discovered but it took several weeks later until her doctors associated it with her Mentor breast implants. In May 2016, Mrs. Cashen had explant surgery and six lymph nodes removed. In July 2017, she began chemotherapy treatments. The Defendants allegedly failed to comply with their post-approval surveillance obligation.
They are represented by Ross Feller Casey, LLP and McEldrew Young, both in Philadelphia, Pennsylvania.
Vieira et al v. Mentor Worldwide, LLC et al
(June 27th, 2018)
Nicole Vieira and Emilia Barozzi filed complaints in Los Angeles County Superior Court, Case No. BC711663. Plaintiffs were implanted with Mentor MemoryGel Silicone Breast Implants and afterwards they “experienced various medical complications, including fatigue, weakness, memory loss, and nausea.” After explantation it was discovered that the implants’ silicone gel had bled. The complaint alleges mistakes in Mentor’s manufacturing of the implants and defects in the silicone used. These resulted in silicone gel to bleed and therefore triggered the medical complications.
In July 2018 the case was moved to Federal Court, Case No. 2:18-cv-06502, and in September it was remanded back to Los Angeles Superior Court. To search the case see lacourt.org and enter BC711663 as the case number.
They are represented by Lenze Lawyers, PLC in Manhattan Beach, California; Finson Law Firm, LLP in Playa Vista and Marina Del Rey, California; and by Angwin Law Firm in Los Angeles, California.
Jacob v. Mentor Worldwide, LLC
(January 29, 2019)
Lalitha Jacob, M.D., filed the complaint pro-se in Florida Middle District Court, Case No. 8:19-cv-00229. She was implanted with Mentor MemoryGel Silicone Breast Implants in 2007. She developed “severely disabling and life-threatening lupus-like syndrome affecting almost every organ in the body.” In 2019, upon explantation, a rupture was discovered. The case alleges “severe systemic chemical and heavy metal toxicity affecting the entire body.”
Gale et al v. Mentor Worldwide, LLC
(February 14, 2019)
Jamie Gale and Amber Brooks filed a complaint in US District Court for the District of Kansas (Federal Court), Case No. 2:2019cv02088. Plaintiffs were both implanted with Mentor MemoryGel Silicone Breast Implants and developed a myriad of adverse symptoms. Brooks had elevated metal levels in body, including barium, tin, mercury, strontium, aluminum and copper. After explantation, silicone was found in tissues in Brook’s chest. Gale had extracapsular silicone that leaked out of the implants and capsules into her body.
They are represented by Lenze Lawyers, PLC in Manhattan Beach, California; Dogali Law Group in Tampa, Florida; and Preuss ∣ Foster in Leawood, Kansas.
Billetts et al v. Mentor Worldside, LLC
Plaintiffs are Brittany Billetts, Leah Johnson, Cornelia Ditto, and Ann Delmonico, with Case No. 2:2019cv02079.
They are represented by Lenze Lawyers, PLC in Manhattan Beach.
Allergan Silicone Breast Implant Lawsuits:
Nicole Weber v. Allergan No. 13-17017 (9th Circuit 2015)
The case was filed in 2012 and moved to trial in early 2018.
“Weber appealed the district court’s dismissal of Weber’s diversity action brought against Allergan Inc, asserting strict product liability and negligence, and alleging that Allergan’s Natrelle Style 20 [silicone] breast implants are dangerous.” (Sept 21, 2015). See youtube video on her 9th Circuit court hearing. (The opposing attorney talks at 37:00)
Her amended claim was found to adequately state parallel state law claims (Oct. 23, 2015).
“Weber has identified to the extent possible without discovery, the standards she believes the manufacture of her implants violated, adequately stating parallel state-law claims.” the court said.
Vivian Skelton v. Allergan – BIA-ALCL
The case was filed as Skelton v. Allergan, No. BC696400 in Los Angeles County Superior Court. It was transferred to California Central District Court and the case number was changed to 2:18-cv-02617. She was diagnosed with breast implant-associated anaplastic large cell lymphoma, this is an Allergan BIA-ALCL Lawsuit.
Rhea v. Allergan – BIA-ALCL
(May 8th, 2018)
Michele Rea and Carl Rea from Fairfax, Virginia filed in the Superior Court of New Jersey in May 2018, see case here.
From Ross Feller Casey in ‘Another Lawsuit Alleges Breast Implants Cause A Rare Cancer‘:
Rea underwent reconstructive surgery for a partial mastectomy in 2011. About five years later, she was diagnosed with anaplastic large cell lymphoma, which was caused by a Natrelle Style 410 [highly cohesive silicone gel] implant made by Allergan, Inc., the suit alleges.
They are represented by Ross Feller Casey, LLP in Philadelphia, Pennsylvania.
Allergan Saline Lawsuits:
In Jacksonville, Florida, the law firm of Terrell Hogan is filing hundreds of lawsuits against two local plastic surgeons – Dr. Loren Clayman and Dr. Mark Clayman. There are also allegations of fraud, as well as a lawsuit against Allergan.
“I represent about 150 women,” said Attorney Chris Shakib.
Shakib, the lead attorney in the case, called his findings unbelievable.
Medical Device Safety Act 2019 H.R. 2669
Please sign and support the Medical Device Safety Act 2019 H.R. 2669, a bill introduced to restore an injured consumer’s rights to sue Class III medical devices that are currently being preempted by federal protection.
Breast implants are categorized as Class III medical devices (along with hip implants, pacemakers, cardiac stents, etc) and are very difficult to sue due to the 2008 Supreme Court case, Riegel v Medtronic which gave broad federal protection to manufacturers. To sue a manufacturer, one would need a product liability case and these are generally governed by state laws under theories of negligence, strict liability, and breach of warranty. The Supreme Court ruling with Riegel created a precedent for preemption of state laws, essentially citing that Class III medical devices are solely accountable to the regulations and surveillance of the FDA. After Riegel, the only way to sue is to assert parallel state law claims where one must prove the manufacturer deviated from a guideline they were approved by (a violation of a federal requirement, such as a FDA guideline), the violation of an identical state law, and how that violation of that federal requirement caused injury.
“What does this mean? It means that patients who are harmed by Class III medical devices have a very difficult, if not impossible, time pursuing litigation if injured, disabled, or killed by a Class III medical device. The manufacturers are, in essence, protected. Most Class III cases get thrown out on the grounds of Federal Preemption.
The purpose of this bill is to restore a patient’s right to litigation should he/she be harmed by a Class III medical device. Even decades after the FDA’s pre market approval of a Class III device, if it is proven to be ineffective or proven to cause harm, individuals still cannot hold the manufacturer liable for injury, even in the case of a recall.”
Example of Federal Preemption:
Mentor MemoryGel Silicone Breast Implant complaints generally allege that had Mentor more “substantially complied with the PMA, rather than flagrantly underperforming the post-approval requirements … [its] disclosures would have led to much wider knowledge of the risks associated with [its] products.”
A judge in part agreed, stating “It is true that the complaint alleges that each such deficiency in Mentor’s post-PMA studies amounts to an independent ‘failure to comply with the [the FDA’s] post approval requirement[s].” and thus that each ‘constituted a ground for withdrawal of the PMA.'”
Yet the judge responds, “Regardless of the consequences of Mentor’s flawed implementation of the required post-PMA follow-up studies, the FDA not traditional state tort law, establishes the requirements for conducting those studies. … ‘[T]he relationship between a federal agency and the entity it regulates is inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law.’). … To the extent the [FDA] was concerned about those gaps but ‘did not take … action against’ Mentor, that decision ‘rest[s] within the enforcement authority of the FDA, not this [c]ourt.‘”” Source: Gravitt et al v. Mentor Worldwide, LLC Memorandum Opinion and Order, June 2018, pages 13, 17, and 18.
Essentially, the FDA has sole sovereignty over class III medical devices and the manufacturers.
The Medical Device Safety Act H.R. 2164 would create an amendment that would allow product liability state laws to not be barred by federal supremacy. Therefore it would allow an avenue to get justice again and hold the manufacturers accountable to the harm they have caused. See “Why You Should Care About the Medical Device Safety Act”.
Facebook Breast Implant Lawsuit Support Groups:
- Allergan McGhan Lawsuit
- Breast Implant Lawsuits
- UK: Breast Implant Group Legal Action U.K. For Allergan Mcghan Inamed Implants
Disclaimer: The materials available at this web site are for informational purposes only and not for the purpose of providing legal advice. You should contact your attorney to obtain advice with respect to any particular issue or problem.