Wednesday, August 28, 2013

J&J’s DePuy Unit Considers Record-Setting $3 Billion Hip Settlement

Drug Watch

Posted by

In March, Johnson & Johnson lost its first DePuy Articular Surface Replacement (ASR) trial to the tune of $8.3 million. Not surprisingly, the device manufacturer continued to deny liability for defective ASR hip implants following the verdict and announced plans to appeal. But now the company is rumored to be contemplating a potentially record-breaking settlement of pending hip implant cases.

According to Bloomberg, sources familiar with the DePuy litigation say that the company is considering a $3 billion global settlement. The rumored settlement would resolve up to 11,500 U.S. lawsuits, involving the controversial ASR hip replacements.

ASR Controversy

In 2010, J&J’s DePuy unit recalled 93,000 ASR implants after data from the National Joint Registry of England and Wales showed an abnormally high failure rate for the devices. Data from the British joint registry and other medical organizations showed that more than 12 percent of the devices failed within five years.

In 2011, the British registry’s data projected the devices could fail in almost one-third of patients who had the implants for six years.

At the time, J&J challenged the data. But according to The New York Times, pre-trial testimony in an ASR lawsuit shows that DePuy estimated failure rates at 37 percent.

Pretrial testimony also shows that DePuy had internal discussions about high concentrations of metal ions in ASR patients. Such concerns are consistent with the claims of plaintiffs who have sued J&J and DePuy over severe, sometimes permanent, injuries from the chromium and cobalt devices.
The lawsuits allege that the ASR’s defective design caused friction between metal-on-metal ball and cup components that shed metallic debris. Injured people claim the debris caused inflammation as well as painful bone and tissue damage.

Possible Uptick in Settlement Expectations

A year ago, unidentified sources close to the litigation told Bloomberg that J&J had negotiated a $600,000 settlement of three ASR cases in Nevada. Litigation settlement amounts typically remain private under the terms of settlement agreements. But if the sources were accurate, the first settlements in the ASR saga clocked in at $200,000 per case.

A University of Michigan business professor who studies the pharmaceutical industry told Bloomberg that the rumored settlements were “at the low end of what the company should have expected.”

According to Professor Eric Gordon, the expected range is $200,000 to $500,000 per case. He also indicated that J&J would benefit from “anchor[ing] settlement expectations at the low end of the range.” He estimated that it would ultimately cost J&J up to $2 billion to resolve all of the cases.
But if sources for the most recent settlement rumors are correct, settlement expectations may be rising. If J&J ultimately agrees to a $3 billion global settlement, the average settlement per claim would be $300,000 per case.

That amount is also 50 percent higher than amounts previously discussed during negotiations. It would also shatter the current record for hip implant settlements, which was $1 billion paid by Switzerland-based device maker Sulzer.

Likely Concern Over Trial Outcomes

If there is indeed an uptick in settlement expectations, it’s likely related to concerns over upcoming trials. According to Bloomberg’s sources, J&J’s settlement negotiations would be affected by the results of seven trials scheduled between September and January.

The outcome of the first ASR trial in March is also a likely factor. A Los Angeles jury ordered J&J to pay more than $8.3 million to a retired Montana prison guard. Loren Kransky alleged that J&J and DePuy failed to warn surgeons and patients about risks associated with the ASR implants. Mr. Kransky’s case was not scheduled to be the first trial, but was moved up due to his terminal cancer diagnosis.

Although his lawyers did not expect him to live through the trial, he was able to hear the jury’s verdict. After more than five days of deliberation, they awarded him $338,000 for medical expenses and $8 million for pain and emotional suffering.

The jury declined to award punitive damages, which could have potentially bolstered J&J’s outlook about upcoming trials. It may also have been encouraged when a Chicago jury ruled in its favor in a case filed by a nurse. But J&J likely understands that future juries could have different, more costly views on liability and punitive damages.

According to The New York Times, evidence in the Kransky trial included internal J&J documents showing that surgeons warned company executives about design flaws. They also urged the device maker to slow or stop implant sales. Even worse, evidence presented at trial showed that J&J considered redesigning the ASR to reduce risks, but ultimately didn’t feel the costs were justified.
This and similar evidence is expected to be presented to a federal jury when federal bellwether trials begin. The first trial is scheduled for Sept. 9. Evidence may include testimony heard in the Kransky case that DePuy sold ASR devices despite being aware as early as 2008 of reports by an English surgeon that the implants release high levels of metallic ions, especially in women.

Notably, the plaintiff in the first federal trial is a 57-year-old mother and small business owner. Earlier this month, she filed her list of 95 potential witnesses with the court.

The outcomes of the federal bellwether trials are expected to have far-reaching impacts on other cases pending in both state and federal courts. J&J may be willing to adjust its own settlement expectations to avoid a series of unfavorable verdicts. The impact of those verdicts could be especially damaging for J&J as the most severe cases go to trial.

California plaintiffs’ attorney Matthew Davis recently told Bloomberg that there is “a significant subset of clients who got very badly hurt by the device.” These cases involve dual hip revisions or long hospital stays from severe infections. According to Davis, juries could potentially return seven-figure awards in those cases.

In 2012, there were about 8,000 ASR pending hip lawsuits, including 6,000 cases designated as federal multidistrict litigation (MDL) and 2,000 cases in California, Nevada and other state courts. An estimated 11,500 cases are currently pending in courts across the nation, including more than 650 cases centralized in a state court in New Jersey, where J&J is headquartered. It also includes 7,860 federal cases pending in MDL No. 2197 in the U.S. District Court for the Northern District of Ohio.
More than 160 MDL cases have been resolved or otherwise removed from the MDL since its creation

Tuesday, August 27, 2013

Very interesting study on immunological sensitized observations with Cr and Co

2013 Aug 8. pii: S0142-9612(13)00887-9. doi: 10.1016/j.biomaterials.2013.07.073. [Epub ahead of print]

Consequences of exposure to peri-articular injections of micro- and nano-particulate cobalt-chromium alloy.


Institute of Medical & Biological Engineering, University of Leeds, Leeds, UK.


Metal hip replacements generate both metal particles and ions. The biological effects of peri-articular exposure to nanometre and micron sized cobalt chrome (CoCr) wear particles were investigated in a mouse model. Mice received injections of two clinically relevant doses of nanoparticles (32 nm), one of micron sized (2.9 μm) CoCr particles or vehicle alone into the right knee joint at 0, 6, 12 and 18 weeks. Mice were analysed for genotoxic and immunological effects 1, 4 and 40 weeks post exposure. Nanoparticles but not micron particles progressively corroded at the injection site. Micron sized particles were physically removed. No increase of Co or Cr was seen in peripheral blood between 1 and 40 weeks post exposure to particles. No significant inflammatory changes were observed in the knee tissues including ALVAL or necrosis. DNA damage was increased in bone marrow at one and forty weeks and in cells isolated from frontal cortex at 40 weeks after injection with nanoparticles. Mice exposed to the micron sized, but not nanoparticles became immunologically sensitized to Cr(III), Cr (VI) and Ni(II) over the 40 week period as determined by lymphocyte transformation and ELISpot (IFN-γ and IL-2) assays. The data indicated that the response to the micron sized particles was Th1 driven, indicative of type IV hypersensitivity. This study adds to understanding of the potential adverse biological reactions to metal wear products.

Microparticles are particles between 0.1 and 100 \mum in size. Commercially available microparticles are available in a wide variety of materials, including ceramics, glass, polymers, and metals. Microparticles encountered in daily life include pollen, sand, dust, flour, and powdered sugar.

In nanotechnology, a particle is defined as a small object that behaves as a whole unit with respect to its transport and properties. Particles are further classified according to diameter.[1] Coarse particles cover a range between 10,000 and 2,500 nanometers. Fine particles are sized between 2,500 and 100 nanometers. Ultrafine particles, or nanoparticles are sized between 1 and 100 nanometers.

Sunday, August 25, 2013

Interesting study on the rapidity of decline of Cr and Co level after metal bearings are removed.

2013 Aug 12. pii: S0883-5403(13)00505-6. doi: 10.1016/j.arth.2013.06.040. [Epub ahead of print]

What Happens to Serum Metal Ion Levels After a Metal-on-Metal Bearing is Removed?


Department of Orthopaedic Surgery, University of California, San Diego, California.


Serum cobalt (Co) and chromium (Cr) levels are commonly used to screen for excessive wear of metal-on-metal hip replacements. However, it is unknown how rapidly these should decline after revision. 25 patients with average Co and Cr ion levels of 56.3μg/L and 20.5μg/L were followed with serial ion level testing post-revision. Over the first 6weeks post-revision, the rate of decline for Co and Cr was approximately 2% per day and this slowed to approximately 1% decline per day over the ensuing 6weeks. This translated to a decline of approximately 80% from the starting value after 6weeks and a decline of approximately 90% after 12weeks post-revision. The rate of decline for both Co and Cr was significantly faster during the first 6weeks (P<0.001). In patients with ultra-high Cr levels>20μg/L, the rate of Cr decline is less predictable and may be protracted leading to persistent elevation above 5μg/L for one year or more post-revision in some cases.

Review of Clinical and epidemiological Studies of MoM hip arthroplasty

2013 Aug 7;8(8):e70359. doi: 10.1371/journal.pone.0070359. eCollection 2013.

Metal Ion Concentrations in Body Fluids after Implantation of Hip Replacements with Metal-on-Metal Bearing - Systematic Review of Clinical and Epidemiological Studies.


University Hospital Carl Gustav Carus Dresden, University Centre for Orthopaedics and Trauma Surgery, Dresden, Germany.



The use of metal-on-metal (MoM) total hip arthroplasty (THA) increased in the last decades. A release of metal products (i.e. particles, ions, metallo-organic compounds) in these implants may cause local and/or systemic adverse reactions. Metal ion concentrations in body fluids are surrogate measures of metal exposure.


To systematically summarize and critically appraise published studies concerning metal ion concentrations after MoM THA.


Systematic review of clinical trials (RCTs) and epidemiological studies with assessment of metal ion levels (cobalt, chromium, titanium, nickel, molybdenum) in body fluids after implantation of metalliferous hip replacements. Systematic search in PubMed and Embase in January 2012 supplemented by hand search. Standardized abstraction of pre- and postoperative metal ion concentrations stratified by type of bearing (primary explanatory factor), patient characteristics as well as study quality characteristics (secondary explanatory factors).


Overall, 104 studies (11 RCTs, 93 epidemiological studies) totaling 9.957 patients with measurement of metal ions in body fluids were identified and analyzed. Consistently, median metal ion concentrations were persistently elevated after implantation of MoM-bearings in all investigated mediums (whole blood, serum, plasma, erythrocytes, urine) irrespective of patient characteristics and study characteristics. In several studies very high serum cobalt concentrations above 50 µg/L were measured (detection limit typically 0.3 µg/L). Highest metal ion concentrations were observed after treatment with stemmed large-head MoM-implants and hip resurfacing arthroplasty.


Due to the risk of local and systemic accumulation of metallic products after treatment with MoM-bearing, risk and benefits should be carefully balanced preoperatively. The authors support a proposed "time out" for stemmed large-head MoM-THA and recommend a restricted indication for hip resurfacing arthroplasty. Patients with implanted MoM-bearing should receive regular and standardized monitoring of metal ion concentrations. Further research is indicated especially with regard to potential systemic reactions due to accumulation of metal products.

Tuesday, August 20, 2013

Will connie continue to publish the transcript overview from the Kransky trial?

Yes, I just took a break from that project.  Very time consuming but will resume that review in the next few weeks.  Work projects have interfered.  Sorry for the lack of continuity with those transcripts.


Filing deadlines?

I have read many conflicting opinions on when the statue of limitations runs out.  Each state has their own law. 

  I just saw this press release appear from North Carolina stating the following:

 "... The three-year statute of limitations could possibly be interpreted as ending on August 23, 2013, or three years from August 24, 2010 – the date on which DePuy announced a voluntary recall of the medical device.   A party alleging injury and loss due to the product defect must file a lawsuit within three years after the injury occurred or when a person would have reasonably known about the injury".

I just got an opinion re my own situation and  was told that the date of injury can be the date of revision.  In my case, I had a revision  2 years after the notice for the recall, therefore, my statute of limitations won't run out for another 2 years.

You certainly need to speak with an attorney to discuss your situation but it is clear to me that the event which actually triggers the start of the time line seems to be open for interpretation.


First Bellweather case to go before a Jury in the MDL on Sept 8th

Injury Lawyer News

Judge David Katz recently ruled on several motions regarding a lawsuit in the DePuy multidistrict litigation (MDL), which is proceeding in the U.S. District Court for the Northern District of Ohio. The MDL consolidates federal DePuy ASR hip lawsuits filed by plaintiffs who allege problems with the now recalled hip replacement system. The order, which was issued on July 8, 2013, specifically concerns motions filed in the bellwether case of plaintiff Ann McCracken, who is scheduled to have her day in court on September 9, 2013.

Judge Katz rules DePuy hip recall evidence inadmissable

Judge Katz granted a motion filed by the defendants, DePuy Orthopaedics, regarding the exclusion of certain evidence. All evidence concerning the voluntary ASR hip implant recall, which was issued in August of 2010, has been found inadmissible, pursuant to the Federal Rules of Civil Procedure.
Ann McCracken had noted in her complaint that she experienced significant mobility impairment and pain and suffering subsequent to the implantation of her device. Since the plaintiff claims her injuries began before the defendants issued the recall, the Judge ruled evidence regarding the recall inadmissible. According to the order, “The recall is a subsequent remedial measure which, if it had occurred prior to the implantation, would have prevented the harm. As such, the recall is inadmissible under Rule 407."

The Judge also denied the plaintiff’s motion to exclude evidence regarding payments made to her. According to the order, the plaintiff allegedly received payments as compensation for her injuries from a third-party vendor contracted by the defendants. According to the order, “The Court also notes that this ruling is subject to modification depending upon how the evidence unfolds at trial.”
Other motions ruled on included the presentation of evidence regarding the 510(k) clearance procedure from the FDA. The Judge ruled the defendants were allowed to present evidence of this process.

Bellwether cases underway

Ann McCracken’s DePuy hip recall lawsuit is the first in the MDL to go before a jury. Her case is known as a bellwether trial, which allows both parties to analyze jury reactions. Other bellwether cases have yet to be assigned a trial date.

Currently, the MDL includes more than 7,800 DePuy ASR hip lawsuits. The plaintiffs share similar allegations, including premature failure of the device. Although hip implants generally last 15 to 20 years, many plaintiffs have alleged the need for revision surgery and removal of the failed devices in just a few years. Some estimates suggest the rate of failure of the metal-on-metal hip implant is about 12 to 13 percent, while other studies indicate failure rates significantly higher than this.

When a hip implant fails, the patient typically experiences significant pain and the loss of mobility. Patients may need to undergo additional surgery to replace the defective device. Furthermore, with a metal-on-metal implant device, they are at risk of metallosis, or metal contamination in the bloodstream and surrounding tissues.

Recall acknowledged device failure

In August 2010, DePuy Orthopaedics acknowledged the high level of hip implant failures and issued a voluntary DePuy hip recall. The recall involved the DePuy ASR XL model, which plaintiff Ann McCracken had received. Although the recall was not issued until August, a field safety notice indicates that the company acknowledged the problems with the device as early as March 2010. The notice, which discussed the potential complications, was sent to healthcare professionals. Prior to the recall of the DePuy hip replacement, more than 90,000 patients in various countries had already received the implants.

Wednesday, August 14, 2013

Pinnacle Hip Gone for Good - but It’s Not a DePuy Pinnacle Recall

. By

Lawyers and
Washington, DC: This is the month that DePuy Pinnacle manufacturer Johnson & Johnson (J&J) will be pulling metal-on-metal DePuy Pinnacle hip replacement components and other products based on the same materials from distribution after announcing in May that it’s giving up on the troublesome products.

Pinnacle Hip Gone for Good - but It’s Not a DePuy Pinnacle RecallThe announcement was a victory of sorts for health advocates critical of the 510(k) process that cleared the way for all-metal and metal-on-ceramic hip replacement products to appear on the market without intensive clinical trials. The 510(k) “loophole,” for lack of a better word, is a guideline employed by the US Food and Drug Administration (FDA) that allows new products onto the market provided they are substantially similar to existing products. The idea of the 510(k) was to bring promising products to market more quickly in order to benefit consumers - and to save manufacturers from the expense of redundant testing.

However, with some new-age hip and knee replacements, the idea has backfired. DePuy Orthopaedics decided in 2010 to recall its problematic ASR metal-on-metal hip replacement products, and is currently facing in excess of 10,000 lawsuits, according to the New York Times (5/17/13). In addition, 3,300 DePuy Pinnacle lawsuits are on the books.

When the FDA, in January, ordered all manufacturers of metal-on-metal hip replacements - including DePuy Pinnacle hip - to undertake post-market testing of any product approved under the 510(k) program, DePuy decided to cut its losses and discontinue the Pinnacle rather than sink additional funds into costly post-market clinical trials. DePuy also noted that demand for all-metal devices had been steadily waning in the face of high failure rates.

The manufacturer of DePuy Pinnacle was also to discontinue this month a metal component that was heretofore available for use with the Complete ceramic hip implant.

While it may be a victory for health advocates critical of the 510(k) program and the metal-on-metal devices in general, it doesn’t help the thousands of patients who have received the Pinnacle hip replacement and who may be in need of revision surgery. At one time, according to the New York Times, one in three hip replacement procedures in the US utilized the metal-on-metal design.

The latter, at one time hailed as a breakthrough in artificial hips, was soon reduced to a scourge, with high failure rates and increasingly dire health issues for patients negatively impacted when metal surfaces began to wear and break down, causing tissue and muscular issues and risking metal toxicity in the blood. Patients were requiring revision procedures and began launching DePuy Pinnacle hip lawsuits. According to The Star-Ledger of Newark, New Jersey (5/19/13), market share of metal-on-metal components dropped from a 20 percent share in 2007 to less than two percent in 2012.

   In 2010, when DePuy issued the ASR recall, it reiterated the safety and effectiveness of its DePuy Pinnacle hip replacement system. That changed in May of this year, when DePuy decided to pull the plug. However, that decision is not based on safety or effectiveness, and is not a DePuy Pinnacle recall, said a DePuy spokesperson in comments made to Bloomberg News (5/19/13), regardless of how it appears.

“We won’t have any metal-on-metal or ceramic-on-metal hips any longer,” said Mindy Tinsley, a spokeswoman for J&J’s DePuy unit, in a telephone interview with Bloomberg.We’ve seen, for example, a 90 percent decline in metal-on-metal sales industry wide in the US and Europe since 2007. There’s really not a viable market for these bearing combinations anymore.”

As for the thousands of patients currently fitted with metal-on-metal Pinnacle hip replacement, their only recourse is to hope their DePuy Pinnacle hip defies the early failure trend. Failing that is the expectation of additional DePuy Pinnacle hip replacement lawsuits on the horizon.

Tuesday, August 13, 2013

FDA to Conduct Study on Metal-on-Metal Hip Implant Corrosion

HealthPoint Capital


In order to close a loophole in the Medical Device Amendments of 1976, the federal law under which medical devices were first regulated, the FDA issued a proposed order in January that required metal-on-metal (MoM) hip arthroplasty implant manufacturers to submit premarket approval applications. This course of action came about as a mounting body of evidence demonstrated MoM systems have failed prematurely and have instigated severe tissue and bone damage as a result of tiny particles of metallic debris released during artificial joint movement.

Just recently, the FDA has cited a “renewed concern of wear and corrosion of conical head/stem taper junctions in modern modular total hip replacements,” and therefore is commissioning a study to investigate the relationship between volumetric wear and corrosion in total hip replacements and any potential link to clinical outcomes.

The study, which is estimated to take two years to conduct, will examine 250 explanted MoM hip replacements of various sizes and genders and use the American Society for Testing and Materials (ASTM) protocol for corrosion testing to analyze them.

The objective of the project is to generate a peer-reviewed journal article explaining correlations between wear and corrosion and relevant parameters (e.g. implantation time, lateral offset, head size, materials, and modularity), which will further help develop test methodologies and special controls for preclinical studies of total hip implants.

The FDA noted new design changes like MoM bearings, larger femoral heads and modular designs have reintroduced the issue even as the new features more closely approximate patient features.
The FDA is currently seeking private sector contractors to help it design and conduct the study.

Johnson & Johnson can exclude recall evidence in DePuy ASR bellwether lawsuit

Mass Device

August 9, 2013 by Brad Perriello

Evidence of the recall of the DePuy ASR metal-on-metal hip implant can be excluded from a bellwether trial over the device, a federal judge ruled last month.

Johnson & Johnson's (NYSE:JNJ) DePuy Orthopaedics division pulled the DePuy ASR device from the market in 2010, prompting thousands of personal injury lawsuits across the country.
Many of the suits filed in federal courts have been consolidated into multi-district litigation overseen by Judge David Katz of the U.S. District Court for Northern Ohio. The 1st bellwether trial in that litigation, Ann McCracken v. DePuy Orthopaedics, is slated for trial in September, according to court documents.

Katz ruled last month on a number of pre-trial motions from both sides, granting DePuy's bid to keep evidence about the recall out of the trial. McCracken had argued that the recall shouldn't count as a "subsequent remedial measure" following the 2009 implantation of a DePuy ASR LX model.

Katz disagreed, on the grounds that McCracken is likely to assert her claim as having begun at the time of her hip replacement surgery in 2009 (a revision surgery was performed in January 2011, according to the documents).

"Her injury began with the initial implantation and, but for that event, she would not have suffered injury, including the revision surgery," Katz wrote. "Assuming the plaintiff will claim her harm commenced before the recall, in this instance, the recall is a subsequent remedial measure which, if it had occurred prior to the implantation, would have prevented the harm. As such, the recall is inadmissible."

DePuy can present evidence of the FDA granting 510(k) clearance for the DePuy ASR hip implant, Katz ruled.

"The court is persuaded that Defendants are entitled to present evidence of the 510(k) clearance as it represents the process by which the device came to be on the market and is, therefore, relevant," he wrote. "Despite plaintiff's protestations, the probative value outweighs the danger of unfair prejudice or jury confusion and this evidence will also be subject to a special jury
 instruction. Therefore, plaintiff's motion to exclude evidence of 510(k) clearance is denied."
The judge also granted DePuy's motion to use split-screen video depositions, writing that "the presentation of a split-screen method is no different from what the jury would see in the live courtroom, therefore, no prejudice results to either side."

DePuy can also exclude evidence of compensation paid to expert witnesses in prior trials (but must divulge if asked evidence of payments to experts in this trial). Evidence of payments from Broadspire Services, a 3rd-party administrator that handled DePuy ASR claims, can be included in the trial, the judge ruled.

In a separate ruling, Katz granted McCracken's bid to exclude any reference to lawyer advertising and any suggestion that the high revision rates on the ASR devices "are driven by lawyers," according to the documents. DePuy withdrew a motion to exclude "evidence and argument that DePuy misled the FDA, violated federal law, or should have conducted clinical testing," but can re-file the motion later, the judge ruled.

Monday, August 12, 2013

In Need of a New Hip, but Priced Out of the U.S.

New York Times
By | Published: August 3, 2013

WARSAW, Ind. — Michael Shopenn’s artificial hip was made by a company based in this remote town, a global center of joint manufacturing. But he had to fly to Europe to have it installed.
Mr. Shopenn, 67, an architectural photographer and avid snowboarder, had been in such pain from arthritis that he could not stand long enough to make coffee, let alone work. He had health insurance, but it would not cover a joint replacement because his degenerative disease was related to an old sports injury, thus considered a pre-existing condition.
Throughout this article, readers have shared their experiences by responding to questions on joint replacements and health care. Comments are now closed, but you may explore the responses received. I will write a follow-up article about your comments on Monday, Aug. 5.
— Elisabeth Rosenthal, Reporter

Desperate to find an affordable solution, he reached out to a sailing buddy with friends at a medical device manufacturer, which arranged to provide his local hospital with an implant at what was described as the “list price” of $13,000, with no markup. But when the hospital’s finance office estimated that the hospital charges would run another $65,000, not including the surgeon’s fee, he knew he had to think outside the box, and outside the country.
“That was a third of my savings at the time,” Mr. Shopenn said recently from the living room of his condo in Boulder, Colo. “It wasn’t happening.”
“Very leery” of going to a developing country like India or Thailand, which both draw so-called medical tourists, he ultimately chose to have his hip replaced in 2007 at a private hospital outside Brussels for $13,660. That price included not only a hip joint, made by Warsaw-based Zimmer Holdings, but also all doctors’ fees, operating room charges, crutches, medicine, a hospital room for five days, a week in rehab and a round-trip ticket from America.
“We have the most expensive health care in the world, but it doesn’t necessarily mean it’s the best,” Mr. Shopenn said. “I’m kind of the poster child for that.”
As the United States struggles to rein in its growing $2.7 trillion health care bill, the cost of medical devices like joint implants, pacemakers and artificial urinary valves offers a cautionary tale. Like many medical products or procedures, they cost far more in the United States than in many other developed countries.
Makers of artificial implants — the biggest single cost of most joint replacement surgeries — have proved particularly adept at commanding inflated prices, according to health economists. Multiple intermediaries then mark up the charges. While Mr. Shopenn was offered an implant in the United States for $13,000, many privately insured patients are billed two to nearly three times that amount.
An artificial hip, however, costs only about $350 to manufacture in the United States, according to Dr. Blair Rhode, an orthopedist and entrepreneur whose company is developing generic implants. In Asia, it costs about $150, though some quality control issues could arise there, he said.
So why are implant list prices so high, and rising by more than 5 percent a year? In the United States, nearly all hip and knee implants — sterilized pieces of tooled metal, plastic or ceramics — are made by five companies, which some economists describe as a cartel. Manufacturers tweak old models and patent the changes as new products, with ever-bigger price tags.
Generic or foreign-made joint implants have been kept out of the United States by trade policy, patents and an expensive Food and Drug Administration approval process that deters start-ups from entering the market. The “companies defend this turf ferociously,” said Dr. Peter M. Cram, a physician at the University of Iowa medical school who studies the costs of health care.
Though the five companies make similar models, each cultivates intense brand loyalty through financial ties to surgeons and the use of a different tool kit and operating system for the installation of its products; orthopedists typically stay with the system they learned on. The thousands of hospitals and clinics that purchase implants try to bargain for deep discounts from manufacturers, but they have limited leverage since each buys a relatively small quantity from any one company.
In addition, device makers typically require doctors’ groups and hospitals to sign nondisclosure agreements about prices, which means institutions do not know what their competitors are paying. This secrecy erodes bargaining power and has allowed a small industry of profit-taking middlemen to flourish: joint implant purchasing consultants, implant billing companies, joint brokers. There are as many as 13 layers of vendors between the physician and the patient for a hip replacement, according to Kate Willhite, a former executive director of the Manitowoc Surgery Center in Wisconsin.

Hospitals and orthopedic clinics typically pay $4,500 to $7,500 for an artificial hip, according to MD Buyline and Orthopedic Network News, which track device pricing. But those numbers balloon with the cost of installation equipment and all the intermediaries’ fees, including an often hefty hospital markup.
That is why the hip implant for Joe Catugno, a patient at the Hospital for Joint Diseases in New York, accounted for nearly $37,000 of his approximately $100,000 hospital bill; Cigna, his insurer, paid close to $70,000 of the charges. At Mills-Peninsula Health Services in San Mateo, Calif., Susan Foley’s artificial knee, which costs about the same as a hip joint, was billed at $26,000 in a total hospital tally of $112,317. The components of Sonja Nelson’s hip at Sacred Heart Hospital in Pensacola, Fla., accounted for $30,581 of her $50,935 hospital bill. Insurers negotiate discounts on those charges, and patients have limited responsibility for the differences.
The basic design of artificial joints has not changed for decades. But increased volume — about one million knee and hip replacements are performed in the United States annually — and competition have not lowered prices, as would typically happen with products like clothes or cars. “There are a bunch of implants that are reasonably similar,” said James C. Robinson, a health economist at the University of California, Berkeley. “That should be great for the consumer, but it isn’t.”

Comparing Two Operations

‘Sticky Pricing’
The American health care market is plagued by such “sticky pricing,” in which prices of products remain high or even increase over time instead of dropping. The list price of a total hip implant increased nearly 300 percent from 1998 to 2011, according to Orthopedic Network News, a newsletter about the industry. That is a result, economists say, of how American medicine generally sets charges: without government regulation or genuine marketplace competition.
“Manufacturers will tell you it’s R&D and liability that makes implants so expensive and that they have the only one like it,” said Dr. Rory Wright, an orthopedist at the Orthopedic Hospital of Wisconsin, a top specialty clinic. “They price this way because they can.”
Zimmer Holdings declined to comment on pricing. But Sheryl Conley, a longtime Zimmer manager who is now the chief executive of OrthoWorx, a local trade group in Warsaw, said that high prices reflected the increasing complexity of the joint implant business, including more advanced materials, new regulatory requirements and the logistics of providing a now huge array of devices. “When I started, there weren’t even left and right knee components,” she said. “It was one size fits all.”
Mr. Shopenn’s Zimmer hip has transformed his life, as did the replacement joint for Mr. Catugno, a TV director; Ms. Foley, a lawyer; and Ms. Nelson, a software development executive. Mr. Shopenn, an exuberant man who maintains a busy work schedule, recently hosted his son’s wedding and spent 26 days last winter teaching snowboarding to disabled people.
His joint implant and surgery in Belgium were priced according to a different logic. Like many other countries, Belgium oversees major medical purchases, approving dozens of different types of implants from a selection of manufacturers, and determining the allowed wholesale price for each of them, for example. That price, which is published, currently averages about $3,000, depending on the model, and can be marked up by about $180 per implant. (The Belgian hospital paid about $4,000 for Mr. Shopenn’s high-end Zimmer implant at a time when American hospitals were paying an average of over $8,000 for the same model.)
“The manufacturers do not have the right to sell an implant at a higher rate,” said Philip Boussauw, director of human resources and administration at St. Rembert’s, the hospital where Mr. Shopenn had his surgery. Nonetheless, he said, there was “a lot of competition” among American joint manufacturers to work with Belgian hospitals. “I’m sure they are making money,” he added.
Dr. Cram, the Iowa health cost expert, points out that joint manufacturers are businesses, operating within the constraints of varying laws and markets.
“Imagine you’re the C.E.O. of Zimmer,” he said. “Why charge $1,000 for the implant in the U.S. when you can charge $14,000? How would you answer to your shareholders?” Expecting device makers “to do otherwise is like asking, ‘Couldn’t Apple just charge $50 for an iPhone?’ because that’s what it costs to make them.” 
But do Americans want medical devices priced like smartphones? “That,” Dr. Cram said, “is a different question.”
 A Miracle for Many       
When joint replacement surgery first became widely used in the 1970s, it was reserved for older patients with crippling pain from arthritis, to offer relief and restore some mobility. But as technology and techniques improved, its use broadened to include younger, less debilitated patients who wanted to maintain an active lifestyle, including vigorous sports or exercise.

In the first few decades, implants were typically cemented into place. But since the 1980s, many surgeons have used implants made of more sophisticated materials that allow the patient’s own bone to grow in to hold the device in place. For most patients, implants have proved miraculous in improving quality of life, which is why socialized medical systems tend to cover them. Per capita, more hip replacements are done in Britain, Sweden and the Netherlands, for example, than in the United States.
Motivated in part by science and in part by the need to create new markets, joint makers churn out new designs that are patented, priced higher and introduced with free training courses for surgeons. Some use more durable materials so that a patient requiring a hip implant at age 40 or 50 might rely on it longer than the standard 20 years, while other models are streamlined and require smaller incisions.
Zimmer got a big sales bump a few years ago when it began promoting its new “female knee,” a slightly slimmer version of its standard design, in an advertising campaign directed at patients. Hospitals on average pay about $800 more to buy the gender-specific knee implants, according to MD Buyline.
Many doctors say that for most patients, older, standard implants with a successful track record are appropriate. Expensive modifications make no difference for the typical patient, but they drive up prices for all models and have sometimes proved to be deeply flawed, they say.
In the last few years, joint manufacturers have faced lawsuits and have settled claims with patients after new, all-metal implants, which were meant to be more durable than the standard version, had unusually high failure rates. As for those “female knees,” a study featured at the meeting of the American College of Orthopedic Surgeons this year concluded, “While we certainly use the female components frequently in surgery, we don’t detect any objective improvement in clinical outcomes.”
That is why Dr. Scott S. Kelley, an orthopedist affiliated with Duke University Medical Center, generally tries to dissuade patients who request “new, improved” joints. “I tell them: ‘That’s taking a big risk for the potential of a few percentage points of improvement. You wouldn’t invest your retirement account this way.’ ”
A Town’s Lifeblood
The power and profits of the medical device industry are on display here in Warsaw, which has trademarked itself the Orthopedic Capital of the World. Four of the big five joint manufacturers in the world are based in the United States; the other is in Britain. Three of these giants — Zimmer, Biomet and DePuy, a division of Johnson & Johnson — have their headquarters here, a town of 14,000.
An industry that began as a splint-making shop in 1895 has made Warsaw the center of a global multibillion-dollar business. The companies based here produce about 60 percent of the hip and knee devices used in the United States and one-third of the world’s orthopedic sales volume, local officials said. Nearly half the jobs in Kosciusko County, where Warsaw is, are tied to the industry. Residents joke that a mixed marriage is when one spouse works for Zimmer and the other for DePuy.
The industry’s benefits are evident. The county has the lowest unemployment rate in Northern Indiana, and the median family income of $50,000 puts it significantly above the state average. The town boasts lush golf courses and streets lined with spacious homes. The lobby of the elegant City Hall, which is in a restored 1912 bank, features plaques about device manufacturers.
“We eat, sleep and breathe orthopedics,” said Ms. Conley of OrthoWorx, which she said was set up to “plan for the future of the orthopedic industry here.” OrthoWorx’s board of directors includes executives from Biomet and DePuy.
With a high-tech industry as its lifeblood, Ms. Conley said, Warsaw needed to attract engineers and doctors from afar and train local youths for “the business.” It has upgraded the public schools and helped create programs at local colleges in orthopedic regulation and advanced machinist techniques. 
Officials at OrthoWorx say the device makers do not discuss “competitive issues” among themselves, including the prices of implants, even as employees stand together watching their children play baseball. Still, it is in everyone’s interest not to undercut the competition. In 2011, all three manufacturers had joint implant sales exceeding $1 billion and spent about only 5 percent of revenues on research and development, compared with 20 percent in the pharmaceutical industry, said Stan Mendenhall, the editor of Orthopedic Network News. They each paid their chief executives over $8 million.
“It’s amazing to think there is $5 billion to $6 billion going through this little place in Northern Indiana,” said Mr. Mendenhall, adding that the recession has meant only single-digit annual revenue growth rather than the double-digit growth of the past.
Device makers have used some of their profits to lobby Congress and to buy brand loyalty. In 2007, joint makers paid $311 million to settle Justice Department accusations that they were paying kickbacks to surgeons who used their devices; Zimmer paid the biggest fine, $169.5 million. That year, nearly 1,000 orthopedists in the United States received a total of about $200 million in payments from joint manufacturers for consulting, royalties and other activities, according to data released as part of the settlement.
Despite that penalty, payments continued, according to a paper published in The Archives of Internal Medicine in 2011. While some of the orthopedists are doing research for the companies, the roles of others is unclear, said Dr. Cram, one of the study’s authors.
Although only a tiny percentage of orthopedists receive payments directly from manufacturers, the web of connections is nonetheless tangled.
Companies “build a personal relationship with the doctor,” said Professor Robinson, the Berkeley economist. “The companies hire sales reps who are good at engineering and good at golf. They bring suitcases into the operating room,” advising which tools might work best among the hundreds they carry, he said. And some studies have shown that operations attended by a company representative are more likely to use more and costlier medical equipment. While some hospitals have banned manufacturers’ representatives from the operating room, or have at least blocked salesmanship there, most have not.
No Gift Shop
There are, of course, a number of factors that explain why Mr. Shopenn’s surgery in Belgium would cost many times more in the United States. In America, fees for hospitals, scans, physical therapy and surgeons are generally far higher. And in Belgium, even private hospitals are more spartan.
When Mr. Shopenn arrived at the hospital, he was taken aback by the contrast with NewYork-Presbyterian Hospital, where his father had been a patient a year before. The New York facility had “comfortable waiting rooms, an elegant lobby and newsstands,” Mr. Shopenn remembered.
But in Belgium, he said, “I was immediately scared because at first I thought, this is really old. The chairs in the waiting rooms were metal, the walls were painted a pale green, there was no gift shop. But then I realized everything was new. It was just functional. There wasn’t much of a nod to comfort because they were there to provide health care.”

The pricing system in Belgium does not encourage amenities, though the country has among the lowest surgical infection rates in the world — lower than in the United States — and is known for good doctors. While most Belgian physicians and hospitals are in business for themselves, the government sets pricing and limits profits. Hospitals get a fixed daily rate and surgeons receive a fee for each surgery, which are negotiated each year between national medical groups and the state.
While doctors may charge more than the rate, few do so because most patients would refuse to pay it, said Mr. Boussauw, the hospital administrator. Doctors and hospitals must provide estimates. European orthopedists tend to make about half the income of their American counterparts, whose annual income averaged $442,450 in 2011, according to a survey by the Commonwealth Fund, a foundation that studies health policy.
Belgium pays for health care through a mandatory national insurance plan, which requires contributions from employers and workers and pays for 80 percent of each treatment. Except for the poor, patients are generally responsible for the remaining 20 percent of charges, and many get private insurance to cover that portion.
Mr. Shopenn’s surgery, which was uneventful, took place on a Tuesday. On Friday he was transferred for a week to the hospital’s rehabilitation unit, where he was taught exercises to perform once he got home.
Twelve days after his arrival, he paid the hospital’s standard price for hip replacements for foreign patients. Six weeks later he saw an orthopedist in Seattle, where he was living at the time, to remove stitches and take a postoperative X-ray. “He said there was no need for further visits, that the hip looked great, to go out and enjoy myself,” Mr. Shopenn said.

Staying Active

The number of hip replacements has risen sharply in recent years, with much of the growth coming from people younger than 65.

  • Show total numbers
  • Show proportions

With baby boomers determined to continue skiing, biking and running into their 60s and beyond, economists predict a surge in joint replacement surgeries, and more procedures for younger patients. The number of hip and knee replacements is expected to roughly double between 2010 and 2020, according to Exponent, a scientific consulting firm, and perhaps quadruple by 2030. If insurers paid $36,000 for each surgery, a fairly typical price in the commercial sector, the total cost would be $144 billion, about a sixth of the nation’s military budget last year.
So far, attempts to bring down the price of medical devices have been undercut by the industry.
When Dr. Daniel S. Elliott of the Mayo Clinic decided to continue using an older, cheaper valve to cure incontinence because studies showed that it was just as good as a newer, more expensive model, the manufacturer raised its price.
“If there was a generic, I’d be there tomorrow,” he said.
With artificial joints, cost-trimming efforts have been similarly ineffective. Medicare does not negotiate directly with manufacturers, but offers all-inclusive payments for surgery to hospitals to prompt them to bargain harder for better implant prices. Instead, hospitals complain that acquiring the implant consumes 50 percent to 70 percent of Medicare’s reimbursement, which now averages $12,099, up 25 percent from $9,645 in 1993. Meanwhile, surgeons’ fees have dropped by nearly half.
With the federal government unwilling to intervene directly, some doctors and insurance plans are themselves trying to reduce the costs by mandating preset prices or forcing more competition and transparency
After concluding that hip replacements billed at $100,000 yielded no better results than less expensive ones, the California Public Employees’ Retirement System, or Calpers, told members that it would pay hospitals $30,000 for a hip or knee replacement, and dozens of hospitals have met that number.
Dr. Wright’s orthopedic hospital near Milwaukee has driven down payments for joints by more than 30 percent by resolving to use only two types of hip implants and requiring blind bids directly from the manufacturers; part of the savings is passed on to patients.
The Affordable Care Act tries to recoup some of the medical device manufacturers’ profits by imposing a 2.3 percent tax on their revenues, effective this year. But Brad Bishop, the executive director of OrthoWorx and a former Zimmer executive, said that the approach would harm an innovative American industry, and that the cost would ultimately be borne by joint replacement patients “whose average age is 67.” He argued that the best way to reduce the cost of joint replacement surgery was to rescind the tax and decrease government interference.
The medical device industry spent nearly $30 million last year on lobbying, according to the Center for Responsive Politics. The Senate moved to repeal the tax, and the House is expected to take it up this fall. The bill’s supporters included both senators from Indiana.
Mr. Shopenn’s new hip worked so well that a few months after returning from Belgium he needed a hernia operation — a result of too much working out at the gym. He was home by 4 p.m. the day of the outpatient surgery, but the bill came to $16,500. Though his insurance company covered the procedure, he called the hospital’s finance department for an explanation.
He remembers in particular a “surreal” discussion with a “very nice” administrator about a $750 bill for a surgical drain, which he called “a piece of plastic in a sealed bag.”
“It was mind-boggling to me that the surgery could possibly cost this much,” he said, “after what I’d just done in Belgium.”

    Reporter's Response: The Growing Popularity of Having Surgery Overseas

Sunday, August 11, 2013

Video Interview with Stuart Cain, a hip replacement patient and spokesperson for the Depuy patients in Austrialia

From Earl's View Blog in a note from Stuart Cain.

Here in Australia the peak professional body for Orthopaedic Surgeons (apparently these people are ‘independent’ of any medical company or other organisation) is the Australian Orthopaedic Association (AOA). The AOA has recently sent a memo to their members with the following directive:

“When discussing with patients the issue of elevated Cobalt/Chromium levels, please be mindful of the following points. Up until now elevated levels of these two elements have been referred to as ‘Cobalt/Chromium Toxicity’ or ‘Cobalt/Chromium Poisoning’. It is advised that in the current climate, that this should now be referred to as ‘Cobalt/Chromium Sensitivity’!

Friday, August 9, 2013

What is the legal argument behind disallowing the discussion of the Depuy voluntary recall in upcomming MDL trial?

Miller and Zois LLC

With the first MDL trial around the corner, DePuy wants to keep the recall out of evidence.  Why?  Because it is pretty much game, set, match for the idea that the ASR metal-on-metal replacement was awful.

DePuy’s Legal Argument

DePuy’s argument is twofold.  First, its voluntary recall (I know it was voluntary because they have told us that 1000 times)  should not be admitted because it is a subsequent remedial measure.  Second, the probative value of the fact that there was a recall in 2010 is greatly outweighed by its potential for prejudice.

Federal Rule of Evidence 407 excludes subsequent remedial measures when it provides that when measures are taken that would have made an earlier injury or harm less likely to occur, evidence of the subsequent measures is not admissible to prove:  negligence,  culpable conduct,  a product or design defect,  or a need for a warning  doctors and/or patients.   Why? Because you don’t want someone to not take a safety precaution because they are worried about having it shoved back in their face.

There are some situations where the defendant cannot hide behind subsequent remedial measures.   If the evidence of subsequent remedial measures is to show ownership or feasibility of precautionary measures, it can be admissible.  But that is not what we have here in these suits.

So DePuy wants to jump in this safe harbor.  The federal judge overseeing the case agreed to let them avail themselves to this doctrine.  I don’t like the ruling because I think the recall tells the jury so much about these cases… but I do understand the bigger picture wisdom, too.

Statute Of Limitations has not yet run out in the following states for filing

The statute of limitations on the recalled DePuy ASR metal on metal hip implant has not yet run out in Arkansas, Washington D.C., Florida, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Rhode Island, South Carolina, South Dakota, Vermont, Washington, Wisconsin, and Wyoming

DePuy Hip Class I Recall Announced By FDA of Its DePuy LPS Lower Extremity Dovetail Intercalary Hip Implant Component Due to Risk of Fracturing

Wright Schulte
The Food and Drug Administration (FDA) has recently announced that DePuy Orthopaedics, Inc. has issued an Urgent Medical Device Recall for one of its popular hip implant components, the LPS Lower Extremity Dovetail Intercalary component. This DePuy recall has been issued due to the component’s propensity to fracture. While DePuy issued its recall of this component on July 11, 2013, as of August 1, 2013, the FDA elevated this DePuy recall to a Class I recall status – the most serious type of recall that can be issued – due to the likelihood of alleged serious injury or death associated with these malfunctioning DePuy hip implant components.

According to the FDA’s DePuy recall announcement, the recalled LPS hip implant component can fracture under “normal physiologic loads while walking.” This means that it does not take a lot of weight on these components in order to increase the likelihood that they will break. Patients with the highest risk of experiencing an LPS hip implant fracture include those who weigh more than 200 pounds and/or who are highly active individuals.

In the event that the LPS Lower Extremity Dovetail Intercalary component does fracture, patients will likely experience severe hip pain and immediate loss of hip function. In most cases of the component fracturing, patients will need to undergo risky revision surgery to remove the broken component. Additionally, patients who experience a component fracture will typically also suffer from serious nerve injuries and may even lose the leg connected to the fractured device.

Read more:

Tuesday, August 6, 2013

DePuy ASR Lawsuit News: Bernstein Liebhard LLP Notes DePuy Orthopaedic’s Motion for Summary Judgment in California Bellwether Case

PR Wed

New York, New York (PRWEB) August 03, 2013
Lawsuits filed in the wake of the 2010 DePuy ASR recall ( continue to move forward in courts around the country. On July 26th, DePuy Orthopaedics moved for summary judgment in a bellwether case scheduled to go to trial October 1st in a consolidated proceeding now underway in California Superior Court. According to court documents, the Plaintiff has until August 30th to file an opposition to the motion. Judge Richard A. Kramer, who is overseeing the California DePuy ASR recall litigation, has scheduled a hearing on dispositive motions for September 13, 2013. (DePuy ASR HIP System Cases, No. CJC-10-004649; Calif. Super. Ct., San Francisco Cty.)

[What is a summary Judgment:

In law, a summary judgment (also judgment as a matter of law) is a judgment entered by a court for one party and against another party summarily, i.e., without a full trial. Such a judgment may be issued on the merits of an entire case, or on discrete issues in that case.

In common-law systems, questions about what the law actually is in a particular case are decided by judges; in rare cases jury nullification of the law may act to contravene or complement the instructions or orders of the judge, or other officers of the court. A factfinder has to decide what the facts are and apply the law. In traditional common law the factfinder was a jury, but in many jurisdictions the judge now acts as the factfinder as well. It is the factfinder who decides "what really happened," and it is the judge who applies the law to the facts as determined by the factfinder, whether directly or by giving instructions to the jury.
Absent an award of summary judgment (or some type of pretrial dismissal), a lawsuit will ordinarily proceed to trial, which is an opportunity for litigants to present evidence in an attempt to persuade the factfinder that they are saying "what really happened," and that, under the applicable law, they should prevail.

The necessary steps before a case can get to trial include disclosing documents to the opponent by discovery, showing the other side the evidence, often in the form of witness statements. This process is lengthy, and can be difficult and costly.

A party moving (applying) for summary judgment is attempting to avoid the time and expense of a trial when the outcome is obvious. A party may also move for summary judgement in order to eliminate the risk of losing at trial, and possibly avoid having to go through discovery (i.e., by moving at the outset of discovery), by demonstrating to the judge, via sworn statements and documentary evidence, that there are no material factual issues remaining to be tried. If there's nothing for the factfinder to decide, then the moving party asks rhetorically, why have a trial? The moving party will also attempt to persuade the court that the undisputed material facts require judgment to be entered in its favor. In many jurisdictions, a party moving for summary judgment takes the risk that, although the judge may agree there are no material issues of fact remaining for trial, the judge may also find that it is the non-moving party that is entitled to judgment as a matter of law.]

I see this motion by Depuy as a positive step for the plaintiffs.  You have a number of aggressive litigation attorneys in So Calif and Depuy lost the first trial there with an award to the Plaintiff of $8M dollars!

Court Grants DePuy Motion to Bar Evidence of Voluntary ASR Hip Recall from Bellwether Trial

Harris Martin

Important News for those considering law suit filings through the MDL!

TOLEDO, Ohio — U.S. District Judge David A. Katz has granted a motion by DePuy Orthopaedics (NYSE: JNJ) to exclude evidence of the voluntary August 2010 recall of its ASR hip device at a September trial, saying it is inadmissible under the Federal Rules of Civil Procedure.

That was one of several rulings issued by Judge Katz July 26 on in limine motions in the lawsuit brought by Ann McCracken, which is to be the first of the ASR MDL cases to be tried.

[Implication:  I am wondering what the power is of the MDL at this point.  This is a big blow to the MDL.  Essentially, the Depuy MOM plaintiff suits can't present a piece of critical information to the jury; the fact that there was a voluntary recall.  Yikes!

I also understand that unlike the trial in LA where the Plaintiffs prevailed in eliminating certain things in the pretrial motions to the judge, this trial will enable Depuy to enter the evidence that FDA had a process for quickly approving new devices to the market if they were substantially familiar to those that preceded the new ones.  While that process was not a result of any active investigative  approval of the Depuy ASR, the fast approval process is likely to confuse the jury and appear as though the regulatory agency was involved actively in reviewing the full construct of the ASR which it was not.  As we all know, as a result of this ASR approval, the whole process of device and implant approval through the FDA is under investigation.

If there are any MDL attorneys reading the blog today, I wonder if you can send us a note and advise why any patient at this point should file through the MDL?  Aren't these two motions really problematic for the bell weather trial?

What are the alternatives to the MDL in light of this development last week?  State court filing in a venue which is more accepting of the plaintiff motions.]