Brian Howard v. Sulzer Orthopedics, Inc.

NOT RECOMMENDED FOR FULL-TEXT PUBLICATION
File Name: 10a0367n.06

No. 09-3406 FILED
Jun 16, 2010
UNITED STATES COURT OF APPEALS LEONARD GREEN, Clerk
FOR THE SIXTH CIRCUIT

BRIAN C. HOWARD, )
)
Plaintiff-Appellant, )
)
v. ) ON APPEAL FROM THE UNITED
) STATES DISTRICT COURT FOR
SULZER ORTHOPEDICS, INC., fka Centerpulse ) THE NORTHERN DISTRICT OF
Orthopedics, Inc., nka Zimmer Austin, Inc.; SULZER ) OHIO
MEDICA USA HOLDING CO.; SULZER MEDICA )
USA INC., )
)
Defendants-Appellees. )
)
)
)

Before: GUY, CLAY, and KETHLEDGE, Circuit Judges.

KETHLEDGE, Circuit Judge. Plaintiff Brian C. Howard, M.D. appeals the district court’s

order granting summary judgment, on preemption grounds, in favor of defendant Sulzer Orthopedics,

Inc. (Sulzer) on their negligence per se claim. Howard argues that Sulzer failed to comply with

certain Food and Drug Administration (FDA) regulations when it manufactured a knee implant that

failed in Howard’s body. Howard also argues that the court erred when it refused to transfer his case

back to the Northern District of Oklahoma—which is where he filed it—because in his view the

Ohio district court lacked personal jurisdiction over him. Although Howard’s jurisdictional claim

is meritless, we conclude that the district court erred when it found that Howard’s negligence per se

claim was preempted. We therefore vacate and remand for further proceedings on Sulzer’s

summary-judgment motion.
No. 09-3406
Howard v. Sulzer Orthopedics, Inc.

Sulzer designs, manufactures, and distributes orthopedic joint implants. For one such device,

the “Inter-Op acetabular shell” (Inter-Op) hip implant, originally the company first machined the

metal implant parts, and then applied a porous coating to assist bonding between the device and the

patient’s bone. Sulzer thereafter switched these steps, applying the porous coating first, and then

machining the parts. Unbeknownst to Sulzer, however, this new process left lubricating machine

oil on the implants. Although Sulzer used an FDA-approved cleaning process for each device, the

process failed to remove the oily residue that the new manufacturing process left behind. As a result,

thousands of patients’ Inter-Op shells failed to bond with the bone. Sulzer discovered the problem

and voluntarily recalled about 40,000 of the implants.

The problem was not limited to the Inter-Op shell. Sulzer discovered that it had also used

the new manufacturing process for some “Natural Knee II Tibial Baseplate” (NK-II) implants.

Consequently, Sulzer instituted another recall. For both the Inter-Op shell and the NK-II, thousands

of patients underwent “revision surgery” to replace the defective implants.

Litigation followed. As a patient whose NK-II failed, Howard sued Sulzer in the United

States District Court for the Northern District of Oklahoma. The Judicial Panel on Multidistrict

Litigation thereafter transferred all the federal cases, including Howard’s, to the Northern District

of Ohio for multi-district-litigation (MDL) pre-trial proceedings. After identifying which implants

had been manufactured with the new process (the “affected lots”), Sulzer entered into a settlement

agreement with patients who had received them. The district court approved the settlement.

Howard’s case was excluded from the settlement because his device was not in an affected

lot. He alleged nonetheless that oily residue caused his NK-II implant to fail. Sulzer responded with

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a motion for summary judgment, which argued that Howard’s claims were preempted. The motion

was based upon the NK-II’s Premarket Approval (PMA) application. For any Class III medical

device, like a knee implant, the PMA prescribes the manufacturer’s obligations in manufacturing and

distributing the device. Sulzer contended that it met all those obligations with regard to Howard’s

device, which rendered his claims preempted.

The district court agreed with Sulzer as to most of Howard’s claims: for strict liability,

negligence, breach of implied and express warranty, and deceit. The court initially determined that

there was no preemption for Howard’s negligence per se claim, however, because that claim was

based on allegations that Sulzer failed to comply with FDA manufacturing requirements that the

PMA incorporated. See In re Sulzer Hip Prosthesis and Knee Prosthesis Liab. Litig., 455 F. Supp.

2d 709, 716 (N.D. Ohio 2006).

Sulzer renewed its summary-judgment motion on the negligence per se claim after further

discovery. It argued that Howard lacked evidence creating a genuine fact issue that Sulzer violated

any FDA requirement. Howard presented several theories as to how Sulzer violated FDA

requirements, including that his NK-II actually was part of an affected lot, and that Sulzer did not

follow the manufacturing process outlined in the NK-II PMA when it made Howard’s implant. To

support these theories, Howard presented, in part, a chemical test on his implant that showed “at least

two or more hydrocarbon components that are normally associated with mineral oil.” Howard also

submitted expert affidavits that purported to explain how Sulzer had deviated from the

manufacturing steps outlined in the PMA. The court rejected most of these theories as unsupported

by the evidence, finding no genuine issue as to whether Sulzer had followed (and documented) the

processes mandated by the PMA when it made Howard’s implant.

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Howard v. Sulzer Orthopedics, Inc.

Howard’s last theory presented a closer case. He argued that the NK-II PMA required Sulzer

to follow not only the specific manufacturing steps it listed, but also the more general Good

Manufacturing Practices (GMPs) that the PMA incorporated. The GMPs are FDA regulations based

upon manufacturing standards that apply to all FDA-regulated medical devices. See generally 21

C.F.R. § 820. They require, among other things, a process to remove manufacturing materials like

lubricating oil. Sulzer responded that the GMPs, although incorporated into the PMA, did not

require it to take any steps beyond the specific steps outlined elsewhere in the PMA; and Sulzer said

it followed those steps.

The district court agreed with Sulzer, finding that the GMPs imposed no additional

obligations other than those otherwise spelled out in the PMA. That meant Howard’s claim did

impose obligations beyond those in the PMA, and was therefore preempted. So the court granted

summary judgment on Howard’s negligence per se claim. The court also denied Howard’s motion

to transfer his case back to the Northern District of Oklahoma.

This appeal followed.

II.

We review de novo a district court’s grant of summary judgment, viewing the evidence in

the light most favorable to the nonmoving party. Upshaw v. Ford Motor Co., 576 F.3d 576, 584 (6th

Cir. 2009). Summary judgment is appropriate when “the pleadings, the discovery and disclosure

materials on file, and any affidavits show that there is no genuine issue as to any material fact and

that the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(c).

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Howard v. Sulzer Orthopedics, Inc.

The Medical Device Amendments of 1976 (MDA) to the Food, Drug and Cosmetic Act

contain an express preemption clause:

[N]o State or political subdivision of a State may establish or continue in effect with
respect to a device intended for human use any requirement—

(1) which is different from, or in addition to, any requirement applicable under
this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other
matter included in a requirement applicable to the device under this chapter.

21 U.S.C. § 360k(a) (emphasis added).

The Supreme Court has interpreted § 360k(a) to preempt most common-law tort duties.

Riegel v. Medtronic, Inc., 552 U.S. 312, 323-25 (2008). The Court’s reasoning was that state-law

tort suits would interfere with the requirements that the FDA imposed for a particular device through

the extensive PMA process for Class III devices like knee implants. That holding applies, however,

“only to the extent that [the state-law requirements] are ‘different from, or in addition to’ the

requirements imposed by federal law.” Riegel, 552 U.S. at 330 (quoting 21 U.S.C. § 360k(a)(1)).

“Thus, § 360k does not prevent a State from providing a damages remedy for claims premised on

a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal

requirements.” Id.

Here, Howard argues that, even if Sulzer followed the specific manufacturing steps outlined

in the PMA, the PMA itself incorporated the GMP standards, which in turn imposed additional

requirements. Sulzer tries to head this argument off at the pass, arguing that the GMPs are “simply

too generic, standing alone, to serve as the basis for Plaintiffs’ manufacturing-defect claims.” See

In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F. Supp. 2d 1147, 1157 (D. Minn.

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2009).

The Spring Fidelis opinion—on which Sulzer relies—cites the FDA’s final rulemaking for

the GMPs, which states that, “[b]ecause this regulation must apply to so many different types of

devices, the regulation does not prescribe in detail how a manufacturer must produce a specific

device.” Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality

System Regulation, 61 Fed. Reg. 52,602, 52,603 (Oct. 7, 1996). But the alleged violations in Sprint

Fidelis were different from the ones here; and moreover the plaintiff there did not even identify a

specific GMP that he thought had been violated. Howard, in contrast, has done that; and, as we

explain below, the particular GMP that he cites is not so vague as to be incapable of enforcement.

We thus reject Sulzer’s argument that the relevant GMP is categorically unenforceable here.

We turn to that GMP. It provides:

Manufacturing material. Where a manufacturing material could reasonably be
expected to have an adverse effect on product quality, the manufacturer shall
establish and maintain procedures for the use and removal of such manufacturing
material to ensure that it is removed or limited to an amount that does not adversely
affect the device’s quality. The removal or reduction of such manufacturing material
shall be documented.

21 C.F.R. § 820.70(h) (emphasis added).

It is undisputed that lubricating oil falls within the definition of manufacturing material. See

21 C.F.R. § 820.3(p). Howard argues that the presence of “hydrocarbon components that are

normally associated with mineral oil” on his NK-II means that Sulzer failed to “ensure” that it had

removed manufacturing material in compliance with § 820.70(h). Sulzer responds that it followed

the PMA-prescribed process for removing machining oil, which in its view was all that § 820.70(h)

required.

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The question, then, is whether this subsection requires compliance with a validated cleaning

process, or whether it also requires a specific result: namely, actual removal. The district court held

that only compliance with the cleaning process was required.

Facially, at least, § 820.70(h) can be read either way. On the one hand, it states that “the

manufacturer shall establish and maintain procedures” to clean the devices—which favors Sulzer’s

interpretation. On the other, it says that the procedures should “ensure that [manufacturing material]

is removed or limited to an amount that does not adversely affect the device’s quality.” See 21

C.F.R. § 820.70(h) (emphasis added). That language suggests that actual removal is required.

An agency’s interpretation of its own regulation controls unless “plainly erroneous or

inconsistent with the regulation.” See Auer v. Robbins, 519 U.S. 452, 461 (1997) (internal quotation

marks and citation omitted). Neither of the proposed interpretations here would fall outside those

bounds. But we do not have the benefit of the FDA’s interpretation of these regulations. So we do

the best we can with what we have.

What we have are the FDA’s comments in its final rulemaking and some FDA “guidance

documents” that generally discuss the GMPs. The comments imply that actual removal is required.

One comment states: “[Section 820.70(h)] only requires that the fact that manufacturing material

was removed or reduced be documented, not how much was removed.” 61 Fed. Reg. at 52,629

(emphasis added). An illustration in the commentary agrees: “For example, some components, such

as natural rubber latex, contain allergenic proteins that must be reduced or removed from the finished

devices.” Id. at 52,610 (emphasis added).

The guidance documents point the same way. Although they speak repeatedly of the need

to establish processes, they include language implying that actual removal is necessary as well. For

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example, one such document states:

When manufacturing materials such as oils . . . are used on or in equipment,
manufacturers should:
• provide written procedures for the use and removal of materials; and
• remove the material or limit it to a safe amount;
• document the removal.

Medical Device Quality Systems Manual: A Small Entity Compliance Guide, HHS. Pub. FDA 97-

4179, at 7-4 (Dec. 1996) (emphasis added).

In light of these materials, the better reading of this provision—so far as we can tell—is that

it requires actual removal. Sulzer suggests, not unreasonably, that this reading renders it liable even

in circumstances where it complied fully with the specific cleaning process approved by the FDA.

But the risk of a defective device must fall somewhere. We would not think it irrational for the FDA

to assign that risk to that party that actually can do something to minimize it—like preventing oil

from getting on a device in the first place—rather than assign the risk to the party that cannot. And

if the FDA may require a manufacturer to keep a device oil-free, a state may provide a damages

remedy for violations of an identical state requirement. See Riegel, 552 U.S. at 330. So we adhere

to our reading of this provision.

We do not suggest, however, that our reading is definitive. The provision, as we say and as

the dissent illustrates, can reasonably be read either way. Our decision in this appeal, however, is

to reverse the district court’s preemption holding on the negligence per se claim because the GMPs

required Sulzer to actually remove machine oil.

We address several housekeeping concerns for purposes of remand. First, we agree with

Sulzer that Howard’s experts are not competent to testify to legal conclusions about what the GMPs

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require. See Berry v. City of Detroit, 25 F.3d 1342, 1354 (6th Cir. 1994). We therefore do not rely

on those conclusions in our analysis. Nor do we endorse the experts’ suggestion that Sulzer was

required to test Howard’s implant (and everyone else’s) using “destructive” testing that would have

rendered the device useless.

Third, since the district court granted summary judgment on preemption grounds alone, it did

not reach the question whether Howard had actually created a genuine issue that oil was left on his

device. We likewise do not reach that issue in this appeal. We also leave it to the district court to

consider Sulzer’s alternative ground for summary judgment: namely, whether Oklahoma law

recognizes a negligence per se action based on violations of FDA regulations. All that we decide

today, rather, is that Howard’s negligence per se claim for GMP violations is not preempted.

Howard argues that the court’s refusal to transfer the case back to the Oklahoma district court

violated due process. In his view, the Ohio court lacked personal jurisdiction over him because he

did not have sufficient “minimum contacts” with Ohio. He contends that due process requires that

he have the opportunity to “opt out” of the MDL procedure, just as absent class plaintiffs can opt out

of a class action suit under Phillips v. Shutts, 472 U.S. 797 (1985).

Howard’s argument is meritless. As an initial matter, “Congress could provide for service

of process anywhere in the United States.” Mississippi Publ’g Corp. v. Murphree, 326 U.S. 438, 442

(1946). The MDL statute (28 U.S.C. § 1407) is, in fact, legislation “authorizing the federal courts

to exercise nationwide personal jurisdiction.” In re “Agent Orange” Prod. Liab. Litig., 818 F.2d

145, 163 (2d Cir. 1987); see also In re FMC Corp. Patent Litig., 422 F. Supp. 1163, 1165 (J.P.M.L.

1976) (“Transfers under Section 1407 are simply not encumbered by considerations of in personam

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jurisdiction and venue. . . . Following a transfer, the transferee judge has all the jurisdiction and

powers over pretrial proceedings in the actions transferred to him that the transferor judge would

have had in the absence of transfer”). Contacts with the United States, and not a particular state, are

what matters in federal court.

Here, the transferor court in the Northern District of Oklahoma had personal jurisdiction over

Howard, and through § 1407 the Northern District of Ohio did as well. The district court did not err

in refusing to transfer the case back to the Northern District of Oklahoma.

***

We reverse the district court’s preemption holding on the negligence per se claim, vacate its

grant of summary judgment, and remand the case for proceedings consistent with this opinion.

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RALPH B. GUY, JR., Circuit Judge, dissenting. I depart from the majority

because I believe the Good Manufacturing Practices (GMPs) set forth in 21 C.F.R. §

820.70(h) and incorporated into the FDA’s Premarket Approval (PMA) for the NK-II implant

should not be interpreted as establishing a “requirement” of “actual removal” upon which a

negligence per se claim may be predicated. The Supreme Court in Riegel found that the

FDA’s premarket approval of a Class III medical device imposed device-specific

requirements, and that such requirements would preempt state common-law claims to the

extent that the state requirements “are ‘different from, or in addition to’ the requirements

imposed by federal law.” Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008) (quoting 21

U.S.C. § 360k(a)). That also means that § 360k(a) will not bar a state-law remedy premised

upon violation of federal regulation if “the state duties in such a case ‘parallel,’ rather than

add to, federal requirements.” Id. (citation omitted). Thus, plaintiff’s remaining negligence

per se theory premised upon an alleged violation of § 820.70(h), may escape preemption if

it is based on duties that are “parallel” to the FDA’s federal requirements for the NK-II

implant.

The PMA for the NK-II implant imposed extensive device-specific requirements

concerning design, manufacture, quality control, and marketing. Each step of the

manufacturing process was detailed—including providing procedures and protocols for at

least six different cleaning processes. As the district court found, the PMA application

specified the cleaning procedures to be used for the removal of “manufacturing materials”

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such as machine oil. Plaintiff was unable to show that Sulzer failed to comply with the

PMA’s procedures and protocols, and a common-law claim for failure to use a different

cleaning method would be preempted. What remains is plaintiff’s claim that, irrespective of

whether Sulzer complied with the approved device-specific procedures for cleaning the NK-

II implant, Sulzer’s statement in the PMA application that it would comply with the GMPs

for all medical devices established a federal requirement that it actually remove any

manufacturing materials that “could reasonably be expected to have an adverse effect on

product quality.” 21 C.F.R § 820.70(h) (“Subpart G—Production and Process Controls”).

The pertinent language from § 820.70(h), which bears repeating, states that “the

manufacturer shall establish and maintain procedures for the use and removal of such

manufacturing material to ensure that it is removed or limited to an amount that does not

adversely affect the device’s quality.” As the majority opinion illustrates, this language is

susceptible to more than one interpretation. In my view, however, § 820.70(h) should not

be interpreted to both require procedures and mandate outcomes. It would be another story

if the regulation said “and ensure” rather than “to ensure”; but it does not. See also Medical

Device Quality Systems Manual, HHS. Pub. No. 97-4179, at 7-4 (“Section 820.70(h) requires

a written procedure for the use and removal of manufacturing materials that can have an

adverse effect on devices.”). Nor do the references to “removal” in the FDA’s comments and

guidance document persuade me otherwise because removal (or reduction) of such materials

is plainly the object of the procedures which are explicitly required by § 820.70(h). This

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view is also consistent with the requirements of other Quality System Regulations that make

up the GMPs for a broad range of medical devices (“Part 820–Quality System Regulation”).

In the absence of a more explicit indication that § 820.70(h) requires “actual removal,” I

would affirm the judgment of the district court.

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