2015

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Back in April, we blogged about the Massachusetts Supreme Court’s head-scratching rejection of defendants’ preemption defense in Reckis v. Johnson & Johnson, 471 Mass. 272, 2015 Mass. LEXIS 169 (Mass. April 17, 2015).  As that post described in detail, Reckis involved devastating injuries to a 7-year-old child whose toxic epidermal necrolysis (“TEN”) was allegedly caused by Children’s Motrin   The jury awarded $50 million in compensatory damages, and awarded $6.5 million in loss-of-consortium damages to each of the child’s parents.

After trial, defendants moved for JNOV, arguing, inter alia, that they were entitled to judgment as a matter of law because plaintiffs’ warnings claim was preempted, under principles of implied conflict preemption.  Under Wyeth v. Levine, defendants’ argument seemed airtight. Under Levine, 555 U.S. 555, 571 (2009), there is “impossibility preemption” – preemption because it is impossible to comply with both state and federal requirements – when there is “clear evidence that the FDA would not have approved” the labeling change the plaintiffs seek.  Plaintiffs’ failure-to-warn claim argued that the Children’s Motrin label should have contained certain specific language related to TEN. But the FDA had already rejected identical language when that language was the subject of a Citizen Petition.   Could there be any clearer evidence than an FDA decision rejecting the very language plaintiffs identified?   The Reckis court apparently thought so, since “actually did not” wasn’t “clear” enough for that court.  Even though the substantive FDCA standards were identical, the court speculated that it could have made a difference if the FDA had considered a manufacturer’s request instead of a third party’s petition, 471 Mass. at 290, a rationale that impermissibly assumes that the FDA doesn’t always adhere to its own evidentiary standards.  The Reckis court’s refusal to recognize preemption under any set of facts was so blatant that we concluded, “If the Supreme Court meant what it said in Levine, evidently it will have to say so again.”And the Court will have that opportunity, if it chooses to seize it. On August 18, defendants filed their Petition for a Writ of Certiorari, posing this question:  “Whether the Massachusetts Supreme Judicial Court erred when it held, in direct conflict with the Seventh Circuit, that FDA’s rejection of warning language proposed in a Citizen Petition is not “clear evidence” sufficient to preempt state tort claims that the manufacturer was obligated to add the FDA-rejected language to its drug’s labeling.” Johnson & Johnson v. Reckis, 2015 WL 6083499 (U.S.) at *i.Continue Reading J & J Files Cert Petition in Massachusetts Supreme Court’s Unsupportable Rejection of Preemption Defense in Reckis TEN/Children’s Motrin Case

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This post is from the non-Reed Smith side of the blog.

Last week we posted about the decision in In re Incretin-Based Therapies Products Liability Litigation (S.D. Cal.) dismissing plaintiffs’ failure to warn claims as preempted based on the Wyeth v. Levine  “clear evidence” standard.  That is “clear evidence” that the FDA would have rejected the warning sought by plaintiffs, which leads to implied preemption based on impossibility.

At that time we had heard that the judge presiding over the consolidated incretin litigation in state court in California would be issuing a similar ruling.  That turned out to be correct.   Here is a link to the decision, In re: Byetta Cases, Case No. JCCP 4574 (Cal. Super. Nov. 13, 2015).  The ultimate conclusion is the same:  the evidence demonstrates that on multiple occasions the FDA considered and rejected a causal association between incretin and pancreatic cancer and likewise concluded that the drug’s labeling did not require revision.  In re: Byetta Cases, slip op. at 15-18.

We aren’t going to re-hash the impossibility preemption analysis again; we think the federal court decision handled the issue more than well enough.  But, we will point out a few interesting points made in the state court decision.Continue Reading Incretin Preemption Part II – California Tosses Failure to Warn Claims Too

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We’ve read a fascinating new case out of Texas, Verticor, Ltd. v. Wood, ___ S.W.3d ___, 2015 WL 7166024, No. 03-14-00277-CV, slip op. (Tex. App. Nov. 13, 2015), posing the question whether a medical device company can be a “health care provider” within the meaning of that state’s pretty restrictive laws regarding medical malpractice.  While rejecting the manufacturer’s appeal on the record before it, the court in Verticor didn’t flatly say “no.”  Instead, it held:

As the issue is framed here, [[manufacturer’s] license authorizes it “to provide” (at least in the sense of manufacturing and selling) the [device] − and nothing more.  Consequently, [manufacturer] can be “licensed . . . by the State of Texas to provide health care” only if the [device] is, in itself, “health care” as the [statute] defines that term. . . .  Under it, “health care” is distinguished by either of two nouns − “act” or “treatment” − that is “performed or furnished,” or should have been, “for, to, or on behalf of a patient during the patient’s medical care, treatment, or confinement.”  The first alternative, an “act,” denotes some sort of deed or activity.  As an inanimate object, [the device], in itself, could not be an “act,” although it might be utilized in acts that qualify as “health care,” such as surgery.  Similarly, the other alternative, “treatment” also denotes some form of activity that is performed or furnished for or to a patient. Consequently, the [device] would not, in itself, be a “treatment,” although it might be utilized in a “treatment.”

Verticor, slip op. at 10 (footnotes omitted).  All this manufacturer submitted was that it was licensed to manufacture medical
devices.  That wasn’t enough.  Texas medical malpractice tort reform was separate from that state’s product liability tort reform.  Id. at 11-12.  Further, the “common usage” (how such statutes are construed) of the term “health care” denoted something different from manufacturing:

In common usage, one associates “health care” with medical intervention, assistance, or other acts − e.g., one’s family doctor performing an annual physical or a nurse administering a flu shot − as opposed to the mere making or selling of a product used in providing such services.  Focusing as it does on acts and treatment provided to patients, the [statute’s] definition of “health care” does not clearly depart from this basic notion.

Id. at 13.Continue Reading Medical Device Manufacturers as “Health Care Providers”

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Not quite two years ago, we posted about how, under Wyeth v. Levine, 555 U.S. 555 (2009), and subsequent Supreme Court cases, private plaintiffs can’t make claims that so-and-so should have warned about such-and-such with respect to the off-label use of a prescription medical product.  That’s because the FDA zealously guards its authority over warnings concerning off-label uses and does not allow such warnings unless the Agency specifically says so.  That’s crystal clear for drugs.  21 C.F.R. §§201.57(c)(6)(i), 21 C.F.R. §201.80(e).  It’s a little more roundabout for devices (which we explained in that post), but for now, we’re talking about drugs.  Bottom line − since off-label warnings aren’t something a manufacturer can do unilaterally under the CBE regulation, a la Levine, any tort claim demanding such warnings is preempted.

The remedy is to file a citizen’s petition asking the FDA to impose such a warning.

A former colleague recently passed along an example of how such a petition can crash and burn, making preemption even more likely in any civil litigation.  Earlier in the same year (2013) we wrote our post, one James P. Reichmann filed a citizen’s petition concerning the drug ondansetron asserting that it was used off-label for relief of morning sickness (“nausea and vomiting during pregnancy,” or “NVP”) and that the FDA should require warnings (and some other stuff) about birth defects.  The FDA therefore opened up Docket No. 2013-P-0048.  The FDA took its time because the petition “raise[d] complex issues requiring extensive review and analysis by Agency officials.”Continue Reading The Ghost of Bendectin – Exorcized by the FDA?

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This post comes from the Cozen O’Connor side of the blog, not the Reed Smith side.

Last July, in the Tapia v. Davol, Inc. hernia patch case, Davol won its motion to dismiss the plaintiff’s failure to warn claim.  2015 U.S. Dist. LEXIS 98521 at *16-17 (S.D. Cal. July 28, 2015).  The court was clear on why.  While plaintiff alleged facts on what was supposedly missing from the warnings, he alleged no facts suggesting that his own doctor didn’t receive a warning or that, if he had, he would not have prescribed the patch to plaintiff.  In other words, plaintiff did not allege facts to suggest proximate causation.  The court was explicit:

As to Defendant’s second argument regarding causation, while Plaintiff alleges the specific defect in Defendants’ product and specific warnings they failed to provide, he does not allege that Defendants failed to warn his own prescribing physician and that his own physician would not have used the Patch if warnings had been given.

Id. at *16-17.  Allegations about “‘physicians’ in general and the ‘healthcare community’” didn’t provide facts to suggest the existence of proximate causation.  Plaintiff needed to allege “facts as to his own prescribing physician.”  Id. at *17.Continue Reading How Easy Is It to Allege Proximate Causation in a Medical Device Case

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Is it a food or is it a drug?  The answer makes a difference because different laws apply.  And then there are dietary supplements, which come under the “food” umbrella, but have some unique rules of their own.  It can get complicated, but one thing is for sure—the proper outcome of litigation can depend on getting your dispute into the correct bucket.  That is one lesson from Kanfer v. Pharmacare US, Inc., No. 15-cv-0120, 2015 U.S. Dist. LEXIS 150105 (S.D. Cal. Nov. 4, 2015), where the district court somehow treated the product at issue as a food, and a drug, and a dietary supplement all at the same time, resulting in the court allowing the plaintiff to proceed on all counts.  The truth is that the matter should not have proceeded at all beyond the pleadings.

Here is what happened. The product at issue in Kanfer is an over-the-counter male sexual performance enhancer, a combination of herbs and spices about which the seller makes various claims.  Many of them would get trapped in your spam filters, but the gist is that the product is “designed to intensify your endurance, stamina, and sexual performance” so you can make a “long lasting impression.”  Id. at **3-4.  The list of ingredients includes a number of herbs plus “ginger, cinnamon, nutmeg, and cayenne.”  Id. at *3.  Yikes.  This sounds more like the ingredients for a warm beverage that one would sip after a chilly evening of Christmas caroling, not a performance supplement, but what do we know?

We do know that the search for products that can improve your sex life has been underway for millennia, and we also expect the industry dedicated to selling such products is substantial.  It is no doubt substantial enough to attract litigation, as in Kanfer.  The plaintiff was a fellow who purchased the product and claimed that “it did not deliver the promised benefits.”  Id. at *4.  He therefore sued on behalf of himself and a nationwide class of others who bought the product, alleging multiple warranty and consumer protection claims under California law.  Id. at *2.Continue Reading Preemption Should Have Taken Down Performance Enhancement Class Action

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What?  You were expecting another of our insensitive blogpost headlines?

Nope, we’re playing this one straight down the middle.  In In re Testosterone Replacement Therapy Products Liability Litigation, 2015 WL 6859286 (N.D. Ill. Nov. 9, 2015) (“TRT”), the court ruled that all claims against all makers of generic testosterone replacement drugs were preempted.  Indeed, except for those generic manufacturers who were also designated by the FDA as “reference listed drugs,” the plaintiffs did not even contest dismissal.  Id. at *1.

Maybe the word is getting through to the other side that the Supreme Court meant what it said in PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013).

The main issue in TRT was whether a generic manufacturer somehow lost the protection of impossibility preemption because the FDA designated that manufacturer’s product as a “reference listed drug” (“RLD”) after the original branded drug left the market.  This issue has been out there for some time, and we discussed in detail in our post on the aberrant Pennsylvania Superior Court metoclopramide-related decisions.  Indeed, we noted that that the FDA had confirmed – on the very day that we wrote that post – that designated generic RLDs remained generic drug manufacturers and were unable to use the preemption-destroying “changes being effected” process to modify their labels.  Id. (citing and quoting “FDA, Guidance for Industry, Safety Labeling Changes − Implementation of Section 505(o)(4) of the FD&C Act, at 7 n.10 (FDA July 30, 2013)).Continue Reading Generic Preemption Prevails in Testosterone MDL

Photo of Eric Alexander

We have no personal anecdote to share, no movie to discuss, no holiday theme to weave in, and no (self-described) clever theme for our post.  It is a beautiful fall day where we have a relative lull in our slate of depositions, briefs, and arguments, so we will get right to it.  Last month, we had trouble making sense of a long Daubert and summary judgment order in a metal-on-metal hip implant bellwether case.  This month, we think that the evidentiary rulings in the same case make more sense.  Christiansen v. Wright Med. Tech. Inc., MDL No. 2329, 1:13-cv-297-WSD, 2015 U.S. Dist. LEXIS 6704750 (N.D. Ga. Nov. 2, 2015).  Except for this:  neither side filed timely motions in limine, they submitted a joint “Position Statement” on evidentiary issues, and the court issued rulings complete with limiting instructions.  That was awfully generous of the court, as most judges will not rule on what evidence can come in absent a timely motion or objection.  It may be too simplistic to say that plaintiff lawyers in drug and device product liability cases prefer the rules of evidence to be fast and loose, allowing them to spin a narrative that riles up the baser instincts in the jury, whereas defense counsel in such cases prefer that evidence be focused on the issues that the jury will be asked to decide.  In any event, knowing what evidence will be coming in on what issues allows both sides to prepare their respective case so that the jury can hear something coherent.  The Federal Rules of Evidence give trial judges a fair amount of latitude to maximize the chance that the jury will understand the evidence presented and how it fits with what they are asked to decide.  The Christiansen rulings do a pretty good job of that.

In addition to what she could offer from her ten experts and apparently friendly implanting surgeon, plaintiff wanted to offer “fact” testimony from four other orthopedic surgeons who had not treated her and were not designated as experts.  We can think of three basic plausible ways, but maybe objectionable depending on the facts, that these non-treating surgeons could be fact witnesses:  1) they could have something to say about their personal involvement in designing the product at issue; 2) they could have some interaction with the manufacturer before the plaintiff’s implant that allegedly provided notice of the risk of the injury that plaintiff claims (“metallosis” per the prior decision); or 3) they could have done some study on the risks and/or benefits of the product that they will talk about.  No, plaintiff wanted them to talk about whether the product was defective under Utah’s consumer expectations test—with an orthopedic surgeon being the consumer for this prescription device—and what the manufacture told them about the device.Continue Reading Evening Things Out Some With Trial Evidence Rulings In A Bellwether Case

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Today is Veteran’s Day.  This is a holiday that escapes the attention of too many people – until they stare at their empty mailboxes in puzzlement.  It is a federal holiday, but most of us go about our usual business. Too bad. The holiday was originally designed for parades and gratitude.   Veteran’s Day was Monday-ized between 1968-75, but right-minded people with a sense of history insisted that it be restored to traditional, date-specific status.  Veteran’s Day is celebrated on November 11 because that is the anniversary of the World War I armistice.  In 1918, the guns went silent on the eleventh hour of the eleventh day of the eleventh month.  The meaning of that date is more important than creating yet another three day weekend to encourage folks to travel and spend.  Odds are that you know of someone in your own family history who served this country in time of war.  Maybe there is a legend about a great-great grandfather who huddled in Flanders’ fields in the Great War.  Or a Marine who hit the beach at Iwo Jima.  Or a soldier who flew helicopters in Da Nang but never wanted to talk about it.  Or a college roommate who is grateful his time over in the sandbox was relatively short.  Or a friend in the reserves who just last month was called to Afghanistan to help move some hardware home.  Maybe you had a big lump in the throat when you shook hands good-bye.

Thanksgiving is three weeks away, but today is also a day for thanks.

President George H.W. Bush is a veteran.  He was a navy aviator in World War II.  On September 2, 1944 Bush piloted a Grumman TBM Avenger plane that attacked Japanese installations on Chichijima.  Bush’s aircraft was hit by flak and his engine caught on fire. Nevertheless, Bush finished the mission and released bombs over his target, scoring several damaging hits. With his engine ablaze, Bush flew several miles away from the island, where he and one other crew member bailed out.  The other man’s parachute did not open. Bush waited for four hours in a raft,  until he was rescued by the lifeguard submarine USS Finback.  According to Bush, while he floated in the Pacific, not knowing for sure whether he would make it, he thought about many things, including the Bill of Rights.  Some ridiculed that story, but are we really so cynical as to discount the possibility that someone contemplating  what they were fighting for might think it right and even a little noble to be on the side that favors freedom of speech?  Thanks to that Greatest Generation, and thanks to all the great generations that followed who served to preserve our freedoms, including the freedoms of defense hack lawyers like us to scribble our silly blogs.

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Today’s case actually has something to do with freedom of speech.  It is an off-label/first amendment speech with a twist – the plaintiff doctor sued a writer for criticizing his off-label use of a drug.  The action was brought under both the Lanham Act and Florida common law.  The issue was whether the speech in question was the type of commercial speech that might be susceptible to such claims (with all the requisite balancing) or whether it was noncommercial speech that was immune from attack.  In Tobinick v. Novella, 2015 U.S. Dist. LEXIS 150083 (S.D. Florida Sept. 30, 2015), the court decided that the speech at issue was not actionable under the Lanham Act because it is not commercial speech, and that the Florida unfair competition claims failed as well because they rely on a similar theory of liability.Continue Reading Happy Veteran’s Day/In Praise of Free Speech and a SD Fla. Decision

Photo of Michelle Yeary

This post is from the non-Reed Smith side of the blog.

It may be early November, but halls (more like malls) are being decked; trees are being trimmed; 24-7 Christmas carol radio stations are in full swing; and there’s some internet-created controversy over whether Starbucks’ cups will have snowflakes and reindeer on them???  Anyway, it’s hard not to start thinking about the holidays when the signs and symbols are everywhere you look.  One of this blogger’s favorite holiday traditions is to read Yes, Virginia.  For those who may be unfamiliar, it is the account of eight-year-old Virginia O’Hanlon’s letter to the editor of The Sun in 1897.  Little Virginia is dismayed by her friends’ lack of belief in Santa Claus.  Her father tells her to write to the The Sun because “if you see it in Sun, it’s so.”  So Virginia simply asks “is there a Santa Claus?”  The response was of course — Yes, Virginia.  He is real.  “He lives and he lives forever.  A thousand years from now, Virginia, nay, ten times ten thousand years from now, he will continue to make glad the heart of childhood.”

Well, we don’t know about a thousand years from now, but as for today and the foreseeable future – preemption makes glad the heart of defense lawyers.  We gave you the link to the decision in In re Incretin-Based Therapies Products Liability Litigation, slip op.  (S.D. Cal. Nov. 9, 2015) this morning. It’s a lot to read, but it’s worth it. The bottom line is the court granted defendants’ motion for summary judgement dismissing all failure to warn claims that had accrued as of October 15, 2015 based on clear evidence that the FDA would have rejected any change to the drugs’ labeling regarding the risk of pancreatic cancer.  Slip op. at 2.  Let’s get you to the highlights of this lengthy decision.Continue Reading Yes, Plaintiffs, There is Clear Evidence

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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.
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