Recently in Defective Drugs Category

March 13, 2014

Federal District Court Judge Rules That Brand Name Manufacturer Can Be Found Negligent For Warning Label On Generic Drug

Recently, a federal district court in Illinois ruled that GlaxoSmithKline could face liability for the suicide of a partner from Reed Smith, even though the partner took a generic version of the company's product, Paxil, instead of the named brand. This is significant, as for a long time, it has been an established belief that brand name manufacturers could not be sued for the flaws in the generic versions. This was the first case of its kind to be considered in the Seventh Circuit.

pills-1161455-m.jpgBack in 2010, six days after he began taking paroxetine hydrochloride for anxiety and depression, Stewart Dolin committed suicide. Dolin's wife, Wendy, then sued GlaxoSmithKlein and the manufacturer of the generic drug, Mylan Inc., arguing that they failed to warn adult users that the drug increased the risk of suicidal behavior. The Illinois district court judge, James Zagel, dismissed part of the lawsuit on the grounds that GlaxoSmithKlein could not be sued for product liability. However, he permitted the rest of the lawsuit to go forward on the issue of whether GlaxoSmithKlein was negligent.

The judge noted that negligence was still available due to a question of whether the warning label on the generic Paxil contained sufficient information highlighting the drug's dangers. His ruling deviated from nearly 90 other decisions on this subject, which found that the brand name manufacturers could not be held responsible for the generic's defects under any circumstances, even in the case of negligence. Only a handful of courts in California, Alabama, and Vermont had determined otherwise.

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February 14, 2014

Sixth Circuit Finds That Manufacturer of Medical Patch Not Immune to Lawsuit in Miller v. Mylan, Inc.

A recent product liability case involving Michigan may have significance for the other states in the Sixth Circuit, including Kentucky. In Miller v. Mylan, Inc., the Sixth Circuit Court of Appeals found that a medical patch could be a "combination product" rather than a drug, making its manufacturer (and similar manufacturers) vulnerable to lawsuit.

pills-2-1160486-m.jpgThe case concerned a fentanyl patch, manufactured by Mylan, Inc., which is a generic version of Duragesic and intended to lessen pain. The patch had two parts: fentanyl, which was its active ingredient, and a "transdermal system," the patch that delivered the drug. The patch was placed on the patient's skin to provide doses of fentanyl to patients at regular intervals over a prolonged period. In the case of Beth Ann Kelly, however, the patch was blamed for giving her an excessive dose of fentanyl, causing her death.

Kelly's estate brought a lawsuit against Mylan in state court for negligence, negligent misrepresentation, product liability, warranty, fraud, and the Michigan Consumer Protection Act. Mylan had the case removed to federal district court and claimed that it was immune from lawsuit under a Michigan statute that gave immunity to the manufacturer of drugs. The court sided with Mylan in finding that the patch was a drug. Kelly's estate then appealed to the Sixth Circuit, arguing that the patch was not a drug as referenced in the statute.

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March 14, 2013

Court to Decide if Generic Drug Makers can be Held Liable for Dangerous Drug Injuries

Almost 80% of all prescriptions in the U.S. are filled with generic medications. These medications can be offered at a lower price than brand-name drugs because the companies that manufacture the generic versions have not invested millions of dollars in the creation and testing of them. Once a patent expires on a drug, other companies can begin to manufacture and sell a generic version of it without getting FDA approval, provided the formula and labeling are not altered in any way.

Such was the case with sulindac, a generic anti-inflammatory drug similar to ibuprofen. Mutual Pharmaceutical Company in Pennsylvania, a subsidiary of another company based in India, was manufacturing sulindac in 2004 when a New Hampshire woman went to her doctor with shoulder pain. He prescribed a clinoril, a mild anti-inflammatory, and she was given sulindac as a generic equivalent. A few weeks after she started taking the drug, her skin began to come off. She ended up losing two-thirds of her skin, requiring a lengthy stay in a hospital burn unit. She also suffered esophagus and lung damage and ended up legally blind. She is now only 53 years old.

As with many other victims of dangerous drugs, the woman filed a lawsuit against the drug manufacturer in the hopes of receiving some compensation for her injuries and suffering. A jury awarded her $21 million, an amount which was also upheld by the Court of Appeals. Now the Supreme Court will hear the case. Groups on both sides of the dangerous and defective drugs argument will be awaiting the higher court's decision.

This would seem to some to be an open-and-shut case. A woman was seriously and permanently injured by a drug manufactured by a pharmaceutical company, and she should be compensated for these injuries. However, the fact that the drug was generic plays a large part in the case. In past cases, generic drug manufacturers have been protected by the higher courts. Why would the higher courts side with the manufacturers? Because generic drug manufacturers are required to reproduce the drug and its corresponding warning labels exactly like the brand-name version. Therefore, according to the courts, they cannot be held accountable for any injuries that occur because they are not responsible for the makeup of the drug or its corresponding labels and warnings.

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February 16, 2013

Health Inspections Find Numerous Issues at Most Massachusetts Compounding Facilities

1285558_injection_needle_macro_2.jpgIn 2012, hundreds of people became ill and 46 people died as a result of tainted medication. The problem was traced back to a compounding facility in Massachusetts that has since closed. Steroid injections given to people with back pain had been contaminated and caused a meningitis outbreak that affected patients in 20 states. Shortly after the source of the outbreak was discovered, the Massachusetts Department of Health started doing surprise health inspections at the other compounding facilities across the state. Their findings, released in February 2013, were surprising and a little scary.

Inspectors visited 37 of these specialty pharmacies and discovered deficiencies at all but four of them. That means there were issues at 33 of the companies. Of this number, 11 had violations so serious that at least parts of their operations were temporarily shut down. One company voluntarily surrendered its license, and the other 21 had more minor violations and were allowed to stay open. Officials were quick to point out that this is not a one-state issue; Massachusetts just happens to be the one state that did these inspections. Some states don't even require their compounding facilities to comply with the guidelines checked by the inspectors in Massachusetts.

While none of the problems discovered were as bad as those found at the facility that caused the outbreak, it is still good that the issues were found and will be corrected. The state has dedicated funds to pay for more routine inspections of compounding pharmacies, and hopefully other states will follow in its footsteps.

Many victims of the meningitis outbreak have filed product liability lawsuits against the now-defunct compounding pharmacy, and the families of some of the victims who died have filed wrongful death claims. But because the company is no longer in business, it is unclear how much anyone would be awarded. Some of the victims may have also filed medical malpractice claims against the medical personnel that administered the tainted injections, but it remains to be seen if any of them will be held accountable.

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November 7, 2012

Indiana Residents Still at Risk for Meningitis Infection from Tainted Steroid Shots

On Monday, November 5, 2012, the Indiana State Department of Health announced that 51 Indiana residents have been infected with fungal meningitis and the death toll rose to four victims. Nationwide, the total number of people sickened stands at 409, and 30 people have died.

How did this epidemic start? Investigators are not sure how the tainting occurred, but they do know that the drugs were manufactured at a drug company in Massachusetts called the New England Compounding Center. The contaminated drugs are steroids that are injected in patients to help relieve pain. The majority of the people who have fallen ill were suffering from chronic back pain and the drug was injected into their spine to provide some relief. An additional 10 people who had the injections in other places, such as hips or elbows have contracted peripheral joint infections, but there have been no deaths reported.

In an attempt to figure out how this happened, Congress has subpoenaed one of the owners of the drug company. Attorneys representing the drug company are saying there are too many differing state and federal laws regarding pharmacies and drug manufacturers and that their client has done nothing wrong. In the meantime, the number of lawsuits continues to grow.

In Indiana, at least one wrongful death lawsuit has been filed by the family of a man who died after receiving an injection that was contaminated by a fungus. They hope that the lawsuit will answer the question of how these dangerous drugs were able to be sold and administered to patients, including their lost loved one. They are seeking compensatory damages for lost income, loss of companionship, and medical and burial expenses. The lawsuit also request punitive damages, which are commonly included in medical malpractice and wrongful death cases. This type of damages is meant to cost the company or individual at fault enough additional expense to deter them from acting in a similar manner in the future. In this case, the drug company, if it is even allowed to reopen for business, will hopefully determine what caused the contamination and take whatever measures are necessary to keep this type of outbreak from occurring again.

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January 10, 2012

Woman Sues Drug Companies over Drug Given to Her Mother before Birth


72201_prescription_med.jpgBetween 1940 and the early 1970s, millions of expectant mothers were given the drug diethylstilbestrol (DES) to help prevent miscarriages and premature births. A study in 1971 found a potential link between the drug and an increased risk for vaginal cancer in young women whose mothers took DES. Doctors were told to stop prescribing it. Many product liability lawsuits have been filed over the years by women who allegedly have vaginal cancer, cervical cancer, or infertility issues as a result of their mothers being given DES during pregnancy.

In a recent lawsuit, a Boston woman is claiming something different. Arline MacCormack developed breast cancer when she was 44. While many women have breast cancer at that age or even younger, her type of cancer is typically not seen in women younger than 60.

After discovering research that linked DES to a significant increase in breast-cancer risks for women, Ms. MacCormack filed her lawsuit against several drug companies that manufactured and sold the drug to women like her mother in the 1960s. Her suit alleges that the drug companies were not only aware that DES did not prevent a woman from having a miscarriage, but also that there were safety issues with the drug that the companies kept from physicians.

The drug companies have filed pre-trial motions stating there is no scientific evidence regarding this supposed link between DES and breast cancer, and the presiding judge has heard testimony from experts for the companies and Ms. MacCormack. If the judge grants the companies' motion, the case will not go to trial. If their motion is denied, the case will go to trial.

Drug liability cases can become very complex. In the case above, the plaintiff, Ms. MacCormack is seeking restitution for a drug that was not even given to her directly, but to her mother 50 years ago. While this can make a case more challenging, this situation is not that uncommon. Side effects of drugs given to women during pregnancy can take years to show up in their offspring. Other types of product liability cases, such as those involving asbestos, can also have a significant delay between the time of the exposure and the appearance of symptoms. Trying to prove which company manufactured and sold the drug that a particular individual took many years ago would be difficult, so oftentimes multiple companies are included in the suit and may share the liability and be required to pay damages.

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September 30, 2010

U.S. Supreme Court To Review Bayer Class Action

Attorneys who represent victims of defective products anxiously await to hear hour the United States Supreme Court decides the Baycol case.

The Court just announced that it will review fourteen cases in it's coming term, one being this Bayer Corp. class action. The case involves Bayer product, Baycol which went on the market in 1997 and is claimed to caused side effects including muscle toxicity which can lead to kidney failure and ultimately to death.

The plaintiffs from West Virginia, found their way to a Minnesota court where several cases had been consolidated. Bayer argues that a judge has already banned these lawsuits in 2005. The Supreme Court will now decide.

Products liability cases are very serious. If your life has been effected by a defective product, including a dangerous drug, it is important that you speak with an attorney to learn more about your rights.

September 26, 2010

Kentucky Family Sues Walmart

A Kentucky family filed a personal injury action against Walmart in Jefferson Count Court on Monday, August 16, 2010. The plaintiffs, Robert and Rosalind Grant, claim that they drank milk purchased at a Sam's Club over the course of three days, only to discover a dead mouse at the bottom of the container.

black_rodent.jpg According to the pleadings, the Grants purchased the carton of milk from the Sam's Club operating on Alliant Avenue on May 3. On May 5, they opened the container and proceeded to drink the contaminated milk for three days. Their granddaughter also consumed the milk. On the third day, Mrs. Grant found the dead mouse in the jug.

After finding the mouse, the Grants reported the incident to the Kentucky Department of Public Health. Their lawsuit alleges that they "suffered embarrassment, humiliation and emotional distress" and that their granddaughter suffered from blood in her stools.

According to the attorney for the family, "This has been a traumatic experience for the Grants.. They were completely shocked."

If you have been injured by a consuming a product, you should speak with an experienced products liability attorney to learn more about your rights.

March 5, 2009

Victory for Victims of Defective Drugs: Drug Company Wyeth Held Accountable

In a landmark decision, the United States Supreme court rejected the arguments of drugmaker Wyeth and held that pharmaceutical companies can be held liable for failure to provide adequate warnings for their products even when their warnings have been approved by federal regulators.  In this case, the plaintiff, Diana Levine, was being treated for a migraine and was given the anti-nausea drug Phenergan manufactured by Wyeth.  She claimed she was improperly injected by an IV-push with this medication, and as a result had to have part of her arm amputated.  A jury in Vermont awarded the Plaintiff $7 million.

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Wyeth appealed the verdict arguing that by having their warning label approved by the U.S. Food and Drug Administration (FDA), the U.S. agency pre-empted state laws and therefore shielded pharmaceutical companies from any damages in state liability claims.  Wyeth argued it would be impossible for drugmakers like themselves to comply with both federal and state labeling requirements.  The Court disagreed in their 6-to-3 decision with Justice Steven's noting in the majority's opinion that Wyeth could comply with both state and federal labeling requirements by adding a stronger labeling requirement.  

For more information please refer to the United States Supreme Court Opinion: Wyeth v. Levine. 

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