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Tom Lamb
Wilmington, NC, USA
Tom Lamb is an attorney, or lawyer, who represents patients and their families in drug injury lawsuits.
Interests: law, news, information, drugs, legal, medical, fda, pharmaceutical, medications, side-effects, drug-injury, drug-safety, regulatory
Recent Activity
Donna: The Pliva, Inc., et al. v. Mensing case was decided by the Supreme Court of the United States (SCOTUS) on June 23, 2011. Justice Clarence Thomas delivered the opinion of the Court, concluding that federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, state law claims. The bottom line is that the US Supreme Court ruled in favor of the generic drug company and against the injured patient such that at the present time any "failure to warn" lawsuit involving a generic drug would be dismissed based on this Mensing case ruling. Justice Sonia Sotomayor, in her dissent opinion, did well in pointing out the apparent absurdity of this new Supreme Court ruling about generic drug company lawsuits: "As a result of today’s decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug. The Court gets one thing right: this outcome 'makes little sense'." Certainly not fair to people like you, I agree; but it is the current legal situation in the US as regards genric drugs. Tom Lamb
1 reply
FDA Letters To AstraZeneca And Novo Nordisk Approve Addition Of Information About Increased Risk For Medullary Thyroid Carcinoma (MTC) (Posted by Tom Lamb at The diabetes drugs Bydureon (exenatide extended-release) for injectable suspension and Victoza (liraglutide [rDNA origin]) injection) were the subject of March 2015 FDA letters concerning the supplemental approval about labeling revisions. Each of these FDA letters, to AstraZeneca and to Novo Nordisk respectively, contain this paragraph: We also refer to our letter dated October 7, 2014, notifying you, under Section 505(o)(4) of the FDCA, of new safety information that we believe should be included in the labeling for long-acting GLP-1 receptor agonist products. This information pertains to the risk of medullary thyroid carcinoma. ___________________________________________________________________ Bydureon / Byetta / Januvia / Victoza Free Case Evaluation Strictly Confidential, No Obligation. ___________________________________________________________________________ In both AstraZeneca's Bydureon Prescribing Information and Novo Nordisk's Victoza Prescribing Information, the March 2015 label revisions concerning medullary thyroid carcinoma (MTC) can be seen in the so-called "Black Box" warning at the beginning of that document as well as at part 5.1 Risk of Thyroid C-cell Tumors in the Warnings and Precautions section. As you may know, these diabetes drugs, Bydureon and Victoza, are alleged to... Continue reading
Posted 5 days ago at Drug Injury Watch
Bayer Claims It Settled About 300 Of These Cases While Another 1300 Lawsuits Were Filed From Mid-October 2014 To The End Of January 2015 (Posted by Tom Lamb at For establishing a baseline as regards the current progress (or lack thereof) being made by Bayer to resolve the YAZ / Yasmin litigation which began back in 2009, from this article, "December 2014 YAZ / Yasmin Litigation Update: Still Over 2000 DVT And/Or PE Cases Not Settled According To Bayer's Most Recent Financial Report", we get these numbers: As of October 13, 2014, the number of claimants in the pending lawsuits and claims in the United States totaled about 4,000 (excluding claims already settled). As of October 13, 2014, Bayer had reached agreements, without admission of liability, to settle the claims of approximately 9,200 claimants in the U.S. for a total amount of about US$1.8 billion. Next, we go to the PRODUCT-RELATED LITIGATION part of Bayer's Annual Report 2014 (at pg. 311 of the PDF document): Yasmin™ / yaz™: As of January 31, 2015, the number of claimants in the pending lawsuits and claims in the United States totaled about 5,000 (excluding claims already settled). Claimants allege that they have... Continue reading
Posted Mar 16, 2015 at Drug Injury Watch
Quoted from U.S. FDA warns of seizure, alcohol risk with Pfizer's Chantix Mon Mar 9, 2015 (Reuters) - The U.S. Food and Drug Administration warned on Monday that Pfizer Inc's quit-smoking drug, Chantix, has been associated with seizures and that some patients who drink while taking the drug may become aggressive or black out. The agency said it approved an update to the drug's label in September but issued the public notice to ensure patients are aware of the changes "and can consider this new information when making prescribing decisions." Typically such warnings are made at the time of... Continue reading
These Two New AstraZeneca Diabetes Medications With Saxagliptin Are Part Of The Incretin Mimetic Class Of Drugs (Posted by Tom Lamb at At an April 14, 2015 meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee, results of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) trial for for AstraZeneca's relatively new diabetes drugs Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin HCI extended-release) will be discussed. For some background, one might want to read this article, "Possible Link Between Heart Failure And Onglyza Diabetes Type 2 Drug Is Being Investigated By FDA, As Announced In February 2014", which we posted about a year ago. From a March 2015 statement issued by AstraZeneca in connection with this upcoming Kombiglyze XR / Onglyza FDA Advisory Committee Meeting: The SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial of Onglyza (saxagliptin) was a randomised, double-blind, controlled trial evaluating the effect of saxagliptin on the incidence of major adverse cardiovascular events in patients with type 2 diabetes mellitus and at an elevated risk for CV events. The SAVOR study was conducted as part of the Postmarketing Requirement for the US New... Continue reading
Posted Mar 9, 2015 at Drug Injury Watch
Quoted from FDA limits use of testosterone drugs, warns of possible heart risk Tue Mar 3, 2015 (Reuters) - The U.S. Food and Drug Administration has asked makers of prescription testosterone therapies to change their labeling to clarify that their products are approved only for men with specific medical conditions and could increase the risk of heart attacks and strokes. Prescriptions for low testosterone, or "Low T" have soared over the past decade, driven by a surge in use by men facing falling testosterone levels as they age. The number of men being prescribed testosterone jumped more than 75... Continue reading
With New Jersey State Court Fosamax Lawsuits Now Assigned To Judge Mayer, We Hope These Cases Get Back On Track (Posted by Tom Lamb at In our last update, "December 2014 Fosamax - Femur Fracture Litigation Update: In The Fosamax Federal Court MDL There Are Dismissals, Appeals, And Court-Ordered Mediations", we only mentioned in passing the New Jersey state court Fosamax femur fracture litigation. Even though there is little new information about those cases, this is where we begin in our first Fosamax update for 2015. From Merck's Form 10-K Annual Report For the Fiscal Year Ended December 31, 2014 we get this information about the femur fracture aspect of the Fosamax products liability litigation (at pp. 110-111 of the PDF document): As of December 31, 2014, approximately 3,005 cases alleging Femur Fractures have been filed in New Jersey state court and are pending before Judge Jessica Mayer in Middlesex County. The parties selected an initial group of 30 cases to be reviewed through fact discovery. Two additional groups of 50 cases each to be reviewed through fact discovery were selected in November 2013 and March 2014, respectively. The current number of these Fosamax lawsuits means there were about... Continue reading
Posted Mar 2, 2015 at Drug Injury Watch
Thank you for your Comment. Please understand, however, that because I am not a physician but only an attorney I am not in a position to give any medical opinion as regards your situation. Perhaps some other qualified person could provide you with some medical guidance. I wish you the best in all aspects going forward. Tom Lamb
1 reply
Quoted from Johnson & Johnson loses first Risperdal jury trial Posted: Wednesday, February 25, 2015, 1:08 AM A Philadelphia jury said Tuesday that drugmaker Johnson & Johnson should pay $2.5 million to a 20-year-old autistic man from Alabama - who developed size 46 DD breasts as a young teenager - because the company failed to adequately warn of that potential side effect from his use of the antipsychotic drug Risperdal. This was the first case related to the condition called gynecomastia that went to a jury, but thousands more lawsuits are lined up in Philadelphia, California, Missouri, and other... Continue reading
Company Is Investigating This Gilenya - PML Case To See Whether Brain Disease Might Be A Side Effect Of Its MS Drug (Posted by Tom Lamb at Gilenya (fingolimod) capsules were approved by the FDA in 2010 and by Health Canada in 2011. We posted this article about Gilenya last week, on February 16, "Various Drug Safety Issues Continue To Be Associated With Novartis Multiple Sclerosis (MS) Medication Gilenya". In that article we looked at the cardiac-related risks associated with Gilenya. A few days later we saw this news report on the website for the Multiple Sclerosis Society of Canada, "Case of PML reported in patient treated with Gilenya®", and from from that article we get this more recent drug safety information: Pharmaceutical company Novartis has reported a case of PML (progressive multifocal leukoencephalopathy) in an individual who had received Gilenya® (fingolimod) for more than 4 years for the treatment of relapsing-remitting multiple sclerosis (RRMS). Novartis has informed the regulatory authorities of this case, and is investigating whether treatment with Gilenya® contributed to the development of PML.... This is the third case of PML observed for Gilenya®. The first case was reported in 2012, wherein Novartis had noted that... Continue reading
Posted Feb 23, 2015 at Drug Injury Watch
Quoted from Study Links Antibiotics to Digestive Complication in Infants HealthDay Feb. 16, 2015 By Tara Haelle HealthDay Reporter MONDAY, Feb. 16, 2015 (HealthDay News) -- Using certain antibiotics early in infancy may raise the risk of a serious gastrointestinal condition called pyloric stenosis, a new study indicates. Doctors have known that using the antibiotic erythromycin can increase the risk of pyloric stenosis in infants. The new findings confirmed that link, and also found that the antibiotic azithromycin (Zithromax) is associated with a higher risk of pyloric stenosis when given to infants under 6 weeks old. "Ingestion of oral... Continue reading
ISMP QuarterWatch Report From 2014 States Adverse Events Reports Show That Gilenya Cardiac Risks "were neither rare nor hypothetical" (Posted by Tom Lamb at The safety profile for the Novartis drug Gilenya (fingolimod) has been controversial for some time now, and the concerns about adverse reactions and side effects continue. As background, in August 2012 we posted this article, "Multiple Sclerosis (MS) Medication Gilenya: Timeline Of Actions Taken In US, Canada, And Europe". And over the past several years we have been monitoring news reports about Gilenya adverse reactions and suspected side effects at our Pharmaceutical Drug Litigations Updates site. Last fall, from the September 24, 2014 edition of the ISMP QuarterWatch publication, we received more data and information about the various safety risks associated with Gilenya. We start with this overview from "Update on Fingolimod (GILENYA)" in the Executive Summary section: ... three years of postmarket and new published data highlight four important safety risks of [Gilenya (fingolimod)].... Adverse event reports for the most recent 12 months showed the cardiac risks were neither rare nor hypothetical.... Also identified was a large group of cases (n = 348) indicating macular degeneration or less specific adverse effects on the eye.... Continue reading
Posted Feb 16, 2015 at Drug Injury Watch
Medical Researchers Find Increased Risk Of Heart Defects And Cleft Palates In Babies Born To Women Using Zofran (Posted by Tom Lamb at Women with severe morning sickness who were prescribed Zofran (ondansetron) -- a GlaxoSmithKline drug approved by FDA for the prevention of nausea and vomiting associated with chemotherapy and radiotherapy -- have had babies born with heart-related birth defects and other congenital malformations such as cleft palate and/or cleft lip. For some background facts regarding this emerging drug-safety issue we begin with a June 2014 investigative news report, "Birth defects blamed on unapproved morning sickness treatment", which was published by the Toronto Star newspaper. Here are three important points taken from that article: [#1] Because most women experience nausea and vomiting during the first trimester, they would be taking the drug at the same time the fetus is most vulnerable to developing malformations and deformities. Roughly 10 to 15 per cent of pregnant women receive drugs to treat morning sickness, according to a recent U.S. study. ********** [#2] In 2012, the U.S. Department of Justice reached a $3-billion settlement with GlaxoSmithKline after the government alleged the company promoted the off-label uses of several drugs, including Zofran, the... Continue reading
Posted Feb 9, 2015 at Drug Injury Watch
Researchers Surprised By Their Finding As Earlier Medical Studies Suggested Anticancer Effect In Prostate (Posted by Tom Lamb at Findings about increased cancer risks being associated with the use of erectile dysfunction (ED) drugs such as Viagra, Cialis, and Levitra are not new, as those relatively popular drugs and others had been associated with melanoma. For more about that drug side effect see our Viagra / Cialis / Levitra / Staxyn / Stendra / Revatio / Adcirca drug information page. The February 2015 edition of The Journal of Urology includes this article, "Use of Phosphodiesterase Type 5 Inhibitors May Adversely Impact Biochemical Recurrence after Radical Prostatectomy", which was published online back in September 2014. From the Abstract for this recent medical journal article about Viagra, Cialis, and Levitra: Purpose Experimental evidence suggests that phosphodiesterase type 5 inhibitors may suppress tumor growth, postpone metastasis and prolong survival, but clinical data are lacking. We studied the effect of phosphodiesterase type 5 inhibitors on biochemical recurrence after radical prostatectomy for prostate cancer. Conclusions Contrary to experimental data, the use of phosphodiesterase type 5 inhibitors after radical prostatectomy may adversely impact biochemical recurrence. Further studies are needed to validate our results. _____________________________________________________________________ Viagra... Continue reading
Posted Feb 2, 2015 at Drug Injury Watch
Thank you for your Comment. Please understand, however, that because I am not a physician but only an attorney I am not in a position to give any medical opinion as regards your daughter's situation. Perhaps others who read the inquiry concerning your daughter can respond with advice, guidance, insight, etc. I wish your daughter and you the best in all aspects going forward. Tom Lamb
1 reply
Quoted from Z-Pak linked to potential heart trouble Posted: Jan 27, 2015 7:40 AM EST By Kevyn Stewart, FOX 5 Medical Team At 55, Hector Diaz, the owner of Carroll County takeout restaurant Latituude 33 works some pretty long hours. He says he can't really afford to take time off. So - twice - when he had a sinus infection - Diaz says he took this popular antibiotic, known as Z-Pak, or Zithromax. "The peculiar thing was each time I took the medication, within 5 days. I had a heart attack," said Diaz. Diaz doesn't what caused his two... Continue reading
Updates Information About Extent Of Serious Developmental Disorders Such As Autism Spectrum Disorders (ASD) As Well As Congenital Malformations And Birth Defects Like Spina Bifida (Posted by Tom Lamb at Depakote, Depakote CP, and Depakote ER (divalproex sodium), Depacon (valproate sodium), and Depakene (valproic acid) are manufactured and sold by the drug company AbbVie Inc. (formerly Abbott). On January 22, 2015 the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) issued a Drug Safety Alert, "Medicines related to valproate: risk of abnormal pregnancy outcomes", which has to do with these drugs. The subtitle of this MHRA warning was plain and clear: Children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and/or congenital malformations (in approximately 10% of cases). From the "Risk of abnormal pregnancy outcomes" section of that MHRA January 2015 warning: Valproate is associated with a dose-dependent risk of abnormal pregnancy outcomes, whether taken alone or in combination with other medicines. Data suggest that when valproate is taken for epilepsy with other medicines, the risk of abnormal pregnancy outcomes is greater than when valproate is taken alone. The risk of congenital malformations is approximately 10% while... Continue reading
Posted Jan 26, 2015 at Drug Injury Watch
Quoted from Former FDA Commissioner David Kessler might testify against J&J in Philly case David Sell Posted: Monday, January 26, 2015, 8:39 AM Former Food and Drug Administration Commissioner Dr. David Kessler might testify for the plaintiff in coming days in a lawsuit against drugmaker Johnson & Johnson that is being heard in Philadelphia Court of Common Pleas. Contrary to several media reports, this is not the first trial of a case involving the antipsychotic drug Risperdal, which was approved more than a decade ago for schizophrenia. J&J has been accused of promoting the drug for unapproved uses in... Continue reading
Health Canada Currently Conducting Epidemiological Study Of These Incretin-Based Type 2 Diabetes Medications To Assess This Potential Drug Safety Issue (Posted by Tom Lamb at From the October 2014 edition of the Canadian Adverse Reaction Newsletter we get this drug safety review of the diabetes drugs Bydureon, Byetta, Januvia, And Victoza, "Incretin-based therapies and the risk of pancreatic cancer". From that relatively recent Health Canada article we get this information: Non-clinical studies have suggested that incretin-based therapies can lead to increased pancreatic cell proliferation. These findings, along with international reports of pancreatic cancer in patients using incretin-based therapies, raised concerns over the potential risk of developing pancreatic cancer with the use of these drugs. Pancreatic cancer is the fourth leading cause of cancer death in Canada with a 5 year relative survival ratio of 8%. Risk factors for pancreatic cancer include, but are not limited to, smoking, obesity, a family history of pancreatic cancer, chronic pancreatitis and diabetes. In 2013, Health Canada informed health care professionals that cases of pancreatic cancer had been reported internationally with the use of exenatide; no Canadian cases were reported at the time. As of July 31, 2014, Health Canada received 13 reports of... Continue reading
Posted Jan 19, 2015 at Drug Injury Watch
Researchers Found An Almost 10-Times Increased Risk Of Severe Intestinal Malabsorption Associated With Benicar After 2-Years Use Compared To Some Other Blood Pressure Medications (Posted by Tom Lamb at We continue to hear about patients who have been diagnosed with sprue-like enteropathy or intestinal malabsorption while using Benicar, Azor, Tribenzor, or Benicar HCT, and we have written previously about the still-emerging Benicar drug injury litigation. In May 2014 the medical journal Gastroenterology published an article, "Severe Malabsorption Associated With Olmesartan: A French Nationwide Cohort Study", which provides some insight concerning the association between Benicar and a side effect that is often initially mistaken for celiac disease. From the Abstract for this medical journal article about that French Benicar study: Introduction: Several cases of severe sprue-like enteropathy have been reported in patients treated with [Benicar (Olmesartan medoxomil)], an angiotensin II receptor blocker (ARB) approved for the treatment of hypertension. The association has been questioned: in the ROADMAP phase 3-trial, the rate of diarrhea was similar in patients who received [Benicar (olmesartan)] and placebo. The objective of this study was to assess in a large, nation-wide patient cohort, the risk of severe intestinal malabsorption associated with [Benicar (olmesartan)], compared with ARBs... Continue reading
Posted Jan 12, 2015 at Drug Injury Watch
Crystal: Thank you for sharing your experience with us. It seems many patients who get started on Eliquis do not receive all the information they may really need in order to make an informed (and safe) decision whether to use this new drug. Tom Lamb
1 reply
Erectile Dysfunction (ED) Drugs And Pulmonary Arterial Hypertension (PAH) Medications May Cause Increased Rate Of Melanoma Metastasis (Posted by Tom Lamb at To start, we get our background facts and some commentary from "Hard Times for Oncogenic BRAF-Expressing Melanoma Cells", a Preview piece in the January 2011 edition of the Cancer Cell medical journal. [Malignant cutaneous melanoma] progression occurs in around 20% of cases to an aggressive, metastasizing form of the disease with extremely poor patient survival rates Nearly half of all melanomas carry an activating mutation in BRAF Recently, Marais and colleagues (Arozarena et al., 2011) have provided an extremely exciting and novel insight into the critical issue of melanoma cell invasiveness, discovering that it can be elicited by the downregulation of PDE5A Active-site directed selective inhibitors of this enzyme are used acutely for the treatment of penile erectile dysfunction (PED) and infantile hypertension This elegant study thus provides an important insight into the mechanism whereby oncogenic B-RAF promotes invasiveness in melanoma cells through a mechanism that pivotally involves PDE5A downregulation and elevation of cGMP levels The study by Marais and colleagues mentioned in those third and fifth points, above, is the subject of this article, "Oncogenic BRAF... Continue reading
Posted Jan 5, 2015 at Drug Injury Watch
While European Drug Regulators Have Been Concerned About This Aspect Of Xolair Safety, FDA Has No Warning About Arteriothrombotic Risks Of Xolair (Posted by Tom Lamb at In September 2014 the FDA issued an update about its safety review of the Genentech asthma medication Xolair (omalizumab), which we reported about in this earlier post, "Xolair Asthma Drug Associated With Higher Rate Of Heart Attacks, Pulmonary Hypertension, Blood Clots Causing PEs And/Or DVTs, And Brain Blood Vessel Problems". From the Data Summary of that September 26, 2014 FDA Drug Safety Communication: The manufacturer of Xolair, Genentech, initiated the postmarketing commitment study titled An Epidemiologic Study of Xolair (omalizumab): Evaluating Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS) in June 2004 to assess the long-term safety of Xolair A higher incidence rate per 1,000 patient years of overall cardiovascular and cerebrovascular serious adverse events was observed in Xolair-treated patients compared to non-Xolair-treated patients, as well as for myocardial infarction, unstable angina, transient ischemic attack, pulmonary embolism/venous thrombosis, and pulmonary hypertension. No increases in the rates of ischemic stroke or cardiovascular death were observed in patients treated with Xolair compared to non-Xolair-treated patients. In this post we... Continue reading
Posted Dec 26, 2014 at Drug Injury Watch
Advertisements As Well As Prescribing Information / Drug Label Seem To Downplay The Fact That There Is No Reversal Agent For Eliquis, Yet (Posted by Tom Lamb at In print advertisements for their relatively new blood thinner medicine Eliquis, Bristol-Myers Squibb and Pfizer state in the Important Safety Information section ("August 2014" version): ELIQUIS can cause bleeding, which can be serious, and rarely may lead to death. But at the very start of these print ads, in larger print, is this point -- #2 of "3 GOOD REASONS": ELIQUIS has less major bleeding than warfarin. If one delves further into the Eliquis advertisements you may see in popular magazines, you will find this: While taking ELIQUIS... it may take longer than usual for any bleeding to stop. What you will not see, however, is any statement to the effect that there is no reversal agent to stop a serious bleeding event that may happen while a patient is on Eliquis. That is, Bristol-Myers Squibb and Pfizer do not state in these advertisements that there is no FDA-approved antidote for Eliquis as regards its blood-thinner effect at this time. Put simply, there seems to be a failure to warn patients... Continue reading
Posted Dec 20, 2014 at Drug Injury Watch
And New Blood Clot Side Effect Lawsuits, Including Some Involving The Lesser-Known Safyral And Beyaz DRSP Pills, Are Still Being Filed Against Bayer (Posted by Tom Lamb at Bayer's latest update on the ongoing litigation concerning its drospirenone (DRSP) birth control pills -- Yasmin, YAZ, Safyral, and Beyaz -- as set forth in its Stockholders' Newsletter Financial Report as of September 30, 2014, published on October 30, 2014, is as follows: Yasmin™ / YAZ™: As of October 13, 2014, the number of claimants in the pending lawsuits and claims in the United States totaled about 4,000 (excluding claims already settled). Claimants allege that they have suffered personal injuries, some of them fatal, from the use of Bayer’s drospirenone-containing oral contraceptive products such as Yasmin™ and / or YAZ™ or from the use of Ocella™ and / or Gianvi™, generic versions of Yasmin™ and YAZ™, respectively, marketed by Barr Laboratories, Inc. in the United States. As of October 13, 2014, Bayer had reached agreements, without admission of liability, to settle the claims of approximately 9,200 claimants in the U.S. for a total amount of about US$1.8 billion. Bayer has only been settling claims in the U.S. for venous clot injuries... Continue reading
Posted Dec 12, 2014 at Drug Injury Watch