Bard Signals Settlement of IVC Filter Lawsuit, while Struggling to Suppress Evidence

03/30/2016 – Plagued with mounting allegations and evidence of wronging related to various IVC Filter Devices C. R. Bard, Inc. made an announcement in recent 10q filings with the SEC that we interpret as Bard announcing an Intent to settle many, if not all lawsuits, related to certain Inferior Vena cava (IVC) Filters.

Bard IVC Filter Lawsuit Settlement News
Bard IVC Filter Lawsuit Settlement News

In the same 10q disclosures in which Bard informed stockholders that certain complaints over their IVC Filter product line had been consolidated in a Multidistrict Litigation in Arizona, Bard also inserted language indicating they intended to settle complaints related to their IVC line, adding that they would fight any claim that did not settle.  We found the last comment interesting as we are unsure what other alternative Bard would have other than to fight claims that did not settle.

Although the indication of a desire to settle claims at such an early stage of Bard IVC Litigation did not surprise many of those following the litigation, it is safe to say that such an early stage settlement indication is extremely unusual. It is more common for defendants in case like the Bard Litigation to at least provide some pretense of defense to their stockholders early such a litigation.

Bard Has a Great Deal They Seem to Want to Hide

One possible explanation for Bards indication of early settlement may stem from Bard exectives concluding that the cost of paying claims will be less damaging to their image and stock price than what may come out in discovery if the litigation goes to forward.

Bard has filed motions to suppress a great deal of evidence, claiming that the evidence is protected work product or shielded from discovery for other reasons.

Some of the evidence Bard has moved to suppress include:

1: The Lehmann Report.  The Lehmann Report was issued by John Lehmann MD in 2004. It appears that Dr. Lehmann was hired by Bard to conduct research ostensibly intended to demonstrate the Safety and Effectiveness of certain Bard IVC Filter Products. What Dr. Lehmann ultimately reported in what is now referred to as the Lehmann report was not what Bard had hoped for.  The report did not support the Safety and Effectiveness of Bard Products in the manner Bard undoubtedly hoped.

Plaintiffs’ Counsel seeks to have The Lehman Report entered into evidence, Bard Counsel seeks to suppress the Lehmann Report as protected work product.

One argument Plaintiffs lawyers have to counter defense arguments related to the Lehmann report being Confidential and Privilege work product arises from the fact that Bard did not diligently protect this supposedly Confidential Work Product.

NBC News was easily able to obtain a copy of The Lehmann report which it featured in a series of reports related to Bards beleaguered IVC products.  Mass Tort Nexus investigators were also able to obtain a copy of The Lehmann Report from public sources with little difficulty. Arguably, Bard did not meet the necessary burden of keeping its confidential document, confidential.

Other documents Bard has moved to suppress include:

  1. Certain Bard Promotional Material.
  2. Bard Media Plan Related to how the company would deal with the publicity from the NBC Reports and other negative attention it was attracting related to their IVC product line.
  3. Communications between Bard and a Public Relations firm it hired to help with the fallout from negative publicity related to its IVC product line.
  4. Certain Adverse Event Reports related to its IVC Product Line.
  5. Certain Communications with the FDA related to its IVC product line.

Again Plaintiffs’ counsel may argue that Bard has failed in their diligence to maintain allegedly confidential documents confidential as both NBC news was able to obtain many of the documents Bard wishes to suppress. Additionally, Mass Tort Nexus was able to obtain copies of the majority of the documents Bard wishes to suppress from public sources.

Copies of many of the documents Bard wishes to suppress may be found at the following link:

Documents Bard Wishes to Suppress

Another factor which may contribute to Bard desiring to end the IVC Filter Litigation sooner rather than later stems from the shellacking they received at the hands of plaintiff attorneys Raymond Lopez and Julia Reed Zinc in a case tried in Arizona before the Bard MDL was formed.

These two capable attorneys took on the giant medical device manufacturer in Phillips v Bard an Arizona case.  The documents and transcripts from that case clearly show why Bard decided to settle that case before it went to a jury.  Raymond and Julia deftly pressed Bard insiders, who appeared to have been coached by a leading member of the actor’s guild, bringing to light truths that Bard would likely have preferred remain in the dark.

See the documents and Transcripts from Philips v. Bard.

Ramon Lopez is now co-lead counsel in the Bard MDL, Julia Reed Zinc also serves in a Plaintiffs Leadership positon. Richard North, Bards defense attorney in Phillips v Bard heads up Bards defense team in the MDL.

Incidentally, Bard now announces the following on its website:

Bard no longer manufactures or sells the Meridian®, Eclipse®, G2X®, G2®, and Recovery Filters.

To stay up to date on all of the developments in the Bard MDL as other ongoing MDLs, subscribe to the Mass Tort Nexus Professional Site at this link:  Sign Up

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Xarelto MDL 2592 Important Developments

Xarelto MDL 2592


Important Developments in the Xarelto Litigation

There have been two important developments in the Xarelto Litigation, one in the Federal Litigation before Judge Eldon Fallon and the other in the Philadelphia court of Common Pleas before Judge Arnold New.

Deadline Set for Filing Bundled Claims In Xarelto MDL 2592

In Xarelto Litigation Federal MDL 2592, on March 21st, Judge Eldon Fallon issued Pretrial Order No. 11E.

PTO 11E sets a deadline for filing bundled complaints in MDL 2592 as well as filing Short Form Complaints. The deadline set by Judge Fallon is May 20th 2016.   This order does not prevent claims from being filed in MDL 2592 after May 20th however, for each complaint filed after May 20th the firm filing the complaint will need to pay the full filing fee for each claim filed and will no longer be able to file multiple claims for a single filing fee.

Firms filing after the May 20th deadline will also no longer be able to file a short from complaint. Complaints filed after May 20th must be filed in accordance with FRCP and Local Court  Rules.

This order will be in effect until such time as Judge Fallon may elect to amend the order. In that Judge Fallon has often expressed a displeasure with firms holding cases which are ripe for filing, preventing him from having a clear picture of the number of potential cases in the Universe of an MDL before him, it is unlikely that he will amend this order.

Deadline for Filing Short Form Complaints in Xarelto MDL 2592

Xarelto MDL 2592 PTO 11E also sets the same May 20th deadline for filing Short Form Complaints in the Xarelto MDL before Judge Fallon. After May 20th, attorneys filing cases in the MDL will be required to file “Long Form”, in the manner a case would be filed in the local Federal Court in the Easter District of Louisiana under any other circumstances.

 

Philadelphia Court of Common Pleas Allows Efficacy Claims

In the State MDL before Judge Arnold New which is ongoing in the Phildelphia Court of Common Pleas, Judge New has elected to allow “Efficacy Claims” to be filed in that MDL in addition to claims related to uncontrolled bleeding. Judge Fallon has yet to follow suit and may not.

Efficacy claims are those that arise from blood clot related injuries, experienced by individuals while taking Xarelto. Arguably, Xarelto should have prevented these injuries from occurring. Plaintiff argues that due to Xarelto’s one time per day dosing, the anticoagulant intensity of Xarelto is depleted long before the patient consumes the next dose, leaving the patient exposed to the very injuries Xaretlo is intended to prevent. Plaintiffs content that the makers Xarelto designed its “one time per day” product simply to gain a marketing advantage over other multi time per day products it was competing against, primarily Pradaxa and Eliguis .

 

Subscribers to www.masstortnexus.com may access all documents related to the Xarelto Litigation MDL 2592 as well as the Xarelto Litigation ongoing in the Philadelphia Court of Common Pleas. Mass Tort Nexus Subscribers also have access to all forms, orders, documents and information related to all ongoing Pharmaceutical and Medical Device Product Liability Litigation’s in the Emerging Phase , Litigation as Phase well as the Settlement Phase.

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FDA Warns about Lead Poisoning with Best Bentonite Clay

bentonite clayThe FDA is warning consumers not to use “Best Bentonite Clay,” a product of Best Bentonite, located in Guthrie, Oklahoma. FDA has determined that the product contains elevated lead levels and may pose a lead poisoning risk. FDA laboratories have found elevated levels of lead in “Best Bentonite Clay.” Exposure to lead can cause serious damage to the central nervous system, kidneys, and immune system. In children, chronic exposure to lead, even at low levels, is associated with cognitive impairment, reduced IQ, behavioral difficulties, and other problems.

Sold on Amazon.com

“Best Bentonite Clay” is sold as a fine powder on Amazon.com and on the Best Bentonite website. According to the Best Bentonite website, customers mix the product with water and ingest it or apply it to their skin.

FDA has not confirmed any cases of lead poisoning associated with “Best Bentonite Clay.”

Consumers should not purchase or use “Best Bentonite Clay.” Anyone who has used this product or given it to a child should consult a health care professional immediately.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Read the MedWatch Safety Alert, including a link to the FDA Alert, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm492157.htm

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Particulate Matter in Sodium Bicarbonate Injection Causes Hospira Recall

sodium bicarbonateHospira, Inc. is recalling one lot of 8.4% Sodium Bicarbonate Injection, USP (NDC: 0409-6625-02, Lot 56-148-EV, Expiry 1AUG2017) at the hospital/retail level due to the presence of a particulate within a single–dose glass fliptop vial. The issue was identified through a confirmed complaint.

The product is packaged 50 mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50mL, Single-dose, packaged 4 boxes of 25 vials per case. The lot was distributed nationwide in the U.S. to wholesalers and hospitals in December 2015.

If the particulate is not observed prior to IV administration and breaks off into smaller particulates, passing through the catheter, it may result in localized inflammation, allergic reaction, including anaphylaxis, granuloma formation or microembolic effects (IV only). Larger particulates may block the infusion of solution, potentially resulting in a delay in therapy.

Treatment of Metabolic Acidosis

Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis; in the treatment of certain drug intoxications, in poisoning by salicylates or methyl alcohol and in certain hemolytic reactions. Sodium bicarbonate also is indicated in severe diarrhea, which is often accompanied by significant loss of bicarbonate.

Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Inform Healthcare Professionals in your organization of this recall. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you.

Further, please instruct entities that may have received the recalled product from you that if they redistributed the product, they should notify their accounts, locations or facilities of the recall to the hospital/retail level. Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States.

For additional assistance, call Stericycle at 1-888-965-6077 between the hours of 8 a.m. to 5 p.m. ET, Mondaythrough Friday. For clinical inquiries, please contact Hospira using the information provided in the press release.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

 

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$502M Bellwether Verdict Against Johnson & Johnson over Hip Replacement

hip implant2Five plaintiffs have won a $502 million verdict against Johnson & Johnson (J&J) in a bellwether trial concerning its DePuy Pinnacle metal-on-metal hip replacement devices. The jury verdict for $142 million compensatory and $360 million punitive damages was reached following 37 days of testimony, in the U.S. District Court for the Northern District of Texas Dallas Division.

The trial, which consolidated cases involving five separate plaintiffs who are residents of Texas, began Jan. 8, 2016. The lawsuits, including those of more than 7,000 plaintiffs nationwide in the multidistrict litigation (MDL), claim that the market-leading DePuy implants were defective and caused metal debris to enter into patients’ bloodstreams, causing severe injuries and sometimes leading to revision surgery.

Millions of dollars in bribes

“The evidence in the testimony against J&J has been ground breaking, particularly in relation to what, in effect, amounted to hundreds of millions of dollars in bribes to orthopedic surgeons to use and recommend this product,” said Jayne Conroy, a shareholder at Simmons Hanly Conroy and co-counsel for the plaintiffs as a member of the Plaintiffs’ Executive Committee for the DePuy Pinnacle MDL.

According to Conroy, plaintiffs’ attorneys also discovered several instances in which physicians lied in medical clinical testing of the devices and forged consent forms for patients who were using the product to lie about the results the patients experienced with the product.

“So, apart from the DePuy Pinnacle implant being a bad device to begin with, the deeper story has a much more evil component to it due to the manipulation of science to sell the product,” Conroy added.

The five cases that were decided today are: Aoki v. DePuy Orthopedics, et al., No. 3:13-cv-01071-K; Christopher v. DePuy Orthopedics, et al., No. 3:14-cv-01994-K; Greer v. DePuy Orthopedics, et al., No. 3:12-cv-01672-K; Klusmann v. DePuy Orthopedics, et al., No. 3:11-cv-02800-K; and Peterson v. DePuy Orthopedics, et al., No. 3:11-cv-01941-K.

The trial outcome is expected to be a significant factor in consideration for a possible settlement program to address the complaints of the remaining plaintiffs with cases involving DePuy Pinnacle, consolidated in the Northern District of Texas and overseen by U.S. District Judge Ed Kinkeade. (DePuy Orthopaedics Inc. Pinnacle Hip Implant Product Liability Litigation, MDL No. 2244).

The DePuy Pinnacle hip implants have not been recalled. The DePuy Pinnacle implant design predates J&J’s Articular Surface Replacement (ASR) metal-on-metal hip device that in 2013 was the focus of a $4 billion settlement with patients who experienced complications with the devices.

 

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$11.75 Million Settlement Proposed in Caldera Transvaginal Mesh Class Action

vaginal-mesh-TVM-Attorneys representing women who were permanently injured by transvaginal mesh (“TVM”) devices manufactured by Caldera Medical, Inc. have proposed a cash settlement fund of $11.75 million for more than 2,000 product liability claims.

The claims involve TVM marketed under the trade names T-Sling, Desara, Ascend, Hydrix, POPmesh and Vertessa. Manufacturers include Caldera, Biomedical Structures, Encision, Coloplast (on its own behalf and as successor in interest to Mpathy), Parker Hannifin and J-PAC LLC .

Allegations against Caldera include negligence, failure to warn of the defects of its TVM devices, the defective design of its TVM devices, breach of express warranties, deceit by concealment, negligent misrepresentation, fraud, and loss of consortium.

Filing deadlines

Attorneys for injured women who have not joined the class action must file a request to appear by April 26, 2016 to participate in the final approval hearing, which is scheduled before US District Judge Stephen V. Wilson on June 13 in Los Angeles. To obtain
any payments parties must join the settlement class and submit a claim form by May 2.

The case is Federal Insurance Company v. Caldera Medical, Inc., U.S.D.C., Central District of California Case No. 2:15- cv-00393. David Bricker of Waters Kraus & Paul of Los Angeles is the class counsel.

Note that this case is separate from several multidistrict litigation dockets in West Virginia federal court involving C. R. Bard, Inc., American Medical Systems, Inc., Boston Scientific Corp., Ethicon, Inc., Coloplast Corp., Cook Medical, Inc. and Neomedic.

Plaintiffs allege Caldera knew or should have known that the TVM devices created an increased risk of serious personal injury, including mesh erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, dyspareunia (pain during sexual intercourse), blood loss, neuropathic and other acute and chronic nerve damage and pain, pudendal nerve damage, pelvic floor damage, chronic pelvic pain, urinary and fecal incontinence and, prolapse of organs.

Level of Injury

Payments will be based on the injury level:

  • Level 1: Device only (no complication).
  • Level 2: Documented complications related to a Caldera Transvaginal Mesh Product.
  • Level 3: One revision or explant surgery under general anesthesia related to a Caldera Transvaginal Mesh Product.
  • Level 4: Two revisions or explant surgeries under general anesthesia related to a Caldera Transvaginal Mesh Product.
  • Level 5: Three or more revisions or explant surgeries under general anesthesia related to a Caldera Transvaginal Mesh Product.

More information is available at www.calderaclaims.com.

The $11.75 million being paid into the settlement fund represents virtually all of Caldera’s funds. The company claims that the only assets it has to pay Transvaginal Mesh Medical Product Claims are the proceeds of insurance policies issued by Federal Insurance Company. Caldera denies any wrongdoing.

The court will decide whether to approve the settlement and whether to certify the settlement class at final approval hearing on June 13.

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Zofran Litigation Update Defendants Summary Judgement Motion Denied

Zofran cleft palate birth defect
Zofran cleft palate birth defect

US District Judge Saylor issued an order denying the defendants Summary Judgement Motion without Prejudice on January 26, 2016.

Although the defendant may continue to argue preemption under Wyeth v Levine and Buckman v Plaintiff Steering Committee, their chances of succeeding in these motions are not favorable in our opinion. Arguably, neither Buckman nor Levine is not applicable case law.  In Buckman the FDA had not brought a Fraud on the FDA Case. Conversely the FDA did bring a case against GSK and GSK admitted quilt  as to the allegations made by the FDA as part of a 3.2 Billion Dollar Settlement involving a number of GSK products.

The Levine arguments made by GSK are also problematic for the defendant. In that Judge Saylor rejected the arguments related to the Citizens Petition, it would be necessary for the defendant to look elsewhere to establish evidence to lead to an absolute conclusion that the FDA would not have approved a stronger birth defects warning for Zofran.

In that Zofran was not approved for use in pregnant women, the FDA had no cause to require strong warnings related to birth defects for the product. The FDA classified Zofran under Birth Defects category B.

Category B

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

In that GSK has never sought approval for the use of Zofran in pregnant women, the FDA did not require studies related to the use of birth defects in pregnant women. Despite GSK having never sought approval for Zofran use in pregnant women, GSK has admitted to off label marketing of Zofran for use in pregnant women in response to allegations brought by the FDA.

Simply put, GSK seeks to take advantage of its own bad acts. GSK never sought FDA approval for use in pregnant women, (despite wide scale off label marketing) ostensibly to avoid being required to conduct the appropriate studies and clinical trials for such an approval,  resulting in Zofran being placed in Birth Defect Category B. “there are no adequate and well-controlled studies in pregnant women.”

GSK now argues that an action or lack of action under FDA rules and governing laws, which they willfully ignored, should insulate GSK from plaintiffs’ claims.

There are no adequate and well-controlled studies in pregnant women.”

The questions posed by Levine “ would the FDA have refused to allow an increase in warnings related to Zofran had GSK sought such changes? ” is not applicable. Levine does not address what the FDA would or would not do when the product in question was marketed for an off label indication. What the FDA would have likely done had GSK sought to change the Zofran label to include stronger birth defects warning would have been to respond in this manner similar to this:

“This product is not approved for use in pregnant women”

After responding in this manner, the FDA would have most likely opened an investigation into the off label promotion of Zoran.

 

Oh Wait.. the FDA did investigate the unlawful off label promotion of Zofran, brought a case against GSK and GSK admitted to their bad acts.

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James Onder, attorney on the recent $72M Talc Case, Speaking at Mass Tort Nexus Course

James Onder
James Onder of Onder, Shelton, O’Leary & Peterson, LLC, St. Louis, MO.

James Onder, one of the lead attorneys on the recent talc case which resulted in a $72 million plaintiffs verdict, will be speaking at the March 11th – 14th Four Days to Mass Tort Success Course. If you are considering getting involved in the Talc Ovarian Cancer Litigation, getting to know James would be a smart move.

Taxotere Emerging Litigation

Darin Shanker of Bachus and Shanker will be discussing the emerging Taxotere litigation at the March 11th-14th course as well. The attorneys are leading the Taxotere emerging litigation. You do not want to miss out on an opportunity to get information from the most authoritative source on this litigation.

If you are not already registered for the Next Four Days to Mass Tort Success course, being held at the W Hotel in Fort Lauderdale Beach March 11-14, contact Barbara Capasso today. The course is full, however, Barbara will add a couple of additional seats for those interested in the talc and Taxotere litigations.

Contact Barbara: (954) 383-3932 or email her at barbara@masstortnexus.com to register for the March Course.

Essure Litigation Update

On February 29, 2016 the United States Food and Drug Administration took certain actions related to the Essure Permanent Birth Control Device. John Ray has published a new paper intended to address certain questions related to if and how the actions of the FDA will impact certain aspects of the ongoing Essure Litigation specifically related to the defendants Prior Market Approval (PMA) preemption arguments.

Read Full Article: https://www.masstortnexus.com/mass-torts-news/essure-litigation-update-post-fda-action/

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Essure Litigation Update Post FDA Action

 essureUpdate on Essure Permanent Birth Control Litigation

03/01/2016: On February 29th 2016 the United States Food and Drug Administration took certain actions related to the Essure Permanent Birth Control Device. This paper is intended to address certain questions related to if and how the actions of the FDA will impact certain aspects of the ongoing Essure Litigation specifically related to the defendants Prior Market Approval (PMA) preemption arguments.

The following is intended to provide information and opinion related to the above questions. Nothing in this document should be interpreted as legal advice.

 

Essure Litigation Background

Essure is a permanent birth control method for women designed as an alternative to tuba ligation.

 

November 2002: Essure gained FDA approval via the Prior Market Approval (PMA) Process on November 4th 2002. More than 750,000 of Essure devices have been implanted in women according to the device maker.

Original Device Approval Granted to : Conceptus, Incorporated San Carlos, CA 94070

October 1 2003: Essure Developer Conceptus and Gynecare, a division of Johnson and Johnson enter  into an exclusive agreement to co-promote Essure.

Women who received an Essure implant allege a variety of injuries caused by the device resulting in a massive number of Adverse Event Reports being filed with through the FDAs adverse event reporting System.

July 2014: The first Essure Lawsuit was filed by Heather Walsh. In the Philadelphia Court of Common Pleas.

December 30, 2014:  Heather Walsh and four other Essure cases were later consolidated in US District Court in Philadelphia before District Judge John R. Pavoda.

April 29 2015: Defendant Moves for Judgement on the Pleadings: Arguing Express Pre-Emption arising from 21 U.S.C. § 360c, et seq., as interpreted in Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008); as well as Fraud on the FDA Claims as interpreted in Buckman v Plaintiff Steering Committee.

January 14 2016: Order Dismissing Certain Plaintiff Claims without Prejudice.

January 15 2016:  Joint Submission regarding Remaining Plaintiff Claims.

 

On February 29, 2016 the FDA issued a press release notifying the public of the following actions taken related to the Essure Permanent Birth Control Device:  See FDA Documents from Press Release

  1. Ordered Bayer to conduct a post market surveillance study to obtain more data about Essure’s benefits and risks.
  2. Intends to require that a boxed warning and Patient Decision Checklist be added to the product labeling to help ensure that a woman receives and understands information regarding the benefits and risks of this type of device. In addition, FDA issued the draft guidance, “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization” to provide the public an opportunity to comment on the proposed language to be included in these warnings.
  3. Is in the process of completing its evaluation of the trade complaint.

 

Will the Action taken by the FDA Impact the Essure Litigation?

The action taken by the FDA on February 29, 2016 has caused renewed interest in the Essure case among Plaintiff Law Firms. The following questions have arose as a result of the FDA action:

  1. Will the action taken by the FDA serve to overcome defendants PMA Preemption arguments?
  2. If the post market surveillance ordered by the FDA results in the recall of the Essure Device under 21 U.S.C. § 360h(e) and 21 C.F.R. §§ 810.10-810.18, would that recall serve to overcome defendants PMA Preemption arguments for causes of action arising prior to that recall?
  3. If the post market surveillance ordered by the FDA results in the Essure PMA being withdrawn, under 21 U.S.C. § 360e(e); 21 C.F.R. § 814.46 , would such a withdrawal serve to overcome defendants PMA Preemption arguments for causes of action arising prior to that PMA withdrawal?

 

 Essure Litigation PMA Preemption Q & A

  1. Will the action taken by the FDA serve to overcome defendants PMA Preemption arguments?

        Highly Unlikely

The action taken by the FDA in February 2016 was probative in nature and issued non-binding recommendations. The action was not a recall nor did the action serve to withdraw the PMA approval of the Essure device under 21 U.S.C. § 360h(e) and 21 C.F.R. §§ 810.10-810.18.

  1. If the post market surveillance ordered by the FDA results in the recall of the Essure Device under 21 U.S.C. § 360h(e) and 21 C.F.R. §§ 810.10-810.18, would that recall serve to overcome defendants PMA Preemption arguments for causes of action arising prior to that recall?

Highly Unlikely

Recalls of medical devices are governed either by:

21 C.F.R. §§ 7.40-7.59 (for voluntary field actions)

21 U.S.C. § 360h(e) and 21 C.F.R. §§ 810.10-810.18 (for recalls mandated by the FDA).

Nothing in these regulations can be interpreted as a recall being equivalent to the withdrawal of the Prior Market Approval of the subject medical device.

Withdrawal of approval is governed under 21 U.S.C. § 360e(e); 21 C.F.R. § 814.46

Even in a recall of a PMA device, Mandated by the FDA when the PMA has not been withdrawn by the FDA would still likely bar State Law Claims: See In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147, 1155-56 (D. Minn. 2009), affirmed 623 F.3d 1200 (8th Cir. Oct 15, 2010);

PMA Preemption survives so long as the FDA has not revoked PMA preemption: Talbott v. C.R. Bard, Inc., 63 F.3d 25, 28 (1st Cir. 1995)

Many Courts have rejected arguments that the recall of a PMA approved device serves to overcome a defendants PMA preemption arguments:

Minnesota

Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147, 1155-56 (D. Minn. 2009)

Kinetic Co. v. Medtronic, Inc., 2011 U.S. Dist. Lexis 42398, slip op. (D. Minn. April 19, 2011

California

Erickson v. Boston Scientific Corp., 2100 WL 7036060, (C.D. Cal. Dec. 12, 2011)

Blanco v. Baxter Healthcare Corp., 70 Cal. Rptr.3d 566, 579-80 (Cal. App. 2008)

New York

Mitaro v. Medtronic, Inc., 2009 WL 1272398, at *3 (N.Y. Sup. Apr. 9, 2009)

North Dakota

Bausch v. Stryker Corp., 2008 WL 5157940, at *3 (N.D. Ill. Dec. 9, 2008)

Texas

Baker v. St. Jude Medical, S.C., Inc., 178 S.W.3d 127 (Tex. App. 2005)

 

South Dakota

Theofanis v. Boston Scientific Corp., 2003 WL 24049229, at *2 ¶16 (S.D. Ind. June 24, 2003);

New Jersey

Steele v. DePuy Orthopedics, Inc., 295 F. Supp. 2d 439 (D.N.J. 2003).

 

Courts in general have held that no statutes or regulations support the notion that a recall, , is sufficient to void PMA approval. Courts have further generally held that plaintiffs’ claims, if allowed to proceed, would interfere with the PMA process by “second-guessing” the FDA’s decision to approve the device in the first place.

 

  1. If the post market surveillance ordered by the FDA results in the Essure PMA being withdrawn, under 21 U.S.C. § 360e(e); 21 C.F.R. § 814.46 , would such a withdrawal serve to overcome defendants PMA Preemption arguments for causes of action arising prior to that PMA withdrawal?

          Unfortunately, probably not

 

See Mays v. Ciba-Geigy Corp., 233 Kan. 38, 52, 661 P.2d 348 (1983 The proper focus in any products liability claim is on the date of manufacture and sale, not some later date.

As noted in the Sprint Fidelis MDL, “Plaintiffs’ argument ignores that the PMA was in place at the time the leads were implanted,” which “is what matters.” 592 F. Supp. 2d at 1156.

Kemp v. Pfizer, Inc., the court noted that preemption applied despite a recall because, “when the [device] was implanted it had received pre-market approval by the FDA.” 835 F. Supp. 1015, 1023 (E.D. Mich. 1993); accord, Blanco, 70 Cal. 3d at 580-81.

 

Are there circumstances under which courts have allowed claims to proceed against a PMA approved device based on a recall ?

However under the very limited scenario in which the FDA has cited the Manufacturer (defendant) for failure to comply with manufacturing requirements or the FDA has cited the defendant for violations of the conditions of the PMA approval:

See Gelber v. Stryker Corp., 788 F. Supp. 2d 145 (S.D.N.Y. April 18, 2011) (relying upon FDA warning letter regarding manufacturing processes);

Maker of Essure Cited by FDA for Failure to Conduct Follow Up

See: Cornett v. Johnson & Johnson, 414 N.J. Super. 365, 998 A.2d 543 (N.J. Super. A.D. July 23, 2010) (FDA warning letter); Phillips v. Stryker Corp., 2010 WL 2270683 (E.D. Tenn. June 3, 2010) (recall was FDA-mandated, not voluntary).

This article was intended for the use of Plaintiff attorneys involved in or interested in the Essure Litigation. The author of this article John Ray invites comments and contradicting opinions. Please feel free to email any comments or opinions to John Ray at john@masstortnexus.com.

Essure is a registered Trademark. The authors of this documents are not the manufacturer nor the holder of the Essure trademark nor in anyway associated with the holder of the Essure Trademark.  The opinions expressed in this document are those of its author. 

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