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MEDICAL DEVICESWestlaw Journal

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VOLUME 21, ISSUE 25 / FEBRUARY 10, 2015

TRANSVAGINAL MESH

6 Ethicon settles first wrongful-death mesh case to reach trial

Budke v. Ethicon Inc. (Mo. Cir. Ct.)

BREAST IMPLANTS

7 6th Circuit rejects Dow bankruptcy plan breast implant claimant payments

In re Settlement Facility Dow Corning Trust (6th Cir.)

TRANSVAGINAL MESH

8 Bard’s $2 million loss in first transvaginal mesh trial upheld

Cisson v. C.R. Bard Inc. (S.D. W. Va.)

PROSTHETIC HIP

9 Suit over cobalt exposure from hip implant dismissed

Becker v. Smith & Nephew (D.N.J.)

PAIN PUMP

10 9th Circuit reverses preemption ruling in pain-pump suit

McClellan v. I-Flow Corp. (9th Cir.)

SURGICAL STAPLER

11 Discovery limits set in Minnesota surgical stapler injury suit

Webb v. Ethicon Endo-Surgery (D. Minn.)

VASCULAR GRAFT (PATENTS)

12 Bard wins $208 million more in medical device patent battle with Gore

Bard Peripheral Vascular v. W.L. Gore & Assocs. (Fed. Cir.) SEE PAGE 3

CONTINUED ON PAGE 16

COMMENTARY

FDA defines medical device accessory, proposes new means for classification

Medical device law practitioner Jennifer D. Newberger of Hyman Phelps & McNamara says that although the U.S. Food and Drug Administration’s just-released draft guidance officially defining medical device accessories is appreciated, it may not offer the level of help needed.

COMMENTARY

No defect? No problem. Proving product liability claims through circumstantial evidenceGoldberg Segalla attorneys Brian J. Benoit and Davis J. Kim discuss whether product liability cases can succeed if plaintiffs lack evidence of a defect and offer no expert testimony but can pro-vide circumstantial evidence and show that an incident causing a plaintiff’s harm does not normally occur absent a defect.

SEE PAGE 4

BONE GROWTH STIMULANT

Hawaii federal court approves revised suit over Medtronic bone-growth deviceBy Ronald V. Baker, Senior Legal Writer, Westlaw Journals

A Hawaii woman who claims she was injured be-cause Medtronic Inc. improperly marketed its Infuse bone-growth device for unapproved use has won the opportunity to proceed with her lawsuit against the company.

Beavers-Gabriel v. Medtronic Inc. et al., No. 1:13-cv-00686, 2015 WL 143944 (D. Haw. Jan. 9, 2015).

Judge J. Michael Seabright of the U.S. District Court for the District of Hawaii refused to dismiss an amended complaint by Karla Beavers-Gabriel. He rejected Medtronic’s assertion that her fraud, breach-of-warranty and other allegations either were federally preempted by the Medical Device Amendments to the Food, Drug and Cosmetic Act, 21 U.S.C. § 301, or failed to state a valid claim.

The plaintiff says the off-label use of Medtronic’s Infuse device during her spinal operation caused uncontrolled bone growth and nerve damage. A spine X-ray is shown here.

© 2015 Thomson Reuters2 | WESTLAW JOURNAL n MEDICAL DEVICES

Westlaw Journal Medical DevicesPublished since June 1994

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Westlaw Journal Medical Devices (ISSN 2155-725X) is published biweekly by Thomson Reuters.

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TABLE OF CONTENTS

Bone Growth Stimulant: Beavers-Gabriel v. Medtronic Inc.Hawaii federal court approves revised suit over Medtronic bone-growth device (D. Haw.) ............................1

Commentary: By Jennifer D. Newberger, Esq., Hyman Phelps & McNamaraFDA defines medical device accessory, proposes new means for classification ............................................ 3

Commentary: By Brian J. Benoit, Esq., and Davis J. Kim, Esq., Goldberg Segalla LLPNo defect? No problem. Proving product liability claims through circumstantial evidence ........................4

Transvaginal Mesh: Budke v. Ethicon Inc.Ethicon settles first wrongful-death mesh case to reach trial (Mo. Cir. Ct.) ....................................................6

Breast Implants: In re Settlement Facility Dow Corning Trust6th Circuit rejects Dow bankruptcy plan breast implant claimant payments (6th Cir.) ................................. 7

Transvaginal Mesh: Cisson v. C.R. Bard Inc.Bard’s $2 million loss in first transvaginal mesh trial upheld (S.D. W. Va.) .....................................................8

Prosthetic Hip: Becker v. Smith & NephewSuit over cobalt exposure from hip implant dismissed (D.N.J.) .......................................................................9

Pain Pump: McClellan v. I-Flow Corp.9th Circuit reverses preemption ruling in pain-pump suit (9th Cir.) .............................................................. 10

Surgical Stapler: Webb v. Ethicon Endo-SurgeryDiscovery limits set in Minnesota surgical stapler injury suit (D. Minn.) .........................................................11

Vascular Graft (Patents): Bard Peripheral Vascular v. W.L. Gore & Assocs.Bard wins $208 million more in medical device patent battle with Gore (Fed. Cir.) .....................................12

Needle Device (Trademarks): Grey Matter Med. Prods. v. Schreiner GroupJudge refuses to toss needle device trademark suit (W.D. Wash.) ..................................................................13

Transvaginal Mesh: In re Ethicon Inc. Pelvic Repair Sys. Prods. Liab. Litig.Plaintiffs’ lawyers reject J&J claims of fraud in mesh lawsuits (S.D. W. Va.) ..................................................14

Regulatory Action: United States v. 2035 Inc.U.S. blocks sales of laser treatment product (D S.D.) .....................................................................................15

News in Brief ..................................................................................................................................................... 17

Case and Document Index ...............................................................................................................................18

FEBRUARY 10, 2015 n VOLUME 21 n ISSUE 25 | 3© 2015 Thomson Reuters

Jennifer D. Newberger is an associate at Hyman Phelps & McNamara in Washington. She helps medical device clients develop regulatory strategies; prepare product applications; comply with labeling, advertising and promotion; and address enforcement actions. She provides counsel on U.S. Food and Drug Administration aspects of regulatory due diligence, contracts and transactions, and represents medical device companies before the FDA. This commentary originally appeared Jan. 29 on Hyman Phelps’ FDA Law Blog, www.fdalawblog.net. Reprinted with permission.

COMMENTARY

FDA defines medical device accessory, proposes new means for classification By Jennifer D. Newberger, Esq. Hyman Phelps & McNamara

The question of what constitutes an accessory has never been well answered. In a December 1996 guidance document, Medical Device Quality Systems Manual: A Small Entity Compliance Guide, the FDA said that accessory devices are devices “packaged, labeled, and distributed separately to a hospital, physician, etc., for health-related purposes.” Apart from this, no definition of this statutory term was ever provided. Despite the lack of a definition for accessories, the FDA historically classified accessories either by classifying the accessory in the same class as the parent device, or by issuing a separate classification regulation.

On January 20, 2015, the FDA issued a draft guidance document putting forth a definition for accessory, and proposing a new way of classifying accessories. The draft guidance defines an accessory as a “device that is intended to support, supplement, and/or augment the performance of one or more parent devices.” This definition is further parsed as follows:

• “Adevicesupports the performance of a parent device by enabling or facilitating that device to perform according to its intended use.”

• “Adevicesupplements the performance of a parent device if it adds a new function or a new way of using the parent device, without changing the intended use of the parent device.”

• “Adeviceaugments the performance of a parent device by enabling the device to perform its intended use more safely or effectively.”

number of devices than previously believed to be accessories, and could presumably include any device that, for any purpose, is intended to be used with another device.

In addition to questionable examples of accessories, the draft guidance proposes that manufacturers consider submitting de novo classification petitions for device accessories. The intent behind the proposal may be well-founded: some accessories may have a lower risk profile than their parent, and therefore may warrant being regulated in a lower class. The application, however, seems flawed.

These distinctions are likely to be difficult to apply in practice. To provide more clarity, the FDA gave some examples, some of which seem questionable. For example, the FDA states that a rechargeable battery intended to operate when paired with an automated external defibrillator is an accessory to the AED because it is intended to support the AED by enabling it to defibrillate. It would not seem that a battery that is required for the operation and function of the parent device would be considered an accessory, but rather part of the parent device itself.

While it is welcome to have the FDA provide a definition of an accessory, the examples given do not seem to fit the traditional

understanding of an accessory.

As an example of an accessory that “supplements” the parent, the FDA cited a pulse oximeter that allows a multi-parameter monitor to display oxygen saturation but does not change its intended use: to record and display multiple physiological parameters. While multi-parameter monitors are cleared to display specific parameters, including oxygen saturation, they are rarely cleared for use with specific devices.

Additionally, a pulse oximeter is a finished device with its own regulatory classification that requires 510(k) clearance. It is therefore not evident that a pulse oximeter would appropriately be considered an “accessory” to a multi-parameter monitor. In light of the examples provided, the definition of an accessory would seem to include a larger

First, as noted above with respect to the AED battery, some “accessories” are key to the functionality of the device, and it is debatable whether FDA would clear or approve a submission that did not include a key part of the product. Second, the utility of the de novo process for accessories would be limited because it would apply only to accessories “of a new type.”

Finally, it is not clear in what circumstances use of de novo for an accessory would be appropriate or practical. The FDA proposes this approach in very high-level, theoretical terms, but provides no examples of when de novo classification for an accessory may actually be suitable.

While it is welcome to, at long last, have the FDA provide a definition of an accessory, the examples provided do not seem to fit the traditional understanding of an accessory. Furthermore, the proposal to utilize the de novo pathway is likely to be beneficial only in limited circumstances that are not entirely evident. Thus, while the draft guidance does provide a definition, it will not likely alter the way in which accessories are cleared. WJ

4 | WESTLAW JOURNAL n MEDICAL DEVICES © 2015 Thomson Reuters

COMMENTARY

No defect? No problem. Proving product liability claims through circumstantial evidenceBy Brian J. Benoit, Esq., and Davis J. Kim, Esq. Goldberg Segalla LLP

When and how can a plaintiff be divorced of the burden to show a specific defect? Illinois and a majority of jurisdictions have long held that evidence of a defective product may be proven through circumstantial evidence.1 Consistent with Illinois law, the Restatement (thiRd) of toRts: PRoducts LiabiLity § 3, “Circumstantial Evidence Supporting Inference of Product Defect” (1998), states, in relevant part, as follows:

It may be inferred that the harm sustained by the plaintiff was caused by a product defect existing at the time of sale or distribution, without proof of a specific defect, when the incident that harmed the plaintiff:

(a) was of a kind that ordinarily occurs as a result of product defect; and

(b) was not, in the particular case, solely the result of causes other than product defect existing at the time of sale or distribution.

Notably, the comments to Restat. (3d) of toRts: PRoducts LiabiLity § 3 trace the “historical antecedents to the law of negligence” and cite specifically to Restatement (second) of toRts, § 328D (1965), the restatement pertaining to res ipsa loquitur. Yet, there are fundamental differences between product liability proven through circumstantial evidence and the theory of res ipsa loquitur.

Understanding the differences between the two will help the practitioner investigate and defend a case wherein the plaintiff is relying on circumstantial evidence to prove a defect in a product liability case.

Illinois law provides that “a plaintiff may create an inference that a product was defective by direct or circumstantial evidence that: (1) there was no abnormal use of the product; (2) that there was no reasonable secondary cause of the injury; and

Brian J. Benoit (L) is partner in the Chicago office of Goldberg Segalla LLP. His practice takes him to courts across the country defending product manufacturers in catastrophic-loss cases, and often specializes in the defense of claims involving fires and explosions. Davis J. Kim (R) is an associate in Goldberg Segalla’s Princeton, N.J., office. In addition to his defense of product manufacturers, he represents commercial property owners, property managers, general contractors, subcontractors and manufacturers in personal injury and property damage cases. The original version of this commentary appeared in the Illinois Association of Defense Trial Counsel’s “IDC Quarterly” at www.iadtc.org. Reprinted with permission.

defendant’s control at the time of the incident, the incident would not have occurred but for some fault on the part of the defendant. Product liability cases differ in that the focus is not on the fault of the manufacturer, but on the condition of the product itself at the time the product leaves the manufacturer.

While there have not been any earth-shattering Illinois cases demonstrating the specific thresholds to overcome in order to prove a strict liability claim absent a specific

There are fundamental differences between product liability proven through circumstantial evidence and the

theory of res ipsa loquitur.

(3) that the product failed to perform in the manner reasonably to be expected in light of its nature and intended function.”2 This language, in large part, tracks the language of the Restatement Third. By contrast, the 7th Circuit U.S. Court of Appeals, interpreting Illinois law, specifically rejected the notion that res ipsa loquitur is applicable in products cases.3

Res ipsa loquitur is grounded on the presumption that since the instrumentality that created the incident was in the

defect, the Connecticut case of White v. Mazda Motor of Am., which was recently ruled on by the Connecticut Supreme Court, provides unique insight into some of the issues that need to be addressed when defending a strict product liability case based on circumstantial evidence.4

In White, the plaintiff filed a product liability action against a vehicle manufacturer and dealership alleging that he was injured when his vehicle caught fire one month after he purchased it. The plaintiff specifically alleged that his injuries were caused by a defective and unreasonably dangerous condition with the vehicle. In support of its claim, plaintiff cited a laundry list of various alleged defects within the vehicle that may have caused the fire. Under cross examination, the plaintiff’s expert admitted that “he was ‘not offering an opinion that the [vehicle] was defective….’”5

The defendants filed a motion for summary judgment arguing that the plaintiff failed to produce any evidence, expert or otherwise, to establish that the vehicle was defectively designed or manufactured. The trial court agreed and granted the defendant’s motion. On appeal, the plaintiff focused on the sufficiency of its expert’s opinions and, for the first time, argued that he could prove his


case through circumstantial evidence, i.e., the malfunction theory.

The Connecticut Appellate Court affirmed citing the need for expert testimony in product liability cases despite the existence of the malfunction theory. The appellate court did not however consider the malfunction theory in their ruling which upheld the trial court’s decision because plaintiff failed to raise it at the trial court level.

Connecticut Appellate Court Justice Thomas G. West authored a dissenting opinion however, stating that the plaintiff had asserted the malfunction theory at the trial court level and that it could have defeated summary judgment based on the existence of circumstantial evidence. Justice West pointed out that a plaintiff may prove a product liability case in the absence of direct evidence of a defect when it is shown that:

(1) the incident that caused the plaintiff’s harm was of a kind that ordinarily does not occur in the absence of a product defect, and (2) any defect most likely existed at the time the product left the manufacturer’s or seller’s control and was not the result of other reasonably possible causes not attributable to the manufacturer or seller.6

The dissent further noted that the two above elements could be established through “various forms of circumstantial evidence” which include evidence of:

(1) the history and use of the particular product, (2) the manner in which the product malfunctioned, (3) similar malfunctions in similar products that may negate the possibility of other causes, (4) the age of the product in relation to its life expectancy, and (5) the most likely causes of the malfunction. Id.

White was appealed to the Connecticut Supreme Court.7 During oral argument, there was substantial discussion on whether the plaintiff’s expert ruled out all potential alternative causes. These potential causes, as discussed by the justices, could have ranged from a rock puncturing the fuel tank to a bird taking refuge in the engine compartment. The plaintiff’s counsel argued that there was no testimony regarding alternative causes and, as a result, the “lack of alternative causes” factor had been met by the plaintiff.

The justices, however, took the lack of testimony by plaintiff’s experts regarding alternative causes to suggest that potential alternative causes were not eliminated by the plaintiff’s expert. Similar to res ipsa loquitur cases, the justices’ questions appeared to place the burden of eliminating potential alternative causes on the plaintiff.

In its opinion, the Supreme Court stressed the general rule that an appellate court cannot decide an issue for the first time on appeal. Our appellate courts, as a general practice, will not review claims made for the first time on appeal.8

to the Defendant’s motion for summary and then again at oral argument, the Court refused to divest itself of the rule that facts in support of a claim under the malfunction theory must be affirmatively pled. The court likened this requirement to the pleading rules when asserting a claim based on res ipsa. The court acknowledged the difference between a res ipsa claim and a claim based on the malfunction theory, but stated that the requirement for pleading specific facts to place the defense on notice was necessary. Id. at 629-630.

A logical follow-up question to the burden on plaintiff’s expert in ruling out potential alternative causes, is whether expert testimony is even necessary in the first place. A few cases stand for the proposition that no expert testimony is required in a malfunction theory case. Those cases are uncommon and typically involve an incident in which there were direct witnesses to the accident.

For example, in Potter v. Chicago Pneumatic Tool Co., the court held that the plaintiffs, who alleged that they sustained injuries as a result of excessive vibration from power tools used during their employment, did not need expert testimony to prove a design defect because “a jury may, under appropriate circumstances, infer a defect from the evidence….”9

Despite the burden on the plaintiff, the defense must take an active role in evaluating potential alternative causes. It has been said that a good defense is nice, but it’s much better to have the ball. The defense can establish its own alternative causation scenarios with which to confront plaintiffs’

Despite the burden on the plaintiff, the defense must take an active role in evaluating potential

alternative causes.

The plaintiff therefore, must, in order to put defendants on notice of the theory of liability, plead such theory in their complaint. Id. at 621. In order to effectively plead a claim under the malfunction theory, the Supreme Court required that the two main elements of a malfunction theory claim be plead: “1) the incident that caused the plaintiff’s harm was of a kind that ordinarily does not occur in the absence of a product defect, and (2) any defect most likely existed at the time the product left the manufacturer’s or seller’s control and was not the result of the reasonably possible causes not attributable to the manufacturer or seller. Id. at 623.”

The defense can establish its own alternative causation scenarios with which to confront plaintiffs’ experts or cast

doubt on the elimination of alternative causes.

While there does not need to be a separate count devoted to the malfunction theory, the court held that sufficient facts must be pled to place the defendant on notice of the allegations. While, the court explained, this theory lowered the burden of proving direct evidence of a defect, it raised the burden on the plaintiff in negating other possible causes. Id at 626.

In response to Plaintiff’s arguments that the malfunction theory was raised in response

experts or cast doubt on the elimination of alternative causes.

To do so may require expert consultation by the defense at the outset, but will preserve the defense’s ability to evaluate any evidence of alternative theories while it still exists. Evidence in product liability cases can be very fluid and should be preserved as soon as possible.

At first glance, the malfunction theory seems to provide plaintiffs with an “out” when a


TRANSVAGINAL MESH

Ethicon settles first wrongful-death mesh case to reach trial(Reuters Legal) – Johnson & Johnson’s Ethicon Inc. subsidiary has agreed to settle the first wrongful-death lawsuit involving a transvaginal mesh device to reach trial.

The plaintiff said Ethicon’s Gynecare Prolift mesh system caused his wife to develop an infection

that contributed to her death.

specific defect cannot be pinpointed. The recent case law suggests, however, that the malfunction theory carries with it the additional burden on a plaintiff to rule out other potential explanations for the incident. Therefore, it is the defense attorney and defense expert’s job to ensure that the plaintiff’s analysis in excluding all other causes is grounded in truth and fact. WJ

NOTES1 Doyle v. White Metal Rolling & Stamping Corp., 249 Ill. App. 3d 370 (1st Dist. 1993).

2 Doyle, 249 Ill. App. 3d at 377.

3 Welge v. Planters Lifesavers Co., 17 F. 3d 209 (7th Cir. 1994).

4 White v. Mazda Motor of Am. Inc., No. HHDCV086003322S, 2011 WL 3211221, at *5 (Conn. Super. Ct. June 22, 2011) aff’d, 139 Conn. App. 39, 54 A.3d 643 (2012) aff’d, 313 Conn. 610, 99 A.3d 1079 (2014)

5 White v. Mazda Motor of Am., 139 Conn. App. 39 (2012)

6 White, 139 Conn. App. at 57 (West, J. dissenting).

7 The oral argument can be viewed in its entirety at http://ct-n.com/ctnplayer.asp?odID=9559

8 White v. Mazda Motor of Am. Inc., 313 Conn. 610 (2014)

9 Potter v. Chicago Pneumatic Tool Co., 241 Conn. 199, 217–218 (1997).

Budke v. Ethicon Inc., No. 10CM-CC00085, settlement announced (Mo. Cir. Ct., Camden County Jan 21, 2015).

Adam M. Slater, a lawyer for plaintiff Donald Budke, said the settlement was reached Jan. 21, right before closing arguments were set to begin following a two-week trial before Judge William Hass in Missouri’s Camden County Circuit Court. He declined to say how much Ethicon paid, citing a confidentiality agreement.

Budke’s 2010 lawsuit was the first wrongful-death case to reach trial over transvaginal mesh, which is used to treat stress urinary incontinence and pelvic organ prolapse,

and that the company had rushed the Prolift to market without performing critical safety studies. The company also underreported the number of reported mesh complications and failures, according to testimony from one expert witness, Anne Weber, a gynecologist.

Ethicon’s lawyers said Budke’s death was not caused by mesh but rather a rare blood-vessel disorder. The Prolift was safe and effective as designed, the company has said in court filings.

Budke’s claims included design defect, failure to warn and negligence. A claim for punitive damages was dismissed by the judge mid-trial, according to Slater.

and which has become the subject of tens of thousands of lawsuits against multiple companies. New Jersey-based Ethicon is facing approximately 35,600 mesh cases in state and federal courts.

According to Budke’s 2010 lawsuit, his wife, Joan, was implanted with Ethicon’s Gynecare Prolift system in 2008 to treat pelvic organ prolapse. The next year, the mesh caused an infection that spread throughout her body, ultimately contributing to her death, according to the lawsuit.

The complaint claimed the company had sold a defective device and failed to warn patients about known mesh risks. A trial started Jan. 7.

At trial, lawyers for Ethicon and the plaintiff sparred over the cause of Joan Budke’s death. Budke’s lawyers said the infection was a direct result of her mesh implantation,

Ethicon could not immediately be reached for comment.

Budke’s suit was the first involving a wrongful-death claim to go to trial against any mesh manufacturer. Ethicon had previously won one trial and lost three others involving personal-injury claims over mesh devices. WJ

(Reporting by Jessica Dye)

Attorneys:Plaintiff: Adam M. Slater, Mazie Slater Katz & Freeman, Roseland, N.J.; Amy C. Gunn and Anne Brockland, Simon Law Firm, St. Louis; Ben Anderson, Anderson Law Offices, Cleveland

Defendants: Dan Ball and Bettina Strauss, Bryan Cave LLP, St. Louis; Paul S. Rosenblatt and Christy D. Jones, Butler Snow O’Mara Stevens & Cannada, Ridgeland, Miss.

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BREAST IMPLANTS

6th Circuit rejects Dow bankruptcy plan breast implant claimant paymentsBy Michael Nordskog, Senior Content Writer, Westlaw Daily Briefing

Payments to a category of breast-implant-injury claimants from a product liability settlement fund created by Dow Corning’s Chapter 11 plan were not properly authorized, a federal appeals panel has ruled in reversing a district court decision.

In re Settlement Facility Dow Corning Trust; Dow Corning Corp. et al. v. Claimant’s Advisory Committee et al., No. 14-1090, 2015 WL 348899 (6th Cir. Jan. 27, 2015).

Any proposal to make lower-priority payments before all preferential claims are settled must “virtually guarantee” that sufficient funds will remain to pay the higher-priority claimants, a 6th U.S. Circuit Court of Appeals panel said.

Dow Corning Corp. filed for Chapter 11 relief in 1995 to hammer out a settlement of thousands of product liability suits related to breast implants, according to the panel’s opinion.

Tens of thousands of implant recipients sued Dow and other implant manufacturers after the FDA ordered the removal of the products from the market in 1992. Medical studies had shown that exposure to silicone gel in the implants could cause autoimmune reactions such as lupus and rheumatoid arthritis.

In 1998 the U.S. Bankruptcy Court for the Eastern District of Michigan confirmed a reorganization plan providing up to $2.35 billion to claimants who sought relief through separate settlement or litigation trust funds before the end of 2019.

The plan authorized the U.S. District Court for the Eastern District of Michigan to resolve any disputes or controversies over interpreting or implementing the bankruptcy plan.

SETTLEMENT PAYMENT PRIORITIES

The settlement fund agreement created four payment-priority categories, granting first priority to payments based on the type of claim as provided in a settlement value chart.

The second-priority category, consisting of three subcategories, provided for premium payments to claimants who had suffered ruptures of implants, increased payments to claimants whose conditions worsened, and reimbursement to Dow for settlements paid prior to the plan’s effective date, the opinion said.

The agreement provided that the fund’s finance committee must seek District Court approval before distributing any second-priority payments and could do so only if “adequate provision has been made to assure” that all first-priority claims will be paid.

In 2011 the committee sought to distribute 50 percent of payments under the premium subcategory before all higher-priority payments were disbursed, based on an estimate that more than $150 million would remain after all priority payments were made. A claimant’s advisory committee supported the request, the opinion said.

Dow and affiliated parties opposed the request, arguing that the ability to pay out first-priority claims must be “virtually guaranteed” and disputing the finance committee’s estimates. They also argued that all three second-priority subcategories must be paid simultaneously.

In December 2013 the District Court authorized the distributions, rejecting the standard proposed by Dow, and declining to address the question regarding the other two subcategories.

The Dow parties appealed.

’VIRTUAL GUARANTEE’ VS. ‘ADEQUATE ASSURANCE’

The 6th Circuit panel said the District Court abused its discretion by finding the

agreement’s provision for authorizing second-priority payments required only “adequate assurance” of payment rather than a virtual guarantee.

“Adequate assurance” is a term of art from Section 365(b)(1)(C) of the Bankruptcy Code, 11 U.S.C.A. § 365(b)(1)(C), regarding a trustee’s assurance of performance in assuming a contract or lease after default.

“This level of assurance falls below ‘absolute guarantee,’ … and can mean ‘a strong likelihood’ … or ‘more probable than not,’” the panel said, quoting various bankruptcy court opinions.

Noting that the District Court construed the term “assure” in the agreement as being modified by “adequate provision,” the panel said it was the other way around. “The term ‘assure’ provides context for the term ‘adequate provision,’” they said.

The panel said “assure” means “guarantee” in the context of the agreement, while stopping short of requiring an absolute guarantee in light of possible future uncertainties.

“We adopt the appellant’s terminology of ‘virtual guarantee’ to describe the required confidence standard,” the panel said, remanding for further proceedings consistent with that interpretation.

The panel also reversed the District Court’s judgment that it had discretion to ignore reports and testimony offered by Dow to challenge the finance committee’s estimates.

Finally, while declining to dispose of the issue, the panel also noted the settlement agreement’s express requirements that all subcategories of second-priority claims be made “on the same basis and with the same priority.” WJ

Related Court Document:Opinion: 2015 WL 348899

REUTERS/Benoit Tessier

Tens of thousands of breast implant recipients sued Dow and other companies after the FDA ordered the removal of the silicone products, like the one shown here, from the market in 1992.


TRANSVAGINAL MESH

Bard’s $2 million loss in first transvaginal mesh trial upheld(Reuters Legal) – A federal judge in West Virginia has denied C.R. Bard’s bid to slash damages and get a new trial more than a year after it was hit with a $2 million verdict in what was the first federal transvaginal mesh case to reach a jury.

Cisson v. C.R. Bard Inc., No. 11-195, order denying motion for new trial issued (S.D. W. Va. Jan. 20, 2015).

In a pair of rulings handed down Jan. 20, U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia said Bard had not shown there were any reversible trial errors, and rejected the company’s argument that the $1.75 million in punitive damages awarded to plaintiff Donna Cisson was too high.

However, Judge Goodwin also rejected Cisson’s request to declare unconstitutional a law from Georgia, where she was implanted with the device, that requires prevailing plaintiffs in product liability actions to turn over 75 percent of their punitive damages to the state.

Judge Goodwin is overseeing more than 70,000 lawsuits against seven manufacturers over transvaginal mesh devices, which have been consolidated in the West Virginia federal court.

Cisson’s 2011 lawsuit said she suffered physical and emotional damage caused by the Bard Avaulta Plus device she was implanted with in 2009 to treat pelvic organ

prolapse. Her claims included design defect and failure to warn.

Jurors returned a verdict for Cisson in August 2013, awarding $250,000 in compensatory damages and $1.75 million in punitive damages.

New Jersey-based Bard, a medical equipment and device manufacturer, asked Judge Goodwin to throw out the verdict and hold a new trial, saying that evidentiary errors had tainted the outcome.

Among those errors, Bard said in court filings, was Judge Goodwin’s decision to exclude evidence that the Avaulta Plus had been approved by the Food and Drug Administration, as well as a ruling that allowed plaintiffs to use at trial a document detailing one supplier’s concerns about using polypropylene resin — a key component of the mesh — in devices permanently implanted in humans.

Bard separately moved to slash Cisson’s punitive damages award to $250,000, saying $1.75 million was unfairly high and unjustified by the evidence.

Judge Goodwin disagreed on both counts. The trial was fair, and the punitive damages

reflected the jury’s view that Bard’s “longstanding and continuous behavior strongly indicates reprehensibility,” he wrote.

He also rejected Cisson’s motion to void the Georgia law, which her lawyers said violated the 14th Amendment’s Equal Protection Clause and the Takings Clause in the Fifth Amendment. The Georgia Supreme Court had upheld the law, and other states had affirmed the constitutionality of similar statutes, Judge Goodwin wrote.

A lawyer for Cisson declined to comment, and Bard did not immediately return a request for comment. The company has previously indicated it intends to appeal the verdict. WJ


Attorneys:Plaintiff: Henry G. Garrard III, Blasingame Burch Garrard & Ashley, Athens, Ga.; Paul Farrell, Greene Ketchum Bailey Walker Farrell & Tweel, Huntington, W.Va.; Anthony J. Majestro, Powell & Majestro, Charleston, W.Va.

Defendant: Melissa F. Bird, Nelson Mullins Riley & Scarborough, Huntington, W.Va.; Lori G. Cohen, Greenberg Traurig LLP, Atlanta; Daniel Smulian, Greenberg Traurig LLP, New York


PROSTHETIC HIP

Suit over cobalt exposure from hip implant dismissedA woman who alleged a defective metal hip implant exposed her to high levels of cobalt has not provided enough factual details to proceed with her product liability action, a New Jersey federal judge has ruled.

Becker et al. v. Smith & Nephew Inc. et al., No. 2:14-cv-05452 WHW-CLW, 2015 WL 268857 (D.N.J., Jan. 20, 2015).

Senior U.S. District Judge William H. Walls of the District of New Jersey granted defendant Smith & Nephew’s motion to dismiss the suit, finding the “bare-bones” allegations in the complaint could not support a claim for relief under the New Jersey Products Liability Act, N.J. Stat. Ann. § 2A:58C–1.

Plaintiff Deborah Becker has not specified how the implant allegedly deviated from its intended design or manufacturer specifications or explained how Smith & Nephew failed to adequately warn her, Judge Walls said.

Becker underwent surgery in 2007 to install a hip implant designed and manufactured by Smith & Nephew, according to the suit.

Smith & Nephew issued a voluntary recall of the metal implant in June 2012, but Becker did not receive notice until April 2013, the complaint said.

She said in the suit that she had the implant removed that September after blood work allegedly revealed high levels of cobalt in her system.

Excessive exposure to cobalt can lead to diseases of the heart muscle and nerve and thyroid problems, according to the National Institutes of Health.

Becker said Smith & Nephew was strictly liable for her injuries under the New Jersey Products Liability Act. She also asserted claims for negligence, breach of express or implied warranties, failure to warn, punitive damages, and loss of consortium on behalf of her husband.

Smith & Nephew argued in a dismissal motion that the complaint was “fatally flawed” because it does not specify the particular model of hip implant at issue or Becker’s alleged injuries.

Becker failed to indicate which theory of products liability she intended to pursue — manufacturer defect, design defect or

failure to warn — and she did not plead the required elements of any theory, according to a memorandum in support of the motion to dismiss.

Smith & Nephew also said the exclusive remedy for personal injury claims arising from product use in New Jersey is the Products

The plaintiff received her metal hip implant in 2007. Smith & Nephew recalled the device in June 2012, but the plaintiff says she did not receive notice until April 2013. A diagram of a hip implant is shown here.

Courtesy of West Medical Litigator

Doctors removed the plaintiff’s metal hip implant

after blood work revealed high levels of cobalt in her

system, the suit said.

Liability Act, which does not recognize common law claims of negligence or breach of implied warranty.

Becker did not timely respond to the motion, but her counsel sent a letter to the District Court in December asking that the motion be denied and enclosing her purported medical records.

Judge Walls declined to accept the supplementary materials and agreed with Smith & Nephew that the complaint does not allege enough facts to support a product liability claim under any of theory of recovery.

The suit does not specify how the implant was defective or how it proximately caused Becker’s alleged injuries, Judge Walls said.

The judge said Becker’s negligence and breach-of-warranty claims are subject to dismissal under the Products Liability Act, and the punitive damages and loss of consortium claims fail because they are derivative.

He gave Becker 90 days to amend her suit. WJ

Attorneys:Plaintiffs: John S. Voynick Jr., Renda & Voynick, Cedar Grove, N.J.

Defendant: Glenn S. Kerner, Goodwin Procter LLP, New York



PAIN PUMP

9th Circuit reverses preemption ruling in pain-pump suit(Reuters Legal) – A federal appeals court has ordered a new trial in a lawsuit over injuries allegedly caused by a pain-medication pump made by I-Flow Corp. and DJO Inc., after finding the lower court had mistakenly believed that the plaintiff’s jury instructions regarding state law claims were preempted by federal law.

McClellan v. I-Flow Corp. et al., No. 11-35109, 2015 WL 294292 (9th Cir. Jan. 23, 2015).

In a unanimous Jan. 23 opinion, a three-judge panel of the 9th U.S. Circuit Court of Appeals said plaintiff Christina McClellan’s proposed instructions related to state law claims for negligence and strict liability did not encroach on the U.S. Food and Drug Administration’s authority under the Medical Device Amendments of 1976, which established the federal framework for regulating medical devices.

“[T]here is no suggestion that Congress intended to displace traditional tort law by making all policing of

medical labels and warnings the exclusive province of the FDA,” the 9th Circuit said.

The case went to trial in 2010. McClellan’s attorneys requested that jurors be instructed on applicable federal safety standards and the legal consequences of violating those laws to prove her allegations that the company had acted negligently under state law.

But U.S. District Judge Ann Aiken in Oregon denied that request, saying McClellan’s argument that the companies had violated federal law was preempted.

Judgment was returned for the defendants, and McClellan appealed to the 9th Circuit, arguing that the preemption decision was wrong.

In response, I-Flow and DJO pointed to Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), a 2001 ruling from the U.S. Supreme Court. Plaintiffs in that case accused Buckman Co. of misleading the FDA to secure approval for bone screws. But the high court held that those claims were preempted because allowing plaintiffs to sue in state court would impede the agency’s ability to police medical devices.

In its opinion, the 9th Circuit rejected I-Flow and DJO’s attempt to apply Buckman. McClellan was not arguing that the defendants had defrauded the FDA, but rather that the companies should have given better warnings, they wrote.

“[T]here is no suggestion that Congress intended to displace traditional tort law by making all policing of medical labels and warnings the exclusive province of the FDA,” wrote U.S. Circuit Judge Alfred Goodwin, joined by Circuit Judges Harry Pregerson and Morgan Christen.

The panel vacated judgment and ordered a new trial.

Lawyers for McClellan and I-Flow did not return requests for comment. A lawyer for DJO, Richard Nakamura, said the company was reviewing the decision. WJ


Attorneys:Defendant-appellant (I-Flow): Andrew G. Klevorn, Katten Muchin Rosenman, Chicago

Defendant-appellant (DJO): Richard H. Nakamura Jr., Morris Polich & Purdy, Los Angeles

Plaintiff-appellee: Leslie W. O’Leary, Williams O’Leary, Portland, Ore.


McClellan filed suit in 2007 in the U.S. District Court for the District of Oregon claiming that, following shoulder surgery, she was implanted with the PainBuster pump to provide a continuous infusion of pain medication. The PainBuster was made by I-Flow, which was acquired in 2009 by Dallas-based Kimberly Clark Corp., and DJO Inc., a San-Diego based medical device company.

She said problems with the device caused her to develop chondrolysis of the shoulder, which causes the loss of cartilage in the main shoulder joint, and that she had been inadequately warned about that risk.


SURGICAL STAPLER

Discovery limits set in Minnesota surgical stapler injury suitBy Ronald V. Baker, Senior Legal Writer, Westlaw Journals

Ethicon Endo-Surgery Inc. must produce adverse incident reports and other documents related to its TX model surgical stapler in a suit that alleges a woman was injured when one of the tools malfunctioned during a throat operation.

Webb v. Ethicon Endo-Surgery Inc., No. 13-1947, 2015 WL 317215 (D. Minn. Jan. 26, 2015).

U.S. District Judge John R. Tunheim of the District of Minnesota ordered Ethicon to produce data related to problems with the entire line of TX surgical staplers, which dates back to 1996, for plaintiff Susan Webb.

The judge said the requested material is narrowly tailored to products similar to the Model TX60B surgical stapler used during Webb’s 2009 operation.

The hand stitching eventually allowed a postoperative leak, leading to Webb’s re-hospitalization, corrective surgery, and what she calls “persistent and permanent health effects.”

The suit includes claims for strict product liability, negligent manufacture and breach of the warranty of merchantability.

Aside from moving to quash Webb’s discovery requests, Ethicon sought to limit any discovery, if approved, to the TX60B model stapler.

The plaintiff says she was injured when an Ethicon TX60B surgical stapler used during a tumor removal procedure failed,

forcing her surgeon to hand-stitch the incision.

He adopted a magistrate judge’s report and recommendation on Ethicon’s motion for protective orders and a request to quash Webb’s discovery request.

Webb sued Ethicon in 2013, claiming she sustained permanent injuries when the TX60B surgical stapler her surgeon tried to use during a procedure to remove an esophageal tumor failed to fire. Because the device could not close an internal incision, the surgeon was forced to hand-stitch a suture line, the suit said.

It told the court that a search for data on all similar TX model proximate linear staplers could cost it $62,400. That, the company said, would pose a disproportionate financial burden given that Webb claims damages “well in excess of $50,000.”

In an Aug. 8, 2014, discovery order, U.S. Magistrate Judge Jeanne J. Graham partially granted Webb’s discovery motion, restricting its scope to the TX model line.

Judge Tunheim said Judge Graham “appropriately took expense, burden,

and likely benefit into account” in her recommendations. He noted that Judge Graham heard testimony from Ethicon research and development project director Michael Cronin, who explained that requiring discovery beyond Ethicon’s TX model products would offer little benefit, given the differences in design and manufacture of non-TX staplers.

“The magistrate judge concluded that a key issue in this case is how the stapler used in Webb’s surgery compares to similar staplers that may share a record of analogous accidents or injuries, and these stark differences are highly relevant to that issue,” Judge Tunheim said. WJ

Attorneys:Plaintiff: William L. Tilton, Michael J. Gross, George R. Dunn and Grace Davies, Tilton & Dunn, St. Paul, Minn.

Defendant: David R. Noteware, Janelle L. Davis and Timothy E. Hudson, Thompson & Knight, Dallas; Kim M. Schmid and Sheryl A. Bjork, Bowman & Brooke, Minneapolis

Related Court Document:Memorandum opinion and order: 2015 WL 317215

See Document Section B (P. 31) for the memorandum opinion and order.


VASCULAR GRAFT (PATENTS)

Bard wins $208 million more in medical device patent battle with Gore(Reuters Legal) – C.R. Bard Inc. has won the latest round in a patent fight with W.L. Gore & Associates Inc. over prosthetic vascular grafts used in sur-gery, in a decision that will increase a judgment that has already reached $1 billion.

Bard Peripheral Vascular Inc. et al. v. W.L. Gore & Associates Inc., No. 2014-1114, 2015 WL 151557 (Fed. Cir. Jan. 13, 2015).

The U.S. Court of Appeals for the Federal Circuit on Jan. 13 affirmed that Gore had willfully infringed Bard’s patent. Lawyers familiar with the case said the decision would increase the award by another $208 million.

The appeals court had ruled in 2012 that Gore infringed a patent for a vascular graft but, in an en banc decision by all the judges

In the latest round, Gore had argued that the infringement was not willful because a Gore employee, Peter Cooper, originally supplied the tubing used to make the graft and was thus an unnamed co-inventor.

The appeals court also rebuffed Gore’s assertion that only C.R. Bard had standing to allege infringement, not others named as plaintiffs: Bard Peripheral Vascular Inc. and David Goldfarb, who was granted the original patent.

Bard received nearly $1 billion in damages in 2013, and this decision will add another $208 million or so, according to lawyers familiar with the case.

A Gore spokeswoman said that the company was disappointed in the ruling but that the decision would not cause disruption.

“We have paid Bard all outstanding damages owed pursuant to the court’s orders, except for approximately $208 million in willfulness damages, which have been in escrow pending the outcome of this appeal,” said Jenny Maher in an email. WJ

(Reporting by Diane Bartz)

Attorneys:Plaintiffs-appellees: Michael W. McConnell, Kirkland & Ellis, Washington

Defendant-appellant: James W. Poradek, Faegre Baker Daniels LLP, Minneapolis


See Document Section C (P. 37) for the opinion.

C.R. Bard Inc. received nearly $1 billion in damages

in 2013, and this decision will add another

$208 million or so, according to lawyers

familiar with the case.

in the court, asked the U.S. District Court in Arizona, where the case began in 2003, to reconsider its decision that Gore had willfully infringed. Bard Peripheral Vascular et al. v. W.L. Gore & Assocs., 682 F.3d 1003 (Fed. Cir. 2012).

The lower court again found that the infringement was willful. Bard Peripheral Vascular et al. v. W.L. Gore & Assocs., 2013 WL 5670909 (D. Ariz. Oct. 17, 2013).

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NEEDLE DEVICE (TRADEMARKS)

Judge refuses to toss needle device trademark suitA dispute over when a trademarked device used to protect health care work-ers from needle injuries was first used in commerce was sufficient to doom a competing device manufacturer’s motion for summary judgment in an infringement suit against it, a federal judge has ruled.

Grey Matter Medical Products LLC v. Schreiner Group LP et al., No. 13-5861, 2015 WL 106199 (W.D. Wash., Tacoma Div. Jan. 7, 2015).

Grey Matter Medical Products raised sufficient factual questions about when its NeedleTrap device had been used in commerce to defeat the motion by Schreiner Group, U.S. District Judge Benjamin H. Settle of the Western District of Washington said.

Matter had abandoned the mark and that the plaintiff had no trademark to enforce under state law.

In response, Grey Matter countered that its market research, a 2005 sales pitch, disclosures to manufacturers, and Food and Drug Administration approval activities established its right to use the trademark.

Judge Settle denied Schreiner’s motion, saying that under the “totality of the circumstances,” Grey Matter had submitted sufficient evidence to defeat the motion on the issue of commercial use. He noted, however, that the FDA approval activities are one of the “less traditional” trademark uses that Congress intended to protect.

Grey Matter also submitted sufficient evidence of sporadic use of the trademark to defeat Schreiner’s claims of abandonment, and evidence of website activity in Washington state created material questions of fact regarding its state law claims, the judge said. WJ

Related Court Document:Order: 2015 WL 106199

REUTERS/Gael Gonzalez

Under the “totality of the circumstances,” the plaintiff had submitted sufficient evidence to defeat the defendant’s

summary judgment motion on the issue of commercial use.

Grey Matter sued Schreiner on Oct. 1, 2013, for alleged infringement of its NeedleTrap trademark, used in connection with a one-handed device to recap needles.

According to the judge’s order, Grey Matter owner Cory Dobak developed the device to protect health care workers from being stuck by needles.

Dobak said the NeedleTrap mark was first used in commerce in August 2005, when he transported the device from Oregon to a hospital in Spokane, Wash. Grey Matter registered the trademark in March 2009.

Schreiner markets a similar device called the Needle-Trap, for which it sought trademark registration in 2012. The U.S. Patent and Trademark Office denied the application because of Grey Matter’s existing trademark.

Under federal trademark law, 15 U.S.C. § 1127, the “use in commerce” requirement for a trademark is met when a mark is placed on goods which are then “sold or transported in commerce.”

Schreiner moved for summary judgment last November, asserting that Grey Matter’s mark had not been used in commerce, that Grey

WESTLAW JOURNAL

PHARMACEUTICAL

This publication provides up-to-date information

on developments in litigation, legislation, and regulation involving the

pharmaceutical industry, with reproductions of the

leading court opinions, complaints, briefs, and responses. The lawsuits

covered range from product liability suits

to patent infringement, and from wrongful death

to FDA approval. This publication is critical to anyone who needs to

keep up-to-date on FDA regulation, negligence and standards of care, generic

competition, Daubert issues, trade secrets, and

wrongful death.




TRANSVAGINAL MESH

Plaintiffs’ lawyers reject J&J claims of fraud in mesh lawsuits(Reuters) – Lawyers for thousands of women suing Johnson & Johnson’s Ethicon Inc. over transvaginal mesh devices are fighting back against the company’s claim that illegal phone solicitations may have resulted in baseless lawsuits.

In re Ethicon Inc. Pelvic Repair System Products Liability Litigation, No. 2:12-md-2327, response brief filed (S.D. W. Va., Charleston Div. Jan. 22, 2015).

Plaintiffs’ lawyers said in a court filing Jan. 22 there was “no evidence of fraud” tainting nearly 23,000 federal mesh injury lawsuits, which have been consolidated before U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia.

The filing came in response to a Jan. 14 motion from Johnson & Johnson asking Judge Goodwin to allow an investigation into whether women are being illegally solicited to join mesh litigation by unknown callers, some of whom seemed to have knowledge of private medical data. The company said it was concerned the calls may have resulted in bogus claims.

J&J has asked Judge Goodwin to make plaintiffs offer proof they had been injured by an Ethicon device, and have their lawyers

answer questions under oath about any knowledge of solicitation calls.

While strongly denouncing the “rogue call center’s shenanigans,” lead plaintiffs’ lawyers said J&J was using the calls to justify imposing unnecessary and burdensome measures that “would grind this litigation to a screeching halt.”

Lead plaintiffs’ counsel said they had raised a similar issue more than a year ago with Judge Goodwin, after several clients told them they had received, unsolicited, a letter from a call center bearing the U.S. Food and Drug Administration’s logo and promising $25,000 in compensation. They turned the letter over to the judge and asked him to investigate, the filing said.

“We thought it was improper at the time, and still do,” said plaintiffs’ lawyer Henry Garrard in an email.

J&J could show no direct link between the calls and plaintiffs’ firms, the filing said.

Furthermore, random sampling of the Ethicon cases last year showed that plaintiffs had all been implanted with mesh, although a handful had mistakenly identified the maker of their device, the filing said.

Ethicon spokeswoman Samantha Lucas said the company was still reviewing the filing. “Based on the reports we received, we were compelled to report these activities to the judge,” she said in a statement.

Ethicon is one of seven companies that collectively face more than 70,000 suits before Judge Goodwin over transvaginal mesh devices, used to treat stress urinary incontinence and pelvic organ prolapse. Women claim the devices were defective, resulting in painful complications like infection, nerve damage and bleeding. WJ

(Reporting by Jessica Dye; editing by Alexia Garamfalvi and David Gregorio)

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REGULATORY ACTION

U.S. blocks sales of laser treatment product(Reuters Legal) – The U.S. government has won an injunction blocking a South Dakota company from selling laser devices for home use that purportedly treat a wide range of illnesses including AIDS and cancer.

United States v. 2035 Inc. et al., No. 5:14-cv-5075, 2015 WL 213170 (D.S.D., W. Div. Jan. 14, 2015).

The Department of Justice said Jan. 16 that Judge Jeffrey L. Viken of the District of South Dakota had entered a preliminary injunction against QLasers PMA and its president, Robert Lytle, two days earlier.

In October the DOJ sued Lytle, who was a dentist until 1998 when he lost his license, claiming he marketed his QLaser products as a medical treatment without approval from the Food and Drug Administration.

QLaser’s website claims the products use “bio photonic energy that actually communicates with the cells” to treat ailments.

The DOJ claimed Lytle had marketed his products as a treatment for diseases including cancer, AIDS and diabetes. It said the FDA had approved two of Lytle’s products for short-term pain relief in arthritis patients but had never approved them for

any other use, and there was no evidence that they were effective.

According to the October lawsuit, the FDA repeatedly told Lytle he was violating federal law, but he refused to stop selling his products.

Judge Viken said in his Jan. 14 order that the government was likely to succeed on the merits.

South Dakota U.S. Attorney Brendan Johnson said in a press release that the injunction would give consumers “a new sense of confidence.”

Lytle, who does not have an attorney, could not be reached for comment. WJ

(Reporting by Brendan Pierson)

Attorneys:Plaintiff: Camela C. Theeler, U.S. attorney’s office, Sioux Falls, S.D.

Defendant: Robert L. Lytle, Rapid City, S.D., pro se

Related Court Document: Order: 2015 WL 213170

QLaser’s website claimed the products use “bio photonic energy that actually communicates with the cells” to treat ailments, the Department of Justice said.

WESTLAW JOURNAL

HEALTH LAW

As the health litigation arena becomes more

complex, and laws and regulations keep

changing, you can rely on this reporter to provide

comprehensive coverage of the latest developments

in all aspects of the field of health care law. Each issue details cases and legislation regarding

such topics as hospital billing, health insurance disputes, health provider contracts, malpractice,

legislation such as EMTALA, ERISA, and

HCQIA, abortions, medical devices, pharmaceuticals and vaccines, diet drugs, medical marijuana, AIDS,

the duty of care and confidentiality.




The ruling follows Judge Seabright’s April 2014 decision in the product liability suit, in which he granted Medtronic’s dismissal motion but allowed Beavers-Gabriel to file an amended complaint. Beavers-Gabriel v. Medtronic Inc. et al., 15 F. Supp. 3d 1021 (D. Haw. 2014) (see Westlaw Journal Medical Devices, Vol. 21, Iss. 5, 21 No. 5 WJMEDDEV 5).

Beavers-Gabriel alleges that during her 2008 spinal operation her surgeon used the Infuse device in an “off label” manner not specified by U.S. Food and Drug Administration labeling.

The FDA’s approval of the Infuse system is limited to anterior lumbar interbody fusion, or ALIF, surgeries, according to the judge’s order. The device consists of a sponge-like pad soaked with a bone-growth-promoting protein, rhBMP-2, and placed inside a Medtronic metallic screen-like enclosure called the LT-Cage.

Beavers-Gabriel says that, at the suggestion of Medtronic sales representatives, her surgeon instead placed rhBMP-2 both inside and outside cages made by other companies and failed to use the anterior approach, operating from the front of the body, as the FDA required.

The off-label use of the device caused uncontrolled bone growth and spinal nerve damage, she says.

Her amended complaint asserted causes of action for fraudulent misrepresentation, fraud by omission, negligent misrepresentation, strict product liability for failure to warn the FDA, negligent failure to warn the FDA and breach of express warranty.

Medtronic moved for dismissal, again alleging federal preemption and lack of

plausible claims. Judge Seabright denied the motion and allowed the suit to proceed.

The judge called “misdirected” Medtronic’s assertion that Beavers-Gabriel’s fraud-by-omission claim was an attack on Infuse’s FDA-approved labeling, which the company said did, in fact, warn that off-label surgical procedures could cause unwanted bone growth.

Those materials typically directed surgeons to off-label uses, since Graham does not perform ALIF procedures, the judge said. Beavers-Gabriel also says that Graham relied on Cloward, who attended nearly every procedure in which he used Infuse, to provide updated dosing rates for off-label Infuse surgeries.

Beavers-Gabriel claims that Cloward gave dosing suggestions even though “there is insufficient evidence on proper dosages of rhBMP-2 for use in unapproved procedures.”

Judge Seabright also decided that Beavers-Gabriel sufficiently claims that Medtronic’s failure to report off-label-related adverse events to the FDA caused her harm in the long run. With Medtronic keeping such data from the FDA, the judge said, surgeons like Graham chose Infuse based partially on incomplete FDA information.

He said the plaintiff does not need to provide evidence of specific Medtronic reporting failures because the information she offers sufficiently indicates there were general reporting lapses.

“Thus, these allegations suggest that Medtronic’s alleged widespread failure to report adverse events to the FDA contributed to Dr. Graham’s decision to use the Infuse device for the plaintiff’s surgery,” Judge Seabright said. WJ

Attorneys:Plaintiff: Marlene J. Goldenberg and Stuart L. Goldenberg, GoldenbergLaw, Minneapolis; Wayne D. Parsons, Honolulu

Defendant: Corlis J. Chang and Thomas Benedict, Goodsill Anderson Quinn & Stifel, Honolulu; Lisa M. Baird and Michael K. Brown, Reed Smith, Los Angeles

Related Court Document:Order: 2015 WL 143944

See Document Section A (P. 19) for the order.

Bone-growth deviceCONTINUED FROM PAGE 1

The judge said the plaintiff sufficiently claims that

Medtronic’s failure to report off-label-related adverse events to the FDA caused her harm in the long run.

The claims, Medtronic said, impermissibly challenge the label’s sufficiency.

Beavers-Gabriel’s fraud-by-omission claim, the judge said, is not aimed at Infuse’s labeling. Instead, it targets Medtronic’s alleged failure to disclose relevant information on the off-label use of Infuse to the FDA and her surgeon, Dr. Jon Graham.

Judge Seabright said the fraud claim can proceed because it does not challenge the device’s labeling.

“Indeed, the representations and omissions plaintiff has identified are not directed to labeling, but rather directed to the statements and omissions Medtronic has made outside of the labeling and in promoting the Infuse device for off-label purposes (and after the labeling was approved),” the judge said.

He noted that Beavers-Gabriel has data to support her negligent-misrepresentation claim through her allegation that Medtronic representative Geoff Cloward responded to Graham’s request for literature on Infuse with subjective promotional materials.


NEWS IN BRIEF

BREAST CANCER PATIENT SAYS INFECTION CAUSED MEMORY LOSS

A breast cancer patient alleges in Oregon state court that an infected tissue expander device caused her to suffer permanent disfigurement and memory loss. The suit says physicians at Oregon Health and Sciences University failed to recognize the severity of Kathleen S. Houck’s infection and provide necessary treatment. Houck, who was diagnosed with breast cancer in January 2011, underwent chemotherapy treatment and surgery to implant a tissue expander device. The expander became infected and caused Houck pain, and OHSU physicians performed six corrective surgeries to clean the expander before removing it entirely, the suit says. Houck alleges the lingering infection caused her to develop cellulitis and a painfully tight scar. She seeks $590,000 in economic damages for medical expenses and lost income, plus $409,000 for pain and suffering.

Houck v. Oregon Health and Sciences University et al., No. 15-CV-00043, complaint filed (Or. Cir. Ct., Multnomah County Jan. 2, 2015).

Related Court Document:Complaint: 2015 WL 40468

FDA APPROVES FIRST GLUCOSE MONITORING MOBILE APP

The U.S. Food and Drug Administration has approved Dexcom Inc.’s Dexcom Share glucose monitoring mobile app, allowing people with diabetes to quickly share data from a blood sugar monitoring device with a doctor or other medical professional. In a Jan. 23 announcement the FDA said that while similar units are on the market, the Dexcom Share is the first to receive the agency’s certification. The externally worn unit uses a small sensor, implanted just under the skin, to provide a stream of data on the user’s glucose levels. The regular reporting allows patients to quickly determine if their blood sugar rates are out of range and must be adjusted. The system does not replace the need for real-time or standard, at-home blood glucose meters, the FDA said.

MINORS SHOULD LIMIT USE OF BONE GROWTH SUBSTITUTES, FDA SAYS

People under age 18 should not routinely receive treatment using bone graft substitutes that contain synthetic peptides or recombinate proteins, the U.S. Food and Drug Administration said in a Jan. 21 statement. The agency said that while the use of such devices has caused excess bone growth, fluid accumulation and inhibited healing in adults, the issues are more critical in those under 18, who are smaller and whose bones are still growing. Any product that affects bone growth could have a negative impact on skeletal growth by altering normal bone formulation and growth, the FDA said. Potential problems include the tightening of bone clearances around the spinal cord.

WESTLAW JOURNAL

HEALTH CARE FRAUD

This reporter provides up-to-date coverage of

federal civil and criminal actions involving health

care fraud. The publication features commentary

from leading health care practitioners and provides nationwide reporting on litigation and legislation

involving Medicare/Medicaid fraud, consumer fraud, nursing home fraud, False Claims Act, qui tam actions, the anti-kickback statute, misappropriation,

and breach of fiduciary duty




CASE AND DOCUMENT INDEX

Bard Peripheral Vascular Inc. et al. v. W.L. Gore & Associates Inc., No. 2014-1114, 2015 WL 151557 (Fed. Cir. Jan. 13, 2015) .......................................... 12 Document Section C ..................................................................................................................................................................................................... 37

Beavers-Gabriel v. Medtronic Inc. et al., No. 1:13-cv-00686, 2015 WL 143944 (D. Haw. Jan. 9, 2015) ...............................................................................1 Document Section A..................................................................................................................................................................................................... 19

Becker et al. v. Smith & Nephew Inc. et al., No. 2:14-cv-05452 WHW-CLW, 2015 WL 268857 (D.N.J., Jan. 20, 2015) ....................................................9

Budke v. Ethicon Inc., No. 10CM-CC00085, settlement announced (Mo. Cir. Ct., Camden County Jan 21, 2015) ............................................................6

Cisson v. C.R. Bard Inc., No. 11-195, order denying motion for new trial issued (S.D. W. Va. Jan. 20, 2015) .......................................................................8

Grey Matter Medical Products LLC v. Schreiner Group LP et al., No. 13-5861, 2015 WL 106199 (W.D. Wash., Tacoma Div. Jan. 7, 2015) .......................13

Houck v. Oregon Health and Sciences University et al., No. 15-CV-00043, complaint filed (Ore. Cir. Ct., Multnomah County Jan. 2, 2015) .................17

In re Ethicon Inc. Pelvic Repair System Products Liability Litigation, No. 2:12-md-2327, response brief filed (S.D. W. Va., Charleston Div. Jan. 22, 2015) ............................................................................................................................................................................................ 14

In re Settlement Facility Dow Corning Trust; Dow Corning Corp. et al. v. Claimant’s Advisory Committee et al., No. 14-1090, 2015 WL 348899 (6th Cir. Jan. 27, 2015) ....................................................................................................................................................... 7

McClellan v. I-Flow Corp. et al., No. 11-35109, 2015 WL 294292 (9th Cir. Jan. 23, 2015) ................................................................................................. 10

United States v. 2035 Inc. et al., No. 5:14-cv-5075, 2015 WL 213170 (D.S.D., W. Div. Jan. 14, 2015) .............................................................................. 15

Webb v. Ethicon Endo-Surgery Inc., No. 13-1947, 2015 WL 317215 (D. Minn. Jan. 26, 2015) ............................................................................................ 11 Document Section B ......................................................................................................................................................................................................31

Westlaw Journal

Documents

Transcript of Westlaw Journal