The U.S. Judicial Panel on Multidistrict Litigation (JPMDL) has allowed claims involving generic docetaxel, a chemotherapy drug, to be included in the Taxotere MDL now underway in the Eastern District of Louisiana.
Judge Sarah S. Vance, Chair of the JPMDL, stated in a letter that the consolidated litigation does include lawsuits against both name-brand and generic forms of the drug.
Taxotere, manufactured by Sanofi, lost its patent protection in late 2010. Half of the cases in the MDL involve generic and quasi-generic manufacturers, whose products obtained FDA approval under 21 USC Sec. 505(b)(2) and not through the more traditional generic approval under 21 USC Sec. 505(j).
The plaintiffs charge that they experienced permanent hair loss following treatment with the chemotherapy agent. While Taxotere was first approved to treat breast cancer in 1996, it wasn’t until December 2015 that mention of permanent alopecia (hair loss) was included on the drug’s U.S. label. It is true that alopecia is a common side effect of chemotherapy.
It is true that alopecia is a common side effect of chemotherapy. However, plaintiffs claim that Taxotere is more likely to result in the permanent loss of hair compared to other equally effective drugs. They also claim that Sanofi-Aventis has long provided information about the potential for permanent alopecia to each patient and regulatory agencies overseas. Yet Taxotere’s U.S. label only included a generic, vague, and insufficient warning that “hair generally grows back.”
Back in December 2016, when only 267 cases were filed in the MDL, Judge Engelhardt appointed plaintiff and defense settlement committees, calling on them to focus less on preparing for trial and more on resolving the case.
Genetic Edge Compounds recalled all lot codes of GEC Laxoplex dietary supplement capsules distributed between February 2, 2015-May 2, 2017 to the retail level and consumer level. FDA analysis found GEC Laxoplex to be tainted with anabolic steroids and steroid-like substances.
The presence of these anabolic steroids and steroid-like substances in GEC Laxoplex renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
Use or consumption of products containing anabolic steroids may cause acute liver injury, which is known to be a possible harmful effect of using steroid-containing products. In addition, abuse of anabolic steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.
GEC Laxoplex is marketed as a dietary supplement and sold as a muscle-enhancing agent. The product is packaged in a white plastic bottle containing 60 capsules with UPC code 0058049984 and can be identified by GEC Laxoplex. The recall affects all lots of GEC Laxoplex. GEC Laxoplex was distributed Nationwide in the USA through various nutritional supplement retail outlets.
Genetic Edge Compounds is notifying its retailers and customers by a formal recall notification and is arranging for a return of all recalled products. Consumers and retailers that have GEC Laxoplex dietary supplement capsules which are being recalled should stop using them and return to place of purchase.
A federal judge in New York dismissed one of 49 cases brought against Bristol-Myers Squibb Company and Pfizer Inc. over their Eliquis anticoagulant, ruling that the plaintiff’s state-law claims were preempted by federal law.
The court said that all the plaintiff’s claims — for failure to warn, design defect claims, warranty violations, fraud, and consumer protection claims — were preempted, adding that the Eliquis label is adequate as a matter of law.
Not ‘newly acquired information’
Showing off her homework in an 85-page opinion, Judge Cote also rejected all nine scientific articles or documents cited by the plaintiffs to create a plausible claim that the Eliquis labeling fails to adequately warn of the risk of excessive bleeding. “The information contained in this literature does not constitute ‘newly acquired information’ under the FDA’s regulation,” the opinion says. “Accordingly, the plaintiffs’ claims are preempted because federal law would not have permitted the defendants to make any change to the Eliquis label.”
“The risk of excessive bleeding from this blood thinner and the lack of an antidote were clearly disclosed to the Food & Drug Administration (“FDA”) when it approved the drug, and are prominently disclosed to medical practitioners and patients on the FDA-approved labeling for the drug,” the judge says.
Charlie Utts of California was diagnosed with atrial fibrillation and prescribed Eliquis by his doctor. After taking Eliquis, he suffered severe gastrointestinal bleeding and was hospitalized in July 2014 for about three weeks to undergo blood transfusions and several rounds of dialysis. He and his wife filed suit in 2016.
Eliquis — the brand name of the prescription medicine apixaban — is a blood-thinning medication used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Eliquis belongs to a class of drugs known as novel oral anticoagulants (“NOACs”). It does not have a known antidote or reversal agent. Unlike anticoagulant medications such as warfarin, NOACs, including Eliquis, do not require periodic blood testing or impose dietary restrictions on users.
Eliquis was approved by the FDA in 2012. The judge said the Eliquis label warns about the risk of serious bleeding five times, and warns that there is no specific antidote two times.
Problems caused by transvaginal mesh have been grossly under-estimated, according to a new survey by an Australian Health Issue Center.
Of these, a shocking 58% say they have been adversely impacted, citing problems such as chronic incontinence, abdominal pain, and pain during intercourse. Sadly, for a quarter of these women, the impact of the implants has led to a breakdown of their marriages or personal relationships.
Just 38% of the respondents believe they made an informed choice to have the procedure.
Of the women who sought remedial medical help, slightly over 10% reported this made things better while 40% reported it made no difference and 11%, that it made matters worse.
The remaining 39% were told that nothing could be done for them.
In just three weeks, 1,250 women completed the online Facebook survey targeting the thousands of women nationwide who have undergone pelvic mesh implants to treat stress urinary incontinence and pelvic organ prolapse.
In the US, there are 80,000 lawsuits against the manufacturers or transvaginal mesh in eight MDLS:
Commenting on the overwhelming response to the survey, HIC CEO, Danny Vadasz, says he has no idea ‘how much of the iceberg has been revealed’ so far but believes there could be considerably more given that HIC is currently averaging over 100 survey responses per day.
“Even if we were to receive no further responses, I think we have already demonstrated that this is a significant public health problem which has been grossly under-estimated — in terms of numbers of women as well as the severity of resultant health problems.
HIC is a not for profit consumer health advocate based in Victoria, Australia, which encourages better health outcomes by encouraging consumers to become involved in their own health care and ensuring the health system is responsive to their needs.
“What we are seeing is a catastrophic failure at all levels of the health system to protect the well-being of thousands of women – the lack of due diligence by the TGA in approving the device given the risks; culpability of manufacturers who despite plenty of evidence of adverse reactions overseas, continue marketing their products; the government which does not have a central register of how many procedures have occurred and how many products have been sold and finally, those surgeons who continue to practise the procedure without informing their patients of the risks and the irreversibility of the implant.
“Clearly a lot of questions need to be asked!”
Vadasz says while transvaginal mesh has been seen by the medical fraternity as having ‘revolutionised’ surgical options for women with stress urinary incontinence and pelvic organ prolapse, the collateral damage for women when it goes wrong, is just too high. “We are calling for the classification of mesh to treat either of the conditions to be upgraded to a higher risk status so the patient consent process reflects the consequences when there are complications.”
Unaware that mesh caused injuries
Despite the number of women coming forward, Vadasz believes that the problem will continue to go underreported given that many women do not associate their symptoms with their mesh implants. On top of this, many have been told by doctors there is no causal relationship.
“This has been borne out by the significant number of survey respondents who told us they were unaware that the pain and problems they had suffered for many years could be linked to their mesh implant. Some have cried at the realization with one woman declaring, ‘Now I know I’m not crazy’.”
Here are some of the more harrowing comments on the HIC Facebook page:
“My specialist told me it was all in my head. He got angry with me and said: “I suggest you stop focussing on the vagina, and get on with your life” in a dismissive and irritated tone. Doctors I have seen since have not been forthcoming on what they can see, it is like they are trying to protect the medical fraternity by not telling me fully what is going on or helping me fine treatment.”
“I was told the mesh cannot be removed. I had complications from the moment I came out of theater. I needed a complete reconstruction but was refused and offered the TVT as part of a study or to put up with consequences of a grossly oversized baby that was a face presentation and a complete episiotomy after he became stuck. I now suffer urge incontinence and a partial vaginal prolapse. I wish I’d never had the TVT done!”
The Health Issues Centre is one of several organizations invited to give input into the senate inquiry into the extent and impact of Transvaginal Mesh Implants (TVM) across Australia. Currently there is little information about the number of women who have undertaken the procedure and less about those who have suffered from side-effects. In order to understand the size of the problem and gain insight into the impact on these women, the consumer health advocacy conducted a highly targeted nationwide survey.
Using the center’s Facebook page to create interest and an online survey, the survey targeted 14,000 women nationally. The questions are as follows:
· Have you undergone a transvaginal mesh, tape or sling implant as treatment for urinary incontinence or pelvic organ prolapse?
· Do you continue to have undiagnosed symptoms of chronic abdominal pain or urinary incontinence?
· Do you feel you were fully informed before agreeing to the procedure?
· Did the procedure satisfactorily resolve your health concerns?
· Could you specify any adverse impacts you may have experienced?
· How would you rate this adverse impact – discomforting, severe, debilitating, unendurable, none of these.
· Have you sought medical assistance to rectify the problem?
· Did your doctor/specialist confirm a causal relationship between your symptoms and the mesh implant?
· If you were offered remedial treatment, did it change your condition?
While launched only three weeks ago, 20,000 have engaged with the survey and 1,250 surveys have been completed. Over 14,000 people have viewed the Facebook video.
This article was originally published in BullsEye, an expert witness and litigation news publication published by IMS ExpertServices. IMS ExpertServices is a full-service expert witness and litigation consultant search firm focused exclusively on providing best-of-class experts to attorneys.
By Annie Dike, Esq.
Summary judgment motions are filed in just about every case. Yet they are denied most of the time. Why is that? Is it because in each of those instances there truly was a genuine issue of material fact?
If you disagree, which is likely, it’s probably because you feel the court is generally averse to granting summary judgment because it requires a detailed analysis and supporting opinion. It is also riskier because the burden is high, making it more subject to reversal on appeal. Our question to you is this: Do you feel the same about the court’s inclination to exclude expert testimony?
The Expert Requirements
It is a bit ironic asking that question when we are about to report on a surprisingly-lengthy opinion excluding multiple experts and their opinions, but perhaps Jones v. Novartis Pharmaceuticals Corp., 2017 WL 372246 (N.D. Ala. Jan. 26, 2017) is a rarity. The plaintiff in Jones alleged her atypical femur fracture (“AFF”) was caused—not only generally, but specifically—by the defendant, Novartis’s, prescription osteoporosis medication, Reclast, a type of bisphosphonate (“BP”) drug. The court began by digging into the three Daubert requirements an expert must meet for admission:
Sounds simple enough, but it took the court 119 pages to do it.
In applying the three-prong test above to the testimony offered by the plaintiff’s numerous experts, the court granted each—some in part, most in whole—motion to exclude based on the following Daubert-specific findings:
Causation expert, Dr. Suzanne Parisian, an FDA Medical Officer and FDA drug regulation specialist, was not qualified to testify as to “Novartis’ intent or state of mind, so any testimony on these issues is not admissible. Additionally, Dr. Parisian is not qualified and will not be permitted to testify about causation or ‘causal association’; whether and when Novartis was put on ‘notice’; whether any advertising or marketing changes might have affected the opinion of a physician; studies conducted on other BP drugs; pharmaceutical industry standards; correlations between AFF and osteonecrosis of the jaw; and other improper legal conclusions.” Jones, 2017 WL 372246, *9.
Causation expert, Dr. William B. Hinshaw, a bio-organic chemist and practicing gynecologist, improperly used the Bradford Hill method for determining causation and he improperly extrapolated from studies of the class of BP drugs where there were significant differences, including regarding the impact on material properties of bone, between the other class BPs, which are administered orally on a weekly or monthly basis, as opposed to Reclast, which is a single IV infusion per year to form his causation opinion and he was not qualified to opine on Novartis’ compliance with FDA regulations. Id. at *16-28.
Causation expert, Dr. Wayne A. Taylor, a statistician, used unreliable and inadequate re-analysis of medical data to form his general causation opinion by improperly including a spiral fracture from another analysis, failed to demonstrate reliability of his one-tailed test versus a two-tailed test and he was not qualified to offer expert opinions on compliance with FDA regulatory standards. Id. at *28-40.
Causation expert, Dr. James Worthen, a board-certified orthopedic surgeon, one of the plaintiff’s treating physicians and a non-retained expert, was not qualified to testify as to causation because he failed to reliably rule out the plaintiff’s steroid use and other risk factors as causes of her injuries. Id. at *40-44.
Causation expert, Dr. Timothy Mark Ricketts, an internist, general practitioner and another treating physician of the plaintiff, and a non-retained expert, was not qualified to offer an opinion that the plaintiff’s fractures were caused by Reclast because they were “of the type described in medical literature caused by BP use” because this opinion relied substantially on the opinions of other physicians. Id. at*44-45.
The Jones court specifically recites the Daubert gatekeeping function as a mandate that the trial court conduct “an exacting analysis of the foundations of expert opinions to ensure they meet the standards for admissibility under Rule 702.” Id. at *2 quoting United States v. Abreu, 406 F.3d 1304, 1306 (11th Cir. 2005). In addition, as we noted in our recent Gorsuch article, the court must also include certain elements, i.e., a specific address to each Daubert objection raised, in the opinion granting a Daubert motion to ensure it will stand up on appeal. That’s a big job.
While the Jones opinion is well-supported and stands as a very helpful example of a thorough Daubert analysis, we’re curious whether you think courts are often not inclined to engage in this kind of detailed, documented review because it requires so much time, effort, and judicial resources. Tell us your thoughts in the comments below.
As a former trial and litigation attorney, Annie Dike has a keen eye for expert evidentiary issues and a clear voice for practical solutions. Annie is a published author of both fiction, non-fiction, and a comprehensive legal practitioner’s guide to hourly billing published by LexisNexis.
Annie graduated from the University of Alabama School of Law cum laude. While in law school, she served as Vice President of both the Bench and Bar Legal Honor Society and the Farrah Law Society and was a member of the Alabama Trial Advocacy Competition Team as well as Lead Articles Editor of The Journal of the Legal Profession. Ms. Dike has published articles in The Alabama Lawyer and DRI MedLaw Update and has spoken on numerous legal issues at various conferences nationwide.
The US Senate approved controversial nominee Dr. Scott Gottlieb to be the new Commissioner of the Food and Drug Administration. He is a physician and former deputy FDA commissioner who has ties to the pharmaceutical industry he is supposed to regulate.
Gottlieb has worked with health care companies as part of global venture capital firm New Enterprise Associates and boutique investment firm T.R. Winston & Co., and he has sat on a board at GlaxoSmithKline PLC, among other positions.
Conflicts of interest
Senator Patty Murray (D-WA) criticized Gottlieb’s industry ties. “I am deeply concerned about Mr. Gottlieb’s extensive ties to the pharmaceutical and biomedical industries and asked him to address potential conflicts of interest that may arise during his tenure at the FDA. I pushed him to commit to making decisions that are in the best interest of public health, and asked how he plans to ensure that his industry ties and the radical views of the Trump administration will not affect his decision-making should he be confirmed.
“President Trump promised to “drain the swamp,” and as it stands, Mr. Gottlieb’s ties to the companies and industries he will regulate do exactly the opposite.
“It is critical that the FDA have independent leadership focused squarely on putting patients and families first, and I look forward to a thorough, rigorous vetting and hearing process to determine whether Mr. Gottlieb is appropriate for this role.”
Gottlieb promoted opiods
Senator Edward J. Markey (D-Mass.) released the following statement today after revelations in a Washington Post story indicate that Dr. Scott Gottlieb, the Trump administration’s nominee to run the FDA, worked on behalf of one company, Cephalon, to raise the quota of the addictive opioid fentanyl at the same time the prescription opioid epidemic was exploding.
The Washington Post story details how Dr. Gottlieb advocated for the Drug Enforcement Administration (DEA) to raise the quota of fentanyl that Cephalon could manufacture and put on the market even while the company was under investigation for pushing doctors to prescribe the addictive painkiller for headaches and back pain when it was meant for late-stage cancer patients. Cephalon pleaded guilty in 2008 to illegally promoting the fentanyl drug and paid a $425 million fine.
Senator Markey has sent a letter to the DEA requesting more information on Dr. Gottlieb’s involvement with this request to increase fentanyl quotas for Cephalon.
“Dr. Gottlieb seems to believe that pharmaceutical profits are more important than the public’s health. When the prescription opioid epidemic was exploding, Dr. Gottlieb advocated to put even more addictive fentanyl onto the market when it wasn’t appropriate or necessary. Dr. Gottlieb said during his confirmation hearing that the FDA unwittingly fueled the opioid epidemic, but he is guilty of intentionally pushing an addictive prescription opioid onto the American public just to benefit one company. Instead of working to prevent this massive public health crisis, Dr. Gottlieb’s actions could have made the opioid crisis worse.
“Serious questions remain about Dr. Gottlieb’s association with Cephalon, which was fined hundreds of millions of dollars for violating FDA rules. We need answers about this potentially disqualifying conflict of interest. We cannot have a leader at the FDA who has worked on behalf of a company that aided and abetted the prescription drug and heroin epidemic. I do not believe Dr. Gottlieb has any place at the FDA.”
Within minutes of the defense verdict being handed down in the first Xarelto bellwether trial, (Boudreaux vs Bayer et.al., Case No. 2:14-cv-02720) the phone lines at Mass Tort Nexus began ringing like a Salvation Army donation site at Christmas.
The primary inquiry was the same: “What effect does the Boudreaux defense verdict have on the overall prospects of the Xarelto litigation?”
Our website www.masstortnexus.com already contained all of the pretrial documents for the Boudreaux case and we ordered an expedited copy of the Boudreaux transcript so that our researchers could get the complete picture and start an autopsy of the case.
If you are a Mass Tort Nexus subscriber you may obtain all documents, including the 1,600+ page transcript from the Boudreaux bellwether trial here.
Before going further, it is important to say to any plaintiff lawyer representing clients in the Xarelto litigation who may be freaking out due to the defense verdict in the first bellwether trial: put the cap back on the Xanax.
In fact, the plaintiff may well lose the second bellwether trial as well, because it appears that the Dr. St. James, the prescribing physician in the Orr case (the second Xarelto bellwether trial set for May 30, Joseph Orr, Jr., Case No. 2:15-cv-03708), is likely to testify in a very similar manner to Dr. Wong, (the prescribing physician in the Boudreaux bellwether case).
Regardless, keep your feet firmly planted on the rail of that bridge you may be thinking of jumping off of. Panic would be extremely premature.
Mass Tort Nexus became aware of how Dr. Wong and Dr. St. James were likely to testify as a result of the motion for summary judgment based on the learned intermediary doctrine filed by the defense revealing deposition testimony of Dr. Wong and Dr. St. James. Both prescribing physicians testified as if someone had given them a script entitled “How a prescribing physician should testify to support a learned intermediary doctrine defense.”
The defense motion for summary judgment was denied as under Louisiana’s version of the learned intermediary doctrine, because the relevant issues are considered matters for a jury to decide under Louisiana Law. Louisiana law applied because both the Boudreaux and the Orr case state of “original jurisdiction” was Louisiana. This had nothing to do with the fact that the MDL is consolidated in Louisiana nor will Louisiana law apply to cases where other states would be the state of “original jurisdiction.”
The Answer to the $64,000 Question
The simple answer to the question, regarding the defense verdict in the first Xarelto bellwether, is that the Boudreaux verdict has no direct impact on any other case other than the case brought on behalf of Joseph Boudreaux.
As to the indirect impact Boudreaux verdict on the overall Xarelto litigation, the analysis must be broadened.
First, the fact that defense based its entire strategy on the learned intermediary doctrine, could be somewhat telling about the defendants and their counsel’s belief that they would prevail under other defense theories. The learned intermediary doctrine is considered by many to be a defense of last resort. When possible, the goal of defendants in pharmaceutical and medical device cases should be to obtain dismissal of every single plaintiff’s case in a mass litigation via preemption or other universal case-killer legal theory. This goal will never be achieved through the learned intermediary doctrine defense.
The learned intermediary doctrine provides that a manufacturer of a product has fulfilled his duty of care when he provides all the necessary information to a “learned intermediary” who then interacts with the consumer of a product.
Although most states have codified some version of the doctrine and the reasoning behind it has been applied in individual cases in all 50 States, it is safe to say that not all states have applied the doctrine in the same manner.
More important is that the learned intermediary doctrine defense is entirely dependent on the testimony of the individual prescribing physician in any given plaintiff’s case. To prevail with the learned intermediary doctrine defense, the prescribing physician must testify, very specifically, in one of two manners:
That the doctor was aware of all the risks associated with the drug and continued to believe that the benefits outweighed the risks with regard to the individual plaintiff (patient).
That any risk not known at the time the doctor prescribed the drug, if known, would not have changed her decision with regard to prescribing the drug for the individual plaintiff patient.
16,285 additional complaints
Plaintiffs and their counsel can safely assume that many of the prescribing physicians for the 39 remaining scheduled Xarelto bellwether cases will not all testify in a manner supporting a learned intermediary doctrine defense. Beyond the 39 bellwether cases, defense has 16,285 (and climbing) additional complaints to contend with. Are all the prescribing physicians in the other 17,000 plus complaints going to fiddle to the music of the learned intermediary doctrine defense? Not bloody likely.
In the Xarelto bellwether trial selection, Judge Eldon Fallon allowed the defense to pick 10 cases, allowed the plaintiffs to pick 10 cases and Judge Fallon selected the remaining 20 cases himself. Plaintiffs are not facing a situation where defense was able to load the bellwether selection with cases in which the individual prescribing physicians gave depositions or otherwise indicated that they would eventually testify by the script the defendants need to prevail under a learned intermediary defense.
In cases where the prescribing physician cannot be counted on to follow the defendants’ learned intermediary doctrine script, the defendant and counsel will be forced to base their arguments on the merits of the case. Without the learned intermediary doctrine knockout, the merits of the Xarelto case favor defense looking as if it was in a fight with Joe Frazier followed by a fight with Mike Tyson.
Putting aside the foregoing, a review of past MDL pharmaceutical product liability bellwether verdicts in which defense has prevailed in the first trial and often in the majority of the bellwether cases may allow some plaintiff lawyers to put the first Xarelto bellwether defense verdict in perspective and take comfort.
39 bellwethers to go
Note: If the prescribing physician takes the stand wearing a Rolex with the defendants’ logo inscribed on the back, no matter how good the case or counsel may be, the plaintiff is probably not going to fare well. Fortunately, in the Xarelto litigation, there are 39 more bellwether trials to go.
If the defense does not settle those 39 cases, there will likely be more bellwethers scheduled. If Judge Fallon at some point determines that the litigation is not going to result in settlement, he could remand all remaining cases for trial.
The only other possible outcome is for the defense to find a way to get all Xarelto cases dismissed on a creative legal theory (which does not exist in the Xarelto case). It is safe to say, we are past the point where all Xarelto cases will be universally dismissed under any legal theory.
Anyone who has attended the Four Days to Mass Tort Success Course has heard me say, “The decisions made in the boardroom of pharmaceutical companies with regard to settling mass litigation cases often have very little to do with the ‘legal’ aspects of the case and although bellwether trials results are not insignificant, they are not as significant as one might assume.”
What is the likely future of the Xarelto bellwether trials? The defense will win some, the plaintiffs will win some and in the final analysis, these wins and losses will not be the primary factor in the defendant’s decision to settle the case. We apologize to anyone who was under the false impression that Big Pharma makes any decision that is not based on the bottom line, including their decision to put dangerous products on the market in the first place. Ultimately it is unlikely that a scenario will appear where the math for the defendant will not favor mass settlement.
Below is a sampling of cases where the first bellwether trial resulted in a defense verdict or the majority of bellwether trials resulted in defense verdicts and yet, the litigation ended in mass settlement.
Bellwether Defense Wins and Settlements
Vioxx MDL 1657
Of the six bellwether trials that occurred in the Vioxx MDL the first bellwether trial ended in a defense verdict. The other five bellwether trials ended in three more defense verdicts, one trial ended in a hung jury and the plaintiffs won only one of the six bellwether trials. Ten additional trials occurred outside of the MDL. Of the total 16 trials that occurred in the Vioxx product liability litigation, 11 resulted in defense verdicts.
The defendant ultimately agreed to settle the vast majority of Vioxx cases for an estimated $4.8 billion.
72 Defense firms participated in the Vioxx product liability defense. According to documents filed on behalf of these firms, the total hours billed for all firms was 350,000 hours. Using a blended rate including averages for partners, associates and other personnel of $475 per hour. The defendant’s legal fees were about $165,550,000.
If you are doing the math, inclusive of the legal fees paid for the defendant’s legal fees in the MDL and the 16 Vioxx trials, the defendant spent on average $10,343,750 per tried case. Winning does not feel that great when your own lawyers dip their hands deeper into your pocket than the opposition.
MDL 1355 Propulsid
The first bellwether trial resulted in a defense verdict. The second and third bellwether trials resulted in defense motions for summary judgment being granted.
The defendant Johnson & Johnson ultimately settled with the majority of the plaintiffs in the Propulsid litigation for an estimated $100 million.
Prempro Product Liability Litigation
The first bellwether trial resulted in a defense verdict. The defendant went on to win the majority of the 15 bellwether trials.
Ultimately the defendant settled the vast majority of the plaintiffs’ cases for about $1 billion.
Defense summary judgment granted in all Group I bellwether cases. The defendant agreed to settle the majority of NuvaRing cases for approximately $100 million.
Traysol Product Liability Litigation MDL 1928
The first two bellwether trials were dismissed on a defense motion for summary judgment. The defendant Bayer ultimately settled the Traysol Litigation for an average of approximately $400,000 per plaintiff.
Actos Product Liability Litigation MDL 2299
The first three bellwether trials resulted in plaintiff’s verdicts with jury awards of $6.5 million, $1.76 million and $2.05 million. The fourth bellwether trial resulted in a defense verdict. Takeda settled Actos cases for a total of approximately $2.4 billion.
Fen-Phen Product Liability Litigation MDL 1023
Despite having prevailed in many bellwether trials including Weston v. Wyeth, No. 03-CV-679878 (Jasper Co., Mo., Cir. Ct. 2006). Geers v. Wyeth, No. MO-03-CA-107-H (W.D. Texas 2006), Townley v. Wyeth, Nos. 0402-03094 and 0402-03171 (Philadelphia Co., Pa., Ct. C.P. 2006), Smith v. American Home Products, No. 97-55545 as well as others — Wyeth ultimately settled the Fen-Phen Litigation for approximately $2.74 billion.
In a gambit to dismiss 1,700 lawsuits against its IVC filter, CR Bard is pressing a novel argument that the FDA’s quickie 510(k) approval process has become more rigorous, thus entitling it to a ruling that the plaintiffs’ state-law claims are preempted by federal law.
The argument is a stretch because courts have often declined to hold claims preempted where medical devices were cleared under the shortcut 510(k) process, as opposed to the more rigorous premarket approval (PMA) process.
All of Bard’s IVC filters involved in MDL 2641 – the Recovery, G2, G2, Express, G2 X, EclipseTM, Meridian, and Denali Filters — got approval via the lenient 510(k) process. The case is IN RE: Bard IVC Filters Products Liability Litigation, Case No. 2:15-MD-02641-DGC before US District Judge David G. Campbell in Arizona.
Bard argues in its summary judgment motion that the plaintiff’s master long and short form complaints, asserting state-law claims, are expressly and impliedly preempted by federal law.
FDA approval through Sec. 510(k) of the Medical Device Amendments of 1976 merely requires that a new device is “substantially equivalent” to a predicate device — but not a review of its safety or efficacy as would happen in a premarket approval application (PMA).
“The 510(k) program has changed greatly since Lohr (Medtronic v. Lohr, 518 U.S. 470 (1996),” Bard argues. “In 1990, Congress dramatically altered the 510(k) process in section 12 of the SMDA (Safe Medical Devices Act). The language expressly linked FDA substantial findings to “safety” and “efficacy”/”effectiveness”:
[T]he term “substantially equivalent” or “substantial equivalence” means . . . that the device . . . (ii)(1) has different technological characteristics and the information submitted . . . contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that the device is as safe and effective as a legally marketed device, and (II) does not raise different questions of safety and efficacy than the predicate device.
Bard says that in its 510(k) approvals:
The FDA required compliance with special controls.
FDA required Bard to conduct clinical studies of its filters.
FDA required additional testing, labeling, and other information during its review.
“These device-specific guidances are intended to address specific risks or issues related to specific devices or device types, and where, as here, FDA has required manufacturers to follow them, they become device-specific federal requirements entitled to preemptive effect,” Bard asserts.
Bard quotes an FDA 2010 Working Report, saying that “the 510(k) program has changed significantly since its inception…. Through various statutory and regulatory modifications over time, it has become a multifaceted premarket review process that is expected to assure that cleared devices, subject to general and applicable special controls, provide reasonable assurance of safety and effectiveness, and to facilitate innovation in the medical device industry.”
“The Court in Levine [Wyeth v. Levine, 555 U.S. 555 (2009)] held that a state failure to warn claim against a brand-name drug manufacturer was not preempted by federal law, finding that Congress had clearly intended the judicial branch to work in concert with the FDA to protect against unnecessary risk,” the court held.
The judge added, “The court in Guidry [Guidry v. Janssen Pharms., Inc., No. 15-4591, 2016 U.S. Dist. LEXIS 115447, at *48 (E.D. La. Aug. 29, 2016)], relying on Wyeth, found that Plaintiff’s pre-market defective design claims under the LPLA [Louisiana Products Liability Act] were not preempted. “Federal law does not prevent a drug manufacturer from complying with this state-imposed duty before seeking FDA approval. Far from impossible, the two are complimentary, preferable, and perhaps necessary to protect the public health and assure the safety, effectiveness, and reliability of drugs.”
Plaintiffs argue that IVC filters cause injuries as follows:
Migration downward and upward. The IVC Filters can tilt or shift, making them almost impossible to remove.
Device fracture, causing blood clots (embolism) in the heart, lung, liver and kidneys. Research shows that the devices experienced fracture rates of 37% to 40% after five and a half years.
Perforation, where stress on the IVC Filter struts leads to fractures that puncture adjacent organs and vessels.
Asked by plaintiff attorney Allen Smith to punish Johnson & Johnson for its “reprehensible” actions in selling cancer-causing talcum powder to women, a jury in St. Louis state court delivered a bombshell $110,000,000 verdict for the plaintiff.
Attorney Allen Smith of The Smith Law Firm of Ridgeland, MS, represented plaintiff Lois Slemp, age 62, of Virginia. She used J&J’s baby power and Shower to Shower talc products for more than 40 years before she was diagnosed with ovarian cancer in 2012.
Slemp, whose cancer has since spread to her liver, was too ill to attend the trial. Her lawsuit is among more than 1,000 filed in St. Louis by women across the country, taking advantage of a Missouri law that allows suits to be filed there by plaintiffs with no connection to the state.
The case is Lois Slemp v. Johnson & Johnson et al., case number 1422-CC09326-01, in the 22nd Judicial Circuit Court of Missouri before Judge Rex Burlison. More talc trials are set in St. Louis for June and July, with the first case in Caifornia set to go to trial in July.
The St. Louis jury returned a verdict in favor of the plaintiff in all of her claims, including conspiracy, breach of implied warranty and negligence.
The jury also held Imerys Talc America liable for $100,000. Imerys supplied talc to J&J and placed health warnings on the material safety data sheets for the talc. J&J, however, has never put a health warning on its Baby Powder or Shower to Shower products.
Smith said in his closing argument that J&J is a $70 billion company and that a verdict to of $175 million would be only 1/4 of one percent of that value. “They not going to warn unless you all do something about it,” he told the jury, “and the only way you can do that through this court is through monetary damages.”
Evidence at the trial showed that J&J put corporate profits ahead of consumers. “These defendants…took a warlike mentality and fought regulation by influencing the FDA and the other agencies that are supposed to police this kind of talk, and there’s nothing more reprehensible than that,” he argued.
Spokespeople for the Johnson & Johnson pointed out that the federal judge in New Jersey excluded testimony from key experts who have testified for plaintiffs in St. Louis. Further, the Missouri Court of Appeals will hear oral arguments on May 10 challenging the first talc verdict, when jurors awarded Jacqueline Fox $72 million. And on March 3, 2017, a St. Louis jury returned a defense verdict for J&J and Imerys.
“Once again we’ve shown that these companies ignored the scientific evidence and continue to deny their responsibilities to the women of America,” attorney Ted Meadows said. “I hope this verdict prompts J&J to acknowledge the facts and help educate the medical community and the public about the proper use of their products.”
A federal jury in Louisiana ruled that Johnson & Johnson and Bayer AG provided adequate instructions for the safe use of Xarelto to the doctors who prescribed it to the plaintiff, who suffered severe gastrointestinal bleeding and survived only because of several blood transfusions.
It was the first verdict in the first test case of 16,285 lawsuits, and it has no bearing on future trial outcomes. The plaintiff Joseph Boudreaux, Jr., age 75, of Lafourche Parish, Louisiana. He was prescribed Xarelto in 2014 for atrial fibrillation. He only took the drug for 21 days before he suffered severe gastrointestinal bleeding.
The drug is Bayer’s top-selling product, generating $3.24 billion in sales last year and $2.5 billion in 2015 for the German pharmaceutical company. Xarelto is J&J’s third-largest seller, bringing in $2.29 billion in 2016 as the New Brunswick, New Jersey.
Doctors sink plaintiff’s case
The fatal element for the plaintiff was that his doctor – cardiologist Dr. Kenneth Wong – testified that they stood by their decision to prescribe Xarelto. Further, both doctors testified that they would have used a test to monitor anticoagulation, but only if it were FDA-approved. The defense argued that this test does not exist (although this claim is not accurate).
Xarelto advertised that its predecessor drug warfarin required testing and monitoring — and that Xarelto did not. The makers of Xarelto had to test the prothrombin time (PT)/international normalized ratio (INR) in their clinical trials, so a test does exist.
Accepting the defense argument that there was no approved test means that the makers of Xarelto put a product on the market for which testing/monitoring was needed — yet no test existed and the drug companies didn’t warn of this.
In the Boudreaux case, the defendants argued that the plaintiff was administered a different PT test which showed him in the normal range. Accordingly, the defense argued there is no causal connection between the plaintiffs’ injuries and the failure to warn, and the arguments are barred by the learned intermediary doctrine.
Janssen was represented by Susan Sharko of Drinker Biddle & Reath LLP and Richard Sarver and Celeste Coco-Ewing of Barrasso Usdin Kupperman Freeman & Sarver. Bayer’s attorneys are Beth Wilkinson of Wilkinson Walsh Eskovitz, David Dukes of Nelson Mullins Riley & Scarborough and William Hoffman of Arnold & Porter Kaye Scholer LLP.
The defense succeeded in its argument that the drug label is legally adequate because it prominently warns of the risk of bleeding and the prescribing physicians testified that they were aware of that risk.
The defense succeeded in its argument that the drug label is legally adequate because it prominently warns of the risk of bleeding and the prescribing physicians testified that they were aware of that risk.
The plaintiff emphasized that there is no antidote to Xarelto, unlike warfarin. Therefore, in the event of hemorrhagic complications, there is no available reversal agent. The original U.S. label approved when the drug was first marketed in the U.S. did not contain a warning regarding the lack of antidote, but instead only mentioned this important fact in the overdosage section.
The pharma companies face more bellwether trials in federal court presided over by US District Judge Eldon Fallon in New Orleans. :
May 30, 2017 – Eastern District of Louisiana
To Be Set in June 2017 – Southern District of Mississippi
To Be Set in July 2017 – Northern District of Texas
Independently, the drug companies face 1,390 lawsuits over Xarelto in the Philadelphia Court of Common Pleas.