Thursday, March 31, 2016
Former FDA Head Charges Fraud In Meningitis Outbreak
By Walter F. Roche Jr.
The former head of the U.S. Food and Drug Administration has testified that he believes the operators of a Nashville clinic and officials of a defunct Massachusetts drug compounding firm "were engaged in a fraud" involving faked prescriptions for a spinal steroid that proved deadly.
Testifying in a lengthy deposition, David A. Kessler M.D. stated that the record "clearly evidences that STOPNC, the Saint Thomas Outpatient Neurosurgical Center and NECC (the New England Compounding Center) were engaged in a fraud."
Kessler was head of the FDA from 1990 to 1997, more than a decade before the fatal fungal meningitis outbreak which is at heart of the pending litigation.
Citing prescriptions that included the name "Mickey Mouse" Kessler said, "Those were not prescriptions. We know that."
The testimony comes in a suit brought by victims of the outbreak which sickened 778 patients and killed 76. Tennessee was one of the hardest hit states and most of the victims were injected with fungus laden methylprednisolone acetate from NECC at the Nashville outpatient surgical center.
Tennessee reported that 153 patients were sickened in the outbreak including 16 who died.
The deposition, which took place last month in California, was marked by repeated sharp exchanges between opposing lawyers. C. J. Gideon of Nashville, representing the outpatient clinic and related clients, already has filed a motion to force Kessler to undergo another 3.5 hours of questioning.
"It's been a long time since I've seen a witness this unresponsive," Gideon said as the daylong deposition came to an end early last month. "It's ridiculous."
Gideon said in an email response to a request for comment that he would respond on Friday.
Gideon also made frequent mention of the fact that Kessler has been charging $1,000 an hour for his services in behalf of plaintiffs in the case.
"C.J. quit whining," Nashville attorney Mark Chalos retorted at one point.
Gideon also repeatedly challenged Kessler about the FDA's failure to take action against the Framingham, Mass. drug firm despite a decade long record of complaints.
Asked by Gideon why the FDA did not investigate whether the drug firm was mass producing compounded drugs without the required patient specific prescriptions, Kessler said he regretted that the matter wasn't exposed.
"I mean yes, you are right, I very much wish, okay, that this whole scheme that your client and NECC were engaged in was discovered and exposed. That would have been very nice," Kessler testified.
But under repeated questioning by Gideon, Kessler insisted that actions by Congress and conflicting court opinions left FDA's authority over NECC in question.
"It was unclear," Kessler said when asked about the FDA's authority over NECC. "I think that anyone looking at this would have to say it is unclear what the law governed at the time. I think it is fair to say there was confusion."
Gideon cited FDA and other records showing that the agency had evidence long before the 2012 outbreak that NECC was mass producing compounded drugs without the required individual patient prescriptions.
Records cited included internal NECC emails in which two of NECC's owners discussed the selling of compounded drugs to the Massachusetts Eye and Ear Clinic without required prescriptions.
"And (Barry) Cadden says to (Gregory) Conigliaro, "unless she's a complete fool, she'll know what we are up to," Gideon related.
But Kessler responded by citing the Nashville clinic and its relationship with NECC.
"What (the Nashville clinic) here was to facilitate this scheme of this wrongdoing by signing these things called prescription order forms and giving names when they weren't prescriptions and there wasn't a physician-pharmacist relationship," Kessler testified.
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Monday, March 28, 2016
California Drug Compounder Recall
Compounded Products by Reliable Drug Pharmacy: Recall - Potential for Mislabeling and Lack of Quality Assurance
AUDIENCE: Pharmacy
ISSUE: Reliable Drug Pharmacy is recalling all unexpired lots of compounded products due to concern of lack of quality assurance and potential mislabeling. All unexpired lots are subject to the recall. All recalled products were distributed to patients and veterinarians within California. A few products were shipped to Hawaii, New Mexico, and Michigan.
The recall was issued after a series of onsite inspections by the FDA.
BACKGROUND: All recalled products have a label that includes Reliable Drug name and expiration date. If unsure, customers can call the pharmacy to determine the expiration date. This recall impacts all compounded products distributed between 09/24/2015 and 03/24/2016.
RECOMMENDATION: Customers that have recalled product should immediately stop using it and should contact Reliable Drug Pharmacy to arrange for the return of unused product. Customers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using these products.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[03/25/2016 - Press Release - Reliable Drug Pharmacy]
Page Last Updated: 03/28/2016
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Eight New Victims Seek Late Meningitis Claims Approval
By Walter F. Roche Jr.
Eight additional victims of the 2012 12 fungal meningitis outbreak are seeking court approval for claims filed well after a 2014 deadline.
The request was submitted late last week in U.S. Bankruptcy Court in Boston on behalf of victims who initially did not have attorneys to represent them.
Three of the late filers are from Tennessee while others are from Indiana and Michigan. Two of the Tennessee claimants were injected with a tainted steroid at a Nashville outpatient clinic, while the third was treated at a Crossville facility.
Five of the eight already have submitted claims, while the remaining three are seeking an extension to file the necessary paperwork.
According to the filing all eight had filed claims after the deadline, had their claims denied and then filed appeals under a process approved by a bankruptcy judge.
The eight are seeking a share of some $200 million placed in a trust fund during the bankruptcy of the New England Compounding Center, the now defunct firm blamed for the outbreak which sickened 778 patients across the country, killing 76 of them.
Tennessee, Indiana and Michigan were three of the hardest hit states, according to outbreak data from the U.S. Centers for Disease Control and Prevention.
Paul D. Moore, who served as trustee in the NECC bankruptcy, filed notice today stating he has no objections to the requests.
Filing the motion for the late filers was Annika Martin of the law firm of Lieff Cabraser Heimann and Bernstein. She stated that she was acting not as the attorney for the late filers, but as the court appointed representative of victims without attorneys.
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Friday, March 25, 2016
Outbreak Victim Files Appeal
By Walter F. Roche Jr.
The attorney for an Alabama victim of the 2012 fungal meningitis outbreak has filed an appeal of an award decision that cut about $7,800 from the amount she will receive from a $200 million court approved trust fund.
The appeal in behalf of Kristen Townsley was filed with the administrator of the fund set up to compensate victims of the fungal meningitis outbreak which sickened 778 patients, killing 76 of them.
Townsley was one of hundreds to receive notifications over the past month of awards stemming from the bankruptcy of the New England Compounding Center, the firm blamed for the outbreak,
Federal and state regulators concluded that the Framingham, Mass. firm shipped thousands of vials of methylprednisolone acetate which were tainted with a deadly fungus.
In the appeal letter, Lauren Davis, Townsley's attorney, provided verification that her client was hospitalized twice in 2012 and 2013 after being stricken with meningitis caused by the NECC drugs.
She had been injected three times in 2012 at Pain Consultants of Northwest Florida, for the treatment of rheumatoid arthritis and related ailments.
In addition Davis provided documentation that Townsley received a powerful anti-fungal drug, with serious side effects, for a total of 257 days in 2012 and 2013.
The appeal seeks four additional points for the extended drug treatment and 2 additional points for the lengthy hospitalization.
Under the point system being used in the case each point counts for about $1,300.
The initial awards are estimated to equal a little less than one half of the total each victim will eventually receive.
The $200 million trust fund was established in the bankruptcy case of NECC.
Several of the victims also have filed separate suits against the health care providers who administered the fungus tainted drugs. In one recent settlement in a Michigan class action case, 300 victims who were treated at Michigan Pain Specialists in Genoa, Mich. were awarded a total of $10.5 million.
Suits against the Saint Thomas Outpatient Neurosurgical Center in Nashville, Tenn. are scheduled to go to trial beginning in July.
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Meningitis Victims Learning Mixed Details of Awards
By Walter F. Roche Jr.
From Alabama to Tennessee and on to New Jersey and Michigan victims of the 2012 fungal meningitis outbreak are learning how much if any they can expect to receive from a $200 million trust fund.
Kristen Townsley, 32, an Alabama resident, got a two-page letter informing her that she would be getting some but not all of the points she had requested. The points, valued at about $1,300 apiece, will be used to determine how much of an award she will get.
Townsley and hundreds of others were victims of the 2012 fatal fungal meningitis outbreak caused by fungus laden steroids shipped around the country to health providers in more than 20 states.
Townsley, like several other victims, indicated she is appealing to regain the points shaved off her award.
In Nashville, Tenn. Ray Sharer, another victim, said he got nearly as many points as he had applied for.
But Sharer, like others, says the potential award from a $200 million trust fund, is small recompense for the suffering he continues to undergo.
"It still doesn't amount to peanuts," he said.
Dennis OBrien, another Tennessee victims, said that even those who lost a relative in the outbreak will be getting meager amounts.
" It's just sad!! The pain and suffering back then, and the present and future pain and suffering NOW, not even close! " he said.
She soon became sick but, at first didn't connect it to the recent injections.
"I had no idea," she recalled.
The cause soon became clear when federal health officials disclosed the growing outbreak and its apparent cause, fungus infested steroids from the New England Compounding Center.
"I got a call on Oct. 5 telling me to go to my doctor for blood work," she recalled.
She said confusion followed when she reported to a local hospital and was told, "You look fine."
Tests showed she wasn't.
Subsequent treatment for the fungal infection proved debilitating and she underwent two hospitalizations and two weeks of treatment at the Mayo Clinic. She said doctors have told her she will continue to suffer serious after effects for the rest of her life.
Townsley received a letter dated March 18 informing her that 4 points had been deleted from her claim.
Other victims, or their survivors in fatal cases, also have received award letters in a three-phased process. Under a distribution plan, victims will get an initial award estimated at about 50 percent of the total with a second distribution at a later date.
Sharer noted that unless federal officials reverse their current stand, those awards will be seriously depleted by claims from the federal Medicare and Medicaid programs, which paid for the treatment previously.
"Medicare is going to be standing at the front door,"he said.
Contact: wfrochejr999@gmail.com
Saturday, March 19, 2016
Appeal Filed on Meningitis Product Liability Claims
By Walter F. Roche Jr.
Tennessee victims of the 2012 fungal meningitis outbreak are appealing a recent ruling by a federal judge dismissing millions of dollars in claims under the Volunteer State's unique product liability statute.
A motion for reconsideration was filed this week seeking to have U.S. District Judge Rya W. Zobel reverse her Feb. 29 decision granting the dismissal of the product liability claims against the Saint Thomas Outpatient Neurosurgical Center in Nashville, Tenn.
In a 13-page memorandum backing the request, attorneys for the victims, disputed Zobel's conclusion that because of a conflict between two Tennessee laws, one, the state's medical liability law, "trumped" the product liability statute.
In addition the memo charges that Zobel wrongly stated that the plaintiffs had agreed with the conclusion that the medical liability statute was more specific and thus had precedence.
"The parties plainly do not agree," the memo states, adding that Zobel had reached the "wrong conclusion."
Zobel's decision could have a profound impact on the amounts Tennessee victims are likely to recover in the litigation. If her original ruling stands, claims would be limited to those made under the health care liability law, which sets strict caps on the amounts a court can award.
Though her ruling was focused on the Nashville clinic, it is expected to apply to victims who were injected with fungus tainted steroids at two other Tennessee health facilities located in Oak Ridge and Crossville. It would not necessarily apply in other states with different product liability statutes.
The decision comes in dozens of cases from 20 states where patients were injected in 2012 with fungus tainted steroids shipped from a defunct Massachusetts drug compounding firm. The cases have been consolidated in Zobel's Boston, Mass. courtroom.
The subsequent outbreak sickened 778 patients in 20 states. Seventy-six of them died.
In the brief filed by Nashville attorneys Benjamin Gastel and Gerard Stranch, the plaintiffs argued that the two statutes were not in conflict but applied to different events in the timeline of the deadly outbreak.
The health care liability statute, the brief states, applies to the decision of the Nashville clinic to purchase the fungus ridden steroids, methylprednisolone acetate, from the New England Compounding Center. The product liability statute, they stated, applies to the "sale" of that product to the victims.
The Nashville clinic and related parties have consistently disputed the claim that there was any such purchase.
"The court erred in concluding that the Health Care Liability Act and the Product Liability Act irreconcilably conflict," the reconsideration motion states, adding that in fact the same legislative act that created the health care law also amended the product liability statute.
"The legislature did not intend for either one to trump the other," the filing states.
As for the conclusion that the victims agreed that the health care law was more specific, the memorandum calls that "clear error."
"It was manifestly unjust for the court to rule against the PSC (the plaintiffs), based on concessions of law that the PSC (plaintiffs) did not make," the motion concludes.
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Respectfully, the Plaintiffs’ Steering Committee (“PSC”) asks the Court to reconsider its
February 29, 2016, Opinion and Order.1 There, the Court concluded that:
1. because there is overlap between the Tennessee Products Liability Act (“PLA”) and the Tennessee Healthcare Liability Act (“HCLA”), their conflicting liability and damages provisions preclude application of both, and force a choice between them; and
2. because under Tennessee law the more specific statute should be applied, and here “the parties agree that … the []HCLA is the more specific statute,” the PLA is inapplicable here.
But the Court has erred, and should reconsider its opinion because:
1. the HCLA and the PLA can (and therefore must, per Tennessee law) be construed harmoniously, precisely because the Tennessee Legislature did not intend them to be in conflict, nor intend for one of them to trump the other. Here, the statutes can be construed harmoniously because they each primarily apply to different events in the timeline—the HCLA primarily
1 [Dkt. No. 2700].
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applies to the Tennessee Defendants’2 negligent selection of NECC as the supplier of the steroid drug and their unlawful purchase of that steroid drug from NECC, while the PLA primarily applies to the later sale of that drug product to the Plaintiffs. These are two different events, as illustrated by the diagram below:
June 2012 August/Sept 2012
Defendants’ selection Defendants’ sale of steroid
of NECC as supplier drug product to Plaintiffs of steroid drugs
--------+----------------------------------------------------------------------+--------------
HCLA applies PLA applies
2. Even if the HCLA and the PLA were in conflict (which they are not), the PLA would apply here because it is the more specific statute.
In light of these errors, the PSC respectfully asks the Court to reconsider its decision.
RULE 54 STANDARD
Under Rule 54(b), a district court may revisit an interlocutory decision that is not immediately appealable, including a partial dispositive motion, at any time prior to the entry of final judgment.3 A motion for reconsideration is appropriate when there is a need to correct a
2 Reflecting the nomenclature used in the Court’s opinion, “Tennessee Defendants” or
“defendants” as used herein refers to Saint Thomas Outpatient Neurosurgical Center, LLC (“St. Thomas Neurosurgical”); Howell Allen Clinic, P.C.; John Culclasure, MD; Debra Schamberg, RN, CNOR; and Vaughan Allen.
3 Fed. R. Civ. P. 54(d); Perez-Ruiz v. Crespo-Guillen, 25 F.3d 40, 42 (1st Cir 1994) (“Interlocutory orders, including denials of motions to dismiss, remain open to trial court reconsideration, and do not constitute the law of the case.”); Nieves-Luciano v. Hernandez-Torres, 397 F.3d 1, 4 (1st Cir. 2005) (“[I]nterlocutory orders from which no immediately appeal may be taken . . . remain open to trial court reconsideration until the entry of the judgment.”) (quotation omitted).
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clear error of law or to prevent manifest injustice.4 A Court should also reconsider a decision in which it “has patently misunderstood a party” or “has made an error not of reasoning but apprehension.”5
ARGUMENT
In its February 29, 2016, Opinion and Order, the Court erred in concluding the the HCLA and the PLA irreconcilably conflict here. Proper application of Tennessee’s rules of statutory construction indicate that both statutes can apply here; moreover, the legislative history makes clear that the Tennessee Legislature intended the statutes to be construed harmoniously and did not intend for either one to trump the other.
The Court also erred in its understanding of the parties’ positions—neither the PSC nor the Defendants took the position that the HCLA was the more specific statute; in fact, the PSC argued just the opposite: that the PLA was the more specific statute. It is unjust for the Court to base its opinion on a misapprehension of the parties’ positions, as it has done here.
For these two reasons, the Court should reconsider its February 29, 2016, Order and Opinion.
I. Tennessee’s Rules of Statutory Construction and The Legislative History of the Statutes Lead to The Conclusion That The HCLA and The PLA Do Not Conflict Here.
A. Tennessee Law Requires Statutes to Be Construed Harmoniously if Possible – And They Can Be Here.
The Tennessee Supreme Court requires that, when a court construes two Tennessee statutes, a construction that places “one statute in conflict with another must be avoided;
4 Davis v. Lehane, 89 F. Supp. 2d 142 (D. Mass. 2000); see also United States v. Allen, 573 F.3d 42, 53 (1st Cir. 2009).
5 Ruiz Rivera v. Pfizer Pharms., LLC, 521 F.3d 76, 82 (1st Cir. 2008).
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therefore, [a court] must resolve any possible conflict between statutes in favor of each other, so as to provide a harmonious operation of the laws.”6 Furthermore, in Tennessee, “the repeal of a statute by implication is not favored and there must be an irreconcilable conflict or repugnancy between the statutes that is plain and unavoidable to work a suspension of the earlier statute.”7
Therefore, as the PSC argued: (1) in construing the PLA here, the Court was required to employ the principle of expressio unius est exclusio alterius and was required to give effect to all of the language set forth in the statute; (2) when construing the interaction between the PLA and the HCLA, the Court was required to construe the statutes in harmony if at all possible, so as to promote “harmonious operation of the laws”;8 (3) before reaching the issue of whether one statute should prevail over the other, the Court was required to determine that there was “an
6 Graham v. Caples, 325 S.W.3d 578, 582 (Tenn. 2010); see also State ex rel. Metro. Gov’t of Nashville v. Spicewood Creek Watershed Dist., 848 S.W.2d 60, 62 (Tenn. 1993) (“[C]ourts should avoid a construction which places one statute in conflict with another,” and “potential conflicts between statutes should be resolved in favor of each statute, if possible, to provide a harmonious operation of the laws”) (citing Parkridge Hosp., Inc. v. Woods, 561 S.W.2d 754, 755
(Tenn. 1978)).
7 Oliver v. King, 612 S.W.2d 152, 154 (Tenn. 1981); see also Spence v. Miles Lab., 810 F. Supp.
952, 963-64 (E.D. Tenn. 1992) (finding no irreconcilable conflict between PLA and a section of the Tennessee Code specific to the handling of AIDS-contaminated blood products, and construing statutes to be “harmonious”); Bd. of Educ. of Shelby Cty. v. Memphis Bd. of Educ., 2011 U.S. Dist. LEXIS 87803, at *124-126 (W.D. Tenn. Aug. 8, 2011) (finding that there was a construction that gave meaning and effect to the language of all the provisions at issue, rejecting a proposed construction of the statutes that would place them in conflict, and adopting the harmonious construction of both laws because “the Court may only conclude that [one law] repealed the [other law] by implication if no fair and reasonable construction permits them to stand together and the conflict is irreconcilable”).
8 Graham, 325 S.W.3d at 582 (internal brackets and quotation omitted); see also Spicewood Creek, 848 S.W.2d at 62 (“[C]ourts should avoid a construction which places one statute in conflict with another,” and “potential conflicts between statutes should be resolved in favor of each statute, if possible, to provide a harmonious operation of the laws”) (citing Parkridge Hosp, 561 S.W.2d at 755).
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irreconcilable conflict or repugnancy between the statutes that is plain and unavoidable”,9 and
(4) if the Court found that the statutes could not be read harmoniously and that an irreconcilable conflict existed, then the more specific provision—here the PLA—should control.10 This Court is obligated to undertake that analysis with respect to the PLA and the HCLA,11 but failed to do
so here, which was a clear error under binding Tennessee Supreme Court precedent.
In its February 29, 2016 Opinion and Order, the Court held that the HCLA and PLA were both broadly worded, that both statutes therefore “could” apply to the facts at issue, and that both statutes “ostensibly control.”12 Without attempting to determine whether the statutes could be
read harmoniously, the Court stated that the overlap “force[s] a choice between” the two statutes.
But the subject statutes can be construed harmoniously here because each governs separate transactions. The HCLA governs claims alleging that a healthcare provider caused harm through the provision of medical services13, while the PLA governs claims that do not arise from the healthcare providers’ conduct or services, i.e., claims for harm caused by products.14 That construction of the two statutes gives meaningful effect to both, as both statutes govern within their respective spheres.
9 Oliver v. King, 612 S.W.2d 152, 154 (Tenn. 1981); see also Spence v. Miles Lab., 810 F. Supp.
952, 963-64 (E.D. Tenn. 1992) (finding no irreconcilable conflict between PLA and a section of the Tennessee Code specific to the handling of AIDS-contaminated blood products, and construing statutes to be “harmonious”). 10 Graham, 325 S.W.3d at 582.
11 See also Ellwest Stereo Theater, Inc. v. Boner, 718 F. Supp. 1553, 1578 (M.D. Tenn. 1989) (applying Tennessee principles and finding no irreconcilable conflict among Tennessee statutes at issue).
12 Dkt. No. 2700, at p. 5.
13 Tenn. Code Ann. § 29-26-101(A)(1).
14 Tenn. Code Ann. § 29-28-102(5) & (6).
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In this case, the statutes apply to different transactions in the timeline of events – the HCLA applies to the Tennessee Clinic Defendants’ negligent selection of NECC as the supplier of the steroid drug and their unlawful purchase of it from NECC, while the PLA applies to the sale of that steroid drug product to the Plaintiffs (as illustrated by the diagram above).
1. Tennessee Defendants’ June 2012 Selection of NECC as supplier of MPA Is Governed by the HCLA
A cause of action under the HCLA turns on whether the defendant medical provider breached a duty of care to the plaintiff, and in so doing caused injury to the plaintiff.15 Here, in
June 2012, the Tennessee Defendants chose NECC as its supplier of the steroid drug and began purchasing it from NECC without patient specific prescriptions. If, as Plaintiffs allege, those actions by the Tennessee Defendants violated the relevant standard of care, then those Defendants can be held liable under the HCLA for injuries legally caused by those breaches of the standard of care.
2. Tennessee Defendants’ Sales of MPA to Plaintiffs in August and September of 2012 are Transactions Governed by the PLA.
The PLA holds “sellers,” including medical providers, liable for selling products to their patients, provided that the original manufacturer is insolvent or cannot be served with process.16
Here, in August and September 2012 – months after their selection of NECC and purchase of the steroid drug from NECC – the Tennessee Defendants sold the steroid drug product to Plaintiffs during the course of Plaintiffs’ injections. The product sold to Plaintiffs – the contaminated steroid – is what caused Plaintiffs’ injuries. Each product sale of the steroid to Plaintiffs is governed by the PLA.
15 Tenn. Code Ann. § 29-26-102(b). 16 Tenn. Code Ann. § 29-28-106.
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While it is true that Tennessee Defendants also provided a medical service during the July and August 2012 transactions and that the HCLA would apply to that “service”, that does not change the analysis here. The common wrongdoing Plaintiffs allege regarding the July and August 2012 transactions is the sale of a product – the steroid drug – to Plaintiffs, which product caused Plaintiffs’ injuries. In other words, had Tennessee Defendants sold Plaintiffs a non-defective product (i.e. a steroid from an FDA-regulated manufacturer, such as Pfizer), Plaintiffs would not have been injured.17
B. Legislative History Shows the Tennessee Legislature Intended for the HCLA and PLA to Be Construed Harmoniously
It is clear that the Tennessee Legislature intended the HCLA and the PLA to operate harmoniously, because the Legislature worked on both statutes simultaneously as part of the same Act, the Civil Justice Act of 2011 (“CJA”). As part of the CJA, the Tennessee Legislature both enacted the HCLA and rewrote the PLA.18 The Tennessee Legislature therefore considered both statutes at the same time (amending one, enacting the other) and saw no conflict.19 If it had seen such a conflict, the legislature could have abrogated the PLA, or otherwise indicated how
17 This gives the lie to Tennessee Defendants’ argument that it is impossible to separate the product from the medical treatment ([Dkt. 2463] at 20)—it is not impossible to do so here because providing the same treatment while selling Plaintiffs a different product (say, Pfizer-made steroid) would have have avoided the injury to Plaintiffs.
18 See 2011 Tenn. HB 2008, 2011 Tenn. Pub. Acts 510 (enacted June 16, 2011). With respect to the PLA, the Civil Justice Act of 2011 amended PLA § 104 (Tenn. Code Ann. § 29-28-104), relating to damages, and PLA § 106 (Tenn. Code Ann. § 29-28-106), which relates to the conditions under which a “seller” can be held liable under the PLA at the same time. Effectively, in its amendments to PLA § 106, the Tennessee legislature authorized lawsuits against “sellers” as defined in § 102(7), provided that (among other things) the manufacturer of the product at issue was insolvent.
19 This is contrary to the misleadingly incomplete version of the legislative history offered by the Tennessee Defendants, who state that the HCLA was enacted after the PLA, but fail to mention that the HCLA was enacted in the very same piece of legislation that rewrote the PLA. [Dkt. 2463 at 21].
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such a conflict should be resolved, in the same Civil Justice Act that created the HCLA. But it did not.
The PSC submits that, once the Court conducts the requisite analysis, the Court will conclude that the statutes can be read harmoniously within their spheres, consistent with the intent of the Tennessee legislature. Accordingly, under an appropriate analysis, the Court will conclude that the PLA applies to the sales of the steroid in August and September 2012 that are at issue – as opposed to the distinct transaction by the Tennessee Defendants in choosing to purchase the steroid drug from NECC in June 2012, which is governed by the HCLA.
II. The Court Mistook the Parties’ Positions Concerning Which Is the More Specific Statute.
Reconsideration is also proper where, as here, a Court “has patently misunderstood a party” or “has made an error not of reasoning but apprehension.”20 Here, the Court correctly held that where two statutes are in conflict, Tennessee courts apply the more specific statute in lieu of the more general one. But the Court then went on to state “The parties agree that between the []PLA and the []HCLA, the []HCLA is the more specific statute…” and reasoned “The []HCLA therefore takes precedence, rendering the []PLA inapplicable in these cases.”21
But the parties here plainly do not agree that the HCLA is the more specific statute—in fact, the PSC’s position was the exact opposite: that the PLA was the more specific statute, because Plaintiffs’ injuries here were caused by the Defendants’ sale to them of contaminated drug products.22 And the Tennessee Defendants, for their part, took no position at all on the matter in any of their briefing. It is therefore unclear to the PSC why the Court assumed that the
20 Ruiz Rivera, 521 F.3d at 82.
21 Dkt. 2700 at 5.
22 Dkt. 2508 at 5.
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PSC would have agreed with anyone (let alone Defendants) that the HCLA is the more specific statute, or why the Court assumed that Defendants had taken a position on this issue. It is manifestly unjust for the Court to base its opinion on asserted concessions of law that the parties did not actually make.
As explained above, the HCLA and the PLA are not in conflict here. But if they were, the PLA is plainly the more specific statute. The PLA applies to any cause of action against a manufacturer or seller that is “caused by” a defective product.23 By contrast, the HCLA applies to injuries “related to the provision of . . . health care services...”24 “Caused by” is a more specific, limited term than “related to”—for example, an injury could be “related” to the provision of health care services without being “caused by” the provision of those services, but proving a PLA claim would require a showing of proximate causation and the associated elements – over and above simple “relatedness.”25 As in Graham, where the court found the term
“issued” was more specific and limited than the term “sues out”, and therefore the statute using the more specific term “issued” took precedence over the conflicting statute that used the more general term,26 the Court here should find that the statute using the more specific term “caused by” – the PLA – takes precedence over the HCLA.
23 Tenn. Code Ann. § 29-28-103(a).
24 Tenn. Code Ann. § 29-26-101(a)(2).
25 See, e.g., Whaley v. Rheem Mfg. Co., 900 S.W.2d 296, 300 (Tenn. Ct. App. 1995) (“It almost goes without saying that the identified product defect must be the proximate cause of the plaintiff’s injury.”).
26 Graham, 325 S.W.3d at 582 (“Further, while ‘suing out’ is a broad and general term, susceptible to various definitions in the context of [the statute], the definition of ‘issued’ considered in its statutory context is specific and limited and, therefore, the former must bow to the latter under the rule that a specific statutory provision shall be given effect over a conflicting general provision.”).
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III. CONCLUSION
In sum, the Court’s failure to properly analyze whether the PLA and HCLA can be read harmoniously and therefore not in conflict constituted clear error. It was also manifestly unjust for the Court to rule against the PSC based on concessions of law that the PSC did not make. These errors merit reconsideration of the Court’s February 29, 2016 Opinion and Order, the denial of the defendants’ Rule 56 motion, and the entry of judgment to the plaintiffs on their PLA claims.27
Dated: March 16, 2016 Respectfully submitted,
/s/ Benjamin A. Gastel
J. Gerard Stranch, IV Benjamin A. Gastel
Anthony A. Orlandi
BRANSETTER, STRANCH & JENNINGS PLLC
223 Rosa L. Parks Avenue, Suite 200
Nashville, TN 37201
Telephone: (615) 254-8801 Facsimile: (615) 255-5419 gerards@branstetterlaw.com beng@branstetterlaw.com aorlandi@bsjfirm.com
Plaintiffs’ Steering Committee and TN Chair
27 At a minimum, the Court’s analysis will demonstrate that there is at least a genuine dispute of material fact to be decided by the jury as to whether the defendants’ constitute “sellers” under the PLA.
Case 1:13-md-02419-RWZ Document 2749-1 Filed 03/16/16 Page 10 of 13
PLAINTIFF STEERING COMMITTEE’S MOTION UNDER RULE 54(B) FOR
RECONSIDERATION OF THE COURT’S FEBRUARY 29, 2016, OPINION AND ORDER
The PSC hereby moves under Fed. R. Civ. P. 54 for reconsideration of the Court’s February 29, 2016 Opinion and Order (Dkt. No. 2700).1 For the reasons set forth in the accompanying Memorandum, the PSC respectfully requests that the Court reconsider that order, grant the PSC’s Motion for Partial Summary Judgment Regarding Product Liability Claims
Against Saint Thomas Outpatient Neurosurgical Center (Dkt. No. 2300), deny the Tennessee Defendants’ Cross-Motion for Partial Summary Judgment (Dkt. No. 2462), and enter judgment for the plaintiffs on their claims under the Tennessee Products Liability Act.
Date: March 16, 2016 Respectfully submitted:
/s/ Benjamin A. Gastel
J. Gerard Stranch, IV
Benjamin A. Gastel
Anthony A. Orlandi
BRANSTETTER, STRANCH &
JENNINGS, PLLC
223 Rosa L. Parks Ave., Suite 200
Nashville, TN 37203
Telephone: 615/254-8801
1 Although the Court’s Opinion and Order is dated February 29, 2016, the document was not entered and served on all parties via the ECF system until March 1, 2016.
Case 1:13-md-02419-RWZ Document 2749 Filed 03/16/16 Page 1 of 5
2
Facsimile: 615/255-5419 gerards@bsjfirm.com beng@bsjfirm.com
aorlandi@bsjfirm.com
Plaintiffs’ Steering Committee and TN Chair
Thomas M. Sobol
Kristen Johnson Parker
HAGENS BERMAN SOBOL SHAPIRO, LLP
55 Cambridge Parkway, Suite 301
Cambridge, MA 02142
Telephone: 617/482-3700 Facsimile: 617/482-3003 tom@hbsslaw.com kristenjp@hbsslaw.com
Plaintiffs’ Lead Counsel
Annika K. Martin
Mark P. Chalos
LIEFF CABRASER, HEIMANN & BERNSTEIN, LLP
250 Hudson Street, 8th Floor
New York, NY 10013 Telephone: 212/355-9500 Facsimile: 212/355-9592 akmartin@lchb.com mchalos@lchb.com
Federal/State Liaison
Marc E. Lipton
LIPTON LAW
18930 W. 10 Mile Road
Southfield, MI 48075
Telephone: 248/557-1688 Facsimile: 248/557-6344 marc@liptonlaw.com
Kimberly A. Dougherty
JANET, JENNER & SUGGS, LLC
31 St. James Avenue, Suite 365
Boston, MA 02116 Telephone: 617/933-1265 kdougherty@myadvocates.com
Mark Zamora
Case 1:13-md-02419-RWZ Document 2749 Filed 03/16/16 Page 2 of 5
3
ZAMORA FIRM
6 Concourse Parkway, 22nd Floor
Atlanta, GA 30328
Telephone: 404/451-7781 Facsimile: 404/506-9223 mark@markzamora.com
Patrick T. Fennell (VSB 40393)
CRANDALL & KATT
366 Elm Avenue, S.W.
Roanoke, VA 24016
Telephone: 540/342-2000 Facsimile: 540/400-0616 pfennell@crandalllaw.com
Plaintiffs’ Steering Committee
Case 1:13-md-02419-RWZ Document 2749 Filed 03/16/16 Page 3 of 5
4
CERTIFICATE OF SERVICE
I, Benjamin A. Gastel, hereby certify that I caused a copy of the foregoing document to be filed electronically via the Court’s electronic filing system. Those attorneys who are registered with the Court’s electronic filing system may access these filings through the Court’s system, and notice of these filings will be sent to these parties by operation of the Court’s electronic filing system.
Date: March 16, 2016
/s/ Benjamin A. Gastel
Benjamin A. Gastel
Case 1:13-md-02419-RWZ Document 2749 Filed 03/16/16 Page 4 of 5
Case 1:13-md-02419-RWZ Document 2749 Filed 03/16/16 Page 5 of 5
Thursday, March 3, 2016
Judge Dismisses Meningitis Product Liability Claims
By Walter F. Roche Jr.
In a major setback for victims and a victory for a Nashville clinic, a federal judge has thrown out millions of dollars in product liability claims sought by victims of a 2012 fatal fungal meningitis outbreak.
In a six-page ruling issued this week, U.S. District Judge Rya W. Zobel concluded that because of two conflicting Tennessee statutes, the product liability claims against a Nashville and two other Tennessee clinics will be dismissed.
Her ruling means victims will be limited to claims under the state's strict healthcare liability statute which caps the amount victims can claim.
The ruling comes in competing motions filed by attorneys for the clinics and the victims.
Named as defendant in the suit is the Saint Thomas Outpatient Neurosurgical Center.
The litigation is separate from a bankruptcy case which already has produced a $200 million trust fund which will go to victims of the outbreak and limited other creditors of the New England Compounding Center, the firm that produced fungus tainted steroids that caused the fatal outbreak.
Some 778 patients across the country were sickened in the outbreak and 76 of them died.
Ostensibly, Zobel wrote, both the state's health care and product liability laws could apply.
But, she concluded, a key word in the Tennessee health care liability law, the word "any," gave that law dominance.
"The Tennessee health care liability law encompasses all civil actions with some connection to the provision of health care services," the ruling states.
She added that under Tennessee law a statute that is more specific applies when there is a conflict.
"The Tennessee health care liability law takes precedence, rendering the Tennessee product liability law inapplicable," she concluded, adding that the claims "plainly relate to the provision of health care services."
Lawyers for the victims had argued that because of the wording of the Tennessee product liability law and the fact that NECC had been declared bankrupt, the Nashville clinic could be regarded as the seller of the defective product, the fungus tainted spinal steroid.
Zobel, however, concluded that the state's health care liability trumped the product liability law.
Contact: wfrochejr999@gmail.com
Thursday, March 17, 2016
Denial Letters Mailed on Some Meningitis Claims
By Walter F. Roche Jr.
Some 275 persons who filed claims in the 2012 fungal meningitis outbreak will soon be getting letters denying them a share of a $200 million trust fund.
Fredric Ellis, a Massachusetts attorney representing some of the victims, said Thursday the denial letters are being sent out by a court appointed administrator.
In addition he said another 450 claimants will be getting letters telling them their claims have been approved in part and disapproved in part.
In both categories the claimants will have the right to file appeals.
He said there was one other category of claims still being processed. In those cases the claims may have been filed late or lacked needed information.
All the claims stem from the 2012 fungal meningitis outbreak which sickened 778 patients across the country. Seventy-six of them died.
The $200 million trust fund was established in the federal bankruptcy case of the New England Compounding Center, the company blamed for the deadly outbreak. NECC shipped thousands of vials of fungus laden steroids which were injected into the spines and joints of unsuspecting patients.
The latest round of notices follows mailing of approval notices to some 1,350 victims or their survivors.
Under the court approved plan, victims of the outbreak are awarded points based on the severity of their illnesses.
As an example, survivors of a victim who died in the outbreak would get 55 points, which would translate to an initial award estimated at $71,500. Under the plan an additional slightly larger award would be paid in each of those cases at a later date.
Meanwhile negotiations are continuing between lawyers for victims and the federal government over the amount the tax funded Medicare and Medicaid programs will seek to recoup from victims.
Ellis declined to comment on the ongoing talks, adding that they were at critical stage.
Some attorneys have expressed concerns that because of Medicare and insurance company liens, which must be paid first, some victims could have their awards virtually wiped out.
Thursday, March 10, 2016
Judge Sets Four Tennessee Cases For Fungal Meningitis Trials
By Walter F. Roche Jr.
With the fourth anniversary of a deadly fungal meningitis outbreak approaching, a federal judge has set out a schedule for the first four trials in the cases brought by victims of the outbreak and their survivors.
All four cases involve Tennessee victims of the outbreak that sickened 778 patients, killing 76.
In a 30-minute hearing Thursday in U.S. District Court in Boston, Mass. U.S. District Judge Rya W. Zobel said that the first case filed by Jane Wray, a Tennessee victim in the outbreak, will be held in July.
The case brought by the family of Reba Temple of Nashville, who died in the outbreak, will be held in August followed by Basil McElwee, an outbreak survivor, in September and Reba Skelton in October.
"Those are the four we are going forward with," Zobel said.
The attorney for the Saint Thomas Outpatient Neurosurgical Center, expressed concerns about the July date, but Zobel indicated she wanted to stick to her schedule.
"You'll have to work hard to convince me otherwise," Zobel said.
The four cases were on a list of proposed bellwether cases submitted to Zobel recently by lawyers for the victims and the Saint Thomas clinic.
Wray was injected with methylprednisolone acetate on Aug. 31, 2012 at the Saint Thomas clinic and she was hospitalized with fungal meningitis on Oct. 4.
Reba Temple, a Centerville, Tenn. resident, and a longtime county health department worker, died in early October from fungal meningitis caused by a fungus tainted steroid.
Basil McElwee of Maury County, Tenn. was injected at the Nashville clinic on Aug. 20 and Sept. 4 and subsequently was hospitalized with fungal meningitis.
Reba Skelton of Waynesboro, Tenn. was hospitalized for 17 days in 2012 after being stricken with fungal meningitis stemming from an injection. In an interview in early 2013 she described her continuing painful battle with the after-effects of both the disease and its treatment.
Three additional Tennessee cases are expected to be scheduled after the initial cases are completed. Gerard Stranch, a Nashville attorney representing victims, urged that pre-trial efforts go forward on those additional cases so that they would be readied in case any of the original four are settled before trial.
The first cases will serve as so-called bellwethers, that hopefully will set a pattern for the ultimate resolution of dozens of other suits brought by outbreak victims.
In other action during the 30-minute Thursday session, opposing lawyers set out proposed deadlines for the depositions of witnesses and other pre-trial matters.
The cases before Zobel were brought primarily against health care providers who injected patients with fungus tainted steroids, They are separate from a bankruptcy case involving the New England Compounding Center, the defunct Framingham, Mass. firm which shipped thousands of vials of fungus tainted steroids to health care providers across the country.
Victims are awaiting separate awards from a $200 million trust fund created under the bankruptcy.
Contact: wfrochejr999@gmail.com
Wednesday, March 9, 2016
FDA Warning on Sterile Drugs From I.V. Specialty Ltd.
By Walter F. Roche Jr.
The U.S. Food and Drug Administration (FDA) is advising patients and medical professionals to quarantine and not administer sterile drugs produced by an Austin, Tex. firm cited for repeat violations of sterility requirements.
The advisory was issued Wednesday for products prepared by I.V. Specialty Ltd., a company that had, but lost a license to mass produce compounded drugs under a new law aimed at ending drug compounding abuses.
FDA records show inspectors have cited the firm for multiple violations of sterility requirements.
According to the announcement, the FDA asked the Texas firm to cease the production of sterile drugs and to recall any unused products, but the company refused.
"The company has neither ceased sterile production nor initiated a recall. Therefore, FDA is alerting health care professionals and patients to dispose of and not use drug products intended to be sterile that were produced and distributed by I.V. Specialty," the FDA stated in the alert.
While the agency said that no adverse events have been reported, they advised patients and medical professionals to report any adverse reactions from the company products.
In an April 21, 2015 warning letter to the company the FDA warned that the company practices placed patients at risk.
[Posted 03/09/2016]
AUDIENCE: Pharmacy, Nursing, Veterinary Medicine, Infectious Disease
ISSUE: The U.S. Food and Drug Administration (FDA) is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by I.V. Specialty Ltd., Austin, Texas, due to lack of sterility assurance. On March 7, 2016, FDA recommended that I.V. Specialty cease sterile production until appropriate corrective actions are implemented, and recall all non-expired drug products intended to be sterile. The company has neither ceased sterile production nor initiated a recall. Therefore, FDA is alerting health care professionals and patients to dispose of and not use drug products intended to be sterile that were produced and distributed by I.V. Specialty.
BACKGROUND: During FDA’s recent inspection of I.V. Specialty, investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about I.V. Specialty’s ability to assure the sterility of the drug products it produces. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.
RECOMMENDATION: Health care professionals and consumers should immediately check their medical supplies, quarantine any drug products labeled as sterile from I.V. Specialty, and not administer them to patients. Health care professionals should make alternative arrangements to obtain any medications they administer to patients from reliable sources that adhere to proper quality standards.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
The U.S. Food and Drug Administration (FDA) is advising patients and medical professionals to quarantine and not administer sterile drugs produced by an Austin, Tex. firm cited for repeat violations of sterility requirements.
The advisory was issued Wednesday for products prepared by I.V. Specialty Ltd., a company that had, but lost a license to mass produce compounded drugs under a new law aimed at ending drug compounding abuses.
FDA records show inspectors have cited the firm for multiple violations of sterility requirements.
According to the announcement, the FDA asked the Texas firm to cease the production of sterile drugs and to recall any unused products, but the company refused.
"The company has neither ceased sterile production nor initiated a recall. Therefore, FDA is alerting health care professionals and patients to dispose of and not use drug products intended to be sterile that were produced and distributed by I.V. Specialty," the FDA stated in the alert.
While the agency said that no adverse events have been reported, they advised patients and medical professionals to report any adverse reactions from the company products.
In an April 21, 2015 warning letter to the company the FDA warned that the company practices placed patients at risk.
"During FDA’s inspection of your facility, the investigators observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk. For example, the investigators observed your operators processing sterile drug products with exposed hair, ears, and forehead," the letter stated.On its website the firm lists the following as its products for use in home infusion therapy:
Home Infusion Therapies
I.V. Specialty's team of experts specializes in the following home infusion therapies:
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Human and Animal Sterile Drug Products by I.V. Specialty: FDA Alert - Lack of Sterility Assurance
AUDIENCE: Pharmacy, Nursing, Veterinary Medicine, Infectious Disease
ISSUE: The U.S. Food and Drug Administration (FDA) is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by I.V. Specialty Ltd., Austin, Texas, due to lack of sterility assurance. On March 7, 2016, FDA recommended that I.V. Specialty cease sterile production until appropriate corrective actions are implemented, and recall all non-expired drug products intended to be sterile. The company has neither ceased sterile production nor initiated a recall. Therefore, FDA is alerting health care professionals and patients to dispose of and not use drug products intended to be sterile that were produced and distributed by I.V. Specialty.
BACKGROUND: During FDA’s recent inspection of I.V. Specialty, investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about I.V. Specialty’s ability to assure the sterility of the drug products it produces. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.
RECOMMENDATION: Health care professionals and consumers should immediately check their medical supplies, quarantine any drug products labeled as sterile from I.V. Specialty, and not administer them to patients. Health care professionals should make alternative arrangements to obtain any medications they administer to patients from reliable sources that adhere to proper quality standards.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Page Last Updated: 03/09/2016
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Tuesday, March 8, 2016
Claims Responses Sought From Victims, Survivors
Hello:
I would like to hear from readers/victims about the responses they may have received from the trust fund on their claims. If you are willing to share information I will include it in a story.
Please email me at wfrochejr999@gmail.com
Judge Approves NECC Records Destruction
By Walter F. Roche Jr.
A federal bankruptcy judge has authorized the destruction and disposal of certain records of the bankrupt firm blamed for a fatal fungal meningitis outbreak.
U.S. Judge Henry Boroff Monday approved the request from the post-confirmation officer overseeing the bankruptcy of the New England Compounding Center, the defunct company that shipped fungus tainted drugs to health providers across the country.
Paul D. Moore, who previously served as NECC's trustee, had petitioned the court to destroy unneeded documents, citing the cost of continued storage.
Moore told the court in a prior hearing that documents needed in pending litigation and an NECC autoclave were being preserved.
Moore also has given his approval for a late filed claim submitted by a victim of the outbreak who inadvertently had failed to file needed paperwork.
Justin Bogunia was injected with an NECC steroid at an Indiana facility on Sept. 20, 2012. He was sickened but was not diagnosed with fungal meningitis. He has submitted a claim for $13,291.90 in medical expenses.
Bogunia moved from Indiana to Nashville, according to court filings, and apparently missed a deadline for filing some documentation.
Contact: wfrochejr999@gmail.com
Thursday, March 3, 2016
Ruling Likely to Apply to Other Tennessee Clinics
By Walter F. Roche Jr.
A key ruling in favor of a Nashville clinic issued this week is likely to benefit two other Tennessee clinics, where patients were injected with a fungus tainted steroid in 2012 triggering a nationwide fungal meningitis outbreak.
In a six-page ruling this week U.S. District Judge Rya W. Zobel granted a motion by the Saint Thomas Outpatient Neurosurgical Center to dismiss claims by outbreak victims under Tennessee's product liability law.
Though Zobel made clear her ruling applied solely to the Saint Thomas facility, the same reasoning is likely to apply to claims against two other Tennessee clinics, the Specialty Surgery Center in Crossville and the PCA Pain Center in Oak Ridge.
Meanwhile attorneys for victims of the 2012 fatal outbreak are considering whether or not to appeal Zobel's decision.
"We are considering the options," said Nashville attorney Mark Chalos.
Chris Tardio, one of the attorneys for the Saint Thomas clinic and the Oak Ridge and Crossville facilities, said the ruling was consistent with arguments they made in Zobel's Boston, Mass. courtroom.
He said the clinics agree with Zobel's conclusion that the claims of victims "must proceed under our Health Care Liability Act and actually show some wrongful conduct before an award of money."
Under that health care law the amounts that victims can claim will be sharply limited under caps spelled out in the statute. And, as Tardio noted, victims' lawyers will also have to prove actual fault, a higher standard than required under the product liability statute.
Victims' lawyers had argued that the product liability law should apply because the company that produced the tainted steroid was declared bankrupt.
Zobel, however, concluded that the health care liability law alone applied.
The judge noted in her ruling that 153 Tennessee patients were sickened in the outbreak and 16 of them died. Those numbers, however, are based on data collected by the U.S. Centers for Disease Control and Prevention, which stopped collecting data in October of 2013.
After the CDC stopped counting federal criminal investigators found an additional 25 patients sickened, 12 of whom died. Because they did not provide a state by state breakdown of the new cases, it is not known if some or any of them were in Tennessee.
Barring a successful appeal Zobel's latest decision means any awards will be sharply limited.
However, the decision does not affect awards from a separate but related bankruptcy case under which a $200 million trust fund has been amassed. That fund will be shared by victims and a limited number of creditors of the New England Compounding Center, the defunct drug compounding firm blamed for the fatal outbreak.
Contact: wfrochejr999@gmail.com
Judge Dismisses Meningitis Product Liability Claims
By Walter F. Roche Jr.
In a major setback for victims and a victory for a Nashville clinic, a federal judge has thrown out millions of dollars in product liability claims sought by victims of a 2012 fatal fungal meningitis outbreak.
In a six-page ruling issued this week, U.S. District Judge Rya W. Zobel concluded that because of two conflicting Tennessee statutes, the product liability claims against a Nashville and two other Tennessee clinics will be dismissed.
Her ruling means victims will be limited to claims under the state's strict healthcare liability statute which caps the amount victims can claim.
The ruling comes in competing motions filed by attorneys for the clinics and the victims.
Named as defendant in the suit is the Saint Thomas Outpatient Neurosurgical Center.
The litigation is separate from a bankruptcy case which already has produced a $200 million trust fund which will go to victims of the outbreak and limited other creditors of the New England Compounding Center, the firm that produced fungus tainted steroids that caused the fatal outbreak.
Some 778 patients across the country were sickened in the outbreak and 76 of them died.
Ostensibly, Zobel wrote, both the state's health care and product liability laws could apply.
But, she concluded, a key word in the Tennessee health care liability law, the word "any," gave that law dominance.
"The Tennessee health care liability law encompasses all civil actions with some connection to the provision of health care services," the ruling states.
She added that under Tennessee law a statute that is more specific applies when there is a conflict.
"The Tennessee health care liability law takes precedence, rendering the Tennessee product liability law inapplicable," she concluded, adding that the claims "plainly relate to the provision of health care services."
Lawyers for the victims had argued that because of the wording of the Tennessee product liability law and the fact that NECC had been declared bankrupt, the Nashville clinic could be regarded as the seller of the defective product, the fungus tainted spinal steroid.
Zobel, however, concluded that the state's health care liability trumped the product liability law.
Contact: wfrochejr999@gmail.com
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