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Rachel B. Weil

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We sat through The Revenant again this weekend, at the plaintive (not plaintiff) request of a Drug and Device Law Friend who had yet to see it. Last time, we barely stayed awake. This time, we lost the battle. We have heard all of the incredulous “how could you??” exclamations. Yes, there was lots of violence. There was the ursine animatronic latter-day cousin of “Bruce,” who, like his predecessor, failed to engage or convince us. Bottom line for us was that there was plenty of dramatic stuff going on, but none of it added up to a compelling story.

Without meaning to be flip about the truly tragic facts of today’s case, that was essentially what the court held. In Batoh v. McNeil-PPC, Inc., et al., — F. Supp. 3d –, 2016 WL 922779 (D. Conn. Mar. 10, 2016), the plaintiff’s decedent, her adult son, developed SJS/TEN (Stevens Johnson Syndrome/Toxic Epidermal Necrolysis) after taking over-the-counter Motrin. SJS and TEN are “severe cutaneous adverse reactions” (“SCAR events”) in which skin becomes inflamed, blistered, and necrotic, and sloughs off. The results can be catastrophic. In the plaintiff’s decedent’s case, the SJS/TEN left him with “significant wounds and scarring throughout his body, and damage to his nervous system, eyes, genitals, and feet.” Batoh, 2016 WL 922779 at *4 (citation omitted). A year later, he committed suicide, telling relatives that he could not tolerate living with these residual injuries.

The plaintiff sued the drug’s manufacturer, alleging violations of the Connecticut Products Liability Act based on theories of failure to warn, design defect, breach of warranty, and fraud/misrepresentation. The defendant moved for summary judgment on all of the plaintiff’s claims, and the plaintiff cross-moved on the defendant’s preemption defenses.Continue Reading Silence Would Have Been Golden: Unnecessary Illogical Preemption Decision in Motrin SJS/TENS Summary Judgment Victory

We spend a large portion of our professional life preparing motions to exclude the testimony of plaintiffs’ experts in mass tort litigation.  Our pleasure in reading today’s decision is no doubt a function of the frequent futility of this effort and the consequent inflation of plaintiffs’ settlement demands.  As such, we offer an enthusiastic tip of the hat to Tarek Ismail for sending us a nearly great (we’ll explain the qualification later) opinion out of the Mirena MDL.  In a voluminous opinion in In re Mirena IUD Prods. Liab. Litig., 2016 WL 890251 (S.D.N.Y. Mar. 8, 2016), the United States District Court for the Southern District of New York considered both sides’ Daubert motions.

Defendant’s Medical ExpertsContinue Reading Good Things Sometimes Come in Big Packages: Mirena Rule 702 Rulings Favor the Defense — Big Time

We were not able to make our annual pilgrimage to the Westminster Kennel Club Dog Show this year, so we had to settle for watching the televised portions on the couch with the Drug and Device Law Rescued Ragamuffins.  And the cat.  (We mostly resisted the all-day live feed of the breed judging.)   Since the Best in Show lineup didn’t include a Standard Poodle, our “breed of the heart” (a cute Bulldog named Annabelle beat Ricky, the stunning black Standard Poodle, in the Nonsporting Group), and being nothing if not bandwagon jumpers, we were rooting for “Rumor” a gorgeous German Shepherd who was the top winning show dog of 2015 by many, many points.  And she showed beautifully.  But she was defeated by “C.J.,” a German Shorthaired Pointer. While we don’t count ourselves as sporting breed fanciers, C.J. is a cool dog.  And, most interestingly (maybe not, but it gives us a hook to transition to our case in a minute), C. J.’s grandmother, Carlee, was Best in Show in 2005. Carlee was known for her flawless “free stack” – instead of needing her handler to place her feet in the right positions and stretch out her neck – “stack” her – for the judge’s examination, she did it all by herself in the most striking of fashions.   Westminster trivia:  like the Adamses and the Bushes, Westminster can count one example of a father siring his eventual successor:  Robert, the English Springer Spaniel, was Best in Show in 1993.  His daughter, Samantha, “took the Garden” seven years later.  The ostensible point of dog shows is to reward the best specimens of each breed so they will pass their genes to future generations, so it is neat when a judge’s good decision is affirmed.

And so it was recently in the Third Circuit.  In In re Avandia Marketing, Sales Practices and Products Liability Litigation (Linda and John Schatz, appellants), — Fed. Appx, –, 2016 WL 574074 (3d Cir. Feb. 12, 2016) (applying Pennsylvania law), the panel considered Judge Cynthia Rufe’s grant of summary judgment to the defendant manufacturer in a case in the Avandia MDL. The plaintiff, who had taken Avandia, sustained bone fractures in two accidents and alleged that the manufacturer had failed to adequately warn of the risk of such fractures.  The manufacturer had informed doctors of this risk and, shortly thereafter, updated its warnings to include this information.  While it was not clear whether the plaintiff had already stopped taking the drug at this time, it was undisputed that she resumed taking it for a short time after the “bone fractures” warning was added to the label.Continue Reading Solid Affirmances: Avandia Summary Judgment, and Westminster

Recently, some of the more footloose of the Drug and Device Law Relatives auditioned for the game show Family Feud.  The first step was a mock “round” of the game, played against another auditioning family.   All were instructed that, even if their answers made no logical sense, they should shout them with conviction and applaud them with over-the-top enthusiasm.

While this may be a good audition strategy, it is less appropriate when employed in litigation by witnesses supposedly expert in their fields.  In Sparling v. Doyle, 2016 WL 236266 (W.D. Tex. Jan. 20, 2016), the court considered the plaintiffs’ objections to the magistrate judge’s 72-page opinion striking the testimony of three of plaintiffs’ experts in a dietary supplement death case.  Plaintiffs argued that, contrary to the magistrate’s ruling, their experts’ causation opinions were based on “considerable evidence and reliable methodologies.”  2016 WL 236266 at *4.  Under this general heading, they lodged four specific objections to the magistrate’s opinion.

First, the plaintiffs argued the magistrate had committed error by failing to consider “material scientific admissions” by the defendants’ experts, including the experts’ alleged concessions of “critical causation issues” – namely, the experts’ supposed concession of the mechanism by which the supplement in question allegedly caused hyperthermia and death.  The court responded, “Plaintiffs . . . are conflating evidentiary proof to support their theory of causation with the reliability determination of their experts’ opinions under Daubert. The key issue here is whether the offered testimony by Plaintiffs’ experts is reliable.  Nowhere in Plaintiffs’ experts’ reports do they cite reliance on Defendants’ experts as a basis for their opinions.” Id.  Further, the court explained, a “statement by a defense expert is [at most] an evidentiary admission, and not a judicial admission.”  Id. at 5.  Unlike a binding judicial admission, which is “an intentional waiver, releasing the opponent from proof of a fact,” id. (internal punctuation and citation omitted), “an evidentiary admission is merely a statement of assertion or concession made for some independent purpose,” id., which a party may attempt to contradict and explain.  Because any admissions by the defendants’ experts were not judicial admissions, and were therefore not binding on the court, the court overruled the plaintiffs’ first objection.Continue Reading Plaintiffs’ Experts Out in Dietary Supplement Death Case

Once upon a time there was a federal judge . . . . When we were little, we liked it when our mom spun free-form fairy tales for us.  We would contribute the object of the “was” (“Once upon a time there was a . . . bullfrog”), and she would make up the rest as she went along.  Which is fine for mommies, but less so for federal judges, as today’s (very short) case illustrates.

In Fay v. Depuy Orthopedics, Inc., et al, 2015 U.S. Dist. LEXIS 175344 (D.N.D. June 11, 2015), plaintiff’s hip was replaced with a metal-on-metal hip system.  The system consisted of various components, two of which were at issue:  the femoral head and the acetabular cup.  Both components come in various sizes, but, for the system to work correctly, matched sizes of the two components must be implanted in the patient.

In Fay, it was undisputed that Plaintiff received mismatched components and had to undergo revision surgery.  One of the defendants was a distributor that marketed and sold the system. Plaintiff’s surgeon testified that two specific sales reps employed by the distributor were always in the operating room when he implanted that particular hip system.  According to the surgeon (who was not sued), the reps were responsible, based on a process called “templating” of the patient’s x-rays, for placing an appropriate range of sizes of the two components on a table in the operating room before the surgeon arrived.  From the prepared template, the surgeon would determine what size acetabular cup would be implanted, and would ask for that size cup and the correspondingly-sized femoral head.   The sales reps were allegedly responsible for selecting the components from the implant table, verifying for both that they had pulled the size the surgeon requested, and handing the packaged components to the circulating nurse, who unpacked them and placed them in the sterile field.  In the absence of sales reps, the circulating nurse would be responsible for selecting the correct sizes of components.Continue Reading Sales Reps Denied Summary Judgment in Artificial Hip Case Despite Absence of Legal Duty to the Plaintiff

We spent the past weekend in Cleveland, visiting a dear law school friend of whom we see much too little.  Cleveland deserves more press as a travel destination.  It boasts beautiful architecture, (including spectacular bridges, like the Detroit-Superior Bridge over the Cuyahoga River), reasonable prices, and the Cleveland Clinic.  It is also home to the world-class Cleveland Symphony and the renowned Cleveland Museum of Art.  But (not surprisingly, for regular readers of our posts) our most memorable afternoon was spent in that mecca of popular culture, the Rock and Roll Hall of Fame.  We had to be dragged away from the continuous loop of induction ceremony highlights.  We gleefully donned headphones and entered a simulated recording booth, where we “laid down the harmony track” over a melody line sung by a popular artist.  We stared at Elvis’s army uniform and the sheet of paper on which Neil Young first jotted the lyrics for “Heart of Gold.”  But we were most captivated by a room-size exhibit devoted to one of our personal idols, Graham Nash, a two-time Hall inductee (with the Hollies and with Crosby, Stills and Nash), onetime Joni Mitchell cohabitant, and author of a song in serious contention to be our all-time favorite, the folk-y classic “Teach Your Children.”  (In a minute, we will find a way to tie this, however tenuously, to something legal.  We make no such attempt with this link to a lovely moment from the 2007 American Idol finale, on which Nash sat on a stool with an acoustic guitar and performed this song with an Idol finalist.)

Nash is an intelligent, socially-conscious man of diverse talents that include painting and photography.  Among the tidbits revealed in the headphone-accessible interview clips interspersed throughout the exhibit was the fact that he is also a serious collector of memorabilia.  He seeks to acquire items that capture the seminal moments of significant political and musical events.  (For example, his collection includes a piece of the fence that rings the grassy knoll in Dallas.)  In today’s case (see – we told you!), a minor cautionary tale from the Mississippi Supreme Court, the seminal moment in the demise of the plaintiff’s case occurred 120 days after she filed her First Amended Complaint.  While rock-and-rollers can often flout the rules, it’s always a good idea for lawyers to follow them, as this case demonstrates.

In Meeks v. Hologic, Inc., 2015 Miss. LEXIS 610 (Dec. 17, 2015), plaintiff initially sued a physician and a medical center for injuries she had allegedly sustained two years earlier during outpatient gynecologic surgery.   Both defendants answered the Complaint. Two years and 363 days after she discovered her injuries (this becomes important, because Mississippi has a three-year statute of limitations), with leave of court pursuant to the Mississippi rules, plaintiff filed her First Amended Complaint (“FAC”) adding Hologic, manufacturer of a device used in her surgery, as a defendant, and adding warranty claims against all defendants.  Plaintiff served the doctor and the medical center with the FAC, but never served the FAC upon Hologic.   Neither the doctor nor the medical center answered the FAC.  (This was also important in the plaintiff’s mind, but it wasn’t really.)Continue Reading Mississippi Plaintiff Defeated By Improper Construction of “Amend As A Matter Of Course” Rule

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

Halloween has come and gone.  The Drug and Device Law Little Dogs stayed in their costumes (Batgirl and a rabbi) long enough to be photographed for (unsuccessful) entries for a pet costume contest.  There was ample candy – about 15 pounds, which more than sufficed for the seven times the doorbell rang. And we enjoyed the modest stream of excited kids, flushed with the thrill of pretending to be something they weren’t.

We assume that the plaintiff/relator in United States ex rel Gerasimos Petratos v. Genentech, 2015 U. S. Dist. LEXIS 146525 (D.N.J. Oct. 29, 2015) is less thrilled.  In this qui tam action, plaintiff pretended that the wrongdoing he alleged was something it wasn’t:  a violation of the False Claims Act.  The court summed it up in the first paragraph of its decision: “This case concerns whether the False Claims Act can be extended to cover wrongful behavior that does not lead to a false claim.  It cannot, so Plaintiff’s Amended Complaint must be dismissed.”  Petratos, 2015 U.S. Dist. LEXIS 146525 at *1.  Two big issues were decided:  (1) no product liability-style (prescriber specific) causation in FCA cases; and (2) the FCA is not a catch-all negligence per se statute for regulatory violations.  The defense won both, so this case is significant.

The allegations surrounded defendant Genentech’s anti-cancer drug Avastin, a “monoclonal antibody cancer drug that limits the growth of tumors by preventing the growth of blood vessels that feed tumors.”  Id.  The court explained that, in 2010, the Oncologic Drugs Advisory Committee of the FDA recommended denying approval of Avastin for metastatic breast cancer due to concerns about clinical trial data Genentech had provided.  Nevertheless, later that year, the FDA approved Avastin for treatment of patients with metastatic breast cancer.  Id. at *3.   The approval “was conditioned on completion of adequate studies showing the drug’s clinical benefit.”  Id.   Subsequent clinical studies failed to demonstrate such benefit, and the FDA removed the metastatic breast cancer indication from Avastin’s label in 2011.  Id.  The drug, which can cause serious side effects, remains approved to treat metastatic colorectal cancer, nonsquamous non-small cell lung cancer, glioblastoma, and metastatic renal cell carcinoma.  Id.  In addition, it is used off label for renal cancer, ovarian cancer, ovarian cancer, pancreatic cancer, and various eye diseases.   Id. Continue Reading No False Claims Act Case Where There is No False Claim – DNJ Throws Out Qui Tam Action Against Genentech

We spent the weekend in the Boston area, visiting the Drug and Device Law Rock Climber for “parents’ weekend.” Saturday’s schedule was replete with activities:  a keynote speech by the university president, lectures on topics academic and not, an informative session on the school’s “semester abroad” program (the DDLRC has informed us that she hopes to spend next spring in Australia), and dozens of presentations by student arts groups (theatre, improv, orchestra, a cappella).

We didn’t get to do any of that.  By mid-morning, the DDLRC had tired of being trailed around campus by her parents.  All were shepherded to the “T,” where, several stops down the line, our procession (and its credit cards) descended on the downtown shopping district.  But before we left campus, we insisted on attending one lecture, a sparkling presentation by the head of the theatre department.  The subject was a famous circus mogul who was one of the university’s founding trustees and whose best-remembered donation was the carcass of his equally-famous circus elephant, who has since lent his name to all of the university’s sports teams.  According to legend, the elephant died while pushing a baby elephant out of the way of a speeding train.  The truth was a less-heroic, but equally fatal, elephant vs. train collision. In any event, he was duly stuffed and sent to live in a university museum.  Years later, he was incinerated in a building fire.  Some of his ashes were scooped into a container and displayed in the rebuilt museum, but a grander tribute awaited.  Just this year, a massive bronze statue of the elephant was erected outside the building bearing his patron’s name.  We love this campus attraction, and we wax irrationally sentimental about the whole story.

We are trying to think of a smooth transition to today’s discussion, but this is the best we can do:  like legendary elephants, Daubert and Frye standards for admissibility of expert testimony, as applied by modern courts, frequently defy segregation into discrete containers.  Notwithstanding a hybrid analysis squeezed into a Frye box, the conclusion was clear: plaintiff’s causation experts in a Philadelphia Zoloft case did not meet any relevant admissibility standards, and both were properly excluded.Continue Reading A Frye Opinion By Any Other Name: Zoloft Plaintiffs’ Experts Excluded in Philadelphia

Over the weekend, we watched one of our favorite “chick flicks,” a holiday-themed montage entitled “Love, Actually.”  One of our favorite characters, played by the ever-brilliant Bill Nighy, is an over-the-hill former pop star who resorts to superimposing cheesy holiday lyrics on a familiar melody in an (ultimately successful) attempt to manufacture one last comeback.  A disc jockey, hearing this effort for the first time, exclaims, “How the mighty have fallen!”  This crossed our mind as we read today’s case, a decision on Daubert motions in a leftover breast implant case.

Twenty-some years ago, we cut our Drug and Device teeth on breast implant litigation, arguing motions in the infant Mass Tort Program in Philadelphia  Back then, the high-profile litigation, involving claims that breast implants caused serious auto-immune diseases in recipients, commanded high levels of attention and resources and produced some landmark verdicts.  Now, with the vast bulk of the litigation long settled, key defendants in bankruptcy, and many of plaintiff’s claims resoundingly debunked, all that remains are isolated opt-outs, like In re Dow Corning, Corp., Ezra v. DCC Litigation Facility, Inc., 2015 WL 5737997 ( E.D. Mich. Sept. 30, 2015), a primer on Daubert’s raison d’etre.

Plaintiff in Ezra claimed that her silicone gel implants caused

muscle aches and pains all over her body; metallic taste in the mouth; chronic problems with diarrhea; dizziness/vertigo problems; chronic low-grade fevers; frequent yeast infections; chronic fatigue; severe headaches; loss of taste and smell; memory loss and loss of concentration; frequent gastrointestinal problems; sinus problems with ear aches; difficulty swallowing; problems with choking; easily bruised with slow healing of bruises and cuts; spider veins on legs and feet; coldness of hands, fingers, feet, toes and face; muscle spasms; problems with rashes; tingling and numbness in extremities; difficulty breathing; unexplained dental problems; excessive hair loss; as well as emotional, physical and financial losses.

Ezra, 2015 WL 5737997, at *1.   She proffered the testimony of three causation experts, and defendant moved to exclude all three.Continue Reading Three Strikes and Out of Court for Breast Implant Opt-Out

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