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| [1] | Illinois Supreme Court |
| [2] | Docket No. 86903 |
| [3] | 721 N.E.2d 1149, 242 Ill.Dec. 618, 1999.IL.0042832 <http://www.versuslaw.com> |
| [4] | December 02, 1999 |
| [5] | HAROLD WEILAND, APPELLANT, V. TELECTRONICS PACING SYSTEMS, INC., APPELLEE. |
| [6] | The opinion of the court was delivered by: Justice Heiple |
| [7] | -Agenda 29-September 1999. |
| [8] | The issue in this case is whether section 360k of the Medical Device Amendments
of 1976 (MDA) (21 U.S.C. §360k (1994)) to the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. §301 et seq. (1994)) preempts plaintiff's state common law
claims for breach of warranty and defective design and construction against
Telectronics Pacing Systems, Inc. (TPSI), the distributor of two allegedly
defective pacemakers. The circuit court of Cook County held that section
360k preempts plaintiff's claims and granted summary judgment in favor of
TPSI. The appellate court affirmed. 302 Ill. App. 3d 175. We reverse, and
hold that the Food and Drug Administration's premarket approval of a Class
III medical device does not create a specific federal requirement within
the meaning of section 360k of the MDA which preempts plaintiff's state
common law claims. |
| [9] | BACKGROUND |
| [10] | Plaintiff was diagnosed with coronary heart disease. To treat this condition,
doctors implanted into plaintiff's body a model 8222 pacemaker distributed
in the United States by TPSI. Plaintiff alleges that this pacemaker malfunctioned,
and his doctors were forced to replace it with a model 1230 TPSI pacemaker.
Plaintiff alleges that he had to undergo surgery a second time to remove
the model 1230 pacemaker after it too failed to function properly. Plaintiff
filed a complaint against, among others, TPSI alleging state common law
claims for breach of warranty and defective design and manufacture of the
two pacemakers. The trial court granted TPSI's motion for summary judgment,
holding section 360k of the MDA preempts plaintiff's claims. The appellate
court affirmed. This court granted plaintiff's petition for leave to appeal.
177 Ill. 2d R. 315. |
| [11] | ANALYSIS |
| [12] | The sole issue in this case is whether the MDA preempts plaintiff's state
common law claims. Even when a federal statute such as the MDA contains
an express preemption provision, the starting point for our analysis is
the presumption that " `the historic police powers of the States were
not to be superseded by the Federal Act unless that was the clear and manifest
purpose of Congress.' " Medtronic, Inc. v. Lohr, 518 U.S. 470, 485,
135 L. Ed. 2d 700, 715, 116 S. Ct. 2240, 2250 (1996), quoting Rice v. Santa
Fe Elevator Corp., 331 U.S. 218, 230, 91 L. Ed. 1447, 1459, 67 S. Ct. 1146,
1152 (1947). Such a presumption, the United States Supreme Court has noted,
is "consistent with both federalism concerns and the historic primacy
of state regulation of matters of health and safety." Lohr, 518 U.S.
at 485, 135 L. Ed. 2d at 715, 116 S. Ct. at 2250. As always, the purpose
of Congress is the "ultimate touchstone" of preemption analysis.
Busch v. Graphic Color Corp., 169 Ill. 2d 325, 334 (1996), quoting Cipollone
v. Liggett Group, Inc., 505 U.S. 504, 516, 120 L. Ed. 2d 407, 422, 112 S.
Ct. 2608, 2617 (1992). |
| [13] | Section 360k(a) of the MDA provides: |
| [14] | "[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- |
| [15] | (1) which is different from, or in addition to, any requirement applicable
under this chapter to the device, and |
| [16] | (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) (1994). |
| [17] | This provision, however, is highly ambiguous. Lohr, 518 U.S. at 505, 135
L. Ed. 2d at 728, 116 S. Ct. at 2260 (Breyer, J., Concurring in part and
Concurring in the judgment). Section 360k clearly states "that federal
requirements may pre-empt state requirements, but it says next to nothing
about just when, where, or how they may do so." Lohr, 518 U.S. at 505,
135 L. Ed. 2d at 728, 116 S. Ct. at 2260 (Breyer, J., Concurring in part
and Concurring in the judgment). Fortunately, in Lohr, the United States
Supreme Court developed a standard for determining whether section 360k
of the MDA preempts state common law claims. In order for a federal "requirement"
to have preemptive effect under section 360k, the Lohr Court held, it must
be a specific requirement which applies to a particular device and focuses
on the safety and effectiveness of that device. Lohr, 518 U.S. at 498, 135
L. Ed. 2d at 723, 116 S. Ct. at 2256. Accord Goodlin v. Medtronic, Inc.,
167 F.3d 1367, 1372 (11th Cir. 1999); Mitchell v. Collagen Corp., 126 F.3d
902, 909-10 (7th Cir. 1997). |
| [18] | In Lohr, the Supreme Court held that section 360k of the MDA does not
preempt state common law claims against the manufacturer of an allegedly
defective pacemaker for negligent design, manufacture and assembly as well
as strict products liability. Lohr, 518 U.S. at 492-502, 135 L. Ed. 2d at
719-26, 116 S. Ct. at 2253-58. The Lohr Court's analysis, however, was limited
to a pacemaker which had received FDA approval for marketing under a grandfather
provision in the MDA which requires only that the manufacturer demonstrate
that its medical device is "substantially equivalent" to a medical
device that was on the market prior to the adoption of the MDA in 1976.
21 U.S.C. §360e(b)(1)(B) (1994). TPSI's pacemakers, however, did not receive
approval from the FDA under this section of the MDA. The holding in Lohr,
therefore, does not definitively resolve whether the MDA preempts plaintiff's
claims in this case. |
| [19] | In order to determine whether section 360k preempts plaintiff's claims
in this case, we must examine the process by which the FDA approved TPSI's
request to market its pacemakers. The MDA classifies medical devices into
three categories based on the risk they pose to the public. Class III medical
devices are devices which are "purported or represented to be for a
use in supporting or sustaining human life or for a use which is of substantial
importance in preventing impairment of human health" or "present[]
a potential unreasonable risk of illness or injury." 21 U.S.C. §360c(a)(1)(C)(ii)
(1994). The FDA classifies pacemakers as Class III devices. 21 C.F.R. §870.3610(b)
(1995). Before a manufacturer can market a Class III medical device which
is not "substantially equivalent" to a medical device on the market
prior to the enactment of the MDA, the manufacturer must provide the FDA
with a "reasonable assurance of the [device's] safety and effectiveness."
21 U.S.C. §360c(a)(1)(C)(i) (1994). This "premarket approval"
process is a rigorous one. A manufacturer seeking premarket approval must
submit to the FDA detailed information regarding the safety and effectiveness
of the device, and the FDA spends an average of 1,200 hours reviewing each
submission for premarket approval. Lohr, 518 U.S. at 477, 135 L. Ed. 2d
at 710-11, 116 S. Ct. at 2246-47. Both of TPSI's pacemakers implanted in
plaintiff's body received premarket approval from the FDA. |
| [20] | TPSI argues that the FDA's premarket approval of both pacemakers implanted
in plaintiff's body constitute federal requirements which preempt plaintiff's
state common law claims. As stated above, in order for a federal requirement
to have preemptive effect under section 360k, it must be a specific requirement
which applies to a particular device and focuses on the safety and effectiveness
of that device. The premarket approval process unquestionably focuses on
the safety and effectiveness of a particular Class III medical device; therefore
our inquiry is limited to whether premarket approval of a Class III medical
device imposes a specific federal requirement. We hold that it does not. |
| [21] | The FDA's premarket approval of a Class III medical device represents
"only a finding that the manufacturer's proposal to market a device
has reasonably assured the FDA of the device's safety and effectiveness."
Goodlin, 167 F.3d at 1375. The design of the pacemakers at issue in this
case originated solely with the manufacturer of the device, not the FDA.
The FDA did not require the pacemakers to take any particular form for any
particular reason. See Lohr, 518 U.S. at 493, 135 L. Ed. 2d at 720- 21,
116 S. Ct. at 2254. The FDA merely gave permission to market the design
for the pacemaker submitted by the manufacturer. Premarket approval imposes
no ascertainable substantive requirement on the manufacture or design of
the device. Goodlin, 167 F.3d at 1375. *fn1
If the FDA determines that particular design or manufacturing specifications
for pacemakers are warranted, the FDA has the authority to promulgate specific
requirements independent of the premarket approval process. See, e.g., 21
C.F.R. §861.1(b)(3) (1995) (providing for mandatory performance standards
for Class III medical devices). Thus, for example, if the FDA promulgated
a rule requiring all manufacturers to use ceramic insulators for pacemakers,
section 360k would preempt plaintiff's claim in this case that TPSI's pacemakers
were defective because ceramic insulators are susceptible to cracking. See
Lohr, 518 U.S. at 504, 135 L. Ed. 2d at 727, 116 S. Ct. at 2259 (Breyer,
J., Concurring in part and Concurring in the judgment) (arguing a hypothetical
FDA regulation requiring a two-inch wire for a certain component of hearing
aids would preempt a state common law claim which premises liability on
the manufacturer's failure to use a one-inch wire). TPSI, however, has not
identified a single regulation or order promulgated by the FDA which established
a specific requirement for its pacemakers. |
| [22] | TPSI insists that its interpretation of section 360k would provide manufacturers
of medical devices with only a limited form of immunity from state common
law claims for injuries caused by defective medical devices. TPSI argues
that section 360k of the MDA would not preempt state common law claims that
a manufacturer deviated from the specific design and manufacturing methods
approved by the FDA when it granted premarket approval for the device. TPSI's
argument is specious. TPSI's interpretation of section 360k would have "the
perverse effect of granting complete immunity from design defect liability
to an entire industry that, in the judgment of Congress, needed more stringent
regulation in order `to provide for the safety and effectiveness of medical
devices intended for human use.' " Lohr, 518 U.S. at 487, 135 L. Ed.
2d at 716-17, 116 S. Ct. at 2251 (plurality opinion), quoting Pub. L. No.
94-295, 90 Stat. 539 (1976) (preamble to MDA). Such a sweeping interpretation
of federal preemption under section 360k would also produce a serious intrusion
into state sovereignty. Lohr, 518 U.S. at 488, 135 L. Ed. 2d at 717-18,
116 S. Ct. at 2252 (plurality opinion). The premarket approval process allows
the FDA to assure the minimal safety of medical devices which are marketed
for human consumption; the premarket approval process simply does not address
the appropriate standards of liability once the medical device enters the
market. Goodlin, 167 F.3d at 1378. There is simply no support for TPSI's
assertion that Congress intended to preempt almost all state common law
claims against the manufacturers of medical devices which receive premarket
approval from the FDA. Goodlin, 167 F.3d at 1378. In the absence of a clear
and manifest congressional intent to create the sweeping preemption of state
common law claims suggested by TPSI, we hold that the FDA's premarket approval
of a Class III medical device does not establish a specific federal requirement
which preempts plaintiff's state common law claims. Kernats v. Smith Industries
Medical Systems, Inc., 283 Ill. App. 3d 455 (1996), to the extent it holds
that premarket approval review constitutes a specific federal requirement
within the meaning of section 360k, is overruled. |
| [23] | We acknowledge that the Seventh Circuit Court of Appeals has also addressed
this issue and reached a result contrary to our decision today. See Mitchell
v. Collagen Corp., 126 F.3d 902, 911 (7th Cir. 1997) (holding "[premarket
approval] process constitutes a specific federal regulation of the product").
TPSI insists that in the interest of uniformity, this court should follow
this precedent from the Seventh Circuit. Uniformity is an important consideration
when state courts interpret federal statutes. Wilson v. Norfolk & Western
Ry. Co., 187 Ill. 2d 369, 383 (1999); Busch, 169 Ill. 2d at 335 (noting
decisions of federal courts interpreting federal statutes are controlling
upon Illinois courts). Nonetheless, a concern for uniformity does not command
this court's adherence to the Seventh Circuit's precedent in this case.
The Seventh Circuit Court of Appeals exercises no appellate jurisdiction
over this court. See People v. Kidd, 129 Ill. 2d 432, 457 (1989). This court
need not follow Seventh Circuit precedent interpreting a federal statute
where, as here, the Supreme Court has not ruled on the question presented,
there is a split of authority among the federal circuit courts of appeals,
and, we believe, the case from the Seventh Circuit was wrongly decided.
See Wilson, 187 Ill. 2d at 381 ("elect[ing]" to follow Seventh
Circuit's interpretation of the Federal Employers' Liability Act (FELA)
where there is a conflict among lower federal courts on the issue and the
Seventh Circuit's analysis is "reasonable and logical" and consistent
with other United States Supreme Court precedent). |
| [24] | CONCLUSION |
| [25] | For the reasons stated, the judgments of the appellate and circuit courts
are reversed and the cause is remanded to the circuit court of Cook County
for further proceedings consistent with this opinion. |
| [26] | Reversed and remanded. |
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| Opinion Footnotes | |
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| [27] | *fn1 TPSI emphasizes that the premarket
approval process is more rigorous than the "substantial equivalence"
determination for medical devices grandfathered by the FDA under section
360e(b)(1)(B) (21 U.S.C. §360e(b)(1)(B) (1994)). The mere fact that the
PMA process is more rigorous and intensive than the FDA's review under section
360e(b)(1)(B), however, still does not prove that premarket approval imposes
a "specific" federal requirement. |
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