The definitive source for intelligent commentary on the law that matters for drug and device product liability cases
What follows is a collaborative effort between Bexis and Reed Smith‘s Kevin Hara, who helped research and write this post. It’s not really a guest post, but Kevin had such a large hand in it that his contribution deserves to be separately acknowledged.
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As attorneys, we are fond of rules: they give…
The Ninth Circuit’s opinion in PhRMA v. County of Alameda, No. 13 16833, 2014 WL 4814407 (9th Cir. Sept. 30, 2014), is a triumph of petty local politics over sound public policy. At issue is an ordinance enacted in Alameda County, California, that requires drug manufacturers worldwide to fund a local “stewardship program” under which Alameda County’s residents can dispose of their unused drugs. See Alameda Health and Safety Code §§ 6.53.010 et seq. We support the safe and proper disposal of pharmaceutical products, but this targeted tax on drug companies is remarkably ill conceived.
Under the ordinance, any drug manufacturer in the world whose products find their way into Alameda County—in whatever quantity and by whatever means—has to set up “disposal kiosks” throughout the county for the collection of unused drugs. Not just its own drugs; any company’s drugs. The kiosks must be “convenient and adequate to serve the needs of Alameda County residents,” and manufacturers have to promote the “stewardship program” to the public via “educational and outreach materials.” After drugs are collected in the kiosks, manufacturers are responsible for disposing of the products at medical waste facilities. Id. at *1.
There are additional strings attached, and here is where it gets interesting. The ordinance prohibits manufacturers from implementing any fee to recoup the cost of the “stewardship program,” either at the time the drugs are sold in Alameda County or when the drugs are collected for disposal. The ordinance also exempts local pharmacies from any responsibility for collecting and disposing of unused drugs. This is true even though local pharmacies are most directly connected to the purchase of drugs within the county and are in the best position to spread the cost of collection and disposal among the consumers who actually purchase, use, and dispose of the products. (It may be that county lawmakers were motivated to exempt pharmacies because more than one large pharmacy chain has a world headquarters in Alameda County, but we are speculating.)Continue Reading Local Drug Disposal Tax Should Go Down The Drain
When it comes to food, we’re more often like the kids singing “Food, Glorious Food” in the beginning of the musical Oliver! than like the serious legal mavens we pretend to be. As noted earlier, we usually bloviate over the “D” part of the FDCA, not the “F” part. Nevertheless, sometimes food litigation has useful things to say about the drug-and-device stuff that we work on day after day — our bread-and-butter, if you will.
The Food Liability Law Blog recently posted an interesting item with a real grabber of a title: “Dismissal of ‘I Can’t Believe it’s Not Butter’ Claims: Another example of Iqbal/Twombly Succeeding Where Preemption Cannot.” Recently, it has often felt as if TwIqbal is a necessary alternative to, or consolation for, Levine. The Food Liability Blog discussed a case, Rosen v. Unilever United States, Inc., 2010 U.S. Dist. LEXIS 43797 (N.D. Cal. May 3, 2010), in which the plaintiff claimed that both the label and advertising for I Can’t Believe it’s Not Butter are misleading because they hawk a “blend of nutritious oils” when one of those oils is partially hydrogenated oil, which food fascists say isn’t nutritious at all.
First the bit about preemption not succeeding. The issue was whether the claims were preempted by the Nutrition Labeling and Education Act (NLEA), 21 USC section 346 et seq and the dormant Commerce Clause. The analysis on this issue is very different from what we see in drug and device cases. (Hence our refusal to say ‘We Can’t Believe It’s Not Preempted.’) There is no reference to Levine. Nor should there be. Instead, the court says that regulating food marketing is squarely within historic police powers, citing Farm Raised Salmon Cases, 42 Cal 4th 1077, 1088 (2008). (We blogged about the Farm Raised Salmon cases here and here and other posts referenced therein.) Then the court draws a distinction between the parts of food labelling that are regulated by the NLEA and the parts that are not. It’s not like drug labels, where the entire label is subject to the FDA’s approval. According to the court, the I Can’t Believe it’s Not Butter label’s listing of ingredients is subject to the NLEA, but the allusion to the “nutritious blend” is advertising in the label, and is subject to state consumer protection laws, not the NLEA. (Query whether calls for heightened food label regulations will expand preemption in that area. But we digress.) Anyway, from the perspective of defense lawyers, the first course here is not so tasty.Continue Reading Food for Thought
We expect that none of our readers need reminding about the disastrous Mallory v. Norfolk Southern Railway Co., 600 U.S. 122 (2023), holding that Pennsylvania could constitutionally (under the Due Process Clause, at least) deem the mere act of registering to do business in Pennsylvania as “consent” that permits the Commonwealth’s courts to assert general personal jurisdiction over foreign corporations without any other contact.
At this point, Pennsylvania remains the only state with a general jurisdiction consent-by-registration statute that reaches manufacturers of prescription medical products. Illinois recently passed a more limited consent-by-registration statute, 735 Ill. Comp. Stat. 5/2-209(b)(5), 805 Ill. Comp. Stat. 5/13.20(b), that applies only to “hazardous substances,” so our primary focus for Mallory problems remains Pennsylvania.
There’s been a Pennsylvania legal development that could help some defendants prevent Mallory inspired forum shopping. It’s a recent Pennsylvania state court medical malpractice venue decision – something that may fly under the radar for non-Pennsylvania, non-medmal defense counsel. Of course, we at the blog live for bringing this kind of case to our defense colleagues’ attention (longtime readers may remember our early advocacy of what is now called “snap removal”).
Continue Reading Recent Pennsylvania Decision Suggests Partial, Longer Term Response to Our Mallory ProblemAs our guest post predicted in last Monday, even Hurricane Harvey could not delay the Fifth Circuit long in deciding the Pinnacle Hip MDL mandamus petition. Its decision, denying mandamus but mostly agreeing with the defendant’s substantive position, is available here. In re Depuy Orthopaedics, Inc., ___ F.3d ___, 2017 WL 3768923 (5th…