Pharmaceutical Injuries

Published on: July 20, 2023

How Does the Personal Injury Claim Process Work?

This article will take you through what it generally looks like to work with the Carabin Shaw Law Firm in a Personal Injury Case.

The Personal Injury Claim Process in Texas

If you, like many others in San Antonio, have been injured at work, in an auto accident, by a dog attack, or because of the negligent actions of another individual, you may be wondering what a typical personal claim looks like. While each case is as unique as the individual that files it, there are a few essential elements of the personal injury claim process that you can expect to see in your claims process.

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Published on: April 26, 2021

Texas Medication and Vaccine Injury Lawsuits

By Carabin Shaw

pexels-gustavo-fring-3985170-300x200 Vaccines are one of the most effective ways to prevent the spread of infectious diseases throughout the world. The overwhelming majority of people who receive vaccines do not experience serious problems, and the benefits greatly outweigh the threat of risk. However, similar to the risks associated with natural supplements and other pharmaceuticals, some vaccine recipients may suffer adverse reactions. Depending on the nature and circumstance of the injury, victims may file a Texas medical malpractice or pharmaceutical error lawsuit. Further, the National Vaccine Injury Compensation Program (VICP) provides compensation to individuals who have suffered injuries from certain vaccines.

Nearly 40 years ago, in response to growing lawsuits against medical providers and pharmaceutical companies, the federal government created the VICP. The creation followed a slew of lawsuits stemming from some parents’ beliefs that certain vaccines resulted in injuries to their children. Many companies halted the production of vaccines because of the onslaught of lawsuits. The vaccine shortage posed a serious threat to the nation’s health. As such, the VICP fund works to compensate those who suffer injuries because of a reaction to a childhood vaccine.

The VICP only covers certain vaccines such as those that prevent diphtheria, tetanus, pertussis, Hepatitis A, Hepatitis B, human papillomavirus, influenza, measles, mumps, rubella, polio, rotavirus, and varicella. If a Texas injury victim or their loved ones believe that they suffered a vaccine error, they should contact an attorney to file a petition through the VICP. Currently, the program does not cover the COVID-19 vaccine; however, some sources have reported that Johnson & Johnson’s COVID-19 vaccinations may result in a rare clotting condition. Federal officials have halted the use of the pharmaceutical company’s vaccine to determine, what if any, the vaccine plays in the clotting condition. In many cases, a person’s reaction to a medication or vaccine is not because of a defect in the vaccine or medication but rather an allergic reaction that a medical provider missed.

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Published on: November 15, 2019

Appellate Court Rules on Third-Party Liability in Texas Pharmacy Error Lawsuit

By Carabin Shaw

A Texas appeals court recently issued an opinion addressing whether pharmacies owe third parties a duty of care when an accident occurs because of a pharmacy’s negligence. Two sets of plaintiffs filed a lawsuit against a Texas Walgreens after they negligently gave a customer the wrong prescription. Evidently, Walgreens gave the customer a diabetes medication that can cause a drop in blood pressure, which is often associated with behavioral changes and cognitive impairments. The customer was on the drug when he began driving erratically and caused a fatal Texas car accident. The customer’s son settled a wrongful death lawsuit with Walgreens. The two other victims’ representatives sued Walgreens, alleging that the pharmacy was negligent under third party liability and negligence per se. Walgreens moved to dismiss the case, arguing that pharmacies do not owe third parties a duty of care and that negligence per se does not apply. The lower court found in favor of Walgreens, and the plaintiffs appealed to the Texas Supreme Court.

Generally, under Texas law, pharmacy malpractice is a type of medical malpractice that occurs because of a negligent pharmacist or pharmacy technician. Texas pharmacy errors can have severe and even fatal consequences. Pharmacy errors can cause overdoses, congenital disabilities, allergic reactions, and even death. This can occur when a pharmacy provides a patient with the wrong prescription, fills an incorrect dosage, or fails to provide counseling. When the injury victim is the pharmacy’s customer, establishing liability is relatively straight-forward. Challenges arise in cases where the victim is a third-party that suffered injuries by another party that acted negligently because of a pharmacy error.

Generally, under Texas law, healthcare providers are not liable to a third-party non-patient when that person suffers injuries because of the misdiagnosis or treatment of the healthcare provider’s patient. Typically, pharmacists fall under the purview of healthcare providers; however, there are some instances, such as merely filing an existing prescription, that do not rise to the level of a healthcare provider.

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Published on: August 21, 2019

Recovering after a Texas Pharmacy Error

By Carabin Shaw

Texas patients have to put a great deal of trust in their health care providers. This includes pharmacists, who are responsible for safely and correctly filling and dispensing medications. Texas pharmacy errors can be devastating for victims and their families.

According to a local news source, an Austin woman suffered a terrible injury after receiving a shot from a compounding pharmacy. The woman has a genetic disorder that causes her seizures, which she was able to control several years ago when doctors prescribed her a specific shot. Compounding pharmacies tailor medicine for their patients in cases where those people cannot take a standard drug as manufactured. The woman took her prescription to a compounding pharmacy, and was given the medication in the form of a specific B-12 shot. She received over 250 rounds of the medicine without incident.

Recently, the woman received her tailored shot, and felt a burning sensation. She then developed a headache, dizziness, and disorientation. She looked in a mirror and at that point saw that the shot had burned her skin “and was going deeper.” She went to the emergency room, but because she also had Stage 3 breast cancer she was unable to receive anesthesia because of potential contamination—so, she was forced to do the procedure to scrape out the burn completely awake. A dermatologist said that it was a chemical burn, and lab results showed that the B-12 had a pH level of 13.2, similar to that of bleach. She continued to undergo treatment for the burn to scrape out the wound. The patient, a mom of three, said the pain was extreme, and continued to experience pain at home.

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Published on: July 8, 2019

Texas Woman Seriously Injured after Pharmacy Error

By Carabin Shaw

Medical errors are consistently ranked as one of the leading causes of accidental death in the United States. While there are many different types of medical errors that contribute to this startling statistic, one of the most common types of mistakes is medication error.

A Texas medication error is typically the result of a pharmacist, nurse, or another medical professional, providing a patient with medication that was not intended for the patient. It may be that the nurse mistook one drug for another with a similar name, or that a pharmacist missed a decimal point when dosing a prescription. In any event, medical professionals are human and, as a result, make mistakes. When mistakes are made, patients suffer.

Two years ago, an Austin woman was given a prescription that was 54,000% stronger than the medication that was prescribed by her doctor. According to a local news report covering the error, as well as the woman’s recovery, the woman suffers from a rare disorder called Hashimoto’s disease that causes her immune system to attack her thyroid. As a result, the woman’s thyroid does not make sufficient levels of hormones.

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Published on: December 20, 2013

Multi-Million Dollar Verdicts Awarded in Two Separate Topamax Birth Defect Lawsuits – Gurley v. Ortho-McNeil-Janssen Pharmaceutical and Czimmer v. Ortho-McNeil Janssen Pharmaceutical

By Carabin Shaw

On November 18, 2013, a Philadelphia jury awarded over $10 million to a family whose son was born with a cleft palate and other birth defects after being exposed to the drug Topamax during his mother’s pregnancy. More specifically, in Gurley, et al. v. Ortho-McNeil Janssen Pharmaceutical, Haley Powell was prescribed Topamax for treatment of epilepsy and migraines. More than a year after she began taking the drug, she became pregnant and continued to take it throughout her pregnancy after being told by doctors that the drug was safe.

After their son, now five years old, was born with birth defects that will require at least five surgeries before turning age 21, the South Carolina couple sued the drug manufacturer, Janssen Pharmaceuticals, Inc. (formerly Ortho-McNeil-Janssen Pharmaceutical) in a Pennsylvania state court. The couple alleged that the company failed to warn the Powells doctor that Topamax taken during pregnancy could cause birth defects, despite the company allegedly being aware of the serious risks as early as 1997. Even though the judge threw out most of plaintiffs’ claims against the drug manufacturer, including strict liability-design defect, negligent design, gross negligence and express breach of warranty, and also barred a bid for punitive damages, the jury ultimately found that Janssen negligently failed to warn the patient and the doctor of the risks associated with Topamax when used by patients during pregnancy and awarded the family over $10 million in damages.

The Gurley case was the second of approximately 134 cases pending in Philadelphia relating to Topamax tried in court. Notably, it is also the second largest verdict in recent months against Janssen Pharmaceuticals, Inc., a subsidiary of Johnson and Johnson. In October 2013, a Philadelphia jury in Czimmer v. Janssen Pharmaceuticals, Inc. issued a $4.02 million verdict in favor of April Czimmer, a Virginia woman who took Topamax from August 2006 through February 2007 to treat migraines. Czimmer subsequently gave birth to a boy born with a cleft lip in September 2007. She alleged that she would not have taken the drug for more than six months had she known the risks associated with it. The jury ultimately found that Janssen was negligent when it failed to warn healthcare providers of the extent of the risk of birth defects from Topamax, and awarded approximately $562,000 in future health care costs to Czimmer’s son and an estimated $3.4 million for pain and suffering.

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Published on: April 15, 2013

Anemia Drug Omontys Used to Treat Kidney Dialysis Patients Recalled Following Serious Allergic Reactions

By Carabin Shaw

Less than one year after the U.S. Food and Drug Administration (“FDA”) approved the Omontys (peginesatide) injection, pharmaceutical company Affymax, Inc. (“Affymax”) and its partner, Takeda Pharmaceutical Co. (“Takeda”), voluntarily recalled the anemia treatment for kidney dialysis patients after reports of fatal allergic reactions.

Since its approval by the FDA in March 2012, more than 25,000 kidney dialysis patients have used Omontys to treat anemia stemming from chronic kidney disease. Omontys was favored over other similar drugs because it only had to be infused once a month as opposed to other anemia drugs that often must be given more than a dozen times per month. Omontys also broke the previous monopoly that Amgen’s Epogen and Aranesp had on treating anemia in dialysis clinics. Notably, Epogen and Aranesp have also run into their own safety problems, including an increased risk of heart attacks and strokes associated with the overuse of the drugs.

Unfortunately, on February 23, 2013, the FDA revealed that it had received nineteen reports of anaphylaxis, three to five of which resulted in death. Other patients required prompt medical attention, including resuscitation, or hospitalization. Anaphylaxis is a severe allergic reaction. While the severity of the reaction varies from person to person, symptoms include flushing of the skin, hives, swelling of the tongue and throat, and difficult swallowing and breathing. Symptoms can be life-threatening or fatal.

According to the New York Times, approximately 0.02% of patients treated with Omontys have experience a fatal reaction following the first intravenous administration. Overall, approximately 2 out of every 1,000 patients had a hypersensitivity reaction. These reactions were surprising given that no cases of hypersensitivity were recorded in any of the clinical trials. As a result, the original Omontys warning label contained no warning of possible allergic reactions. By August 2012, however, the FDA was receiving reports about severe allergic reactions to the drug. Additionally, by Fall 2012, Affymax contacted the FDA about adding an updated warning label, cautioning of the risk of severe allergic reaction.

Notably, both the FDA and the drug companies reported that the serious allergic reactions occur within 30 minutes of the drug being administered for the first time. There have been no reports of such allergic reactions in subsequent doses or in patients that completed their dialysis sessions. In fact, according to the press release issued by the drug companies, the most common adverse reactions in clinical studies of patients treated with Omontys were dyspnea, diarrhea, nausea, cough, and arteriovenous fistula site complication.

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Published on: February 21, 2013

Girl Who Suffered Rare Skin Disease and Lost 90% of Her Skin After taking Children’s Motrin Awarded $63 Million by Jury

By Carabin Shaw

Almost ten years after a young girl suffered a life-threatening reaction to the children’s pain reliever, Motrin, that caused her to lose most of her skin and left her legally blind, Johnson & Johnson was ordered to pay $63 million to the girl and her parents.

In 2003, when the then-7-year-old girl from Plymouth, Massachusetts, had a fever, her parents gave her Children’s Motrin. The girl had previously taken Motrin without suffering any side effects. However, this time, instead of her condition improving, she got worse, and ended up in the hospital for months. More specifically, the disease inflamed the girl’s throat, mouth, eyes, esophagus, intestinal tract, respiratory system, and reproductive system, forcing physicians to put her in a coma. Unbeknownst to her parents, ibuprofen, a common painkiller found in Motrin, can cause a rare, and potentially fatal, skin disease known as toxic epidermal necrolysis or “TEN” that eats away at your skin.

The young girl was not only forced to undergo surgery to drill through her skull to relieve some pressure, but she also lost 90% of her skin and is now legally blind. In addition, the girl suffered severe permanent lung and liver damage, and now has only 20% lung capacity. Although she also suffered brain damage, it caused only short-term memory loss.

Following this grueling experience, in 2007, the girl’s parents sued Johnson & Johnson, the maker of Motrin, and its subsidiary, McNeil PPC, Inc., for failing to provide proper warning of the possible side effects. The key issue in the lawsuit was the warning label Johnson & Johnson used for Children’s Motrin, made by McNeil-PPC, Inc. Notably, even though the prescription version of adult Motrin briefly mentions Stevens-Johnson Syndrome, a more common version of TEN, the over-the-counter children’s version of Motrin that was provided to the young girl, contained no such warning at all.

A manufacturer can be sued under one of three theories for injuries caused by a product or drug, including: (1) defective design, (2) defective manufacturing, or (3) defective warning and labeling. Here, the family sued the health care company under the third theory, alleging that the company failed to meet its labeling requirement. When dealing with warning labels, courts can find a product defective because of an inaccurate or inadequate warning label. Importantly, by law, the manufacturer is required to warn consumers of hidden dangers, and instruct users how to use a product in a way that will avoid the dangers.

In this case, the jury agreed that Johnson & Johnson failed to provide adequate warnings about ibuprofen’s potential side effects and awarded the girl, now 16, $50 million, and awarded an additional $6.5 million to each of her parents. With interest, the award totals $109 million.

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Published on: February 11, 2013

Texas Supreme Court Rules that a Manufacturer Satisfies its Duty to Warn by Providing Sufficient Warning to a Doctor: Centocor, Inc. v. Hamilton

By Carabin Shaw

One key product liability issue to watch for in 2013 is reportedly the continued adoption of the learned intermediary doctrine by states. In June 2012, Texas joined 35 other states in holding that a sufficient warning to a treating doctor (the “learned intermediary”) satisfies a manufacturer’s duty to warn in product liability cases involving medicine and medical devices. Adoption of this rule essentially means that pharmaceutical manufacturers are not responsible for conveying drug risks to patients, even when the drug makers advertise their products directly to consumers.

With the Texas Supreme Court’s decision in Centocor, Inc. v. Hamilton, Texas became the largest remaining state where the Supreme Court had not adopted the learned intermediary rule, which requires warnings only to prescribing physicians–not to any health care provider with which the plaintiff may happen to come into contact. Unfortunately for future victims of negligent misbranding, negligent marketing, and fraud in drug/medical device product liability cases, the court all but did away with the direct-to-consumer exception to the rule, making it more difficult for plaintiffs to successfully bring suit against drug manufacturers.

In Centocor, Inc. v. Hamilton, the product at issue was Remicade, a prescription drug manufactured by Centocor, Inc. Patricia Hamilton suffered from Crohn’s disease and sought treatment from her physician, who informed her that her only treatment options were steroids or Remicade intravenous infusions. After her physician informed her of the risks and benefits of each approach, Patricia opted for the Remicade infusions. Following the treatment, Patricia claimed that the Remicade infusions caused her to suffer a serious drug-induced side effect called lupus-like syndrome.

Patricia and Thomas Hamilton brought suit, contending that the informational video shown to Hamilton by her physician in the course of her prescribed treatments provided “inadequate and inappropriate warnings and instruction for use” of its prescription drug Remicade, which made Remicade “defective and unreasonably dangerous.” More specifically, the couple alleged that Centocor’s video over-emphasized the benefits of Remicade and intentionally omitted warnings about the potential side effect of lupus-like syndrome. They argued that the video bypassed the physician-patient relationship and required Centocor to warn Patricia directly of Remicade’s potential risks and side effects, thereby making Centocor liable for Patricia’s injuries.

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Published on: January 28, 2013

Pradaxa May Cause Uncontrollable Internal Bleeding

By Carabin Shaw

Pradaxa was first released into the market in 2010 by German pharmaceutical giant Boehringer-Ingelheim. The drug immediately reached blockbuster status by notching over $1 billion dollars in sales. In its initial stages, Pradaxa was thought to be a next generation drug that would replace the most common drug used to prevent strokes and blood clots, Coumadin, better known as Warfarin.

Coumadin is a blood thinner that has been the primary drug of choice for nearly 60 years to treat atrial fibrillation, or irregular heart rate, and prevent strokes that are associated with atrial fibrillation. One of the disadvantages of Coumadin is that it requires patients to undergo continual blood tests so that dosage adjustments can be made, if necessary.

The optimum dosage will serve to prevent strokes by thinning the blood but not thinning it so much as to cause a bleed. If the dosage is too high and a bleed results, Vitamin K and fresh frozen blood plasma can be given to the patient to reverse the effects and slow the bleeding.

Pradaxa was supposed to be more effective than Coumadin, safer and easier for patients to use. It would also not require the continual blood work regime. Unfortunately, that proved not to be the case. Pradaxa turned out to be a more dangerous substitute for Coumadin.

If a bleed occurs while using Pradaxa, there is no reversal. Simply put, traumatic bleeding cannot be stopped. Often it is even impossible to perform life-saving surgery because excessive bleeding during the procedure might prove to be worse than the initial trauma. Tthe widespread use of Pradaxa is filled with high risk for the patients who use it.

Initially the health risks of using Pradaxa were not provided to the public, specifically that traumatic bleeding cannot be stopped since there is no available reversal agent. This was documented in an issue of the Journal of Neurosurgery in March of 2012, which concluded that once the internal bleeding begins there is not much that can be done to stop it.

The FDA launched an investigation regarding the safety of Pradaxa in December 2011. There was no recall of the drug mandated. However, in September 2012, the Journal for the American Medical Association initiated new demands for a Pradaxa recall, due to the fact that perhaps the FDA overlooked the side effects of internal bleeding as it rushed to approve the drug.

Unfortunately the many patients taking Pradaxa for their atrial fibrillation are exposed to this danger of internal bleeding. The safety of Pradaxa was called into question shortly after usage began in the U.S. Some 542 deaths and 3,781 side effect problems were linked to the drug in 2011.

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