2014

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We at the DDLaw blog wish all our readers a Happy New Year as 2014 recedes inexorably into our rear-view mirror.  We hope that your 2014 was pleasant and (if you’re on our side of the “v.”) prosperous. We’re celebrating the new year in our usual style, with our annual top ten best prescription medical product liability litigation decisions of 2014.  Some people don’t need an excuse to throw a party.  We have many excuses here, and we’re going to tell you about a lot of them in this post.

So, to the envelopes please – we present to you our picks for the ten best judicial decisions of 2014 (and ten more honorable mentions) involving drugs, medical devices, and (if there were any) vaccines.  We do limit ourselves to drug/device litigation, as well FDA-related cases raising similar issues.  That’s why you won’t find on our list the Supreme Court’s personal jurisdiction decision in Daimler AG v. Bauman, ___ U.S. ___, 134 S. Ct. 746 (2014), even though it might end up having greater beneficial impact on drug/device mass torts than any decision we list below.  Cars are simply too far afield, so even for a United States Supreme Court decision, we won’t dilute the drug/device nature of our list that much.Continue Reading Thumbs Up – The Ten Best Prescription Drug/Medical Device Decisions of 2014

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It is the time of year for reflection and resolutions. We look back on the ups and downs of the year that is about to end and look forward to the New Year with hope, promises and predictions.  As for 2015 here at the DDL Blog – we hope we will continue to be helpful and informative to our readers, we promise that Bexis will find at least one decision a quarter worthy of a full-blown tirade, and we predict that McConnell will keep us up-to-date on both legal trends and what’s hot on TV and at the movies.

As for 2014, Bexis is posting his annual Best Of and Worst Of lists.  Keeping with that theme, we decided to post about a case that has some of both, the good and the bad.  The case is Brown v. Johnson & Johnson, 2014 U.S. Dist. LEXIS 173800 (E.D. Pa. Dec. 9, 2014) and it involves the over-the-counter drug Children’s Motrin.  Wanting to end on a high note, we’ll dispense with the low points of the decision first.

First up, the preemption rulings.  The court held that plaintiff’s failure to warn claim was not preempted because the defendant had not shown that it could not have used the CBE process to change the warning label.  Establishing warning preemption in a drug case is an “exacting burden” for defendants requiring clear and convincing evidence that the FDA would have rejected the warning proposed by plaintiff.  Id. at *2-3.  The court applied the same “exacting burden” to defendant’s design-related preemption defense, finding a lack of evidence that the FDA would have rejected a proposed design change as well.  Id. at *6.Continue Reading Celebrating the Highs and Lows

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On December 18, the FDA published its proposed rule for replacing the venerable package insert with “electronic” prescribing information. The cite is 79 Fed. Reg. 75506, and a link to it is here. We’re not regulatory lawyers, so we’ll leave any debate over whether this proposed rule is good or bad to the folks at the FDA Law Blog.

We’re product liability litigators, so when we hear about “electronic” anything, one thing we think about is ediscovery.  Currently, with paper package inserts, when we’re taking discovery, all we have is the prescriber’s say so about whether s/he reviewed the insert, and when.  Nor do we have any sure way of knowing exactly what version of drug/device labeling the prescriber reviewed.  The date of the visit that produced the prescription, when placed against the history of the relevant labeling provides a pretty good idea, but there’s always a chance that the product sat on a shelf somewhere through a label change or two.

If the FDA’s proposal to shift to electronic distribution of the prescribing information that’s now in package inserts takes effect all that could change.  The main avenue of distribution envisioned by the FDA would be a “single, comprehensive Web site” −  an online “repository” operated by the FDA itself:

The proposed rule would require manufacturers and applicants to distribute electronically prescribing information by submitting the labeling in an electronic format that FDA can process, review, and archive . . . to FDA each time the labeling content is changed.  The submitted labeling would be distributed via FDA’s labeling repository Web site (labels.fda.gov), which is a publicly available Web site.Continue Reading Has the FDA Created Another Ediscovery Front?

Posted in FDA
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We again post the day after a holiday, when stores are flooded with shoppers—this time exchanging gifts purchased last time.  We discuss a case involving discussions of “consumer value” and “fair market value.”  So, you might think we would go back to that shopping well.  No.  We have decided to zag.  To us, the opinion on class certifications in Saavedra v. Eli Lilly & Co., No. 2:12-cv-9366-SVW (MANx) (C.D. Cal. Dec. 18, 2014), slip op., evokes another seasonal activity, playoff football.  Depending on how you count the requirements, plaintiffs in a purported class action need to clear three or four hurdles to get the certification they want.  Class certification tends to be a vehicle to settlement, which is what the lawyers who drive class action litigation really want, particularly in the consumer protection context.  Tripping over one of the hurdles typically means the journey was a waste.  In the NFL, four of the twelve playoff teams each need to win three straight games to hoist the Lombardi Trophy; the other eight each need to win four straight.  Teams that lose in the Conference Championship or Super Bowl tend to view the season as a failure, not a success.  The teams and players do profit from incomplete playoff runs, but we are not shaken from our view of the parallel here.

In the top division of college football, there is now a playoff of four teams.  The winner will have to win two straight games.  This would be on top of the conference championship game and “rivalry week” game that each had to win over the preceding weeks.  (Again, three or four hurdles, depending on how you view it.)  We can assume that the three teams that lose in the playoffs will not be “happy to have been here.”  The four universities will have profited quite a bit from the playoffs—and the players not all (which is a different discussion entirely)—but only one will have succeeded once it is done.  Still, once the playoffs start, the champion will be measured objectively:  which team won two playoff games?  In the past, before there was a playoff, the crowning of a champion or champions of this division of college football was a matter of subjectivity:  based on the individual view of the voters of the various groups that might anoint a champion, which team had the best season?   That subjectivity irked fans.  Even with mounds of statistics to measure performance, the lack of the definitive measurable—the results of playoff games—was unsatisfying.  (Yes, we know that the four playoff teams are selected with a large measure of subjectivity, but work with us.)

In consumer protection class actions premised on an alleged misrepresentation about a prescription drug, the plaintiffs should have to allege an objective harm and an objective way to measure it.  When they cannot, they should not have a class (or probably even individual claims of the purported class representatives).  Saavedra comes out of litigation over the risks of withdrawal from a prescription antidepressant.  We have posted previously on summary judgment on warnings claims in personal injury cases with the same product and risk.  Here and here.Continue Reading When It Comes to Class, Objective Is Better Than Subjective

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We’re doing our duty.  We don’t have to like it.  The subject of today’s post is distasteful, but necessary.  Here is our annual compilation of the ten worst court decisions of the year (2014) that occurred in prescription drugs and medical device products liability litigation.  These are decisions that left us shaking our heads at…

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Try as it might, the FDA just can’t seem to articulate sound regulatory policy relating to “promotion” (which still isn’t defined in any regulation) without running headlong into the wall of the First Amendment.  Recently, the FDA released, “for comment purposes only” two draft guidances relating to promotion on the internet.  One of them is called “Guidance for Industry − Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”  You can read that one here.  The other one, entitled “Guidance for Industry − Internet/Social Media Platforms:  Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” can be accessed here.

Both draft guidances seek to regulate what regulated manufacturers can do to “promote” their products on their own websites.  Okay, we have no inherent problem with the Agency doing that.  FDA-regulated manufacturers are, after all, FDA regulated.

Unfortunately, the FDA never seems to be satisfied with regulating only those it is empowered to regulate.  Its bureaucratic empire builders always seem to overreach.  In these draft guidances, they do so by laying claim to authority over non-manufacturer websites that regulated manufacturers “influence.”  For example, in Interactive Promotional Media DG declares:  “A firm is responsible for product promotional communications on sites that are . . . influenced . . . by . . . the firm.” Id. at 3.  What does “influence” mean?  It’s hard to say because the FDA’s discussion is somewhat tautological, but here is the Agency’s “guidance” on that point:

In determining whether a firm must submit promotional material about its product(s) to FDA, the Agency considers whether the firm . . . is influencing . . . the promotional activity or communication in whole or part.  Thus, a firm is responsible if it exerts influence over a site in any particular, even if the influence is limited in scope.  For example, if the firm . . . has editorial, preview, or review privilege over the content provided, then it is responsible for that content.

Id. at 4.  Thus, “regardless of financial support, if a firm has any . . . influence on, the third-party site, even if limited in scope, it is responsible for submission to FDA to meet the postmarketing submission requirements.”  Id.Continue Reading Social Media – Now The FDA Wants To Regulate . . . Us?

Posted in FDA
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A federal court in Washington produced yet another preemption decision dismissing a complaint in the hip implant litigation.  Hernandez, v. Stryker Corp., 2014 U.S. Dist. LEXIS 171697 (W.D. Wa. Dec. 11, 2014).  The plaintiffs’ complaint referenced two FDA warning letters and a product recall but failed to allege facts connecting any of that to plaintiff’s injury.  Moreover, while the warning letters identified alleged failures to follow cGMPs, plaintiffs alleged nothing to suggest that the FDA specifically imposed those cGMPs on the hip implant device.  And, since parallel violation claims must mirror FDA requirements specific to the approved medical device, plaintiffs’ allegations failed to establish a basis for a parallel violation claim.  Plaintiffs’ express warranty claim had similar flaws.  And so the court dismissed the complaint in its entirely.

Given that this decision, while good, offers no groundbreaking law, and that, more importantly, it’s the holiday season, this is a perfect opportunity for a holiday jingle. Last week, Paul McCartney discussed his song Wonderful Christmas Time on the Tonight Show.  Perfect.  For those who need to rekindle the tune in their heads, here it is.Continue Reading Simply Suing One More P-M-A Device

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The district court’s order denying class certification in Rahman v. Mott’s LLP, 2014 U.S. Dist.  LEXIS 167744 (N.D. Cal. Dec. 3, 2014), is a nail-biter in the same sense as the movies Argo and Captain Phillips.  We know the outcomes will be good because history tells us that the hostages leave Iran safely and the captain of the seized container ship Alabama will be rescued unharmed by the modern-day superheroes known as Seal Team 6.  But man, it sure was tense getting there.  If your heart was not beating quickly when the hostages were faking their way through the Tehran airport or when the Navy commandos were leveling their rifles at the ever-more-desperate Somali pirates, you are not human.

We at the Drug and Device Law Blog are human, and although we knew that the outcome of Rahman would be good (because the district court said it would be at the beginning of the order), we had to get through some tense moments to get there.

The lawsuit is one of the sillier cases that we have seen:  The plaintiff filed a class action alleging that an apple juice seller violated California’s Unfair Competition Law (UCL) by printing “No Sugar Added” on the label.  Id. at *2.  Why is that silly?  Because there was no sugar added.  The statement was completely true, yet it purportedly formed the basis for a class action claiming consumer fraud.  Before you bite your nails to the nub in frustration, bear in mind that the phrase “no sugar added” is regulated under the FDCA.  Under the regulations, a food seller can include “no sugar added” on a product’s label only if the product meets certain conditions, including that “the food that it resembles and for which it substitutes normally contains added sugars.”  Id. at **5-6 (citing 21 C.F.R. § 101.60(c)(2)(iv)).  Apparently, you can put “no sugar added” on the label of a frozen desert, but not a frozen pizza, because ice cream “normally contains added sugar” and pizza does not.  You also have to state on the label that the product is not “low calorie” or “calorie reduced.”  Id. at *5 (citing 21 C.F.R. § 101.60(c)(2)(v)).Continue Reading Apple of Our Eye—Class Cert. Denied

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In searching for cases for this blog, we sometimes feel like its Groundhog Day.  Another preemption win in a PMA medical device case.  Another food labeling decision from California.  Another failure to plead fraud with particularity dismissal.  Another “Okay, campers, rise and shine, and don’t forget your booties ’cause it’s cooooold out there today.”  Well, that last one really only applies to Phil Connors, but you get the idea.

Faced with routine rulings, it can be difficult to be creative, to find the new hook or twist.  So, sometimes the answer is simply to not – be creative that is.  Sometimes, a decision is just what it looks like it is on its face.  Another good ruling in an already good body of law.  But that doesn’t mean it should be disregarded either.  We just need to pluck out the good sound bites and add them to top of the pile.

For instance, if faced with a claim for negligent failure to test in Pennsylvania, you can now add Houtz v. Encore Medical Corp., 2014 U.S. Dist. LEXIS 170481 (M.D. Pa. Dec. 10, 2014) to your motion to dismiss on the ground that “Pennsylvania courts have explicitly stated that negligent failure to test is not a viable cause of action.”  Id. at *7.Continue Reading Pennsylvania Sound Bites

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What is that sad, semi-clever thing bartenders have been known to say at closing time?　 “You don’t have to go home, but you can’t stay here.”　 Our days of being around at closing time are in the rear view mirror, growing tinier by the second.　 We are unlikely ever again to reenact that greatest of all Sinatra songs, “One for My Baby” (“It’s quarter to three/there’s no one in the place except you and me”).　 Odds are that at 2 am on any Saturday night, we will be deep asleep, enduring another of those dreams where we showed up late for our Contracts exam, naked and afraid.

This will be the third, and almost certainly last, post we do on the Johnson v. Draeger Safety Diagnostics, Inc. litigation, where a purported class challenged the accuracy of the Alcotest machine used in New Jersey to measure blood alcohol content for driving-while-intoxicated (DWI) arrests and prosecutions. In our first post, Three Dumb Legal Theories Walk Into a Bar, we reported how a New Jersey federal court rejected a claim brought by a pair of plaintiffs whose claim was basically that a defective Alcotest machine forced them to plead guilty to DWI. We thought the theory was wobbly, but let’s remind you of the background. The plaintiffs had been arrested for suspected drunk driving.　 Both submitted to breath tests administered using the Alcotest device, which reported, for each, a blood alcohol concentration (BAC) above .08%. Alcotest readings are admissible in DWI prosecutions as evidence of a per se violation of the DWI statute. The plaintiffs each pleaded guilty to DWI. They did not challenge the Alcotest readings at that time, and the reason for that (we surmise), requires even more background. During the roll-out of the Alcotest, twenty individuals charged with DWI challenged the admissibility of their Alcotest results, and their cases were consolidated for consideration of the evidentiary challenge. The case was called Chun. 　During the Chun case, a Vice-President of the company that manufactured the Alcotest testified that he was “100 percent convinced” that the device was capable of producing accurate readings; that he “strongly believed” that the device was scientifically reliable; and that no maintenance was needed other than verifying proper operation at the time when the unit is calibrated. In 2008, the Supreme Court of New Jersey concluded in the Chun case that the Alcotest was scientifically reliable and that its results would be admissible and could be used to prove a per se violation of the DWI statute.Continue Reading Closing Time for the New Jersey Alcotest Product Liability Case

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