Drug Injury Watch

Stevens-Johnson Syndrome And Toxic Epidermal Necrolysis Are Serious Drug-Induced Skin Reactions

SJS And TEN Differ In The Extent Of Skin Detachment, But Both Are Severe And Life-Threatening Drug Side Effects

(Posted by Tom Lamb at DrugInjuryWatch.com)

Stevens-Johnson syndrome (SJS) was first described in 1922, and toxic epidermal necrolysis (TEN) was first described in 1956.

SJS and TEN -- which, in essence, are different only by the extent of skin detachment -- have been increasingly recognized as rare (affecting approximately 1 or 2 people per 1,000,000 annually) but severe and life-threatening drug side effects.  The average reported mortality rate for patients with SJS is 1% to 5%, and for TEN it is 25% to 35%.

We have written some previous articles about Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

A new article about these serious drug-induced skin reactions was published in the December 2010 edition of Orphanet Journal of Rare Diseases.  This very thorough medical journal article includes a wide-ranging discussion of TEN and SJS -- going from "Clinical Features" to "Etiology and pathogenesis" to "Diagnosis and diagnostic methods" to "Management and Therapy" -- and concludes with 112 references.

From the Asbtract for this article, "Toxic epidermal necrolysis and Stevens-Johnson syndrome", we get these fundamenatal facts:

• [TEN and SJS] are characterized by mucocutaneous tenderness and typically hemorrhagic erosions, erythema and more or less severe epidermal detachment presenting as blisters and areas of denuded skin.
• Diagnosis relies mainly on clinical signs together with the histological analysis of a skin biopsy showing typical full-thickness epidermal necrolysis due to extensive keratinocyte apoptosis. Differential diagnosis includes linear IgA dermatosis and paraneoplastic pemphigus, pemphigus vulgaris and bullous pemphigoid, acute generalized exanthematous pustulosis (AGEP), disseminated fixed bullous drug eruption and staphyloccocal scalded skin syndrome (SSSS).
• Several drugs are at "high" risk of inducing TEN/SJS including: Allopurinol, Trimethoprim-sulfamethoxazole and other sulfonamide-antibiotics, aminopenicillins, cephalosporins, quinolones, carbamazepine, phenytoin, phenobarbital and NSAID's of the oxicam-type.

The full-text (PDF) version of "Toxic epidermal necrolysis and Stevens-Johnson syndrome" is available for free online for those interested in learning more about TEN and SJS, two rare but potentially fatal drug adverse reactions.

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NuvaRing Update: First Trial Dates In MDL And New Jersey Mass Tort Litigation Not Until 2012, Now

Discovery Deadlines And Expert Witness Deposition Dates Are Extended To Allow Time For Additional Document Review

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: First NuvaRing Lawsuit Trials Against Merck Are Currently Scheduled To Start In May 2013 (New Jersey State Court NuvaRing Mass Tort Consolidation) And July 2013 (Federal Court NuvaRing MDL)

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We learned in April 2010 from U.S. District Judge Rodney W. Sippel, who is presiding over the NuvaRing federal court MDL, that the trial for the first of several bellwether, or test, cases in the NuvaRing MDL was scheduled to start in June 2011.

Now, due to some recent changes to the respective discovery schedules, it appears that the first trials in the federal court NuvaRing MDL litigation, as well as the New Jersey state court "mass tort" consolidation, will not begin until the spring or summer of 2012.

As for the MDL, back in mid-September 2010 Judge Sippel issued an Order extending the discovery schedule for the federal court NuvaRing bellwether case trials.  The new cut-off date for all fact discovery, now, is June 24, 2011 -- meaning it has been pushed back about six months from the initial date. The final deadline for the completion of all expert witness depositions is now set for February 20, 2012.

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Moving to the New Jersey NuvaRing litigation, on October 6, 2010 Judge Brian R. Martinotti issued NuvaRing Case Management Order (CMO) #8, which had attached to a Rider which showed the changes made "to coordinate the NJ matter with the MDL matter":

• All fact discovery shall be completed by June 24, 2011.
• Plaintiffs' experts shall be named and reports shall be served by July 25, 2011.
• Depositions of Plaintiffs' experts shall be completed by October 3, 2011.
• Defendants' experts shall be named and reports shall be served by October 31, 2011.
• Depositions of Defendants' experts shall be completed by January 16, 2012.

While no trial date has yet been scheduled for the first NuvaRing bellwether case in the federal court MDL nor the NJ mass tort litigation, given the changes above, it is expected that the first NuvaRing trials will start sometime in the middle part of 2012.

The reason for this delay, in part, is that the Plaintiffs' lawyers need additional time to review some drug company documents that have only recently been made fully available to them, following a discovery dispute ruling by the Court.

As soon as we learn the scheduled dates for the first NuvaRing trials in the MDL and in New Jersey, we will let you know.

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Prempro Litigation Report: Here Is A Tale of Two Very Different Recent Case Outcomes

As Of December 2010 The Fourteen Jury Verdicts Are Evenly Split Between Defendant Pfizer And Plaintiffs

(Posted by Tom Lamb at DrugInjuryWatch.com)

We will start with the more recent case, Torkie-Tork v. Wyeth, 04-cv-945, U.S. District Court for the Eastern District of Virginia (Alexandria).

As indicated by the title of this December 3, 2010 Bloomberg article, "Pfizer Properly Warned About Prempro Risks, Jury Finds", the outcome was a defense verdict, and a quick one at that:

Jurors in federal court in Alexandria, Virginia, deliberated about four hours over two days before finding that Georgia Torkie-Tork couldn’t show that Wyeth officials downplayed the breast-cancer risks associated with Prempro, a hormone-replacement drug.

One of the arguments asserted by Pfizer's lawyers suggests that this case outcome may be "unique" as opposed to any type of barometer for this ongoing Prempro litigation:

Pfizer’s lawyers argued that Torkie-Tork couldn’t prove she and her doctors received inadequate warnings about Prempro’s cancer risks because she couldn’t show which of her doctors prescribed the menopause drug.

Evidence in the case showed that some of her physicians destroyed their records as part of normal business practices and couldn’t remember prescribing the drug for the woman.

Now let's move out west, where the Nevada Supreme Court issued a ruling in late Novemeber 2010 which produced this attention-getting headline, "Pfizer Loses Appeal of $58 Million Prempro Jury Award", on a November 24 Bloomberg article.

The underlying case was Rowatt v. Wyeth Pharmaceuticals Inc., 04-01699, Second Judicial District Court, State of Nevada, Washoe County (Reno), which involved the claims of three women who alleged that Premarin and Prempro caused their breast cancer and that Pfizer failed to properly warn doctors about this serious side effect.

From the November 24 Bloomberg article:

Pfizer Inc. doesn’t deserve a new trial in a Nevada case over the company’s menopause drugs and must pay a $57.6 million jury award to three women who alleged the pills caused their cancers, the state’s highest court ruled.

The Nevada Supreme Court concluded today that jurors properly held Pfizer’s Wyeth unit responsible for hiding the breast-cancer risks of its Premarin and Prempro menopause drugs. The original award totaled $134.1 million in damages to Arlene Rowatt, Jeraldine Scofield and Pamela Forrester. The verdict later was reduced to $57.6 million by the trial judge.

The awards “are supported by substantial evidence” and are “reasonable and proportionate” to Wyeth’s actions, the justices decided.

So there you have it, a Nevada jury decides that the drug company's conduct as concerns Premarin and Prempro warranted a $134 million verdict, which was reduced to $58 million -- and the Nevada Supreme Court agrees -- while a Virginia jury hands back a defense verdict after deliberating for just four hours.

We will continue to watch this Prempro litigation to see which way it is truly headed.

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Use Of Avastin Or Sutent And I.V. Bisphosphonates May Increase Osteonecrosis Of Jaw (ONJ) Risk

MHRA Warns UK Doctors To Monitor Cancer Patients For ONJ Where There Is Concomitant Use Of These Drugs

(Posted by Tom Lamb at DrugInjuryWatch.com)

On November 30, 2010 the Medicines and Healthcare products Regulatory Agency (MHRA) issued two new safety warnings to doctors and other healthcare providers in the UK concerning the cancer drugs Avastin and Sutent.

The first item, "Avastin (bevacizumab) Cases of osteonecrosis of the jaw in patients with cancer treated with bevacizumab and concomitant or previous use of bisphosphonates", simply identified the nature of this emerging drug safety issue:

Cases of osteonecrosis of the jaw (ONJ) have been reported in cancer patients in association with Avastin treatment, the majority of whom had received prior or concomitant treatment with i.v. bisphosphonates.

Avastin treatment may be an additional risk factor for the development of osteonecrosis of the jaw....

Avastin is from the drug company Roche.

The second item, "Sutent (sunitinib) Cases of osteonecrosis of the jaw in patients with cancer treated with sunitinib and concomitant or previous use of bisphosphonates", included a so-called "Dear Doctor" letter from Pfizer with some more information about the extent of this problem, at least as it regards Sutent:

From 26 January 2006 (International Birth Date [IBD]) through 31 January 2010, the worldwide estimated exposure to Sutent is 101400 including post-marketing and clinical trials worldwide.

Overall, a total of 27 cases of ONJ have been reported as of 31 January 2010....

We will watch to see whether there is a similar drug safety warning about Avastin and/or Sutent forthcoming from the FDA as well as whether any Dear Doctor letters are sent out in the U.S. by Roche or Pfizer.

P.S.  "Bevacizumab [Avastin] and sunitinib [Sutent]: risk of osteonecrosis of the jaw"  (January 2011, MHRA's Drug Safety Update newsletter)

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