FDA Label Requirements Fail Consumers Harmed by Generic Defective Drugs

Generic Drug Manufacturers Should Have a Duty to Warn Consumers of New Safety Concerns

Generic drugs account for seventy-five percent of filled prescriptions. Buying generic saves money and, often, the drug is just as effective as its name brand counterpart.

However, a 2011 Supreme Court decision Pliva v. Mensing has resulted in a negative consequence for people taking generics. If you or someone you love is injured while taking a generic version of a brand name drug, Pliva v. Mensing could prevent you from holding the manufacturer accountable in the court system.

Before this ruling, the law was unclear about who was responsible for warning consumers about the dangers of defective drugs – the original brand manufacturer or the generic brand manufacturer. Because of this, the Simmons Firm was able to help people who were seriously injured while taking generic drugs. Not anymore. This ruling clarified the issue, but came down on the wrong side for consumers. 

Because FDA regulations require that generic labels must mirror their brand name counterparts, the court ruled generic drug manufacturers can’t be held responsible when someone is seriously injured while taking a generic version of a defective drug.

Ensuring that generic drugs and their name brand counterparts have the same labels is a legitimate concern. However, no one ever considered what to do if those labels were outdated or if the company was not being completely straightforward about the drug’s actual side effects. 

Because of the way the FDA regulations are written, generic drug manufactures are unable to revise their labels until the brand name labels are changed. Most often, name brand drug manufacturers don’t want to change their label since doing so could result in fewer people buying their drug. As a result, there is little motivation for brand manufacturers to voluntarily change a label. While those who take name brand drugs still have legal recourse for an inadequate label, this type of foot dragging by the brand manufacturer regarding label changes leaves those injured while on generics without a similar remedy.

Despite their decision, some of the supreme court justices involved in the Pliva v. Mensing decision acknowledged that the current regulatory state is extremely unfair for users of generic drugs and urged consumers to impress upon Congress the need for a change.  

Thankfully, Congress is taking steps to safeguard consumers taking generic drugs. On April 18, Senator Patrick Leahy (D-VT) and six co-sponsors introduced the “Patient Safety & Generic Labeling Improvement Act of 2012”.  A companion bill, the “Patient Safety and Drug Labeling Act,” was introduced in the U.S. House of Representatives by Reps. Bruce Braley (D-IA) and Chris Van Hollen (D-MD). In addition, Leahy joined Senators Tom Harkin and Al Franken in writing a letter to Dr. Margaret Hamburg of the FDA urging them to amend the label requirements to better protect consumers.

I applaud the Senators for their efforts and hope the FDA will take steps to ensure that all drug makers, including generics, have the ability to take appropriate steps to provide updated warnings to doctors and consumers. Doing this will restore the original intent of the FDA label requirements to keep consumers safe. It will also allow thousands of people harmed by defective drugs, through no fault of their own, to hold those responsible for their injuries accountable. 

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Vioxx Settlement in Ohio

A November 23, 2011, Cleveland.com article reports that the state of Ohio will receive a $22.8 million settlement from the Merck, the manufacturer of the recalled drug Vioxx. This is according to an announcement made on November 22 by the U.S. Justice Department.

The article also reports that Ohio’s Attorney General Mike DeWine made a statement regarding the resolution saying that this settlement should serve as a reminder to drug manufacturers that they should represent their products truthfully.

The allegations made against Merck claimed that the manufacturer made false statements about the safety of Vioxx and also marketed the drug as a treatment for rheumatoid arthritis before getting regulatory approvals.

To resolve these allegations, Merck made an agreement with the federal government to pay a total of $950 million to 43 states and the District of Columbia but says the settlement does not constitute an admission of liability or wrongdoing.

The article can be read in full detail at http://www.cleveland.com/healthfit/index.ssf/2011/11/ohio_to_get_228m_from_vioxx_se.html.

About Vioxx

Vioxx is a nonsteroidal anti-inflammatory drug (NSAID) that works to reduce inflammation, pain and fever in the body. Many defective drug lawsuits were filed over Vioxx’s link to heart attack and stroke. Finally, the drug was recalled in September 2004.

While the 2004 recall and recent settlement does serve as a victory in the war against pharmaceutical negligence and greed, it does not compare to the human lives lost.

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DePuy Pinnacle Hip Implant Product Problems Result in More Lawsuits

DePuy Pinnacle hip lawsuits are now being filed by consumers who say that they have had to have revision surgery to remove their implants after experiencing problems with the metal-on-metal hip replacement.

The Pinnacle hip replacements, like the previously recalled ASR hip replacements, are metal on metal products. According to the suits filed, Pinnacle products have the same problems as their ASR counter parts. DePuy Orthopaedics, a subsidiary of Johnson & Johnson, issued a voluntarily recall of 90,000 ASR Hip replacement products last fall with additional products in the ASR family being recalled as recently as March 2011.

The metal-on-metal (MoM) products were designed in the hopes that they would last longer then other types of hip replacement devices, such as ceramic on ceramic or metal on polyethylene. But that wasn’t the case. Metal-on-metal hip replacement systems have additional risks compared with other hip replacement systems, according to the FDA. The friction caused by movement has been shown to release metal particles into the blood, causing multiple problems.

The main concern is when the metal ions damage the tissue surrounding the hip area, causing the implant to loosen and fail. This can cause severe pain and require a risky revision surgery where the old device is replaced with a new one. Some people might also experience metal poisoning.

DePuy Pinnacle hip replacement devices haven’t been recalled. The FDA recommends patients who have had MoM hip implants like DePuy Pinnacle or ASR hip implants should be aware of potential symptoms that might occur after surgery and indicate their device has failed. These include:

• Pain in the groin, hip or leg
• Swelling at or near the hip joint
• A limp or change in walking ability

It you or a loved one are experiencing these symptoms and have had a MoM hip implant, you should contact your orthopaedic surgeon for further evaluation. Then, also consider contacting an experienced defective medical device attorney about your DePuy Pinnacle or ASR hip implant.

As an advocate for consumer and patient rights, our experienced Pharmaceutical attorneys are currently investigating claims on behalf of patients injured by DePuy and its hip replacement products.  Follow the links to learn more about DePuy Hip Implants and the Simmons Law Firm’s pharmaceutical injury litigation practice. Comments (0)