Wednesday, September 30, 2009

TortsProf Mondays

The TortsProf blog recently started inviting torts scholars to publish guest posts on Monday mornings.

This is a nice addition to the blog. No matter how prolific a thinker you are, you'll run out of new and clever topics for your blog after you've written your first, say, 1000 posts. (Just ask us.) Inviting others, with new ideas, to contribute guest posts, adds new voices, and issues, to the conversation.

Thus far, the Monday guest bloggers at Torts Prof have contributed interesting posts on "Does Tort Law Really Deter?," "Introducing Real World Concerns in the Teaching of Torts" (what do you want out of 'em? They're academics, for heaven's sake.), and "Health Insurance Reform and ERISA."

According to the TortsProf teaser, the rest of the Fall line-up looks like this:

10/12 – John Oberdiek (Rutgers-Camden);
10/19 – Martha Chamallas (Ohio State);
10/26 – Adam Scales (W&L);
11/2- Jason Solomon (Georgia);
11/9 – John Goldberg (Harvard);
11/16 - Tim Lytton (Albany);
11/23 – Ben Zipursky (Fordham).

What a great idea -- a teaser for your blog!

Here's our teaser:

Monday - Herrmann;
Tuesday - Beck;
Wednesday - Herrmann;
Thursday - Beck;
Friday - Herrmann.

Bet you can hardly wait.

Tuesday, September 29, 2009

A Detour To Pottawattamie County, Iowa

Anyone who reads this blog knows that we do drugs.

But we do civil rights, too (at least in certain contexts, where the representations don't create positional conflicts for our firms).

Herrmann recently filed an amicus curiae brief (link here) on behalf of Black Cops Against Police Brutality in the U.S. Supreme Court case of Pottawattamie County, Iowa v. Harrington, which will be argued on Wednesday, November 4. (Here's a link to the Supreme Court docket for that case.)

The popular press will predictably pick up this story on about November 3 (the day before argument), so we figured we'd give you a preview here first. (We often choose not to publish blog posts about cases in which we're personally involved, but we're not representing a party in this case, and the issue is just too sexy to ignore. Because this post doesn't relate to drug and device law, however, Bexis chose to play no role in writing this. Herrmann alone, who submitted the amicus brief, is responsible for this post.)

The remarkable allegations in the Pottawattamie County complaint (many of which were admitted in opposition to summary judgment) are these:

Two white prosecutors participated in fabricating, and then presenting at trial, perjurious testimony that resulted in the conviction of two black youths for the murder of a white former police chief. The black youths each served 25 years in prison. The key witness at trial then recanted his perjured testimony, and the men were released from prison. They sued the prosecutors for having violated their civil rights. The prosecutors contend that they have absolute immunity from liability.

The Obama administration filed an amicus brief on behalf of the white prosecutors and will defend that position during oral argument.

The legal spat is this: Police officers who are investigating crimes receive only qualified immunity from civil liability if they violate a suspect's rights. After formal criminal proceedings are commenced against a suspect (by indictment, information, arraignment, or preliminary hearing), however, prosecutors generally have absolute immunity from civil liability for their conduct at trial.

In Pottawattamie County, the prosecutors were involved in investigating the crime, and they allegedly conspired with the police to manufacture false evidence. When prosecutors are working alongside police during the investigative phase, are the prosecutors entitled to absolute immunity?

The Pottawattamie County case is thus both big and little. It's big because the allegations are so horrendous, and the stakes are so high. But it's little because the holding will likely affect only those situations where prosecutors helped police to investigate crimes.

SCOTUS wiki has coverage of Pottawattamie County here, and the Volokh gang tackles the issues in the comments to this post. The Black Cops amicus brief is singled out for attention over at Simple Justice.

The issues have been briefed elegantly by the parties. The Black Cops brief merely adds some spice to the stew. Among other things, that brief recounts some sad examples from American legal history of where white cops have manufactured false evidence against black defendants. For example, in Brown v. Mississippi, 297 U.S. 278 (1936), white officers were investigating the murder of a white man. Acting without probable cause, the officers seized a black man named Arthur Ellington from his home, strung him up to a tree, and whipped him. He refused to confess.

The next day, the officers rearrested Ellington and flogged him with a leather strap having a metal buckle. Ellington's confession ultimately "conform[ed] to the demands of [the] torturers." Id. at 282. The jury convicted; the U.S. Supreme Court reversed.

Sadly, similar examples of racially motivated miscarriages of justice in America abound.

In addition to that historical perspective, the Black Cops amicus brief poses a hypothetical question: Suppose prosecutors accompanied the police to the flogging of Arthur Ellington, advising the police and demanding that Ellington change his confession to fit the known facts. Suppose Ellington was then convicted and released from prison only decades later. Is it conceivable, on those hypothetical facts, that the police would be entitled to only qualified immunity from civil liability, but the prosecutors who conspired with them would be given absolute liability?

There's plenty of room for outrage on the Pottawattamie County facts, and there may well be room for outrage in the governing law.

You're sure to read more on all sides of this issue as the case nears argument in six weeks and decision some months later.

Stay tuned.

Muddled testimony precludes class action

Although past history demonstrates the increasing futility of class action certification in pharmaceutical/medical device product liability litigation, the other side still plugs away, most likely for reasons we've discussed here.

The latest denial of class certification came in Solo v. Bausch & Lomb, Inc., slip op., where the plaintiffs sought recovery of purported economic losses from having to throw away allegedly defective product (contact lens solution). Along with the usual litany of reasons for denying class certification, though the court commented upon the testimony of the two class representatives, which it characterized as "muddled." Id. at 12.

How muddled? Let's see. On the critical question of whether the product was thrown away, the first representative changed her story about when she supposedly threw the product away "after returning from a break" in her deposition. Id. at 11. She also changed her story about how much she threw away (and contradicted what the complaint pleaded) "after a bathroom break." Id. at 12. The other class representative was even worse, having "three inconsistent versions of when she purchased [the product] and when she discarded it." Id. Ouch.

The court therefore reasoned that if the class representatives' memories were so bad, the recall of the absent class members would be even worse:

With the named plaintiffs’ documented memory difficulties in mind, the court finds that determining the membership of plaintiffs’ proposed class would require countless factual inquiries into the individual circumstances of potential class members, most of whom will have long ago forgotten the details relevant to plaintiffs’ allegations. Moreover, it is hard to fathom how thousands of unnamed putative class members could possibly provide credible testimony about their class membership more than three years after the fact when the proposed class representatives themselves have presented conflicting testimony that changed over time. It is abundantly clear that the administrative burdens of certification greatly outweigh any
efficiencies to be gained by treating these claims as a class action.

Slip op. at 13-14 (footnote omitted). Certification denied.

There are a lot of reasons for vigorous cross-examination of class representatives, but sometimes the most basic reason is the best.

Monday, September 28, 2009

More On Moving To Dismiss MDL Master Complaints

We raised an electronic eyebrow last month when we stumbled across In re NuvaRing Prods. Liab. Litig., slip op., No. 4:08MD1964 RWS (E.D. Mo. Aug. 6, 2009) (link here).

There, the MDL Panel created a coordinated proceeding to administer the 150 individual lawsuits pleading personal injuries allegedly caused by using Organon's contraceptive NuvaRing. The MDL transferee court granted (by consent) Organon's motion requiring plaintiffs to file a master consolidated complaint. Organon moved to dismiss that master complaint.

And then, the surprise: Judge Sippel concluded "that the filing of the master consolidated complaint in this action was simply meant to be an administrative tool to place in one document all of the claims at issue in this litigation. Neither Plaintiffs when they consented to filing a master complaint, nor I when I entered the order directing a master complaint to be filed, contemplated that Rule 12(b) motion practice would be pursued by Organon against the master complaint." Id. at 3.

Remarkable: First, the court orders the filing of the master complaint, and then the court refuses to use that master complaint as a vehicle to sort out which claims can proceed.

We were delighted to see that the defendants have now moved to certify the denial of their motion to dismiss for an interlocutory appeal to the Eighth Circuit. (Here's a link to the opening brief; here's a link to the reply.) To obtain certification, defendants must show that an order "involves a controlling question of law as to which there is substantial ground for difference of opinion" and "an immediate appeal from the order may materially advance the ultimate termination of the litigation." 28 U.S.C. Sec. 1292(b).

None of those issues strikes our fancy as much as the underlying legal (and practical) principle: MDL transferee judges order plaintiffs to file master complaints to simplify pleading practice. If MDL transferee judges then refuse to allow motion practice aimed at those master complaints, (1) MDLs become less efficient, (2) defendants will file motions to dismiss each of the hundreds of individual complaints to secure the rulings they need (and are entitled to), (3) defendants will be less willing to agree to the creation of MDLs (since there's less benefit to having them), and (4) the sky will fall. (Well, we're not so sure about that last one, but we wanted to make sure you were still reading.)

The NuvaRing defendants provide legal authority for the assertions that we made in the preceding paragraph. (Except for the bit about the sky falling. For that, see Chicken Little.)

First, ample authority tells MDL judges that it makes sense to allow Rule 12 practice as to master complaints. For example, in Ten Steps to Better Case Management: A Guide for Multidistrict Litigation Transferee Judges 4 (2009) (our discussion and a link to the Guide here),
the MDL Panel itself recommends that case management orders "should include the usual interim breakpoints, e.g., filing of a consolidated amended complaint (where appropriate), filing and briefing on motions to dismiss . . . . " And the Manual for Complex Litigation (Fourth) instructs judges overseeing complex cases (at Section 11.32) to "consider ordering that specified pleadings . . . are 'deemed filed' in other MDL cases . . . . The legal insufficiency of a claim or defense may be raised by motion for failure to state a claim . . . ."

Second, the NuvaRing defendants note that other MDL transferee judges in courts within the Eighth Circuit have granted motions to dismiss master complaints filed in MDLs. See In re Guidant Corp. Implantable Defibrillators, 2009 WL 1921902 (D. Minn. July 1, 2009); In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 2009 WL 294353 (D. Minn. Feb. 5, 2009). The defendants suggest that Judge Sippel should have done the same. (In one of our earlier posts on this subject, we looked more broadly than just district courts in the Eighth Circuit, and we found examples of MDL transferee courts all around the country ruling on motions to dismiss master complaints.)

Finally, the defendants raise the practical issue that, if motions directed at pleadings are not decided in a single ruling relating to a master complaint, then the defendant will file identical challenges to the pleadings in each of the hundreds of constituent cases in the MDL. Courts seeking efficiencies should be careful what they ask for; parties will have no choice but to follow court orders.

With luck, the Judge Sippel will certify this appeal, the Eighth Circuit will hear it, and this little glitch in MDL practice will promptly be corrected.

Friday, September 25, 2009

Upcoming Speaking Engagements

The calm of Summer has ended, and that means we'll once again start trotting around the country to give talks. Here's the current line-up for the next three months:

October 2: The two of us will speak to the editors of the American Bar Association's many websites about effective blogging and drawing traffic to a site.

(Pssst: Pick a niche. Keep fresh content flowing. Only be pompous occasionally.

That's it! Now they can cancel the talk!)

October 8: Herrmann will give his hour-long "book talk" about The Curmudgeon's Guide to Practicing Law at the Chicago Bar Association. Here's a link to the details.

October 15: Bexis will speak on a panel at the Product Liability Advisory Council on developments on preemption and pleading.

October 29: Herrmann will participate in a webinar on MDL Litigation and Emerging State Coordination Procedures. Here's a link to the on-line brochure.

November 14: Herrmann will speak on recent developments in preemption at the annual meeting of the American Society of Pharmacy Law.

December 8: Herrmann will be a panelist on "Law in Cyberspace: Legal Blogging and the Courts" at a Northwestern University Judicial Education Program symposium. (That invitation to speak was prompted by our post on the ethics of ex parte blogging, available here for the curious.)

December 9: Herrmann will be a panelist on asserting a preemption defense in the post-Levine, post-Riegel world at the American Conference Institute's 14th Annual Drug and Medical Device Litigation Conference in New York City. Here's a link to the program brochure. (And another link to the discount available for readers of this blog.)

And then it'll be 2010.

'09 sure disappeared in a heartbeat, didn't it?

Thursday, September 24, 2009

Total Recall

We received a copy of Ford Motor Co. v. Reese, ___ S.E.2d ___, 2009 WL 2951299 (Ga. App. Sept 16, 2009) (slip opinion), from Charles Beans over at Goodman McGuffey the other day.


But that’s not a drug or device case.


No it isn’t. But the issue raised in Reese, whether there’s a common-law duty to recall a product that's being legally sold, is a question that can – and has – arisen in prescription drug/medical device cases. In fact that's where these claims originated.


It’s also a topic that we haven’t addressed before – not an easy thing to find after almost three years and over 1,000 posts.


So here goes.


Reese v. Ford involved (surprise, surprise) a car. The plaintiff died when her two-door 1994 Tempo Coupe was hit from behind by a fully-loaded 58,000 pound dump truck. Her lawyers blamed, naturally enough, the car seat. Forget about being rear-ended by a 58,000 pound truck, and knocked over a 371-foot embankment.


One of the plaintiff’s more unusual claims is that Ford should have recalled the car because of the supposed seat back defect – even though no recall had ever been ordered by the federal agency in charge of such things. Fortunately, the Reese court said, “no way, no how,” and joined the vast majority of courts refuse to allow common-law claims for failure to recall a product in the absence of any governmental edict.


For one thing, failure-to-recall claims are barred by the state of the art defense:




[N]o common law duty exists. . .requiring a manufacturer to recall a product after the product has left the manufacturer’s control. Under our products liability jurisprudence, a manufacturer’s duty to implement alternative safer designs is limited to the time the product is manufactured, not months or years later when technology or knowledge may have changed.

2009 WL 2951299, at *3 (citation omitted).


Reese also followed the Restatement (Third) of Torts, Products Liability §11 (1997), which rejects duty to recall claims unless a government-mandated or voluntarily undertaken product recall is negligently conducted. 2009 WL 2951299, at *3.


Finally, the Reese court invoked “important policy concerns” that weighed against allowing common-law claims asserting liability for failure to recall a legally-marketed product:




Because the cost of locating, recalling, and replacing mass-marketed products can be enormous and will likely be passed on to consumers in the form of higher prices, the recall power should not be exercised without extensive consideration of its economic impact. Courts, however, are constituted to define individual cases, and their inquiries are confined to the particular facts and arguments in the cases before them. Decisions to expand a manufacturer’s post-sale duty beyond making reasonable efforts to warn product users about newly discovered dangers should be left to administrative agencies, which are better able to weight the costs and benefits of such action.

Id. at *4 (citation and quotation marks omitted).


The more or less mandatory (both for courts and us) “we aren’t the first court to do this” string citation is found in footnote 4 of the Reese opinion. It cites: Wallace v. Dorsey Trailers Southeast, 849 F.2d 341, 344 (8th Cir. 1988) (applying Missouri law); Stanger v. Smith & Nephew, Inc., 410 F. Supp. 2d 974, 982 (E.D. Mo. 2005); Eschenburg v. Navistar International Transportation Corp., 829 F. Supp. 210, 214-15 (E.D. Mich. 1993); Ostendorf v. Clark Equipment Co., 122 S.W.3d 530, 533-37 (Ky. 2003); Tabieros v. Clark Equipment Co., 944 P.2d 1279, 1295-1301 (Haw. 1997); Gregory v. Cincinnati, Inc., 538 N.W.2d 325, 334-37 (Mich. 1995); Patton v. Hutchinson Wil-Rich Manufacturing Co., 861 P.2d 1299, 1315-16 (Kan. 1993); Modelski v. Navistar International Transportation Corp., 707 N.E.2d 239, 247-48 (Ill. App. 1999).


For the sake of completeness (being the compulsive types we are) we’d have to add to the Reese court’s list the following cases that also reject duty to recall (sometimes masquerading as a “duty to retrofit”) claims: Brown v. Crown Equipment Corp., 501 F.3d 75, 78 (1st Cir. 2007) (applying Maine law); Ahlberg v. Chrysler Corp., 481 F.3d 630, 633 (8th Cir. 2007 (applying Iowa law); Menz v. New Holland North America, Inc., 440 F.3d 1002, 1005 (8th Cir. 2006) (applying Missouri law); Kinser v. Gehl Co., 184 F.3d 1259, 1270 (10th Cir. 1999) (applying Kansas law); Horstmyer v. Black & Decker, (U.S.), Inc., 151 F.3d 765, 883-74 (8th Cir. 1998) (applying Missouri law); Anderson v. Nissan Motor Co., 139 F.3d 599, 602 (8th Cir. 1999) (applying Nebraska law); Burke v. Deere & Co., 6 F.3d 497, 508 n.16 (8th Cir. 1993) (applying Iowa law); Romero v. International Harvester Co., 979 F.2d 1444, 1450 (10th Cir. 1992) (applying Colorado law); Habecker v. Copperloy Corp., 893 F.2d 49, 54 (3d Cir. 1990) (applying Pennsylvania law); Smith v. Firestone Tire & Rubber Co., 755 F.2d 129, 135 (8th Cir. 1985) (applying Missouri law); Syrie v. Knoll International, 748 F.2d 304, 311-12 (5th Cir. 1984) (applying Texas law); Kladivo v. Sportsstuff, Inc., 2008 WL 4933951, at *5 (D. Minn. Sep. 2, 2008); Bear v. Ford Motor Co., 2007 WL 870344, at *3 (E.D. Wash. Mar. 20, 2007); Robinson v. Brandtjen & Kluge, Inc., 2006 WL 2796252, at *8 (D.S.D. Sep. 27, 2006); Hammes v. Yamaha Motor Corp. U.S.A., Inc., 2006 WL 1195907, at *11 (D. Minn. May 4, 2006); Campbell v. Gala Industries, Inc., 2006 WL 1073796, at *5-6 (D.S.C. Apr. 20, 2006); Wicker v. Ford Motor Co., 393 F. Supp.2d 1229, 1236-37 (W.D. Okla. 2005); Morales v. E.D. Etnyre & Co., 382 F. Supp.2d 1285, 1287 (D.N.M. 2005); Hernandez v. Ford Motor Co., 2005 WL 1574474, at *1 (S.D. Tex. June 28, 2005); Padilla v. Black & Decker Corp., 2005 WL 697479, at *7 (E.D. Pa. Mar. 24, 2005); Eberts v. Kawasaki Motors Corp., U.S.A., 2004 WL 224683, at *2 (D.N.D. Feb. 2, 2004); Berczyk v. Emerson Tool Co., 291 F. Supp.2d 1004, 1006 (D. Minn. 2003); Citizens Insurance Co. of America v. Sears Roebuck & Co., 203 F. Supp.2d 837, 843 (W.D. Mich. 2002); Flock v. Scripto-Tokai Corp., 2001 WL 34111725, at *8-9 (S.D. Tex. Sep. 11, 2001); Smith v. BOC Group PLC, 2001 WL 477237, at *5 (N.D. Ill. May 4, 2001); Efting v. Tokai Corp., 75 F. Supp.2d 1006, 1010-11 (W.D. Mo. 1999); Davidson v. Besser Co., 70 F. Supp.2d 1020, 1027 (E.D. Mo. 1999); McDaniel v. Bieffe USA, Inc., 35 F. Supp.2d 735, 743 (D. Minn. 1999); Langehennig v. Sofamor, Inc., 1999 WL 1129683, at *8 (D. Kan. May 28, 1999); Boyer v. Case Corp., 1998 WL 205695, at *2 (E.D. Pa. Apr. 28, 1998); Leslie v. United States, 986 F. Supp. 900, 913 (D.N.J. 1997); McAlpin v. Leeds & Northrup Co., 912 F. Supp. 207, 212 (W.D. Va. 1996); Buettner v. Super Laundry Machinery, 857 F. Supp. 471, 477 (E.D. Va. 1994), aff’d, 47 F.3d 116 (4th Cir. 1995); Spence v. Miles Laboratories, Inc., 810 F. Supp. 952, 958-59 (E.D. Tenn. 1992); Strunk v. Lear Siegler, Inc., 1992 WL 295042, at *3-4 (D. Kan. Sep. 22, 1992); Butler v. Navistar International Transportation Corp., 809 F. Supp. 1202, 1209-10 (W.D. Va. 1991); Girard v. Allis Chalmers Corp., 787 F. Supp. 482, 486 n.3 (W.D. Pa. 1992); Kimmel v. Clark Equipment Co., 773 F. Supp. 828, 829-30 (W.D. Va. 1991); Moorehead v. Clark Equipment Co., 1987 WL 26158, at *2-3 (N.D. Ill. Dec. 2, 1987); National Women’s Health Network, Inc. v. A. H. Robins Co., 545 F. Supp. 1177, 1181 (D. Mass. 1982); Loredo v. Solvay America, Inc., 212 P.3d 614, 632 (Wyo. 2009); Lovick v. Wil-Rich, 588 N.W.2d 688, 696 (Iowa 1999); Ramirez v. Plough, Inc., 863 P.2d 167, 177-78 (Cal. 1993); Patton v. Hutchinson Wil-Rich Manufacturing Co., 861 P.2d 1299, 1315-16 (Kan. 1993); Rogers v. Clark Equipment Co., 744 N.E.2d 364, 370 (Ill. App. 2001); Winn v. Pollard, 62 S.W.3d 611, 617 (Mo. App. 2001); Bragg v. Hi-Ranger, Inc., 462 S.E.2d 321, 331 (S.C. App. 1995); Dion v. Ford Motor Co., 804 S.W.2d 302, 310 (Tex. App.1991); Lynch v. McStome, 548 A.2d 1276, 1281 (Pa. Super. 1988); Smith v. Daimlerchrysler Corp., 2002 WL 31814534, at *6 (Del. Super. Nov. 20, 2002); Grant v. Bridgestone/Firestone, Inc., 55 Pa. D. & C.4th 438, 445-46 (Pa. C.P. Philadelphia Co. 2001) Engle v. BT Industries AB, 41 Pa. D. & C.4th 25, 27 (Pa. C.P. Dauphin Co. 1999).


Naturally, we’re most interested in the recall cases involving prescription medical products. There are five of them. The oldest is National Women’s Health Network from way back in 1982. That’s the oldest duty-to-recall decision of any sort that we’ve found – so it looks like our neck of the woods originated both duty to recall claims and their judicial rejection. NWHN first examined state (Massachusetts) law and concluded “[n]o court has ever ordered a notification and recall campaign on the basis of state law.” 545 F. Supp. at 1181. The court also invoked preemption – holding that the power to recall federally-approved products (the case involved a pre-1976 medical device) properly rested solely with the FDA:



I am also persuaded that even if there were state law authority for a notification and recall campaign, such authority would be preempted by the FDCA for the same reasons that there is no implied right of action. . . . Especially in view of the 1976 amendment to the FDCA which specified the powers of the Secretary in regulating medical devices, any state law which would put these same powers in other hands must be deemed foreclosed. . . . Congress intended the Secretary of the FDA to have discretion as to when to seek recall. Since the federal interest in this area is “dominant” and the regulatory scheme is “pervasive,” preemption must follow.


Id. at 1181 (citations omitted). See also Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir. 2005) (“[a]ny claim. . .that Defendant. . .failed to recall a product” would “not parallel federal safety requirements” and was preempted) (applying Ohio law); In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147, 1159 (D. Minn. 2009) (finding failure to recall claim preempted without determining its viability under state law); Hunsaker v. Surgidev Corp., 818 F.Supp. 744, 755 (M.D. Pa. 1992) (failure to recall claim preempted). Of course, the non-existence of state law failure-to-recall claims impacts modern “parallel claims” preemption analysis – if there’s no analogous state-law failure to recall claim, then a “violation” claim making the same claim has no state law parallel, and it’s merely an improper (and preempted) attempt to assert an FDCA violation under the guise of state law. We discussed that concept at some depth here, among other places.


The Ramirez decision by the California Supreme Court, we hasten to point out, deals with an OTC – not a prescription – drug. But key facts demonstrate its relevance to prescription drugs. Specifically, the court declined to recognize any common-law duty to withdraw a product from the market where the relevant federal agency, the FDA, had not ordered such an action:




We conclude, however, as a matter of law, that defendant may not be held liable for failing to withdraw its product from the mark . . . . A few scientific studies had shown an association between [the product] and [the condition] but the methodology of those studies had been questioned and the FDA had determined that further studies were needed to confirm or disprove the association. Pending completion of those studies, the FDA concluded that product warnings were an adequate public safety measure. Although the FDA’s conclusion is not binding on us, we think it deserves serious consideration.

863 P.2d at 177-78. Thus the California Supreme Court opted for the rule later embraced by Third Restatement §11, that unless and until the relevant federal agency orders a recall, there’s no common-law duty to anticipate that action. Notably, the salience of the FDA’s action in Ramirez was not mandated by preemption, but rather by the court’s deference to the Agency as a matter of state-law jurisprudence. Ramirez is doubly important because it demonstrates the error, at least with respect to the drug/device area, of an outlier decision by one of that state’s intermediate courts (sound familiar?) that purported to recognize a duty to retrofit. See Hernandez v. Badger Construction Equipment Co., 34 Cal.Rptr.2d 732, 754 (Cal. App. 1994).


The Spence case involves an FDA-regulated biological product – human blood. The state of Tennessee passed an AIDS testing statute for blood products, and the plaintiff argued that the passage of the statute created some implied duty to recall all blood that had been collected before the advent of the subsequently mandated tests. Despite that statutory hook, the court refused to recognize a common-law duty to recall:



[The defendant] supplied the [blood product] to the hospital before the effective date of [the statute]. There is nothing in the language of the statute that evidences an intent to require manufacturers and suppliers of blood products to recall and test a product already on the market before the statute took effect.


810 F. Supp. at 958-59.


Most recently a duty to recall claim got the boot under Missouri law in Stanger:



[T]here is no cause of action for negligent recall. There is no indication, by case law, statute, or otherwise, that. . .create[s] a common law duty to recall. Moreover, in light of the fact that there is no recognized duty to recall, we hold such a duty cannot arise as a result of defendant’s voluntary undertaking to recall certain of its products. . . .[I]n order for [plaintiffs] to pursue a negligent recall claim, the defect in the product would have had to exist at the time the product left defendant’s control and entered the stream of commerce. Absent a mandated recall by a governmental agency, defendants had no duty to recall.
401 F. Supp.2d at 982 (citation and quotation marks omitted).


Lastly, Langehennig, holding that there was no duty to recall a prescription medical device after supposedly “discovering” its “dangerous nature,” was pretty much a run-of-the-mill application of state law. The relevant state supreme court (Kansas) had already rejected any duty to recall in another context. 1999 WL 1129683, at *8 (citing Patton, 861 P.2d 1299).


So while we’re on the subject of recalls, what else can we say about them in the context of prescription medical products? Well, for one thing, a product recall that occurs after the time of a plaintiff’s injury is subject to exclusion as a subsequent remedial measure. Kehm v. Procter & Gamble Manufacturing Co., 724 F.2d 613, 622 & n.7 (8th Cir. 1983) (manufacturer instituted recall; admission allowed under pre-1997 version of Fed. R. Civ. P. 407); Figueroa v. Boston Scientific Corp., 2003 WL 21488012, at *4-5 (S.D.N.Y. June 27, 2003) (FDA mandated recall); In re Propulsid Products Liability Litigation, 2003 WL 1090235, at *2 (E.D. La. March 11, 2003) (manufacturer instituted recall); Kociemba v. G.D. Searle & Co., 683 F. Supp. 1579, 1581-82 (D. Minn. 1988) (manufacturer instituted recall); Richardson-Merrell, Inc. “Bendectin” Products Liability Litigation, 624 F. Supp. 1212, 1239 (S.D. Ohio 1985), aff’d, 857 F.2d 290 (6th Cir. 1988) (manufacturer instituted recall); Wolf v. Procter & Gamble Co., 555 F. Supp. 613, 623 (D.N.J. 1982) (manufacturer instituted recall); Cosgrove v. Merrell Dow Pharmaceuticals, Inc., 788 P.2d 1293, 1296-97 (Idaho 1989); Hardin v. Upjohn Co., 47 Pa. D. & C.3d 66, 70 (Pa. C.P. Philadelphia Co. 1986) (FDA mandated recall).


There’s law that private plaintiffs cannot supplant the FDA and demand court-ordered recall notices or similar statements be sent to members of the public. These cases are usually decided on grounds of FDA primary jurisdiction. Clark v. Actavis Group hf, 567 F. Supp.2d 711, 716-17 (D.N.J. 2008); In re Human Tissue Products Liability Litigation, 488 F. Supp.2d 430, 431-32 (D.N.J. 2007), Bernhardt v. Pfizer, 2000 WL 1738645, at *3 (S.D.N.Y. Nov. 22, 2000).


We’ve also seen precedent stating that the mere fact of a product recall does not establish non-compliance with FDA regulations. Horowitz v. Stryker Corp., 613 F. Supp.2d 271, 282 (E.D.N.Y. Feb. 20, 2009); Sprint Fidelis, 592 F. Supp.2d at 1162. Nor does a recall, by itself, create a state law cause of action. Myers-Armstrong v. Actavis Totowa LLC, 2009 WL 1082026, at *4 (N.D. Cal. April 22, 2009) (on grounds of “the shortness of life”); Loomis v. Medtronic, Inc., 2005 WL 1828763, at *5 (N.D. Ohio Aug. 1, 2005); Dunn v. Sandoz Pharmaceuticals Corp., 275 F. Supp.2d 672, 683-84 (M.D.N.C. 2003) (recall can’t establish causation); Drury v. Cardiac Pacemakers, Inc., 2003 WL 23319650, at *4 (M.D. Fla. June 3, 2003) (same); Jensen v. Bayer AG, 862 N.E.2d 1091, 1098-99 (Ill. App. 2007); Arons v. Rite Aid Corp., 2005 WL 975462, at *10 (N.J. Super. L. Mar. 23, 2005) (breach of warranty).


Finally, there’s precedent that, for purposes of preemption, a recall does not deprive a prior pre-market approval of a medical device of its preemptive force. Sprint Fidelis, 592 F. Supp.2d at 1155-56; Bausch v. Stryker Corp., 2008 WL 5157940, at *3 (N.D. Ill. Dec. 9, 2008); Theofanis v. Boston Scientific Corp., 2003 WL 24049229, at *2 ¶16 (S.D. Ind. June 24, 2003); Blanco v. Baxter Healthcare Corp., 70 Cal. Rptr.3d 566, 579-80 (Cal. App. 2008); Mitaro v. Medtronic, Inc., 2009 WL 1272398, at *3 (N.Y. Sup. Apr. 9, 2009).


Anyway, now we’ve got all our recall-related material in one place so we can find it easily whenever we need it.


And so do our readers.

Wednesday, September 23, 2009

New Article On Free Speech and FDA "Intended Use" Regulations

There's an interesting new article in the current issue of the Food and Drug Law Journal, entitled "Criminalizing Knowledge: The Perverse Implications of the Intended Use Regulations for Off-Label Promotion Prosecutions." The author is blog reader Greg Gentry at Morrison Mahoney. Here's a link, to a reprint posted with the permission of the FDLI, which publishes the journal. The F.D.L.J. citation is 64 Food & Drug L.J. 441.

The article examines the FDA's "intended use" regulation, 21 C.F.R. §201.128 (for drugs) and 21 C.F.R. § 801.4 (for devices) (both identically worded), and concludes that they can't possibly actually mean what they say. That's because a literal reading would criminalize mere awareness by a regulated manufacturer that doctors were likely to use its product off-label:
[I]f a manufacturer knows, or has knowledge of facts that would give him notice that a [drug/device] introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a [drug/device] which accords with such other uses to which the article is to be put.

Such "adequate" labeling, of course, can't be added for a new use without going through the FDA's entire drug/device approval process. Given how widespread off-label use is, many manufacturers would have to be wilfully blind not to know of such use. For one thing, they have to collect and submit adverse event reports, whether or not the use involved was a labeled one.

The thesis of the article is that this is a "Catch-22 regulation" that can't possibly be (and hasn't been) enforced as written without both violating the First Amendment rights of free speech and and the statutory rights of doctors to engage in off-label use. For one thing, "objective intent" is an oxymoron, describing something unknown to the law.

The article looks at the FDA's enforcement history and concludes that until 1995 (during the regime of bureaucratic empire builder Commissioner Kessler), the FDA had confined itself pretty consistently to "actual statements made by a manufacturer in the marketplace about its product." 65 F.D.L.J. at 445, see id. at 449-52. There's also FDCA legislative history we haven't seen compiled anywhere else. Id. at 446-48.

We were involved in off-label issues then, and we agree wholeheartedly. For this and lots of other reasons, we recommend this latest scholarship to anyone interested in scientific and corporate free speech issues - especially with respect to off-label use.

Tuesday, September 22, 2009

1000 Posts!

Today's post marks a milestone for us: This is our 1000th post at the Drug and Device Law Blog!
That's 1000 posts in not quite three years, or better than 5 posts in an average week.

We're cookin'!

But enough about us; let's talk about you.

We see you! If you subscribe to our blog (other than by an RSS feed), we see your e-mail address. If you arrive here from the web, we see the search term that brought you to us. If you subscribe by Twitter, we see your user name and the icon (or photograph) by which you identify yourself on-line.

(You could confuse us with the all-powerful Oz.)

Here's what we see. First, about the subscribers:

We currently have over 1000 subscribers to this blog (in addition to 20,000 to 25,000 visitors who find us through the web every month, but who don't subscribe). Nearly 500 folks subscribe through the Google e-mail group; nearly 250 through an RSS feed; and over 300 through Twitter.

Members of our Google e-mail group include a lot of defense lawyers at firms that resemble ours, a fair number of plaintiffs' lawyers or folks affiliated with public interest groups, a bunch of people who work at drug or device companies, law professors and students (or at least people who log on at domain names associated with universities), and lots of people with generic e-mail accounts that don't tell us anything, such as aol.com or gmail.com

We've noticed that our Twitter subscribers are -- how can we phrase this delicately? -- more eclectic than those who subscribe through RSS feeds or the Google group. We can't explain that, but we suspect that Twitter is a bit different from other social media.

What's bringing those folks to us, do you suppose? The fact that the word "drug" is in the title of our blog, or are they simply indiscriminate Twitter "followers"?

(Please don't get us wrong here. If one of our Twitter "followers" happens to be the general counsel of a major pharmaceutical company, then we'd be delighted to make your acquaintance. We're actually flattered by your attention and would like to schedule an appointment with you to discuss our firms' capabilities.)

Second, about search terms:

It's no surprise that a disproportionate number of people find us by plugging the words "drug and device law" into Google. (We assume those are people who have mastered Google, but haven't yet figured out how to subscribe to a blog. Believe us -- despite the apparent technical sophistication of this blog, we empathize with you.)

Many folks find us by searching for the name of a case. We assume those are lawyers doing legal research.

If we mention the name of a law firm (or a company) in a post, we tend to get a bunch of visitors from that firm (or company). We assume those people are receiving Google "alerts" noting that their institutions have been mentioned on-line, so they've come to take a look.

A few people also search for this blog by author. Don't do it!

When you plug "Beck blog" into Google, you annoy Herrmann, and when you type "Herrmann blog" into Google, you piss off Beck.

Don't stir up trouble behind your computer screen! Keeping this *!**!! blog going is hard enough without you throwing fuel on the fire. Just type "Beck and Herrmann." (Or, maybe, occasionally, "Herrmann and Beck"; fair is fair.) We'll be first up in your search results, and you'll avoid creating dissension in the ranks.

Finally, we've recently heard from two readers about subjects we thought we'd share with you.

Many of our posts are dated as of 5:00 a.m. on the day they're published. A reader asked whether we're really up that early in the morning.

Nah! We're bluffing.

Blogger -- the platform for this blog -- lets us draft posts in advance and schedule them for publication at a pre-set time. (That's what makes it look as though we're tending to this blog even on days when we're both pinned down in meetings or at depositions.) We tend to schedule the pre-written posts to appear at 5:00 a.m. blog time, which corresponds to 8:00 a.m. on the east coast. We figure that publishes posts at an early, but civilized, time for many of our readers.

Finally, a plaintiffs' lawyer called us recently with a tip for the blog. We asked if he'd like us to recognize him on-line for having provided the tip. He was horrified:

"Don't name me! I'm a plaintiffs' lawyer! The whole plaintiffs' bar will hold it against me if they find out I called you. Around here, we call you guys 'the Voldemorts.'"

Thanks!

We're flattered!

With that kind of encouragement, there's a chance we'll still be publishing at post number 2000!

Monday, September 21, 2009

Odd Evidentiary Ruling in Philadelphia Paxil Trial

There's a Paxil birth defect trial going on in Philadelphia right now. Neither of our firms are involved in it - but that doesn't mean we're not interested. According to a Bloomberg report from last Friday, a plaintiff witness who once worked for the defendant was permitted to testify that some unknown person had made a "note in the company's files" that a different birth defect incident (not part of this suit) was "likely linked" to the drug. This phantom declarant testimony was allowed even though the witness giving it admitted that what happened might have been a "mistake" and that the phantom could have "checked the box wrong."

That evidentiary ruling, assuming Bloomberg accurately reported it, leaves us scratching our heads. It's blatant hearsay, and since the regularity of the statement by the phantom declarant (and the requisite authority) was obviously unproven, it can't plausibly be considered a business record.

That would leave "admission of a party opponent" as the only other ground for letting that in.

But in Pennsylvania, the law is pretty clear that phantom declarant admissions aren't admissible. In Harris v. Toys “R” Us-Penn, Inc., 880 A.2d 1270 (Pa. Super. 2005), a unanimous panel held that the purported "admission" of a phantom employee that he hadn't "put up right" a carton that later fell off a shelf and hit the plaintiff was inadmissible. To establish an admission, the proponent of the evidence must show "that the declarant was an employee of the principal at the time the statement was made, and the statement concerned a matter within the scope of employment." Id. at 1277. "[I]ncomplete and confusing" testimony that fails to establish the scope of an unknown person's employment doesn't allow admission. Id. Otherwise, opponents could, frankly, make people (or the scope of their employment) up:
In the instant case, the trial court did not accept Appellant's argument in favor of the admissibility of the statement, in part because of doubts as to the credibility of the testimony. . . . This decision was a proper exercise of the gatekeeping function of the judge. Without this safeguard, parties could present to the jury any statements that they assert are admissions by their opponents, effectively gutting the hearsay rule.

Id. at 1278.

That seems like the same problem in the Paxil case. Some box got checked by somebody. Nobody knows who. Nobody can say that the phantom declarant had any right to enter data either in either that document or more generally in the computer system. Admittedly, the information could be wrong. The mystery person might even have been a hacker (although we hope not), for all we know - which is nothing.

Admitting hearsay "admissions" by unknown, unidentified persons has no guarantee of genuineness and implicates all the jurisprudential policies that brought about the creation of the hearsay rule in the first place. This phantom also goes by another name - "reversible error."

Recent Scholarship Roundup

Here's more news from the academy that you might find to be useful:

First, Professors Kevin Clermont (Cornell) and Stephen Yeazell (UCLA) level both barrels at two of our favorite cases, Bell Atlantic v. Twombly and Iqbal v. Ashcroft. The "point of th[eir] Article is that wherever you stand on pleading -- even if you think the federal litigation system is wildly out of control with many frivolous suits, or instead if you think the role of pleading should be further purified to eliminate all of its screening function -- you should find these recent decisions lamentable." Here's a link to the SSRN page, which in turn links to the article, "Inventing Tests, Destabilizing Systems." At times like this, we wish we could pry ourselves free from client work to go into the business of writing rebuttals.

On the other hand, we're happy to stick to client work when we read gems such as A. Mitch Polinsky (Stanford) and Steven Shavell's (Harvard) "The Uneasy Case for Product Liability" (SSRN link here). These sagacious fellows conclude that, if their analysis is accepted, then product liability "should be substantially curtailed or even abolished, at least for widely sold products." Not, bad, huh? And that puppy is forthcoming in the Harvard Law Review. Here's the entire abstract:

"We explain in this Article that the benefits of product liability may well be outweighed by its costs in a wide range of circumstances. One benefit is that the threat of liability may induce firms to improve product safety. However, this benefit is limited: even in the absence of product liability, firms would often be motivated by market forces to enhance product safety because their sales are likely to fall if their products harm consumers; moreover, their products must frequently conform to safety regulations. Consequently, product liability might not be expected to exert a significant additional influence on product safety — and the available empirical evidence suggests that such liability does not in fact have a measurable effect on the frequency of product accidents. A second benefit of product liability is that it causes product prices to increase to reflect the riskiness of products and thereby may improve consumer purchase decisions. But this benefit also involves a detriment, because product prices may rise excessively and undesirably chill purchases. A third benefit of product liability is that it compensates victims of product-related accidents for their losses. Yet this benefit is only partial, for accident victims are already often compensated by their insurers for some or all of their losses. Potentially offsetting the benefits of product liability are its costs, which are great. To transfer a dollar to a victim of a product accident requires more than a dollar on average in legal expenses. Given the limited benefits and the high costs of product liability, we conclude that it may be socially undesirable — especially for widely sold products, with respect to which market forces and regulation are relatively strong. This judgment is in tension both with the broad social endorsement of product liability and with proposals for its reform, which generally do not question its existence. Our more critical assessment of product liability stems from the fact that we engage in an analysis of its benefits and costs, whereas neither the proponents of product liability nor its reformers undertake to do so."

Finally, there's "Jackpot Justice: Verdict Variability and the Mass Tort Class Action" (SSRN link here) by Byron Stier (Southwestern). The issue of the Temple Law Review containing the article is dated 2007, But Stier reports that the article was just published this year. That article criticizes certifying a class and thus having one jury adjudicate the result of many mass tort cases. Instead, Stier advocates "the use of multiple juries in individual cases [as] a superior method of resolving a mass tort." Here's the entire abstract:

"Mass tort scholars, practitioners, and judges struggle with determining the most efficient approach to adjudicate sometimes tens of thousands of cases. Favoring class actions, mass tort scholars and judges have assumed that litigating any issue once is best. But while litigating any one issue could conceivably save attorneys' fees and court resources, a single adjudication of thousands of mass tort claims is unlikely to further tort goals of corrective justice, efficiency, or compensation in a reliable way. That is because, as recent empirical research on jury behavior shows, any one jury's verdict may be an outlier on a potential bell curve of responses applying the law to the facts before it. Indeed, one aberrational, high jury claim valuation, if extrapolated to thousands of claims through a class action, may inappropriately bankrupt an entire industry. Similarly, one unusually low jury verdict might deny legions of plaintiffs the compensation that they deserve. To illustrate the problems of attempting to resolve a mass tort with a single jury, this Article discusses the Engle tobacco class action of Florida smokers, where the application of a single jury verdict to approximately 700,000 smokers appears to be an outlier verdict in light of prior juries' verdicts in Florida tobacco cases. In contrast, this Article argues that the use of multiple juries in individual cases is a superior method of resolving a mass tort. While the use of multiple juries in class actions to create statistically cobbled claim values has been rejected as violating due process and state tort law, no such problems accompany the approach espoused here: that individual-plaintiff lawsuits, each with its own jury, be tried and that the jury verdicts be used by mass tort litigants to develop claim values for broad mass tort settlement. In addition to remaining within the strictures of constitutional and tort law, this clustering of multiple juries around an accurate valuation of mass tort claims and the resulting likely settlement furthers both the procedural goal of litigant autonomy and the tort aims of efficiency, corrective justice, and compensation."

We hope you find our occasional trips into the scholarly literature to be useful.

(We figure most of you are breathing a sigh of relief: "Better them than me!")

Friday, September 18, 2009

Get 40% Off - Bexis' Book On Drug/Device Product Liability

Last week we came through for our readers with a $200 discount to ACI's Drug/Medical Device Conference.

This week, we've gotten Law Journal Press, the publisher of Bexis' book - officially Beck & Vale, "Drug & Medical Device Product Liability Deskbook," (LJP 2004) - to offer it to blog readers at a 40% discount. That's a more than a $100 savings from its ordinary price of $259.

If you like heavily-cited posts like the Limits to Duty essay we put up yesterday, then you'll love Bexis's book. That post discussed the contents of about three footnotes from the book - and the book is more than 700 pages of the same kind of stuff. It covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated products, and it's been updated twice a year ever since 2004 so that everything's current (more work for Bexis).

Interested? If you're involved in product liability litigation involving drugs and medical devices, you should be. To order Bexis' book and save 40%, go to LawCatalog.com, and be sure to use promo code 2121663 at checkout to get your discount. It's for blog readers only, and won't be mentioned anywhere else.

NYT On Accusations Of Ghostwriting

We don't typically re-publish here accusations that are unhelpful to the pharmaceutical industry.

But we figure once something has appeared on the front page of the business section of The New York Times, our blog has little power to add or detract.

So defense lawyers interested in accusations of ghostwriting of articles published in medical journals should click this link to "Medical Editors Push for Crackdown on Ghostwriting" from today's Times.

(Plaintiffs' lawyers: We're sorry to report that the previous link is broken. No reason to bother with it.)

Here's a link to PhRMA's principles on, among other things, the subject of giving authorship credit for articles. We are told that these principles "make ghostwriting a thing of the past."

Thursday, September 17, 2009

Limits to Duty

A couple of cases we’ve posted about recently started us thinking – a dangerous turn of events, we know. There was that Beaumont Hospital case involving allegations about delivery of an incorrect free sample of a device. If somebody – anybody – at the hospital had simply looked at the thing, either when it was initially stored or later when it was taken back out for use, the error would have been readily apparent from the labeling, and the injury would never have occurred. See Johnson v. Settle, 2001 WL 585093, at *8 (Tenn. App. Oct. 29, 2001) (proper labeling trumped erroneous shipment of wrong medical product; incorrect use of properly labeled product held not reasonable foreseeable).


Then there’s the Kovach case, where the plaintiff tried to blame the maker of a measuring cup for a two-fold drug overdose – a whole cup rather than a half. Given the size of the overdose, no alleged illegibility of the little lines on the cup could possibly have made the slightest difference in the result.


What’s going on in those cases is the same thing we’ve already commented about in the context of the big preemption cases, Wyeth v. Levine, 129 S. Ct. 1187 (2009), and Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008) – and elsewhere. These days, a lot of cases that would once have been brought as medical malpractice cases are instead being repackaged (some better than others) as product liability cases. That may be due to strict liability being a less rigorous theory of liability than medical negligence (although our side tries every day trying not to let that happen), or it may be that there’s simply more money in product liability – usually due to malpractice damage caps. Or it could simply be that plaintiffs often would rather settle with the doctor (who's an flesh-and-blood person that a jury may like) and take their chances with a large corporate defendant instead.


Whatever the reason for this phenomenon, it’s got us thinking about the limits to duty. We love doctors. They save people’s lives every day – that's their job – and not incidentally they prescribe our clients’ products while doing that. But what happens when a doctor, as human as any of the rest of us, messes up? Do drug/device manufacturers have a legal duty to act as backstop where a doctor (or other healthcare provider) does something obviously wrong like not checking for drug interactions or failing to sterilize surgical instruments properly?


Not surprisingly, we don’t think so. A couple of cases, one relatively old and one relatively recent, illustrate the problems with imposing such liability on drug and device manufacturers.


The older case is Swayze v. McNeil Laboratories, Inc., 807 F.2d 464 (5th Cir. 1987). We were only baby lawyers back then. In Swayze, the plaintiff allegedly died from an overdose of surgical anesthetic. As stated in the opinion, “[d]uring the operation, a nurse anesthetist determined what dosage to administer [decedent] without receiving proper supervision from an anesthesiologist or the supervising surgeon.” Id. at 465. So did plaintiff sue the nurse and the surgeon? Yes, but plaintiff settled. Id.


There was nothing wrong with the drug’s labeling. It stated all the dosages correctly as well as the consequences of overdose. Plaintiff didn’t really contest that point, but argued instead that improperly supervised use of the anesthetic was “pervasive” among doctors, and thus the defendant could be liable for not “doing more to compel the medical community to properly supervise distribution of its drug.” Id. In blunter terms, the plaintiffs were advocating that drug companies should be medical police, that they had some legal duty to alter or control what doctors did.


Thankfully the court in Swayze essentially said “you’ve got to be kidding” – although it took its sweet time about it, not dismissing the case until a directed verdict motion at the end of the plaintiff’s case. On appeal, the court likewise rejected the plaintiff’s claim that, legally, “more should have been done to force physicians to supervise distribution of the drug.” 807 F.2d at 468.



We have two problems with the plaintiff’s position. First, it is the operating room procedure rather than the danger of the drug that the defendant is challenged to add to the warning. And, second, though defendant markets a reasonably safe product when accompanied by a prudent warning of its danger, we are asked to impose upon defendant an additional duty to intrude itself into the hospital operation as well as the doctor-patient relationship. We see no warrant for that position.


Id. The court found no legal duty for a manufacturer to “enforce” its warning. Once adequate warning is given, no more is legally required of the manufacturer. There was no duty to warn patients directly that doctors could use drugs negligently:




But what would patients do with this information? It might prompt would-be patients to put pressure on their physicians to better supervise, but physicians hardly need more incentive to be non-negligent. In all likelihood, such warnings would only lead to confusion, and perhaps undermine the physician-patient relationship. When the physician-patient relationship does exist, as here, we hesitate to encourage, much less require, a drug manufacturer to intervene in it.

Id. at 471. Nor was there any duty for a manufacturer to act as “big brother” to prescribing physicians:




[T]his practice does not occur in every operating room. . . . It is both impractical and unrealistic to expect drug manufacturers to police individual operating rooms to determine which doctors adequately supervise their surgical teams.


Id. Finally, no common-law duty existed to require a drug company to remove its product from the market simply because doctors didn’t use it properly:




The problem here lies with individual physicians, in certain operating rooms. . . . The defendant cannot control the individual practices of the medical community, even if it is the prevailing practice, and we decline to impose such a duty. Drug manufacturers must adequately warn physicians of the potential side-effects of their prescription drugs; thereafter, the physician, with his special knowledge of the patient's needs, assumes the burden of presiding over the patient's best interests.

Id. at 472.


The more recent case (and another of Bexis’ PLAC amicus projects) is Kennedy v. Medtronic, Inc., 851 N.E.2d 778 (Ill. App. 2006). In Kennedy the doctor implanted a pacemaker, but incorrectly placed the lead in the wrong part of the heart. According to the opinion, he “admitted he deviated from the standard of care” in doing this. Id. at 780-81. There were other alleged oddities about the surgery, such as it being done on an “outpatient” basis at a just-opened clinic, the surgical assistant being unqualified (he was a dentist) and no record being kept of the patient’s vital signs. Id. at 780.


Sounds like a malpractice case, doesn’t it.


Well, a manufacturer’s representative was present for the surgery – to make sure the device was “correctly calibrated” and “functioning properly” – a service that the defendant routinely provided. 851 N.E.2d at 781. The representative “did not assist the doctor in inserting the pacemaker and lead and could not make a judgment as to whether the lead was placed in the appropriate ventricle,” a fact not in dispute. Id. The plaintiff’s theory of liability against the manufacturer was that, the corporate representative had a duty “to refrain from providing a pacemaker to [the surgeon] and from participating in the insertion of the pacemaker” because of its outpatient nature and lack of post-operative recovery facilities.” Id. at 782. It was another, somewhat more sophisticated variant of Swayze – that the manufacturer should have somehow prohibited the doctor from proceeding with the surgery. Id. (plaintiff claimed that without the representative’s calibration, the surgery could not have been conducted).


Again the court said no – this time on summary judgment. 851 N.E.2d at 782. Again the appellate court affirmed. The court of appeal found no legal duty to refrain from providing a medical device because of the doctor’s allegedly improper practice of medicine. The corporate representative was “not responsible” for the conduct of the surgery. Id. at 785.




[T]he burden and consequences of imposing the duty proposed by plaintiff [would] be substantial. It would be a significant burden to require [a manufacturer] to monitor the conditions under which a doctor performs surgery. . . . [A] central aspect of the learned intermediary doctrine. . .is that a licensed physician. . .has the knowledge of his patient’s medical history and background, and, therefore, he is in a better position, utilizing his medical judgment, to determine a patient’s needs and what medical care should be provided. It would be unreasonable, and potentially harmful, to require a [manufacturer’s representative] to delay or prevent a medical procedure simply because she believes the setting is not appropriate or the doctor is unqualified. To hold otherwise would place a medical device manufacturer. . .in the middle of the doctor-patient relationship. . . . Finally, as pointed out by amicus [PLAC], the consequences of requiring such screening by [defendant] would run the risk of imposing additional liability on the manufacturer in the event it determined a physician was not in a position to properly implant a device, refused to provide one, and the patient suffered adverse medical consequences because he did not have access to a needed device.

Id. at 786. That’s three reasons for refusing to recognize a duty: (1) the interference with the physician/patient relationship; (2) the utter impracticality of requiring manufacturers to ride herd over doctors; and (3) the damned if you do/damned if you don’t quality of liability – that the manufacturer could also be liable for injuries to a patient if it withheld a prescribed product.


Nor did a manufacturer voluntarily assume (Restatement Second §324A) any duty by having a representative present during surgery:




[The representative] attended the surgery to provide technical support and ensure that the [device was] correctly calibrated and. . .functioning properly. This limited role did not entail her voluntarily assuming a duty. . .for the placement of the lead into the correct ventricle of the patient's heart.

851 N.E.2d at 787.


These two cases, Swayze and Kennedy, accurately delimit the duties of drug and medical device companies – they are not obligated to tell doctors how to practice medicine. That extends to “matter[s] of general and elemental medical knowledge.” Plenger v. Alza Corp., 13 Cal. Rptr.2d 811, 819 (Cal. App. 1992). We’ve already discussed one aspect of this rule, that there’s no duty to warn doctors about first-year medical student information such as complications caused by notorious conditions such as high blood pressure or diabetes. See the “second hypothetical” in that post.


The issue of how much duty is too much has also arisen elsewhere. Allegations of liability for not providing extremely detailed medical monitoring instructions were rejected in In re Meridia Products Liability Litigation, 328 F. Supp.2d 791, 814 (N.D. Ohio 2004) (“[t]he law does not mandate that pharmaceutical manufacturers and marketers provide such specific instructions that they leave little room for doctors’ reasonable medical judgment”), aff’d, 447 F.3d 861 (6th Cir. 2006). “[S]uch judgments,” the court held, “are often better left to the doctors’ discretion.” Id. Similarly, liability for failure to tell doctors how to diagnose side effects was rejected in Nichols v. Clare Community Hospital, 476 N.W.2d 493, 495 (Mich. App. 1991) (a “manufacturer fulfills its duty to the medical community when it warns of the risk inherent in use of the drug. There is no requirement that the warning apprise the doctor of how to properly diagnose the condition that renders use dangerous”).


A claim that there was a common-law duty to prepare material for a prescriber to pass along to a patient was rejected in Spychala v. G.D. Searle & Co., 705 F. Supp. 1024, 1033 (D.N.J. 1988). The court held that “a manufacturer has no duty to assist the learned intermediary in warning patients of the risks inherent in prescription medicine” Id. A manufacturer “does not have the authority to dictate to physicians how they should practice medicine.” Hunt v. Hoffmann-La Roche, Inc., 785 F. Supp. 547, 550 (D. Md. 1992). A manufacturer that had prepared information that doctors could give to their patients was under no duty to ensure that the doctors did so. Kennedy v. Merck & Co., 2003 WL 21658613, at *5 (Ohio App. July 3, 2003) (defendant “had no additional duty to ensure that the treating physician. . .provided the warning to [plaintiff]”).


Nor has any legal duty been imposed upon manufacturers to interfere with medical practice to ensure that their products are not put to off-label uses:




Neither party disputes that the [use in the case] qualified as an “off-label” usage. . . . [I]t is well established that the FDA does not prohibit “off-label” use of medical devices. While the FDA controls the marketing and labeling of medical devices, it does not attempt to interfere with the practice of medicine. . . . [O]ff-label use is an
accepted and necessary corollary of the FDA's mission to regulate in this area without directly interfering with the practice of medicine.

Davenport v. Medtronic, Inc., 302 F. Supp.2d 419, 439-40 (E.D. Pa. 2004). Accord Harris v. Purdue Pharma, L.P., 218 F.R.D. 590, 596-97 (S.D. Ohio 2003) (defendant “cannot be held liable” for use of drug used more frequently than labeled “at the direction of [plaintiffs'] physicians”); Little v. Depuy Motech, Inc., 2000 WL 1519962, at *9 (S.D. Cal. June 13, 2000) (a doctor’s “decision to use [a] device in an ‘off-label’ manner does not subject the manufacturer to liability, even if it knows of the off-label use”); Cox v. Depuy Motech, Inc., 2000 WL 1160486, at *8-9 (S.D. Cal. Mar. 29, 2000) (“[the] seller is not liable even if it knows of the off-label use”).


Likewise, in Plummer v. Lederle Laboratories, 819 F.2d 349, 357-58 (2d Cir. 1987), and Dunn v. Lederle Laboratories, 328 N.W.2d 576, 581 (Mich. App. 1982), the courts held that nitpicking and rather basic “precautions” – such as “cleanliness” – were not necessary in cases involving infectious diseases (polio). Subsequent New York cases have distilled this reasoning into the proposition that a manufacturer is not “responsible for how a learned intermediary conducts his business.” Billone v. Sulzer Orthopedics, Inc., 2005 WL 2044554, at *5 (W.D.N.Y. Aug. 25, 2005) (device would break if overused); Prohaska v. Sofamor, S.N.C., 138 F.Supp.2d 422, 444 (W.D.N.Y. 2001) (failure to pass along warning to patient); Lawrence v. Sofamor, S.N.C., 1999 WL 592689, at *4 (N.D.N.Y. Aug. 2, 1999) (metal implant will eventually break if bone does not heal); Krasnopolsky v. Warner-Lambert Co., 1346 (E.D.N.Y. 1992) (failure to pass along warning to patient) (quoting Mazur v. Merck & Co., 767 F. Supp. 697, 711 (E.D. Pa. 1991)).


Courts have rejected other overreaching duty theories under various circumstances. For example, there is no duty to provide instructions on how to use a prescription medical product to foreseeable third persons who are not doctors, such as a patient’s relatives:




[T]he defendants here had a duty to warn the hospital physicians and nurses. They satisfied that duty. A hospital’s or medical staff's failures to perform their duties from that point forward do not operate to create, or to extend, a manufacturer’s duty to warn third-party family members, bystanders, or any persons other than the learned intermediary. A manufacturer is not responsible for how a learned intermediary conducts his business.

Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1283 (11th Cir. 2002). There is no “duty to police” rogue doctors who prescribe a product in ways that created “a danger to [their] patients”:




[The] law does not impose a duty on the defendants to interfere with the physician-patient relationship, even if they were aware that the product may have been prescribed inappropriately. Nor have the plaintiffs shown that a special relationship, as defined in [state] law, existed between the defendants and [the prescriber]. Thus there was no duty to control [the prescriber’s] practice of prescribing [the drug].

Labzda v. Purdue Pharma, L.P., 292 F. Supp.2d 1346, 1355 (S.D. Fla. 2003) (involving prescription of controlled substance). See also Lemon v. Anonymous Physician, 2005 WL 2218359 (S.D. Ind. Sept. 12, 2005) (“[a] medical device manufacturer does not automatically have a duty to properly train, instruct or assist a physician on the surgical implantation and use of the device”); Hunt, 785 F. Supp. at 550 (manufacturer had no duty to impose “mandatory” medical testing requirement); Banner v. Hoffmann-La Roche Inc., 891 A.2d 1229, 1241 (N.J. Super. A.D. 2006) (no duty beyond adequate warning to ensure abstinence of persons taking drugs; court “cannot conclude that [defendant] had a duty to withhold from [plaintiff] a medication her doctor determined was an appropriate treatment”); Chamian v. Sharplan Lasers, Inc., 2004 WL 2341569, at *7 (Mass. Super. Sept. 24, 2004) (manufacturer training offered to doctor did not vitiate adequate warning; “[b]y providing training, [the manufacturer] did not become a guarantor of the competence of” the physician).


Thus, once a manufacturer provides an adequate warning to the prescribing doctor, its duty ends and no legal duty exists for it to do more.



[W]arnings must be brief and focused to be effective. It would require an extended discussion, in the nature of a medical journal article, to lay out the debate [at issue]. It is also hard to see what the doctor would gain even if he read the expanded discussion. . . . One must also bear in mind that the warnings are intended to be read by learned intermediaries who are presumed to have considerable medical training as well as the ability to access the medical literature if they require additional information.


Ames v. Apothecon, Inc., 431 F. Supp.2d 566, 573 (D. Md. 2006). See Ralston v. Smith & Nephew Richards, Inc., 275 F.3d 965. 975-76 (10th Cir. 2001) (the “law does not require that a warning warn against every conceivable risk under every conceivable circumstance”); Wright v. Abbott Laboratories, Inc., 259 F.3d 1226, 1233 (10th Cir. 2001) (no duty to instruct on how to store product; adequate warning of risks of product use satisfied duty to warn); Christopher v. Cutter Laboratories, 53 F.3d 1184, 1193 (11th Cir. 1995) (jury should not have been charged that the physician should have known more than what was in concededly adequate warning); Gerber v. Hoffmann-La Roche Inc., 392 F. Supp.2d 907, 921 (S.D. Tex. 2005) (“[r]egardless of [the prescriber’s] subjective opinion of how he might have done things differently had the. . .warnings been different, the warnings. . .were adequate as a matter of law”); Kernke v. Menninger Clinic, Inc., 173 F. Supp.2d 1117, 1122 (D. Kan. 2001) (being “on notice” that physicians were deficient in obtaining informed consent did not impose any further duty upon defendant that provided adequate warnings); E.R. Squibb and Sons, Inc. v. Farnes, 697 So.2d 825, 827 (Fla. 1997) (manufacturer may “rely. . .on the education and training of the ‘learned intermediary’ to explore questions raised by reviewing the insert”); Pfizer, Inc. v. Jones, 272 S.E.2d 43, 45 (Va. 1980) (adequate warning of risk precludes further duty to explain “exactly how the danger would operate”); Brown v. Glaxo, Inc., 790 So.2d 35, 39-40 (La. App. 2000) (“[w]e are not concerned with what [the defendant] could have included in the warning. The test is adequacy.”); Pluto v. Searle Laboratories, 690 N.E.2d 619, 622 (Ill. App. 1997) (where warnings about product were adequate, there was no further duty to warn against high risk “lifestyle choice”); Demmler v. SmithKline Beecham Corp., 671 A.2d 1151, 1155 (Pa. Super. 1996) (where warning was adequate, there was no duty to include “helpful” information about how to treat adverse reaction); Buckner v. Allergan Pharmaceuticals, 400 So. 2d 820, 822-24 (Fla. App. 1981) (duty to warn not expanded by allegation that manufacturer aware that doctors were not passing warnings along to patients).


Basically, the law has wisely maintained the separate sets of duties for doctors on one hand and prescription medical product manufacturers on the other, based upon their essentially separate roles in the provision of safety-related information. Manufacturers provide product-related information to doctors. The doctors then filter that information through the lens of their personal knowledge of individual patients. Manufacturers can’t breach that lens (what the learned intermediary rule is all about), nor are they required to say or do other things that impinge upon a doctor’s right to practice medicine. Problems arising from professional choices made in the course of medical practice are addressed separately – through medical malpractice or through regulatory action.


We think that’s the way the law ought to be.

Wednesday, September 16, 2009

Better Late Than Never?

Everyone in the world - at least everyone who reads our blog - knows that the Supreme Court rejected preemption in Wyeth v. Levine, in large part because the regulatory history of Phenergan (as read by the majority) did not clearly establish a conflict between the plaintiff's warning defect claim and the FDA's regulatory determinations concerning that drug. It was only "intermittant" activity, and in any event the FDA's regulations allowed the defendant to change the warning whenever it wanted to. 129 S. Ct. at 1192, 1196-97. There was "no evidence in this record that either the FDA or the manufacturer gave more than passing attention to the issue of” IV-push versus IV-drip administration." Id. at 1199.

Well guess what?

Everything you thought you knew about Phenergan labelling, might not be true anymore. Today, the FDA announced that it's requiring a black box warning for Phenergan about precisely the same risk involved in Levine. That's the FDA's most serious warning - "passing attention," indeed. As the FDA's just issued press release begins:
The U.S. Food and Drug Administration is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA’s authority to require safety labeling changes, will highlight the risk of serious tissue injury when this drug is administered incorrectly. The agency is also alerting health care professionals to the new boxed warning for this product, which is used as a sedative and to treat nausea and vomiting.
We have no idea how long this has been in the works. That doesn't mean that doing this earlier would have helped our side - it could have been quite prejudicial, depending on the timing of an earlier release. Still, the irony is so thick one can cut it with a knife.

A black box warning also has independent preemption implications. We discussed them in some detail here. The changes being effected procedure relied upon by the Supreme Court in Levine doesn't extend to black box warnings. The FDA's regulations so state. "If a boxed warning is required, its location shall be specified by the Food and Drug Administration.” 21 C.F.R.
§§201.80(e), 201.57(c).

So going forward, it seems that Phenergan's labeling for the risk at issue in Levine - now a black box - will be protected by the very preemption that the FDA's previous "no more than passing attention" did not permit.

According to the Levine opinion, this labeling process goes back to 1981. Better late than never, we suppose. But not for Ms. Levine.

Something Old, Something New: Recent Trials

Something old: Last week, a federal judge in New York declared a mistrial after a jury deadlocked over whether Merck's drug Fosamax was responsible for causing a 71-year-old woman's osteonecrosis of the jaw. Here's a link to a Bloomberg report, although that result was widely covered in both the popular and legal press.

Something new: The first trial began yesterday in Pennsylvania state court over whether the antidepressant Paxil causes birth defects. For recaps of the opening statements, see the AmLaw Litigation Daily, Bloomberg, and The Philadelphia Inquirer.

Something borrowed: Heck, we borrowed this whole post. All you see is links; we didn't write anything original.

Something blue: No bad news for the drug and device industry to report.

Tuesday, September 15, 2009

Maybe Baying At The Moon Helps (Part II)

Yesterday we were pleased to bring you news that the Indiana Supreme Court reversed a case we had previously criticized on precisely the grounds that we had raised.

Perhaps lighting will strike twice. Earlier this year, we criticized a federal district court decision predicting that Delaware would adopt an independent medical monitoring cause of action despite contrary-tending, if not dispositive, law from the Delawere Supreme Court, and the Erie principle that federal courts should not predict expansion of state tort law. We were particularly concerned about medical monitoring in the air, because the court had dismissed all negligence or strict liability claims. We didn't think medical monitoring could exist without actionable tortious conduct either.

Well, we're pleased to report that the trial judge, if not exactly seeing the error of his ways, has at least agreed that the medical monitoring issue is a controlling issue of law on which reasonable minds may differ. In Hess v. A.I. DuPont Hosp. for Children, 2009 U.S. Dist. Lexis 77589 (E.D. Pa. Aug. 28, 2009), the court certified the issue for immediate appeal to the Third Circuit. From there, it could end up where it belongs - before the Delaware Supreme Court.

We expect we'll have more to say about this case before all is said and done.

Awhooooo!

An Odd Device Preemption Tangent

From where we sit, today's post goes 0 for 2:

First, the case involves a lawsuit between health care providers and a medical device company. We don't like to hear about those cases, because device companies don't want to fight with anyone, let alone with health care providers, who are often the companies' customers.


Second, the device company loses.


Ouch! We just hate that.


But the case is interesting, so we'll swallow hard, brush away our tears, and write it up.

A Medtronic sales representative offered to leave with a group of anesthesiologists free samples of "pain pump refill kits" used to refill a Medtronic pain pump. But the representative in fact left two "pain pump refill kits" and one "catheter access kit" with the anesthesiologists. The pain kits are used for pain management, but the catheter kits are mainly a diagnostic tool and allegedly should not have been delivered to an anesthesiology department.

On April 15, 2005, an anesthesiologist tried to refill Kathy Cober's pain pump. But a nurse picked out the "catheter access kit" and gave it to the doctor. When the doctor used that kit to try to refill the pain pump, he caused an overdose.

Lawsuit!


The hospital and physician group settled the case with Ms. Cober's family and then sued Medtronic for contribution, to recover part of the cost of the settlement. William Beaumont Hospital v. Medtronic, Inc., No. 09-CV-11941, 2009 U.S. Dist. LEXIS 77860 (E.D. Mich. Aug. 31, 2009). Medtronic moved to dismiss on the ground that the hospital and physician group had not sufficiently pleaded the elements of a contribution claim.

Much of the court's discussion turns on narrow issues arising under Michigan law of contribution, which isn't of general interest to readers of this blog (or, frankly, to the two of us).

But Medtronic also asserted that the claim for contribution was based on the adequacy of the label on the catheter kit. Since the infusion system that included the catheter kit had received premarket approval from the FDA, Medtronic asserted that the contribution claim was preempted. Id. at *19-20. (See? Preemption turns up everywhere, like a bad penny.)

The court rejected this preemption argument. The court noted that any claim based on failure to warn would be preempted. Id. at *20. But the court reasoned that Medtronic's alleged negligence was based on "sending free samples to an anesthesiology department at a hospital and holding the samples out for use in a refill procedure, when in fact one of the samples was not intended for such use and should not have been sent to an anesthesiology department. Plaintiffs do not allege a failure to adequately warn claim." Id.

The court acknowledged that the nurse's failure to read the label might constitute a superseding cause that would prevent Medtronic from being held liable for its alleged prior negligence, but that would be for a jury to decide at trial. Id. at *21. The court thus denied Medtronic's motion to dismiss.

We thought we'd seen just about every context in which a device preemption argument could be made, but this one surprised us. We'll dutifully add this decision to our device preemption scorecard, and perhaps someone can put this noteworthy curiosity to use in some future case.

Monday, September 14, 2009

A Half Pint, After All (Kovach v. Caligor Midwest)

Last year, we published a post titled, "Is That A Half Pint Or A Half Gallon?" criticizing an opinion out of the Indiana Court of Appeals. Last week, the Indiana Supreme Court came out our way.

In Kovach v. Caligor Midwest, No. 49A04-0707-CV-406, slip op. (Ind. Sept. 8, 2009) (link here), a physician prescribed 15 mL of acetaminophen -- or half of a 30 mL plastic cup -- for pain relief, but the nurse gave the patient 30 mL -- or a whole cup -- instead. This resulted in the patient's death by an opiate overdose. The patient's family sued -- who else? -- the manufacturer of the plastic cup, saying that the cup was not suitable for precision measurements. The trial court granted summary judgment in the cup manufacturer's favor, the Court of Appeals reversed, and we howled.

This is a tragic situation, but it's not the cup manufacturer's fault. If the nurse gave a patient 9 mL instead of the prescribed 8 mL of a drug, one can imagine a situation where the markings on the side of the cup could be at fault. But no one mistakes a half-full cup with an entirely full cup because of blurry line markings. Any problem with the line marking simply could not have caused this injury.

Normally, when we howl, the moon doesn't respond.

But this time, the Indiana Supreme Court did. (Well, it responded either to our howl or the cup manufacturer's brief; it's probably better for our egos if we don't actually pin down that fact.)

Last week, the Indiana Supreme Court reinstated the trial court's grant of summary judgment, and it did so on the ground that we had identified: "The cup was translucent, and acetaminophen with codeine is a red liquid. The nurse knew that she was supposed to administer a half-cup of medication, and anyone observing her could see whether the cup was half full or completely full. . . . The undisputed evidence thus demonstrates that if there was an overdose in this case, it was not caused by an imprecise measurement of medication attributable to less than readily discernible marks." Id. at 7.

Very nice.

Maybe we'll howl more often, hoping that we'll persuade other courts, so we don't see "the best [judicial] minds of [our] generation destroyed by madness, starving hysterical naked."

The "Bisphenol A" Provision Of The Food Safety Enhancement Act of 2009

J.C. McElveen, of Jones Day, contributed the following guest post, for which we thank him. He gets the credit for what follows; we're just the messengers:


In July of this year, the House of Representatives passed a bill called the Food Safety Enhancement Act of 2009 (H.R. 2749). One of the provisions of that bill deals with bisphenol A (BPA), a monomer used in polycarbonate plastics that are used in (among other things) a wide variety of food contact packaging. Section 215 of that bill, as passed by the House of Representatives, directs the Secretary of Health and Human Services to notify Congress, by December 1, 2009:

"a) Whether the available scientific data support a determination that there is a reasonable certainty of no harm, for infants, young children, pregnant women and adults for approved uses of polycarbonate plastic and epoxy resin made with bisphenol A in food and beverage containers, including reusable food and beverage containers, under the conditions of use prescribed in current Food and Drug Administration regulations.

"b) If the Secretary concludes that such a determination cannot be made for any approved use, the Secretary shall notify the Congress of the actions the Secretary intends to take under the Secretary’s authority to regulate food additives to protect the public health."

Such actions might include:

"a) Revoking or modifying any of the approved uses of bisphenol A in food and beverage containers, and

"b) Ensuring that the public is sufficiently informed of such determination and the steps the public may take in response to such determination."

The standard by which the Secretary of Health and Human Services (i.e., the FDA) is to make its determination of the safety of BPA is the “reasonable certainty of no harm” standard which has long been the standard used for approval of food and color additives, and which replaced the Delaney Clause as the safety standard for additives to processed foods in the Food Quality Protection Act of 1996 (P.L. 104–170). By specifying, as the House did, that the determination of “a reasonable certainty of no harm” include a determination as to infants, young children and pregnant women, the House essentially mandated that the determination utilize the additional (usually 10–fold) safety factor for sensitive subpopulations (though that would presumably have been done anyway, because BPA is used in products that infants use, such as baby bottles).

It is interesting that the chemical singled out by the House – BPA – is a so–called “endocrine disruptor,” because it was in the last major overhaul of the food safety laws, the Food Quality Protection Act of 1996 (P.L. 104–170), that Congress mandated that the FDA (and the EPA, for pesticides) consider the potential increased sensitivity of infants and children in its risk assessment processes, and required that a screening program be instituted for chemicals, to determine the nature and extent of endocrine system disruption, by those chemicals.

Although there are a number of so–called “endocrine disruptors,” BPA seems to have become one of the major rallying points for both sides of the debate on the potential hazards of these chemicals with purported estrogenic effects. Allegations exist regarding the “lack of reproducibility” of certain studies which purportedly show adverse effects of BPA in animals, and allegations are made about the “lack of believability” of studies which are funded by industry. Examples of allegations about the quality of the science include: vom Saal, F. and Hughes, C. “An Extensive New Literature Concerning Low–Dose Effects of Bisphenol A Shows the Need for a New Risk Assessment,” Environ. Health Perspect. 2005; 113(8):926–933; Politch, J.A “Bisphenol A and Risk Assessment,” Environ. Health Perspect. 2005; 114 (1):A16; vom Saal “Bisphenol A: vom Saal and Hughes Respond,” Environ. Health Perspect. 2006; 114(1):A16–A17.

More recent studies have looked at endpoints that are not traditional endpoints considered in risk assessments, such as inhibition of adiponectin release in vitro (Environ. Health Perspect. 2008; 116(12):1642–1647) and the induction of preneoplastic lesions in rats (Environ. Health Perspect. 2007; 115(1):80–86).

The National Toxicology Program (NTP) uses a five-level scale of concern about the potential adverse effects of exposures to chemicals. The five levels are:

Negligible Concern
Minimal Concern
Some Concern
Concern
Serious Concern

Very recently, the NTP (and its expert panel) made the following statement:

"In the case of BPA, the NTP and our expert panel expressed 'some concern' for potential exposures to the fetus, infants and children [for effects in the brain, behavior and prostate gland]. There are insufficient data from studies in humans to reach a conclusion on reproductive and developmental hazards presented by current exposures to bisphenol A, but there is limited evidence of developmental changes occurring in some animal studies at doses that are experienced by humans. It is uncertain if similar changes would occur in humans but the possibility of adverse health effects cannot be dismissed."

National Institute of Environmental Health Sciences (NEIHS): Since You Asked – Bisphenol A.

So, what does that mean? Even though the above-mentioned web site is directed to the general public, is this enough for the FDA to have to say that it cannot be said that there is “a reasonable certainty that no harm will result” from the “approved use” of BPA? Or is the FDA entitled to rely on its more traditional methods of assessing risk?

In the final analysis, although Congress has periodically singled out specific chemicals, in legislation, for some type of executive agency action, that is not a very efficient way of regulating chemicals. So, the bisphenol A provision, which is not in the current Senate Food Safety bill (S. 510), may not end up becoming law. Stay tuned.

Addendum:

Thanks, and a tip of the cyber hat to John Dubeck, of Keller and Heckman, who pointed out I may have confused some readers with a reference to the Food Quality Protection Act of 1996, in my discussion regarding bisphenol A. Bisphenol A is obviously not a pesticide, so a more correct (and, in fact, concise) statement in the post would have been : "The standard by which the Secretary of Health and Human Services (i,e., the FDA) is to make its determination of the safety of BPA is the "reasonable certainty of no harm" standard, which has long been the standard used for approval of food and color additives." Period.