Heparin Litigation
Transcript of Heparin Litigation
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HEPARIN LITIGATION
Melanie S. Bailey
Burg Simpson Eldredge Hersh &Jardine, P.C.
Cincinnati, Ohio
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What is heparin?
Heparin is one of a class of medicationscalled anticoagulants that are commonlyreferred to as blood thinners.
Heparin makes an anti-clotting protein inyour body work better, thus decreasing theclotting ability of the blood.
Heparin is made from pig intestines.
Has been marketed in the United Statessince the 1930s.
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General uses of heparin
Prophylaxis purposes to prevent bloodclots.
Coronary artery bypass surgery.
Kidney dialysis to prevent clotting indialysis lines and prevent blood clots when
blood returned to body.
Medically coated stents, catheters, etc.
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Heparin Administration
Heparin is a liquid solution.
Intravenous injections; i.e. bolusdose.
Injection subcutaneously under theskin; usually abdomen.
Intravenous drip; usually mixed withanother solution such as dextrosesodium.
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Baxter Heparin
Baxter Heparin Single Dose and Multi-Dose vials
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Dennis Quaid case
Overdose of heparin, led to extensivebleeding in infant twins.
Received 10,000 u/mL of heparin insteadof 10 u/mL of heparin lock flush.
Inadequate labeling of heparin vialssimilar labeling with blue background.
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Dennis Quaid Case
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Dennis Quaid Testimony
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Dennis Quaid Case
Three premature infants at an IndianaHospital died as a result of an accidentaloverdose of heparin.
In December 2007, Baxter changed thelabeling for its heparin products. Thelabel features an increase of 20 percent
font size, a unique color combination, anda large red cautionary tear-off label.
Baxter press release, Dec. 3, 2007
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Heparin Manufacturing
Pig farmers / slaughter houses use pigintestines to obtain the crude heparin.
Crude heparin is processed to removeimpurities and results in the activepharmaceutical ingredient (API).
API is then used in the final production ofheparin sodium drug.
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Chinese Heparin
Workshop/Slaughterhouse.
NY Times photo
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Chinese Heparin
Consolidators
NY Times photo
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Heparin Contamination Crisis
Scientific Protein Laboratorieslocated inWisconsinmanufactured & distributedheparin API.
In 1999, SPL entered into joint venturewith Changzhou SPL in China to operate aheparin API manufacturing facility in China
Why China?
Pigs are abundant and labor is cheap
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Heparin Contamination
Heparin API from Changzhou SPL in Chinais shipped back to SPL in Wisconsin.
SPL distributes heparin API to variousmanufacturers of heparin sodium,including Baxter.
Baxter uses heparin API in their finishedheparin sodium vials and sells to endusers.
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Heparin Contamination
February 6, 2004, Baxter submitted NDAPrior Approval Supplement to haveChangzhou SPL approved as its supplier of
API for its heparin.
June 8, 2004, Baxter received letter fromFDA that Changzhou SPL is approved as
alternate supplier.
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Heparin Supply Chain
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Heparin Contamination Crisis
In 2007, Baxter was one of the largestproducers of heparin in the United Statesand owned 50% of the marketplace.
In 2007, Baxter sold an estimated 35million units of Heparin per year, withannual sales of ~ $30 million.
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Heparin Contamination Crisis
In November 2007, pediatric dialysisfacility in Missouri identified allergic typereactions during dialysis.
Late December 2007, Baxter received firstadverse event reports associated with useof heparin multi-dose vial products.
January 7, 2008, CDC was notified ofallergic type reactions by Missouri Deptof Health.
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Heparin Contamination Crisis
January 2008, CDC investigated allergictype reactions occurring at dialysis centersand concludes that it may be a result of
heparin. January 9, 2008, CDC notified FDA of
association between allergic type reactionsand heparin.
January 9, 2008, Baxter placed a hold ontheir heparin inventory.
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Heparin Contamination Crisis
January 17, 2008, Baxter issued a recall ofnine lots of its multi-dose heparin vials.
February 2008, Baxter continued receivingreports of adverse reactions to its heparinproducts.
February 29, 2008, Baxter recalled all ofits heparin single dose, multi-dose andheparin flush products.
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Heparin Contamination Crisis
March 19, 2008, FDA identified the heparincontaminate as oversulfated chondroitin sulfate(OSCS).
OSCS: a heparin-like product derived from animalcartilage
FDA determined that OSCS originated from thesource product that came from China.
Levels of OSCS contaminate in Baxter and SPLsheparin ranged from 3% - 30%.
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Heparin Contamination Crisis
In January 2008, FDA learned that it hadmistakenly approved the use of theChangzhou China plant for the
manufacturing of heparin API. FDA never inspected the Changzhou plant.
FDA staff entering information in adatabase confused the name of theChangzhou plant with another plant thathad previously been inspected.
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Heparin Contamination Crisis
Baxter heparin distributed in marketplace fromSept 19, 2008Feb. 29, 2008 (recall).
Recall was not immediate.
Several weeks for Baxter to send out recallnotices to all customers; i.e., hospital, doctors,dialysis clinics, pharmacies, etc.
Concern about shortage of heparin supply.
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Heparin Contamination Crisis
CDC epidemiology study published in NEJM Dec.2008.
Looked at adverse events from 21 dialysis
facilities in 11 different states Conclusion: strongest association with the
adverse reactions was Baxter heparin
Conclusion: no safe level of OSCS contaminate
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Heparin Contamination Crisis
Adverse Reactions Hypotension
Facial edema
Loss of consciousness Sensation of burning, warmth, or flushing
Numbness or tingling
Difficulty swallowing
Shortness of breath, audible wheezing, chesttightness
Tachycardia
Nausea, vomiting, diarrhea
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Heparin Contamination Crisis
McMahon, Pharmacoepidemiology and Drug Safety (2010)
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Heparin CNN Video
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Heparin Litigation
February 14, 2008first lawsuit was filedin N.D. Ohio
May 29, 2008argument at MDL Panel
June 6, 2008cases consolidated andsent to Judge Carr in N.D. Ohio.
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Heparin Litigation
First bellwether case was scheduled to goto trial in March 2011; postponed.
Daubert hearing April 19 & 20, 2011
Daubert opinion issued by Court July 21,2011.
Cases limited to those with symptomsoccurring within 60 minutes of administrationof contaminated heparin; HIT; excessivebleeding/clotting cases
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Heparin Litigation
Problems: Pre-existing medical condition of Plaintiffs
No previous science on OSCS
Product identification Hospitals dont keep track of manufacturer of
heparin or lot numbers of heparin given to patients
Subpoenas to hospitals.
Best evidenceplaintiff was in hospital thatreceived Baxter heparin during contaminationperiod and suffered injuries consistent withcontamination.
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Heparin Contamination
Baxter has never been approved by theFDA to sell heparin since thecontamination.
FDA has never been able to identify whowas responsible for the contamination orwhether it was intentional.
FDA has implemented new testingstandards for heparin to specifically testfor OSCS.
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Heparin Contamination
As of June 2011, the U.S. House Energy andCommerce Committee is still investigating thecontamination incident.
July 2011FDA published Pathway to GlobalProduct Safety and Quality. FDA does not nor will ithave the resources to
adequately keep pace with the pressures ofglobalization.
FDA is developing international plans and operatingmodels in order to provide safety and qualityassurance.
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Heparin Contamination
Sept 14, 2011 Senate hearingsDeborahAutor, Deputy Commissioner for GlobalRegulatory Operations and Policy at FDA
40% of drugs Americans take are madeelsewhere.
80% of API used in drugs manufactured in UScome from outside the U.S. - from more than
150 countries; many with less sophisticatedmanufacturing and regulatory systems thatU.S.
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60 minutes video
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