Mattioli & Munley are partners with the Law Firm of Minora, Minora, Colbassani, Krowiak, Mattioli & Munley.

Pharmaceutical Drugs

Pharmaceuticals can have serious side effects.

It is often all too easy to take a prescription without giving it a second thought or thoroughly reading all of the literature that may accompany it. It is important, however, to educate yourself on what goes into your body and the risks that you may be assuming along with it. Many of the drugs listed below can have serious, if not fatal, side effects. If you or a loved one was prescribed something harmful, or was given a defective drug, there may be action you can take.

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Accutane

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Albuterol

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Celexa

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Darvocet

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Gardasil

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Nexium

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Seroquel

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Acetaminophen

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Ativan

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Chantix

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Duract

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Lexapro

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Nuvaring

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Wellbutrin

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Actavis

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Avandia

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Cipro

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Ephedra

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Lipitor

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Oxycontin

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Yaz/Yasmin

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Actos

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Botox

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Crestor

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Fen phen

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Meridia

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Prozac

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Zyprexa

Pharmaceutical Drug News

Montana Parents Say Zofran Caused Cleft Palate & Lip

Over the first months of 2015, at least seven families have filed lawsuits against GlaxoSmithKline, alleging that the company’s anti-nausea drug Zofran causes major birth defects. The fifth claim, filed by parents from Montana in the United States District Court of Montana, is notable for naming cleft lip and cleft palate as the birth defects allegedly caused by Zofran. In 2012, medical researchers and public health officials at Harvard and Boston Universityfound that women prescribed Zofran’s active ingredient during the first trimester were more than twice as likely to have babies with a cleft palate. Family In Montana Claims Zofran Caused Daughter’s Cleft Palate & Lip Filed under case number 1:15-cv-00026-SPW-CSO, the family’s complaint makes a number of serious allegations against Zofran’s manufacturer, international pharmaceutical giant GlaxoSmithKline. The lawsuit was filed on April 3, 2015. Plaintiffs allege that their daughter, named as M.M. in court documents, was born with a cleft lip and palate, and claim that these birth defects were caused by prenatal exposure to Zofran. The parents say that their daughter, who is now sixteen, has been forced to undergo 10 separate surgical procedures “to try and correct her cleft lip and palate.” They claim that the birth defect with which she was born “impairs her development” and hinders her ability to enjoy a normal life. PLAINTIFFS SAY GLAXOSMITHKLINE UNLAWFULLY PROMOTED ZOFRAN FOR USE DURING PREGNANCY The US Food & Drug Administration has approved Zofran, a potent anti-nausea drug, for the treatment of patients suffering from severe nausea and vomiting during the course of cancer treatments, like chemotherapy and radiotherapy. And while Zofran’s approval was eventually extended to cover post-operative... read more

Massive Fraud In Merck MMR Vaccine Testing

Merck’s Measles-Mumps-Rubella (MMR) vaccine is under fire following allegations of wrongdoing from several parties, namely two former Merck scientists-turned-whistleblowers. A third whistleblower is a senior scientist at the Centers for Disease Control (CDC), who has confessed to misconduct involving the same MMR vaccine. A U.S. judge rejected Merck’s attempt at a dismissal after determining there was plausible grounds for the claims. Therefore the medical giant is being forced to defend themselves and their vaccine in at least two federal cases. Merck could also be forced to defend itself in Congress. Representative Bill Posey (R-FL) – a known critic of the CDC whom is investigating the link between autism and vaccines – is reviewing hundreds of documents turned over by the CDC whistleblower. According to the whistleblowers’ court documents, Merck’s misconduct was far-ranging: It “failed to disclose that its mumps vaccine was not as effective as Merck represented, (ii) used improper testing techniques, (iii) manipulated testing methodology, (iv) abandoned undesirable test results, (v) falsified test data, (vi) failed to adequately investigate and report the diminished efficacy of its mumps vaccine, (vii) falsely verified that each manufacturing lot of mumps vaccine would be as effective as identified in the labeling, (viii) falsely certified the accuracy of applications filed with the FDA, (ix) falsely certified compliance with the terms of the CDC purchase contract, (x) engaged in the fraud and concealment describe herein for the purpose of illegally monopolizing the U.S. market for mumps vaccine, (xi) mislabeled, misbranded, and falsely certified its mumps vaccine, and (xii) engaged in the other acts described herein to conceal the diminished efficacy of the vaccine the government... read more

FDA’s Faster Prescription Drug Approval Process Leads to Safety Issues

FDA’s Faster Drug Approval Process Linked to Safety Issues In 1992, the FDA sped up its drug approval process with the passage of the Prescription Drug User Free Act (PDUFA).  Overall, the PDUFA allowed the FDA to collect large fees from prescription drug companies to fund the drug approval process.  In return for these “user fees”, the FDA must meet a certain set of benchmarks during the approval process; particularly, the speed at which a drug is approved.  The primary argument was that prior to the imposition of “user fees”, the FDA could not approve drugs for distribution oon the market in a timely manner, leading to dissatisfaction among consumers, prescription drug manufacturers, and the FDA.  However, since that time, the number of “black box warnings” and drug withdrawals have increased, according to recent research conducted by scientists from the Cambridge Health Alliance in Massachusetts. Scientists Look at Hundreds of Drugs Approved During Thirty Year Stretch The researchers looked at 748 drugs approved between 1975 and 2009.  They compared the safety issues of drugs approved prior to PDUFA in 1992 and those approved after and found distinctive differences.  Specifically, of the drugs approved after PDUFA, 114 or 15.2% received a black box warning and 32 or 4.3% were withdrawn from the market altogether for serious safety reasons.  Overall, a total of 208 drugs either received a black box warning or were withdrawn from the market; half of the warnings were issued within 12 years of PDUFA and half of the withdrawals occurred within 5 years of PDUFA.  The rate of black box warnings or withdrawals also climbed from 21.2 per 100 boxes to 26.7 per 100 after PDUFA. FDA Issues... read more

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