Articles Posted in Defective Medical Device

The device can break and perforate internal organs

When you purchase birth control, you should be able to trust that it’s safe for use. Unfortunately, that’s notwoman2-200x300 always the case, as the attorneys at Jeffrey Glassman Injury Lawyers can confirm.

One form of birth control that has been making headlines in recent months is a copper IUD called Paragard that has been around for decades. In fact, the Paragard website touts that the device is the only IUD on the market that has had U.S. Food and Drug Administration approval for more than 30 years.

When it comes to health care in the United States, it’s consumer beware.

A look at medical device and pharmaceutical drug recalls issued by the U.S. Food & Drug Administration in 2018 illustrates the consequences of a lax regulatory and approval process run largely by the drug companies and medical device manufacturers: A primary focus of the watchdog agency task with the nation’s safety must be warning consumers about the dozens of dangerous drugs and medical devices that it has approved for market.Boston Products Liability

Experienced Massachusetts product liability attorneys know too well that the nation’s healthcare system is a primary offender when it comes to consumer harm caused by dangerous or defective products.

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A products liability lawsuit involves an injury caused by a dangerous or defective product. This can involve dangerous drugs like Xarelto, or defective artificial hips like the Pinnacle ASR metal-on-metal hip manufactured by DePuy, or it can involve seemingly harmless household products that possess hidden dangers. There are various factors that will determine if a company is liable for a product that caused an injury including the following:

  • Whether the product was defective.
  • Whether the product works for the purpose for which it was designed without causing personal injury.
  • Whether the company knew or should have known of a hidden or less-than-obvious danger.
  • Whether the manufacturer adequately warned potential plaintiffs of potential dangers.
  • Whether the type good is covered the under Uniform Commercial Code (U.C.C) as adopted by Massachusetts.
  • Various other reasons not included in this list. Products Liability

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There is no question that medical devices and durable medical equipment are big business. There is also a lot of competition and these medical device firms are trying to get as many new products on the market as possible to maximize profits. While that can result in a lot of good for patients in need of new treatments, The rush to market can also result in shortcuts being taken, and these shortcuts are often taken at the expense of patients’ health and safety.

Boston products liablity One of the reasons they are able to get these new devices on the market so quickly is because of  a loophole of sorts in the medical device regulations governed by the U.S. Food and Drug Administration (FDA).  If there is a similar device already on the market, and there often is, the company may be able to skip certain testing and then go back and do post-market testing.  Continue reading

There are various types of claims that can be filed in a civil tort lawsuit.  Briefly, according to the Second Restatement of Torts, a tort is an act or omission that gives rise to injury or harm to another and amounts to a civil wrong for which the courts may impose liability.  This definition is the one used by judges and is taught to every law student in America.  Essentially, this definition means that when someone does something that causes an injury to another person, and this is the type of conduct for which the court will impose a remedy, a case can be filed on this basis.

Products liablity There are various different types of torts, and there are also what are known as intentional torts and negligence torts.  For the purposes of personal injury law, we are mainly talking about negligence torts, though, there can also be a lawsuit for intentional torts like assault and battery, false imprisonment (civil kidnapping), arson, conversation (theft) and various others. Continue reading

According to a recent news article from NASDAQ, Medtronic has begun to voluntarily recall all unused units of their StrataMR product lines.  StrataMR is a line of adjustable valves and shunts that patients and doctors have been complaining about lately.  These complaints range from minor issues to potentially deadly adverse events.  One person has died, but the company has yet to determine the exact cause of the death.xray

The medical devices are used to treat a medical condition known as hydrocephalus, which involves the buildup of fluid on a patient’s brain.  If this fluid is allowed to build up, it presses against the inner layer of skull known as the dura, and this creates a tremendous amount of pressure.  If untreated, this can result in permanent brain injury or even death. Continue reading

Lawsuits against Atrium Medical Corp. for its C-QUR hernia mesh product alleging these devices were not safe for use by humans. hands

One of the most recent cases is one filed in Florida Middle District Court in Orlando just this past month. In his filing, which alleges negligent manufacturing and strict product liability, plaintiff alleges he underwent surgery in April 2013 to repair multiple hernias. His surgeon used the C-QUR product. Subsequently, plaintiff alleges, he suffered injury.

Although the recent Florida Record article reporting the filing does not offer specific details on the man’s injury, we can make the inference based on previous claims, the type of liability asserted here and also what we know about the company’s history.  Continue reading

When you go into a hospital on the day of your surgery, you have likely met with your surgeon and discussed the risk and benefits of the benefits of whatever procedure you are scheduled to have that day, assuming you are not brought into the emergency room and rushed into an operating room.  You are likely confident that surgeon has the skill and experience to do his or her job properly, and while this is very likely true, if your surgeon is unknowingly using a defectively-designed medical device, the chance of a complication may be exceedingly high.

surgeonIn a case from the Washington State Supreme Court, a surgeon who had used a defendant’s surgical assist robot on numerous occasions spoke to the patient about his intention to use the relatively new device to operate on the patient’s prostate cancer. The doctor obtained informed consent from the patient, who was considered severely obese at the time of his surgery.   Continue reading

Hernia mesh manufacturer Atrium Medical Corp. will face multi-district litigation (MDL) in a federal New Hampshire court, after a  judicial panel surgeryagreed to centralize all federally-filed claims against the company for its C-QUR product. More than a dozen claims are pending at this juncture.

Atrium’s C-QUR hernia mesh was produced for use in reinforcing the abdominal wall as a permanent solution after hernia surgery. The company has said its unique Omega-3 coating lowers the risk of adhesions to internal organ tissue – which had been a major problem with other hernia mesh devices. However, plaintiffs in these pending lawsuits say the polypopylene patches were negligently designed and the company fraudulently convinced doctors the product was safe when executives and scientists with the firm knew it wasn’t.

Specifically, plaintiffs allege the netting of the product is “biologically incompatible” to be used with human tissue. This resulted in an unreasonable risk of serious medical complications, including infections.  Continue reading

A subsidiary of product manufacturing behemoth Johnson & Johnson is facing a product liability lawsuit for allegedly selling defective breast implants to unsuspecting women, causing them to suffer health woes such as muscle pain and nausea. The defective implants are reportedly made of a silicone base, and leakage has resulted in a host of problems for patients. woman

Bloomberg reports the subsidiary, Mentor Worldwide, is accused of negligence for its alleged failure to carry out proper studies of its implants. In particular, plaintiff alleges the company refused to explore potential health risks, as it was required by federal regulation agencies to do. The lawsuit, filed in a state court in California, alleges that leaks occur as a result of normal use, and the silicone in the products cause serious injury when it seeps out of the device and into the body.

You may recall that the U.S. Food & Drug Administration had forbidden any companies from selling silicone-based breast implants for nearly 15 years, beginning in 1992. The devices were shown to cause cancer and Rheumatoid arthritis. Initially, a $4 billion settlement was reached to cover all those claims, but that deal eventually fell apart and several firms filed for bankruptcy. The blanket ban on breast implants was lifted in 2006 and today, there are still only three companies – Mentor Worldwide included – that are permitted to sell silicone-based breast implants. Last year, the total market for breast implants nationally topped nearly $640 million. According to the American Society of Plastic Surgeons, about 8 in 10 women undergoing breast implant procedure choose to have the silicone-based product. Continue reading

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