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Rachel B. Weil

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This past weekend, we paid a return visit to Cleveland, the home of our best law school friend, who braved the (figurative) waters of New Haven with us so many years ago.  In deference to the Drug and Device Law Traveling Companion, we visited the Pro Football Hall of Fame.  In contrast to the stunning rotunda of our beloved Country Music Hall of Fame, the Football Hall stacks all of the inductees’ busts against a single wall – sort of a warehouse of disembodied heads.  We felt like we were in the parts department of Dr. Frankenstein’s laboratory.  But we enjoyed the visit and paid fond homage to the bust of Tommy McDonald.  We also visited the Rock and Roll Hall of Fame, which we had seen before and which we continue to find both impressive and tons of fun.  This time, we lingered at the “One-Hit Wonders” display, commemorating so many recording artists who disappeared after just a bit of noise, never to be heard from again.

The plaintiff in today’s case followed the same trajectory, albeit after his apparently meritless case languished on an MDL docket for eight years.  In Wilhelm v. Pfizer, Inc. 2016 U.S. Dist. LEXIS 127269 (D. Nev. Sept. 19, 2016), the complaint was originally filed in 2006 in the District of Nevada by fourteen plaintiffs alleging that the defendant’s product caused suicidal ideations.  The JPML transferred the case to the Neurontin MDL after it was filed, and remanded it back to the transferor court in July 2013 with three plaintiffs remaining.   One month later, the court permitted counsel for these plaintiffs to withdraw.  Two of the plaintiffs dropped out, leaving a single plaintiff, proceeding pro se. In February 2014, the defendant moved for summary judgment, arguing that the plaintiff could not produce any expert evidence proving that the defendant’s product caused his injuries.  The plaintiff filed for Chapter 7 bankruptcy in June 2014.  He never disclosed his product liability lawsuit in the course of his bankruptcy proceedings.Continue Reading The End of the Road for Pro Se Neurontin Plaintiff with No Evidence of Causation

We (in its blog-specific singular version) are longstanding country music fans. There is backstory – call us when you are in Philadelphia and we will tell you about it over coffee. Suffice it to say that Nashville, the Grand Ole Opry, and country greats from the 1970’s and 1980’s occupy a significant and permanent place in our soul.  So we were moved by a new video making the rounds of social media today. Entitled “Forever Country,” it is features 30 Country Music Association Award winners – both modern and legendary – in a beautiful montage celebrating 50 years of the CMA awards. You can see it here. There is also some pretty cool irony in the choice of “Take Me Home, Country Roads” as the song that opens the video and winds its way throughout. In 1975, John Denver was nominated as Country Music Association Entertainer of the Year. The previous year’s winner, Charlie Rich, was a bit “in his cups,” as they say, when he read the nominations. As he announced Denver as the winner, he struck a match and lit the card on fire in protest, because he did not think Denver was truly “country.” Happy to debate that when we have coffee, but we (unashamedly) love John Denver, as our office neighbors will attest. We are happy that Denver’s signature song was used in this celebration of country music. If it wins him some new fans, better late than never.

Also better late than never to report on today’s case, which just appeared online though it was decided 2 ½ years ago. In Peterson v. Wright Medical Technology, 2014 U.S. Dist. LEXIS 189473 (C.D. Ill. Feb. 13, 2014), the United States District Court for the Central District of Illinois considered the defendant’s motion for summary judgment on the plaintiff’s failure-to-warn claim in a hip implant case. The plaintiff, who was obese, received a new modular artificial hip to address his “significant end stage osteoarthritis” caused by an earlier accident. At the time of the plaintiff’s hip implant, his surgeon “had been an orthopedic surgeon for 31 years and had seen many evolutions of hip implants. He had read several journal articles about modular implants, including the [subject implant].” He had also read the Instructions for Use (“IFU”) included with the implant. He “knew that a patient’s weight and activity level could have an effect on the ultimate outcome of the surgery but had no reason to believe that Plaintiff was not an appropriate candidate for the implantation of this device.” The surgeon explained all of these risks to the plaintiff and required him to attend a two-hour teaching session before obtaining his informed consent.  Peterson, 2014 U.S. Dist. LEXIS 189743 at *3-4.

Two years after the plaintiff’s surgery, the titanium modular neck of his artificial hip broke into two pieces. In his complaint, the plaintiff asserted the usual strict liability and negligence claims, along with a punitive damages claim that was later dropped. The defendant moved for summary judgment on the plaintiff’s warnings claims sounding in both strict liability and negligence.

Continue Reading Defendant Did Not “Fail to Warn” Where It Warned of Exactly What Happened to the Plaintiff’s Artificial Hip

We spend the vast bulk of our professional life working in the context of MDLs.   We know the drill:  plaintiff lawyers file hundreds or thousands or tens of thousands of cases.  At some point, the cream rises to the top in the form of “bellwether” cases – cases with enough merit that a plaintiff expert of (relative) repute can verify the injury and attest to a causal link between that injury and our client’s product.  But that leaves the vast bulk of the docket — plaintiffs who may have seen an ad on late-night television, or received a cold call, or heard that a friend made some money in a tort suit.  These cases will never be the focus of the plaintiff lawyers’ attention, and most will remain untouched until they queue up, hands outstretched, as part of a “settlement inventory,” unless defense counsel mount pro-active efforts (and expend their resources and the court’s) to weed them out through dispositive motions.

In recent years, MDL judges have become more aware of, and less patient with, this reality, prompting increasing (and laudable) use of “Lone Pine” orders. We love Lone Pine orders, as we’ve discussed here and here.  But Lone Pine orders are remedial – while they may eventuate in the dismissal of meritless cases, they do not operate, in any significant fashion, to deter the filing of such cases in the first instance or the failure to dismiss them when their lack of merit first becomes clear.Continue Reading Put Up or Pay Up: Mentor Obtape MDL Judge Promises Sanctions to Plaintiff Attorneys Filing Meritless Cases

This weekend, the Drug and Device Law Rock Climber hosted a sleepover to say goodbye to her friends as she headed back to college. Somehow, between our last survey of heads on pillows and the convergence on the breakfast table, the number of non-resident young adults increased, prompting the logical question (as we cracked a few more eggs), “How did you guys get here?”

In In re Mortgage Electronic Registration Systems (MERS) Litigation, 2016 WL 3931820 (D. Ariz. July 21, 2016), the United States District Court for the District of Arizona asked a similar question.  This is obviously not a drug or device case, but it is relevant to all of us who defend clients in MDLs. In MERS, cases related to the formation and operation of the subject mortgage registration systems were consolidated in an MDL.  After the court dismissed a number of associated cases, the plaintiffs filed a Consolidated Amended Complaint (“CAC”). One of the named plaintiffs in the CAC had not been named in the previous complaint and “had never filed a lawsuit that the Judicial Panel on Multidistrict Litigation transferred to [the court].” MERS, 2016 WL 3931820 at *1.

A complicated procedural sequence ensued. The district court dismissed the CAC for failure to state a claim upon which relief could be granted.  In its discussion of its dismissal of Count I of the CAC, the court stated, “[The new] alleged Plaintiff . . . is not a named Plaintiff in any member case of this MDL.  Accordingly, Plaintiffs’ claim cannot rest on allegations relating to [this plaintiff].”  Id. at *1.  The Ninth Circuit affirmed the dismissal of the CAC except that it reversed and remanded as to Count I.  And so, the parties ended up back before the MDL court, where the defendants moved for summary judgment on the new plaintiff’s claims.  The defendants argued, “[This plaintiff] never filed a lawsuit that the [JPML] transferred to this Court.  Rather, [he] was joined when Plaintiffs filed their Consolidated Master Complaint – which is impermissible – and thus, this Court’s jurisdiction has not been invoked.” Id. at *2 (citations omitted).  In the alternative, the defendants asked that the new plaintiff’s claims be dismissed for lack of jurisdiction.

The court requested supplemental briefing on the following questions: 1) Does a transferee MDL court have the authority to join ‘new’ plaintiffs in an MDL when such plaintiffs never filed their own case (nor paid the filing fee) and never had their cases transferred to this Court by the panel on multidistrict litigation; and 2) what was the basis for federal subject matter jurisdiction over the new plaintiff’s case. Id. In their supplemental brief, the plaintiffs argued that the new plaintiff’s case was properly joined in the MDL because, like other plaintiffs, the defendants were allegedly involved in recording false documents related to the new plaintiff’s property.  Plaintiffs also argued that the court had diversity jurisdiction over the new plaintiff’s claims.  The defendants countered, “The jurisdictional issue relating to [the new plaintiff] does not involve whether there was diversity jurisdiction or federal question jurisdiction relating to [his] claims.  Rather, the issue is whether the Court’s jurisdiction is sufficiently invoked because [the new plaintiff] never filed a lawsuit in this federal court or in any other federal court that was then transferred to the MDL Court by the [JPML].” Id. at *3.Continue Reading MDL Court Says “You Don’t Belong Here” to Plaintiff “Added by Amendment”

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”

Back in October, all of the Philadelphia Reed Smith bloggers participated in an in-house CLE presentation attended by colleagues and clients.  Our portion of the presentation dealt with third party litigation funding.  There are several different funding models, but all are united by a common theme: funding companies, aided by plaintiffs’ lawyers, identify vulnerable litigants…

Last week, we (along with many of you, we assume) attended the DRI Drug and Medical Device conference in Chicago. We re-connected with friends dating to the beginning of our lengthy career (literally – ran into the head of our decades-ago summer associate program), met lots of new people, and attended great parties.  (Perhaps we are biased, but we thought the reception Reed Smith co-sponsored was particularly fabulous – stunning venue, fantastic food, great company and ambiance.)

Squeezed in among the parties was a whole seminar program, covering all manner of hot topics in the mass tort space in which we practice. We were (as we always are) awed by the sheer intellectual firepower the speakers brought to bear and by the depth of their knowledge and the thoroughness of their preparation.  We also enjoyed observing the diversity of presenters’ styles.  Some were earnest and academic, some deceptively casual and colloquial, still others politician-impassioned.  As wordsmiths, we always delight in this, and we count it among the reasons we like today’s case, which follows a mostly serious and measured (albeit dismissive) majority opinion with a snarky and stylized dissent.  (Guess which one was more fun to read.)

Milward v. Rust-Oleum Corp., 2016 U.S. App. LEXIS 7470 (1st Cir. Apr. 25, 2016), is not a drug or device case. It is the First Circuit’s review of the District of Massachusetts’s exclusion of the plaintiffs’ specific causation expert in a benzene-exposure toxic tort case, but the issues are identical to Daubert issues we face in our cases.Continue Reading First Circuit: Plaintiffs’ Specific Causation Expert Fails to Pass Muster in Benzene Case

This week, as Drug and Device Law Jews, we are preparing for Passover, which, like most Jewish holidays, begins with a multi-generational dinner at the home of the Drug and Device Law Bubbie (our mother). Although we of the second generation (there are now four) still fancy ourselves to be the “kids’ table” at this dinner – giggling at the solemn points of the reading, singing endless choruses of our favorite Passover song in defiance of the “just one time” edict, and generally disrupting the proceedings as much as possible – the reality is that we are all upper-middle-aged adults. And, as our matriarch ages (at least on paper), we assume more and more of the food preparation for the Seder dinner. And there’s the rub. For, much as we would enjoy the occasional stroke of rogue creativity, we know that nothing unfamiliar will be allowed on the table and that each of the traditional dishes must taste exactly as it has tasted for the past 50-plus (if not 2,000) years. Every ingredient and every step of preparation is subject to scrutiny, and Bubbie is the gatekeeper. (You know where this is going).

As everyone knows, under SCOTUS’s Daubert decision, the trial court is the gatekeeper when it comes to admitting or excluding the testimony of expert witnesses. We who practice in the mass tort space have gratefully experienced judges who take this responsibility seriously and have endured those who “punt” these determinations, nearly always to the benefit of plaintiffs whose dime-store experts – lacking qualifications, methodologies, or both – are permitted to peddle their wares to unsuspecting juries.

The Lipitor MDL judge falls resoundingly into the former camp. In In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices, and Prods. Liab. Litig., 2016 WL 1251828 (D.S. C. Mar. 30, 2016), considered the defendant’s Daubert motions addressed to the plaintiffs’ four causation experts, and wholly or partially excluded all four. But there is backstory. Lipitor is prescribed in four different doses – 10 mg, 20 mg, 40 mg, and 80 mg. This is an MDL, so our readers can guess which doses most of these plaintiffs took. While several studies show a statistically significant association between higher doses and new-onset diabetes, none shows such an association at the lowest dose. After the plaintiffs’ experts submitted their initial reports, the court “was concerned as to whether Plaintiffs’ experts had sufficient facts and data to support their causation opinions at all doses . . . , and even whether the experts would be willing to offer an opinion at low doses, given the available data.” In re Lipitor, 2016 WL 1251828 at *3. Over the defendant’s objections, the court allowed all four of the plaintiffs’ experts to submit supplemental reports addressing whether the drug caused diabetes at particular doses. Id. at *5. The defendant’s Daubert motions followed submission of the supplemental reports.Continue Reading Gutsy Gatekeeping: Plaintiffs’ Experts Excluded in Lipitor MDL

How much is “enough?” Will we have enough money to retire someday? Did the Drug and Device Law College Sophomore study enough for her computer science midterm? Is there enough salt in the matzo ball soup? In the realm of summary judgment, we who represent defendants are painfully familiar with courts that dodge this question, allowing claims to proceed and avoiding the complicated issues of admissibility that determine whether a plaintiff has presented enough evidence to create a genuine issue of material fact.

Not so in United States of America ex rel. John King and Tammy Drummond, et. al. v. Solvay S.A., et al.. 2016 U.S. Dist. LEXIS 43133 (S.D. Tex. Mar. 31, 2016). In King, a False Claims Act case, the Relators claimed that the defendant promoted three drugs for off-label uses, and that the off-label promotion resulted in false claims being submitted for prescriptions paid for by government health care programs. King, 2016 U.S. Dist. LEXIS at *5. The defendants moved for summary judgment on these claims, arguing that the relators did not have any admissible evidence of false claims. Specifically, the defendants argued that the Relators relied on inadmissible Texas and New York claims data to create summary charts of supposed false claims and didn’t disclose who created the charts or explain how they were created. Further, the defendants objected to the Relators’ reliance on sales representatives’ “call notes,” arguing that the call notes contained hearsay and lacked foundation. Id. at *8-9.

New York Claims Data

The Relators claimed that the New York claims data was self-authenticating because it was produced in response to a subpoena. The court disagreed, holding, “. . .[W]hile certainly Relators’ assertion that the State of New York produced the New York Claims Data pursuant to a subpoena must be what was requested in the subpoena,” documents produced pursuant to a subpoena are not always self-authenticating. Id. at *13. In contrast to a case cited by the Relators, which involved documents that were going to be used against that producing party, the Relators, who sued on behalf of the State of New York, were using the documents to benefit New York. The court concluded that the New York claims data was not self-authenticating “simply because it was produced pursuant to a subpoena.” Id. at *13-14.Continue Reading Summary Judgment for Defendants in FCA Action: No Admissible Evidence of False Claims

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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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