Eliquis Plaintiffs Must Show Cause Why Their Cases Shouldn’t Be Dismissed from MDL

eliquis-internal-bleeding-lawsuitJudge Denise Cote of the U.S. District Court for the Southern District of New York, who is supervising the Eliquis MDL, ordered all plaintiffs to show cause by May 23 why her dismissal of one case should not be applied to all cases.

The case is In Re:  Eliquis [Apixaban] Products Liability Litigation, MDL 2754, No. 17-md-2754, Charlie Utts, et al. v. Bristol-Myers Squibb Company, et al., No. 16-5668, S.D. N.Y., 2017).

On May 8 the judge dismissed the Utts case, 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.

On May 9, Judge Cote gave plaintiffs until May 23 to file amended complaints “and to show cause in a memorandum no longer than 20 pages why the amended complaint should not be dismissed based on the analysis in the May 8 Utts Opinion.”  Future lawsuits transferred into the MDL will have 14 days to provide the same information, the judge said.

The judge added that “it is unlikely that the plaintiffs in any of these actions will have a further opportunity to amend.”  She said the defendants will file a reply or replies by June 20, “at which point the motions to dismiss each action will be considered fully submitted.”

Gastrointestinal bleeding

Plaintiff 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.

The plaintiffs argued that despite there being no antidote for uncontrolled bleeding while taking Eliquis, the dosage recommendation was not individually tailored and that Bristol-Myers and Pfizer did not recommend constant monitoring of blood clotting times in patients.

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.

Well-Known to FDA

“These two complaints concern features of the design of the drug that were well known to the FDA [Food and Drug Administration] when it approved the drug,” Judge Cote wrote.

“Faced with the fact that, as of today, there is no research or clinical experience to suggest that any changes to the Eliquis label’s disclosures related to a risk of excessive bleeding are warranted, the plaintiffs argue vehemently that the motion to dismiss should be denied and that they should be permitted to conduct discovery to try to locate evidence in the defendants’ files that might support their failure to warn claims,” the judge continued.

“They emphasize that there is substantial ongoing litigation over the earlier drugs in the class of drugs to which Eliquis belongs,” the judge continued.  “But, the ability of other plaintiffs in other litigation over other drugs to survive a motion to dismiss does not relieve the plaintiffs of the requirements imposed by Rule 12(b)[Fed. R. Civ. P., 12(b)].  Accordingly, the claims in the [second amended complaint], which reduced to their essence are attacks on the design of this drug, will be dismissed.”

 

The Uttses are represented by Hunter J. Shkolnik and Nicholas Farnolo of Napoli Shkolnik in Melville, N.Y.

Read More

A Closer Look at Advertising Response within a Guaranteed Cost Structure

The three co-founders of Amicus Media Group: George Young, Bill Tilley and Chad Nell.
The three co-founders of Amicus Media Group: George Young, Bill Tilley and Chad Nell.

By George Young, Partner, Amicus Media Group

In a world where consumers are presented with an overwhelming choice of television, radio, and online platforms, how can a law firm be assured that media time purchased to generate cases will perform? What if media time is purchased and no one calls or responds?  Performance media addresses ROI concerns, as this model to media depends on paying for the responsive results, instead of the media time itself.

Performance media addresses ROI concerns, as this model to media depends on paying for the responsive results, instead of the media time itself.

By taking a closer look at performance media, we can begin to understand why law firms use this model to reach potential clients at a guaranteed cost and improve profitability with less risk.

Performance Media as a Model of Predictability

Comparing the cost structure between different models of media buying, a more predictable model emerges through performance media campaigns. In the traditional model of dedicated media purchased for attorney advertising, the law firm provides a budget to the advertising agency for buying media time to drive calls or leads to the firm from people who have been harmed by a dangerous drug, medical device, or any other type of injury case.  The typical cost to media for generating a call will likely fluctuate from week to week, as media spot cost, call response, and other factors will ultimately affect the lead cost and unpredictably impact the campaign effectiveness.

While the performance model for attorney advertising similarly requires the law firm to provide a marketing budget to the media agency the key difference is that the cost to generate a call or lead from advertising is secured at a guaranteed rate for an actual response.  As the financial risk is shifted from the law firm to media, the onus to perform is placed squarely on the media running the campaign. The risk of budget burning for subpar results is mitigated for the law firm, due to the potential client response cost being known.  

As a clear example, consider the traditional media cash buying model of advertising where the law firm commits to specific times and networks and is required to pay for media time regardless whether the target audience responds. In contrast, if the same advertising spot runs as a national or regional performance campaign and no one responds, zero dollars are owed. Certainly, performance media offers a reliable model by guaranteeing a more predictable cost of advertising.

How and Why Networks offer Guaranteed Cost Structures

While only a few agencies can offer performance media, this type of advertising holds several key advantages for the networks as well as law firm advertisers.  Performance media provides stations the capability of adding revenue spots to the daily inventory of avails on demand, where they can fill unsold schedule openings, or replace last minute cancellations.  These media avails can be provided to law firms at a much lower cost compared to advertisers that buy specific media time slots.  Consequently, performance media allows networks to monetize inventory that historically would likely go unsold and therefore air non-revenue broadcasts such as public service announcements or promotional spots. Performance media offers a flexibility in programming that ensures every possible commercial break is monetized.

Where Performance Media Campaigns Work Best

Performance advertising is also called “Opportunity Media”, as television and radio networks may place the spot during any time of day where an open avail (opportunity) in their schedule exists.  As such, traditional prelogs (schedules indicating when spots are expected to run) and post logs (schedules showing when spots went live) are not provided by the networks.   Instead, each week the networks bill for the total number of calls or leads generated by the previous week’s advertising.   While performance marketing can deliver significant cost savings to law firms compared to specific advertising time purchased, there are instances where traditional media cash buy may propose a more reasonable option. An example where a traditional media cash buy might be strategic would include instances where a law firm requires complete control over spot placement or online display of the advertising.

Considerations when Launching a Performance Media Campaign:

Each year law firms across the country use performance media to save millions of dollars in acquiring mass tort, personal injury, and other types of cases.  

Performance Media Attributes include:

  • Campaign Launch Timeline:  Expect about 2 weeks to get the phones ringing and 4-6 weeks for full call volume to emerge.  
  • Refundable Deposit:  A refundable deposit is typically held on account equal to about three weeks of billing.
  • Billing:  Television networks bill each Monday for the previous week’s calls/leads. The marketing agency remits same day payment.   
  • Cancellation: 21-day notice is required to pull a campaign for any reason.

Another necessary consideration for the success of either a traditional cash buy or performance media advertising campaign is managing the intake of audience responses. Although most of the avails (and thus most of the calls and leads) will be generated during daytime hours, and correspond with operating hours of the law firm, the intake center activity extends beyond business hours.  Commonly, the law firm engages a 24/7/365 legal intake call center solution, as potential clients often see or hear an advertisement during the daytime hours, and later decide to respond by calling at any time of day or night.

For competitive law firms, performance media provides a cost-effective solution for finding new clients through a marketing channel that removes much of the risk of lead generation performance from the law firm and shifts the risk of results directly to media. Its unique combination of scalability, favorable cost per intake economics and predictability makes it a powerful strategy in the face of fierce competition for case acquisition.


AMICUS MEDIA GROUP, LLC

Amicus Media Group is a full-service media agency comprised of some of the nation’s most respected professionals in media, communications, marketing, finance, and practice management to offer law firms the highest level of expertise in case acquisition and practice growth. 

Amicus Media Group offers direct response marketing services for lead generation campaigns. Agency services span from negotiating rates, broadcast planning and scheduling, media buying, campaign management, performance marketing, intake and creative production. Holding key relationships with top media executives throughout the nation, Amicus Media Group establishes a combined multi-decade prowess in legal marketing.  

To contact Amicus Media Group call (888) 700. 1088 or email George Young at GeorgeYoung@AmicusMediaGroup.com or Chad Nell at ChadNell@AmicusMediaGroup.com

 

Read More

Invokana Cases Move Forward with Discovery Plan, Bellwether Case Selection, Scheduling of Trials

The federal multidistrict litigation overseeing hundreds of products liability lawsuits involving Invokana and Invokamet are moving forward in the U.S. District Court, District of New Jersey. On May 1, 2017, the court has established an initial discovery plan addressing, among other things, bellwether case selection protocol, scheduling and trial dates. The Court had previously indicated that the litigation’s first bellwether trials could begin in September 2018.

There are 288 lawsuits filed in MDL 2750 before US District Judge Brian R. Martinotti in IN RE: Invokana (Canagliflozin) Products Liability Litigation. Plaintiffs who suffered ketoacidosis or kidney damage allegedly related to the use of Invokana or Invokamet.  They accuse the drugs’ manufacturers of failing to warn patients about the serious risks potentially associated with the medications.

In an order dated May 5, 2017, the court has barred the filing of multi-plaintiff complaints, apart from those that name a derivative plaintiff, such as a spouse. Multi-plaintiff cases already pending in the litigation as of May 5 are to be severed.

“We are pleased that the Court is moving forward with plans for bellwether trials, as verdicts in these cases could give some insight into how other juries might decide similar lawsuits involving Invokana or Invokamet,” says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices.

FDA Boxed Warning

In related news, the FDA issued a safety alert on May 17 that Invokana and Invokamet have an increased risk of leg and foot amputations.

Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.

Final results from two clinical trials – the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) – showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment. Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs.

Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine.

Invokana and Invokamet Side Effects

Invokana was brought to market in March 2013, and was the first SGLT2 inhibitor approved by the U.S. Food & Drug Administration (FDA) to treat Type 2 diabetes. The agency approved Invokamet in November 2014. Both drugs lower blood glucose levels by preventing the absorption of sugar by the kidneys, thereby causing it to be eliminated via urine.

The FDA has since issued several safety alerts to warn of side effects potentially associated with the use of Invokana and other SGLT2 inhibitors. In December 2015, for example, the agency announced that the labels for all drugs in this class would be updated to include information about diabetic ketoacidosis, a potentially deadly complication related to the accumulation of toxic acids (ketones) in the bloodstream. The labels were also modified with information about life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that originate as urinary tract infections.

In June 2015, the FDA mandated stronger kidney warnings for several SGLT2 inhibitors, including Invokana and Invokamet, after the medications were cited in more than 100 reports of acute kidney injury.

Read More

European Study Says Depakote Caused Thousands of Severe Birth Defects

A new European study finds that pregnant women who took epilepsy drug valproate — sold in the US as Depakote — were four times more likely to give birth to a baby with birth defects.

The report, jointly issued by the French National Agency for the Safety of Medicines (ANSM) and the national health insurance administration, confirmed that the drug is “highly teratogenic”, meaning that it can disturb the development of an embryo.

A total of 129 lawsuits, involving about 698 plaintiffs, have been filed against Abbott Laboratories in In Re Depakote, Case No. 12-CV-52-NJR-SCW, in the Southern District of Illinois before US District Judge Nancy J. Rosenstengel.

  • Plaintiffs recovered $38 million in punitive and compensatory damages against Abbot in May 2015. Attorneys from Williams Kherkher argued that Abbott underplayed the risk of birth defects, making it appear that Depakote had about the same level as other anti-epileptic drugs available.  As attorneys John Eddie and John Boundas were able to argue, in reality it was the most dangerous anti-epileptic drug.
  • Last November there was a £10.7m ($13.8 million) settlement in France for people harmed by sodium valproate during pregnancy.

On the market since 1967

Valproate — known in France under the brand name Depakine — has been on sale there since 1967, and in Britain under the name Epilim since 1973. In the US, Depakote was approved by the FDA in June 1996 to treat epilepsy.

Valproate products are FDA-approved drugs to treat seizures, and manic or mixed episodes associated with bipolar disorder (manic-depressive disorder), and to prevent migraine headaches. They are also used off-label (for unapproved uses) for other conditions, particularly for other psychiatric conditions.

The FDA warned doctors in December, 2009, that fetal exposure to valproate sodium (Depacon, Abbott), valproic acid (Depakene, Stavzor, Abbott), and divalproex sodium (Depakote, Depakote CP, Depakote ER, Abbott) is associated with birth defects, according to the US Food and Drug Administration (FDA).

The FDA said the drug can cause birth defects including neural tube, craniofacial, and cardiovascular defects, and warned doctors to “inform women of childbearing potential about these risks, and consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening.”

Depakote litigation

The first cases were filed in state court in 2010 and removed to federal court on January 18, 2012. Judge Rosenstengel said, “the bellwether process and global settlement efforts have failed,” after several trial dates fell through. As a result, “The Court intends to hold joint trials as to common issues of fact and law to the maximum extent possible.”

The judge intends to try the majority of the cases in joint trials by the end of 2017.

Judge Rosenstengel dismissed nine cases on April 12 under the Indiana repose issue, ruling that all the acts leading to the alleged birth defects in the nine cases took place in Indiana, and that Indiana’s 10-year statute of repose therefore applied. An Illinois statute favored by the plaintiffs would have allowed the claims to go forward.

Abbott agreed to pay $1.5 billion to settle civil claims and criminal charges from the FDA that the drugmaker misbranded Depakote and Depakote ER between 1998 and 2006. Abbott also received repeated notices from the FDA between 1982 and 2009 that the company was misbranding the drug or promoting it for unapproved uses, the plaintiffs said.

The plaintiffs are represented by Christopher Cueto and Michael Gras of the Law Office of Christopher Cueto Ltd., Janet G. Abaray of Burg Simpson Eldredge Hersh & Jardine PC, John T. Boundas of Williams Kherkher Hart Boundas, and Bruce L. Sampson Jr. of Bracewell LLP.

 

Read More

Generic Taxotere Lawsuits Allowed in Federal MDL

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.

The panel’s letter was in response to District Judge Kurt D. Engelhardt, who wrote to the panel for clarification in December. Judge Engelhardt is overseeing 1,006 lawsuits filed in 2740, IN RE: Taxotere (Docetaxel) Products Liability Litigation.

Half of cases against generics

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.

Read More

GEC Laxoplex Muscle-Building Supplement Recalled for Containing Steroids

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.

 

Read More

Eliquis State-Law Claims Preempted, MDL Case Dismissed

eliquis-internal-bleeding-lawsuitA 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.

Granting a motion to dismiss, Judge Denise Cote threw out Utts et al v. Bristol-Myers Squibb Company et al, case number 1:16-cv-05668, in the U.S. District Court for the Southern District of New York, In Re: Eliquis (Apixaban) Products Liability Litigation, MDL No. 2754.

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.

Read More

Australian Survey Finds that 58% were Injured by Pelvic Mesh Implant

HIC CEO, Danny Vadasz
HIC CEO, Danny Vadasz says “This is a significant public health problem which has been grossly underestimated — in terms of numbers of women as well as the severity of resultant health problems.”

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:

A catastrophic failure

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!”

 Vadasz is calling on women who have had an implant (or believe they may have) to complete the HIC survey: https://www.facebook.com/pg/UnderstandingPelvicMesh/about/

About the survey

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.

 

 

Read More

Are Courts Daubert Averse?

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.
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.

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.

Daubert gatekeeping

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.

Read More

New FDA Commissioner Gottlieb is Nothing More than an Agent for Big Pharma

scott gottlieb tool of pharma industry
Gottlieb has extensive ties to the pharmaceutical and biomedical industries, which the FDA is supposed to regulate.

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.”

Read More