Stryker ShapeMatch Cutting Guide Lawsuits

In May 2011, Stryker announced the FDA approval for the ShapeMatch Cutting Guide through 510(k) clearance, an approval shortcut maintained by the US Food and Drug Administration and allowable when a device is found to be substantially similar to a previous device and can be marketed safely. The ShapeMatch Cutting Guides were considered advantageous to standard cutting guides because they were custom fit for an individual patient and not the one-size-fits-all model that was previously on the market.

Within 18 months, Stryker was instructing surgeons to stop using the ShapeMatch Cutting Guide, and to refrain from ordering any more units of the customized cutting guides. The company formally recalled the ShapeMatch Cutting Guides in January 2013.

The FDA responded three months later with a Class I recall of the product. A Class I recall is the most serious of recalls in the FDA response roster. Class I recalls are reserved for “a situation in which there is a reasonable probability that the use of or exposure to a volatile product will cause serious adverse health consequences or death.”

The ShapeMatch Cutting Guides were designed to be customized for each patient based on a surgeon’s pre-surgery planning parameters. Once in place, the guide was designed to achieve more efficient and precise cutting of bone in order to place the Triathlon Knee implants.

However, it was found, potentially due to a software glitch, that the customized cutting guides were not manufactured to the surgeon’s specifications for the individual patient.

 Thus, the implant could be misaligned, causing Stryker Triathlon Knee implant pain, and other issues pertaining to mobility and stability, for the patient.



It does not appear that the problematic ShapeMatch Cutting Guides, designed to work with Stryker’s Triathlon Knee implant, adversely affects the Triathlon Knee implant itself. The Triathlon Knee is still on the market and heavily promoted by Stryker.

The ShapeMatch Cutting Guides were mostly implemented on the two coasts; concentrated areas include Pennsylvania.

Pittman, Dutton & Hellums, P.C., is currently investigating claims against Stryker over their ShapeMatch Cutting Guides. If you or a love one was adversely affected by Stryker’s ShapeMatch Cutting Guide, please contact Booth Samuels at booths@pittmandutton.com or call toll free 1-866-515-8880.

Deepwater Horizon News

Halliburton has agreed to pay $1.1 billion to settle a substantial portion of plaintiff claims arising from the 2010 Gulf of Mexico oil spill. Halliburton was British Petroleum’s (“BP”) cement contractor on the drilling rig. The explosion killed 11 workers and triggering the largest offshore oil spill in U.S. history.

The deal will settle claims assigned to Halliburton as a result of BP's settlement in 2012 and punitive damages from the loss of property or commercial fishing activity resulting from the oil spill.

Earlier this month, Judge Barbier, the US District Judge for the Eastern District of Louisiana who is overseeing the BP lawsuits, ruled that BP’s conduct was “reckless”. This has a huge impact on the amount of damages BP will be liable to pay, and could nearly quadruple damages. BP already has agreed to pay billions of dollars in criminal fines and compensation to people and businesses affected by the disaster.

Judge Barbier essentially divided blame among the three companies involved in the spill; ruling that BP bears 67 percent of the blame; Swiss-based drilling rig owner Transocean Ltd. takes 30 percent; and Houston-based cement contractor Halliburton Energy Service takes 3 percent.

The ruling finding BP was reckless instead of merely negligent means BP could face as much as $17.6 billion in civil fines under the Clean Water Act. Under the Act, a polluter can be forced to pay a maximum of either $1,100 or $4,300 per barrel of spilled oil. The higher limit applies if the company is found grossly negligent or reckless. However, penalties can be assessed at amounts lower than those caps.

Government experts estimated that 4.2 million barrels, or 176 million gallons, spilled into the Gulf. BP urged Barbier to use an estimate of 2.45 million barrels, or nearly 103 million gallons, in calculating any Clean Water Act penalties. Both sides agreed that 810,000 barrels, or 34 million gallons, of oil escaped the well but were captured before it could pollute the Gulf.

BP has stated it will appeal the ruling.

Boston Scientific Loses Pelvic Mesh Case

Following up on one of my blog posts from earlier this week, it was announced this morning that Boston Scientific was hit with a $73 Million verdict in a trial that took place in Dallas, Texas. The jury awarded $23 Million in compensatory damages and $50 Million in punitive damages to the Plaintiff. Boston Scientific faces upwards of 12,000 similar lawsuits.

It was reported the Texas jury deliberated for one day.

The defendant will certainly appeal.

Is Soriatane the Next Accutane?

Soriatane is a drug used to treat sever psoriasis in adults. It is manufactured by Roche Holding, AG, (Hoffman-La Roche), and the generic name is Acitretin. It is a retinoid compound and is similar to Accutane. Soriatane was launched in 1997.

Soriatane has been linked to several dangerous side effects including serious birth defects, depression and suicidal thoughts.

Birth Defects: A pregnancy prevention program has been implemented since the drug first came to the market. There are stringent guidelines in place that must be followed before a doctor can prescribe the drug to a woman. They must present two negative pregnancy tests, use two or more birth control methods one month prior to treatment, and they must continue their birth control treatment for three years after discontinuing use of the drug. Women must also sign an informed consent agreement before treatment.

Depression/Suicide: In May 2003, Roche added a warning to Soriatane’s label, alerting the public of the drug’s link to depression, aggression and thoughts of self-harm. Similar to Accutane, common Soriatane side effects include depression, aggressive feelings, mood swings, suicidal ideation, and self-harm.

Other Side Effects: Increased intracranial pressure, alteration in lipid levels, eye problems, cardiovascular effects, bone spurs, and pancreatitis.

There has not been an MDL formed to consolidate Soriatane lawsuits. There are too few cases to merit an MDL at this time. 

Pittman, Dutton & Hellums, P.C., is not currently pursuing lawsuits for this drug, but we will continue to monitor any new FDA warning label changes which could affect the legal landscape.

Two Pelvic Mesh Juries Give Two Differing Results

Over the last two weeks, two strikingly different results have occurred involving transvaginal mesh trials.

A jury in a West Virginia federal court slammed Johnson & Johnson subsidiary Ethicon Inc., with a $3.27 million verdict last Friday in a bellwether trial. The jury found Ethicon's transvaginal sling was defectively designed and the company failed to warn of its potential risks. 

It was reported that the jury returned the compensatory damages verdict after deliberating for just three hours and found for the plaintiff on all counts. The trial lasted two weeks.

Johnson and Johnson faces nearly 33,000 similar lawsuits.

On August 29, the previous Friday, a Massachusetts jury sided with Boston Scientific Corp., in the second bellwether trial involving the company’s pelvic mesh devices. The jury found that a transvaginal sling was not defectively designed and the company adequately warned of risks associated with the device. That trial lasted two weeks and the jury deliberated for over two days. This trial was heard in state court.

These bellwether trials illustrate the multitude of different outcomes in transvaginal mesh litigation on both the state and federal level. On one hand, we have seen summary judgment granted for the defendants, while on the other we have seen near Billion dollar settlements (see my previous blog posts regarding such). The MDL system and bellwether trials are designed to help both sides of the aisle evaluate their positions reasonably. These latest bellwether trials will probably do little to help either side assess their positions and instead push them to keep trying cases.                                         

First Pinnacle Bellwether Trail To Start Today

Jury selection is set to begin today in the first bellwether case in the DePuy Pinnacle MDL. It is among more than 6,000 cases currently pending in the MDL. The cases have been consolidated before U.S. District Judge Ed Kinkeade in Dallas. Judge Kinkeade will preside over the trial.

Depuy is a subsidiary of Johnson & Johnson (“J&J”). The plaintiffs allege metal-on-metal version of the Pinnacle hip was defectively designed and caused metal debris to leech into patients’ bloodstreams. 

J&J had heavily touted the metal-on-metal implants, first sold in the U.S. in 2005, as a design that would last 20 years and offer greater range of motion. However, J&J stopped selling the metal-on-metal version of the Pinnacle hip in August 2013 after the U.S. Food and Drug Administration said it would require device makers to submit new versions of the artificial hips for pre-market approval.

The Pinnacle line of hips wasn’t covered by J&J’s $2.5 billion settlement of claims that its ASR hip devices shed chromium and cobalt debris from the metal-on-metal which caused tissue death and increased metal ions in the blood. Other complications from the ASR hip devices included dislocations, pain, and required surgical removal.

It is estimated the trial will last up to six weeks.