Search theriot

Back in the antediluvian era of the Bone Screw Litigation some 25 years ago, Bexis was responsible for crafting (and sometimes outright inventing, see fraud on the FDA) defenses for that then-unusual medical device-related mass tort.  One of the first post-MDL-remand Bone Screw cases involved a Louisiana statute, La. Stat. Rev. §9:2800.56, requiring that, for a product to be “unreasonably dangerous in design,” the plaintiff must establish that “[t]here existed an alternative design for the product that was capable of preventing the claimant’s damage” based on the statute’s risk/utility test.Continue Reading A Primer on Alternative Design

Sure, it was enjoyable to read In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Product Liability Litigation, ___ F.3d ___, 2018 WL 1954759 (5th Cir. April 25, 2018) (“Pinnacle Hip”), to see plaintiffs’ counsel hoisted on their own petard of improper and prejudicial evidence and arguments.  But there’s more to Pinnacle Hip…

Next week, we are traveling to Budapest, with a side trip to Vienna. We are visiting the Drug and Device Law Rock Climber, who is spending this semester abroad studying computer science (in Budapest) and climbing rocks (in Majorca, etc.).  Aside from the beloved visage of our only child, we are most excited about seeing…

Over the Fourth of July weekend, we in the Philadelphia area learned that 120 of the “new, state-of-the-art” trains in our regional commuter rail system were being pulled out of service. Someone noticed that the trains were listing to one side as they traveled down the tracks, and, on inspection, discovered cracks in structural beams in the cars’ undercarriage. So the defective trains are out of service, the rail system’s capacity has been reduced by one-third, and the result is bedlam.   Trains packed with standing passengers bypass stations toward the ends of their lines, leaving commuters stranded.  Train frequency has been slashed, delays and cancellations are rampant, and everyone is pretty upset.  And pretty vocal about it.  Oh, and did I mention that the problem won’t be rectified until at least the end of August, cementing this anarchy right through the Democratic National Convention, headed for our fair city in less than three weeks.   Two of the three Philadelphia bloggers (McConnell and Weil) commute from the suburbs (Bexis lives a 45-minute walk from the office in West Philly), and the disruption has been substantial.  But we suppose we should be grateful that the cracks were discovered before the house of cards tumbled tragically down.

Cracks also plague the foundation of today’s decision. In Crochet v. Bristol-Myers Squibb and Otsuka America Pharmaceuticals, Inc., 2016 U.S. Dist. LEXIS 83685 (M.D. La. June 28, 2016), the plaintiff alleged that the prescription drug Abilify caused him to develop tardive dyskinesia (“TD”), a neurological disorder that resulted in permanent, uncontrollable movements of his mouth and jaw, including lip smacking and jaw clenching.  Among the plaintiff’s claims were a design defect claim under the Louisiana Products Liability Act (“LPLA”) and a claim for “redhibition” under Louisiana law.  (Our co-blogger, Mr. McConnell, suggested this case for blogging just so we could use the word “redhibition” – but we already had, )  As the court explained, “Under Louisiana law, a buyer has a warranty against redhibitory defects, or vices, in the thing sold.  A defect is redhibitory when . . . its use is so inconvenient that it must be presumed that a buyer would not have bought the thing had he known of the defect.” Crochet, 2016 U.S. Dist. LEXIS 83685 at *10 (internal punctuation and citation omitted).  Recovery under the theory of redhibition is limited to economic loss, including rescission of purchase price – it does not include recovery for personal injury.  The defendants filed a 12(b)(6) motion seeking dismissal of the plaintiff’s design defect and redhibition claims.Continue Reading Middle District of Louisiana Gets it Wrong: A Different Product is not an “Alternative Design”

Maybe you’ve noticed that many of our recent posts have reported good decisions out of Mississippi. Here, here, and here, for example.  It’s as if there has been an outburst of judicial common sense in that fair state.   But it has not really been such a sudden thing.  Looking back over last year, sound reasoning and clear decision-making seem to be commonplace in Mississippi opinions.  You just had to look for these things, and you didn’t have to look all that hard.

Consider Mealer v. 3M Co., 2015 WL 9692735 (Miss. March 28, 2015).  That opinion came out ten months ago, and is now available on Westlaw.  It isn’t a drug or device case, but its holding on the safer alternative requirement is important for any product liability design defect claim.

The product at issue was a one-use, disposable respirator mask.  The plaintiff wore one while wielding a jackhammer in a demolition project.  The claim was that the mask did not adequately filter out silica particulates, and that the plaintiff ultimately contracted a fatal lung disease as a result.  The plaintiff’s experts opined that there was no design change that could make a disposable respirator mask adequate.  Instead, the safer, feasible alternatives included such things as elastomeric respirators with cartridge filters and exhalation and inhalation filters with rubber seals.  The court held that those weren’t safer alternatives but were, instead, different products altogether.  The disposable mask used by the plaintiff was a simple fiber piece that costs about a dollar.  By contrast, the elastomeric respirator costs about $25-30.  As the court reasoned, “[t]hey are completely different and their utility is completely different, the variation in longevity of the two products is obvious.”Continue Reading Mississippi Gives Teeth to the Safer Alternative Requirement

As large swaths of the country continue to get pounded by a variety of winter precipitation, we know that there are many over-the-counter cold and flu preparations being consumed by our readers. We assume many of our readers have minor children who are taking the pediatric versions of these preparations after suitable review of the…

A Reed Smith team, including our own Eric Alexander, recently won a nifty little summary judgment decision, Schmidt v. C.R. Bard, Inc., 2013 WL 3802804 (D. Nev. July 22, 2013).  It’s a surgical (not vaginal) mesh case, and the plaintiff claimed a “rare and severe inflammatory reaction” to the product.  Id. at *1.  The warning claims failed, (1) because the plaintiff lacked expert testimony that the defendant’s warnings were inadequate, and (2) because the prescribing surgeon didn’t “ever review[]” the warnings in the first place.  Id. at *2.  The other informational claims (warranty and consumer fraud) failed for reason #2 above – lack of reliance by the surgeon.  Id. at *2-3.  All nice, but those rulings wouldn’t have prompted this post.

One of the grounds for dismissal of the design defect claim did that.  The design claim also failed for lack of expert testimony, id. at *2 (expert “concedes that he is not qualified to offer . . . medical device design testimony”), but more significant to us was the court’s holding about alternative design:

Neither is the Court swayed by Plaintiff’s argument that the testimony of [the expert] to the effect that Plaintiff’s [surgery] could have been accomplished without use of [the product].  The fact that an alternative method of [surgery] was potentially available does not supports Plaintiff’s design defect claim.  As argued by Defendants, non-mesh repair is not an alternative design and does not meet Plaintiff’s burden to support this particular claim.

Schmidt, 2013 WL 3802804, at *2 (emphasis added).

That eminently reasonable legal proposition – that an alternative method of medical treatment not utilizing the product at all is not an “alternative design” – brings back memories.  Back in the Bone Screw litigation, plaintiffs repeatedly made the same argument, that surgery without any of the screws in question could be an alternative design.  This argument, of course, is a disguised form of absolute liability, that is, it’s another way of saying that the product should simply not have been used at all, that “nonuse” is the alternative design.  Fortunately, the courts back then saw the argument for what it was:

[Plaintiff] therefore argues that other products that do not use pedicle screws should be considered as alternative designs. . . .  Underlying this argument is the assumption that all pedicle screws are defective and there can be no system using pedicle screws that would be an acceptable product.  The problem with this argument is that it really takes issues with the choice of treatment made by [plaintiff’s] physician, not with a specific fault of the pedicle screw sold by [defendant].

Theriot v. Danek Medical, Inc., 168 F.3d 253, 255 (5th Cir. 1999).  Theriot is only one of a raft of Bone Screw decisions adopting this reasoning.  First, there are a bunch of other Bone Screw cases under Louisiana law that follow Theriot – most because they were bound (by Theriot) to do so.  See Hornbeck v. Danek Medical, Inc., 2000 WL 1028981, at *1 (5th Cir. 2000) (in table at 226 F.3d 641) (“alternative methods of treatment are not alternative designs”); McDowell v. Smith & Nephew Richards, Inc., 1999 WL 980159, at *1 (E.D. La. Oct. 27, 1999) (“that the [product] can be applied with hooks rather than with screws . . . goes to an alternative treatment, not an alternative design”); Williams v. Danek Medical, Inc., 1999 WL 639555, at *1 (E.D. La. Aug. 23, 1999) (“plaintiff has not produced evidence of an alternative design”; “testimony goes to an alternative treatment [is] not an alternative design”); Harris v. Danek Medical, Inc., 1999 WL 1117106, at *2 (M.D. La. July 22, 1999) (“that there are alternatives to using” the product at all “does not provide an alternative design”); McMillen v. Danek Medical, Inc., 1999 WL 1117104, at *2 (E.D. La. July 16, 1999) (“plaintiff and his experts have confused the existence of alternative methods with alternative designs”); Doucet v. Danek Medical, Inc., 1999 WL 1129648, at *2 (W.D. La. June 28, 1999) (“a different procedure is not an alternative product design”); Bell v. Danek Medical, Inc., 1999 WL 335612, at *3 (E.D. La. May 24, 1999) (“Plaintiff confuses choice of treatment with alternative design”) (all courts following Theriot under Louisiana law); McCarthy v. Danek Medical, Inc., 65 F. Supp.2d 410, 412 (E.D. La. 1999) (“plaintiffs and their experts have confused the existence of alternative methods with alternative designs”); Toll v. Smith & Nephew Richards, Inc., 1998 WL 398062, at *2 (E.D. La. July 14, 1998) (“Plaintiffs have only suggested alternative methods of [surgery]”; “plaintiffs have not established an alternative design”) (both reaching same conclusion before Theriot).Continue Reading On Alternative Design

It was the last blank space on the legal map – the only state with no precedent whatsoever.  As we mentioned earlier in the week, Rhode Island has now fallen.  There now remains no state in the country totally without precedent concerning the learned intermediary rule.  Granted, for now it’s only an oral ruling in a transcript, but a federal judge has predicted that Rhode Island would join the overwhelming consensus of jurisdictions and follow the learned intermediary rule:

First of all, after the learned intermediary doctrine, that has been adopted by over two dozen jurisdictions and, I think, Rhode Island would adopt it as well.
I see nothing in Rhode Island case law, including the Castrugnano [sic, should be Castrignano] case, to suggest that Rhode Island would require direct patient warning in pharmaceutical drug cases.  Just because 4024 A [sic, should be 402A] of the second restatement says nothing about the learned intermediary doctrine doesn’t bother me.  There are a lot of states that adopted both.
If Rhode Island doesn’t accept the doctrine in the way that most courts have, then it’s likely it’s going to look to the third restatement, which requires direct warnings when the manufacturer has reason to know that the health care provider will not be in a position to reduce the risk to the patient.
Unlike the mass inoculation vaccine scenario that the restatement mention in one of its comments, Zometa is a very serious therapy that is commenced after consultation with doctors. . . . As intended there Zometa is a type of drug learned intermediary doctrine encourages a doctor-patient dialogue.
Zometa does not fall within the exception of the restatement and I, therefore, find a direct warning to Mr. Hogan was not required.

Hogan v. Novartis Pharmaceuticals Corp., 06 CV 260, Trial Tr. (5/23/11), at 387-88 (E.D.N.Y.).  The same court had discussed the learned intermediary rule with approval, but avoided a direct ruling, in Hogan v. Novartis Pharmaceuticals Corp., 2011 WL 1533467, at *9 (E.D.N.Y. April 24, 2011).Continue Reading The Closing Of The Learned Intermediary Frontier

In the last month, we’ve seen two more appellate decisions definitively rejecting the idea of some sort of separate cause of action – apart from warning or design defect – for “failure to test,” whatever that might be.  In the drug area, as we reported before, the Pennsylvania Superior Court thoroughly killed the concept in Lance v. Wyeth:

[Plaintiff] also maintains that her alleged her causes of action, including her claims for “unreasonable marketing” and “negligent failure to withdraw,” are sustainable because they are akin to a failure to inspect and/or test claim.  Citing Hoffman v. Sterling Drug, Inc., 485 F.2d 132, 140-41 (3d. Cir.1973), [plaintiff] argues that a failure to test claim is valid cause of action. We disagree.
In Hoffman, the United States Court of Appeals for the Third Circuit applied Pennsylvania law and concluded that there was sufficient evidence for the jury to find that the manufacturer failed to adequately test its drug to discover potentially harmful side-effects.  485 F.2d at 140-41.  Regardless of the Hoffman decision, which is not binding upon this Court, Pennsylvania law has not recognized an independent tort for negligent failure to test.  In fact, we have held that “the claim for ‘negligent failure to test’ is not a viable cause of action recognized by our courts[.]”  Viguers v. Philip Morris USA, Inc., 837 A.2d 534, 541 (Pa. Super. 2003), aff’d, 881 A.2d 1262 (Pa. 2005).
If there is a duty to test and/or inspect in Pennsylvania, it does not exist as an independent cause of action, but rather, is subsumed within [plaintiff’s] other claims. . . . Therefore, even if there is a general duty to inspect and/or test under Pennsylvania law, it would be subsumed within [plaintiff’s] design defect claims and/or any potential failure to warn claim that [plaintiff] may have had. Because failure to test is not an independent cause of action in Pennsylvania, [plaintiff’s] arguments to the contrary fail.

4 A.3d 160, 168-69 (Pa. Super Aug. 2, 2010) (some citations omitted).  In Lance, plaintiffs did not pursue an independent testing-related claim in the Pennsylvania Supreme Court and conceded that testing was “part and parcel of her negligent-marketing claim.”  Lance v. Wyeth, 85 A.3d 434, 460 (Pa. 2014).

Then along comes the South Carolina Supreme Court, and (as we also mentioned before) it does a number on the purported duty to test in Branham v. Ford Motor Co.:

In addition, [defendant] asserts there is no separate “failure to test claim” apart from the duty to design and manufacture a product that is not defective and unreasonably dangerous. We agree, for if a product is not in a defective condition unreasonably dangerous to the user, an alleged failure to test cannot be the proximate cause of an injury. The failure to establish that the seatbelt sleeve was in a defective condition unreasonably dangerous to the user for purposes of the strict liability claim requires the dismissal of the companion negligence claim.

2010 WL 3219499, at *2 (S.C. Aug. 16, 2010).
Inspired by these two recent decisions – one in our pharma sandbox, and the other a more general product liability case – we’ve decided to make the non-existent duty to test the subject for our latest cheat sheet.  So that’s what the rest of this post is, a list of all the cases we could find where the misbegotten idea of some separate and independent duty to test has been rejected by a court.  No half-measures here.  To get on this list the court has to hold that there is no separate duty to test apart from well-established product liability claims for warning, design, or (maybe) manufacturing defect.Continue Reading Duty To Test Cheat Sheet

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Learn More About This Book