United States Court of Appeals,

Fifth Circuit.

No. 96-30307.

Dorothy Marie REEVES, Plaintiff-Appellee-Cross-Appellant,

Randy J. Ungar, Intervenor,

v.

ACROMED CORP. et al., Defendants-Appellants-Cross-Appellees.

Jan. 20, 1997.

Appeal from the United States District Court for the Eastern District of Louisiana.

Before KING, JOLLY and DENNIS, Circuit Judges.

DENNIS, Circuit Judge:

This is the second appeal arising from a products liability

action filed by the plaintiff-appellee, Dorothy Marie Reeves

("Reeves"), alleging that a metal bone implant manufactured and

marketed by the defendant-appellant, AcroMed Corporation

("AcroMed") aggravated and compounded her back injuries. In the

first appeal this court vacated the district court's judgment in

favor of Reeves based on a jury verdict awarding her damages of

$475,000 against AcroMed and remanded the case for retrial. Reeves

v. AcroMed Corporation,

(5th Cir. 1995), cert. denied,

--- U.S. ----,

,

(1995)("Reeves I").

After retrial, the district court rendered judgment in favor of

Reeves against AcroMed and Dr. Arthur Steffee ("Steffee"), chairman

of AcroMed and inventor of the metal bone implant, implementing a

1 jury award to Reeves of $318,000 in damages. We affirm the

judgment against AcroMed but reverse it insofar as it affects

Steffee. Reeves' unreasonably dangerous per se claim is not

preempted by the Medical Device Amendments of 1976 to the Food,

Drug, and Cosmetic Act. 21 U.S.C. § 360k(a). Under the law of this

case established in Reeves I we will not reexamine whether Reeves'

unreasonably dangerous per se claim should have been presented to

the jury. Steffee was not a manufacturer of the metal bone implant

because he personally did not place the product on the market or

introduce it into the stream of commerce.

BACKGROUND

In December 1985, the plaintiff-appellee, Dorothy Marie

Reeves, seriously injured her back. She was diagnosed as having

spinal stenosis. To alleviate this condition, her neurosurgeon

attempted a complicated procedure that entailed fusing grafts of

bone from Reeves' hip into her spine at four different levels of

her vertebrae. As part of this surgery, metal bone plates and

screws manufactured by the appellant, AcroMed, were implanted into

Reeves' back to secure the fusion. Reeves' condition initially

improved after surgery. However, six months after the surgery,

Reeves began to suffer from back pain that had not existed prior to

the surgery. Reeves continued to suffer from this pain and in

December 1991, filed suit against AcroMed alleging that AcroMed's

products implanted in her back were defective. Reeves based her

2 cause of action on several theories of recovery including, failure

to warn, defective design, defective manufacturing, and the

"unreasonably dangerous per se" category of products liability.

Reeves I, at 308; See Halphen v. Johns-Manville Sales Corp.,

(La. 1986). The jury returned a verdict in favor

of Reeves, but did not specify upon which legal theory the verdict

was based.

In Reeves I, this court held that the failure to warn theory

was preempted by the Medical Device Amendments to the Food, Drug,

and Cosmetic Act,

et seq., and that Reeves failed

to produce sufficient evidence to recover on her defective design

and manufacturing theories. Accordingly, we vacated the judgment

of the district court and remanded for retrial of Reeves' action

predicated solely on the unreasonably dangerous per se theory.

However, in Reeves I we found that Reeves presented sufficient

evidence to have her unreasonably dangerous per se claim submitted

to the jury, including the questions of whether the medical device

was an unreasonably dangerous per se product and, if so, whether

this product condition caused the exacerbation of Reeves' back

injury.

.

After trial on remand, the jury awarded Reeves $318,000

finding that AcroMed's medical device was unreasonably dangerous

per se and this product condition caused the aggravation and

compounding of Reeves' back injuries. On remand Reeves also

3 brought a cause of action based on the unreasonably dangerous per

se theory of recovery against Dr. Arthur Steffee, the inventor of

the metal bone plates and screws implanted in Reeves' back and the

chairman of the board of AcroMed.1 Before the commencement of

Reeves' jury trial, the parties stipulated that if the jury

returned a verdict in favor of Reeves, the judge would rule on

Steffee's liability. After the jury rendered a verdict in Reeves'

favor, the trial judge determined that Dr. Steffee was personally

liable. We conclude that Reeves' unreasonably dangerous per se

claim is not preempted, the law of the case doctrine mandates that

we not reconsider the sufficiency of the evidence and causation

issues with respect to Reeves' unreasonably dangerous per se claim

against AcroMed, and the jury acted reasonably in awarding Reeves

$318,000. However, we conclude that the district court erred in

part by holding Steffee liable.

STANDARD OF REVIEW

We employ a three-tiered standard of review in this case. A

court's findings of fact are reviewed for clear error and

conclusions of law are reviewed de novo. Peaches Entertainment v.

Entertainment Repertoire,

(5th Cir. 1995). In

reviewing a jury's findings of fact, we apply the standard set out

1 In Reeves I, Reeves also brought a claim against Dr. Steffee, but the parties apparently agreed not to submit the claim against Dr. Steffee to the jury because AcroMed's insurance would cover any judgment. However, Dr. Steffee was never dismissed as a party.

4 in Boeing Co. v. Shipman

(5th Cir. 1969): "[A] jury

verdict will not be overturned unless the facts and inferences

point so strongly and overwhelmingly in favor of one party that the

court believes that reasonable [jurors] could not arrive at a

contrary verdict."

DISCUSSION

I. Reeves' Claim Against AcroMed

AcroMed first asserts that Reeves' state law unreasonably

dangerous per se claim is preempted by the Medical Device

Amendments of 1976 (MDA or Act) to the Food, Drug, and Cosmetic

Act.

.

, et. seq. In light of the

Supreme Court's decision in Medtronic, Inc. v. Lohr, 518 U.S. ----,

,

(1996), this argument is not

persuasive.

Congress enacted the MDA to give the FDA authority to

regulate medical devices. Lohr, 518 U.S. at ----,

. In Lohr, the Supreme Court explained the critical provisions

of the MDA as background for its preemption analysis.

Medical devices are divided into three classes. Class III

devices present potential unreasonable risks and are subject to the

most intensive regulation.

The metal bone plates and screws

implanted in Reeves' back are Class III devices. In order for a

new Class III device to be marketed, the manufacturer of the device

must provide the FDA with a reasonable assurance that the device is

5 both safe and effective.

(citing 21 U.S.C. § 360e(d)(2)).

This process, known as the "premarket approval" (PMA) process, is

quite rigorous in that the FDA spends an average of 1200 hours on

each submission. Id. at ---- - ----,

.

There are two exceptions to the PMA requirement. First, the

statute grandfathers in all pre-1976 devices and allows those

devices to remain on the market until the FDA initiates and

completes a PMA.

at ----,

(citing 21 U.S.C.

§ 360e(b)(1)(A)). Second, to prevent manufacturers of

grandfathered devices from monopolizing the market while new

devices clear the PMA hurdle, and to ensure rapid introduction of

improvements, the Act also permits devices that are "substantially

equivalent" to preexisting devices to be marketed without the

rigorous PMA review. Id. (citing 21 U.S.C. § 360e(b)(1)(B)).

However, all "substantially equivalent" devices are subject to

the requirements of

(k). That section imposes a

limited form of review on every manufacturer intending to market a

new device by requiring it to submit a "premarket notification" to

the FDA. This process is also known as the "§ 510(k) notification

or process," after the number of the section in the original act.

We will use it hereinafter to avoid confusion between

(k)(§ 510(k) notification or process) and 21 U.S.C. §

360k(a)(preemption provision). If the FDA concludes on the basis

of the § 510(k) notification that the device is "substantially

6 equivalent" to a pre-existing device, it can be marketed until the

FDA initiates the PMA process for the underlying pre-1976 device to

which the new device is "substantially equivalent." Id. In

contrast to the rigorous PMA process, the § 510(k) process averages

only 20 hours instead of 1200. Id.

The preemption provision of the MDA, 21 U.S.C. § 360k(a),

reads as follows:

§ 360k. State and local requirements respecting devices

(a) General rule

Except as provided in subsection (b) of this section, no 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.

In Medtronic, Inc. v. Lohr, 518 U.S. ----,

,

(1996), petitioner Medtronic Inc.'s pacemaker was a

Class III device found substantially equivalent under the § 510(k)

process. Cross-petitioners Lohrs filed a state court suit in

Florida alleging strict liability and negligence claims because of

the failure of her Medtronic pacemaker. Medtronic removed the case

to federal district court. That court dismissed the complaint as

having been pre-empted by 21 U.S.C. § 360k(a) because it was based

on state law claims which, if successful, would impose a

7 requirement different from or in addition to any requirement

applicable to the device under the MDA relating to the safety or

effectiveness of the device. The Eleventh Circuit Court of Appeals

reversed in part and affirmed in part, concluding that the Lohrs'

negligent design claims were not pre-empted, but that their

negligent manufacturing and failure to warn claims were. Lohr, 518

U.S. at ----,

. The Supreme Court reversed in

part, affirmed in part, and remanded, concluding that the MDA does

not pre-empt the Lohrs' common law claims.

at ----,

.

Although the Supreme Court determined that it need not go

beyond § 360k(a)'s pre-emptive language to determine whether

Congress intended the MDA to pre-empt at least some state law,

citing Cipollone v. Liggett Group, Inc.,

,

,

(1992), the Court concluded that

the domain expressly pre-empted by that language must be

identified. The Court further noted that its interpretation of the

text is informed by the assumptions that the States' historic

police powers cannot be superseded by a Federal Act unless that is

Congress' clear and manifest purpose, citing Rice v. Santa Fe

Elevator Corp.,

,

,

(1947), and that any understanding of a pre-emption statute's

scope rests primarily on "a fair understanding of congressional

purpose," quoting Cipollone,

,

.

8 The Court determined that the Lohrs' design claims were not

pre-empted because the FDA's "substantially equivalent"

determination as well as its continuing authority to exclude a

device from the market do not amount to a specific, federally

enforceable design requirement that cannot be affected by the type

of state law pressures imposed by those claims. Because the §

510(k) process is focused on equivalence, not safety, the Court

observed, substantial equivalence determinations provide little

protection to the public. Neither the statutory scheme nor

legislative history suggests that the § 510(k) process was intended

to do anything other than maintain the status quo, which included

the possibility that a device's manufacturer would have to defend

itself against state law negligent design claims. Lohr, 518 U.S.

at ---- - ----,

.

The Supreme Court also held that the Lohrs' manufacturing and

labeling claims are not pre-empted because § 360k(a) does not

pre-empt state rules that merely duplicate the FDA's rules

regulating manufacturing practices and labeling. That the state

requirements may be narrower than the federal rules does not make

them "different" under § 360k(a). Id. at ----,

.

Nor does the presence of a damages remedy amount to an additional

or different "requirement"; it merely provides another reason for

manufacturers to comply with identical existing federal law

"requirements."

The Court found that this view is supported by

9 the regulations of the FDA, to which Congress has delegated

authority to implement the MDA.

In the present case, we conclude, for the same reasons, that

Reeves' unreasonably dangerous per se claim is not preempted by §

360k(a). As the Supreme Court noted, quoting the court below with

approval, " "[t]he 510(k) process is focused on equivalence, not

safety.' Lohr v. Medtronic, Inc.,

(11th

Cir. 1995). As a result, "substantial equivalence' determinations

provide little protection to the public." Lohr, 518 U.S. at ----,

. " "These determinations simply compare a post-

1976 device to a pre-1976 device to ascertain whether the later

device is no more dangerous and no less effective than the earlier

device. If the earlier device poses a severe risk or is

ineffective, then the later device may also be risky or

ineffective.' "

(quoting Adler, 43 Food Drug Cosm. L. J., at

516). The design of Medtronic's pacemaker, the Court remarked, as

with the design of pre-1976 and other "substantially equivalent"

devices, has never been formally reviewed under the MDA for safety

or efficacy.

In concluding its review with respect to the Lohrs' defective

design claims, the Court stated:

Thus, even though the FDA may well examine § 510(k) applications for Class III devices (as it examines the entire medical device industry) with a concern for the safety and effectiveness of the device ..., it did not "require" Medtronics' pacemaker to take any particular form for any particular reason; the agency simply allowed the pacemaker,

10 as a device substantially equivalent to one that existed before 1976, to be marketed without running the gauntlet of the PMA process.... There is no suggestion in either the statutory scheme or the legislative history that the § 510(k) exemption process was intended to do anything other than maintain the status quo with respect to the marketing of existing medical devices and their substantial equivalents. That status quo included the possibility that the manufacturer of the device would have to defend itself against state-law claims of negligent design.... [T]he Court of Appeals properly concluded that the "substantial equivalence" provision did not pre-empt the Lohrs' design claims.

Id. at ---- - ----,

.

Applying these principles to the present case, we conclude

that the "substantial equivalence" provision did not pre-empt

Reeves' unreasonably dangerous per se claim. When Reeves' claim

arose, Louisiana and many other jurisdictions recognized that a

product may be unreasonably dangerous because of its design for

reasons very similar to those underlying the unreasonably dangerous

per se claim. This widely recognized defective design theory

accrued when "[a] reasonable person would conclude that the

danger-in-fact, whether foreseeable or not, outweighs the utility

of the product." Halphen v. Johns-Manville Sales Corp.,

. See also Elmore v. Owens-Illinois, Inc.,

(Mo. 1984); Turner v. General Motors Corp.,

(Tex. 1979); Carter v. Johns-Manville Sales Corp.,

(E.D.Tex. 1983); Prosser and Keeton on Torts, p. 699 (5th Ed. 1984);

Keeton, Torts, Annual Survey of Texas Law, 1981, 35 Sw.L.J. 1, 9

(1981); Keeton, The Meaning of Defective in Products Liability

Law, 45 Mo.L.Rev. 579, 592 (1980). "This is the same

11 danger-utility test applied in determining whether a product is

unreasonably dangerous per se."

The design of AcroMed's metal

bone implant, as with the design of pre-1976 and other

"substantially equivalent" devices, has never been formally

reviewed under the MDA for safety or efficacy. Thus the FDA did

not "require" AcroMed's medical device to take any particular form

for any particular reason; the metal bone implant was simply

allowed by the agency, as a device substantially equivalent to one

that existed before 1976, to be marketed without running the

gauntlet of the PMA process. As the Supreme Court took notice with

regard to Lohr's pacemaker, there is no suggestion that the §

510(k) process was intended to do anything other than maintain the

marketing status quo, and that status quo included the possibility

that AcroMed, the manufacturer of the metal bone implant, would

have to defend itself against state-law claims of unreasonably

dangerous products liability claims, including strict liability

defective design and unreasonably dangerous per se claims. Accord:

Moore v. Kimberly-Clark Corporation,

(5th

Cir. 1989)(Louisiana strict liability claims based on defective

design, construction and composition of tampon were not preempted

by § 360k(a) of MDA).

This court's decision in Feldt v. Mentor Corp.,

(5th Cir. 1995) fully anticipated the reasoning and holding of Lohr

that we now apply. In Feldt, we decided that the MDA does not

12 preempt Texas design defect and implied warranty claims against the

manufacturer of a pump-activated inflatable penile prosthesis.

This court noted that there was no regulation relating specifically

to design quality of the prosthesis approved for marketing based on

substantial equivalence to prior devices.

.

Moreover, we noted that "[t]he FDA ... may approve an unreasonably

dangerous device so long as the device has the same technological

characteristics or, if the device has different technological

characteristics, is as safe and effective as the predicate device.

21 U.S.C. § 360c(i). To say that a new device is as safe as its

predicate thus indicates nothing, absolutely, about how safe either

product is; a new device may be as safe as a predicate device that

itself is unreasonably dangerous." Id. at 438, n. 12.

Considering the background behind the "substantial

equivalence" exemption, the fact that the purpose of Congress is

the ultimate touchstone in every pre-emption case, Lohr, 518 U.S.

at ----,

, and the presumption against

pre-emption,

we conclude that the "substantial equivalence"

provision did not pre-empt Reeves' unreasonably dangerous per se

claim.

Alternatively, AcroMed asserts that the judgment of the

district court should be reversed because there was not sufficient

evidence from which a reasonable juror could find that the medical

device was unreasonably dangerous per se and that this condition of

13 the product caused the aggravation of Reeves' injuries. In Reeves

I this court concluded, however, that Reeves' evidence was

sufficient to support submitting her unreasonably dangerous per se

claim to the jury, including the questions of whether the product

was unreasonably dangerous per se and whether that product

condition caused the exacerbation of Reeves' back injuries. On

this appeal these issues are controlled by the law of the case

doctrine.

Under the law of the case doctrine, we follow the prior decisions in a case as the law of that case. Thus, we will not reexamine issues of law addressed by a prior panel opinion in a subsequent appeal of the same case unless: "(i) the evidence on a subsequent trial was substantially different, (ii) controlling authority has since made a contrary decision of the law applicable to such issues, or (iii) the decision was clearly erroneous and would work a manifest injustice."

Alberti v. Klevenhagen,

, 1351 n. 1 (5th

Cir. 1995)(quoting North Mississippi Communications v. Jones,

(5th Cir. 1992), cert. denied,

,

,

(1993)). Because none of the above enumerated

exceptions apply to this case, we are governed herein by the

decisions of legal questions by Reeves I. Therefore, under the law

of this case there was sufficient evidence to support the

submission of all elements of Reeves' unreasonably dangerous per se

claim to the jury.

We find nothing improper or unreasonable regarding the jury's

verdict with respect to the quantum of damages. In light of the

deference that we are required to give, we cannot overrule the

14 jury's verdict in this case. The record indicates that the jury's

award of compensatory damages to Reeves was within reasonable

bounds.

II. Reeves' Claim Against Dr. Steffee

Finally, we address whether the district court erred in

holding Steffee liable as the manufacturer or supplier of an

unreasonably dangerous product. Under product liability theories

of recovery, the plaintiff must establish that the defendant was

the manufacturer or supplier of the defective product.2 See e.g.

Halphen v. Johns-Manville Sales Corp.,

(La. 1986). A manufacturer or supplier is one who places a product

on the market or introduces it into the stream of commerce. See

CNG Producing Co. v. Columbia Gulf Transmission,

(1983); Heirs of Fruge v. Blood Services,

(5th

Cir. 1975); Carney v. Marathon Oil Company,

(W.D.La. 1986); Restatement (Second) of Torts, § 402A comment f

(1965). Cf. La.R.S. 9:2800.53(1) and (3). The facts that Steffee

2 The Louisiana Supreme Court has recognized that professional vendors may also be subject to liability under product liability theories. See e.g., Shortess v. Touro Infirmary,

(La. 1988); Rowell v. Carter Mobile Homes, Inc.

(1987); Chappuis v. Sears Roebuck & Co.,

(La. 1978). In order to qualify as a professional vendor, one must do more than occasionally place a product in the stream of commerce; one must be in the business of selling the product. See

(where a bank which only occasionally sold mobile homes which it was forced to acquire in foreclosures was held not to be a professional vendor); See also Restatement (Second) of Torts, § 402A(1)(a) (1965).

15 invented the metal bone plates and screws and served as chairman of

the board of AcroMed do not suffice to make him a manufacturer,

supplier, or professional vendor. Steffee invented the bone

implant, but he, in his capacity of an individual person, did not

place the medical device on the market, introduce it into the

stream of commerce, or act as a professional vendor of the product.

CONCLUSION

For the foregoing reasons, the judgment of the district court

in favor of Reeves is affirmed insofar as it was rendered against

AcroMed but it is reversed insofar as it affects Steffee.

Accordingly, the judgment of the district court is AFFIRMED IN PART

AND REVERSED IN PART.

16