UNITED STATES DISTRICT COURT 

NORTHERN DISTRICT OF INDIANA

SOUTH BEND DIVISION

LESLIE CACCIA and )

ALLISON CACCIA, )

)

Plaintiffs )

)

vs. ) CAUSE NO. 3:13-CV-73 RLM

)

BIOMET, INC., et al., )

)

Defendants )

OPINION and ORDER

This cause is before me on the motion of Biomet, Inc. and Biomet

Orthopedics, LLC (collectively, Biomet) to dismiss the plaintiffs’ complaint in its

entirety under Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim.1

Biomet also asks me to take judicial notice of documents submitted in support of

its motion. In response, Leslie and Allison Caccia ask me to convert the motion to

dismiss to one for summary judgment based on Biomet’s reliance on the exhibits

it attached to the motion to dismiss, and then defer ruling on the summary

judgment motion until they have had a reasonable opportunity to conduct

necessary discovery. Oral argument was held on June 17, and I took the matter

under advisement. Having reviewed the parties’ submissions and arguments, I

deny the motion to dismiss and the parties’ related requests.

1

 The Caccias’ complaint contains claims of negligence, strict products liability

(manufacturing defect, design defect, inadequate warning), breach of express warranty, breach of

implied warranty, negligent misrepresentation, violation of consumer protection laws, and loss of

consortium.
Federal Rule of Civil Procedure 12(b)(6) allows a defendant to seek dismissal

of a complaint, or a portion of a complaint, that states no claim upon which relief

can be granted. A court deciding a Rule 12(b)(6) motion must accept “the wellpleaded facts in the complaint as true, but legal conclusions and conclusory

allegations merely reciting the elements of the claim are not entitled to this

presumption of truth.” McCauley v. City of Chicago, 671 F.3d 611, 616 (7th Cir.

2011). I must draw all reasonable inferences in favor of the plaintiffs without

engaging in fact-finding. Reger Dev., LLC v. National City Bank, 592 F.3d 759, 763

(7th Cir. 2010). “To survive a motion to dismiss, a complaint must contain

sufficient factual matter, accepted as true, to ‘state a claim to relief that is

plausible on its face.’ A claim has facial plausibility when the plaintiff pleads

factual content that allows the court to draw the reasonable inference that the

defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662,

678 (2009) (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007)).

Under the pleading standard of Federal Rule of Civil Procedure 8(a), a complaint

needn’t contain “detailed factual allegations,” but the complaint’s allegations

“must be enough to raise a right to relief above the speculative level” and give the

defendant fair notice of the claims being asserted and the grounds upon which

they rest. Bell Atl. Corp. v. Twombly, 550 U.S. at 555.

Resurfacing Surgeries

2
Biomet asserts that the Caccias’ state law claims relating to Mr. Caccia’s hip

surgeries should be dismissed as preempted by the Medical Device Amendments,

21 U.S.C. § 360c et seq., to the Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et

seq. Biomet hypothesizes, and the plaintiffs seem to agree, that (i) Mr. Caccia’s hip

resurfacing surgeries (right hip, 2007; left hip, 2008) involved use of the Biomet

ReCap Femoral Resurfacing System (“ReCap System”), which, at the time of Mr.

Caccia’s surgeries, was approved by the FDA under the Investigational Device

Exemption process to be part of a clinical investigation to assess the safety and

effectiveness of the system, and (ii) Mr. Caccia wasn’t part of the IDE study of the

ReCap System. Based on that understanding, Biomet maintains the preemption

provision of the MDA and the IDE regulations bar the Caccias’ claims.

Manufacturers who want to investigate the safety and effectiveness of a new

medical device and generate the data necessary to obtain premarket approval for

the device must apply to the FDA for permission to undertake a clinical

investigation pursuant to the requirements and regulations governing IDEs. 21

U.S.C. § 360j(g)(2). “The IDE process allows a manufacturer with an experimental

device to obtain FDA approval for the device with a less rigorous review process

than usual. The purpose of the exemption is to encourage experimentation that

would lead to new developments. See 21 U.S.C. § 360j(g). In order to obtain an

IDE, a manufacturer must provide the FDA with information about, among other

things, the device, its manufacture, and the experimental plan for its use.”

3
Chambers v. Osteonics Corp., 109 F.3d 1243, 1245 (7th Cir. 1997). IDE devices

remain under the FDA’s supervision during the clinical trial process.

Biomet says the FDA evaluated and approved its ReCap System as part of

the “rigorous requirements” of the IDE process, so the numerous regulations

relating to IDE devices govern the ReCap System. See 21 C.F.R. §§ 812.1–812.150.

Thus, Biomet says, the Caccias’ state law claims relating to the system are

preempted by the express preemption provision of the MDA, which states that

no 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).

Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), established the procedure for

deciding whether state law claims are preempted: the court must determine if the

federal government has established requirements applicable to the device at issue

and, if so, whether the common-law claims are based on state law requirements

that relate to the safety and effectiveness of the device and are different from or

in addition to the federal requirements. 552 U.S. at 321-322. The Riegel Court

held that premarket approval “is specific to individual devices” and so “imposes

‘requirements’ under the MDA,” 552 U.S. at 322-323, and that reference in the

statute to a “state’s requirements” includes its common law duties. 552 U.S. at

4
324. Biomet maintains the preemption provision deemed applicable to PMA

devices in Riegel applies equally to devices approved and used pursuant to an

IDE: “[P]roduct liability claims challenging the safety and efficacy of devices

received in investigational studies are in conflict with FDA requirements and

preempted since ‘the standards implicit in the state tort actions would be different

from or in addition to those requirements of both the FDCA and the IDE

regulations.’” Memo., at 8 (quoting Gile v. Optical Radiation Corp., 22 F.3d 540,

545 (3d Cir. 1994)). 

Biomet contends that Mr. Caccia’s participation in the clinical study of the

ReCap System wasn’t required for preemption to bar his claims. Biomet says the

appropriate analysis should focus on “the FDA approval process and requirements

and not on the actions or the mindset of the physician.” Reply, at 6. Biomet relies

on Dawson v. Howmedica, Inc., 886 F. Supp. 1402 (E.D. Tenn. 1995), in which

Mr. Dawson, like Mr. Caccia, received an implant while an IDE was in place but

wasn’t a participant in the investigational study of the device. Biomet cites to the

Dawson court’s conclusion that the doctor’s “use of the device is not the focus.

Rather, the focus must be upon the extensive federal requirements to which the

[IDE device] had been subjected and the fact that plaintiffs’ claims would establish

state requirements different from or in addition to those extensive federal

requirements.” 886 F. Supp. at 1408 n.8.

Biomet also cites to Berish v. Richards Medical Co., 928 F. Supp. 185

(N.D.N.Y. 1996), involving a similar fact scenario in which Mr. Berish, like Mr.

5
Caccia, wasn’t a participant in the clinical trial of the implanted IDE device. The

Berish court, relying on Dawson v. Howmedica, agreed with the Dawson court’s

conclusion that the preemption analysis shouldn’t focus on the use of the device,

but rather on the federal requirements applied to the device in the IDE process.

928 F. Supp. at 191 (quoting Dawson, 886 F. Supp. at 1048 n.8). The Berish court

found “no support” for plaintiff’s contention that “if the doctor who performed the

procedure was not part of the IDE test study, the device is not subject to an IDE.”

928 F. Supp. at 191.

I can’t agree with Biomet’s discounting that Mr. Caccia wasn’t part of the

clinical study of the ReCap System, even when considering Dawson and Berish —

cases that aren’t binding and which I don’t find persuasive.2

 The applicable

regulations provide that the IDE process “permits a device that otherwise would

be required to comply with a performance standard or to have premarket approval

to be shipped lawfully for the purpose of conducting investigations of that device.”

21 C.F.R. § 812.1(a). The regulations contain “procedures for the conduct of

2

 The other cases Biomet relies on to support its claim that preemption should bar the

Caccias’ state law claims are distinguishable – those cases involved plaintiffs who were participants

in the IDE clinical studies of the devices at issue. See, e.g., Martin v. Telectronics Pacing Sys., Inc.,

105 F.3d 1090 (6th Cir. 1997) (plaintiff was part of investigational study); Gile v. Optical Radiation

Corp., 22 F.3d 540 (3d Cir. 1994) (same); Slater v. Optical Radiation Corp., 961 F.2d 1330 (7th Cir.

1992) (same); Blinn v. Smith & Nephew Richards, Inc., 55 F. Supp. 2d 1353 (N.D. Fla. 1999)

(plaintiff was part of clinical trial and signed consent form acknowledging same); Chmielewski v.

Stryker Sales Corp., 966 F. Supp. 839, 841 (D. Minn. 1997) (“In accordance with FDA

requirements for IDEs, plaintiff signed an informed consent form prior to surgery.”); Hunsaker v.

Surgidev, 818 F. Supp. 744 (M.D. Pa. 1992) (plaintiff was participant in clinical study); Burgos v.

Satiety, Inc., No. 10-CV-2680, 2010 WL 4907764 (E.D.N.Y. Nov. 30, 2010) (plaintiff part of IDE

clinical trial); Touchet v. Ace Medical Co., No. Civ. A 96-3534, 1998 WL 531887 (E.D. La. Aug. 24,

1998) (same).

6
clinical investigations of [IDE] devices,” 21 C.F.R. § 812.1(a), applicable “to all

clinical investigations” of those devices. 21 C.F.R. § 812.2(a). The regulations

further define an “investigational device” as a device “that is the object of an

investigation,” 21 C.F.R. § 812.3(g); an “investigation” as “a clinical investigation

or research involving one or more subjects to determine the safety or effectiveness

of a device,” 21 C.F.R. § 812.3(h); and a “subject” as “a human who participates

in an investigation, either as an individual on whom or on whose specimen an

investigation device is used or as a control.” 21 C.F.R. § 812.3(p). The regulations

contain specifics for conducting and monitoring the clinical trial, maintaining

records of the use of the device in the trial, permitting inspections by the FDA of

the device and records of the study, and preparing progress and final reports

addressing all aspects of the approved investigation. 21 C.F.R. §§ 812.40-812.150.

While the IDE regulations exempt an approved device from complying with certain

FDA requirements, those exemptions apply to devices approved for use in clinical

investigations. See 21 C.F.R. § 812.1(a).

The FDA approved Biomet’s ReCap System under the IDE process for use

in a specific clinical trial to determine the device’s safety and effectiveness. 21

U.S.C. § 360j(g); 21 C.F.R. § 812.1 et seq. Use of the ReCap System outside the

controlled study, i.e., without proper monitoring, record-keeping, and FDA

oversight, wouldn’t advance the aims of the clinical trial. A clinical study “is not

worthwhile if it is not conducted using agreed-upon standards and procedures.

The results of an uncontrolled experiment would not be a reliable indicator of the

7
usefulness and safety of the proposed device, defeating the reason for granting the

IDE in the first place.” Chambers v. Osteonics Corp., 109 F.3d 1243, 1248 (7th

Cir. 1997); see also In re Orthopedic Bone Screw Products Liability Litigation, No.

MDL 1014, 1999 WL 33740509, at *3 (E.D. Pa. Jan. 11, 1999) (An investigational

device “may not be promoted for commercial distribution or test marketed outside

the IDE.” (citing 21 C.F.R. § 812.7(a)); In re Orthopedic Bone Screw Products

Liability Litigation, No. MDL 1014, 1996 WL 221784, at *2 (E.D. Pa. Apr. 8, 1996)

(approval of an investigational device “does not amount to FDA approval to market

the device to the general public”).

The PMA process imposes specific requirements applicable to a device for

preemption purposes, see Riegel v. Medtronic, Inc., 552 U.S. at 322-323

(“[P]emarket approval is specific to individual devices. And it is in no sense an

exemption from federal safety review – it is federal safety review.”), but in the IDE

process, the FDA doesn’t make any finding that the device provides a reasonable

assurance of safety and effectiveness; the IDE process allows an investigation to

evaluate and determine the safety and effectiveness of a device and imposes

requirements for use of the device in the approved study – requirements that

wouldn’t apply to devices used outside the study. See English v. Mentor Corp., 67

F.3d 477, 480 (3d Cir. 1995) (“The FDA had initially granted an Investigational

Device Exemption to Mentor, permitting it to test its prosthesis on human

subjects; [plaintiff], however, did not receive a device as part of an IDE test study

and thus Mentor cannot rely on IDE regulations in support of its argument that

8
[plaintiff’s] state tort claims are preempted.”), vacated on other grounds, 518 U.S.

1030 (1996). The parties have agreed that Mr. Caccia didn’t receive the ReCap

System as part of the clinical trial of the device; it would be a reasonable inference

that the components used in Mr. Caccia’s resurfacing surgeries were available to

his doctor via the 510(k) notification process. Thus, 21 U.S.C. § 360k(a) wouldn’t

exempt the Caccias’ state law claims. See Lohr v. Medtronic, Inc., 518 U.S. 470,

493-494 (1996) (Section 510(k) premarket notification process imposes no

“requirements” specific to the device). 

I’m not persuaded that a manufacturer that obtains IDE status for a device

to be used in a controlled investigational setting is, during the time the study is

being conducted, exempt from liability for use of that device outside the clinical

trial. Pursuant to the IDE, the manufacturer is charged with use of the device in

a controlled setting to gather information and statistics to determine the safety

and effectiveness of the device – use outside the study wouldn’t advance the

purpose of the clinical trial or provide the information necessary for a reliable

determination of the safety and effectiveness of the device. Because Mr. Caccia

didn’t receive the ReCap System as part of the IDE study, Biomet can’t rely on the

IDE regulations to support its claim that the Caccias’ state claims are preempted.

See McMullen v. Medtronic, Inc., No. 2:03-CV-5, 2004 WL 2538642, at *4 n.3

(S.D. Ind. Sept. 16, 2004) (“But under 21 C.F.R. § 812.2(a), IDE regulations apply

only, with certain enumerated exceptions inapplicable to this case, to clinical

investigations of devices to determine safety and effectiveness of which Mr.

9
McMullen was not a participant.”). Biomet’s request to dismiss the Caccias’ state

law claims relating to Mr. Caccia’s resurfacing surgeries must be denied.

Hip Replacement Surgeries

Biomet also seeks dismissal of the Caccias’ state law claims concerning Mr.

Caccia’s hip replacement arthroplasties – surgeries the parties say involved

retention of the M2a-Magnum Acetabular Shell and replacement of the ReCap

Femoral Resurfacing Component with a Taperloc femoral stem and an M2aMagnum modular head – based on preemption because, Biomet says, the FDA

“evaluated the ReCap Femoral Resurfacing Component and the M2a-Magnum

Acetabular Shell as part of the rigorous requirements of an Investigational Device

Exemption to study the ReCap Femoral Resurfacing System.” Memo., at 1-2.

Biomet notes that the M2a-Magnum PF Cups used in Mr. Caccia’s resurfacing

procedures weren’t removed or replaced during the second surgeries and claims

that even though different components (i.e., the Taperloc femoral stem and the

M2a-Magnum Modular Head) were substituted into the hip replacement systems

in the second surgeries, those new components served the same purpose as those

removed. Biomet concludes that because the M2a-Magnum PF Cups that had

been “implanted and evaluated for their performance with other components

during the IDE remained in [Mr. Caccia] throughout all times relevant to this

lawsuit . . . those components should also be covered by preemption.” Reply, at

4-5; see also Memo., at 10-11.

10
I can’t agree with Biomet’s argument that the law affords different

preemption status to individual parts of a total system or, as in this case, coupling

one component (the M2a-Magnum PF Cup) of an IDE-approved device (the ReCap

System) with other components (the Taperloc femoral stem and the M2a-Magnum

Modular Head) to create a different system – the M2a-Magnum Hip Replacement

System – converts the second system’s status to IDE status for preemption

purposes. In fact, I addressed that scenario with defense counsel at the hearing

on the motion to dismiss:

THE COURT: So your position is, any component that’s within the

IDE, there’s preemption for use of it, even outside the

study and even outside the system?

MR. WINTER: No, Your Honor. It’s as a system. . . . So when you

combined those two to create the ReCap System that is

subject to the IDE, that creates preemption. If you had

just taken the resurfacing piece and didn’t put in a cup,

that would be a 510(k) use not entitled to preemption.

But it’s when you put the system together . . . when it’s

a combination of the two different components and that

makes up a product that you want to get PMA clearance

by an IDE, preemption applies, so you have to use them,

the system, together.

Hrg. Tr. [docket # 43], at 5-6. 

“To require that a distinction be drawn between the approval process of the

individual components of a system and the system itself, would, it seems, add a

level of complication to the medical device approval process not anticipated by

Congress, the FDA, or medical device manufacturers.” Lewkut v. Stryker Corp.,

724 F. Supp. 2d 648, 656 (S.D. Tex. 2010). “It makes no sense – indeed, it would

11
probably be impossible – to pick apart the components of a medical device and

apply different preemption analyses to different components.” Riley v. Cordis

Corp., 625 F. Supp. 2d 769, 780 (D.Minn. 2009); see also Gross v. Stryker Corp.,

885 F. Supp. 2d 466, 487 (W.D. Penn. 2012) (“[T]he focus remains on the

approved device and whether plaintiff’s claims challenge the effectiveness of the

approved device.”). I deny Biomet’s request for preemption of the Caccias’ claims

relating to the M2a-Magnum Hip Replacement System based on the IDE status

of one component of that total hip replacement system.

Conclusion

Based on the foregoing, I DENY Biomet’s motion to dismiss the entirety of

the Caccias’ complaint on preemption grounds [docket # 10], DENY Biomet’s

request to take judicial notice of the exhibits to their motion, and DENY as

unnecessary the Caccias’ request to convert this motion to one for summary

judgment.

SO ORDERED.

ENTERED: August 21, 2013 

 /s/ Robert L. Miller, Jr. 

Judge, United States District Court

12