Drug Injury Attorney Blog

The menopause drug Prempro is a major area of interest right now for pharmaceutical liability attorneys like me. Prempro was prescribed widely about a decade ago for symptoms of menopause, such as hot flashes, but fell out of favor in 2002 after studies connected it to an increased risk of cancer. Since then, manufacturer Pfizer has faced numerous lawsuits alleging that the drug is responsible for their new breast cancer diagnoses. One of these, in Pennsylvania state court, ended with a victory for three women, according to Bloomberg News. Susan Elfont, Bernadette Kalenkoski and Judy Mulderig received a verdict totaling $72 million in their Prempro cancer lawsuit. This is the tenth loss of 18 Prempro lawsuits that have gone to trial, the article said.

All three women are in their late sixties, and none had a family history of breast cancer before being diagnosed. Kalenkoski, a former nursing home aide, took Prempro for more than four years; the others took a combination of the prescription drugs Premarin and Provera, which were combined in Prempro starting in 1995. In all three cases, experts testified that their use of the drugs was likely the reason for the cancer. The initial cancer finding came from a long-term FDA study of 16,000 women taking either Prempro or a placebo. The study was stopped in 2002 after researchers found a much greater rate of breast cancer, stroke and heart attacks in the Prempro patients. The finding halved the number of American women on hormone replacement therapy and led the FDA to require its strictest warning label starting in 2003. A follow-up study in 2010 found that Prempro patients were twice as likely to die.

As a dangerous drug lawyer, I’m pleased to hear that these patients have won their lawsuit. The article mentions that Pfizer has put aside $772 million to settle or try Prempro cancer lawsuits, so it is clearly expecting many more. That’s good, because at the height of the drug’s popularity, six million American women were taking it. Though not all of those patients will be diagnosed with Prempro-related breast cancer, even a fraction of those six million could add up to many thousands who would have the right to seek fair compensation from Pfizer. To make matters worse, there is some evidence that the company’s Wyeth division tried to plant shoddy research in medical journals to downplay the bad results. Suppressing or downplaying negative research may protect profits, but it can put thousands of patients at risk.

At Carey, Danis & Lowe, we represent clients who suffered serious injuries or lost a family member because they took a prescription drug they thought they could trust. Just like all manufacturers, the makers of prescription medications have a legal responsibility to make sure their products are safe to use as directed and carry adequate warnings to patients. When they fail to do this, they are legally liable for any injuries suffered by patients. That includes the loss of a loved one to an avoidable cancer diagnosis or other serious illnesses. Our defective drug attorneys help clients across the United States claim financial damages, including money for all of their medical costs, lost wages and other financial expenses and compensation for their pain, suffering and emotional losses.

Continue reading "Jury Awards $72 Million to Women Who Developed Breast Cancer After Taking Prempro" »

As a Levaquin injury attorney, I was interested to read about a jury verdict that came down in favor of Levaquin (levofloxacin) maker Johnson & Johnson. According to Bloomberg News, a New Jersey jury decided this month that the manufacturer had not failed to adequately warn patients about Levaquin’s risk of tendon problems. The decision rejects the claims of Robert Beare and Paul Gaffney, both of whom had an Achilles tendon snap after they took Levaquin, leaving them unable to walk. The dispute was not over whether Levaquin caused the injuries, which are a known risk of the drug, but over whether the warnings on the drug’s label were sufficient. The case was at least the third case to go to trial on similar claims, but Johnson & Johnson faces more than 2,600 lawsuits over Levaquin across the United States.

Levaquin is a flouroquinolone antibiotic, a class of drugs used when other antibiotics have failed, but which carry varying degrees of risk for tendonitis and tendon injuries. In 2008, after more than a decade of requests from activists, the U.S. Food and Drug Administration required all flouroquinolones to carry a black box warning, the agency’s strongest, about the risk of tendon damage. The risk is especially high in people taking corticosteroid drugs, certain transplant patients and patients over age 60. Gaffney is 67 and Beare is 72. Both were originally prescribed Levaquin to treat sinus infections that developed into pneumonia, and both required surgery in order to walk again after their tendons snapped. Their attorneys argued that Johnson & Johnson knew Levaquin posed the highest risk of tendon rupture of any flouroquinolone antibiotic, but failed to say so, depriving doctors and patients of needed information. But the jury sided with the manufacturer, which argued that it was not federally required to make that warning.

Unfortunately, the jury was right. As a dangerous drug lawyer, I know very well that there’s a difference between what the FDA requires and the information needed to help patients and doctors make well-informed decisions about their care. And thanks to recent Supreme Court rulings, it has become easier than ever for drug manufacturers to argue that they should not be held responsible for any actions that stay within federal regulatory boundaries. Ideally, the FDA would respond to this by tightening its regulations, but past history suggests that this is unlikely. For example, for flouroquinolone antibiotics, the FDA said in 1995 that it would add warnings about tendon rupture to the drugs’ labels; name-brand drugs got those warnings in 2008, 13 years later. Histories like this make it difficult to trust that federal regulators are enough to protect the public.

At Carey, Danis & Lowe, we help victims of severe drug injuries by holding drug manufacturers responsible for selling defective and dangerous products. This includes cases of failure to warn about a serious risk, like that of Levaquin, but also of drugs that were defective in the first place or negligently treated. We take medications our doctors prescribe because we trust that they will help, but sometimes that trust is misplaced. When it is, patients can suffer real harm — an injury or a serious illness, sometimes turning into a new lifelong health problem. In a lawsuit, our defective drug attorneys can help patients claim money for all the medical costs of the injury and any related financial costs, such as losing a job. You can also claim compensation for your pain, emotional suffering, loss of quality of life and more.

Continue reading "Jury Finds for Pharmaceutical Company in New Jersey Levaquin Side Effects Lawsuit" »

As a pharmaceutical liability attorney, I know vaccines are somewhat out of fashion these days. Rates of vaccination of schoolchildren have gone down, causing certain diseases to make a reappearance and triggering debates about whether vaccinations should be optional. Into that fray went Lombardi v. Secretary of Health and Human Services, a claim before the United States Court of Appeals for the Federal Circuit for damages from a documented vaccine reaction. Cheryl Lombardi developed chest pain after the third of three shots that constitute the hepatitis B vaccine, but only a year later was she diagnosed with post-vaccine syndrome. In this case, the Federal Circuit upheld a decision by the U.S. Court of Federal Claims that Lombardi failed to prove the vaccine was responsible for her illness.

Lombardi, born in 1946, received the first two shots of the hepatitis B vaccine without incident in 1997. Eleven days after the third shot, however, she went to the emergency room complaining of chest pain, with no symptoms found. The hospital visit and non-diagnosis was repeated less than a week later. In January of 1998, she saw several doctors who considered but ruled out lupus as a cause for her right-side pain, nausea, fatigue and elevated levels of an autoimmune disease marker. Other problems were found, but none that led to a diagnosis until July of 1998, when Lombardi saw a doctor who diagnosed her with chronic fatigue syndrome caused by the hepatitis B vaccine. Various other aspects of Lombardi’s medical and personal history were discussed, including later diagnoses of small kidney stones and pressure on her spine. In 1999, Lombardi filed a claim for damages under the Vaccine Act, eventually claiming she suffered from transverse myelitis, chronic fatigue syndrome and systematic lupus. None of these are in the Vaccine Injury Table, which required Lombardi to prove her claim. At hearings, the government’s experts offered alternative diagnoses, and a special master ruled against her. The Claims Court upheld this decision.

Lombardi had no better results on appeal. She argued to the Federal Circuit that the lower court improperly focused on whether she had the claimed illnesses at all, rather than whether they were caused by the vaccine, and that she had shown causation. However, the Federal Circuit said, under recent caselaw, identifying the injury is a necessary first step toward proving causation. The experts at the original hearings, both for Lombardi and for the government, offered at least eight different diagnoses; the appeals court said this disagreement created a genuine question of what illness Lombardi may have. As for each individual claim, the Federal Circuit rejected the transverse myelitis diagnosis because Lombardi’s treating physicians had never diagnosed it, and her expert diagnosed it using an MRI whose results did not suggest it. The chronic fatigue syndrome may have been diagnosed by Lombardi’s previous treating physicians, the court said — but this is a diagnosis of exclusion, and the government’s experts offered plausible alternative theories of osteoarthritis and vitamin B12 deficiency. The court next rejected the lupus diagnosis, saying no doctor had diagnosed her with it before; indeed, two had ruled it out. Finally, it rejected as irrelevant Lombardi’s contention that the special master in her case is biased against petitioners. The court noted that Lombardi obviously has symptoms, but failed to connect them to the hepatitis B vaccine well enough.

As a dangerous drug lawyer, I’m interested in this case because vaccines have fallen so far out of favor recently. The Vaccine Act was enacted in 1986 to address concerns about vaccines hurting children and litigation over those concerns potentially hurting the supply of vaccines. It’s a no-fault system, similar to workers’ compensation, where petitioners don’t need to prove that the pharmaceutical company did something negligent — merely that they were hurt by the vaccine. However, as this case shows, petitioners still must connect the dots to the satisfaction of the special master. This is not the usual route for people who were injured by a prescription drug; in most cases, victims may file a lawsuit against the manufacturer. This is true only in limited circumstances for vaccines. Nonetheless, as a defective drug attorney, I offer free consultations to families suffering from adverse reactions to vaccines or any other medical product they thought would help them.

Continue reading "Federal Circuit Denies Damages to Woman Claiming Injuries From Vaccine – Lombardi v. Secretary of HHS" »

As a pharmaceutical liability attorney, I’m always interested in news about over-the-counter drugs because so many millions of people take and trust those drugs. However, a June 3 story from ABC News reminded us that those drugs aren’t always worthy of our trust. The article said a Philadelphia jury has awarded $10 million to Brianna Maya of Tennessee, who was blinded and suffered severe burns after she developed Stevens-Johnson syndrome and toxic epidermic necrolysis syndrome in reaction to the children’s Motrin her pediatrician had recommended. Her parents successfully sued drug maker Johnson & Johnson/McNeil because the company failed to warn parents about the risks.

Maya was three in 2000, when she developed a high fever. Her parents followed the doctor’s instructions to alternate children’s Motrin and children’s Tylenol and followed the package directions. But unlike most children, Maya had a bad reaction that included a skin rash, redness around the eyes, and eventually, burns inside and outside her body and oxygen deprivation. Now 13, she is blinded in one eye, suffers seizures and recurring infections, and will never be able to have ordinary sexual intercourse or children. In December of 2005, the FDA required over-the-counter drugs in Motrin’s category (nonsteroidal anti-inflammatory drugs like ibuprofin) to add information about symptoms of an “allergic reaction” without mentioning SJS or TENS by name.

Maya’s mother, Alicia Maya Donaldson, said she’d prefer more information so that patients can make well-informed decisions. I strongly agree with this. As a dangerous drug lawyer, I work frequently with patients who used drugs exactly as directed and still got sick. While it’s not always possible to predict an allergic reaction, warning patients about the risk of one allows them to identify the problem and get help quickly, hopefully minimizing the damage. At least two other people hurt by SJS have filed similar lawsuits; one, in California, is pending. Millions of Americans take ibuprofin and other NSAIDs, so even if a reaction is rare, it’s not at all impossible — and it chances victims’ lives forever.

Continue reading "Jury Awards $10 Million to Family of Girl Injured by Rare Reaction to Children’s Motrin" »

I’ve discussed the antibiotic Levaquin and its risks frequently here, from my perspective as a pharmaceutical liability attorney. Levaquin (levofloxacin) is part of a group of antibiotics called fluoroquinolones, which have come under fire for safety reasons in the past decade. The U.S. Food and Drug Administration has added safety warnings to Levaquin’s packaging at least twice since 2004, including a 2008 warning that the drug increases the risk of tendonitis and spontaneous tendon ruptures, which are disabling and painful and take months to heal. This and other Levaquin serious side effects have led to thousands of lawsuits across the U.S. The first of these went to trial in Minnesota last week, Bloomberg News reported Dec. 8, and ended with a $1.1 million jury award to patient John Schedin.

Schedin, 82, received Levaquin for a respiratory infection in 2005. His attorneys said he was active for his age at the time, but that ended when he ruptured not one but both Achilles tendons. These are the tendons connecting the back of the foot with the calf, and they are an especially common site for a Levaquin-related tendon rupture. In his lawsuit, Schedin alleged that manufacturer Johnson & Johnson failed to adequately warn him or his doctor about the high risk of tendon ruptures, something that was fixed after the FDA ordered a black box warning three years later. This risk is higher in people over 60 and people taking steroids -- both of which described Schedin -- and people who are organ transplant recipients. The jury awarded Schedin $700,000 in actual damages, which are compensation for direct losses, and $400,000 more in punitive damages intended to penalize the manufacturer for deliberate disregard for patients’ safety.

As a Levaquin injury lawyer, I’m pleased that the jury decided this way, especially since the decision is likely to affect other Levaquin injury lawsuits. One juror said he and his colleagues talked seriously about the drug manufacturer’s responsibilities, especially responsibilities to warn doctors. Evidence shows that Johnson & Johnson knew about the tendon-related risks of Levaquin at least since 2001, and that those risks were higher in the elderly. Nonetheless, Schedin’s attorneys said the manufacturer didn’t send warning letters to doctors until it had to because of the 2008 black box warning. Meanwhile, Levaquin was prescribed millions of times around the world, for a total of 430 million prescriptions according to the article. In the first nine months of 2010 alone, the article said, its sales totaled $957 million. It’s not hard to imagine that a company might prefer to suppress negative information about a drug to preserve sales that size, but that’s not the right thing to do when people’s health is at risk.

Continue reading "First Lawsuit on Antibiotic Levaquin Ends With $1.1 Million Verdict for Injured Man" »

Last month, a Chicago jury awarded nearly $16.6 million to the family of a mother who died while using a Duragesic pain patch, the Associated Press reports.

Janice DiCosolo, a 38-year-old mother of three, died on Feb. 15, 2004. She had been prescribed a Duragesic patch by her doctor to help manage the constant pain she suffered as a result of reflex sympathetic dystrophy, a neurological condition.

Duragesic, made by two Johnson & Johnson subsidiaries, contains the gel form of the powerful drug fentanyl, which is 100-times stronger than morphine.

DiCosolo’s family filed a wrongful death lawsuit against Titusville, N.J.-based Janssen Pharmaceutica Inc. and Mountain View, Calif.-based ALZA Corporation. The family alleged that the companies knew the patches leaked fentanyl in large enough doses to kill patients.

The patch DiCosolo was using was part of a larger group of defective patches that were recalled in 2004 by the Food and Drug Administration.

The defense experts who inspected the patch DiCosolo used asserted it was not defective and claimed the woman’s death was caused by mix of incompatible medications.

However, the jury disagreed. After a three-week trial, jurors concluded that the fentanyl patch leaked a fatal dose of the drug and killed DiCosolo. They awarded the family $16,560,000.

In 2005 and 2007, the FDA issued public health warnings after receiving reports of serious injuries and deaths in patients who used the fentanyl pain patches.

If you have experienced complications after using a fentanyl pain patch such as Duragesic or a family member has become ill or died after using a fentanyl pain patch, please contact our attorneys for legal assistance as soon as possible.

The lawyers of The Lowe Law Firm are experienced in helping people injured by dangerous drugs. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases. For more information, fill out our online contact form or call 314-678-3400 or toll free 877-678-3400.