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Tom Lamb
Wilmington, NC, USA
Tom Lamb is a lawyer who represents patients and their family in drug injury lawsuits.
Interests: law, news, information, drugs, legal, medical, fda, pharmaceutical, medications, side-effects, drug-injury, drug-safety, regulatory
Recent Activity
Thank you for leaving this Comment. My law firm cannot help you with this matter, as we are not handling Effient drug injury cases. I suggest you contact another law firm at this time. I wish you the best in all aspects going forward. Tom Lamb
1 reply
Thank you for leaving this Comment. My law firm cannot help you with this matter, as we are not handling metformin drug injury cases. I suggest you contact another law firm at this time. I wish you the best in all aspects going forward. Tom Lamb
1 reply
More Medical Studies Reach Different Conclusions About Whether New Hepatitis C Virus Medications Might Cause The Return Of Liver Cancer (Posted by Tom Lamb at DrugInjuryWatch.com) We continue to hear reports of patients who used Harvoni or Sovaldi for to cure their hepatitis C only to afterwards have the return of their earlier liver cancer, which had been in remission before their "Hep-C" was treated by one of these so-called "direct-acting antiviral" (DAA) drugs. As background, we first wrote about this still-emerging drug safety issue about a year ago, in April 2016, when we posted this article, "European Drug Regulators Consider Whether Harvoni, Sovaldi, And Other New "Hep-C" Drugs May Cause Liver Cancer Return, Hepatitis B Reactivation". More recently, in January 2017, we posted this article, "Is Liver Cancer Associated With Harvoni, Sovaldi, And Other Direct-Acting Antiviral Medications For Hepatitis C?" Earlier today we found an April 25, 2017 news report, "The Link Between Direct-Acting Antiviral Therapy for Hepatitis C Virus and Liver Cancer Risk Continues To Be Debated", which was published on the PracticeUpdate website (free registration required). This recent report draws upon eight new medical studies which were presented at the International Liver Congress 2017, from April 19... Continue reading
Posted 2 days ago at Drug Injury Watch
I am saddened to hear about the loss of your father. 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 father's situation. I wish you and your family the best in all aspects going forward. Tom Lamb
1 reply
Several theories on how a rare cancer develops from breast implants have arisen. Though rare, this disease severely affects the women diagnosed with it. Continue reading
Posted Apr 20, 2017 at Drug Safety Developments
Focus On Medical Journal Articles About The Diagnosis And Treatment Of This Breast Implants Lymphoma Cancer Published In 2015 (Posted by Tom Lamb at DrugInjuryWatch.com) In January 2011 the U.S. Food and Drug Administration (FDA) first announced a possible association between breast implants and anaplastic large cell lymphoma (ALCL), which was likened to systemic ALCL and treated accordingly. See "Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses". Over the next couple of years there were some, but not many, medical journal articles reporting on findings about breast implant-associated ALCL (BIA-ALCL) having to do with diagnosis and treatment of this rare form of lymphoma. For example, from the September 2013 edition of Current Hematologic Malignancy Reports, there was this article, "Breast implant-associated anaplastic large cell lymphoma: a systematic review of the literature and mini-meta analysis": Breast implant-associated ALCL (BIA-ALCL) is a rare, but likely under-reported entity, which most commonly presents with an effusion developing between the breast implant and the host fibrous capsule that surrounds it. It has been described in association with breast implants used for post-cancer reconstructive surgery and when implanted for purely cosmetic reasons. Two different presentations are seen; presentation with... Continue reading
Posted Apr 20, 2017 at Drug Injury Watch
A recent study showing a possible link between beta-blocker drug use in pregnant mothers & increased risk of fetal congenital heart defects is questioned. Continue reading
Posted Apr 19, 2017 at Drug Safety Developments
An Observational Study Compared Myocardial Infarction / Heart Attack Risks As Between The Use Of Newer Blood Thinners And The Use Of Warfarin (Posted by Tom Lamb at DrugInjuryWatch.com) In the US, there are currently four direct-acting oral anticoagulants (DOACs), a relatively new class of blood thinners, approved for the prevention of stroke in patients with atrial fibrillation (AF): Pradaxa (dabigatran) -- approved by FDA in 2010 -- Boehringer Ingelheim Pharmaceuticals Xarelto (rivaroxaban) -- approved by FDA in 2011 -- Janssen Pharmaceuticals Eliquis (apixaban) -- approved by FDA in 2012 -- Pfizer and Bristol-Myers Squibb Savaysa (edoxaban) -- approved by FDA in 2015 -- Daiichi Sankyo To date, there have been various medical journal articles published with conflicting results regarding the risk of acute myocardial infarction (AMI), or heart attack, with the use of these DOACs. This has especially been the situation with Pradaxa -- classified as a "IIa inhibitor" (as opposed to an "Xa inhibitor") -- in comparison with vitamin K antagonists (VKAs), such as warfarin. In March 2017 the British Journal of Clinical Pharmacology published this article, "Risk of myocardial infarction in patients with atrial fibrillation using vitamin K antagonists, aspirin or direct acting oral anticoagulants", which reports... Continue reading
Posted Apr 12, 2017 at Drug Injury Watch
March 2017 FDA Report Provides Update On Emerging Safety Issue: Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) (Posted by Tom Lamb at DrugInjuryWatch.com) In March 2017 the FDA updated its "Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)" information page (accessed 3/31/17). The most notable new facts are found in the Medical Device Reports part of this FDA breast implants - lymphoma page, specifically the most-current figures on the number of BIA-ALCL cases: As of February 1, 2017, the FDA has received a total of 359 medical device reports (MDRs) of BIA-ALCL, including nine deaths. There are 231 reports that included information on the implant surface. Of these, 203 were reported to be textured implants and 28 reported to be smooth implants. Most of the reports contained no information about the surface textures of any previous implants. In addition, 312 of the 359 reports included information on implant fill types. Of these, 186 reported implants filled with silicone gel and 126 reported implants filled with saline. From this March 21, 2017 article, "9 Deaths Are Linked to Rare Cancer From Breast Implants", published by The New York Times (NYT), we get some background information and observations regarding this still-emerging health problem:... Continue reading
Posted Mar 31, 2017 at Drug Injury Watch
The FDA recently reported an increased possibility in the link between breast implants and a rare form of non-Hodgkin lymphoma. Continue reading
Posted Mar 28, 2017 at Drug Safety Developments
Third Circuit Panel Reverses Earlier Dismissal Of Plaintiffs Cases By District Court Judge Pisano On Federal Preemption Grounds (Posted by Tom Lamb at DrugInjuryWatch.com) In a lengthy and long-awaited Opinion issued March 22, 2017, the Third Circuit Court of Appeals decided to reverse a ruling by U.S. District Court Joel Pisano which had dismissed all the federal court Fosamax - femur fracture cases on federal preemption grounds. In turn, hundreds of those Fosamax lawsuits have been reinstated at the trial court level. Essentially, the Third Circuit held that the ultimate question of whether the FDA would have rejected a Fosamax label change by Merck to warn about an increased risk of femur fractures is a question of fact for the jury -- rather than for Judge Pisano -- to decide. From a March 22, 2017 Reuters news report, "Merck must face renewed Fosamax warning claims: U.S. appeals court", we get these basic facts about this recent appellate decision in the Fosamax - femur fracture MDL litigation: In a 3-0 decision, the 3rd U.S. Circuit Court of Appeals in Philadelphia said the plaintiffs may proceed to trial on their failure-to-warn claims, and a lower court judge erred in finding the claims... Continue reading
Posted Mar 24, 2017 at Drug Injury Watch
The manufacturer of heartburn and acid reflux drug Prilosec released Nexium as a way to boost profits, rather than help patients. Continue reading
Posted Mar 21, 2017 at Drug Safety Developments
The Bottom Line: Pradaxa Is Still Associated With Serious Bleeding Events, Including Patient Deaths, And New Pradaxa Drug Injury Cases Are Still Being Filed (Posted by Tom Lamb at DrugInjuryWatch.com) Pradaxa (dabigatran) is a relatively new blood thinner, or anticoagulant, medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF). It was approved for use by the US Food and Drug Administration (FDA) in October 2010. Boehringer Ingelheim Pharmaceuticals, Inc. markets this prescription anticoagulant drug. Pradaxa is part of a class of novel oral anti-coagulants (NOACs), which includes Xarelto (rivaroxaban), Eliquis (apixaban), and Savaysa (edoxaban). These NOACs are alternatives for patients who had been or would have been treated with Coumadin or warfarin in the past. As can be seen from the following set of drug safety alerts, Pradaxa has caused significant concern among doctors and patients since soon after it first became available for use in the US. In early December 2011 the FDA announced it would evaluate reports of bleeding in patients taking Pradaxa that have been submitted to the agency's Adverse Events Reporting System (AERS) database to determine whether serious side effects are occurring at a higher rate than should be expected.... Continue reading
Posted Mar 21, 2017 at Drug Injury Watch
A December 2016 Judicial Panel for Multidistrict Litigation (JPML) Order Consolidated All Invokana And Invokamet Cases (Posted by Tom Lamb at DrugInjuryWatch.com) In September 2016, pursuant to 28 U.S.C. § 1407, a motion was filed to establish IN RE: INVOKANA (CANAGLIFLOZIN) PRODUCTS LIABILITY LITIGATION, MDL Docket No. 2750. In October 2016 the attorneys for Defendant Janssen Pharmaceuticals, Inc. (“Janssen”) indicated, in their legal document filed as a response to this MDL motion, that all Invokana cases filed in the federal court system should be consolidated. Further, they agreed that federal Judge Brian Martinotti, of the District of New Jersey, would be an appropriate choice by the Judicial Panel for Multidistrict Litigation (JPML) for the so-called "transferee judge" presiding over this Invokana MDL. In December 2016 the JPML issued an Order establishing this consolidation of all Invokana federal court lawsuits. From a December 8, 2016 New Jersey Law Journal article, "Invokana Kidney Damage MDL Established in New Jersey" (free registration required), we get the following information about this legal case development: The panel said in its order that the cases have enough in common to warrant centralization. "On the basis of the papers filed and the hearing session held, we find... Continue reading
Posted Mar 14, 2017 at Drug Injury Watch
These New Diabetes Drugs Have Increased Risks Of Serious Side Effects Such As Diabetic Ketoacidosis (DKA) And Acute Kidney Injury (Posted by Tom Lamb at DrugInjuryWatch.com) Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin and metformin extended-release) are diabetes medicines in the Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors class of drugs. These relatively new diabetes drugs are from AstraZeneca Pharmaceuticals and were initially approved in 2014 by the FDA. In June 2016 the FDA announced it had strengthened the existing warning about the risk of acute kidney injury for Farxiga and Xigduo XR by means of issuing this document, "FDA Drug Safety Communication: FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)". Prior to that time the FDA was mostly investigating a connection between Farxiga and Xigduo XR with these several other drug side effects: diabetic ketoacidosis (DKA); ketoacidosis; and, ketosis. Related to these various safety issues, in the legal realm, there have been drug injury lawsuits filed involving Farxiga and Xigduo XR. ____________________________________________ Invokana / Farxiga / Jardiance Free Case Evaluation Strictly Confidential, No Obligation. ____________________________________________ Those lawsuits recently gave rise to a request for the consolidation of all Farxiga and Xigduo XR cases pending in the... Continue reading
Posted Mar 8, 2017 at Drug Injury Watch
Most Of These Patients Did Not Experience Any Kidney Or Renal Problems Before Developing CKD Linked To PPI Heartburn Drugs Or Reflux Medicines (Posted by Tom Lamb at DrugInjuryWatch.com) A recent medical study done by medical researchers in St. Louis, Missouri adds to the growing body of evidence which indicates that some popular heartburn drugs and acid reflux medicines like Prevacid, Prilosec, and Nexium can cause serious kidney-related side effects, including these conditions: Acute Interstitial Nephritis (AIN) Chronic Kidney Disease (CKD) End-Stage Renal Disease (ESRD) Severe Renal Impairment Kidney / Renal Failure Acute Kidney Injury This newest study indicates that more than half of those patients who develop chronic kidney damage (CKD) while using proton pump inhibitors (PPIs) heartburn drugs and acid reflux medicines do not experience acute kidney problems before their CKD diagnosis. These researchers at Washington University School of Medicine in St. Louis and the Veterans Affairs St. Louis Health Care System published their findings in this February 2107 article, "Long-term kidney outcomes among users of proton pump inhibitors without intervening acute kidney injury", published in the Kidney International medical journal. ___________________________________________ Nexium / Prevacid / Prilosec Free Case Evaluation Strictly Confidential, No Obligation. __________________________________________ A February 22,... Continue reading
Posted Feb 23, 2017 at Drug Injury Watch
Drug Safety Regulators Flag An Increased Risk Of Hepatitis B Virus Reactivation Which Can Result In Cases Of Fulminant Hepatitis, Liver Failure, And Death (Posted by Tom Lamb at DrugInjuryWatch.com) In February 2017 a so-called "black-box" warning was added to the drug labels for Harvoni, Sovaldi, Technivie, Viekira Pak, and other direct-acting antivirals, warning doctors and patients that cases of hepatitis B virus (HBV) reactivation have been reported. Further, it states that some of those cases resulted in fulminant hepatitis, hepatic failure, and death. You can view the Prescribing Information for Sovaldi (accessed 2/16/17) to see how this new black-box, or bolded, warning appears on the drug label. For more details, we get the following from the Warnings and Precautions part of the February 2017 revised Sovaldi drug label: 5.1 Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals, and who were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive and also in patients... Continue reading
Posted Feb 16, 2017 at Drug Injury Watch
The EMA released a statement that it will be reviewing the safety of pulmonary arterial hypertension drug, Uptravi, after five patients in France died. Continue reading
Posted Feb 15, 2017 at Drug Safety Developments
The EMA recently released study findings concerning the link between diabetes drugs Invokana / Invokamet and an increased risk of lower-limb amputations. Continue reading
Posted Feb 10, 2017 at Drug Safety Developments
For Eliquis Cases Filed In California State Court, JCCP Case Coordination Petition Is Still Pending, With Determination Expected In Next Couple Of Months (Posted by Tom Lamb at DrugInjuryWatch.com) The Eliquis drug injury litigation is still at its beginning stages, with less than 100 lawsuits across the country having been filed to date. Eliquis (apixaban) was approved by the FDA in 2012. Pfizer and Bristol-Myers Squibb are the two drug companies responsible for Eliquis. Eliquis does not have an antidote for a patient experiencing a trauma-induced bleeding event or needing emergency surgery. These medical conditions may have been caused by the use of Eliquis: • Serious Bleeding Events • Irreversible Fatal Bleeding Events • Trauma-induced Atypical Bleeding Incidents • Gastrointestinal (GI) Bleeds • Rectal Bleeding • Hemorrhages • Brain Hemorrhage • Intracranial Hemorrhage • Hemorrhagic Stroke • Cardiac Bleeds During the past year or so, an increasing number of Eliquis lawsuits have been filed involving people who had excessive bleeding, bled to death, or experienced other serious side effects of Eliquis. In the federal court system, there are now more than 50 Eliquis lawsuits filed, and more of these drug injury and death cases are expected. Given this situation, in... Continue reading
Posted Feb 10, 2017 at Drug Injury Watch
Besides Hepatotoxicity, Progressive Multifocal Leukoencephalopathy, Renal Toxicity, And Other Safety Issues Have Surfaced Since Clinical Trials (Posted by Tom Lamb at DrugInjuryWatch.com) Tecfidera (dimethyl fumarate) was approved by the FDA in 2013 as a treatment of patients with relapsing forms of multiple sclerosis (MS). In February 2016 a rare but potentially fatal neurological disorder, progressive multifocal leukoencephalopathy (PML), was added to the Warnings and Precautions part of the Prescribing Information document, or drug label, for Tecfidera. A more recent major change came in January 2017, with this one adding liver injury to the Warnings and Precautions part, as seen in the current Tecfidera drug label (accessed 2/7/17): 5.4 Liver Injury Clinically significant cases of liver injury have been reported in patients treated with TECFIDERA in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment with TECFIDERA. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed. These abnormalities resolved upon treatment discontinuation. Some cases required hospitalization. None of the reported cases resulted in liver... Continue reading
Posted Feb 7, 2017 at Drug Injury Watch
The safety of newer hepatitis C treatment drugs is being called into question due to liver damage and Hepatitis B reactivation among users of these drugs. Continue reading
Posted Jan 30, 2017 at Drug Safety Developments
January 2017 ISMP Report: FDA Database Has 524 Cases Of Liver Failure, Including 165 Deaths, And 1,058 Reports Of Severe Liver Injury (Posted by Tom Lamb at DrugInjuryWatch.com) A January 24, 2017 article published by The New York Times, "Are New Drugs for Hepatitis C Safe? A Report Raises Concerns", sets the stage for and captures the essence of this emerging drug safety issue for a relatively new class of drugs: The drugs covered in the new report include two blockbusters, Sovaldi and Harvoni, both made by Gilead Sciences and priced at $1,000 a pill, with billions of dollars in sales. Sovaldi was approved in 2013, and Harvoni in 2014. These drugs and other antivirals can cure the disease in 12 weeks in many patients. Earlier drugs were less effective, had to be taken for much longer and had harsh side effects that left many patients unable to finish the course of therapy. About 250,000 people took the newer drugs in 2015, the report said, at tremendous expense: $55,000 to $125,000 per patient. In those treated during the year ending June 30, 2016, the report identified 524 with liver failure, 165 of whom died. Of those with liver failure, 386... Continue reading
Posted Jan 27, 2017 at Drug Injury Watch
After women in France who took Depakine gave birth to infants with birth defects, they started a class-action lawsuit against drug manufacturer, Sanofi. Continue reading
Posted Jan 26, 2017 at Drug Safety Developments
Black-Box Warning Now Includes Venous Thromboembolism As Well As Various Types Of Arterial Occlusions, And There Are More New Safety Issues (Posted by Tom Lamb at DrugInjuryWatch.com) Iclusig (ponatinib) is a kinase inhibitor approved by the FDA as a treatment for certain types of leukemia in adult patients. On November 28, 2016 we learned about several alerting and wide-ranging safety labeling changes for Iclusig which were recently approved by the FDA Center for Drug Evaluation and Research (CDER). The complete set of new side effects warnings can be seen on the FDA's Drug Safety Labeling Changes (SLC) page for Iclusig. __________________________________________________________________ Iclusig Free Case Evaluation Strictly Confidential, No Obligation. __________________________________________________________________ Here is overview of this rather significant and substantial November 2016 Iclusig Prescribing Information revision which was mandated by the FDA. In the Boxed Warning section of the Iclusig drug label there was some additional safety information put in the pre-existing parts about (1) various types of arterial occlusions and (2) heart failure. Also, there is a new part entitled Venous Thromboembolism which addresses venous occlusive events. Under the Warnings and Precautions section of the Iclusig drug label there were some additional facts and new information put in the following... Continue reading
Posted Jan 19, 2017 at Drug Injury Watch