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Doctors warn patients and decide which warnings to give. Manufacturers warn doctors and, if a particular doctor already knows a particular risk, it doesn’t even matter—in a court room, that is—whether the manufacturer warned the doctor. That is the interplay between the learned intermediary doctrine and the proximate causation element of a failure to warn claim.

And, in Tomaselli v. Zimmer, Inc., 2017 WL 1011492 (S.D.N.Y. Mar. 15, 2017), they came together to hand summary judgment to the defendant manufacturer and distributor. The doctor in Tomaselli surgically implanted a hip repair device into one of his patients to repair the patient’s greater trochanter, part of the femur bone near the hip. Later, one of the device’s cables unwound while inside the patient so that it was laying alongside her femur, causing her some level of pain. The doctor discovered this but, ultimately, recommended to the patient that it not be removed. Thereafter, the patient and her husband sued the manufacturer, the distributor and other defendants.

But they ran into a problem, something that usually isn’t a problem unless you’re in a court room asserting a failure to warn claim. The doctor was very experienced. He had performed more than 5,000 hip surgeries over the course of a 30-year career. He knew things. And one of the things he knew was that cables in hip repair devices can fail:

Based on his experience. . . Dr. Nercessian testified that cable breakage is “a known risk of any wire, any cable,” and that cables tend to break “[b]y reaching and exceeding the maximum fatigue strength of the metal.” Asked whether a cable implanted to repair a greater trochanter fracture may break if the fracture fails to fully heal—a so-called “nonunion”—Dr. Nercessian replied, “Definitely.”

Id. at *1 (citations omitted).

So this doctor knew the risk. That meant that, for purposes of the plaintiffs’ failure to warn claim, it didn’t matter whether the manufacturer had warned the doctor. He already knew. Moreover, this doctor chose, for whatever reason, not to warn this patient about that risk. That didn’t matter either. The doctor’s knowledge of that risk, whether he chose to convey it to his patient or not, cut off proximate causation. Here is the court laying out these principles under New York law:

Under the “informed intermediary” doctrine, a manufacturer “discharges its duty by providing the physician with sufficient information concerning the risks of the device.” Moreover, “where the treating physician is independently aware of potential adverse events, that knowledge is an intervening event relieving the manufacturer of any liability to a patient under the failure to warn theory.” “A physician’s existing awareness of a potential risk or side effect thus severs the causal chain between an allegedly inadequate warning and a plaintiff’s injury.”

Id. at *3 (citations omitted). And, finding no proximate causation, the court granted summary judgment to the manufacturer and distributor on plaintiffs’ failure to warn claim.

A couple of months ago, we reported on the magistrate’s report and recommendation in this case to grant summary judgment against all plaintiff’s claims, which included her failure to warn, design defect and warranty claims. At that time, we seriously doubted that plaintiff would object to the report and recommendation. It was so well-reasoned. You can read our discussion of that report, which was much more detailed, here. As it turns out, plaintiff did object, but only to the failure to warn recommendation. And, as it also turns out, we were right. The report and recommendation was well reasoned. With this decision, the district judge adopted the magistrate’s “thorough and well-reasoned Report in its entirety.”  Id. at *4.  And, now, we can be virtually certain that this is the last we will hear of this case.

 

This post comes from the Cozen O’Connor side of the blog.

We’ve been following the Pinnacle MDL closely through the last two bellwether trials, starting with the news coming out of the second bellwether trial of particularly curious and prejudicial evidence being presented to the jury. Given that evidence, we expected a plaintiffs’ victory, an expectation that was borne out with a whopping $498 million verdict. It raised an immediate question: “What will the Fifth Circuit do?”

Well, we’re on our way to finding out. The defense recently filed their opening appellate brief. While it features the controversial evidentiary rulings, much more is in play. If you would like to take a look for yourself, here is the brief.  Below are some of the key issues, along with a quick description of the defense’s arguments:

Design Defect Claim against DePuy (Brief at 20-29): Claim that all metal-on-metal hip implants are defective is not viable under Texas law because a wholly different product cannot serve as a safer design; design claim is preempted because the FDA approved metal-on-metal hip implants; and design claim fails under Restatement (Second) of Torts 402A comment k (adopted in Texas), which recognizes that products like implantable devices are unavoidably unsafe and therefore not defective if properly made and warned about.

Continue Reading Briefing Underway in Appeal of Half-Billion-Dollar Verdict in Pinnacle MDL

Court Finds Fraudulent Joinder by Relying on a Sales Rep’s Affidavit and Common Sense

Buckles v. Coombs, 2016 U.S. Dist. Ct. LEXIS 180784 (S.D. Fla. Jan. 4 2017), is a decision that illustrates how a defendant’s proper introduction of facts via an affidavit and a court’s introduction of common sense into its decision process can come together to result in the denial of a plaintiff’s motion to remand an action to state court.

In Buckles, the plaintiff alleged that she was injured due to an allegedly defective cutting device used in her knee replacement. In her state-court complaint, she sued not only the diverse manufacturer, Howmedica, but its non-diverse sales rep. The defendants, having seen that move before, claimed fraudulent joinder of the sales rep and removed the action to federal court based on diversity jurisdiction.

Plaintiff moved to remand the action back to state court. Plaintiff argued that the sales rep was, in fact, a proper defendant because he had been negligent in promoting, marketing, testing and warning about the device—and so on. She supported these arguments with nothing more than the allegations in her complaint, which were fairly broad and conclusory. That was her mistake.

The court made clear that the proper standard under which a court should determine whether a non-diverse defendant has been fraudulently joined is like that applied to summary judgment motions, not the standard for motions to dismiss: “A district court’s process for resolving a claim of fraudulent joinder is similar to that used for ruling on a motion for summary judgment.” Id. at * 5 (citing Crowe v. Coleman, 113 F.3d 1536, 1538 (11th Cir. 1997). And the defendants were relying on more than the general allegations in the complaint. They offered facts from the sales rep himself in an affidavit in which he specifically refuted the general allegations of the complaint:

As set forth in [the sales rep’s] affidavit, however: (1) he was present during [plaintiff’s] surgery “only to facilitate bringing the implants to the operating room and for no other purpose” (2) he did not call on [plaintiff’s] surgeon at any time prior to her surgery on August 21, 2012, or anytime thereafter (3) he did not “promote, advertise, represent, recommend or sell” the Cutting Guide used during [plaintiff’s] surgery; (4) he had no involvement in the preoperative imaging for [plaintiff’s] Cutting Guide and had no other involvement in the planning of her surgery; and (5) he has no medical training, but rather, relies on the materials and information provided to him by Howmedica in carrying out his job duties.

Id. at *8.

Continue Reading Court Finds Fraudulent Joinder by Relying on a Sales Rep’s Affidavit and Common Sense

We’ve addressed many times Texas Civil Practice & Remedies Code §82.007, a tort reform statute that, essentially, creates a presumption in drugs cases that a drug’s warning is adequate if the FDA approved it. See §82.007(a)(1). The statute gives plaintiffs with five ways to rebut that presumption, one of which is to show that the defendant withheld information from, or misrepresented information to, the FDA. §82.007(b)(1). That means of rebuttal, however, was held to be preempted by the Fifth Circuit under Buckman because it requires a plaintiff to prove fraud on the FDA. Lofton v. McNeil Consumer & Specialty Pharma., 672 F.3d 372 (5th Cir. 2012).

We recently uncovered a case in which a plaintiff actually tried to expand the Fifth Circuit’s ruling as a way around §82.007’s presumption of warning adequacy. See T.R.M. v. GlaxoSmithKline LLC, 2015 U.S. Dist. LEXIS 183272, (S.D. Tex. Aug. 21, 2015). In particular, the plaintiff argued that, if Buckman preemption applies at all, it must invalidate all of §82.007, not just its fraud-on-the-FDA based rebuttal. In short, even though the statute created a presumption of adequacy and five ways to rebut it, the plaintiff asked the court to scrap the entire presumption regime because one means of rebuttal was preempted.

Uh, no.

Rules of statutory construction require courts to give effect to as much of a statute as possible while maintaining its original purpose, severing only as little as necessary. Preempting only the fraud-on-the-FDA rebuttal provision of §82.007 accomplishes that. Plaintiffs still have the potential options of four other means of rebuttal and, in fact, might even be able to use the fraud-on-the-FDA rebuttal if the FDA itself made such a finding.

Continue Reading Texas Federal Court Rejects Attempt to Misapply Buckman to Invalidate Statutory Rebuttable Presumption of Warning Adequacy

Well that was something. When we left you last Thursday, the jury for the third bellwether trial in the Pinnacle Hip Implant MDL had just started its deliberations, and we once again expressed concern over the trial’s evidentiary and procedural rulings and the effect they might have on the verdict. Our concern-level was high. Last time, amidst similar concerns, the jury came back with a half-billion dollar verdict.

Apparently that was chump change. Everything is bigger in Texas. And this time it was over one billion. Let that sink in. Over one billion. That’s a massive amount of money. Has anyone even ever won that in a lottery? It’s 1,000 winners of Who Wants to Be A Millionaire. And then you have to add about 40 more winners because the actual verdict was about $1.04 billion.

Continue Reading The One-Billion-Dollar Verdict

This post comes from the Cozen O’Connor side of the blog.

After two months, the third bellwether trial in the Pinnacle Hip Implant MDL is coming to an end. The jury heard closing arguments yesterday and began deliberating late in the afternoon. They start up again this morning.

Much like the second bellwether trial, this trial was not without controversy. The signs were ominous before it began.  Two weeks before trial, the court issued a sua sponte order consolidating six separate plaintiffs for the trial, close to any defendant’s worst nightmare. The court also ruled that plaintiffs could serve notices that would require company witnesses who were outside the geographic reach of the court to nonetheless testify live via satellite. Defendants could not substitute trial depositions for the satellite testimony, even though trial depositions had already been taken, complete with cross-examination of the witnesses by plaintiffs’ counsel. This order was sufficiently controversial that a Fifth Circuit judge, while concurring with his colleagues’ decision to reject defendants’ writ of mandamus challenging the order, chose to issue a one-sentence concurring opinion saying that the MDL judge got it wrong.

Continue Reading Buckle Up: The Jury Is Out in the Pinnacle Hip Implant MDL’s Third Bellwether Trial

Are any of you Walmart shoppers? Would you admit it? This DDL blogger does. Walmart sells everything, and at prices too good to pass up: HDTVs, electronics, car stuff, refurbished Titleist golf balls so cheap you almost don’t mind losing them in the woods.

And, yes, we know there’s a downside. Walmart stores are huge. You get lost. It’s loud. Its aisles are crowded. The cashier section in the front is busy like midtown traffic. You always screw up the self-serve check-out and have to wait for help. The store seems to ring and buzz like a casino. The parking lot is the same. There seem to be hundreds of thousands of cars. Available parking spots are few and never near the building. Cars seem like predators stalking the lot, searching, turning, honking, never signaling. Just leaving the store and stepping off the curb is nerve-wracking.

But what if you found a way around all that? What if your trip to Walmart was quiet, with plentiful parking spaces close to the building, the smell of flowers and a plants surrounding you, quiet aisles, a single, friendly cashier with a smile and no lines, and a short walk back to your car in a serene, empty parking lot? Well, that’s what this blogger experiences. Every time.

Yet, the Walmart we visit is no different from yours. It’s huge and there’s a busy parking lot. And so, the first thing to do, is never use that lot. Never. Just across one of the internal mall streets, there’s a different parking lot. It’s for smaller businesses, like cellphone and vitamin stores, in a small stand-alone building. That lot always has plenty of spaces. Always. You then have a short, 100-foot walk via a cross-walk to Walmart. No one else seems to have cracked this code. Perfect. When you get to Walmart, you’re standing in front of its garden center, which sits quietly on the far right side of the building. That’s your entry point. Always. Don’t go anywhere near the front entrance. Never. Instead, just grab a cart if you need one, and stroll into the garden center. It’s calm. It smells nice, plants and flowers and other gardeny things. There’s one cashier, just one. He’s friendly, relaxed, and not busy. “Welcome to Walmart.” Smile, and say “hi” back. Then turn left and walk through the large doorway that connects the garden center to Walmart proper. From there, in the distance, you can see it all. Everything you missed by not going in the front entrance—the busy aisles, the people, the large, loud cashier area, the hugeness. See it, but don’t ever go near it. Instead, turn right and walk down the aisle just on the other side of the wall from the garden center. There’s almost no one there. Who knows what’s even being sold in this aisle? Doesn’t matter. It’s quiet. Stroll to the back of the store. And, voila, there before you is the automotive section, the sporting goods section and, just a few feet to your left, the electronics section. Sweet. Seconds ago, you left your car in a quiet lot, saw three people, and now you’re in the electronics section. So get what you want, put it in your cart, and go. Walk back the way you came, down the very same quiet aisle. Go nowhere near the front of the store. Don’t even think about using the cashiers up front. Just stay under the radar and quietly, sanely head back to your new friend, the garden center cashier. Yes, the garden center cashier will ring up your HDTV. He’ll ring up your can of Turtle Wax. Every time. Once again, enjoy the smell of the garden. Smile at the—at most—one other person in line, likely buying a plant. Ask the cashier whether those birds are often in the rafters tweeting. Discuss the weather. Relax. Once you pay, say goodbye and casually walk out the garden center door through which you entered, look to your right at the teeming mass of blech that you never stepped into, and then turn left and walk the 100-feet across the crosswalk to your lonely car. Place your wildly cheap goods in the trunk, take a seat in the car, turn on the radio, and glide out of the empty parking lot. It was like a trip to the spa—except you get to leave with an HDTV that cost twelve cents.

We’ve never bought OTC medication at Walmart, but that’s the subject of Nelson v. Wal-Mart Stores, Inc., 2014 WL 12461056 (N.D. Fla. Mar. 26, 2014), an older case that just recently made its way onto Westlaw. Nelson is a putative class action in which the named plaintiff claimed that Walmart engaged in deceptive sales practices related to two generic OTC pain relievers—Equate Extra Strength Headache Relief and Equate Migraine Relief—because the price for the Migraine medication was greater than the price of the Headache medication, even though their active ingredients were the same. Walmart moved to dismiss, and the court’s decision holds some interest for us because it involved Mensing.

Continue Reading A Day Shopping At Walmart and Mensing Preemption

Drug and device cases regularly involve plaintiffs who have suffered serious injuries, the type that engender sympathy, even from defense attorneys. It’s understandable that a plaintiff who suffered such trauma would turn to the courts for redress. But bad experiences do not make a viable drug or device claim. Drugs and devices have inherent risks, so the law requires more than injury due to those risks for a viable products liability claim. Generally, the injury must result from a defect of some sort, such as a design, manufacturing or warning defect. If a plaintiff doesn’t allege such a defect, the court must dismiss the claim, no matter how traumatic the plaintiff’s injury.

Smith v. Pride Mobility Products Corp., 2016 U.S. Dist. LEXIS 149955 (N.D. Cal. Oct. 28, 2016), illustrates this. The plaintiff was wheelchair-bound and claimed that, while attending a Renaissance Fair, the power to her wheelchair gave out as she was trying to climb a steep hill. Ultimately, the wheelchair went into a free-wheel fall at a sharp angle down the hill, throwing plaintiff from the wheelchair to the ground. Plaintiff claimed serious injury to her neck and knee, permanent disability to one of her toes, whiplash and serious psychological and emotional distress resulting from the event and her injuries.

These allegations no doubt suggest great trauma for the plaintiff. But do they state a claim? The initial consideration for a court is not the severity of the injuries or the trauma that led to them but whether the plaintiff’s allegations are sufficient to state a viable products liability claim. Here, the Smith court did its job. It reviewed plaintiff’s allegations dispassionately and determined that plaintiff had not made the type of allegations necessary to state a manufacturing defect claim:

In order to allege a strict products liability claim under a manufacturing-defect theory, a plaintiff “must identify/explain how the [product] either deviated from [the company’s] intended result/design or how the [product] deviated from other seemingly identical” models of the product.

Here, Plaintiff states that the wheelchair started “freewheeling down [a] hill” after Plaintiff placed the wheelchair in reverse on a hill and that the wheelchair “was either defective or . . . deliberately designed to” freewheel in such a manner. The complaint does not state how the wheelchair that Plaintiff purchased is different from the design of the wheelchair that Defendant intended or from other identical models of the wheelchair. Rather, “Plaintiff[] make[s] only conclusory allegations” that the product is defective, which is insufficient to allege a manufacturing defect claim.

Id. at *25-26 (citations omitted).

Continue Reading Bad Experiences and Serious Injury Do Not Make a Drug and Device Law Claim

We found a hidden (at least from us) Georgia federal court decision that we want to discuss because it hits on many of the effective defenses sometimes available to defendants on motions to dismiss. It’s two years old and, for whatever reason, we’re just now finding it. But better late than never.  In Connolly v. Sandoz Pharma. Corp., 2014 U.S. Dist. LEXIS 190163 (N.D. Ga. 2014), the court dismissed with prejudice a generic-drug complaint by invoking Mensing, Buckman and the learned intermediary doctrine. That’s a pretty good line-up.

It all turned on the plaintiffs’ decision to assert failure-to-warn claims. With generic drugs, that triggers Mensing preemption. Federal regulations do not allow generic drug manufactures to unilaterally change the content of the warnings in their labels, so a state-law claim seeking to impose liability for insufficient content in a label is preempted.

Plaintiffs tried to juke their way around this problem, however, by arguing that their claims were not about label content but instead defendants’ failure to follow federal regulations that would ensure that medication guides reached patients. Id. at *11-12.

Continue Reading A Recently Discovered Gem

The Third Circuit just confirmed what we all knew had to be true in device litigation: pointing to the failure of another device in another patient or to a supposedly better label for a different device is not nearly enough to get to trial on design defect or failure to warn claims. That’s precisely what the Zimmer hip-implant plaintiff tried in Kline v. Zimmer Holdings, Inc., 2016 WL 5864886 (3d Cir. Oct. 7, 2016), and the Third Circuit rejected it.

To support his design defect claim, the plaintiff submitted an affidavit from his treating doctor discussing a different patient who also had a failure of a Zimmer hip implant. But the occurrence of two purported failures does not clear the way to trial. In fact, the court only had to scratch the surface of the affidavit to see its problems. The other patient’s product was a different Zimmer product. The circumstances of the other patient, the implant and its failure were different. There was no evidence as to what caused the other device’s failure. And the other patient’s implant failed after the device had already been implanted in plaintiff. These facts so solidly established the irrelevance of the affidavit that the Third Circuit held it inadmissible. The plaintiff also tried a host of design defect theories from his experts that were just that—theories—but with, as the Third Circuit held, no “record evidence showing any of these design choices were unreasonable.” It then upheld summary judgment against plaintiff’s design defect claims.

The Third Circuit was equally unimpressed with plaintiff’s failure-to-warn evidence. That evidence consisted of pointing to another product’s label, which included a contraindication for patients at a certain weight or BMI, something that the label for the Zimmer product did not have. But that was the extent of plaintiff’s evidence. He did not show that the other device was similar to the Zimmer device. He did not show that the other device’s contraindication was reasonable or why. And he did not show that the risk of fracture in the Zimmer device with patients at such a weight or BMI was high enough to warrant a contraindication. It seems that plaintiff thought that, like pointing to another patient who experienced a failure of a different device, pointing to a contraindication in a different device’s label would get him to trial. It did not. The Third Circuit upheld summary judgment against plaintiff on his failure to warn claim.

Not surprisingly, pointing to the mere existence of other products’ failures or labeling isn’t nearly enough to prove a plaintiff’s claims. We all knew that. To the extent we had any doubts, the Third Circuit just dispelled them.