32 Ucc Rep - Serv.2d 1101, Prod - Liab.rep. (CCH) P 14,986 John M. Martin, Sr. v. American Medical Systems, Incorporated, 116 F.3d 102, 4th Cir. (1997)
32 Ucc Rep - Serv.2d 1101, Prod - Liab.rep. (CCH) P 14,986 John M. Martin, Sr. v. American Medical Systems, Incorporated, 116 F.3d 102, 4th Cir. (1997)
3d 102
I.
2
The infection raged on, however. He was again treated with intravenous
antibiotics in August. From November 29, 1993, through May 13, 1994, he was
hospitalized five times for surgery, including debridement of dead tissue, skin
grafts, removal of a cyst and an abscess, and subtotal phallic reconstruction. His
penis is now disfigured and shortened.
Martin filed this personal injury suit in state court in Chesapeake, Virginia. He
alleged several tort and warranty theories against American Medical Systems,
the gravamen of all of which was that the defendant failed to ensure that the
Dynaflex would be sterile and hence safe for implantation in the human body.
The defendant removed the case to district court based on diversity of
citizenship.
Martin appeals.
II.
8
Martin first attacks the district court's holding that his tort and implied warranty
claims are preempted. This issue dominates Martin's brief, but, in its response,
American Medical Systems concedes that under the Supreme Court's decision
in Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700
For context's sake, we will briefly describe what this issue was all about.
Before 1976, the Food and Drug Administration (FDA)'s rigorous premarketing
approval did not extend to medical devices. The Dalkon Shield disaster, among
others, prompted Congress to change that. Today, the maker of a new "Class
III" device--the most potentially dangerous--must apply for FDA approval and
must cool its heels while the FDA thoroughly investigates the device's
effectiveness. 21 U.S.C. 360e(d)(2). The Dynaflex is a Class III device.
10
Because the 1976 amendments so abruptly changed the status quo, Congress
was compelled to take the existing market into account. Any device on the
market at the time was permitted to stay on the market until and unless the
FDA, after conducting a review like that for new devices, ordered otherwise. 21
U.S.C. 360e(b)(1)(A).
11
12
13
Except
[where the FDA has exempted a particular state requirement], 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-14 which is different from, or in addition to, any requirement applicable under this
(1)
chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter
15
17
Subsequently, the Supreme Court decided Medtronic. In that case, the Court
held that, as regards 510(k) devices, state-law claims are not preempted. The
Court reasoned that the 510(k) process does not constitute FDA approval of the
safety or effectiveness of the device, but was rather merely the preservation of
the pre-1976 status quo, which included potential liability under state law.3
18
Thus, an intervening decision of the Supreme Court requires that we set aside
the summary judgment on all of Martin's claims except the one for breach of
express warranty. On the latter claim, to which we now turn, the summary
judgment did not rest solely on Duvall, and American Medical Systems
contends that it can be affirmed notwithstanding Medtronic.
III.
19
Under Duvall, some warranty claims could be brought against the manufacturer
of a 510(k) device. Because the Medical Device preemption provision relates to
state laws that add safety and quality requirements in excess of FDA premarket
approval, we reasoned that a manufacturer could voluntarily make claims about
its product and thereby incur contractual liability; an obligation freely assumed
by contract is not one required by general state law.
20
Here, the district court correctly held that Martin's warranty claim was not
preempted per se. However, the court held that summary judgment for the
defendant was appropriate, because (1) Martin was unaware of the Limited
Warranty when he got the implant, and (2) language in the Limited Warranty
restricting it to the direct purchaser and disclaiming liability for consequential
damages was effective, notwithstanding contrary Virginia law. On this second
point, the court reasoned that any warranty coverage for Martin would be on
account of state law, not American Medical Systems' voluntary undertaking,
and so the state law was preempted.
21
318 states:
22 of privity between plaintiff and defendant shall be no defense in any action
Lack
brought against the manufacturer or seller of goods to recover damages for breach of
warranty, express or implied, or for negligence, although the plaintiff did not
purchase the goods from the defendant, if the plaintiff was a person whom the
manufacturer or seller might reasonably have expected to use, consume, or be
affected by the goods[.]
23
Obviously, American Medical Systems knows that the direct purchaser of its
Dynaflex prosthesis--a surgeon or hospital--is not the ultimate user. It therefore
cannot rely on language in its "Limited Warranty" restricting coverage to the
direct purchaser.
24
25
Having concluded that Virginia law applies and would extend any express
warranty to Martin, we turn to whether an express warranty was even made.
The district court pointed out that Martin did not know of the express warranty
that the prosthesis was sterile until this litigation began; therefore, he could not
have relied upon it.
26
Clear Virginia authority is to the contrary. Any description of the goods, other
than the seller's mere opinion about the product, constitutes part of the basis of
the bargain and is therefore an express warranty. It is unnecessary that the
buyer actually rely upon it. Daughtrey v. Ashe, 243 Va. 73, 413 S.E.2d 336
(1992). In Daughtrey, a jeweler had described a gem as being of higher quality
than it actually was. In a subsequent breach of warranty suit, the jeweler
asserted that the buyer had not been aware of the description and had not relied
upon it. The Virginia Supreme Court held that it did not matter. The express
warranty inquiry focuses on what it is that the seller agreed to sell, and, absent
clear proof that the parties did not intend their bargain to include the seller's
description of the goods, that description is an express warranty. 413 S.E.2d at
338-339.
27
The facts of this case militate even more strongly in favor of an express
warranty than in Daughtrey. In both cases, the seller described the goods, but
the buyer was unaware of the description. Here, though, unlike in Daughtrey,
Martin surely did rely on and expect the fact warranted to be true: i.e. the
implant was sterile. Martin may assert a claim for breach of express warranty.
28
The judgment of the district court is vacated, and the case is remanded for
further proceedings consistent with this opinion.
29
The relevant warranty is "The AMS Dynaflex Penile Prosthesis ... [is] delivered
to the hospital prefilled and sterile."
The Court later vacated Duvall v. Bristol-Myers Squibb Co., --- U.S. ----, 116
S.Ct. 2575, 135 L.Ed.2d 1090 (1996), and remanded it for our reconsideration.
For our decision on remand, see Duvall v. Bristol-Myers-Squibb Co., 103 F.3d
324 (4th Cir.1996)