This, that, and the other thing.
Odds and sods.
Whatever. This post is about stuff that we learned about recently that relate to our prior posts. Other than that, they have nothing in common with each other.
Together, they add up to enough material for a decent post.
Some time ago we posted about what we thought – and still think – was an aberrant vaccine preemption decision in Georgia that ginned up an almost absolute presumption against preemption to ignore what we (and every other court that had ever examined the question) viewed as extremely strong evidence of the preemptive intent of Congress.
After that, for a while, things seemed to go okay. Within a month or two, a federal court decided that the Georgia decision was all wet and went along with what had previously been unanimous precedent in favor of vaccine preemption.
Then the Georgia Supreme Court accepted an appeal.
And only recently, a judge in the Philadelphia Court of Common Pleas, a court that’s often no friend of preemption, also held that the Vaccine Act was preemptive in the same circumstances. See Wright v. Aventis Pasteur, Inc., 2008 WL 4144386 (C.P. Pa. Aug. 27, 2008).
So we were thinking “reversal” in the Georgia Supreme Court. A southern state, right? They’re conservative down there, right?
Loud wrong, in fact. Our side – the preemption side – got skunked. We didn’t garner a single vote in American Home Products Corp. v. Ferrari, ___ S.E.2d ___, 2008 WL 4452358 (Ga. 2008).
It looks like they’re still rebels on the Georgia Supreme Court, and they don’t cotton (we think we’re using this verb right; if not, blame Jim Carville) to being told what to do by Congress or anybody else in the federal government.
The facts in Ferrari were discussed in our prior post, so we won’t go into them. Suffice it to say that the plaintiff was injured by a vaccine that’s covered by the Vaccine Act, went through (and rejected the result of) the administrative process and then, as the Act allows, brought a civil suit.
The Georgia Supreme Court did get one thing right. It ditched the lower court’s strange interpretation of some language in Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005), as creating an irrebuttable presumption against preemption that overrode congressional intent:
The Court of Appeals viewed Bates as having drastically changed this traditional preemption analysis, so as to make the presumption against preemption irrebuttable and to require examination of the statutory language alone. However, Bates does not require a court to automatically accept a plausible interpretation of a statute which disfavors preemption. Bates quotes from [Lohr], which sets forth the presumption against preemption, without any indication of disapproval. Furthermore, Bates itself relies on the congressional intent behind the statute before it when applying the rule disfavoring preemption. It therefore appears that the Court of Appeals took one part of the Bates ruling out of its context, and gave it broader scope than is appropriate.
2008 WL 4452358, at *3 (citation and quotation marks omitted).
That’s almost exactly what we said about the first Ferrari decision. So our side should win, right?
Nope. In place of a unique reading of Bates, the new Ferrari opinion substitutes an equally unique reading of the legislative history of the Vaccine Act.
That statute imposes – or at least we thought it did – restrictions on the types of state-law claims that plaintiffs can pursue. In order to reduce litigation pressure that was adversely affecting the availability of critical vaccines, in the Vaccine Act Congress restricted product liability litigation in several ways. Chief among them, Congress declared that all federally-approved vaccines were “unavoidably unsafe.” Every other court to address the question has found the legislative history of the Vaccine Act definitively shows intent to preempt and preclude a case-by-case determination about whether a vaccine is “unavoidably unsafe,” and instead to charge the FDA with determining what vaccines are safe enough to be on the market. See Bruesewitz v. Wyeth, Inc., 508 F. Supp.2d 430, 443-46 (E.D. Pa. 2007); Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289, 299-303 (E.D. Pa. 2007); Blackmon v. American Home Products Corp., 328 F. Supp.2d 659, 663-666 (S.D. Tex. 2004); Militrano v. Lederle Laboratories, 26 A.D.3d 475, 810 N.Y.S.2d 506, 508-509 (N.Y. App. Div. 2006), appeal denied, 857 N.E.2d 1137 (N.Y. 2006); Wright, supra.
The Georgia Supreme Court begs to differ. It points out that the “majority” view interpreting Restatement (Second) of Torts §402A, comment k (where the “unavoidably unsafe” concept comes from), is that there should be a case-by-case determination of the “unavoidability” of a vaccine’s (or a drug’s) risks. 2008 WL 4452358, at *4. Essentially, the court’s right about comment k, as far as that goes. Case-by-case is indeed the position of the majority of jurisdictions to consider the issue. Bexis’ book has a whole subsection (§2.02) just on this aspect of comment k. It cites precedent from 25 states that follow the case-by-case approach.
Back to Ferrari.
Building on its conclusion about comment k, the Georgia Court reasons from this “majority” reading of comment k and concludes that Congress must have meant that reading when it adopted comment k in the Vaccine Act:
An analysis of the language and intent of 42 U.S.C. §300aa-22 (b)(1), unhindered by the mistakes of [cases going the other way], shows that Congress not only adopted comment k, but understood that comment in the same way that. . .the great majority of other courts came to understand it. . . . [T]he committee report on which [the cases going the other way] rely states, without qualification, that “[t]his provision sets forth the principle contained in Comment k of Section 402A of the Restatement of Torts (Second)….” H.R. Rep. 99-908, at 25 (1986).
2008 WL 4452358, at *4 (citations to a variety of cases omitted).
That’s the Ferrari court’s essential syllogism: Congress adopted comment k in the Vaccine Act. The majority view of comment k is case-by-case. Therefore, Congress must have adopted case-by-case.
The rest of the opinion is a somewhat strained view of the rest of what the court calls “legislative history,” but which includes not only statements by a subsequent Congress but also inferences from amendments that Congress did not pass. 2008 WL 4452358, at *7. Adding all that into the mix, the court ends where it began, with the presumption against preemption:
Even if the language of [the section] is ambiguous, the legislative history hardly shows a “clear and manifest” congressional purpose to supplant state tort law with respect to claims of defective design. Thus, although the Court of Appeals mistakenly construed Bates to preclude reliance on any indication of congressional intent other than the statutory language, Bates would nonetheless apply to resolve any ambiguity in [the section] against preemption.
We think all this makes no sense. It either forgets or ignores why Congress adopted the Vaccine Act in the first place. Lawsuits were driving vaccines off the market. Congress acted to restrict litigation when it enacted the statute – not to expand liability, which is what the Ferrari ruling does.
In discussing the “majority” view, Ferrari ignore a significant minority of states – including some very big ones – that rejects the legal guerilla warfare model that is part and parcel of the case-by-case approach. Those jurisdictions, although not as numerous, have taken a different view of the malleable language of comment k. They take the position that all prescription medical products are “unavoidably unsafe,” because (1) the FDA’s approved them, and (2) the existence of inherent risks is why prescription products require prescriptions in the first place:
- Alabama: Stone v. Smith, Kline & French Laboratories, 447 So.2d 1301, 1303 (Ala. 1984).
- California: Carlin v. Superior Court, 920 P.2d 1347, 1351 n.2 (Cal. 1996); Brown v. Superior Court, 751 P.2d 470, 481-83 (Cal. 1988).
- Connecticut: Hurley v. The Heart Physicians, P.C., 898 A.2d 777, 783 (Conn. 2006); Vitanza v. Upjohn Co., 778 A.2d 829, 836-37 (Conn. 2001).
- District of Columbia: Dyson v. Winfield, 113 F. Supp.2d 35, 39-40 (D.D.C. 2000), aff’d, 21 Fed. Appx. 2 (D.C. Cir. 2001).
- Florida: Buckner v. Allergan Pharmaceuticals, Inc., 400 So.2d 820, 823 (Fla. App. 1981) (a different Florida intermediate appellate decision supports case-by-case).
- Indiana: Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541, 545-46 (Ind. App. 1979) (a federal decision supports case-by-case).
- Iowa: Moore v. Vanderloo, 386 N.W.2d 108, 116 (Iowa 1986).
- Kentucky: Larkin v. Pfizer, Inc., 153 S.W.3d 758, 762 (Ky. 2004) (not a holding, but dictum suggesting broad comment k application).
- Louisiana: Kinney v. Hutchinson, 468 So.2d 714, 718 (La. App. 1985); Williams v. Ciba-Geigy Corp., 686 F. Supp. 573, 577 (W.D. La. 1988), aff’d mem., 864 F.2d 789 (5th Cir. 1988).
- Massachusetts: Lareau v. Page, 840 F. Supp. 920, 933 (D. Mass. 1993), aff’d, 39 F.3d 384 (1st Cir. 1994).
- Montana: Davis v. Wyeth Laboratories, Inc., 399 F.2d 121, 129 (9th Cir. 1968).
- New Mexico: Perfetti v. McGahn Medical, 662 P.2d 646, 650 (N.M. App. 1983) (a different New Mexico intermediate appellate decision supports case-by-case).
- New York: Wolfgruber v. Upjohn Co., 423 N.Y.S.2d 95, 97 (N.Y.A.D. 1979), aff’d mem., 417 N.E.2d 1002 (N.Y. 1980) (adopting lower court opinion); Bravman v. Baxter Healthcare Corp., 984 F.2d 71, 75-76 (2d Cir. 1993); Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 8, 90-91 (2d Cir. 1980).
- North Carolina: N.C. Gen. Stat. §99B-6(d).
- Pennsylvania: Hahn v. Richter, 673 A.2d 888, 890-91 (Pa. 1996).
- South Carolina: Brooks v. Medtronic, Inc., 750 F.2d 1227, 1230-31 (4th Cir. 1984).
- Texas: Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1273 (5th Cir. 1974); Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 595 (W.D. Tex. 2002).
- Utah: Schaerrer v. Stewart’s Plaza Pharmacy, Inc., 79 P.3d 922, 928 (Utah 2003); Grundberg v. Upjohn Co., 813 P.2d 89, 95 (Utah 1991).
- Washington: Young v. Key Pharmaceuticals, Inc., 922 P.2d 59, 64 (Wash. 1996); Terhune v. A.H. Robbins Co., 577 P.2d 975, 977-78 (Wash. 1978).
- Wyoming: Jacobs v. Dista Products Co., 693 F. Supp. 1029, 1031 (D. Wyo. 1988).
Now, admittedly, that’s only twenty jurisdictions in favor of the so-called “across the board” application of comment k – compared to 25 (three of which have conflicting authority) for the case-by-case approach that Ferrari represents – but we think that size matters some, too. California, Texas, New York, Florida, and Pennsylvania all fall into this category, with only Florida in some dispute (shades of Bush v. Gore).
In this political season, we note that these twenty states total 284 electoral votes, which is more than half the total. Even giving the case-by-case approach all the divided states, those 25 states muster only 233 electoral votes. So what’s a “majority” is a matter of definition. Case-by-case has more states, but across-the-board is where more people (and thus more potential litigants) live.
The point of this exercise is that, by applying a presumption against preemption to congressional intent about the Vaccine Act, Ferrari winds up holding that Congress would have done something bizarre. Excuse us, but we don’t think that, in a statute designed throughout to reduce vaccine manufacturer’s liability, Congress would have chosen instead to increase that liability by overriding – “preempting,” if you will – a pro-defense view of the law that existed in a whole lot of very big states.
Sometimes common sense should count for something.
And that’s particularly true of this particular rule, because forcing vaccine manufacturers to defend the design of their products time and time again in case after case was one of the major costs of litigation that was driving them to leave the marketplace to begin with. This was not something Congress overlooked.
Thus, while we acknowledge that it was a nifty little syllogism the Ferrari court put together, we just don’t think it has much to do with the reality Congress actually faced when it passed the Vaccine Act.
Ferrari simply took a wrong turn, and once again the presumption against preemption is the culprit.
Given the product – vaccines, the epitome of a life-saving product, the weakness of the core logic in Ferrari, and where we think the FDA would come out with respect to the Vaccine Act (even under a D administration), we’re content to have this case go to the Supreme Court. Not only that, but it’s only fair that the vaccine folks get their shot at establishing preemption on the big stage.
In another post, we examined precedent holding that Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), preempts not only causes of action involving fraud on the FDA, but also evidence of fraud on the FDA that plaintiffs seek to introduce to poison the well against defendants in litigation not involving explicit fraud allegations. We mentioned four such cases in that post. Well, we’ve found a fifth, Skibniewski v. American Home Products Corp., 2004 WL 5628157, at *13 (W.D. Mo. April 1, 2004).
We follow Buckman issues pretty closely, and we’re not quite sure how Skibniewski all of a sudden popped up after four years (we can’t take any credit for it) – but we’re glad it did.
Over a year ago, we posted an argument in support of our position that, given the territorial limitations that due process puts on punitive damages, a state where none of the wrongful conduct occurred does not have constitutional power to impose punitive damages.
That sounds strange – and it is – but it happens more often than ever in mass-tort litigation when plaintiffs from all over the country file in litigation-friendly courts in jurisdictions that have nothing to do with the facts of their cases.
As that post indicates, it’s not something that gets decided very often. We could cite only six cases that supported our argument (we’re not going to say whether there’s any contrary law – the other side can do its own research).
Well, we’ve found another, Daniel v. Wyeth, 2007 WL 5528724 (Pa. C.P. April 23, 2007). The court holds that it, a Pennsylvania court, has no constitutional power to punish an alleged failure to warn that occurred (assuming it happened at all) in Arkansas. Punitive damages were only for an Arkansas court:
Federal constitutional law precludes a state from awarding punitive damages based on out-of-state conduct. Pennsylvania may not use punitive damages to punish [defendant] for any conduct – lawful or not – that occurred in Arkansas. All of the conduct and events relating to [plaintiff’s] lawsuit occurred in Arkansas, where she resided, obtained, and ingested [the] drug, and developed the breast cancer she claims resulted.
[Defendant’s] legal duty to warn was to an Arkansas doctor practicing in Arkansas, where the warning was communicated. While Pennsylvania was able to employ its courts to judge [defendant’s] conduct in Arkansas for the purpose of compensating [plaintiff] specifically, it cannot use its courts to punish [defendant] for the purpose of vindicating Arkansas’s interest in protecting its citizens. Pennsylvania courts are prohibited from attempting to vindicate the interests of Arkansas citizens.
That’s precisely what we were arguing in our post. We’re adding Daniel to our argument, and we recommend that other defense counsel do the same. But be aware, the Daniel case is currently on appeal.
Finally, we’ve been following decisions under consumer protection acts where our side successfully invokes the “safe harbor” provisions that many of these statutes contain for government approved/regulated activity. As we’ve pointed out, the language of these provisions varies considerably.
At first we knew of seven opinions involving drug manufacturers that dismissed claims as barred by statutory safe harbors. Last year, the number dropped down to six when the Third Circuit reversed a Delaware law ruling. Fortunately, the court then went on and found the claims preempted.
Well, we’re back up to seven again. A new decision, Peter v. Stryker, holds that Michigan consumer protection claims against a device manufacturer were barred as a matter of law by the state act’s safe harbor for “[a] transaction or conduct specifically authorized under laws administered by . . . the United States.” Slip op. at 4-5. As long as the product was FDA approved, then the Michigan safe harbor applies:
Here, the specific misconduct Plaintiff complains of is Defendant’s “failure to provide the promised benefits in connection-ion [sic] with the transaction at issue.” The general transaction, however, is the sale of the prosthetic knee. Prosthetic knees are medical devices, which are heavily regulated by the FDA. In fact, the FDA specifically authorized Defendant to market the prosthetic knee at issue in this litigation. Because Defendant was specifically authorized to sell the prosthetic knee at issue, even though Plaintiff alleges that the device was defective, the MPCA does not apply. Defendant is, therefore, entitled to summary judgment on Plaintiff’s MPCA claim.
Id. at 5. Thus the court slams the door on a possible “out” from Michigan’s statutory bar on most product liability claims involving FDA-approved devices.
Thus, we’re back up to seven – again. May there be more.